FiDA Failed Implant Device Alliance

Minnesota Medical Board ranked 51st for 3 straight years: Public Citizen

2012-02-29T14:38:00.000-08:00

Some states taking medical board cash

Posted: February 24, 2012 - 1:15 pm ET

An inquiry by three senators into why HHS' inspector general's office has discontinued evaluations of state medical boards has led to questions about another issue: States using medical boards' financial reserves—money collected from physician license fees—to plug holes found elsewhere in their budgets.

Sens. Max Baucus (D-Mont.), Charles Grassley (R-Iowa), and Orrin Hatch (R-Utah) have sent a letter (PDF) to HHS Inspector General Daniel Levinson requesting his office resume its past practice of evaluating state medical boards. The letter cited research by consumer advocacy group Public Citizen noting that serious disciplinary actions by state boards dropped by 20% between 2010 and 2004, and that state boards did not take action against 167 physicians whose hospital admitting privileges had been revoked after being deemed an “immediate threat to health or safety.”

“We met with Grassley's staff and we're pleased they're doing this, and we hope the inspector general will respond,” said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, noting that the evaluations started in 1981 and then the inspector general "just stopped doing them" 15 years ago.

“Most medical boards are doing a terrible job,” Wolfe added.

Wolfe noted that since board operations are financed through license fees, states cannot use budget problems as an excuse for poor performance. “It's a flow of money that acts independently of any financial crisis most states are in,” Wolfe said.

However, some states are dipping into medical board operating funds or cash reserves to plug holes that exist elsewhere in their budgets, he said.

Wolfe said he has testified against this practice in California and New Jersey, and—according to the Federation of State Medical Boards—it's also been done in Arizona, Colorado, New Mexico, Washington state and probably others as well.

“It's not an uncommon practice—unfortunately,” said Lisa Robin, chief advocacy officer for the medical board federation. “State boards should be adequately funded if we expect a robust regulatory environment.”

Robin said the federation would be happy to cooperate with the inspector general on any evaluation they might undertake, and she added that the federation has been working with HHS to get doctor disciplinary action information stored in its National Practitioner Data Bank more easily shared with state medical boards. Robin said some hospitals will file reports with the NPDB but not their state board, so work is being done so reports can be filed with both simultaneously.

She also said that Public Citizen-provided material that was included in the senators' letter could be characterized as misleading.

“We don't know enough information about these physicians who had (hospital) privileges revoked and why boards didn't take action against them,” Robin said. She also explained how the senators' letter cites a December 2010 article discussing how the Connecticut Medical Examining Board doesn't take action against doctors practicing in the state who have been disciplined elsewhere, but what isn't mentioned is that the board didn't have the statutory authority to do so until now and how, at the time the cited article was published, legislation giving that authority was still pending.

Robin said the same is true in Missouri.

Robert Leach, executive director of the Minnesota Board of Medical Practice since 1995, also had complaints about how his organization was characterized in the senators' letter and by Public Citizen in the past.

For example, Leach said the Minnesota board has been criticized for not posting information on malpractice judgments and settlements, but he explained that they don't have the statutory authority to do. “If our state Legislature changes the law, we'd be more than happy to post,” he said.

Leach adds that the state has also dipped into the board's financial reserves—set aside for “extraordinarily extended cases”—and used it for deficits elsewhere in the state's general fund, and he said legislation is being crafted to prevent future occurrences.

“We object because it's another tax on healthcare professionals,” he said. “When their license fees go elsewhere in the budget, they're essentially paying taxes twice.”

For three straight years, Public Citizen has listed Minnesota 51st in its ranking of the medicals boards from all 50 states and the District of Columbia. The rankings are based on a three-year average of federation data on “serious disciplinary actions,” which include license suspension and revocations.

Leach said Public Citizen doesn't count the board's remediation agreements with doctors, which are kept confidential and are used for cases in which there was no patient harm, a small number of patients were exposed to any potential risk and there was no sexual misconduct.

He added that the state has few remaining independent physicians, so most belong to systems where they are subject to internal peer review and, as a result, “Minnesota is world-famous for the quality of its healthcare.”

In the meantime, Leach said he would “absolutely welcome” an evaluation of his board by HHS' inspector general's office. “I'm anxious to see what comes out of this,” Leach said. “Hopefully, something positive.”

Patient Harm resulting from poor regulation of implanted medical devices.

2012-02-29T09:34:00.000-08:00

LINK HERE: Medpage Today full article

Medpage Today:

Report Slams Response to Metal Hip Troubles

By John Gever, Senior Editor, MedPage Today

Published: February 28, 2012

Regulators on both sides of the Atlantic were slow to inform patients and their doctors about problems with metal-on-metal hip implants and relied on industry officials and consultants in crafting their responses, the BMJ charged.

According to a report appearing online in BMJ, regulators in the U.K., the U.S., and elsewhere should have prevented "a whole class of failing hip implant [sic] from being used in hundreds of thousands of people globally."

The report is based on an investigation commissioned by the journal and the BBC's Newsnight program.

BMJ investigations editor Deborah Cohen reported that the U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA) first became aware of problems with metal-on-metal implants in 2006, but it was not until 2010 that the agency issued a formal warning to physicians and the public. Complications included high failure rates and possible systemic effects from elevated metal ion levels in the blood.

On Tuesday, just hours before the BMJ report was set for publication, the MHRA issued an advisory to surgeons, telling them that patients who have received metal-on-metal implants should have annual checkups for life.

The evaluations should include testing for metal ions in the blood as well as for clinical symptoms of device failure, the MHRA said.

In the U.S., the FDA took no steps to inform the public about concerns with metal-on-metal implants until February 2011. It has not suggested that patients or physicians avoid them, nor has it recommended special follow-up procedures.

The BMJ-BBC investigation also found that regulators asked few questions when manufacturers began redesigning their metal-on-metal hip implant models, clearing them for sale without demanding new safety and efficacy studies.

"And so a whole new class of implant -- with the potential to release high concentrations of toxic ions -- was launched onto the U.S. and European markets without the need to conduct clinical trials and without any long term post-marketing studies," Cohen wrote.

Her report also noted that, when the MHRA assembled an ad hoc advisory committee on metal-on-metal implants in 2006, three of its eight members had relationships with industry.

One was director of product development for Smith & Nephew, and two were consultants for Johnson & Johnson's DePuy unit, both of which are prominent makers of metal-on-metal implants.

Many of the report's charges were echoed in a companion BMJ editorial by Carl Heneghan, DPhil, of the University of Oxford in Oxford, England, and colleagues.

They suggested, for example, that device regulations in general are slanted toward industry.

"Guidelines from the EU for manufacturers state: 'The depth and extent of clinical evaluations should be flexible and not unduly burdensome.' This seems curious given the potential risks associated with some medical devices," Heneghan and colleagues wrote.

They also criticized the current registry-based data collection system on hip implants, in which revision surgery is usually the first adverse outcome to be recorded.

"Thus the patient has to develop symptoms and present them to an orthopaedic surgeon, who has to investigate these symptoms and then consider revision," the researchers indicated.

"Only when that joint is removed will the information reach the registry offices. There is a further considerable time lag before data are analyzed and finally presented. In fact, in some cases there is confusion about how 'revision surgery' is defined."

Heneghan and colleagues recommended that the 510(k) system in the U.S. and its European equivalent be reformed, with "an independent system for post-marketing analysis for implantable medical devices."

Neither Cohen nor the editorialists mentioned that orthopedic surgeons began turning away from metal-on-metal implants years ago, spurred by journal publications and meeting presentations that highlighted problems with the devices.

It's estimated that metal-on-metal products now account for no more than 5% of the hip-implant market, down from about 30% a decade ago.

Earlier this month, at the American Academy of Orthopaedic Surgeons' annual meeting, discussions on metal-on-metal implants focused primarily on what to do about patients who already have them, rather on whether the devices should continue to be used.

There was little consensus on whether revision should be considered in the absence of clear symptoms of device failure. For example, in one presentation, David Langton, MRCS, of University Hospital of North Tees in Stockton, England, one of Heneghan's co-authors on the BMJ editorial, suggested that high serum levels of metal ions were a reliable indicator of impending failure.

But William L. Griffin, MD, of OrthoCarolina Hip and Knee Center in Charlotte, N.C., presented data on 90 patients who still underwent revision surgery despite having low ion levels. He said there was no cutoff for ion levels that produced useful positive or negative predictive values.

Moreover, analysis of Kaiser Permanente's large patient database indicated that failure of metal-on-metal implants was still the exception rather than the rule. About 98% of metal-on-metal implants in Kaiser members were still in place after five years, virtually identical to the rate seen with metal-on-highly crosslinked polyethylene.

Cohen declared she had no conflicts of interest.

Heneghan disclosed that he has received payments from the BBC, BMJ, and BUPA, a U.K. health insurance provider, for publications and critical assessments on devices and orthopedic interventions. He has also received payments for teaching and attending FDA workshops.

Langton disclosed that he has received travel and accommodation reimbursement from DePuy, Zimmer, Smith & Nephew, and Wright Medical to attend educational conferences.

Bipartisan Senators encounter OMB delay in their effort to improve safety of implanted medical devices.

2012-02-28T15:17:00.000-08:00

LINK HERE: POLITICAL NEWS FULL ARTICLE
Feb 12,2012 - Kohl, Grassley, Blumenthal Urge Release of Delayed Medical Device Rule Senators Push OMB for Strong Post-Market Surveillance WASHINGTON – U.S. Senators Herb Kohl, D-Wis., Chuck Grassley, R-Iowa, and Richard Blumenthal, D-Conn., urged the release of a key new rule on post-market surveillance of medical devices. Kohl, Grassley and Blumenthal wrote to the Office of Management and Budget (OMB) Acting Director Jeffry Zients to express their concerns about the delayed release of the Unique Device Identifier rule written by the Food and Drug Administration (FDA). The Unique Device Identifier (UDI) is a tracking system for medical devices approved by Congress in 2007. UDI will enhance post-market surveillance of medical devices, improve data collection on medical devices, and allow companies and the FDA to track faulty devices when problems occur. Kohl, Grassley and Blumenthal wrote that "we take seriously our responsibilities to oversee the safety of medical devices that are used by, and implanted into, millions of Americans on a daily basis" and that "due to our strong desire for a robust post-market environment, we are very concerned with the delayed implementation of the UDI." The letter can be found here. FDA sent the proposed regulation to OMB in July 2011, and under standard procedure, OMB has 90 days to review and release the rule. To date, OMB has yet to release the UDI rule. "As we heard during last year's Aging Committee hearing on medical device safety, patients sometimes don't even know who manufactured their implanted device, and manufacturers can face significant challenges in trying to find and notify patients about recalls," Kohl said. "Unique Device Identifiers provide an important post-market safety tool that will reduce the time it takes to track and locate problematic devices. The longer we wait for a system to be in place, the greater the number of patients placed at risk." "The FDA needs this tool to do a better job of tracking medical device safety," Grassley said. "The sooner the system is in place, the better for patients who have received medical devices. It's frustrating that even when the FDA is trying to beef up patient safety, another part of the government is delaying action. OMB needs to move this forward." "To save lives and stop suffering, we cannot delay implementing this medical device rule any longer," said Blumenthal. "This rule assures that only safe devices already on the market continue in use. There must be tracking of faulty devices when problems occur so that patients are informed and spared risk." Grassley, Kohl and Blumenthal have been working to improve post-market safety of medical devices and have introduced the Medical Device Patient Safety Act (S. 1995), which aims at ensuring problems with faulty devices are discovered more quickly and that recalls are better managed when problems occur.

Join with Harmed Patients and Demand Safe Implanted Medical Devices

2012-02-28T14:52:00.000-08:00

LINK HERE: Harmed patients demand safer implanted medical devices

For months the medical device industry has been lobbying Congress to keep lax safety oversight over medical implants, including heart valves, replacement joints and surgical mesh. To make sure elected officials hear from Americans who’ve been harmed by outdated safety laws, Consumers Union’s Safe Patient Project brought 10 activists from seven states to Washington D.C. to share their medical device experiences and demand improvements.

And it had a huge impact! Activists had more than 20 meetings over two and a half days with key decision-makers. And many Congressional staff told us it was the first time they heard from ‘real people’ about this issue.

Our D.C. event was preceded by more than 160,000 messages from constituents to Congress – generated by Consumers Union – in support of key safety reforms. And it all comes at a crucial time – the medical device oversight law is reviewed every five years by Congress and we have only until September to get lawmakers to adopt important safety improvements. You can add your voice by taking action now.

One critical improvement is to make sure implantable or life-saving devices are safety tested before going on the market, rather than allowing manufacturers to merely show that their new device is similar to one already on the market. Over 90 percent of devices are cleared without safety testing.

Many of those who traveled to Washington D.C. were harmed by devices that were never safety tested prior to being sold. Among them — Jim Shull, of Brown Mills, N.J., who told congressional staffers that his implanted hernia mesh hardened and destroyed tissue in his groin that required painful surgeries to remove. Shull says he continues to live in constant pain and must use a cane to walk. Unfortunately, his experience is far too common.

As a result of our efforts, Shull and Consumers Union were invited to testify before the House Energy and Commerce Committee on device safety, telling members that the fast and furious pace of approving medical devices should not trump safety and effectiveness. (You can watch their testimony here.)

With continued support of consumer activists, Consumers Union will work to make medical devices as safe and effective as possible. We will counter the industry claims that FDA safety standards impede innovation. After all, a medical device is innovative only if it works and doesn’t harm people.

A Senate draft of the legislation is expected soon, and we will count on consumers to join us in raising their voices so Congress will put the interests of patients first. The best way to do this is to be sure they hear from people harmed by untested medical devices. If you or someone you know has an experience to share, please take a moment to tell us about it.

PCORI - Patient Centered Outcomes Research - My Testimony today

2012-02-27T11:29:00.000-08:00

Hello. I am Joleen Chambers - a volunteer and uncompensated patient advocate, blogger and tweeter for safer implanted medical devices. I am grateful that PCORI and this badly needed forum for patient care discussion and research now exists.

Failed implanted medical devices place patients in medical and legal purgatory.

Patient centered outcomes research is essential to provide vulnerable patients with real time information about the #1 expenditure of Medicare: joint replacements.

PCORI research could

provide real-time post market data that would help patients & their chosen clinicians select life-enhancing medical device implants

PCORI research could

Facilitate a transparent and accessible registry that would be responsive to patient/consumer input about the quality of life risk/benefits of joint replacement

PCORI research could

Allow scientific information to determine which implanted devices are safe and effective and should remain on the US market. Devices that underperform will be exposed and will be either recalled or retooled so they would not compete with successful innovations.

PCORI research could

Clarify when implanted medical devices fail to deliver benefit to patients. If the device harms patients, the path to patient compensation and care will not be in conflict with device industry, surgeon or regulatory defensiveness.

My personal story is that my brother in 2008 received a rare elbow implant paid by private insurance at one of the most highly respected medical facilities in the US. It failed after just 4 months and was unsuccessfully surgically “revised”. He lives in constant pain. Powerful prescribed painkillers have caused his teeth to disentegrate and fall out while he sleeps. He is in medical and legal purgatory.

He is just one of tens of thousands. Federal public policy must change to alter the entitlement of the medical device industry. Now the FDA clears these implants through 510(k) with no clinical testing and there is no post-market data that would expose the patient harm and prevent others from selecting the same failed treatment. FDA patient representatives are not full voting stakeholders and patient advocates are restricted to speaking only at FDA Town Hall meetings for 5 minutes. Patient-centered it is not.

