Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements.
Twitter: JjrkCh

Friday, October 28, 2011

Cutting MediCARE but not MediCOSTS ! Bipartisan greed.

(link) Minneapolis Star Tribune Editorial ignores patient safety issues.

Please add your comments on the Star Tribune webpage!

This editorial in the Minneapolis Star Tribune gushes over innovation and bipartisanship, but misses the point: jobs and profit do not trump patient safety.
It is critical that the medical industry listen to citizens and patients-we support our doctors and innovation that proves to be safer and more effective, but joint replacement is now the #1 expenditure of Medicare.  Elders do not need an expensive and questionably functional hip/knee/stent/pacemaker at age 65 that may bankrupt the Medicare program.
Medical devices are proliferating and the medical device industry refuses to respond to overwhelming information that nearly 20% of their products fail placing patients in medical and legal purgatory.  The independent IOM (Institute of Medicine) reported on 7/29/11 that the FDA clears most implanted medical devices without any pre-market clinical testing.  Further, there is no post-market data registry, making it nearly impossible for patients and their trusted clinicians to make intelligent decisions about which device would enhance their lives.  When devices fail, the cash-strapped FDA is not usually the entity that informs the public:  registries in other countries caught 37,000 DePuy Johnson & Johnson hip failures.  There is no warranty on product.

Thursday, October 27, 2011

Consumer Reports: Essential Medical Harm Prevention Tips from Patient Advocates

Consumer Reports Health logo
Patient-safety advocates offer some unusual tips
Oct 26, 2011 5:10 PM
A group of 32 advocates from our Safe Patient Project gathered at our headquarters in Yonkers yesterday to talk about making hospitals safer places for patients. One theme: Do your homework, and get information from lots of different sources. Here are five of their more unusual suggestions.
1. Watch a You Tube surgery video. OK, not everyone really wants to know exactly what’s entailed in, say, a hip replacement. But one of our advocates said that too often patients underestimate what surgery really involves, and thus take the procedure and recovery too lightly. Nothing, he says, can wake you up to the reality like seeing the operation being performed. And you might be surprised what you can find online.
2. Yelp! Granted, anecdotal information is no substitute for data. And hospitals are unlikely to have more than a few user reviews. But reading through patient experiences on Yelp! might alert you to some of the snafus other patients ran into.
3. Ask a malpractice attorney. After several botched procedures, one advocate said he finally asked a lawyer in town…who turned out to have lots of insights into which surgeons to see, and which ones to stay away from.
4. Bring a wireless device to the hospital. Doesn’t matter if it’s a smart phone or computer or iPad, but bring something so you can do research on the fly.
5. Don’t be alone. Actually, just about everyone said this. The single most important thing you can do, they emphasized, is to make sure you have a friend or family member with you as much as possible to act as your advocate and to keep a record of what’s going on.
Read more about our Safe Patient Project. And check out our tips on how to stay safe in the hospital as well as our hospital Ratings for comprehensive information about hospital infection rates and patient experiences.
—Joel Keehn

Tuesday, October 25, 2011

The medical device industry venture capitalists fund politicians.

(link) Medical device venture capitalists fund friendly politicians.


