FDA Commissioner Dr. Califf: The Fox is in the Henhouse!

F.D.A. Asks If Faulty Blood Monitor Tainted Xarelto Approval

By KATIE THOMAS FEB. 22, 2016

The Food and Drug Administration is investigating whether a faulty blood-testing device may have compromised the results of a clinical trial that led to the approval of Xarelto, a blockbuster anticlotting drug that has been prescribed to millions of Americans since it arrived on the market in 2011.

The agency has asked the drug’s manufacturer, Johnson & Johnson, detailed questions about whether there was evidence that the device was malfunctioning while the trial was underway, according to a legal brief filed in federal court on Monday by lawyers for patients and their families who say they were injured by the drug. The lawyers also cited internal company documents that they said showed doctors were complaining to the trial leadership during the course of the study.

The clinical trial, known as Rocket AF, was led by Dr. Robert M. Califf, currently President Obama’s nominee for head of the Food and Drug Administration. It involved more than 14,000 patients worldwide and took place from 2006 to 2010.

Xarelto, which is also known by its scientific name, rivaroxaban, is one of a new class of drugs that are seen as a replacement for warfarin, a cumbersome 60-year-old drug used to prevent strokes in people with a heart-rhythm disorder known as atrial fibrillation. Warfarin requires careful monitoring of a patient’s diet and drug regimen, and frequent blood tests to ensure that is working. If patients receive too little of the drug, they could experience a stroke. But if they receive too much, their lives could be threatened by catastrophic bleeding.

Questions about the trial have been stirring since last fall, when Johnson & Johnson and Bayer, which sells Xarelto overseas, notified regulators that the device that was used in the trial had been recalled in 2014 because it was understating patients’ risk of bleeding. The device, the INRatio sold by Alere, was used in the trial to help doctors gauge whether patients were getting the right dose of warfarin. The trial compared the number of strokes and bleeding events experienced by patients taking Xarelto to those of patients who were given warfarin.

Regulators are looking at whether the malfunctioning device might have led doctors to give patients the wrong dose of warfarin, which could have led to additional bleeding episodes and given an unfair advantage to Xarelto.

This month, researchers with the Duke Clinical Research Institute, which oversaw the trial, published their own analysis in the New England Journal of Medicine and concluded that the faulty device did not affect the trial’s outcome. A few days later, an analysis by the European Medicines Agency, the F.D.A.’s European counterpart, came to the same conclusion.

But rather than settling the matter, the analyses have raised additional questions and have come under harsh criticism from some medical experts. The Duke researchers, for example, never mentioned the existence of central laboratory tests — taken at two points during the trial — that could have been used to assess whether the device’s readings were accurate. And the analysis released by the European drug agency, while it did include those readings, was done by the companies themselves and not by independent statisticians.

“There are so many questions that are yet unaddressed,” said Dr. Harlan M. Krumholz, a cardiologist and director of the Yale University Open Data Access Project, which has an agreement with Johnson & Johnson to make the company’s data from clinical trials available to outside researchers. He has asked the company for access to the trial data, he said, and the company has agreed — but Bayer has refused.

Dr. Krumholz called on Alere to release more information about its device. “We do not know why the device did not work well,” he said.

In a statement, a spokeswoman for the F.D.A. said that while the agency was looking into the issue, it had not changed its recommendations for the drug, which “provides an important health benefit when used as directed.”

A spokeswoman for Alere declined to comment, and a representative for Duke referred to an earlier statement detailing the results of its reanalysis.

Johnson & Johnson said the INRatio device was selected because it was F.D.A.-approved and easy to use. It said it was not informed of the device recall until last September, when it and Bayer “acted with urgency, diligence and in the best interests of patients and prescribers.” The company said that it has provided answers to the questions the F.D.A. asked and that the analysis published in the New England Journal of Medicine confirmed the safety and efficacy of the drug.

A spokesman for Bayer said the company was confident in the results of the trial and dismissed the issue as being driven by plaintiffs’ lawyers, saying, “They have cherry-picked testimony and documents divorced from any context.”

Dr. Califf is the former director of the Duke Clinical Research Institute, which conducted the trial, and served as the study’s co-chairman. He has since left Duke and is now a deputy commissioner of the F.D.A. Dr. Califf, who did not respond to an email, has no role in the inquiry into the Rocket AF trial, the F.D.A. has said. The Senate was expected to vote Tuesday on whether to confirm his nomination as head of the agency.