In fact, in yesterdays’ Star Tribune Eric Campbell a director of research at Harvard said “ the first thing people have to realize is that (the medical device industry) makes a product to sell a product.” Patients/citizens wrongfully assume that regulation and science are driving these decisions. PCORI research will help us all to make better decisions and the medical device industry will benefit from elevation of it’s reputation and products globally.

CONSUMER BEWARE ! YOUR SAFETY IS NOT VALUED ! Implanted medical device profit prevails.

2012-02-26T12:24:00.000-08:00

LINK HERE: FDA/politicians/lobbyists prefer profit over safety of implanted medical devices
Follow the link above or read the copy below for an excellent analysis in today's Sunday Business section of the Minneapolis StarTribune 2/26/12

(Disclosure: I have added bold and underlines and Steven Baker-FDA MedWatch adverse event #5009052- is my brother. The metal piece he is holding was removed by the designer/surgeon just 4 months after the original implant.)

Minnesota resident Steven Baker says the FDA-approved prosthetic elbow implanted in his arm has never worked properly and continues to cause excruciating pain. Records show that the part of the prosthesis that malfunctioned in Baker’s arm had been the subject of two recalls in Canada and an “adverse event report” of the U.S. Food and Drug Administration.

Medical device makers gain political momentum

Article by: JIM SPENCER and JAMES WALSH , Star Tribune staff writers Updated: February 25, 2012 - 3:39 PM

Consumer safety proponents press for tougher standards while firms want faster approvals.

WASHINGTON - Steven Baker's artificial elbow locked up as he was going through a metal detector at a Senate office building recently. The malfunctioning FDA-approved joint left the 56-year-old Minnesota millwright in a world of hurt.

Not unlike the consumer movement he represents.

As victims of faulty medical devices press for tougher standards, the focus of the debate in Congress has shifted from consumer safety to quickening the approval process for new devices. Critics and proponents alike agree that the medical device industry, which has deep roots in Minnesota, has successfully pushed a D.C. agenda that seeks to simplify federal oversight of product development.

"Well-funded lobbyists are skewing the vision," said Baker, who came to Capitol Hill as part of an effort by the Consumers Union Safe Patient Project to show what happens when medical devices fail.

Despite such efforts, the device industry's political momentum is building along a number of fronts. Among them:

•A bill in the U.S. House aims to change the mission statement of the Food and Drug Administration to include "job creation" as well as safety.

•Another bill, introduced by Rep. Erik Paulsen, R-Minn., gives private reviewers outside the FDA new powers in the approval process for some life-sustaining and permanently implanted medical devices.

•In the Senate, Minnesota Democrat Amy Klobuchar introduced legislation that, in part, loosens conflict-of-interest rules for those who review the safety of medical devices.

•An FDA-funded report by the Institute of Medicine has gone nowhere, despite strongly concluding that a program allowing certain devices to go to market without testing was not in the public's best interest. In fact, the device industry so effectively countered concerns raised by the institute that one congressman suggested the FDA seek a refund.

Meanwhile, rules to create an identification system for medical devices to help recall unsafe products remains stalled, several months after they should have been published. The medical device industry has called the ID system burdensome. A high-ranking FDA official said he cannot say if the administration will release the rules this year.

Steve Ubl, who helps represent the interests of the medical device industry, acknowledges that policy discussions among Congress and federal regulators have broadened and become less acrimonious over the past year.

"Today, we're discussing the role of FDA regulation in the context of innovation, investment, economic growth and global competitiveness," said Ubl, president of AdvaMed, which bills itself "the world's largest medical technology association."

Officials with Medtronic, the world's largest device maker, say they like the direction of policy proposals in Washington.

"We look forward to continuing to work with FDA to strengthen the process and assure that safe and effective technologies get to market in the U.S. in an appropriately timely manner," said Amy von Walter, spokeswoman for Medtronic, which is based in Minnesota.

Boston Scientific, which also has a huge Minnesota presence, agreed:

"Boston Scientific's first priority is patient safety," said Denise Kaigler, senior vice president of corporate communications. "The FDA routinely requires the submission of extensive testing results and scientific data."

Balancing speed and safety

Regulators, businesses, politicians and patients have battled for years over whether America's public health is better served by avoiding risks or by faster innovations in the medical device industry.

For people like Baker, who received a device that doesn't work properly, the fast-track process frustrates and confuses. For Minnesota's 400 medical technology companies and their 35,000 employees, changes to the system could be time-consuming and costly.

Experts agree that roughly 1 percent of medical devices introduced in the U.S. get recalled. Where they struggle is reaching consensus over whether that is a positive outcome.

Industry representatives and some patient groups say time is the problem. They say inefficient device approval procedures keep Americans from getting cures or pain relief as fast as patients in many other countries, especially the European Union.

The medical device industry "is behaving as they are supposed to," said Eric Campbell, director of research at the Mongan Institute for Health Policy at Harvard Medical School. "The first thing people have to realize is that they make a product to sell a product."

What consumers need, Campbell said, is "a policy champion who is an elected official." Otherwise, no one addresses situations like Baker, who lives with excruciating pain from an FDA-approved medical device that he says never worked right.

Baker met with staff members in the offices of Paulsen, Klobuchar and Sen. Al Franken. In statements after the meetings, the Minnesota trio affirmed their commitments to patient safety while emphasizing the need for faster device approval.

"We need to ensure patients have access to safe, lifesaving treatments and services," Klobuchar said. "This includes preventing regulatory burdens from getting in the way of delivering lifesaving products to patients who need them, while still ensuring the highest level of patient safety."

Patients share their stories

Dr. Jeff Shuren, the physician who directs the FDA's section on medical devices, said the agency is "not moving away from patient safety." He defended the current device approval system as "safe and effective."

"All devices have risks," he said. "What we look for is where are there problems. We don't have to make a major overhaul."

Lisa McGiffert, director of the Consumers Union Safe Patient Project, says it's critical that patient advocates demonstrate the serious consequences when a medical device fails.

"Statistics are one thing," she said. "Real people have a much stronger impact and are harder to ignore."

Medical device victims like Baker and Jim Shull of Browns Mill, N.J., hope so.

On a recent day, Shull shifted awkwardly from sitting to standing as he waited to testify before a House subcommittee. Shull lives with constant nerve pain and a long, disfiguring scar that marks the removal of a malfunctioning piece of FDA-approved surgical mesh implanted during a hernia operation.

Most of the testimony concerned getting medical devices to market faster. There was little talk about protecting patients.

"For me to get their attention," Shull mused, "I would need to take every one of these committee members into a back room, drop my drawers and show them what happened."

Jim Spencer • 202-408-2752 Jim Walsh • 612-673-7428

Reused orthopedic surgical arthroscopic shavers may be contaminated.

2012-02-22T08:59:00.000-08:00

LINK HERE: FDA investigating contamination of re-use of orthopedic surgical instruments

Another question patients must ask before joint replacement implant surgery.

Resigned J&J CEO Weldon on "halo" effect of baby products/medical devices marketing

2012-02-22T05:36:00.000-08:00

LINK HERE: Forbes story: J&J baby medicine "halo effect" for failed hips, defibrillators, stents

Under the cover of a respected purveyor of baby products is an aggressive and very profitable medical device industry.
When the priority of a business entity selling implantable medical devices is solely profit there must be regulation and judicial accountability to provide for patient safety.

Johnson & Johnson CEO resigns

2012-02-22T05:24:00.000-08:00

LINK HERE: CNN story on sudden resignation of J&J CEO.

Multiple failures of leadership led to catastrophic patient harm and cost taxpayers millions of dollars. Trust is broken. The person accountable for these "business decisions" and "missteps" is allowed to resign and retain his fortune. This is not justice. This will not deter others from continuing the corruption of our health system.

Failed DePuy Hip marketing a "business decision"

2012-02-22T03:42:00.000-08:00

LINK HERE: DePuy business decision to market failed DePuy hip

Barry Meier, reporter for the New York Times reports that Johnson & Johnson DePuy executives discussed the FDA refusal to clear the metal on metal hip one year before the recall. Aware that the hips were performing worse than the control group and patients were experiencing painful revision surgeries, executives did not stop sales nor did they inform clinicians and their patients.

This is why patient advocates are demanding "Give us our damned data." Our government pays for these failed products and the failures will be identified in real time if each product is followed post-market. Medicare pays for a large portion of these implanted devices and there should be a transparent mechanism for the data to be shared with patients in a meaningful way. We can evaluate new cars and new appliances. It should be mandated for all implanted medical devices. A minimum warranty is a useful feedback mechanism to the producer of the implanted medical device! Now there is no accountability. Patients are in medical and legal purgatory when a device fails. Legal justice may offer 5 cents on the dollar compensation, but no one can restore health and trust.

ACTION ALERT !!! Please join me in supporting FDA employees that are doing their jobs.

2012-02-21T15:14:00.000-08:00

LINK HERE: Give FDA Medical Device Safety Whistleblowers your support!

State of the Union & National Research Center & Consumers Union

2012-02-20T18:10:00.000-08:00

LINK HERE: Failed medical devices like financial fraud and toxic dumping.

President Obama likened failed medical devices to financial fraud and toxic dumping in his State of the Union Address.

Consumers Union and National Research Center for Women and Families agree.

This week (President' Day) is a recess for Congress. They are home in their districts. Please take the time to contact your two US Senators and your U.S. House Representative and inform them that you expect heightened scrutiny by FDA of medical devices that are placed in human bodies. They will respond to constituents!

Implanted Medical Device Guinea Pigs no more: Consumers Union on Capitol Hill

2012-02-17T14:11:00.000-08:00

LINK HERE: MDUFA reauthorization must include patient safety

Improve review of devices before they enter the market
improve monitoring of devices after they enter the market
Retain current conflict of interest standards for federal advisory committees

Public Citizen: US Implanted Medical Devices: Substantially Unsafe

2012-02-17T11:45:00.000-08:00

LINK HERE -Public Citizen report on implanted medical devices

This is a very thorough report that reveals the medical and legal purgatory that patients experience as a result of medical device industry lobbying. Congress must address this legislatively flawed process. Assure the American public that implanted medical devices are safe and effective.

FDA scientist whistleblowers on medical devices

2012-02-17T11:14:00.000-08:00

FDA is charged with clearing implanted medical devices that are safe and effective. The commissioned report by the IOM 7/29/11 stated that the FDA 510(k) method is legislatively flawed. Federal employees who are answering to Congress cannot be interfered with. The medical device industry must be honest about the products it sells to US citizens. Profit & jobs must come from high standards and cooperation.

LINK HERE: New York Times Opinion 02/14/12

EDITORIAL

Pursuit of the Whistle-Blowers

Published: February 14,2012

A federal lawsuit filed against the Food and Drug Administration raises disturbing questions about whether the agency retaliated against whistle-blowers for trying to warn Congress that medical devices were being pushed toward approval despite safety concerns.

The suit was filed by six scientists and physicians who are former or current employees and contractors. They contend that the agency monitored their computers and e-mail accounts to learn how they planned to convey concerns to Congress or other authorities. The F.D.A. tried but failed to have criminal charges brought against several employees and then ended their employment.

The plaintiffs had challenged the safety and effectiveness of devices used in detecting colon cancer, breast cancer or other medical problems. Virtually all of the devices were approved by supervisors who disagreed with their judgments. Based on material found on the computers, the F.D.A. concluded the employees violated federal law by disclosing confidential information submitted by manufacturers in the agency’s premarket review process. However, the inspector general’s office for the Department of Health and Human Services twice concluded that there was no evidence of criminal misconduct, and the Justice Department declined to prosecute. The federal Office of Special Counsel, in reviewing one case, found reasonable grounds to believe that the individual was fired in retaliation for constitutionally protected speech.

Senator Charles Grassley, the ranking member of the Senate Judiciary Committee, complained in a letter to the F.D.A. last month that an e-mail to his staff had been intercepted. He warned agency officials that interfering with a Congressional inquiry is against the law. If the court finds that the F.D.A. acted improperly, the agency should punish the managers responsible.

Honoring women leaders- Give us our Damned Data !

2012-02-17T09:33:00.000-08:00

Congress Hears All-Male Testimony on Female Contraception

Yesterday I attended the Dallas Planned Parenthood luncheon-the largest in the nation(positive). In the evening, I trained to resume as a grant reviewer for Dallas Womens Foundation(positive). On TV, I caught the ugly visual of a group of men testifying about women's health in our nations' Capitol(negative). Politicizing health and using gender as a wedge issue is evil and should be criminal. Refuse to be an easy target. Stand up and speak out!

Regina Holliday is prominently honored in this timely and excellent blog by Katie Matlack.
Suzannah Fox is a fellow member of the Society for Participatory Medicine.

We are all demanding "give us our damned data" so that we can make life-enhancing decisions. Implanted medical devices must be tracked & researched post-market to inform clinicians and consumers.

Blog by Katie Matlack - summary

Need to Know: 5 Women in Health IT

You want irony? Try this: the Kaiser Family Foundation reports that we women are the ones make the health care choices for the kids in 8 out of 10 families. Yet women are far and away the minority gender in the world of health IT leaders. Health IT is one of the most important segments of health care, during a time of great change. If women are the ones who’ll be where the rubber hits the road when it comes to the future of health, why aren’t more of us, more involved, in determining what that future of health looks like?

While this is by no means the definitive list, I’ve done some research on the women who ARE making their mark in HIT. I list five to know below. They’ve been included both for their individual accomplishments and for the attention I think that’s due in the areas of health IT where they’re active.

Regina Holliday - The Patient Advocate

Regina uses art to lobby for attention to be paid to patients; she became a patient advocate after witnessing her late husband’s struggle to receive appropriate care for kidney cancer. She paints at big-time medical conventions, reminding attendees that Meaningful Use (MU) requirements of new electronic medical records programs--oft discussed today in the context of government payouts--were created with the intent to improve patient care and save lives. And she reminds us that electronic health records (EHRs) should be clear and transparent. Why does an artist get top billing in a piece on information technology? Because her point--the that the goal of the technology is to make it easier for people to be and stay well--is, well, pretty important.

Judith Faulkner - The Veteran

More than three decades ago Judith Faulkner started a small company, Epic, that has today grown into the provider of the EHR software for most of the largest hospitals in the US. Epic is also the system used by Kaiser Permanente, the biggest care provider in the country that’s not an arm of the government. And it’s in the running to be the solution used by the Veteran’s Administration (VA). Given that Faulkner is staunchly against an effort to have all EHRs move towards becoming interoperable with one another, this last fact has some folks mighty alarmed. Faulkner is still involved in any major company decision and drives the company’s unique corporate culture, and she’s got a seat on President Obama’s Health IT Policy Committee that’ll be making recommendations on “development and adoption of a nationwide health information infrastructure, including standards for the exchange of patient medical information.”

Susannah Fox - The Researcher

She’s responsible for studying what goes on at the crossroads of technology, health and the interwebs, as the Researcher on Health and Health Care for the Pew Internet Project. So Susannah Fox brings us some mighty interesting data about the habits of Americans when it comes to how many of us look online for health information (59 percent), what specific kinds of health information we seek (specific diseases or conditions, treatments or procedures, and doctors or other health professionals), and who we seek it from (increasingly, from other people who might have conditions similar to ours). Fox blogs regularly on e-Patients.net and is helping researchers understand the habits of patients so that health IT can better meet those needs.

