Delayed FDA removal of Darvon from market has cost more than 1,000 U.S. lives

The announcement by the U.S.Food and Drug Administration (FDA) that propoxyphene-containing products are finally going to be taken off the market – because of dangers previously known and acted upon, with bans announced in the UK almost six years ago, and in Europe, almost 1½ years ago – is a serious indictment of the FDA’s long-lasting unwillingness to protect people in this country from a deadly but barely effective painkiller. In announcing the ban in 2005, the UK stated that the efficacy of propoxyphene (sold generically and under the brand name Darvon) “is poorly established and the risk of toxicity in overdose, both accidental and deliberate, is unacceptable” and that “[I]n relation to safety, there is evidence that fatal toxicity may occur with a small multiple of the normal therapeutic dose and a proportion of fatalities are caused by inadvertent overdose.” The FDA’s claim that this is the first evidence that the drug is dangerous at the “standard therapeutic dose” thus rings dangerously hollow.

The FDA’s deadly delay in this case starkly illustrates how one of the most important public health concepts, the precautionary principle, was embraced by the UK and Europe, but was for too long recklessly rejected by the FDA. 

Read Full Post »

FDA admits it messed up, revokes approval for ReGen medical device that Public Citizen testified against

The FDA has announced that it will revoke approval of a medical device for injured knees because, as Public Citizen testified in 2008, the Menaflex device made by New Jersey-based ReGen Biologics should never have been approved in the first place.

Public Citizen researchers told the FDA there was no scientific evidence to support the device’s approval. Subsequent events revealed how political pressure from some New Jersey members of Congress forced the device  through the FDA approval process. Dr. Jonas Hines, the Public Citizen researcher who appeared before the FDA, said that political shenanigans “cast a shadow on the ostensibly objective approval process.” The FDA’s decision to revoke the ReGen approval should be the agency’s first step in overhauling the medical device approval process.

“Although we are pleased that the FDA acknowledges its mistake in clearing the ReGen Menaflex, this decision is long overdue,” Jonas said. “We hope this represents the beginning of a new era in medical device approval, one in which the health of Americans supersedes any industry threat of the stifling effect on innovation of improvements in regulation.”

Gardiner Harris in the NYT writes that the FDA “had never before admitted that it approved a drug or device mistakenly, never rescinded such an approval without citing new information about the product, never admitted that a regulatory decision was influenced by politics, and never accused a former commissioner of questionable conduct.”

So is it a “new day” at the FDA? It might be a little premature to bust out the champagne, but following the decision earlier this month to pull the dangerous diet pill Meridia from the shelves, we will go so far to say that October has been a good month for patients.

Read Full Post »

For victims of diet pill Meridia, FDA’s decision to ban it comes too late

 

Dr. Wolfe

 

The Food and Drug Administration (FDA) approved Meridia in 1997 despite pre-approval randomized trial evidence of significantly increased blood pressure and heart rate (both risk factors for heart attacks) and despite the opposition of the FDA medical officer who reviewed the drug and the FDA’s advisory committee. Our 2002 petition to the FDA to ban the drug was based on this information and a growing number of post-marketing cases of heart attacks with no other explanation in relatively young patients.

Since then, more than 3 million prescriptions have been filled for Meridia, with many patients inevitably having had heart attacks or strokes because of its known toxicity. Even since January of this year (after our December 2009 re-petition to ban the drug), when the European Medicines Agency decided to withdraw the drug from Europe, there have been more than 160,000 prescriptions filled for Meridia in the U.S.

The FDA’s decision today to ask pharmaceutical maker Abbott to withdraw the drug is commendable, but dangerously too late for all of the victims of its unacceptable risks. It appears that it was banned only because of the rare concordance about banning a drug between FDA’s Office of New Drugs (OND) and FDA’s Office of Surveillance and Epidemiology (OSE), as documented in last week’s Oct. 4 memo from those two divisions to Center for Drug Evaluation and Research Director Dr. Janet Woodcock.

In both of the other cases in which drugs have recently been taken off the market in Europe – Darvon (propoxyphene) and Avandia (rosiglitazone) – OSE also urged a ban in this country but was “overruled” because of the reckless unwillingness of OND or Dr. Woodcock to ban the drugs. Thus, both of these unacceptably dangerous drugs remain on the market in this country, predictably injuring or killing many people, who, unlike their European counterparts, do not have the government protecting them from drugs with no unique benefits, but significant, unique risks.

Dr. Sidney Wolfe is the director of Public Citizen’s Health Research Group.

Read Full Post »

While Avandia patients died, drugmaker schemed how to turn drug’s side effects into profits

Last week, the Food and Drug Administration took the inadequate measure of restricting the sale of the dangerous diabetes drug Avandia. Public Citizen has long been pushing the FDA to ban Avandia, much like its European counterparts recently did.