Just as the trial was getting underway in 2006, the INRatio was facing scrutiny by the F.D.A. In 2005 and 2006, the agency sent warning letters to HemoSense, then the manufacturer of INRatio, claiming that the devices were generating “clinically significant” erroneous values and that the company, which was later acquired by Alere, was not properly investigating the complaints.

In 2014, Alere recalled the INRatio monitors, saying that they might provide inaccurate results.

However, the connection to the Rocket trial was not made public until this past fall, when a journalist for the British Medical Journal began asking the companies about it. A spokesman for Johnson & Johnson told the journal that the company had been unaware of the recall. The revelation led to the reanalysis by the Duke researchers as well as inquiries by the European Medicines Agency and the F.D.A.

But while the European agency concluded that the trial outcome was not affected by problems with the device, the F.D.A. appears to be taking a closer look, asking pointed questions about whether the company had evidence that the device was malfunctioning during the trial and what actions it took, according to the legal document, which was filed with Judge Eldon E. Fallon in the Eastern District of Louisiana.

The legal motion filed on Monday also cited internal emails that, the lawyers said, showed that some doctors were questioning the accuracy of the device while the trial was underway. The lawyers said so many concerns were raised about the device that a special program was set up to investigate the malfunctions, but none of these details were provided to the F.D.A. when Johnson & Johnson responded to the agency this month.

The Rocket trial has previously come under criticism. In 2011, the F.D.A.’s medical reviewers recommended against approval of Xarelto, citing concerns that the patients receiving warfarin during the trial were being poorly managed, which could give an unfair advantage to Xarelto.

An outside advisory committee later voted to approve the drug — although several members cited reservations — and the agency allowed it to go on the market. It has since become the best-selling drug in its class, bringing in $1.9 billion in the United States in 2015, according to Johnson & Johnson.

Some said the fact that Xarelto has been on the market since 2011 gave them faith in the safety of the product. “The real world has already made the case for this drug,” said Dr. Jürgen vom Dahl, a German cardiologist who served as an investigator in the trial, who said he did not recall encountering any problems with the device.

Dr. vom Dahl also said that he and his German colleagues have wondered whether Dr. Califf’s F.D.A. nomination was playing a role in the renewed questions about the trial. “We don’t know what is real science, and what is more politics,” he said.

But others say that plenty of questions remain, and that they are disheartened by a seeming reluctance by Duke, Johnson & Johnson and Bayer to be forthright about the problem.

“It depends on where you put the flashlight,” said Robert Powell, a clinical pharmacologist who has worked in the drug industry, as well as for six years at the F.D.A. “I think they were directing people away from the problem.”

Sabrina Tavernise contributed reporting.

Toxic medical device cartel penetrates government at the highest levels.

 May 13, 2013 by Brian Johnson

J.C. Scott, SVP, government affairs for AdvaMed is named one of the top lobbyists in theBeltway by CEO Update, a publication covering trade councils

AdvaMed's government affairs guru J.C. Scott has been named a "top lobbyist" by CEO Update, a publication that covers the trade association industry.

Scott received praised by the publication for his work on efforts to repeal the medical device tax,. He was one of only two healthcare related lobbyists on the list.

"[Scott] built bipartisan support for repealing the medical device tax, resulting in a nonbinding 79-20 Senate vote,"the publication wrote. "Helped lead Hill efforts to reauthorize user fees, and then to allow FDA to spend the full amount collected."

AdvaMed hired Scott away from the American Council of Life Insurers 2 years ago. He is a Capitol Hill veteran, having cut his teeth on the Hill as deputy director for policy at the House Republican Conference and in a number of capacities for Rep. Deborah Pryce (R-Ohio) before spending seven years at ACLI.

His predecessor, Brett Loper, left Advamed in early 2011 to become the policy director for House Speaker John Boehner (R-Ohio).

Jury trial for first of 7,000 failed implanted hips?

Rochester woman in bellwether case on hip implants

By WILL ASTOR

Rochester Business Journal

January 7, 2013

A Rochester area woman’s court complaint has been selected to be heard as one of two bellwether cases that will help decide the outcome of several thousand suits targeting DePuy Orthopaedics Inc. and Johnson & Johnson for selling allegedly defective hip implants.