Halle Tecco - The Connecter

The company she co-founded has yet to celebrate its second birthday. Yet Tecco’s Rock Health --an accelerator “powering the future of the digital health ecosystem” by providing capital and mentorship to health startups--has funding from giants like Microsoft and Quest Diagnostics, and two of its “graduates” have secured additional funding from other investors. Tecco was chosen because of the power of her idea: that innovators could put tools and systems out there that could rejuvenate healthcare, make it not “just okay” but make it really rock. She was also chosen because she shows you don’t need to have gone to medical school to make a big impact in medicine: Tecco’s background is in tech (Apple, Intel) and business (she went to Harvard Business School).

Amy Sheng - The Inventor

Sheng also co-created CellScope, Inc., with Erik Douglas, less than two years ago. CellScope uses optical attachments to transform smartphones into diagnostic-quality imaging systems. In the right hands, this technology has the potential to transform lives: in the developing world it can be used in village clinics, while here in the US consumers can use the CellScope to access expert diagnosis and advice. Sheng’s work demonstrates the great potential for telehealth solutions to break down the barriers separating developing countries from high quality health care.

Have I left anyone important off the list? Please email me at katie@softwareadvice.com with your suggestions and feedback. I sincerely appreciate it!

Katie Matlack is the Medical Analyst for Software Advice, a company based in Austin, Texas. You can view more of her work on the Software Advice blog.

US Congress discusses medical device safety.

2012-02-15T12:01:00.000-08:00

Consumers Union To Testify For Stronger Medical Device

Safety Oversight at House Hearing Today

Congress Shouldn’t Sacrifice Patient Safety In The Driveto Speed Up Medical Device Approvals, CU Says

WASHINGTON, D.C. – Lisa Swirsky, senior health policy analyst for Consumers Union, will urge Congress today to strengthen medical device safety oversight in testimony before the House Energy & Commerce Health Subcommittee. The subcommittee will hold a hearing on the reauthorization of the Medical Device User Fee Act beginning at 10:15 AM in Room 2322 of the Rayburn House Office Building.

Recent safety problems with metal hip implants and surgical mesh have underscored how lax federal oversight of medical devices fails to protect patients. Consumers Union has called on Congress to require more rigorous testing before medical implants are allowed on the market and to establish a better system for monitoring devices after approval, including a national system for notifying doctors and patients when safety problems come to light.

“Congress has the opportunity to fix a flawed system that allows too many unsafe medical devices to enter the market,” said Lisa Swirsky, senior health policy analyst for Consumers Union, the nonprofit advocacy arm of Consumer Reports. “But so far, the debate in Washington has been all about how to make it easier for industry to rush new devices to the market without addressing the need to protect patients from potential safety hazards. Americans are counting on lawmakers to strengthen the law to ensure timely access to new medical devices without sacrificing patient safety.”

In her testimony before the subcommittee, Swirsky notes that the recent user fee agreement negotiated by the U.S. Food and Drug Administration (FDA) and the medical device industry, fails to make any patient safety improvements and falls short of providing the resources needed to meet the increasing demands on the agency. The FDA had previously indicated that it needed between $770 million and 1.15 billion to implement the performance goals pushed by industry. Instead, the medical device industry has agreed to $595 million in user fees.

Swirsky’s testimony highlights additional concerns about the agreement, including new performance goals for the FDA that may inhibit the agency’s ability to get the information it needs to properly evaluate medical device applications. Her testimony also raises concerns about potential conflicts of interests involving industry-funded patient groups that could be involved in evaluating new devices.

In addition, Jim Shull of Browns Mills, New Jersey, will testify at the hearing about his experience as a patient harmed by synthetic mesh used for a hernia operation. Six years after his operation, Shull is living with daily pain from the mesh that has caused severe nerve damage and other debilitating complications.

“The mesh that was put inside of me has caused so much damage that none of the nerves can ever be repaired,” said Shull. “Now I face a lifetime of pain and struggle because of it. Surgical mesh and other medical devices should be tested for safety before they are allowed to be implanted into people like myself.”  For more details on the reforms Consumers Union is urging Congress to adopt, see the Safe Patient Project’s Improve the Safety of Medical Devices fact sheet.

Contact: David Butler, dbutler@consumer.org or Kara Kelber, kkelber@consumer.org, 202-462-6262 or Michael McCauley, mmccauley@consumer.org, 415-902-9537 (cell)

2011 report: 10% of Medicare payments go toward fraudulent claims.

2012-02-15T05:08:00.000-08:00

MedPage 2/14/2011 Emily P. Walker LINK HERE

2011 Healthcare Fraud Recovery Largest Ever

By Emily P. Walker, Washington Correspondent, MedPage Today

Published: February 14, 2012

WASHINGTON -- The federal government recovered $4.1 billion in fraudulent healthcare payments in fiscal 2011, the largest amount ever collected in a single year, federal officials announced Tuesday.

Ramped-up fraud-fighting efforts led to a 50% increase from 2009 to 2011 in judgments and settlements of payments fraudulently obtained from Medicare and Medicaid, according to the Justice Department and the Department of Health and Human Services (HHS).

The payback results from another record number: criminal charges were filed against 1,430 defendants for healthcare fraud-related crimes, according to HHS.

A total of 743 defendants were convicted during the year, HHS said. The cases included durable medical equipment fraud; illegal marketing of medical devices or drugs for uses not approved by the FDA, including unlawful pricing by drugmakers; and violations of self-referral and anti-kickback laws.

Much of the success stemmed from the Health Care Fraud Prevention & Enforcement Team (HEAT), a task force created in 2009 to prevent fraud, and the Medicare Fraud Strike Force teams.

Those teams use data analysis to identify high billing levels in healthcare fraud hot spots -- such as Detroit and Miami -- to target for investigation and possible prosecution. In 2011, the teams added Chicago and Dallas to their "hot spot" list, which brought the total number of targeted cities to nine, including Los Angeles, Houston, Brooklyn, N.Y., Baton Rouge, La., and Tampa, Fla.

"Fighting fraud is one of our top priorities and we have recovered an unprecedented number of taxpayer dollars," said HHS Secretary Kathleen Sebelius in a press release. "Our efforts strengthen the integrity of our healthcare programs and meet the president's call for a return to American values that ensure everyone gets a fair shot, everyone does their fair share, and everyone plays by the same rules."

The Affordable Care Act includes $350 million in healthcare fraud-fighting funds. One new provision in the law requires those providers and suppliers wishing to participate in Medicare, Medicaid, and the Children's Health Insurance Program that have been deemed to be at higher risk of fraud or abuse to undergo licensure checks and site visits to confirm legitimacy.

The $4.1 billion was either paid back to the U.S. Treasury or to the Centers for Medicare & Medicaid Services, transferred to other federal agencies that administer healthcare programs, or paid to private persons who were the victims of Medicare fraud.

Since the Health Insurance Portability and Accountability Act established a national healthcare fraud and abuse program in 1997, $20.6 billion has been paid back to the Medicare program.

A government report from 2011 found that nearly 10% of all Medicare payments go toward fraudulent claims.

1 Comment

Joleen Chambers

Today 2/15/12 at 10 ET the House Energy and Commerce Committee/Subcommittee on Health will be discussing Reauthorization of MDUFA: What It Means for Jobs, Innovation and Patients. The #1 expenditure of Medicare is joint replacement and the IOM 7/29/11 reported that the FDA mechanism for clearing implanted medical devices - 510(k)- is legislatively flawed and should be scrapped. Victims of failed implanted medical devices are in medical and legal purgatory and our economy is in peril as a result of these expensive mistakes. Innovation does not equate success. Our economy will be sustainable when citizens have jobs that enhance our nation. The medical industry does not get a "pass". It is revealing that "patients" are mentioned last-again!

US Safety Advocates Lobby Congress for Safer Implanted Medical Devices: Consumers Union

2012-02-14T15:12:00.000-08:00

Safety Advocates Unveil Device Safety Agenda, Ramp Up Lobbying

Consumer safety advocates are unveiling a broad medical device reform agenda as they increase lobbying efforts on Capitol Hill, with groups focusing on more rigorous approval for implantable devices, restrictions on using recalled predicates, increased requirements for post-market studies, implementation of the delayed unique identifier system and a national device registry, and greater scrutiny of direct-to-consumer medical device advertising. A safety advocate said there is momentum in the Senate to include some reforms in the user fee act legislation.
Consumers Union's Safe Patient Project this week brought eight patient safety activists from around the country to Washington to meet with lawmakers and press for improvements to the Medical Device User Fee Act. Consumer groups are also meeting with congressional staff as lawmakers work on legislation in this area, according to sources.
The activity comes as FDA and industry work to put the finishing touches on a negotiated agreement on medical device user fees, with a hearing on the issue scheduled for Feb. 15. Consumer advocates said the agreement does not reflect the safety priorities that they had discussed with FDA during the negotiations, such as not allowing companies to use recalled predicates for 510(k) clearance and giving the agency the authority to require post-market studies.
Safety advocates are now turning their attention to Capitol Hill, and banking on news about faulty medical devices to help bolster their cause, although some sources have said medical device safety measures could be a difficult sell as lawmakers increasingly focus on reducing regulation to promote innovation in the medical device sector.
One source said while there is interest in Congress around safety reforms, lawmakers are still working out their plans for moving these ideas forward. Legislation could be introduced as a side-car to the user fee bill, but one source said there have been some bipartisan conversations in the Senate around including some reforms in the user fee act itself.
"They are developing language that will be ready to go one way or another," one safety advocate said.
Reforms aimed at direct-to-consumer advertising for medical devices, like billboards, are gaining traction in Congress, according to one safety advocate, who added that this issue, along with UDI, and predicate reform -- included in a recently introduced House bill -- are getting the most attention on Capitol Hill right now. The source said post-market reforms are more broad at this point.
"While the user fee program is structured in a way that FDA has to be more responsive to industry than to us, Congress is still responsive to their constituents," the safety advocate said.
Consumers Union is pushing a broad medical device safety agenda that includes pre-market and post-market reforms, as well as retaining current conflict-of-interest rules -- an area some in Congress are seeking to loosen although FDA has indicated a legislative fix might not be necessary.
Specifically, the group wants all implantable devices to go through the pre-market approval process, and wants to prohibit use of recalled devices or devices with a warning to be used as predicates in the 510(k) clearance progress. It also proposes to give FDA authority to require post-market studies, including long-term studies to demonstrate longevity of devices, and raise the safety standard for devices in line with prescription drugs by changing the PMA standard from "reasonable assurance" of safety to "substantial evidence" of safety.
The group is also calling on FDA to implement the UDI system, which has been held up at the White House Office of Management and Budget, create a national registry for devices, and ensure the agency has adequate resources for better post-market surveillance programs including MedWatch, MAUDE and Sentinel. In addition, Consumers Union said the current conflict-of-interest standards should be retained, a measure they advocated for five years ago during the last reauthorization of user fees.
Some of these measures have already garnered interest on Capitol Hill, with a group of House Democrats introducing legislation that would prevent recalled devices from being used as predicates. A group of senators also introduced a bill that would require conditional approval for some devices cleared through the 510(k) process, although the legislation has met opposition from industry and some consumer groups, who have said those reforms do not go far enough and could loosen some pre-market requirements.

The US exports failed medical devices to the UK

2012-02-12T16:04:00.000-08:00

LINK HERE: Failed hips causing international concern

U.S. GAO- Government Accounting Office- uncovers secrecy on medical device prices

2012-02-12T08:32:00.000-08:00

LINK HERE to full story by Star Tribune reporter James Walsh

Secrecy on medical-device prices hurts buyers, GAO says

• Article by: JAMES WALSH

• Star Tribune

• February 11, 2012 - 2:40 PM

Hospitals are paying widely varying prices for the same implantable medical devices, according to a new study that suggests that secretive sales agreements prevent many buyers from getting the best deals.

The report from the U.S. General Accounting Office -- which turned up a difference of more than $8,000 for one cardiac device alone -- found that confidentiality clauses in sales contracts keep even the physicians who decide which devices to use in the dark about prices.

The study, which was requested by U.S. Sen. Max Baucus, a Montana Democrat who chairs the Senate Finance Committee, could add fuel to a push to lift the price veil.

"The real problem is that, on the local level, there are these gag clauses that prohibit the sharing of pricing information," said Curtis Rooney, president of the Healthcare Supply Chain Association (HSCA). "I do think [the GAO report] lays the groundwork for more questions to be asked."

Don May, vice president of policy for the American Hospital Association, said the study "highlighted some of the real concerns about devices."

Device pricing is an issue of critical importance locally. Minnesota is a primary medical technology hub, home to industry giants Medtronic and St. Jude Medical and hundreds of other smaller companies employing thousands of people.

Officials with top local device companies declined to comment on the GAO's findings, referring calls to the Advanced Medical Technology Association (AdvaMed), a medical device trade association.

David Nexon, a senior executive vice president for AdvaMed, said the industry is extremely competitive and that pricing involves many factors. Overall, however, he said that medical technology prices "have risen far more slowly than price increases for other medical goods and services and substantially less than even general price increases in the economy as a whole."

Nexon did not specifically address confidentiality clauses. But he said prices reflect "the number of competitors in the marketplace, a particular hospital's volume of business in a particular procedure and the volume of other products sold to that hospital by a manufacturer."

As the GAO report noted, hospitals typically negotiate device prices with manufacturers directly or through group purchasing organizations (GPOs). But device manufacturers often require hospitals to sign confidentiality clauses that forbid them from revealing to third parties the price they paid. Those third parties often include physicians, whose device preferences influence hospital purchasing decisions.

"It really is this relationship between the manufacturer and the physician," Rooney said. "The physician orders the product but can't know what the price is. The hospital becomes the third-party payer."

The GAO sought information for its study from more than five dozen medical centers and others involved in the health care system. It received detailed information on cardiac device prices from 31 hospitals, one GPO and one Department of Defense medical center. Only 14 hospitals and two Department of Defense facilities gave detailed information on orthopedic devices.

Those responses showed huge price differences. For example, the difference between what the lowest- and highest-price hospitals paid for a particular model of automated implantable cardioverter defibrillator (AICD) was $6,844. For another, the price difference was $8,723. Median prices for four AICD models ranged from $16,445 to $19,007.

The cost to the government alone could be substantial. Considering that Medicare spent nearly $20 billion on implantable medical device hospital procedures in 2009, a rate equal to what Medicare spent for all other hospital procedures, "excess or unnecessary IMD costs that hospitals incur may be passed on to the Medicare program," the GAO report said.

'Armed for battle'

There are hospitals that go in with their eyes open.

Minneapolis-based Allina Health won't accept gag clauses in its contracts, according to Cheryl Harelstad, vice president for supply chain management. Years ago, she said, such clauses weren't really questioned.

"A lot of health care providers are working hard, saying, 'Wait a minute. This doesn't put us in a very good position,'" she said.

Allina belongs to a GPO, Novation, that strikes agreements with suppliers and establishes multiple price tiers for devices, Harelstad said. GPO members pay a fee for that information and sharing it is critical, she said. Allina, which has some buying clout because of its size, will then go to manufacturers to adjust prices further.

"We go in armed for battle," Harelstad said of the importance of pricing information.