October 25, 2011

Venture Capitalists Put Money on Easing Medical Device Rules



One afternoon last spring, a little-known congressman from Minnesota made an impassioned plea before a House oversight committee.
Rein in the Food and Drug Administration’s uncertain approval process for new medical devices, urged the Minnesota congressman, Erik Paulsen, or Minnesota and other states stand to lose up to 400,000 jobs because of lost investment in the device industry.
Over the following month, Mr. Paulsen’s campaign committee took in $74,000 from people with a stake in device regulation, much of it from executives affiliated with venture capital funds and their spouses. Now Mr. Paulsen, a two-term Republican, is a sponsor of a bill that would make it easier to bring new medical products to market.
As Congress considers reauthorizing a law that sets the fees for medical device makers, venture capitalists are emerging as a rich and influential ally of device companies eager to remove what they say are regulatory roadblocks in the approval process. The push has alarmed patient advocates and some doctors, who have been calling on the F.D.A. to intensify its oversight of devices, particularly in light of some all-metal artificial hips that are failing prematurely at an unusually high rate.
“They have this unwritten assumption that every new device is innovative,” Dr. Rita Redberg, who is the editor of the Archives of Internal Medicine, said, referring to the venture capital funds. But some devices, she said, “are killing people or causing significant harm.”
People associated with funds that underwrite companies developing new devices and other health products have made more than $3.3 million in political donations to Republicans, Democrats and political action committees over the past five years, according to an analysis of federal contributions by The New York Times.
Though such people donate for many reasons, about 20 percent of the money from the 182 donors identified by The Times went directly to candidates and political action committees supporting a streamlining of F.D.A. policy or other issues of importance to medical products producers. The total contributions from such donors could be much higher; The Times limited its analysis to individuals affiliated with venture capital funds that have joined two lobbying associations.
to run new and costly tests constantly, often duplicating past efforts.
Investment funds and business groups have also increased their lobbying in Washington and have generated a stream of reports arguing that regulations are crippling innovation and driving away investment.
“This is about survival,” said Michael Carusi, a general manager at an investment fund in Palo Alto, Calif., Advanced Technology Ventures, who contributed $1,000 to Mr. Paulsen. “We are deeply concerned about the future.”
Medical devices encompass a wide array of products, such as heart defibrillators, artificial joints and diagnostic equipment.
Lobbying to smooth the approval process has intensified over the last year as Congress prepares to reauthorize the law that requires device producers to pay fees to the F.D.A., fees that are used to pay the agency’s operating costs. Lawmakers have an opportunity to alter the agency’s regulatory procedures for the first time since the law last came up for renewal in 2007.
An industry lobbying group, the National Venture Capital Association, has intensified its focus on device regulation. In 2010, the association, which lobbies on many issues, spent more than $2.5 million, according to data from the nonpartisan Center for Responsive Politics. About $350,000 of that was related to devices, drugs and health care, a figure that is expected to increase to $450,000 this year, said an association spokeswoman, Emily Mendell.
While it is not unusual for businesses to point to regulation as a barrier to economic and job growth, medical device investors have found a particularly receptive audience on Capitol Hill in recent months. In October alone, 10 bills have been introduced by Republicans in the House to speed up the F.D.A. device approval process; in the Senate, similar legislation has been introduced by Amy Klobuchar, a Democrat of Minnesota.
Since February, four House panels have held hearings on the impact of F.D.A. procedures on device approval. At those sessions, 19 of the 26 listed witnesses were investors, entrepreneurs, industry consultants, trade group officials or patients who said that agency delays in approving a device had harmed them or a loved one. The list included no patients injured by a flawed device; one hearing in the Senate had a more varied witness list. Two weeks ago, four Democratic congressmen wrote to their Republican counterparts about the imbalance in the House testimony and suggested the hearings had failed to address potential dangers “if medical devices are not appropriately regulated.”
The letter, signed by Henry A. Waxman of California, Diana DeGette of Colorado, John Dingell of Michigan and Frank Pallone of New Jersey, also urged that hearings be held on the metal hip problem and similar issues.
Venture fund executives like Mr. Carusi and lawmakers like Mr. Paulsen insist that they are equally concerned about safety. However, in their view, a big part of the problem at the F.D.A. is philosophical; top officials, these critics say, have overreacted to recent episodes involving flawed products and become risk-averse. As a result, devices are available first in Europe, they say.
“The key is to strike the right balance,” said Dr. Josh Makower, a device developer and a consultant to New Enterprise Associates, a venture fund in Palo Alto.
F.D.A. officials said they have recently tried to address investors’ concerns by announcing programs to encourage innovation and reduce regulatory burdens. Still, the head of the agency’s device division, Dr. Jeffrey E. Shuren, said that executives like Dr. Makower seemed more interested in politicizing the issue than resolving it through discussion.
“The dialogue has become more political and adversarial,” Dr. Shuren said.
Some medical experts have also questioned recent studies about the negative impact of regulations, calling the reviews flawed in methodology.
William Vodra, a lawyer in Washington who has worked closely with medical device producers, said that investors had legitimate concerns about regulatory speed. That is because the approval of a new device can begin a process in which a start-up company is acquired by a larger manufacturer and early investors profit by cashing out.
But such investors may be less interested in what happens to that device after it reaches the market because they have already moved on, said Mr. Vodra, who served on an Institute of Medicine panel that recently concluded the F.D.A. failed to properly assess the safety and effectiveness of many new devices.
Mr. Paulsen, the Minnesota congressman, did not respond to requests for an interview. But a spokesman, Tom Erickson, said that the lawmaker’s testimony this spring was unrelated to any campaign donations and reflected his long-held view that the F.D.A. was undermining an industry crucial to Minnesota.
“He gave his testimony because he feels these jobs are being threatened by an inconsistent and unpredictable F.D.A.,” Mr. Erickson said. Mr. Paulsen, along with Democrats and Republicans from states that are home to device makers, has also sought to repeal a tax on sales imposed on the industry under the health care overhaul law.
Dr. Makower, the venture fund consultant, has donated $5,000 to Mr. Paulsen, records show.
“I think that he understands this issue,” said Dr. Makower.