Owner of the Good Sign Co., Ann McCracken is one of 7,000 U.S. hip-replacement patients who have sued the companies over DePuy’s ASR XL Acetabular System.

LINK TO FULL ARTICLE HERE

http://www.rbj.net/article.asp?aID=193659

READ THE FULL LAWSUIT HERE
http://www.scribd.com/doc/50063815/Hip-Replacement-Lawsuit

Regulators favor implant manufacturers over patient safety.

Faulty medical implantsinvestigation: 'A system in disarray that favours manufacturers at the expenseof safety'

By Carl Heneghan     The Telegraph  (FiDA highlight added.

6:55AM BST 23 Oct 2012

 Carl Heneghan is director of the Centre for Evidence-Based Medicine, University of Oxford

In terms of regulation, the role of the European Union is to ensure the highest level of patient safety. But what has been found out by the Telegraph and the BMJ’s investigation now puts this claim in serious doubt.

To put it bluntly, device regulation is in disarray: the evidence requirements at the time of approval are woeful, the conduct of notified bodies is sub-standard, and individuals supposedly representing the regulatory system are conflicted and in many cases under-qualified.

This all means that the system now heavily favours manufacturers at the expense of patient safety.

Notified bodies are organisations authorised to grant a CE mark in the EU. A company is free to select any notified body it sees fit to undertake certification of a new device.

An application for a metal hip should raise significant alarm bells, particularly given the worldwide alerts that exist to its problems. A Google search immediately retrieves “compensation”, “implant failure” and “could cause cancer”. But, in this case it did not raise concerns among eight of the contacted notified bodies.

It gets worse. In the evidence document submitted for application, the device was based on two previous recalled devices and a number of deliberate errors were inserted into the document: tests for corrosion didn’t add up, the hip data showed it wore at a very high rate and the data implied the hip would literally “fall out”.

Basically, it couldn’t be any worse for the device. But some notified bodies seem to want a device to get through at any cost. One said that they would provide a “solution for certification, somehow”.

European regulations state that companies should submit clinical data at the time of device approval, yet this can be as little as an evaluation of the scientific literature. This data is supposed to relate to the “safety, performance, design characteristics and intended purpose of the device”.

The investigation informs us that submitted data can be wrong, refer to previous recalled devices and not demonstrate safety at all. To date, no one adequately knows the make-up of notified bodies, their qualification or their skills.

But in this investigation they were certainly not equipped to deal with this case. Indeed, they had never dealt with a hip implant.

There have been many unsubstantiated reports that companies shop around for the best deal. As the Telegraph/BMJ investigation shows, the notified body does not need to see the device, clinical data can be sub-standard and wrong, the organisation with oversight of the device approval process does not need to reside in Europe, and they certainly do not need relevant skills. And despite all this you can access the European market, for an implantable device, without a single patient ever having received it.

The current situation needs urgent remediable action. At a minimum, and as a quick fix, there should be a requirement for new devices to have published clinical data.

The investigation has revealed appalling loopholes in the current system that could allow defective devices onto the European market. What is needed is transparency.

None of the regulators has a register of approved devices and none of them get to see the submitted data for the device. This can’t be right.

http://www.telegraph.co.uk/health/9626921/Faulty-medical-implants-investigation-A-system-in-disarray-that-favours-manufacturers-at-the-expense-of-safety.html

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Insurance companies demand failed implant device reimbursements.

http://www.reuters.com/article/2012/10/08/us-devices-recall-idUSBRE8970E220121008

Analysis: When implanted medical devices go wrong, who pays?

By Debra Sherman

CHICAGO | Mon Oct 8, 2012 7:03am EDT

(Reuters) - Insurance companies, often stuck with the tab for health services when a medical device fails, are ready to share the pain.

As the number of costly, high-profile recalls rises, along with pressure to cut their own spending, insurers are starting to pin more of the responsibility on manufacturers.

If they succeed, medical device makers - already worried about weaker global demand for many of their products and the impact of a new U.S. tax on their profits - will have even more costs in the wake of product recalls, the biggest of which can already lead to billions of dollars in expenses.

"The (insurance) plans are being more aggressive. The reason it gets so much more focus now is because there are so many cases," said Mark Fischer, chairman of Rawlings & Associates, a unit of the Rawlings Group that helps insurance companies recoup payments from the party that was deemed at fault for claims, a legal service known as subrogation.

In recent years, more than a hundred medical devices were recalled out of concern they could cause serious injury or death.