"To be fair," she said, "our suppliers work well with us on this."

Rooney said confidentially clauses in device contracts are not new. "This has been going on quite a while -- at least a decade," he said. Legislation requiring more price transparency was introduced in Congress in 2007, but was not enacted.

Now, as more Americans age and health care costs become an even bigger issue, Rooney said the issue of device costs is heating up again.

"This begins the conversation that needs to occur in Congress," he said. "In the era of cost containment, people should know they are getting the value they deserve in terms of health care costs. People are getting older and grayer, and more of these devices will be implanted."

James Walsh • 612-673-7428

explanthisFeb. 12, 128:07 AM

http://fida-advocate.blogspot.com/ FDA MedWatch Adverse Event #5009052 was not investigated and according to Freedom of Information, the record was "lost". Mayo Clinic and the surgeon/designer are legally able to abandon the patient. The entitlement of the medical device industry will cripple not only our elders, but our nation. Medical and legal purgatory is not an "innovation" that patients demand but if a device fails, that is the result. No pre-market clinical testing, mass production and no registry for devices and an uninformed consumer is the recipe for disaster. Is the GAO report "shrill" or accurate? I vote for accurate!

Knee replacements have tripled from 1997 to 2009

2012-02-11T11:28:00.000-08:00

(Link here) 5% of Americans over age 50 have artificial knees!

The article was published today by AP reporter, Lindsey Tanner. The US does not have a national registry of implanted devices and the medical device industry has resisted it for 20 years. Consumer/taxpayer outrage must counter the powerful lobby of the medical device industry to propel Congress to change the charter of the FDA. Give us our damned data so that we can make life-enhancing decisions! Joint replacements are the #1 expenditure of Medicare. Taxpayers paid for a large majority of procedures and the aggregate data generated from those purchases should be made available to patients/citizens/taxpayers. It is NOT proprietary information!

The Department of Transportation investigates/regulates/recalls effectively:

(Link here) Toyota RAV4 recalled for power window switch defect that may cause fire.

Product Safety Commission investigates/regulates/recalls effectively:
(Link here) Coffee makers recalled for burn risk.

The FDA missed the failures of 37,000 failed J&J metal on metal hips.

Our economy is dependent upon getting this right. No more victims of medical and legal purgatory of failed implanted devices!

Congress: put public health before medical device industry

2012-02-09T03:21:00.000-08:00

U.S. Victims bravely tell their stories. This is so very wrong.

My brother and I are grateful to be with the Consumers Union Patient Safety Project. We have met with Congressional office holders and their staffs to demand better regulation of implanted medical devices. The response has been discouraging since there are 12 proposed pieces of legislation pertaining to medical devices, but none includes patient safety and public health protections. The medical device industry is lucrative and has a powerful lobby. This is an election year and politicians are raising money. That is an excuse for not doing their job: protecting American citizens from unsafe and unproven implanted medical devices. Corporations that have been granted the privilege (not entitlement) by the citizens of the United States to do business in our country must act as lawful and ethical businesses. Using influence to corrupt regulations so that failed medical devices are not identified and banned and obscuring information that would inform patients so they can select life-enhancing devices is criminal. It must stop.
Steven Baker, MedWatch # 5009052 came to Washington, DC and encountered the metal detector at the Senate Hart Office Building. He was asked to take off belt and shoes and his implanted elbow suddenly went "out of alignment" . During his presentation he was asked if we should call an ambulance. It is unreasonable to ask the victims to do anymore. It is time for the medical device industry to be honest, responsible and account for the failures as well as the successful innovations that it produces. Our economy cannot sustain this and no patient deserves this medical and legal purgatory.

Regina Holliday and bridging the divide at Health 2.0 2010 San Francisco

2012-02-01T08:44:00.000-08:00

Eight minute YouTube on the collision of art and advocacy.

Regina Holliday's blog is featured (linked) to the right on this page.

Consumers Union announcement of hospital rating data availability

2012-02-01T07:51:00.000-08:00

CONSUMERS UNION NEWS RELEASE

For Immediate Release: Wednesday, February 1, 2012

Contact: Michael McCauley – mmccauley@consumer.org, 415-902-9537 (cell) or 415-431-6747, ext 126 (office) or Lisa McGiffert, lmcgiffert@consumer.org, 512-477-4431, ext 115

Central Line Bloodstream Infections Disclosed at Hospitals Nationwide

Infection Disclosure Is A Milestone Following A Multi-Year Campaign

By Consumer Advocates to Make Information Public

WASHINGTON, D.C. – The Department of Health & Human Services is now disclosing for the first time how hospitals across the country compare when it comes to central line associated bloodstream infections (CLABSIs) in intensive care units. CLABSI information for each hospital is posted on the federal Hospital Compare web site and will be updated quarterly. The web site will provide information for other hospital-acquired infections in the future.

National hospital infection reporting follows a multi-year campaign by Consumers Union and other consumer advocates to mandate such disclosure. The Centers for Disease Control & Prevention (CDC) estimates that nearly 100,000 people die each year due to hospital-acquired infections and the hospital costs associated with these infections are estimated to be as high as $45 billion annually.

“Consumer advocates across the nation have worked tirelessly to end the secrecy over hospital infection rates,” said Lisa McGiffert, director of Consumers Union’s Safe Patient Project (www.SafePatientProject.org). “This is a milestone for patient safety that begins to make hospitals accountable for the two million patients who are infected each year. Finally, Americans in all 50 states will be able to find out how well their hospital prevents these particular infections. Public disclosure drives hospitals to improve care and helps patients choose hospitals with better safety records.”

Consumers Union, the nonprofit advocacy arm of Consumer Reports, has prepared a set of tips for accessing the CLABSI information on Hospital Compare web site.

Since 2004, Consumers Union has worked with a national network of consumer advocates to enact hospital infection reporting laws and helped pass such requirements in thirty states. The majority of those state laws were based on Consumers Union’s model hospital infection reporting law. Since launching the Safe Patient Project, Consumers Union has heard from thousands of patients harmed by infections who joined the campaign to push for reform.
Beginning in January 2011, the federal government’s Medicare payment policies have required hospitals to report to the CDC’s National Healthcare Safety Network (NHSN) when patients develop CLABSIs in intensive care units. The NHSN is the same system used by most of the states with reporting mandates.
The CDC estimated that 18,000 patients developed CLABSI infections in the ICU in 2009. Of those patients who develop bloodstream infections in the hospital, up to one in four die.
The CLABSI infection information disclosed on Hospital Compare are based on only three months of data (January-March 2011) and show how each hospital stacks up against the national benchmark for such infections. But building a longer record over the coming year will provide a better indication of trends at each hospital.
“If your hospital is no different than the national benchmark, that means too many patients are still suffering and dying from infections that could have been prevented with better care,” said McGiffert. “The benchmark for success that hospitals should be striving to reach is zero.”
Hospitals have started reporting surgical site infection rates to the CDC and that information will be posted on Hospital Compare every quarter beginning in 2013, starting with abdominal hysterectomy and colon surgeries. According to the CDC, surgical site infections account for 20 percent of all hospital acquired infections. In addition, information on the incidence of catheter-associated urinary tract infections will be available on Hospital Compare in 2013.
The new reporting requirements apply to hospitals that participate in the Centers for Medicare and Medicaid Services (CMS) “pay-for-reporting” program and includes infections occurring in all patients, not just Medicare patients. Virtually all U.S. hospitals, excluding critical access hospitals, participate because they earn a higher Medicare payment for doing so.

See Consumer Reports’hospital survival guide for advice on staying safe in the hospital. For information on more than 3,000 hospitals in all states, including infection Ratings for over 1,000 hospitals, see Consumer Reports Ratings (available to Consumer Reports subscribers). Or try the new Consumer Reports hospital Ratings app which can be downloaded from the iTunes app store for $2.99.

###

Who Owns Data From Inside Your Body? - On The Media

2012-01-24T08:16:00.000-08:00

Who Owns Data From Inside Your Body? - On The Media

Please listen to this 8 minute audio from NPR.

Hugo Campos is a patient advocate who is working for safer and more effective implanted medical devices on the federal level. Like my brother, he found that there is a "catch" to having an implanted medical devices.

Steven Baker's implanted elbow that failed had two components removed during "revision" surgery and it took him more than a year to establish his ownership of those implanted components. Hugo believes the patient "owns" the information that is compiled by his implanted cardiac device ICD.

You can help reduce unsafe and ineffective implanted medical devices.

2012-01-20T07:19:00.000-08:00

Medical Devices: Consumers Union Safe Patient Project

http://safepatientproject.org/

Medical Devices should not be ticking time bombs!

We shouldn’t be used as guinea pigs when it comes to something as serious as a medical implant. Yet everyday, Americans are finding out that the medical device they are using to improve their health may actually cause serious harm, permanent disability or death!

Because of intense lobbying from the medical device industry, more than 90 percent of devices do not have to undergo testing on humans before they are sold to, or implanted in, us. That means heart valves and other high-risk devices can receive less scrutiny and testing than a drug for an upset stomach.

Further, implants are not tracked universally. That means there's no way to notify patients that they may have a defective product that should be removed. If you don’t think this makes sense, let your members of Congress know. They’re writing legislation right now that will decide how safe medical devices must be.

Tell them you want safety standards for most medical devices to be brought in line with prescription drugs. Just fill in the form below, adjust the letter with your own comments, and our system will automatically direct your message to your own Representative and Senators based on your address.

https://secure.consumersunion.org/site/Advocacy?cmd=display&page=UserAction&id=2613

Medicare Study Shows Most Medical Errors Go Unreported

2012-01-08T16:57:00.000-08:00

Link to Consumers Union announcement (text copy below).

Posted 01/06/12 at 3:19 pm

CONSUMERS UNION NEWS RELEASE

For Immediate Release: Friday, January 6, 2012 Contact: Michael McCauley, mmccauley@consumer.org, 415-431-6747, ext 126 or 415-902-9537 (cell) or Lisa McGiffert, lmcgiffert@consumer.org, 512-477-4431, ext 115

Medicare Study Shows Most Medical Errors Go Unreported

CMS Will Work to Make Hospitals Track Errors Better Internally But Information Will Be Kept From The Public

WASHINGTON, D.C. — A new study released today by the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) found that hospital employees are only reporting fourteen percent of all medical errors and usually don’t change their practices to prevent future harm to patients.

The study was based on an independent review of patient records. Federal regulations require hospitals to track all medical errors and adverse events that harm patients and to implement preventive measures to protect patients. Only five of the 293 reported cases of medical errors reviewed by federal investigators led to changes in policies or practices by hospitals to prevent harm to patients.

“One in four hospital patients are harmed by medical errors and infections, which translates to about 9 million people each year,” said Lisa McGiffert, Director of Consumers Union’s Safe Patient Project. “Today’s report confirms what many other studies have already documented. Too many hospitals are doing a poor job of tracking preventable infections and medical errors and making the changes necessary to keep patients safe. It’s time that hospitals make patient safety a higher priority.”

The OIG report recommends that the Centers for Medicare and Medicaid Services (CMS) provide hospitals with a standard list of medical errors that should be tracked and reported to the agency. But Consumers Union noted that public reporting of medical errors is critical to driving improvement in patient safety.

“Hospitals should be pushed to do a better job at tracking medical harm, but public reporting is what drives change and the public should have access to this critical information,” said McGiffert. “The solutions arrived at in this report take us down the tired and worn out path of secret reporting of medical harm.”

A previous 2010 study by the OIG estimated that an estimated 15,000 Medicare patients experienced medical errors in the hospital that contributed to their deaths each month. That amounts to about 180,000 patients annually. The OIG calculated that Medicare patients harmed during that month required an additional $324 million in hospital care. The study estimated the annual cost for these events in hospital care alone at $4.4 billion.

EU grapples with failed medical devices.

2012-01-06T20:24:00.000-08:00

Link Here. Implanted Medical Devices and Toys have similar regulation requirements.

Medical devices and Chinese toys share same level of safety checks

Sarah Boseley, health editor guardian.co.uk, Friday 6 January 2012 14.30 EST

Manufacturers of breast implants and hip joints must get CE mark rather than license based on evidence from clinical trials.

Many people would suppose that medical devices are subject to the same stringent approval and inspection processes as medicines. But they would be wrong.

When it comes to devices such as hip joints and breast implants, a manufacturer is not required to win a license based on evidence of safety and efficacy from clinical trials. Instead, they must get a CE mark which certifies the product reaches a certain European quality standard. It is the same mark that a Chinese toy company, for example, would have to obtain to sell yo-yos in Europe.

Medical devices are an enormous global industry, with 18,000 companies in Europe alone. As production has become cheaper elsewhere, so companies have moved.

The world leader in breast implants is the US company Allergan, which used to make them in Ireland. In the past couple of years, it has moved to Costa Rica. Its products have a CE mark, which means they have been quality-approved by a "notified body" in Europe. Inspectors, it says, come from all over the world to ensure standards remain high.

This is because EU directives lay out what commercial companies have to do to get the CE mark, wherever in the world they are based. "It is the same thing with toys. All products must have a CE mark," said Frederic Vincent, EU spokesman on health and consumer policy. "Some 80% of toys are produced in China. Manufacturing plants in China have all the papers needed."

Regulating the number and variety of medical devices is a huge job. The CE mark assessment must be done by one of the EU's accredited "notified bodies", but it does not have to be in the country of the manufacturer – the company gets to choose. PIP (Poly Implant Prothèse), the French manufacturer of the sub-standard breast implants that have caused the scandal, elected to apply not to a French notified body, but to one in Germany, called TÜV Rheinland.

The assessment is necessarily much tougher for breast implants, which have been reclassified in recent years as class III medical devices, than for bandages, for example, which are class I. PIP would have had to submit a dossier of evidence that its products were of high quality and its factory processes would have been examined.

The trouble began after PIP had obtained its CE mark. TÜV Rheinland, which has a good reputation in Germany, did send in inspectors on occasion. But PIP knew they were coming. A defiant Jean Claude Mas, the owner of the company, admits he was buying cheap industrial-grade silicone to fill the implants, costing €5 a litre, instead of medical-grade which cost €35.

"TÜV would announce its visits 10 days beforehand," he told French journalists. "That was the routine. I would give the order to hide all the documents regarding the non-authorised PIP gel and as far as the containers were concerned, the staff would organise themselves to make them disappear."

Thierry Brinon, technical director of the company, who said he was recruited from "a small ad", told investigators that "for as long as organisations give us systematic notice of inspection, any kind of malpractice can be hidden".

That was fraud, points out Vincent. Nonetheless, there are now questions over the safety of the European regulatory system. If unannounced inspections are not carried out, then the only warning of problems with the devices is when they go wrong. But it could take a long time for the authorities to realise there is a serious problem.

Doctors and surgeons are supposed to report adverse events – side-effects or health issues they suspect are caused by the devices – to the company and to the regulator in their own country. A company such as PIP may take no notice, even though it is under an obligation to report serious problems. The rupture of a breast implant is not considered serious enough to be reportable, because it can be caused by an accident.

Problems in the UK should be reported to the regulator, the Medicines and Healthcare Products Regulatory Authority (MHRA). Although the MHRA licenses drugs, it has no responsibility for approving medical devices. All it can do, if it has evidence of issues, is send out a letter warning doctors.

That happened in April 2005. The MHRA had concerns about the safety of breast implants made of polyurethane foam and filled with silicone. They were introduced in the 1970s and withdrawn worldwide in 1991 because of fears the polyurethane coating could break down, releasing carcinogens.

