START A PETITION 25,136,189 members: the world's largest community for good
START A PETITION
x
1,330,656 people care about Politics

Corporate Cash Pushing For Weaker Medical Device Oversight

Corporate Cash Pushing For Weaker Medical Device Oversight

A new report by the watchdog group Public Citizen exposes the massive lobbying efforts by the medical device industry designed to weaken already lax oversight and hasten review of high-risk products.

The report “Substantially Unsafe” coincides with today’s hearing in the U.S. House of Representatives over the re-authorization of the Medical Device User Fee Act (MDUFA) and highlights the dangerous influence corporate lobbyists play in writing our laws.

For example, the report highlights that the device industry dispatched at least 225 lobbyists, including 107 previously employed by the federal government, to work on medical device regulatory issues in just the third and fourth quarters of 2011. Nearly half of these lobbyists entered the legislative push in the fourth quarter, as Congress prepared to take up the issue. These lobbyists sponsored at least 40 fundraisers for members of Congress in 2011. The industry spent $33.3 million on lobbying in 2011, bringing its total to $158.7 million since 2007. The industry has made nearly $20 million in campaign contributions to federal candidates since the 2006 election cycle with sponsors of 10 House bills that try to weaken FDA approval standards receiving a near three-fold increase in campaign funds.

“The industry is campaigning for expanded regulatory loopholes and subpar standards – measures that would put more and more patients at risk for encountering unsafe devices. These demands represent exactly the wrong course of action for Congress,” said Negah Mouzoon, researcher with Public Citizen’s Congress Watch division and the lead author of the report. “Congress instead should insist that standards be strengthened and that the FDA step up its efforts to remove demonstrably dangerous devices from the market.”

In fact, the report uncovers that the need for stronger FDA oversight and enforcement, not the opposite. The Food and Drug Administration (FDA) receives reports of more than 200,000 device-related injuries and malfunctions every year, and more than 2,000 deaths. In recent years, recalls for both moderate and high-risk devices have more than doubled .

The report identifies a handful of problem devices to underscore this point. Recently recalled devices include an implantable pad designed to shield breast tissue from radiation treatment that sheds small particles of tungsten into the breast; an infusion pump that shuts down unexpectedly or dispenses an incorrect dose of medicine; faulty defibrillators that inappropriately deliver severely painful and potentially dangerous electrical jolts to the heart; a surgical clip designed to clamp off arteries that pops off, causing patients to bleed to death internally; and an artificial hip that sheds metal fragments into the bone and surrounding tissue, wearing away tissues and causing extreme pain and limited mobility.

For those riskiest devices approval is often easiest to come by, and industry lobbyists are working hard to make this flawed process even worse. The process for approving the highest-risk products (called the premarket approval (PMA) process) is much weaker than that used for approving new drugs.

Worse, the process used to clear at least 95 percent of moderate- and high-risk medical devices is shockingly less stringent than that used for the sliver of devices subject to the PMA process. This process, called the 510(k) process after a section of legislation, clears devices based on a mere demonstration that they are “substantially equivalent” to devices already on the market, which provides little assurance of safety or effectiveness, especially because most of the existing products were never demonstrated to be safe or effective. The Institute of Medicine in 2011 recommended that the FDA scrap the 510(k) process because it does not ensure safety or effectiveness.

The changes industry lobbyist are pushing for would ultimately undermine the entire purpose of the agency.  These bills would further reduce already weak standards for clearing and approving medical devices; shift the emphasis of the FDA’s mission from protecting public health to promoting medical innovation; weaken the “conflict of interest” prohibition for serving on the FDA advisory committee that oversees device approvals; expand “third-party” companies that can review a device application to include those with significant financial relationships with the device industry; and more.

“Many patients would be shocked to learn that, unlike prescription and over-the-counter drugs, many moderate- and high-risk devices, including many that are surgically implanted, have either never been tested to ensure that they are safe and effective or have undergone woefully inadequate testing,” said Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group and co-author of the report. “Congress should reject the medical device industry’s lobbying campaign to weaken medical device regulations and instead require a dramatic overhaul of the device approval and clearance processes to improve patient safety.”