Rawlings is one of the largest firms providing claims recovery services for the healthcare industry, along with Trover Solutions Group, both based in Louisville, Kentucky. Others include HealthCare Subrogation Group and Meridian Resource Company.

Rawlings is currently retained to pursue more than 30 mass tort cases related to healthcare, compared with an average of about three in a given year just a decade ago, Fischer said.

"There has been a drastic increase in the number of cases being pursued," he said. Insurers tend to hire Rawlings when there are enough cases being filed over a product to warrant multi-district litigation status.

Fischer helped recover funds for insurers from claims on Sulzer Medica's defective hip implants in 2000 and Medtronic Inc's faulty Fidelis defibrillator leads in 2007.

In the Fidelis case, Medtronic settled U.S. lawsuits covering more than 9,000 individual personal injury cases for $221 million, according to their regulatory filings.

Fischer then pursued Medtronic to recover money for clients like WellPoint Inc that had paid doctors and hospitals for treatment relating to the defective leads, or wires that connect an implantable defibrillator to the heart.

He expects a settlement - the first collected from a medical device maker - to be signed by year's end, but would not give a dollar amount.

WellPoint spokeswoman Lori McLaughlin said the insurer routinely tries to collect from manufacturers on recall-related health claims.

Aetna Inc, the nation's third largest insurer, said it has managed to wrest reimbursement from drug and device markers, and has negotiated payments to patients for costs from defective or recalled products, without providing details.

Trover Solutions Chief Executive Robert Bader reckons that about 80 percent of health insurers turn to firms like his to pursue manufacturers in recall cases.

"It's the fiduciary responsibility of the insurer to recover members' premiums from the manufacturer. It's a highly specialized process and so a lot of them outsource," Bader said.

The government's Medicare health plan for the elderly recovers part of the money it paid for recall-related medical services once a settlement is reached, said spokeswoman Kathryn Ceja. She would not give details on how it pursues those funds.

FALLOUT OVER THE RIATA RECALL

A 2010 recall of Riata defibrillator leads by St. Jude Medical could become the next tug-of-war between insurers and medical device makers over who picks up the tab.

Some 79,000 U.S. heart patients still have the lead implanted in a blood vessel leading to the heart. Deciding on how to proceed is tricky since removing the leads may be riskier than leaving them in.

The Food and Drug Administration in August said all Riata patients should receive medical imaging tests to see whether the insulation covering the thin wires eroded, exposing the cables and making them more prone to short-circuit, as well as making the surrounding tissue vulnerable to heat damage.

The agency did not say how often imaging tests should be performed. But ordering just one test per patient will add millions of dollars to the cost of their care.

A single fluoroscopy - which shows a real-time, continuous X-ray image on a monitor - for each Riata patient could cost between $7.9 million and $45.3 million overall, based on a Reuters review of the procedure's cost at different hospitals.

Doctors say more than one X-ray would be needed to monitor the leads, which can remain in a patient's body for many years. Dr. Bruce Lindsay, section head of Cardiovascular Medicine at the Cleveland Clinic, said doing an annual imaging study would probably be sufficient.

Even before the FDA guidelines, Medicare covered the extra cost of imaging studies in almost every instance, doctors say. But some private insurers had balked.

"I've had to call (insurers) constantly and justify it," said Dr. Martin Burke, director of the Heart Rhythm Center at the University of Chicago Medicine.

"We're definitely finding more problems (with Riata leads), but surveillance has gone up. We're finding more because we're looking more," he said.

St. Jude spokeswoman Amy Jo Meyer said the company has expanded its regular warranty to include a baseline fluoroscopic or X-ray screening if a patient's insurer does not cover it. Paying for additional imaging would be reviewed on a case-by-case basis.

"It would not be in device makers' best interest to balk at paying these costs. In the end, they do have to stand behind their products and these products do sometimes fail," said Debbie Wang, an analyst with Morningstar.

TALLYING THE COSTS

Burke and colleagues estimate that Medtronic's Fidelis recall cost Medicare some $287 million over five years for monitoring or replacing the leads, according to a study published in the Heart Rhythm Journal.

Medtronic spokesman Chris Garland said the company gave a credit to patients for its recalled Fidelis leads, plus $1,200 for "reasonable unreimbursed medical expenses." He would not say how many people received the replacement and additional funds.