The manufacturer, Polytech Silimed Europe, presented the MHRA with new safety data, but its experts said they could not be sure the improvements outweighed "the remote but unquantifiable carcinogenic risk". However, the MHRA could not stop the company selling its CE-marked implants in the UK. "As the implants are CE-marked medical devices, the MHRA accepts that they can legitimately be placed on the UK market, provided users and potential recipients are appropriately informed about their risks and benefits," it said in the 2005 letter.

It takes a substantial weight of evidence of harm – which has to come from all over Europe – to get an implant banned. If there are a few cases in the UK, a handful in France and some in Italy, the regulators in each country would have to talk to the others for the problem to be taken seriously. If the company is behaving ethically, it will be the first to know because it will get complaints from everywhere and can alert the rest of the world. But a company like PIP can sit on the evidence.

Breast implants have a long history of anxieties and recalls, followed by attempts by women to get legal redress and compensation. In 2000, hydrogel implants manufactured by PIP and given to 4,000 women since 1994 were voluntarily withdrawn. But there were warning signs around PIP even at that time. The MHRA stated that its review "has identified that the manufacturer's biological safety assessment of this product in inadequate, due to the lack of long-term toxicity data or clinical follow-up, together with methodological flaws in some of the pre-clinical tests".

Women sued and the UK courts awarded compensation, but PIP's insurers refused to pay up. Mark Harvey of Hugh James, the Cardiff-based solicitors, who ran claims then and has 300 women on his books over the latest PIP implant scandal, maintains the MHRA is to blame. "PIP has been able to come back into this country with a defective product and walk away again," Harvey said.

He also said the agency had not been sufficiently alert and responsive in the past year or more since the implants had been banned. "I do not believe the MHRA's reaction to date has been satisfactory; it is unbelievable the MHRA has not ensured that it was involved with the consultations in France about a product that affects such a large amount of women in this country.

"I am and have been very critical of its role throughout the history of this product. This stems from allowing this company to sell these implants in the UK in the first place, its refusal to respond when I alerted it to the problems, its refusal to meet with any of my clients to discuss their concerns and now this latest health concern."

There have been other warnings that tougher regulation is needed. Thousands of patients in the UK and many more around the world are facing operations to replace an artificial hip joint which was found to cause great pain and deposit toxic metal in the blood. The joint, made by DePuy, which is part of the huge Johnson & Johnson group, was made entirely of metal, instead of metal and plastic. The MHRA issued a recall in September last year.

Doctors and surgeons have to play their part in ensuring the safety of devices. There have been allegations that the relationships between some doctors and employees of the manufacturers are too cosy. "The device companies have tried to have good relationships with surgeons for decades," said Alison Dennis, a partner at law firm Field Fisher Waterhouse who has long worked with the industry. "That is how devices are developed." Surgeons advise companies and test out their products but sometimes the relationships, built up over years, go beyond the professional, she said.

The European-wide trade body, Eucomed, set out an ethical code in 2008, requiring members not to meet doctors unless for work and not to offer rounds of golf or visits to the spa. The major companies, she said, had taken the code on board, helped by major fines for malpractice in the US.

Surgical mesh medical implants: FDA requires post-market data

2012-01-05T06:40:00.000-08:00

Post-market data will help reduce risk to patients

Congratulations to Lana Keeton and Truth in Medicine (blog cited on right column) for tenacity and diligence leading to federal public policy changes that will elevate safety and effectiveness of U.S. medical devices and will make jobs in that industry more stable and respected.

Act now & you can help!

2011-12-28T09:42:00.000-08:00

Call and write to your two U.S. Senators and your U.S. Congress(wo)man :

Let your legislators know you are watching and want to make sure they don't sacrifice safer review of devices when negotiating MDUFA. The medical device industry has an active, powerful lobby but individual taxpayers/patients/citizens are a potent antidote for the paid lobbyist! Please join me and many others in this effort.

Thank you so much and have a very Happy (and healthy) New Year!

"It is just not right."

2011-12-28T09:30:00.000-08:00

(LINK) Barry Meier NYT 12/27/11 "The High Cost of Failing Artificial Hips"

The most widespread medical implant failure in decades — involving thousands of all-metal artificial hips that need to be replaced prematurely — has entered the money phase.
Medical and legal experts estimate the hip failures may cost taxpayers, insurers, employers and others billions of dollars in coming years, contributing to the soaring cost of health care. The financial fallout is expected to be unusually large and complex because the episode involves a class of products, not a single device or just one company.
The case of Thomas Dougherty represents one particularly costly example. He spent five months this year without a left hip, largely stuck on a recliner watching his medical bills soar.
In August, Mr. Dougherty underwent an operation to replace a failed artificial hip, but his pelvis fractured soon afterward. The replacement hip was abandoned and then a serious infection set in. Some of the bills: $400,776 in charges related to hospitalizations, and $28,081 in doctors’ bills.
“I’m sitting here on a La-Z-Boy meant for someone who is 80 and I’m 55,” said Mr. Dougherty, who lives in Groveland, Ill., and works at Caterpillar, the heavy equipment manufacturer. His bills are “five times as much” as he paid for his home.
The so-called metal-on-metal hips like Mr. Dougherty’s, ones in which a device’s ball and joint are made of metal, are failing at high rates within a few years instead of lasting 15 years or more, as artificial joints normally do. The wear of metal parts against each other is generating debris that is damaging tissue and, in some cases, crippling patients.
The incidents have set off a financial scramble. Recently, lawsuits and complaints against makers of all-metal replacement hips passed the 5,000 mark. Insurers are alerting patients that they plan to recover their expenses from any settlement money that patients receive. Medicare is also expected to try to recover its costs.
While his insurer has covered his bills so far, Mr. Dougherty said he was preparing to sue his surgeon, who may have implanted the device incorrectly, and Johnson & Johnson, which produced his artificial hip, to help recoup some of the insurer’s money.
“All these payers want to be paid back,” said Matt Garretson, the founding partner of the Garretson Resolution Group, a firm in Cincinnati that manages product liability cases.
Until a recent sharp decline, all-metal implants accounted for nearly one-third of the estimated 250,000 hip replacements performed each year in the United States. Some 500,000 patients have received an all-metal replacement hip, according to one estimate. A new study found that no new artificial hip or knee introduced during a recent five-year period — implants that included some of the all-metal hips — were more durable than older devices, and 30 percent were worse.
One troubled all-metal model, implanted in 40,000 patients in the United States, was recalled last year by the DePuy division of Johnson & Johnson. As of October, some 3,500 patients had filed a lawsuit involving that device.
There is no data on the number of all-metal hips that have failed prematurely in this country because the outcomes of orthopedic procedures are not formally tracked by the government or private companies.
But extrapolating from overseas data and the estimate of metal hip use here, tens of thousands of patients in the United States may have to undergo operations over the next decade to replace the implants, said Dr. Art Sedrakyan, a researcher at Weill Cornell Medical College of Cornell University, who is studying the hip problem.
A decade ago, Sulzer Orthopedics paid a record $1 billion to settle claims by 6,800 patients who received artificial hips and knees that were contaminated with industrial oil during the manufacturing process. “We have been dwarfed by this,” said Teresa Ford, a lawyer who worked at Sulzer at the time and is now in private practice.
Device producers have taken differing stances to covering patient expenses. Zimmer Holdings, which says its all-metal implants are safe, has settled hundreds of patient claims, lawyers involved in those cases say. Also, DePuy is covering costs related to the device it recalled last year, the A.S.R., or Articular Surface Replacement.
DePuy would not comment on how much it had paid in recall-related costs. But a spokeswoman, Mindy Tinsley, said in a statement that DePuy was working with patients and insurers.
Things have not gone smoothly for everyone who has taken DePuy’s payment offer. One patient, Paula Laverty, received a hospital bill for $41,578 and a call from the facility warning her that the bill would be turned over soon to a collection agency.
Ms. Laverty, of Cape Elizabeth, Me., said she spent weeks calling the firm handling claims related to DePuy’s A.S.R. She said she eventually learned that the implant maker had paid the hospital $18,000 for her replacement procedure and that the $41,578 represented the remaining charges.
This month, DePuy made an additional payment to the hospital, according to Ms. Tinsley, the company spokeswoman.
Along with A.S.R.-related cases, DePuy also faces over 560 lawsuits in connection with the all-metal version of another hip model, called the Pinnacle, the device that Mr. Dougherty received. Because the company says that the model is performing well, costs for its replacement are being borne by Medicare, insurers or patients themselves.
To recoup their expenses, insurers typically notify patients through lawyers that they expect to be reimbursed from any settlement money that patients receive, rather than pursue their own lawsuits with the device makers. Also, Medicare is expected to enforce new laws next year that will make it easier for the agency to recover taxpayer dollars spent treating patients injured by problem drugs and medical devices, legal experts said.
Still, some patients are weathering some of the financial impacts on their own. While Charmin McCune, a teacher in Wylie, Tex., is recuperating well from a recent replacement operation, she said that she and her husband, also a teacher, have had more than $12,000 in expenses that have not been covered by insurance.
Mr. Dougherty, the Illinois patient, underwent a procedure this month to get a new hip implant. All went well, he said, so he hopes to spend next year back on his feet and at work.
“You can’t do anything,” he said of his current situation. “You see your wife doing everything for you. It is just not right.”

New Joints Don't Always Last

2011-12-26T20:00:00.000-08:00

(LINK) New Joints Don't Always Last.

New joints don't always last

By Rick Ruggles

WORLD-HERALD STAFF WRITER

Those who endure the pain leading to hip or knee replacement know they eventually might have to do it all over again.

Baby boomers are growing old. Obesity is an increasing problem, putting stress on joints. Consequently, the need has increased for what once was a niche in surgery: redoing hip and knee replacements.

Surgeons have had good results with joint replacements in senior citizens, so younger patients with bad joints are more and more likely to undergo replacement surgery, too. And the longer an artificial joint is in place, the more likely it will have to be redone. There's no such thing as a permanent repair.

Several hundred thousand knees and hips are replaced each year in the United States. Sometimes the hardware loosens or breaks down. Sometimes remaining bone wears down and cracks. Sometimes infection requires a redo.

Asked when revisions started to become a booming part of surgery, Dr. Todd Sekundiak at Creighton University Medical Center gave a short answer: "Now."

Hip and knee replacements, and the redos sometimes required, have become so common that a medical journal last year warned there might not be enough surgeons to meet demand five years from now.

Sekundiak, 48, said he does about 600 hip and knee replacement surgeries a year, and 30 percent to 40 percent are revisions. Typically, they are referrals from other clinics and towns. While many surgeons do first-time hip and knee replacements, fewer do revisions because they can be complex and risky.

"Historically, revisions were just kind of a niche market," Sekundiak said. This year he added a partner, Dr. Ian Weber, to help with the demand for replacements and revisions.

Dr. Kevin Garvin also performs revision surgeries. "I've hired two partners in the last three years," said Garvin, chairman of orthopedic surgery at the University of Nebraska Medical Center. Garvin said he and his partners do 750 to 1,000 hip and knee replacements a year, and about 20 percent are redos.

Leland Greving of Central City, Neb., sat with his wife, Shirley, in Sekundiak's west Omaha office one recent morning, hoping their winter plans weren't about to be dashed.

Sekundiak performed hip revision surgery on Greving, 79, in late October. Greving knows the operations can go awry. He had his first hip replacement in 2000 and it had to be redone in 2002. He had trouble with that revision and was referred to Sekundiak this year.

The Grevings went to his office Wednesday for the first follow-up appointment. They hoped to hear from the surgeon that Greving had recuperated enough for them to go ahead with their annual winter retreat to Texas.

"I want to travel and walk when we take vacations and stuff," the retired farmer said before Sekundiak walked in the room.

"We're anxious about it," his wife said. "We want to go to Texas."

Sekundiak sees the anxiety on his patients' faces all the time. They've undergone surgery they hoped would cure their problem. Usually it does. But sometimes the pain returns and the cutting must occur again.

"They're demoralized. They're debilitated," Sekundiak said of many patients who have to undergo redos. "And so the level of anxiety is high. The level of stress is high. And for us, too, because your heart yearns for them."

Dr. Nicolas Noiseux, an orthopedic surgeon at the University of Iowa, said that in patients 55 and older, 80 percent of knee replacements work well for the first 20 years. The percentage is higher for hip replacements.

But Noiseux tells 40-year-old patients receiving a replacement that there's a 100 percent chance they'll need a redo if they live to old age.

Surgeons began replacing hip and knee joints in large numbers in the 1970s. Senior citizens usually received the implants, which proved so successful that younger patients began undergoing the surgery. The numbers will shoot up dramatically over the next few decades.

A 2007 article in the Journal of Bone and Joint Surgery estimated that first-time hip and knee replacements would increase from about 660,000 in 2005 to 4 million in 2030. The number of revisions may rise from close to 80,000 in 2005 to about 365,000 in 2030.

Revisions are harder to do than first-time replacements in many cases. "They can be very simple," UNMC's Garvin said. "But they can be very complex."

Some revisions involve removing only the implanted hip socket liner and the ball that fits into the socket. Others require the surgeon to delicately chisel bone from rods before he removes everything that was put in the first time. Then new rods, cables, screws and other material must go in.

The redos can take several hours to perform and, because of their complexity, involve higher risk of medical complications such as infection and pneumonia.

Surgeons doing revisions sometimes have little bone to work with. Bones can be thin or damaged from prior surgery or trauma.

Microscopic particles caused by friction between the artificial ball and socket can lead to an immune-system response that diminishes bone in the area.

They may use bone grafts or artificial pegs and devices to bulk up the area. Ultimately, surgeons want the bone to grow into the implants. This process can be promoted by coating implants with calcium or manufacturing them with tiny pores into which bone grows. The technology and implants have improved over time.

Still, implanted materials sometimes are recalled by manufacturers because they don't meet expectations. A recall may require removal of implants, but not necessarily.

Patients are encouraged to get up and start walking soon after revision surgery because bone is living tissue, and walking helps bone in the hips and knees to strengthen and thicken.

If bone doesn't grow into the implant, the artificial material loosens, and the surgery must be redone.

Sekundiak, a Canadian who trained in Phoenix and Chicago and practiced in Winnipeg and at the Nebraska Medical Center before joining Creighton, said he receives referrals from throughout the Midwest.

He said a first-time hip replacement may cost around $20,000, while a redo can cost more than $100,000 if it's especially difficult. Insurance usually covers much of the cost.

Sekundiak said annual follow-ups are important. Sometimes devices loosen or fail without causing the patient great pain.

"If you wait till it hurts, usually it's a mess," he said.

Richard Cornelison, a retired letter carrier and school bus driver in Red Oak, Iowa, didn't want to have another hip revision surgery last year. Cornelison, now 78, had a first-time hip replacement in 1995. It became infected and had to be redone that year.

The infection simmered in his system and his surgeon referred him to Sekundiak in 2003.

Evidently the infection stemmed from a case of shingles that Cornelison experienced in 1995. Shingles is a virus, but the rash it caused allowed bacteria to enter his system and migrate to the hip implant, Sekundiak said.

Bacteria love hip and knee implants, the surgeon said, because there's no blood flow there to carry immune-system defenses to fight them. Sekundiak did what he calls a "temporary" redo on Cornelison in 2003, placing antibiotic-coated implants in with the intention of replacing them with permanent material.