Simply put, the industry’s champions argue that the F.D.A. suffers from high personnel turnover, an unwieldy bureaucracy and a regimen that forces start-up device companies 

Medical Device industry woos your surgeon!

(link) Reuters reports that Orthopedic surgeons have received hundreds of millions of dollars from joint implant manufacturers in recent years, according to a report released Monday.

Thursday, October 20, 2011

The goal is safer patients - the tool is transparency!

(link) An implanted joint replacement device must prove that it is better than no device at all.


Hip Surgery Option Loses Key Backer


Injury From Metal Debris in Artificial Hips

All hip implants shed particles as they wear. Over time, debris from plastic components can lead to bone loss and device loosening. But in some patients, researchers believe, metallic debris, which is finer and greater in volume, can set off a different, more aggressive response.Related Article »

"media spin" to cover reductions in hip, knee replacements

(link) The medical device industry does not "own up" to post-market failures.

Joint replacements are the #1 expenditure of Medicare.

IOM 7/29/11 stated that the FDA 510(k) should be scrapped.
No post-market independent registry.
No warranty on product.
Industry entitlement from state court justice.
Patient/consumer stakeholders restricted from voting in FDA advisory panels.
Direct-to-consumer misleading advertising.

Mercury Fillings are a Failed Implanted Medical Device FiDA

(link) Cautionary YouTube video about mercury toxicity and dental amalgam

FDA Town Hall meetings in Irving, TX  3/10/11 and San Francisco 9/22/11 were attended by speakers on this topic.

Congratulations!: $25,000 Award to Empowered Patient Coalition

(link) Consumers Union - Excellence in Consumer Advocacy - Winner 

(link) Empowered Patient Coalition

Tuesday, October 18, 2011

Device Data and essential Patient Rights

Hugo Campos serenades Medtronic in this YouTube video. (link)

(video link) Hugo Campos at Patient 2.0 in SF 9/25/11

He is talking about basic citizen rights!  Please help him by communicating this issue to your U.S. Representatives today.

Hugo was a fellow speaker at the FDA SF Town Hall meeting 9/22/11 and the Health 2.0 conference in SF.
Dr. Jeffrey Shuren (FDA/CDRH Director) agrees with Hugo that patient data should belong to the patient!

FaceBook:  www.facebook.com.bit.ly/ICDUG
Blog: ICDUserGroup.org
Twitter:  ICDUserGroup.org

Entitlement demand by pharma CEO

Pfizer CEO: Direct-to-Consumer ads are a "fundamental right" !!

my posted comment:
To stop DTC (direct-to-consumer) bad ads contact: Deborah A. Wolf, JD, Regulatory Counsel, Office of Compliance FDA/CDRH deborah.wolf@fda.hhs.gov DTC direct-to-consumer advertising for implanted medical devices such as hips and knees is driving sales and unrealistic expectations by younger/”boomer” consumers while joint replacement is the #1 expenditure of Medicare. In the September/October 2011 issue of AARP magazine, page 11, Johnson & Johnson touts a hip replacement by picturing a young-ish, attractive bicyclist (philanthropist) climbing a hill. IMPORTANT UNSTATED CAVEAT: The demographic for most hips is a woman in her seventies. Joint replacements are expected to function only for approximately 15 years. If a patient experiences device failure the doctor is not legally required to report the failure and there is no device warranty. FDA MedWatch does not provide a registry of post-market data nor does it systematically follow up on adverse events. The medical device industry gained pre-emption (entitlement) from state court in Supreme Court decision 2/2008 Riegel v. Medtronic placing patients in medical and legal purgatory. When devices are cleared for the U.S. market the FDA uses 510(k) process that does not require any clinical testing nor a vote by an advisory committee. Patient and Consumer Representatives on the advisory committee are not full stakeholders and are not allowed to vote.--- Sick and wrong! Public health and healthcare funding suffer for private greed.

Friday, October 7, 2011

Medical Malpractice Limits Do Not Belong in Deficit Proposal

Twenty one patient advocacy groups write to Congress. (link here)
October 6, 2011

