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

LINK HERE: full article

Some states taking medical board cash

By Andis Robeznieks

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

Tags: Minnesota, Physicians, Quality

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2010 and 2004, and that state boards did not take action against 167 physicians whose hospital admitting privileges had been revoked after being deemed an “immediate threat to health or safety.”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.

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.

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

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

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.

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.

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

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

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"

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.

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

	Stop the FDA's Harassment of Whistleblowers The FDA's illegal program of singling out whistleblowers for special monitoring has become national news. When the FDA found out that employees had reported dangerous medical devices, it decided to squash the employees rather than the faulty products. FDA managers put industry interests above patient safety. Senator Grassley and Representative Issa have now launched Congressional investigations of the FDA, demanding answers about why whistleblowers were singled out for special surveillance Please follow the link above and support the federal employees that are doing their jobs:  protecting the citizens of the United States.

State of the Union & National Research Center & Consumers Union

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

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

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

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 !

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.

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.

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!