Regina Holliday/Mayo Scholarship & Medical Device Safety

Regina Holliday's Medical Advocacy Blog: Spare Parts: When I was a young teen I went with my little sister Esther to get my ears pierced at Claire’s Boutique in the local Mall.  If you are n...

Medical Errors

http://www.peoplespharmacy.com/2012/07/21/865-the-hidden-epidemic/index.php

Joleen C. | July 21, 2012 3:27 PM | Reply

It is very disturbing yet essential that Robert M. Wachter, MD, Professor and Associate Chair of the Department of Medicine at the University of California, San Francisco and chief of the medical service at UCSF Medical Center must communicate to the public about the epidemic of hospital errors.

In addition to the lack of accountability of hospitals and an increase in errors at for-profit hospitals, there is a parallel in the medical device industry. Joint replacement is the #1 expenditure of Medicare, yet we learn of the devastating failure of metal-on-metal hips from foreign registries after tens of thousands of implants and revisions have taken place.

The FDA charter does not legally require surgeons to report device failures unless there is a fatality. 510(k) approvals allow untested devices to be implanted with no independent post-market follow up. Patient harm is not acknowledged and therefore the patient harm continues unabated. The industry gets more profitable and powerful and potentially more destructive of limited public healthcare funding.

The cries to protect industry jobs and threats that the industry will abandon the U.S. to profit overseas would not be necessary if the products were actually safe and effective, as advertised.

MAC | July 21, 2012 7:52 PM | Reply

Excellent program.

Although it was mentioned how in some cases "mistakes" are made for the sake of profits, it was not said that many well intentioned health care providers cannot report these systems due to gagging clauses in their contracts.

Those who report issues to their upper levels many times face hostility and have to leave their jobs.

Is about time to lobby for legislation that protects "whistle blowers" on issues of safety and negligent practices. Including cancellation of "non compete" clauses on their contracts when they have to leave their jobs after reporting their institution/employer.

Thanks.

Listen to the program that prompted these responses:

The audio link to the People's Pharmacy is here!

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Joleen C. – Scholarship Contest Essay

Posted on July 16, 2012 by Randy Schwarz

Editor’s Note:  Joleen C. is a patient/caregiver who submitted the following essay as part of the Mayo Clinic Center for Social Media Patient, Caregiver Scholarship Contest. To vote, simply use the Facebook “Like” or Twitter “Tweet” buttons at the bottom of each post to share or leave a positive comment. The top vote-getters will be finalists.

Login, “Like” Twitter & Post:  When the Medical Device Safety Act is passed by Congress and the Charter of the FDA is amended to include voting Patient Representatives on the medical device panel (as in pharmaceuticals), social media will be able to claim a large part of the victory.

Four years ago I began handling phone, mail and other correspondence for a family member who experienced early failure of a joint replacement implant.  Internet research revealed the medical and legal purgatory of thousands of joint replacement implant patients.  Navigating the medical system (for a disabled person prescribed maximum dose painkiller and living 1,000 miles apart) is challenging but not uncommon situation for many caregivers, I learned.  Because the root of the problem was intractable (poor federal public policy) my role transitioned to unpaid full-time advocate. I applied and was selected in September 2010 to attend the FDA Patient Representative workshop, which expanded my advocacy to all patients with failed implanted medical devices.

My stated goal is to help patients with failed devices access the medical care that they require and to work toward the conclusions of the Institute of Medicine’s 7/29/2011 report. It advised the FDA to restrict the use of FDA 510(k) approvals for implanted devices and provide a post-market UDI national registry that would be accessible to patients and their medical providers.

This quest prompted me to join with a number of effective advocacy organizations such as The Society for Preventative Medicine, Consumers Union and SpeakerLink.  I created a blog (http://fida-advocate.blogspot.com) and regularly participate on FaceBook, Twitter (@JjrkCh) and LinkedIn.  I have testified twice at FDA/CDRH Town Hall meetings and have traveled from my home in Dallas, TX to Minnesota, Washington, DC -4 times-, San Francisco, CA, Irving & San Antonio & Austin, TX in my role as advocate.  Recently, financial limitations prevented me from attending Regina Holliday’s The Walking Gallery and the HDI Forum in Washington, D.C. (both with registration complete) so I participated virtually on a webinar.