The coated implants don't bond well with the bone but help knock out infection.

Cornelison was so pleased with the temporary implant that he squawked at having another redo. "I said, 'I'm not ready,'" Cornelison recalled. "He said, 'Well, I think it's time.'"

And so Sekundiak performed another redo on Cornelison last year. The Iowa man who once played baseball and basketball at a high level and bowled avidly now uses a cane and has a limp. Nevertheless, he still mows lawns, plays cards with his buddies and enjoys his wife of 52 years and their nine grandchildren.

"Been doing fine," he said last week. "I'm not in any pain at all."

Back in Omaha, the Grevings of Central City awaited the surgeon's verdict on their winter trek to Texas.

Sekundiak walked into the exam room. "How you doin'?" he asked.

"Good. I've been exercising every day," Leland Greving said. "I haven't got much faith in hips. I've got a lot of faith in you."

Sekundiak said he understood Greving's decade-long frustration with hips and hip surgery. "The problem is, when they (artificial hip joints) go bad, they don't go a little bad. They go way bad."

He told the Grevings that the bone must grow into the implant, and that will take time. As for the trip to Texas, he said, go ahead.

The couple beamed.

"Well, I really want to thank you," the farmer said.

Sekundiak told him to be true to his follow-up appointments.

"You can never divorce me," Sekundiak said.

"I don't want to," Greving said.

Contact the writer:

402-444-1123, rick.ruggles@owh.com

Graphite carbon found in metal-on-metal hip implant study

2011-12-24T03:32:00.000-08:00

NIH researchers uncover clues related to metal-on-metal hip implants

"Graphite carbon is a key element in the lubricating layer that forms on metal-on-metal hip implants. The lubricant has more in common with the lubrication of a combustion engine than that of a natural joint."

research is relevant to several hundred thousand Americans undergo hip replacement each year
typical life of implant is more than 10 years but material improvement is needed for patients younger than age 60
prior to this study, it was thought that proteins from the body entered the joint and adhered to the implant

Foreign Medical Device Implant Registry Study: New Not Better

2011-12-24T03:06:00.000-08:00

New York Times: New Models of Hip and Knee Implants Not Better Study Finds / Barry Meier

"The study, which draws on data from Australia's orthopedic registry, covered implants introduced from 2003 to 2007 and was published this week. The findings are significant for patients in the United States because many of the new designs, like so-called metal-on-metal hips, are widely used here. Those implants, which have both a ball and cup made of metal, are expected to fail prematurely in tens of thousands of patients rather than lasting 15 years or more as artificial joints are supposed to do."

no new implant performed better than older ones
many new implants performed worse than older ones
newer implants tended to cost more
deficiencies in regulation must be addressed
focus on patient safety will save billions of dollars
an orthopedic registry can be a useful tool to identify implant problems
surgeon bias is widespread
regulation of "innovation" protects patients and companies

Medical Device Double Jeopardy?

2011-12-22T09:16:00.000-08:00

Link to NEJM here. Breast Implant disappears during Pilates exercise.

This very brief article remarks upon treatment of a Maryland woman who had breast implant prosthesis (breast cancer). She reported that her breast implant was swallowed into her body and disappeared. The medical providers located the implant and added surgical mesh!

Surgical mesh is a medical device that is being questioned for its' safety and effectiveness, yet surgeons continue to implant it into unsuspecting patients. www.truthinmedicine.us.com

What protections will she be provided if the surgical mesh proves to be a problem rather than a solution? That is what Congress is responsible for determining: right now, the charter of the FDA disallows patient stakeholder voting rights, there is no independent, accessible post-market data registry and legal protections unfairly favor the medical provider and medical device industry. Patients beware!

Study finds improved patient health care delivery a must for orthopedic surgeons

2011-12-15T14:53:00.000-08:00

Chair of Orthopedic Surgery at Mayo Clinic: Daniel J. Berry

Study finds improved patient health care delivery a must for orthopedic surgeons

ORLANDO, Fla. — For the specialty to survive, orthopedic surgeons must provide patients with new methods ofhealth care delivery in the form of improved safety, value and care, according to a presentation at the Current Concepts in Joint Replacement 2011 Winter Meeting, here.

“We will not thrive as a profession if the population cannot afford our care,” Daniel J. Berry, MD, said.

In his presentation, Berry, who chairs the orthopedic department at the Mayo Clinic in Rochester, Minn., outlined five ways that he believes orthopedic medicine can “out distance” other specialties: innovations in patient safety, fostering research and development, creating affordable and accessible care, improving quality of work, and attracting the best talent to the profession.

The tendency to rush to adopt new technology has hurt the specialty in the past, Berry noted, citing the recent metal-on-metal hip implant recalls as an example of this problem.

The public is also aware of these controversies, he said.

Berry also mentioned that surgeons should collectively fight for more funds for musculoskeletal research, noting that such scientific efforts are under-funded in orthopedics compared with other medical professions, despite the prevalence of orthopedic care throughout our society.

“We keep people working [and] we keep them independent,” Berry said.

Reference:
Berry DJ. Optimizing health care delivery: best in class. Paper #35. Presented at the Current Concepts in Joint Replacement 2011 Winter Meeting. Dec. 7-10. Orlando, Fla.
Disclosure: Berry receives royalties from DePuy.

Health Leaders article: Docs Need to Blow the Whistle on Fraud

2011-12-15T14:37:00.000-08:00

Doctors need to blow the whistle on fraud. (Link to Health Leaders/Joe Cantalupe article)

Docs Need to Blow the Whistle on Fraud

Joe Cantlupe, for HealthLeaders Media , December 15, 2011

Without skipping a beat, a huge medical device manufacturer allegedly found an easy way to influence physicians to use that company's brand of defibrillators and pacemakers.

How? By giving doctors kickbacks, the Justice Department says.

In a settlement agreement reached this week, Medtronic Inc. of Fridley, MN, agreed to pay $23.5 million to resolve allegations that it used physician payments as kickbacks to "induce doctors" to implant the company's products.

Daniel R. Levinson, inspector general of the U.S. Department of Health and Human Services, noted in a statement, "Patients trust that decisions to implant certain pacemakers or other medical devices are based on their own health interests and not influenced by kickbacks."

This kind of news can certainly erode patients' trust in doctors. And there's more.

The Justice Department's announcement about the Medtronic settlement was barely 24 hours old when, in a separate, unrelated case, several dozen federal and state investigators swooped into a radiology and diagnostic facility in Orange, NJ, arresting 13 doctors and a nurse practitioner in a cash-for-tests referral scheme.

"When physicians take kickbacks that influence how they practice medicine, it has the potential to taint the medical advice and care that is provided to their patients," Office of Inspector General Special Agent Tom O'Donnell said in an official statement.

Bribes and kickbacks are only part of the problem in healthcare fraud, which includes identity theft, illegal prescription drug sales, and countless other areas of wrongdoing. These transgressions do occasionally involve doctors.
The wrongdoing at Medtronic unraveled after two whistleblowers sued the company and alerted authorities to the problem, according to the Justice Department.

Because of their role, the do-gooders will receive a tidy sum of more than $3.96 million. Neither whistleblower was a physician. Justice Department officials declined to comment when I asked how many physicians may have been involved in the Medtronic case.

That's too bad. Physicians need to step up to ferret out fraud, not be a part of it. Most are honest, upholding the profession's reputation. The actions of a few can cast a long, foreboding shadow on the legions of honorable practitioners.

Shortly after he resigned as head of CMS, Don Berwick, MD, touched on the fraud issue in a conversation with journalists. In his 18-month tenure, Berwick said he found that fraud, waste, and abuse were more significant problems than he previously thought. Apparently, Berwick didn't realize how widespread the problem really is.

That's surprising. There were plenty of clues before Berwick stepped into his office in April 2011 that fraud was a big and burgeoning trouble spot in healthcare. Now that he has left, CMS appears to be struggling still with how to uncover fraud, as the behemoth agency tries to raise quality standards under healthcare reform, while also dealing with inadequate data systems that would improve its watchdog functions (more on that in a moment).

As for Berwick, one federal official who is knowledgeable about these decisions told me the CMS leader "was concentrating on other things," such as forming Accountable Care Organizations.

It seems that fraud in Medicare and Medicaid will be a major challenge for Berwick's successor to overcome. Federal officials want physicians to play an instrumental role in helping to stop fraud, and they're backing up that desire with the power of the dollar. Healthcare reform provides fiscal incentives to do so. Berwick had estimated that fraud, waste, and abuse total about $30 billion a year for the whole healthcare system, including up to $10 billion just within CMS.

The week Berwick talked about fraud with journalists, Gary Cantrell, assistant inspector general for the Office of Inspector General (OIG) at HHS, addressed the extent of Medicaid fraud in Congressional testimony. His comments didn't make headlines, but they were revealing nevertheless, as he described the widespread scope of Medicaid fraud, including prescription drug abuse and problems in the home health care services arena.

"We are now seeing more Medicaid fraud cases involving home health services than any other single program area," Cantrell told two House subcommittees. One investigation of a leading home health services company, Maxim Healthcare Services, led to a $150 million settlement of fraud charges.

Fraud in home health services is not a new problem. There have been repeated warnings that CMS needs to address the issue.

"Auditors have been concerned about fraud in home health care for years, but the problem never seems to get solved," according to a 2009 report from the Cato Institute, a think tank in Washington, D.C.

As in Medicare, Cantrell identified "persistent fraud trends" involving misuse of prescription drugs in Medicaid. He referred to a case in Washington state in which a physician established connections with local heroin users and wrote medically unnecessary prescriptions for narcotics, including Oxycodone and Vicodin.

Cantrell also revealed that the OIG has a list of the 10 "most wanted" healthcare fugitives. Among them: an Illinois physician, Gautam Gupta, MD, sought for allegedly defrauding Medicaid and private insurance companies of more than $24 million, through weight loss clinics.

Whether it's improper billing procedures or weight loss fraud, Medicaid investigations are hampered by a lack of "national-level, timely Medicaid data," he says. While the Medicare databases are efficient, Medicaid's Medicaid Statistical Information System (MSIS) is the only source of nationwide Medicaid claims, but it is typically 1½ years old when released by CMS to users for data analysis purposes, which renders it ineffective for investigative purposes. "In law enforcement, a 1½-year time lag is an eternity," Cantrell says.

Essentially, the OIG is waiting for CMS to get its act together.

In the meantime, Cantrell says he's hoping that providers and patients get more involved in thwarting fraud. The OIG's website offers a tip line for fraud cases. And the OIG recently published a white paper, A Roadmap for New Physicians: Avoiding Medicare and Medicaid Fraud and Abuse.

This roadmap offers a journey worth taking, because the integrity of the profession is at a crossroads.

Joe Cantlupe is a senior editor with HealthLeaders Media Online. He can be reached atjcantlupe@healthleadersmedia.com.

Back

Insurance decision delayed is treatment denied for patients . . . profit for industry.

2011-12-14T20:02:00.000-08:00

Link to Huffington Post story about insurance shenanigans that hurt patients/consumers.
Tom Wilson, CEO of Allstate, earned $9.3 million in 2010.

Insurance Claim Delays Deliver Massive Profits To Industry By Shorting Customers

First Posted: 12/13/11 05:24 PM ET Updated: 12/13/11 05:52 PM ET

WASHINGTON -- Unlike many other businesses, the insurance industry is bound by law to act in good faith with its customers. Because of their protective role in the lives of ordinary citizens, insurers have long operated as semi-public trusts. But since the mid-1990s, a new profit-hungry model, combined with weak regulation, has upended that ancient social contract.

"Claims has been converted into a money-making process," said Russ Roberts, a New Mexico-based management consultant and former business professor at Northwestern University who has studied the insurance industry's evolution from a service business to a profit-driven machine.

The change started when consulting giant McKinsey & Company sold Allstate and other leading insurance companies on a new system to boost the bottom line: Rather than adjusting claims the traditional way, which gave claims managers wide latitude to serve customers, insurers embraced a computer-driven method that produced purposefully low offers to claimants.

Those who took the low-ball offers received prompt service, while those who didn't had their claims delayed and potentially were reduced to bringing expensive lawsuits to fight for their benefits. As former Allstate agent Shannon Kmatz told the American Association for Justice, the trial lawyers' lobby, the strategy was to make claims "so expensive and so time-consuming that lawyers would start refusing to help clients." The strategy was dubbed "Good Hands or Boxing Gloves" by the consultants, riffing on Allstate's advertising slogan.

McKinsey, which was reportedly hired by Allstate in 1992, prepared about 12,500 PowerPoint slides to present its plan. The slides were introduced in litigation in 2005, when the insurer turned them over under a temporary protective order. David Berardinelli, a New Mexico-based trial lawyer who was working on the case, detailed the slides in his 2008 book, "From Good Hands to Boxing Gloves: The Dark Side of Insurance."

McKinsey's strategy put profits above all. One slide in the McKinsey presentation illustrated this philosophy by painting the insurance business as a zero-sum game: "Improving Allstate's casualty economics will have a negative economic impact on some medical providers, plaintiff attorneys, and claimants. ... Allstate gains -- others must lose."

Allstate has certainly gained: It made $4.6 billion in profits in 2007, double its earnings in the 1990s. The stunning increase, said Russ Roberts, came through "driving down loss values to an average of 30 percent below the actual market cost" -- that is, paying dramatically less on claims.

"An insurance company can make a lot of money on the small claims," said Jay Feinman, a professor at Rutgers University School of Law, "because if you save a few dollars on a huge number of claims, it's worth more than saving a lot of dollars on a very small number of claims."

Allstate is the best-known user of the McKinsey model, topping the list of the "Ten Worst Insurance Companies in America" published by the American Association for Justice. But Allstate's rise in profits has led most of the industry to adopt the same approach. McKinsey has worked with State Farm, another insurance giant, and other companies in redesigning their claims systems. Feinman cautioned in his book "Delay, Deny, Defend" that the two major names "are just the largest players in the industry ... [the ones] whose involvement with McKinsey & Company in the transformation of claims is the best documented."

Roberts told HuffPost that, by his estimate, the companies that take in 70 percent of total insurance profits in the United States now abuse their obligations to their policyholders. When Allstate CEO Tom Wilson earned $9.3 million last year, he was not even on the top 10 list of best-paid insurance executives, compiled by New York Law School's Center for Justice and Democracy. (The top 10 list was led by William R. Berkley of W.R. Berkley, who made $24.6 million in 2010.)

Yolande Daeninck, spokeswoman for McKinsey & Company, said, "In line with our firm's longstanding policy to not discuss our client work, we decline to comment."

A HOUSE BURNS DOWN

According to an unpublished Harris Interactive Poll conducted in September, 16 percent of surveyed adults have experienced financial hardship while waiting for an insurance claim to be settled or know someone who has. The same poll found that 59 percent of adults believe that most insurers intentionally delay claims -- and those with an income of $35,000 or less were more likely to agree.

With 15.3 percent of Americans -- about 46.2 million people -- living in poverty, close to 10 percent unemployment, and roughly 2 million people who've been looking for work for more than two years, Allstate's business model is profiting off many consumers at their most vulnerable. A claim delayed by even a month can spell financial disaster for a family. As a National Bureau of Economic Research study found, about 25 percent of Americans could not come up with $2,000 in a 30-day period.

