Posts Tagged ‘FDA’

November22

FDA’s rejection of our Avandia ban translates to more harm to patients

By: Sidney Wolfe, M.D.

"dr wolfe"Late yesterday, the FDA faxed Public Citizen its letter rejecting our October 30, 2008 petition in which we asked the FDA to ban Avandia (rosiglitazone) because its benefits were greatly outweighed by its multiple risks, including increased heart attacks, heart failure, fractures, vision-threatening macular edema and other serious problems. In September of 2010, the European Medicines Agency (EMA) announced a ban of the drug because of its decision that Avandia’s benefits were clearly outweighed by its risks and that additional restrictions to reduce risk could not be identified*. Subsequently, it has also been banned in New Zealand, India and other countries.

In the year since the EMA announcement, according to health-care analytics experts IMS, there have been approximately 1.1 million prescriptions for Avandia-containing drugs filled in the U.S., thereby ensuring the occurrence of hundreds or more patients suffering heart attacks, and cases of severe heart failure – including many deaths and hospitalizations. All of this from a drug deemed too dangerous to stay on the market in all of Europe and in an increasing number of other countries.

The FDA’s decision not to ban the drug but to limit prescriptions for the drug, so that patients will have allegedly tried other treatments first, is a dangerous and reckless refutation of the precautionary principle that is supposed to guide decisions involving public health.  The evidence shows the drug has no unique clinical benefits but unique risks. Unless the FDA can provide evidence that Americans are more resistant to the life-threatening adverse effects of Avandia than people in Europe and the other countries that have banned the drug, this decision, unlike the wise decision last week concerning Avastin, cannot be described as science-based or rational.

The FDA’s rejection of our petition closely follows the announcement by the manufacturer of rosiglitazone, GSK, that it has agreed to pay $3 billion in civil and criminal penalties including the illegal marketing of this drug.

*From the EMA press release announcing the ban:

“The availability of recent studies has added to the knowledge about rosiglitazone and overall, the accumulated data support an increased cardiovascular risk of rosiglitazone. In view of the restrictions already in place on the use of rosiglitazone, the Committee could not identify additional measures that would reduce the cardiovascular risk.  The Committee therefore concluded that the benefits of rosiglitazone no longer outweigh its risks and recommended the suspension of the marketing authorisation of the medicines.”

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

 

Posted in: Consumer Protection, Health, Pharmaceuticals, Product Safety, Regulation, Uncategorized3 comments

November15

Big Pharma & medical device industry are anxious to ride the deregulatory wave

By: Christine Hines

Bad news. The dangerous anti-regulation campaign sweeping Congress has hit the Food and Drug Administration (FDA) – the agency tasked with ensuring the safety of our drugs and medical devices. Over the last two months, several members of Congress have introduced misguided bills that would make it easier for manufacturers to sell new, unsafe medical devices, and in turn put patients’ lives at risk.

"FDA drug approval"

FDA commissioner Margaret Hamburg (right) speaks with Public Citizen president Robert Weissman (left) at a Public Citizen event on July 25, 2011. Click on the photo above to view YouTube video of this event.

Evidently, some members of Congress are buying into the arguments from the medical device and pharmaceutical industries that the process to approve drugs and devices is too lengthy, blocking their products from the market, and depriving pharma and device companies of their precious profits. However, contrary to industry’s statements, the FDA recently reported that its approvals of new drugs have increased.

The industries’ predictable talking points come as they negotiate with the FDA and Congress over a process to reauthorize fees collected from the industry and reevaluate FDA rules and practices. The process is expected to be completed in 2012. Unfortunately, if these anti-safety initiatives gain traction the lives of patients will take a back seat in the negotiations.

The innovation and continued improvement of drugs and medical devices are important health care goals, but the FDA shouldn’t lose focus on ensuring their safety. Recent history shows that dangerous drugs and devices have unnecessarily injured or killed hundreds of thousands of patients, strongly indicating that industry profits trumped patient safety in numerous instances.

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Posted in: Activism, Congress, Consumer Protection, Health, Pharmaceuticals, Product Safety, Regulation, Uncategorized2 comments

November4

For Big Pharma, crime pays

By: Sidney Wolfe, M.D.

Glaxo-Smith-Kline (GSK), the world’s fourth largest pharmaceutical company announced yesterday that it had tentatively reached a $3 billion settlement – the largest ever – with the feds to conclude an investigation into illegal activity going back at least seven years.