In my work toward the goal of safer and more effective implant devices I would value and benefit from discussions with trained social media professionals and other advocates.  I wish to elevate my advocacy skills and clarity of purpose so that I capably  represent the patients who have been harmed and are often unable to travel or spare time/money for this endeavor.  Exposure to new ideas/attitudes would refresh and enhance my implementation of more targeted social media communications.  My advocacy includes educating the public, the device industry, administrators and legislators about federal public policy and legislative changes that would strengthen patient safety and reduce patient harm.

I appreciate that Mayo Social Media has many qualified applicants for these three scholarships.  Thank you for your consideration and this valued opportunity to communicate via social media!  – Joleen Chambers

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Reuters: Nearly $5B failed metal hip implants

http://reut.rs/NneL9r

Insight: As lawsuits climb, J&J may have new hip trauma

Thu, Jul 12 2012

By Debra Sherman  Reuters  (FiDA blog bold, highlight color)

CHICAGO (Reuters) - Johnson & Johnson faces a potentially more damaging and costly sequel to the $3 billion recall of its ASR all-metal artificial hips two years ago, one of the most expensive medical device failures in U.S. history.

A successor to ASR, the Pinnacle metal-on-metal hip system has nearly 1,600 lawsuits pending in U.S. courts. Doctors who are tracking large groups of patients with both products estimate that more than 10 percent of the Pinnacle all-metal hips will have failed in the next two to three years.

Metal-on-metal hip implants were sold on being more durable than those made of other materials, such as polyethylene or ceramic. They are meant to last up to 15 years, but as controversy over all metal-on-metal implants heats up, fewer surgeons are using them.

A survey taken by the American Academy of Orthopaedic Surgeons in 2010 showed 16 percent of surgeons were using metal-on-metal implants before the U.S. Food and Drug Administration warned of potential problems. That number dropped to 10 percent since the FDA warning, and doctors say the number probably has dwindled further.

Many patients with the Pinnacle metal-on-metal device are experiencing the same problems as those who got the ASR product, including pain and swelling, limited mobility, and dislocation. Perhaps most concerning, some doctors say, is the high levels of cobalt and chromium in the bloodstream resulting from wear of the all-metal implants. Metallosis, as it is known, can lead to cardiovascular, neurological, renal and thyroid problems, in addition to destroying soft tissue, muscle and bone.

"We're simply seeing the tip of the iceberg with metal-on-metal failures," Dr Mary O'Connor, an orthopedic surgeon at the Mayo Clinic in Jacksonville, Florida, said of the entire class of metal-on-metal devices. O'Connor said she does not use metal-on-metal hip implants because she has been concerned about metal poisoning for years.

The new round of complaints represents a significant threat for J&J's DePuy Orthopedics unit, whose Pinnacle line includes non-metal models and covers a much wider range of products than ASR. The diversified healthcare giant, under new Chief Executive Alex Gorsky, has also just raised its bet on orthopedic products with the $20 billion purchase of device maker Synthes.

"Litigation is what it is, but the ASR is a very different system and has a very different design and has very different clinical performance" than the Pinnacle, said Mindy Tinsley, a spokeswoman for DePuy. "We recalled it because it was not performing as it should."

She said DePuy is closely monitoring the performance of the Pinnacle metal-on-metal system, but is "very confident" in the product and will vigorously defend itself against lawsuits. DePuy did not make other executives available for comment.

DePuy and FDA officials said there is not sufficient evidence linking metal ions in the blood to health risks.

A total of 500,000 patients in the United States have received metal-on-metal hips, according to government data. Of those patients, an estimated 150,000 received the Pinnacle device, and 37,000 got the ASR implant. But while J&J has set aside $3 billion to settle the 3,000 ASR lawsuits, it is fighting complaints related to the Pinnacle device -- meaning that patients with virtually identical problems are facing different financial burdens.