The Fidelis case was just one out of 113 medical device recalls between 2005 and 2009 classified as serious enough to cause significant health problems or death, according to an analysis published in the Archives of Internal Medicine last year. Most involved devices that correct heart problems.

The study found that 24,000 patients underwent procedures in 2005 related to problems with devices from Medtronic or from Guidant, now part of Boston Scientific Corp.

"We expect manufacturers to take reasonable responsibility for costs associated with a recall of their products to prevent the healthcare system from absorbing the impact," said Aetna spokeswoman Tammy Arnold.

(Editing by Michele Gershberg, Bernard Orr)

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.

FDA: Metal on Metal Hips, higher failure rates for women

FDA Panel Discussing Safety of Metal-On-Metal Hip Implants

Published June 27, 2012

Dow Jones Newswires

The Food and Drug Administration on Wednesday convened a two-day advisory panel meeting to discuss the safety of metal hip implants, amid concerns there are more side effects than with implants made out of such materials as ceramic or plastic.

The advisory panel is being asked to make recommendations whether additional warnings and other information is needed for metal hip systems, and to make recommendations about which types of patients would benefit the most from metal implants as well those who shouldn't get them. The panel is not being asked to discuss regulatory changes like requiring the devices to go through more stringent clinical testing.

In 2010, Johnson & Johnson's (JNJ) DePuy Orthopaedics Inc. recalled 93,000 of its ASR total hip implants after they were linked to higher failure rates than other implants. The ASR device is no longer sold but is still implanted in many patients, and the company faces about 6,000 lawsuits.

One of the safety concerns involves the wear on the implants and its breaking down of the metal, which in some patients causes joint and muscle destruction and other health problems.

Elizabeth Frank, an FDA medical reviewer, said Tuesday that patients vary in their reactions to metal particulate, with some having a severe inflammatory response to having no reaction.

Because hip implants were on the market before FDA started regulating medical devices in 1976, such companies as DePuy and Wright Medical Group Inc. (WMGI) only need to show a hip implant is similar to a device already on the market and don't need to conduct clinical studies showing safety and effectiveness, a process that has been criticized by some policy makers and many patients.

Major changes to devices, however, do require additional testing, and hip resurfacing systems, including ones made by Smith & Nephew PLC (SNN), are required to go through FDA's premarket approval process, which requires companies to conduct clinical studies in humans looking at the devices' performance. The FDA said other companies with metal hip implants on the market include Biomet Inc., Zimmer Holdings Inc. (ZMH) and Encore Medical L.P.

There are about 400,000 hip implant surgeries in the U.S. each year. About 25% of surgeries involve metal-on-metal implants, according to recent U.S. government data.

Information from patient registries outside of the U.S. suggest more patients need to have the metal implants fixed than other types of implants. The U.S. doesn't have a national registry and studies looking at implant failure rates in the U.S. have been mixed. Some data suggest women have higher failure, or revision rates, compared to men while other data suggests there might be more problems with implants that have a larger component, called the femoral head, than smaller components.

"Could it be the size of the head when we are attributing all the problems to metal?" said Raj Rao, a panel member from the orthopaedic surgery department of the Medical College of Wisconsin.

Although the panel had not formally started addressing FDA's questions Wednesday, preliminary discussion suggests the panel may struggle to adopt clear recommendations given the number of products and conflicting data.

"I don't believe the failure mechanism of these devices is the same," said Edward Cheng, a panelist from the University of Minnesota Medical School and Cancer Center.

Information prepared for the meeting by the FDA showed there's been almost 17,000 adverse-event reports submitted to FDA involving the metal-on-metal implants from 1992 through 2011. There were 22,000 for nonmetal hip implants. Of the metal-on-metal reports, about 12,000 were submitted in 2011 with 9,000 attributed to the DePuy ASR. The reports cited problems including the need for revision--or additional surgery to fix or replace the implant--pain, dislocation and bone infections.

In a presentation to the panel, Paul Voorhorst, the director for biostatistics and data management for DePuy Orthopaedics, said not all "metal-on-metal implants are the same and each should be evaluated on its own merits." Mr. Voorhorst didn't specifically mention the recalled ASR product and instead focused on another product. However, he said the company believes all patients with joint replacements need to be monitored.

Read more: http://www.foxbusiness.com/news/2012/06/27/fda-panel-discussing-safety-metal-on-metal-hip-implants/#ixzz1z3LUiUKx           LINK