I have written on several occasions about the excellent work that has been done by Public Citizen relating to drug safety. Without any doubt, that work was badly needed and the need continues. Each year, more than 100,000 people die from adverse drug reactions and another 2,000,000 people are seriously injured. Unfortunately, the U.S. Food and Drug Administration (FDA) hasn’t always done its job when it comes to drug safety. In large part, that’s because the agency has been grossly underfunded and not adequately staffed. The FDA has even had to depend on the drug industry for part of its funding. It’s most interesting that a regulatory agency has to look to the industry it regulates as a funding source.
A prime example of why Public Citizen’s work is so important involves the drug Rezulin. By the time the FDA banned Rezulin, the drug had caused hundreds of cases of liver damage, including 63 reported deaths. A publication, Worst Pills, Best Pills News, put out by Public Citizen, had warned of Rezulin’s potential danger a full 18 months before the FDA finally took the drug off the market.
Worst Pills, Best Pills News was started by Dr. Sidney Wolfe at Public Citizen to warn consumers about dangerous prescription drugs, sometimes years before they are finally taken off the market. It should be noted that Public Citizen has helped to remove 23 dangerous drugs from the market. That really should have been the FDA’s job, but for a number of reasons, the agency doesn’t always act promptly to protect folks against the dangers of unsafe drugs.
The most recent example was when the FDA dropped the ball on regulating a large compounding pharmacy company, allowing it to continue to manufacture fungus-contaminated steroid injections that so far have sickened at least 745 people in 20 states, resulting in 58 deaths. What is particularly tragic for those who have been sickened or killed by the tainted drug, and for their loved ones, is that this situation was completely avoidable.
Readers were warned about compounding pharmacies in Worst Pills, Best Pills News back in 2001. Subsequent articles appeared in the publication’s reports in 2006 and 2007. Even earlier, Public Citizen had tried to get FDA to act. And since the outbreak began, Dr. Sidney Wolfe has issued several letters to the Secretary of Health and Human Services, the Food and Drug Administration, and Congress criticizing the FDA and the Centers for Medicare and Medicaid Services for years of oversight failures that led to this public health catastrophe and calling for an independent investigation of these failures.
The work of Dr. Wolfe and Public Citizen has been widely covered by numerous media outlets including The New York Times, The Washington Post, USA Today, CNN, National Public Radio’s “The Diane Rehm Show” and “NBC Nightly News.” Many believe Public Citizen is doing work that the FDA should be doing. Unfortunately, the FDA is not the gold-standard agency it once was. For that reason, Public Citizen has had to step up its efforts to keep consumers safe. Public Citizen, among other things, has:
• Formally petitioned the FDA to remove unsafe drugs from the market or issue black box warnings. For drugs approved between 1975 and 2000, partly because the FDA sped up the approval process to accommodate the demands of the drug industry, one in five new drugs has to be removed from the market or receive a black box warning after FDA approval. One in five!
• Closely monitored the FDA where the drug review process is heavily dependent on industry financing. In fiscal year 2011, total drug industry user fees to the FDA central drug office – where drugs are reviewed – were $619 million. This means that approximately 60 percent of the total budget for reviewing drugs came directly from these “regulated” companies. Because of this unhealthy financial relationship, we have had to further increase the speed and intensity of our challenges to the safety of many drugs by petitioning the FDA to ban or relabel them. This responds to the urgent need to supplement the inadequate FDA (and Congressional) oversight of the drug industry.
• Had Medical experts from PC testify regularly at FDA advisory committee meetings about the safety of drugs, trying to stop dangerous drugs from being approved or arguing for them to be banned.
• Taken an active role in stopping Congress from destroying Medicare and that work is very important.
Unlike most other publications or websites, Public Citizen does not accept money or advertisements from drug companies. This ensures that Public Citizen can remain independent and do its work without worrying about offending Big Pharma. Their judgment is not clouded by commercial interests and that’s very important. The only obligation Public Citizen has is to people and not to powerful corporations and that is also critically important.
I have encouraged our readers in prior issues to support Public Citizen. I again make that request. One way you can help is by subscribing to Worst Pills, Best Pills News. You can actually become an advocate for your own health and that of your family and friends. Public Citizen can be your advocate for safe drugs. One way you can help support this work to keep dangerous drugs off the market is by sending in a financial contribution, large or small, today to Public Citizen. You can write Public Citizen at 1600 20th Street, NW, Washington, D.C. 20009 or call 1-202-588-1000. Public Citizen’s email address is email@example.com and their website is www.citizen.org. For more information on Worst Pills, Best Pills News you can go to www.worstpills.org.
Source: Public Citizen
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