Frances Grisham, 50, from Jackson, Tennessee, recently had surgery to repair a fracture to her left hip caused by the ASR implant. She was reimbursed for most of her out-of-pocket expenses and could be eligible for some of the settlement funds.

Harriett Bowen, 64, from Salisbury, Maryland, received the Pinnacle all-metal hip in 2008. She soon developed the same symptoms as Grisham: pain, limited mobility and elevated levels of cobalt and chromium in her blood. In July 2011, Bowen's left hip fractured at the implant site, requiring more surgery.

Bowen's doctor determined she had a cobalt and chromium count of 7 micrograms per liter (mcg/L), a level flagged by UK health authorities as worrying. "He said, 'Look, we've got to get this thing out of you.' It nearly scared me to death."

Unlike Grisham, she has received no compensation for the repair from J&J. Bowen is suing J&J.

"I have never done anything like this before, but considering what I went through for three years, I feel like I should be compensated," said Bowen.

PROBLEMS WITH ALL-METAL CITED ACROSS INDUSTRY

While other makers of total hip replacement systems -- including Smith & Nephew, Zimmer Holdings, Wright Medical and Biomet Inc -- face similar complaints, the numbers of devices involved is much smaller. The next most widely used product belongs to Biomet, which is defending itself against lawsuits over its metal-on-metal M2a Magnum Hip System.

Legal experts say J&J is taking a harder line defending itself against Pinnacle metal-on-metal claims, hiring a top product liability defense firm and refusing to recognize patient complaints or pay for replacing the hip devices - known as revision surgery. It maintains the device performs better than other all-metal hip implants.

Paul Voorhorst, director of biostatistics and data management at DePuy, told an FDA advisory panel last month that the Pinnacle metal-on-metal device "is performing consistent with or better than other metal-on-metal products."

Should the Pinnacle lawsuits be found to have merit, J&J could end up paying nearly $5 billion to cover revision surgeries alone, according to plaintiff attorneys. DePuy revenue last year was $5.81 billion, or 9 percent of J&J's total.

Legal experts not involved in the cases say J&J probably is just taking its chances to see how the first few lawsuits play out - a common strategy for Big Pharma in major drug litigation cases. They say J&J may be aided in its defense by the lack of any U.S. program to track the performance of medical devices once they are implanted in people's bodies.

"The last thing plaintiff lawyers want is to go one by one (for each case). With so much unknown, proving cause and effect may be difficult," said Carl Tobias, Williams professor of law at the University of Richmond School of Law.

Cindy Schipani, professor of business law at the University of Michigan, said J&J could be playing with fire if the Pinnacle metal-on-metal devices are shown to be defective.

"They lose credibility if they keep saying they're not responsible and then it turns out the product is the problem," she said. "I question this strategy."

NO HARD DATA

While doctors can report problems about the Pinnacle to an FDA database, products with that name also include artificial hips that are not exclusively made of metal. One product is metal-on-polyethylene, the most popular of the Pinnacle devices, and another is metal-on-ceramic. A Reuters search of the database could not isolate adverse events reported for the all-metal Pinnacle, which is the least used of the Pinnacle products.

There is also no hard data yet on the Pinnacle's failure rate, partly because DePuy does not publicly disclose how many were implanted. DePuy's Voorhorst told the FDA advisory panel that 4 percent to 4.5 percent of these Pinnacle implants require a second surgery to fix the devices within five years after implantation, which is in line with other hip devices.

Felecia Stern, an attorney with Bernstein Liebhard LLP, represents Bowen, Grisham and many other patients who received the ASR and Pinnacle all-metal devices. She noted that the recall of 93,000 ASR implants in 2010 led doctors to notify patients and monitor for high metal levels. But problems with the Pinnacle are being reported less systematically since the devices weren't pulled from the market.

"At the end of the day we will see a similar occurrence of high metal levels in Pinnacle metal-on-metal recipients as more and more of them get their blood tested. That is certainly what we are seeing in our client population," she said.

Her firm also serves on the Plaintiffs Steering Committee for the federal Pinnacle lawsuits, which have been consolidated into a multi-district litigation in Texas.