Now comes this troubling look at the extent to which GlaxoSmithKline, the maker of Avandia, covered up the life-threatening side effects of its diabetes medication. Paul Thacker, who was the leading investigator for Sen. Chuck Grassley’s Finance Committee,  writes in Mother Jones what he learned during his three-year investigation:

During that time, my colleagues and I combed through over 250,000 pages of internal GSK documents and interviewed dozens of witnesses and whistleblowers. What emerged was a troubling picture of a company that had placed corporate profits over patient safety. While suppressing inconvenient evidence about the risks of its top-selling drug, the company even began to develop another drug to treat the very side effect Avandia has been linked to.

Yes, you read that right — Instead of recalling Avandia, which was linked to causing heart attacks in patients, GlaxoSmithKline decided the better thing to do was to develop another drug that could treat the condition caused by Avandia.

Read Full Post »

FDA’s decision not to take Avandia off the market jeopardizes public health

Wolfe

By failing to ban the dangerous diabetes drug, Avandia, generic name rosiglitazone, the Food and Drug Administration (FDA) again caved to industry pressure. Although the FDA has made progress highlighting the risks of using Avandia by severely restricting the drug, it did not go far enough. Too many people could still be exposed to this dangerous product. Rather, the FDA should have acted with its European counterpart and outright banned Avandia from the market.

Why did it take the FDA so long to decide that a drug with no evidence of any advantage in health benefits, but abundant evidence of a variety of risks compared to other diabetes drugs, should be severely restricted? Why did it not ban this unsafe product?

More than three years ago at an FDA advisory committee meeting, Public Citizen urged the FDA to ban Avandia. Since then, 9 million prescriptions for the drug have been filled in the United States. This means that, just in the past three years alone, tens of thousands more patients have needlessly suffered hospitalizations for heart failure or deaths than would have had they taken Actos, a comparable, but safer drug.

There is not a single study finding that Avandia is safer than Actos, but there are numerous studies finding that Avandia is more dangerous than Actos. The FDA and GlaxoSmithKline have acted recklessly in allowing Avandia to stay on the market for so long after its unique dangers have been known.

The FDA should reconsider its decision to merely restrict such a hazardous product and directly remove it from the market.

Public Citizen petitioned the FDA in 2008 to ban Avandia.

Click here to learn more about Public Citizen’s work on Avandia.

Dr. Sidney Wolfe is the director of Public Citizen’s Health Research Group.

Read Full Post »

Public Citizen researchers on medical device safety

On Tuesday, Public Citizen researchers published an article in PLoS Medicine about the safety of various medical devices. The authors of the article found that the FDA approval process does not adequately weed out ineffective and sometimes dangerous devices. From the press release issued Tuesday:

The weaknesses identified by the authors include:
• A lower approval standard for devices than for drugs;
• Lax interpretation of the requirements for the medical device approval process;
• A loophole that allows manufacturers of novel devices to circumvent the premarket approval process;
• Failure of the FDA to appropriately regulate many types of devices that were first marketed prior to the 1976 enactment of the current regulatory scheme; and
• A superfluous appeal mechanism that gives manufacturers a second go for approval after FDA has rejected a device.

The authors enumerated specific cases where FDA allowed dangerous products to be sent to market. In one particularly egregious instance, a device was approved by the FDA director after other FDA board members had expressed significant concerns about the device, the vagus nerve stimulator, which is supposed to treat severe depression. Currently, the Centers for Medicare and Medicaid considers the device to be of such questionable value that it refuses to reimburse for it.

In the words of one of the researchers, Dr. Sidney Wolfe,

“The FDA’s mission is to protect public health, but allowing questionably effective products onto the market is inconsistent with that mission.”

The article can be found in the latest issue of PLoS Medicine.

Read Full Post »

Sidney Wolfe to testify about Avandia tomorrow

Tomorrow, our own Sid Wolfe will be testifying before an FDA advisory committee about the much talked about diabetes drug Avandia, manufactured by drug maker GlaxoSmithKline.  The New York Times reported today that GlaxoSmithKline hid data indicating Avandia’s adverse effects for 11 years. The New York Times also explained the history of this dangerous drug.

In the fall of 1999, the drug giant SmithKline Beecham secretly began a study to find out if its diabetes medicine, Avandia, was safer for the heart than a competing pill, Actos, made by Takeda.

Avandia’s success was crucial to SmithKline, whose labs were otherwise all but barren of new products. But the study’s results, completed that same year, were disastrous. Not only was Avandia no better than Actos, but the study also provided clear signs that it was riskier to the heart.

But instead of publishing the results, the company spent the next 11 years trying to cover them up, according to documents recently obtained by The New York Times. The company did not post the results on its Web site or submit them to federal drug regulators, as is required in most cases by law.

Excuse our impatience, but we’ve been warning about Avandia for a decade. We petitioned the Food and Drug Administration to ban Avandia (also known as Rosiglitazone) back in 2000. Sid Wolfe has been saying all the things “recently uncovered” for years. It finally looks like something might happen though; the FDA is meeting to discuss Avandia today.