Congress is right to review the medical device clearance and approval process, but what it is considering as a replacement is simply unacceptable. Public Citizen has outlined a series of reforms that would represent real protections for consumers without stifling innovation and growth. Among those reforms include a call to Congress to replace the medical device clearance and approval processes with a process that requires the same scrutiny as new drugs. In the interim, Congress and the FDA should require additional safeguards for the current 510(k) process, more rigorous clinical trials for PMA applications, stricter reporting of adverse events, the maintenance and analysis of a database of device recalls to ensure that they are implemented effectively, and improved device tracking to patients.

Congress also needs to restore the ability of patients to sue certain manufacturers of defective devices– a right taken away in the 2008 Supreme Court decision of Reigel v. Medtronic.

Without an effective and aggressive FDA to police the medical technology industry consumers will fall prey to the drive to maximize corporate profits. We should not allow corporate interests to trump public welfare in any context, but this is especially true with regards to health care where lives are quite literally on the line.

Related Stories:

House GOP Gaming Ethics Reform

ALEC Makes Another Push For Tort Reform

Read more: , , , , , ,

Photo from tracy o via flickr.

have you shared this story yet?

some of the best people we know are doing it

17 comments

+ add your own
7:13AM PST on Feb 8, 2013

sad, thanks for article!

4:37PM PST on Feb 16, 2012

Like the old saying goes: "Don't get sick in America". Yeah, right.

11:46AM PST on Feb 16, 2012

Shameful, money talks and we get screwed.

11:15AM PST on Feb 16, 2012

This is what you get, when the culture worships the dollar rather than life. There's good reasons that people end up dying, when that's CHEAPER than having a properly made product.

8:59AM PST on Feb 16, 2012

It's a simple equation: less oversight means higher profits.

However, it is an equally simple equation that less oversight means more death.

This isn't a choice between good math and bad math; as equations, both are equally valid. The issue is whether or not human life and safety are worth more than increasing corporate profits.

6:53AM PST on Feb 16, 2012

It's time to boycott the Medical-Industrial complex! Starve the corporatocracy!!!

6:05AM PST on Feb 16, 2012

Where did my comment go?Since where did yahoo start and end? I thought this was care.com? I thought my comment was clean and to the point?
FDA is suppose to be there for the health and safety protection of the citizens of this country, not another government agency plagued by corruption. The vicitms of such medical device failures are the ones who lose this battle. Not the makers of these devices for their inept and sleazy behavior, or the lawyers who file class action suits who take most of the money that is rewarded to the victim or victim's family for their loss of life and monetary losses and limited life expectancy, because of such medical device failures.

5:55AM PST on Feb 16, 2012

Yeah! That's always a smart move. For every medical device that fails, there will be more class action suits. For the victims of such failed devices, they end up on the losing side no matter what happens. Even if they sued, they will never get their lives back or the money owed, because the lawyers take most of it, the court costs, etc. This is not only dangerous to the health of many, but not economically feasible. If there are any spelling errors, I am sorry for that.

5:43AM PST on Feb 16, 2012

Follow the wallet ladies and gentleman, even the current administration has deep pockets with big pharma and monsanto. Health care isn't based on "need" of society it's based on what's 'hot', what's 'wired' and the squeaky wheel.

5:29AM PST on Feb 16, 2012

Just another example of America at its best.

add your comment



Disclaimer: The views expressed above are solely those of the author and may not reflect those of
Care2, Inc., its employees or advertisers.

ads keep care2 free
Story idea? Want to blog? Contact the editors!
ads keep care2 free

more from causes

Animal Welfare

Causes Canada

Causes UK

Children

Civil Rights

Education

Endangered Wildlife

Environment & Wildlife

Global Development

Global Warming

Health Policy

Human Rights

LGBT rights

Politics

Real Food

Trailblazers For Good

Women's Rights




Select names from your address book   |   Help
   

We hate spam. We do not sell or share the email addresses you provide.