The FDA has been monitoring problems with all-metal hip implants and convened the panel of outside advisers last month to discuss their safety. The panel concluded there was little reason for surgeons to use these devices given the risks.

In May 2011, the agency ordered device makers to conduct follow-up studies in cases in which an implant's failure could have serious consequences. Companies would be expected to take blood samples from patients to measure metal ion levels. But more than a year later, the FDA and device manufacturers agreed on study protocols for less than one quarter of the devices. Most of the study plans, including DePuy's, have not been finalized.

"We need more data to better understand how these devices perform," FDA spokeswoman Michelle Bolek said. "We are open to a more collaborative effort, if it helps us get the data we need."

MINIMIZING RISK

The final failure rate for the ASR device has not yet been established, but a study released last March by the British Orthopaedic Association and the British Hip Society indicated a failure rate of up to 49 percent after six years - nearly four times the rate cited by DePuy when it recalled the device.

Dr David Langton is an orthopedist who has studied all-metal implants for years and supplied the two British organizations with data. He said he expects the ASR failure rate to rise to 80 percent at eight years. Based on a cohort of about 1,000 patients he is tracking at North Tees Hospital in the UK, the Pinnacle metal-on-metal hip has a failure rate of 8 percent at five years. He said that rate climbs to 16 percent after 6-1/2 years.

About 150,000 Pinnacle metal-on-metal devices are estimated to be implanted in patients outside the United States.

Several differences between the ASR and Pinnacle metal-on-metal could explain a lower failure rate.

One main reason is that the Pinnacle has a smaller head; larger heads are associated with higher failure rates because there is more friction.

Langton believes it is just be a matter of time before Pinnacle all-metal device failure rates climb, as more metal debris from the implant are released into the bloodstream and tissue. And while the failure rate might be lower than ASR, the absolute number of patients is higher.

"We believe the (Pinnacle) failure rate will be far above 10 percent," said attorney Brian Devine of Seeger Salvas LLP, which is handling both ASR and Pinnacle cases.

That would translate into second replacement surgery for 15,000 patients, he said. In 2002, Sulzer Medica AG paid an average of $250,000 per revision on its 2001 recall of its InterOp hip. Adjusting for inflation, an average J&J settlement could be $319,000 per revision, or $4.785 billion in total, he said.

Mayo Clinic's O'Connor is worried that the entry of metal ions into the bloodstream will damage internal organs, not just the surrounding tissues in the hip socket. There are also concerns high ion levels cause cancer, though that has not been proven.

"Autopsy studies of patients with metal-on-metal implants showed metal ions were everywhere the body - in the liver, the spleen, all over the place," O'Connor said.

(Reporting by Debra Sherman; Editing by Michele Gershberg, Edward Tobin, Leslie Adler)

(Reporting by Debra Sherman; Editing by Michele Gershberg, Edward Tobin, Leslie Adler)

Patient harm is profitable!

(@NewHealthDialog)

New drugs and devices should be considered experimental after approval until proven otherwise. bit.ly/Mj4tUm

 Letting Big Pharma Review Its Own Drugs — What Could Go Wrong?

By SHANNON BROWNLEE & JOE COLUCCI

JUL 11 2012, 11:11 AM ET 1  (FiDA blog bold)

http://www.theatlantic.com/health/archive/2012/07/letting-big-pharma-review-its-own-drugs-8212-what-could-go-wrong/259666/

We can't trust drug companies to disclose product safety hazards when they stand to gain so much from fudging the facts.

When British drugmaker GlaxoSmithKline (GSK) agreed to pay $3 billion in criminal and civil fines for illegal marketing of several drugs and hiding safety from the U.S. Food and Drug Administration (FDA), it probably seemed to many people like fitting punishment. It's the largest fine ever levied against a pharmaceutical company, and the civil and criminal charges against GSK included marketing its antidepressants Paxil and Wellbutrin for unapproved (read: unproven) uses, giving Medicaid false information about prices it was charging for the drugs, and failing to report patient safety data about diabetes medication Avandia to the FDA. But even $3 billion is probably not going to get GSK to change its ways -- and fines do virtually nothing to protect patients.