Madeleine Burdette, a retiree, is an Allstate customer who reported her experience on the popular website AllstateInsuranceSucks.com. When her Georgia home burned in November 2010, Burdette was in Ohio, where she lives most of the year. She said the fire marshal in Georgia told her that her house would have to be torn down. "The entire middle of the house was gone," Burdette said. "It took out everything. Just the outside walls were left untouched."

The next day, she said, Burdette's Allstate adjuster told her the house could be repaired. Allstate also said it would have to do a thorough investigation to determine if the fire was caused by arson. If it was arson, the adjuster told Burdette, Allstate would not pay for any damages. According to former employees, such investigations are a common practice at Allstate and are encouraged by supervisors as a way to avoid paying claims quickly.

Burdette, who lives on her Social Security checks, flew from Ohio to survey the damage herself. While in Georgia, she contacted public adjuster Anita Taff. Public adjusters serve as advocates for individuals who feel they need another set of eyes on a claim. Taff met with Burdette at the house, Burdette said, and discussed the damage with the contractor Burdette had hired. Upon returning to Ohio, Burdette spoke with Taff over the phone to find out what her impression was. Burdette said Taff warned her that the contractor might go along with Allstate's insistence that the house could be repaired.

"I believe [delaying claims] is an effort to put the squeeze on policyholders," Taff told HuffPost. She explained that while a claim is being held up, the insurance company may stop paying the policyholder's additional living expenses, forcing the policyholder to cover mortgage and rent entirely out of pocket. "That's something that many people cannot afford to do, so they're forced to take a lower settlement," Taff said.

Burdette said she immediately called the contractor and told him not to go near her house. According to Burdette, she received a phone call within 10 minutes from her Allstate adjuster asking her not to hire Taff or any other public adjuster. "He said, 'If you hire a public adjuster, I'm going to deny and delay this claim for as long as possible,'" Burdette told HuffPost. Taken aback, she then asked if it wasn't in his best interest to settle the claim. "Not really," he replied, according to Burdette.

Although the Allstate adjuster eventually agreed to work with Taff on Burdette's claim, her troubles did not end. The contractor who had been banned from her property nevertheless worked on the house and billed Allstate for $22,000. Burdette had explicitly told Allstate not to pay the contractor a dime, she said, but the company paid him under her policy anyway. The contractor couldn't be reached for comment.

More than a year later, Burdette's home is still being repaired and Allstate refuses to reimburse the $22,000. She consulted four different lawyers to see if she had a legal case. While she said they all agreed that she was entitled to reimbursement, she said they also agreed that she lacked the funds to fight the insurance giant. "They told me, 'You'll run out of money,'" she said.

NO FLUKES

Roberts, the management consultant, said that companies like Allstate attempt to pass off claims delays as fluke occurrences. But, he said, they are actually routine and intentional products of the McKinsey system: "The Allstate/McKinsey system for 'lowballing' claims payments ... is driven by the claims performance management and pay systems from the top to the bottom of the organization."

Feinman, the Rutgers law professor, also suggested the deck is stacked against individuals who make claims. "You have an accident or a fire in your house. You call up the insurance company. You describe the circumstances. Maybe they send an adjuster out, and they say it's not covered, or it's covered but here's the dollar amount that we're obligated to pay you," he said. Most people, Feinman said, do not have the expertise "to know whether or not that's right."

Allstate spokeswoman Laura Strykowski said the company can't comment on specific cases because of privacy requirements, but considers its claims process both legal and effective. "Our customers and claimants receive prompt and courteous claim service and our goal is to settle each claim fairly and efficiently," she wrote to HuffPost. "As a regulated company, Allstate's claim practices are available to and regularly reviewed by state departments of insurance."

But experts like Feinman argue that insurance regulation has become little more than a fig leaf. State insurance departments are usually understaffed and overwhelmed. And even if they had the legal firepower to contend with giant insurance companies, Feinman said, "the regulators are closer to the industry than they are consumers." Eleven of the past 15 presidents of the National Association of Insurance Commissioners (NAIC) went on to work for the insurance industry after leaving office, while a 17-year study from two Georgia State University professors found that around half of state-level insurance commissioners did so as well.

When combined with penalties that Feinman described as "laughably low" in many states, this close relationship means that regulation does not provide an effective check on insurance companies. And state governments themselves have incentive to place consumers on the backburner. Because insurance taxes are a major source of revenue for the states, said Roberts, insurance oversight commissions are usually more concerned with keeping companies solvent than resolving the problems of policyholders.

With the exception of the federal Affordable Care Act, insurance is regulated on a state-by-state basis. Although most states set a specific timeline for how quickly an insurance company must initially respond to claims, there is much more leeway when it comes to settling those claims. For example, in Missouri, an insurer must acknowledge receipt of a claim within 10 days and either pay or deny it within 15 days of receiving all necessary documentation. However, if the insurer decides it needs more time to investigate, it may keep delaying as long as it updates the policyholder every 45 days. In Georgia, where Burdette's house burned down, the insurer must notify the policyholder if it will affirm or deny a claim within 60 days. However, the insurer does not have to settle the amount it will pay within that period. Many states have similar provisions that allow insurers to put off paying claims indefinitely.

According to NAIC data, claim delays have long been the most frequent cause of policyholder complaint. As of Nov. 28, 2011, the NAIC had received 11,053 delay-related complaints this year alone, comprising almost a quarter of the year's total complaints. These data only reflect confirmed complaints -- the ones that the state insurance commission has investigated -- so the actual number of delayed claims is likely much higher.

Complaining to state regulators about the insurer's delay is always an option, but its effectiveness is questionable at best. "I have not seen it be successful," said Taff.

Lawsuit: Public Citizen represents patients' right to criticize dentist.

2011-11-30T17:51:00.000-08:00

PUBLIC CITIZEN PRESS RELEASE:
For Immediate Release: Contact: Angela Bradbery (202) 588-7741
Nov. 30, 2011 Dorry Samuels (202) 588-7742

Requiring Patients to Give Up Right to Criticize Medical Practitioners Is Unconscionable, Lawsuit Says

Public Citizen Represents Maryland Man in First-of-Its-Kind Suit Against New York Dentist

WASHINGTON, D.C. – A New York dentist’s requirement that patients sign a contract agreeing not to criticize her is unconscionable, and the dentist should be prohibited from forcing patients to make such a promise in the future, Public Citizen said in a lawsuit filed late Tuesday.

The suit highlights a growing trend: doctors and dentists conditioning medical care on patients promising not to post negative comments about them online. The pledges are contained in paperwork that patients must sign before the doctor or dentist will see them. Public Citizen represents Robert Allen Lee, a Huntingtown, Md., resident and former patient of the New York dentist, Dr. Stacy Makhnevich.

A North Carolina company called “Medical Justice” sells forms containing these conditions to medical providers, marketing the forms as an effective way to prevent negative comments that may have an adverse effect on their practices. Medical Justice has been quoted as claiming that about 3,000 doctors and dentists use its products, including these forms. This lawsuit is believed to be the first over the provision restricting criticism.

Moreover, the provision the dentist required the patient to sign in the case purported to give the dentist ownership of the criticism through a copyright clause. And Makhnevich has claimed that by posting criticism online, Lee was violating the copyright clause and so owes Makhnevich $100 a day.

“What began as a case of a sore tooth is now showcasing an unconscionable practice in which doctors and dentists force patients to leave their constitutional rights at the office door,” said Paul Alan Levy, the Public Citizen attorney representing Lee. “If people are upset about their care, they have a First Amendment right to tell people about it – by going online and posting their thoughts on Yelp, Facebook, Twitter and the like.”

The case began in October 2010, when Lee developed a severely sore tooth. The next month, he went to Makhnevich, whom he selected because the practice was covered by his insurance. Before he could be treated, he was handed forms to sign. One of them required Lee to agree not to publish any commentary about the dentist, not to disparage the dentist and to assign copyright to the dentist for any commentary that Lee wrote. Lee was reluctant to give up his right to publish commentary, but he was in severe pain and so signed the form.

Makhnevich billed Lee $4,766 for the dental work performed. Lee paid and asked the dentist to send the necessary paperwork to his insurance company, but the dentist sent the information to the wrong insurance provider. Lee then asked for his records so he could submit the claim himself; Makhnevich refused and instead referred Lee to a third party that demanded five percent of the total bill for copying the records.

In August 2011, Lee criticized Makhnevich on Yelp, DoctorBase and other online sites. The dentist then sent Lee a letter warning that Lee had violated the agreement and threatened to sue Lee for breach of contract and copyright infringement. The next month, Makhnevich contacted Yelp and DoctorBase and demanded Lee’s comments be removed. The review sites refused to remove the comments, because they regard purported copyright assignments as legally unenforceable. Makhnevich then sent invoices to Lee for $100 a day for copyright infringement in September and October, and sent another letter threatening to sue Lee.

This suit, which seeks class-action status, contends that the agreement Lee was required to sign is unconscionable and should be declared null and void. Further, requiring patients to surrender the right to publish truthful criticism violates medical practitioners’ duty to patients because they are placing their own interests above those of their patients. In addition, the agreement misuses copyright law to suppress expression.

“It is outrageous that a patient would have to sign away his constitutionally protected right to get treatment for a toothache,” Lee said. “I have to wonder what this dentist’s other patients have said to make her feel it was necessary to go to this extreme.”

Bruce Keller and Jeffrey Cunard of the New York-based law firm Debevoise & Plimpton LLP are co-counsel with Levy in the case.

A copy of the complaint is available at http://www.citizen.org/litigation/forms/cases/getlinkforcase.cfm?cID=706.

25% of an orthopedic surgeons' income may be from device industry payments!

2011-11-30T17:39:00.000-08:00

Link to article on study evaluating device industry payments to surgeons.

From Medscape Medical News

Some Orthos Getting 25% of Salary From Device Makers

Ricki Lewis, PhD

Authors and Disclosures

October 25, 2011 — Analysis of data on payments from orthopaedic device manufacturers to orthopaedic surgeons before and after a Department of Justice (DOJ) investigation illuminates a complex situation that requires further analysis, concludes a report published in the October 24 issue of the Archives of Internal Medicine.

Jason M. Hockenberry, PhD, now from the Rollins School of Public Health at Emory University, Atlanta, Georgia, and colleagues examined the information. The DOJ case considered payments for consulting, royalties, and research support, excluding reimbursement of travel costs.

In 2005, the DOJ began investigating payments made to surgeons providing hip and knee implants from the 5 manufacturers that sell 95% of these devices: Biomet Orthopedics, DePuy Orthopaedics Inc, Smith & Nephew plc, Stryker Orthopaedics, and Zimmer Inc. The 2007 settlement required the companies to disclose on their Web sites the name, location, and fees paid to each physician. Only DePuy, Smith & Nephew, and Stryker continued to post data through 2010.

In 2007, 939 orthopaedic surgeons received 1041 payments exceeding $198 million. In 2008, after the settlement, 526 orthopaedic surgeons received 568 payments totaling more than $228 million, but this figure fell to $119 million after subtracting a 1-time royalty buyout payment from Zimmer. Mean payments to orthopaedic surgeons were $212,740 in 2007, $193,943 in 2008, $246,867 in 2009, and $233,108 in 2010, which would make up at least 25% of a surgeon's annual salary. Payments ranged from less than $25,000 to more than $1 million, and the decline in number disproportionately reflected smaller disbursements.

Representation by academia showed a "modest increase" from 39.4% in 2007 to 44.9% in 2008, a percentage maintained in 2009 and 2010. This trend, the authors suggest, could reflect a strategy to target surgeons who train other surgeons. Yet Hockenberry and colleagues also note that more than 25% of the surgeons receiving industry money had fewer than 2 publications, indicating perhaps that industry is also targeting high-volume practices, in which presumably surgeons would have little time to conduct studies or write articles.

The physicians in the DOJ investigation represent only about 4% of the 25,000 orthopaedic surgeons in the United States. Although the settlement required that physicians disclose their relationships with device makers to patients, the authors cite studies suggesting that such payments might "interfere with physician judgment and pose a threat to scientific integrity and patient trust."

Limitations of the study, the authors write, include inconsistencies in categorizing payments and continued disclosure by only 3 firms. In addition, points out Robert Steinbrook, MD, from the Yale School of Medicine, New Haven, Connective, in an invited commentary, "the public data provide no information about how the payments relate to research and device development."

Dr. Hockenberry and colleagues conclude that, "universal and detailed disclosure with standardized reporting formats and data elements would make these data more useful to patients, providers, and policymakers." Because the Patient Protection and Affordable Care Act requires public disclosure of gifts and payments from drug and device industries to physicians, such practices will soon be more transparent.

Dr. Hockenberry and one coauthor received funding from the Department of Veterans Affairs. The coauthor also received support from the National Institutes of Health and the Robert Wood Johnson Physician Faculty Scholars Program, and consulted for Consumers Union and Vanguard Health. None of these sources provided support for this article. Dr. Steinbrook has disclosed no relevant financial relationships.

Arch Intern Med. 2011;171:1759-1766. Abstract

Mayo Clinic Elbow Replacement "opportunity".

2011-11-17T14:18:00.000-08:00

Link to Mayo Clinic YouTube video about elbow replacement.

It takes a mighty good joint replacement to be better than no joint replacement at all. Joint replacements are now the #1 expenditure of Medicare.

Where is the scientific evidence? There is no public accessible post-market registry. No plan to care for patients with the 20% or so failed joint replacements. No legal requirement for the surgeons to notify the FDA of adverse events. No warranty on product. Cleared through 510(k) process that the IOM Institute of Medicine 7/29/11 stated does not protect the patient from unsafe and ineffective joint replacements. Patient representatives/consumer representatives are restricted from full voting stakeholder position on FDA orthopedic medical device advisory panel. Aggressive marketing direct-to-consume and no transparency in surgeons' financial incentives from the medical device industry. How is this patient-centered?

'Occupy Health' Protesters at the Chamber of Commerce DC/Blue Cross

2011-11-16T09:43:00.000-08:00

Link to 5 minute video of peaceful occupation on 11/14/11

Sadly, it has come to this . . . healthcare is a "profit center" and an "industry" for the Chamber of Commerce. Health care leaders do things FIRST, not necessarily ethically.

Respect must be earned.

Leadership is doing it first. Wisdom is knowing the right thing to do. Integrity is doing the right thing. Character is doing it in the face of adversity. Grace is doing it even though the recipient appears undeserving.  Servant-hood is doing it even if it's "below your pay grade". Generosity is doing it with no expectation of reward or acknowledgement.

Failed implanted medical devices-Senate hearing Tuesday 11/15/11

2011-11-14T16:18:00.000-08:00

Click here to view video of Steven Baker's comments.

Hello.

My name is Steven Baker. These are my comments to be presented to the

November 15, 2011 - 2:30pm Senate Health, Education, Labor and Pensions full committee on Medical Devices: Protecting Patients and Promoting Innovation.

Have any of you heard of the 1950’s radio/TV show ‘Truth or Consequences’? The medical device industry lobby is playing the game ‘NO Truth and NO Consequences’ with Congress. Congress is enabling this industry to fleece the taxpayer of essential and limited healthcare funds and endanger patients and their families for profit. You must change Federal public policy.