Check out Public Citizen’s history advocating for the removal of Avandia from store shelves.

You should also look at worstpills.org, our comprehensive fact-check website for all sorts of medications.

Read Full Post »

From BP to Avandia: Public Citizen’s media hits roundup

As government officials try to get to the bottom of who is to blame for the massive BP oil spill, Public Citizen has been featured in top media coverage of the catastrophe. Tyson Slocum, Public Citizen’s Energy Program director, has become a go-to guy on the issue, being interviewed on radio and television networks across the country. Slocum was featured on Bloomberg TV’s “Inside Track,” SiriusXM/POTUS radio talking about the government’s reaction to the spill and CBS Radio’s “The John Carney” show about BP’s history of safety records. He noted that BP has “one of the worst safety records of any oil company operating in America.”

Slocum made headlines in Canada and Cuba, as well. Slocum has been featured in a variety of articles from coast to coast including The New York Times and Los Angeles Times. Public Citizen also has been quoted on the issue by Reuters, Albany Times Union, Politico, The Washington Independent, The NACS, “The People’s Voice,” 2TheAdvocate.com and The Palestine Telegraph.

Also making headlines is Public Citizen calling on the Food and Drug Administration to stop the risky trail of GlaxoSmithKline’s diabetes drug, Avandia. The drug is believed to put patients at risk for heart attack and chest pain.

As Sidney Wolfe, director of Public Citizen’s Health Research Group, wrote in a letter to the FDA, which was quoted in a Reuters article:

The Avandia trial is “exposing thousands of high-risk patients with diabetes to a drug with an unfavorable safety profile and no clinical advantage over its comparator.”

Public Citizen’s efforts to stop the trial have gained international attention. Sidney Wolfe was quoted on CBC across Canada as well as in a Metro Canada Toronto story on the trial. The story gained attention in parts of Europe and was featured on Pharmacy Europe, a website for European hospitals and clinical pharmacists. Back in the States, Public Citizen was quoted in the Los Angeles Times, Post Chronicle, National Post, Business Spectator, and msnbc.com.

Public Citizen has also made headlines with many other issues including, the climate bill, Capitol Hill’s limits on lobbying and Florida’s doctor discipline system. Keep checking back for more!

Read Full Post »

Public Citizen to FDA: Stop this dangerous and unethical study

We’ve written about the dangers of the diabetes drug Avandia and have told Congress about an unethical international clinical trial, requested by the FDA, being performed by Avandia’s manufacturer, GlaxoSmithKline.

Now Public Citizen and Canadian researcher/physician David Juurlink go straight to the source, sending a letter to FDA Commissioner Margaret Hamburg asking her to halt the study, which pits Avandia against its competitor, Actos.

From the Reuters story:

“A wealth of data now suggests” that Avandia carries greater risks than Actos, the researchers said. Patients are also not adequately informed about the safety differences between the two medicines when deciding whether to participate in the trial, they added.

But FDA officials, who have said they are already taking a closer look at Avandia, are not likely to act so quickly.

And the Los Angeles Times:

In act, both drugs [Avandia and Actos] have been tagged with safety issues: In addition to raising rates of cardiovascular events, the class of Type 2 diabetes drugs known as thiazolidinediones (or TZDs) have been linked in studies to higher rates of edema, macular edema, bony fractures, anemia and acute liver injury. Older diabetes medicine such as metformin and sulfonylurea are widely believed to be safer alternatives.

But to no avail — the FDA likely won’t examine the study until July, FiercePharma reports.

Read Full Post »

Makers of dangerous diabetes drug are also involved in unethical study

Public Citizen has been concerned about the heart dangers caused by the diebetes drug Avandia for a decade. But to add insult to injury, the makers of the drug are also now involved in an international unethical study involving it. If that weren’t bad enough, this study was ordered by the FDA. What?! Something isn’t right here.

Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, testified on the Hill yesterday in a House appropriations subcommittee hearing on Avandia. He presented new data since we last urged the FDA in 2008 to remove Avandia from the market.

GlaxoSmithKline, Avandia’s manufacturer, pressed forward with the FDA-requested study, drawing a pool of 16,000 subjects from 14 countries. It pits the diabetes drug against its competitor, Actos, even though some FDA officials have called the trial “exploitive of patients.”

“Thousands of high-risk patients with diabetes are being needlessly exposed to a drug with an unfavorable safety profile and no clinical advantage,” Wolfe told the lawmakers.

But FDA Commissioner Margaret Hamburg defended the study, as reported by the AP and picked up by Bloomberg BusinessWeek. Hopefully it won’t take until the end of the study in 2015 for someone to step in and protect these patients, who are suffering from type 2 diabetes without knowing that their so-called treatment could be causing them further harm.

Read Full Post »