When it submitted false price information to Medicaid, GSK was harming taxpayers, a financial crime that is amply repaid by the $300 million the company is paying for that offence. But discouraging future bad behavior is a different story, because GSK is one of the world's biggest drug makers, with annual revenue of more than $40 billion. A $300 million fine starts to look like just the cost of doing business when spread over the period of time when the company was bilking Medicaid.

Fines are even less effective when it comes to preventing patients from being physically harmed. GSK is accused of illegally marketing two antidepressants -- Paxil for depression in adolescents, and Wellbutrin for weight loss, substance addiction, ADHD and other problems. Paxil has been shown to have significant side-effects, including triggering suicidal thoughts and behavior in some patients, and neither antidepressant is much more effective than a sugar pill in the vast majority of patients with depression. Fining the company after the fact doesn't do much for the patients who have already been hurt by their marketing practices.

That's even more the case for GSK's egregious behavior regarding its diabetes drug Avandia. When a new drug comes on the market, sometimes the FDA will ask or require that the manufacturer to do a study, called a post-marketing trial, to look for rare side effects and establish whether the drug is safe over the long term. That's important because often the clinical trials that are done before a drug is approved aren't big enough, and don't last long enough, to say whether a drug is safe to use over a long period.

With Avandia, GSK fudged the results of those post-marketing trials. The company claimed that its RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes) trial showed no evidence that Avandia caused heart attacks or other cardiac diseases. But when outside researchers looked at the data they found massive irregularities and plenty of cases of harm, including patients who died and then mysteriously disappeared from the clinical trial records.

GSK hasn't admitted anything more than "inadvertently" failing to inform the FDA of problems, and the fine isn't going to protect patients from future Avandias. What we really need is a better system for tracking drugs once they are on the market.

Right now, we leave this crucial task to the very companies that have every reason to fudge data, ignore problems -- even deaths -- and keep doctors and patients in the dark, because they are making too much money to do otherwise. At its peak, Avandia earned GSK $2.2 billion a year. It was a phenomenally lucrative drug. The $250 million levied against the company for that part of the fine amounts to less than a slap on the wrist.

The solution isn't stiffer punishments for fraud -- we should take away the power to do harm in the first place. That means we need to stop giving drug companies the opportunity to sell out patient safety in exchange for another few months or years on the market. The simplest way to do that is to have automatic, external post-market surveillance for all new drugs.

Any new drug should be considered by both patients and doctors to be experimental for the first few months, or even years it is on the market, and the FDA should treat the approval of the drug as provisional. (The same goes for new medical devices.) For at least two years, any patient who might receive a new drug or medical device has to be fully informed of its known side effects, and of its experimental status. Data on those patients should be tracked (anonymously), and compared to patients receiving other treatments. Most importantly, automatic algorithms can search those data for patterns revealing any negative effects of the new product, so safety problems can be caught quickly.

An automatic review system would be a huge improvement on our existing review process. It would take the burden of reporting off manufacturers, and let them focus on developing new treatments instead of monitoring old ones. It would remove the financial conflict of interest that encourages companies to hurt patients in order to squeeze a few more months or years of sales out of a new product before problems finally surface. (The only reason Avandia's tendency to kill patients came to light as quickly as it did is because a sharp-eyed cardiologist named Steve Nissen at the Cleveland Clinic happened to be looking at European data that clearly showed the drug was dangerous.)

Perhaps most importantly, it would force us to admit that we don't truly know that our treatments are safe when we start using them -- and that would give patients a chance to be more informed about their choices. That seems like a better system that letting companies kill patients, and then pretending to fix the problem by slapping them with fines every few years.

SHANNON BROWNLEE & JOE COLUCCI - Shannon Brownlee is the acting director of the health policy program at the New America Foundation. She has written previously for The Atlantic, New York Times Magazine, and The New Republic, among others. Joe Colucci is a research associate in the New America Foundation's Health Policy Program and editor of the program's New Health Dialogue blog.