On October 5 - ten years ago - I was a valued 23-year union millwright, proud Air Force veteran and father of two middle school children living on Cardiff Lane, less than a mile from Republican Congressman Erik Paulsen’s Minnesota 3^rd district office. That day I was offloading a clients’ catalog printing press to be compressed at a scrap yard when another worker’s mistake pushed me - forcing me to fall four feet down into the scrap. My right arm was badly mangled. Seven surgeries and 8 years later, it was clear that I could not return to the work I loved and I reluctantly began receiving SSDI for my permanent injury. My surgeon recommended that I consult the Mayo Clinic because there was a new innovative elbow joint replacement option that would reduce pain and increase function.

The Tornier Lateral Elbow prosthesis was surgically implanted in my right arm on May 19, 2008. It was paid for by private insurance covering my work injury. The healing process went well for several weeks, but then I noticed that - during movement - it would make a popping or creaking sound. Early in September 2008 in a phone conversation, I told my sister, Joleen Chambers, that the elbow was blue/green and I was in extreme pain. She was so concerned that she took it upon herself to fax the Mayo Clinic. On September 29, 2008 the prosthesis was surgically “revised” just 4 months after the original implant. The surgeon designer told me he would re-attach the radial stem to the head, but both components were removed and confiscated for 1 year. I asked the doctor to report the adverse event to FDA MedWatch. He didn’t. On November 18, 2008, number #5009052 was assigned to my self-report. Freedom of Information FOI reported March 4, 2009 that the file could not be located. There was no investigation.

I am now in medical and legal purgatory. The private insurance company is balking at paying for another surgery, I am in extreme and constant pain, the elbow does not function, my teeth are falling out because I have been prescribed long-term, maximum dose hydrocodone pain medication which dries the mouth, producing cavities that weaken my teeth so much that they disintegrate & disappear as I sleep. Tornier declines to help innovate a custom device solution. The Mayo Clinic sent me a letter stating that no care other than federally mandated emergency care would be provided.

I have done all the normal things an enlightened and empowered patient could do. I have tried to communicate first with my doctor, the hospital patient affairs office, the trustees of the Mayo Clinic, my U.S. Congressman Erik Paulsen, the U.S. Senators Al Franken and Amy Klobuchar and the FDA. All this I have done while disabled, medically impoverished and in pain.

Too late, I learned that medical devices are not properly regulated. Implanted medical devices should be given the most rigorous scrutiny, yet they are

cleared through the 510(k) process that on July 29, 2011 the IOM-Institute of Medicine-reported should be scrapped. There is no clinical testing prior to clearance and no national independent, robust post-market registry to show that innovations are any improvement over no surgical implant device or the ones that are currently available! Legal entitlement of the medical device industry conflicts with patient’s individual civil rights. My Mayo Clinic surgeon was the designer of the device and he also is paid to train other doctors by that device company-contrary to Mayo stated policy of having only salaried physicians on staff.

Joint replacements are now the #1 expenditure of Medicare. The life cycle of medical devices from inception to FDA clearance to market to surgical implant excludes the patient stakeholder. Patients/consumers and their advocates should be full voting partners in this endeavor. Marketing, politics and lobbying currently drive decisions by practitioners, purveyors, and payers in selecting what they anticipate to be life-enhancing implanted medical devices. Experience, data and science are evaded and suppressed.

On May 28, 2009 I had an appointment with Representative Paulsen. He and his staff offered me no constituent services and the meeting was brief. The revelation that he is spearheading the effort to eliminate medical device industry Medical Device User Fees clarifies his cavalier attitude about the failed implanted medical device that brought me to his office. My elbow was produced by Tornier, a company with its’ world headquarters just 6 short miles from his office.

Because of my disability I must leave my family and my life-long home in Minnesota each winter to avoid the painful cold and dangerous icy conditions.

Valuable jobs in the medical device industry will be secured only by a regulatory system that truly rewards safe and effective innovation. I am a big fan of innovation and proved it by twice trusting Tornier, the surgeon/designer and the Mayo Clinic with my life. My advice to this committee: halt this dangerous game of NO Truth and NO Consequences. Properly regulate this industry.

Contact :

Steven Baker 952.261.5204

Joleen Chambers

1717 Arts Plaza #2109

Dallas, TX 75201

h 214.965.9730

m 214.394.4432

Blog:

Failed Implanted Medical Devices

http://fida-advocate.blogspot.com/

Video:

http://www.youtube.com/watch?v=6yIZTafOZJw

Twitter: @JjrkCh

The monkey is being punished for the organ grinder's offense.

2011-11-11T07:21:00.000-08:00

Failed public policy by Congress has put in motion an aggressive and powerful medical device industry unfettered by consequences. Joint replacements are the #1 expenditure of Medicare.
Watch the Senate HELP Hearing on Medical Devices 2:30P Tuesday, November 15, 2001

Salisbury stent doctor sentenced to federal prison.
Cardiologist falsified patient records to justify unnecessary procedures

By Tricia Bishop, The Baltimore Sun
7:43 p.m. EST, November 10, 2011
John R. McLean, a Salisbury physician, was sentenced to eight years in federal prison Thursday, making him the second cardiologist in the country to face incarceration for implanting unnecessary coronary stents in dozens of patients, then fraudulently billing insurers thousands for the work.
A Louisiana doctor was sentenced to 10 years in prison in 2009 under similar allegations. And a half-dozen other physicians, including Towson's Dr. Mark G. Midei, are accused in civil lawsuits of overusing stents, though they have not been charged criminally.
"I conclude, sadly, that this was a crime of greed," U.S. District Judge William D. Quarles Jr. said of McLean's actions, which include falsifying patient records at Peninsula Regional Medical Center to justify the expensive procedures, then prescribing gratuitous follow-up tests for months afterward.
He was ordered to spend 97 months in prison, forfeit $579,000 in illegal proceeds and to pay the same amount in restitution to the public and private insurers he illegally billed. His lawyer plans to file an appeal and will ask that McLean, who was ordered to report for prison in February shortly after his 60th birthday, be allowed to remain free until the matter is resolved.
The sentence stunned his family, some of whom sobbed throughout the lengthy hearing, and sent a message about the "seriousness" of the crime, Quarles said.
Improper stenting has been a focus at the state and national levels over the past several years after Midei, a star cardiologist at St. Joseph Medical Center, was accused of implanting the tiny mesh tubes in hundreds of people whose arteries didn't need them. The allegations led to national media attention, a U.S. Senate inquiry, a multimillion-dollar settlement from the hospital and a debate in the medical community about the role of a physician's judgment in medical care.
Supporters of the embattled cardiologists — many of them stent patients — contend that the physicians are making sound calls based on certain symptoms. But malpractice attorneys, and in some cases prosecutors, say the doctors are overdoing the relatively simple procedures — which typically cost about $10,000 — driven by money and their egos.
McLean's desire to be the "biggest and the best cardiologist" at PRMC drove him to perform the unwarranted procedures, said Assistant U.S. Attorney Sandra Wilkinson.
"There's just some arrogance there," Wilkinson said. "At the end of the day, he made a lot of money, but he also made a really good reputation for himself."
McLean was indicted last year on charges he ran the fraudulent stent scheme from 2003 through 2007, when he resigned his practice privileges at PRMC after a hospital investigation. He was convicted this summer of health care fraud and of making false statements, and PRMC agreed to a $1.8 million settlement afterward to settle claims it did not put a stop to the improper procedures.
Several patients who received improper stents testified during the trial, according to court papers.
One man said he nearly died from blood loss after being required to take blood thinners. Another patient said she had a heart attack, brought on by the dye used in the procedure, while on the operating table.
"These people are looking to their cardiologists almost as if they're a god … we're talking about [their] hearts," Wilkinson said. "They're thinking that Dr. McLean is saving their life when really he's just looking for an opportunity."
McLean insisted he never meant to hurt anyone.
"I've worked hard all my life," he told the judge, characterizing himself as a perfectionist who lived for his practice, spending every other night on call for a decade and missing many of his daughter's milestones. The young woman, now 25, wiped away tears as he spoke.
"I never ever did anything intentionally dishonest to a patient," he said, denying that money drove him to do wrong. "I did the best I could, I always did the best I could."
He called himself a "broken man" and ticked off a list of ailments, including diabetes, vision problems and a previous heart attack. He said his mother is elderly and begged the court for "leniency and mercy" in sentencing.
His lawyer, Richard W. Westling, said he feared McLean would die in prison if forced to serve a lengthy term.
Quarles noted that McLean, a Baltimore native, had never been in trouble before, and commended him for the many good works he has done. Some of his supposed victims wrote letters to the court praising the doctor for saving lives and doing excellent work.
He "has done many positive things," Quarles said before sentencing him. "It's also clear that Dr. McLean implemented medically unnecessary stents for the basest of reasons … largely for the money."
Louisiana cardiologist Mehmood M. Patel, who was sentenced to 10 years in prison in 2009 after being convicted of 51 counts of fraud connected to improper stents, is also appealing his conviction and is free on bond. Arguments were heard in Patel's appeals case Tuesday.
Westling said he will be watching closely for the outcome.
tricia.bishop@baltsun.com

National Women's Health Network speaks out on failed dangerous medical device implants.

2011-11-10T10:59:00.000-08:00

About | Donate

Dear Friends,

Yet again the health and safety of women are taking a backseat to corporate interests! You’ve heard from us before about terrible harm done to women by dangerous – like devices breast implants and weight loss devices – that the Food and Drug Administration (FDA) has approved without adequate research to demonstrate that the products are safe and effective. Now the House of Representatives is considering 10 bills that would further weaken the FDA’s standards for medical devices. The changes proposed by the leadership of the House Energy and Commerce Committee would:

restrict what questions the FDA can ask the manufacturer about a new device
require the FDA to review devices faster without allowing adequate time to review safety concerns
change the FDA’s mission, tilting the balance away from protecting public health

Medical device manufacturers claim these changes are needed to foster innovation. But the NWHN believes that innovative medical devices have to be safe and effective, and they should address unmet health needs. If these bills become law, many more people would be exposed to untested devices that may be ineffective or dangerous. Innovative products that harm patients, will do no good for women’s health.

The experience of the millions of women who have been hurt by dangerous devices shows that the standard for approving medical devices is already too low. In many cases a company doesn’t even have to prove that a new device is safe and effective to be allowed to market it – all they have to do is prove that it is similar to a device already on the market. Congress needs to make the FDA’s standards for medical devices stronger – not weaker -- and to encourage the agency to do a better job monitoring what happens to the devices it has approved.

Contact your Representative and urge them to protect women’s health by opposing these 10 bills and supporting legislation that would raise the standard for device approvals and provide the FDA with the authority it needs to conduct adequate post-market safety surveillance.

Thank you,

Cindy Pearson
Executive Director

P.S. Be sure to "Like" us on Facebook and follow us on Twitter to keep up with the latest women's health news.

National Women's Health Network

PH: 202.682.2640 | FAX: 202.682.2648 | For health information: 202.682.2646
1413 K Street, NW, 4th floor, Washington DC 20005
www.nwhn.org

FDA fee for 90% of device applications is less than $5K

2011-11-09T08:56:00.000-08:00

The FDA requires adequate industry financial support for essential regulatory protections.

The Patient, Consumer, and Public Health Coalition Priorities:
Medical Device User Fee Act (MDUFA III) Reauthorization

Every five years, the FDA’s user fees for prescription drugs and
medical devices must be reauthorized, and that legislation has to pass
because the FDA could not survive without it. Negotiations between
the medical device industry and FDA on the medical device user fees
have been contentious this year. If device companies keep refusing to
significantly increase user fees over the next 5 years, patients will
be harmed.
User fees improve staffing and resources needed to ensure the safety
and effectiveness of millions of devices that we all rely on, such as
contact lenses, mammograms, artificial knees, and tests for HIV and
cancer. However, the user fees should be used to improve the ability
of the FDA to ensure safety and effectiveness, not just to speed up
the review process. When the FDA lacks resources to do its job well,
it means more recalls, which are bad for patients and companies. For
example, recent recalls of dangerous hips will cost billions of
dollars for replacement surgery paid by Medicare, Medicaid, VA, and by
individual taxpayers. Recalls also mean red ink for companies and job
losses for employees.
We support legislative and regulatory efforts to bring safe and
effective devices to market as quickly as possible. However, ensuring
proof of safety and effectiveness is the most important mission of the
FDA. Careful review and clear, consistent FDA policies ensure that
new medical products will be beneficial to patients and consumers as
well as the companies’ financial health.
More than 90% of medical devices are not required to be proven safe or
effective in clinical trials, and instead are reviewed through the
510(k) process, which is much less rigorous than the approval process
for medications. The recent Institute of Medicine report on medical
devices stated that the 510(k) process should be replaced because it
does not determine that a device is either safe or effective. It
notes that 510(k) approval decisions are based on their substantial
equivalence to devices already on the market—which were also not
necessarily proven safe and effective. The report also concluded that
the process “does not reward innovation” and it can’t be determined if
the process “has had a positive or negative effect on innovation.”
Given the FDA’s lack of resources and pressures from industry to
quickly approve devices, the Agency will not revamp the 510(k) process
in the near future. We therefore recommend incremental changes based
on the IOM recommendations and other reports.
For MDUFA reauthorization, we support reforms that:
• Strengthen the standards for approval, such as requiring clinical
trials for implanted devices
• Create a unique ID system for medical devices, similar to the one
for cars and toasters
• Improve the adverse event reporting database for devices (called
MAUDE)
• Review direct-to-consumer (DTC) advertising before it can be used,
to ensure accuracy
• Revamp the de Novo process, but not as a substitute for a PMA for
higher-risk devices.
We oppose efforts to weaken the conflict-of-interest rules for
advisory committee members.
User fees for medical devices are dramatically lower than user fees
for drugs. The FY2012 user fees for more than 90% of device
applications, including artificial hips and knees and many cardiac
devices, is $4,049 per application (less than half of 1% of the cost
of a drug application). The largest companies currently pay user fees
of $220,050 for the most complicated life-saving device applications,
which is 12% of the same company’s user fees for prescription drug
applications ($1,841,500), and about 20% of what the device review
actually costs the FDA. Smaller companies pay much less in user
fees. As a result, FDA lacks the resources it needs to review device
applications in a timely and comprehensive manner, and to require the
clinical trials that are needed to assure the safety of all implanted
devices. Congress must ensure that the FDA has the appropriations it
needs, and device user fees must make a more equitable contribution.

FDA report: Adverse events grew 17%, the medical device industry grew by 9%

2011-11-07T19:38:00.000-08:00

Report: Growth in Medical Device Adverse Events Outpaces Industry Growth

By Abby Callard | November 02, 2011

The medical device industry grew 9 percent annually from 2001-2009, but serious adverse events — death, life-threatening condition, disability or hospitalization — grew 17 percent during that same time period, according to an FDA report.

The report also found cardiovascular, in vitro diagnostic and general hospital/surgical devices accounted for 60 percent of all adverse events reported. Twenty of the 1189 active product codes accounted for 65 percent of all serious adverse events reported between 2005 and 2009.

The report is part of an FDA initiative with the Center for Devices and Radiological Health to assess and understand gaps in medical device quality and create a plan for improvement.

"Attempts to improve quality are hindered by challenges within the industry as well as specific aspects of the Agency's regulatory approach. Moving toward greater visibility into device quality and properly aligning FDA's regulatory approach will be important to catalyzing industry movement towards improved device quality. Investment by FDA now in a holistic quality infrastructure will support a next generation of medical devices that are as safe and well made as they are innovative," the report said.