GSK allegedly promoted multiple drugs, including the dangerous diabetes drug Avandia for uses for which they were not approved, going so far as to pay kickbacks to get doctors to prescribe the medications. The purported settlement breaks the previous $2.3 billion settlement record set in 2009 by Pfizer.

GSK has repeatedly been fined for unlawful conduct. A 2010 Public Citizen report found that, over the past 20 years, GSK racked up $4.5 billion – more than any other company – in fines levied by the federal and state governments for a plethora of illegal activities.

The pharmaceutical industry has paid more in penalties to the federal government as a result of these settlements than any other industry. The profits generated by such activities are massive, and when companies are caught, CEOs get off scot-free, while the penalties handed down barely put a dent in their bottom lines.

The $3 billion settlement may seem like a sizeable sum, but consider that, according to The New York Times, GSK reaped profits of $5 billion on $43 billion worth of sales in just this past year alone. And by announcing the settlement in advance of its official conclusion, GSK put an end to years of investor uncertainty. The company’s stock rose 3 percent following the announcement, confirming yet again that, for Big Pharma, at least, crime does indeed pay.

Posted in: Health, Pharmaceuticals, Product Safety, Uncategorized1 comments

October24

This Week in the Halls of Power: Lawmakers tackle regulations, we tell super committee how to cut spending and petition the FDA

By: Dorry Samuels

Flickr photo by visulogik

Public Citizen is still operating in overdrive after last week’s hugely successful 40th Anniversary Gala. (Read a recap here and check out pictures here.) We plan to post video of the gala’s speeches early this week, so check back!

This week, we have a lot on tap.

We will be asking the FDA to place a stronger warning on the label of a drug because of its increased risk of mortality.

And Tyson Slocum, director of Public Citizen’s Energy Program, will participate in a briefing on Capitol Hill regarding a coalition report we put out telling Congress’ supercommittee how it can cut billions of dollars of federal spending by trimming environmentally harmful subsidies.

Speaking of action on the Hill, many pro-Big Business lawmakers will be back at it tomorrow, pressing their anti-consumer agenda, which involves blocking federal agencies from being able to issue life-saving safeguards that protect public health, the environment and more. We will be there to counter them. Watch for a double-header tomorrow: First up, the House Judiciary Committee will hold a hearing on the Regulatory Accountability Act, followed by a mark-up of the REINS Act. That’s the bill that would require Congress to approve every single health, safety and environmental rule – which of course would bring our regulatory system to a standstill. Stay tuned for Public Citizen’s take on the legislation.

Also on the regulatory front, Public Citizen will be chatting this week with small business owners who disagree with the U.S. Chamber of Commerce and value regulation. We’ll hear their stories and report back.

And on the direct action front, we continue to push for a constitutional amendment to overturn Citizens United v. Federal Election Commission [the U.S. Supreme Court ruling that said corporations can spend as much as they want to influence elections]  and are excited to have U.S. Sen. Bernie Sanders (I-Vt.) on board for our November 9 house party calls. There is still time to get involved!

Well, lots to do now, so time to get back to work. Thanks for checking in and be sure to check back often to see what else is coming down the pipeline. (Yes, that’s also something we’re working on.)

Posted in: Congress, Energy, Environment, Pharmaceuticals, Regulation, This Week0 comments

August25

Mesh to repair common pelvic condition should be pulled from the market

By: Dorry Samuels

Flickr photo by esc.ape(d)

A product used to treat a common problem afflicting women primarily of child-bearing age should be pulled from the market and recalled, Public Citizen told the FDA in a petition today.

WARNING: I’ll go into some graphic descriptions in this blog post. Have a weak stomach? Proceed at your own risk.

The condition is called pelvic organ prolapse (POP), and approximately 300,000 women in the U.S. were treated for it last year. In this condition, one or more of a woman’s pelvic organs (think bladder, rectum or uterus) bulges or descends into her vaginal cavity, sometimes past the opening of the vagina, because of weakness in the connective tissue and muscles that surround and support the pelvic organs.

Most women with POP have no symptoms. For symptomatic patients, treatment can involve surgical or non-surgical interventions; in surgical procedures, non-absorbable mesh often is implanted transvaginally (through incisions and punctures made through the wall of the vagina) with the intent of reinforcing the tissues around the pelvic organ that prolapsed and increasing the longevity of the repairs. Public Citizen estimates that approximately 67,500 of these procedures last year used non-absorbable mesh.

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Posted in: Consumer Protection, Health, Product Safety0 comments

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