Rep. Jeb Hensarling, Co-Chair Sen. Patty Murray, Co-Chair Joint Select Committee on Deficit Reduction
CONSUMER AND PATIENT SAFETY GROUPS STRONGLY OPPOSE INCLUDING ANTI-PATIENT MEDICAL LIABILITY LIMITS IN YOUR FORTHCOMING DEFICIT REDUCTION RECOMMENDATIONS
Dear Co-Chairs Murray and Hensarling:
The undersigned consumer and patient-safety groups strongly oppose including restrictions on patients’ legal rights in your deficit reduction recommendations. That would include provisions like those embodied in H.R. 5, the Help Efficient, Accessible, Low-cost, Timely Healthcare Act of 2011 and in recommendation 3.3.12 of the report by the National Commission on Fiscal Responsibility and Reform (Bowles-Simpson Commission). Such legal limits would not only severely harm already injured patients, but would also increase the deficit in significant ways. Moreover, imposing federal malpractice laws on all 50 states would be an unprecedented interference with states and the work of local judges and juries.
Even if H.R. 5’s provisions applied only to doctors and hospitals,1 the Congressional Budget Office (CBO) believes they would save no more than 0.4 percent in health care costs, which is likely a significant overestimate.2 At the same time, CBO admits that the U.S. death rate could increase by 0.2 percent, killing another 4,000 people each year.3 But CBO and the Bowles- Simpson Commission failed to consider new financial burdens on the government should these laws pass:
New Burdens on Medicaid and Medicare. If a patient is brain damaged, mutilated or rendered paraplegic as a result of the medical negligence but cannot obtain compensation from the culpable party through the tort system, he or she may be forced to turn elsewhere for compensation, typically taxpayer-funded programs such as Medicaid and Medicare. None of these increased Medicaid costs are considered.
Liens and Subrogation. Following a successful medical malpractice lawsuit, Medicare and Medicaid can both claim either liens or subrogation interests in the patient’s recovery, reimbursing the government for some of the patient’s health care expenditures. Without the lawsuit, Medicare and Medicaid will lose funds that the government would otherwise be able to recoup.
Patient Safety. Provisions that would restrict the health care industry’s liability would weaken the deterrent potential of the tort system (which even CBO acknowledges but does not consider in its cost calculations), leading to less accountable and more unsafe
1 H.R. 5’s provisions are not limited to doctors and hospitals. In fact, H.R. 5 is so broadly drafted that it would also limit remedies against the for-profit nursing home, insurance, and pharmaceutical industries. 2 http://www.cbo.gov/ftpdocs/106xx/doc10641/10-09-Tort_Reform.pdf. 3 Id.hospitals, and with accompanying increases in cost and physician utilization inherent in
caring for newly maimed patients. 
Joint-and-several liability. According to CBO, modifying joint and several liability
“may increase the volume and intensity of physician services.”4 In other words, this change could cause a deficit increase, not decrease.
The policies in H.R. 5 and the Bowles-Simpson recommendations explicitly preempt state law, denying states the freedom to create their own approach to malpractice liability and to decide what is in the best interests of the people in their states.
In sum, your committee should focus on reducing the deficit, not on increasing the burdens on taxpayers, encroaching on states’ rights, and insulating negligent providers from accountability. We strongly urge your committee to exclude medical liability restrictions from your forthcoming deficit reduction recommendations.
Sincerely,
Alliance for Justice 
Alliance for Safety Awareness for Patients (ASAP) 
Center for Justice & Democracy
Compassion & Choices 
Connecticut Center for Patient Safety 
Consumer Action 
Consumer Watchdog 
Consumers Advancing Patient Safety (CAPS) 
Consumers Union 
Mothers Against Medical Error 
MRSA Survivors Network 
New Hampshire Patient Voices 
Patient Safety America 
Public Citizen 
Sepsis Alliance South Carolina 
Voices for Patient Safety (SCVPS) 
Texas Watch 
The Coalition for Patient's Rights 
The Empowered Patient Coalition 
The National Consumer 
Voice for Quality Long-Term Care 
WoodyMatters
cc: Sen. Max Baucus Rep. Xavier Becerra Rep. Dave Camp
4 Center for Justice & Democracy, TELLING THE TRUTH ABOUT MEDICAL MALPRACTICE: A “RETORT” TO THE NATIONAL COMMISSION ON FISCAL RESPONSIBILITY AND REFORM REPORT, “THE MOMENT OF TRUTH”, December 2010, available at http://centerjd.org/archives/issuesfacts/DeficitAnalysisF.pdf.
Rep. Jim Clyburn Sen. John Kerry Sen. Jon Kyl Sen. Rob Portman Sen. Pat Toomey Rep. Fred Upton Rep. Chris Van Hollen

Saturday, October 1, 2011

Congress must act immediately to protect patients

Link here: NYT: Mounting Evidence about Failed Implanted Joints
Demand that Congress act to
-give FDA Patient & Consumer Representatives full voting stakeholder rights
-revoke Supreme Court 2/2008 decision Riegel v. Medtronic - which violates citizen basic rights to justice
-require a device warranty on a percentage of the defined life of the product
-have a robust registry similar to the Clarimed system that was launched at Health 2.0 conference 9/2011

Safe and effective products:  the medical device industry must look inward and respond with integrity to this criticism.  A defensive posture is status quo.