Dr. Sidney Wolfe, a long-time health and safety advocate, who is with Public Citizen, sent out some very interesting information last month. Dr. Wolfe has been the editor of Worst Pills, Best Pills, a publication that comes out each month. He turned over the reins as Editor last month. Dr. Wolfe warns folks about “bad drugs” that should not be on the market. He points out that “what you don’t know can hurt you.” The diabetes drug Rezulin, approved in 1997 and then banned by the Food and Drug Administration (FDA) three years later is a prime example of what Dr. Wolfe was saying. In those three years Rezulin had already caused hundreds of cases of liver damage, including 63 reported deaths. Worst Pills, Best Pills News warned of Rezulin’s potential danger in 1998, a year and half earlier. In 1998, Public Citizen petitioned the FDA to ban the medication.
The Health Research Group at Public Citizen, the publisher of Worst Pills, Best Pills News, has helped to remove 25 such dangerous drugs from the market. Dr. Wolfe started the newsletter to warn consumers about dangerous prescription drugs, sometimes years before they are pulled from pharmacy shelves, and it has been effective. Public Citizen does vital work in other ways to protect the health and safety of the American people. The following are some prime examples of the work done by Public Citizen:
- In 2012, the FDA dropped the ball on regulating a large compounding pharmacy company, allowing it to continue to manufacture steroid injections that were contaminated by fungus. As a result, at least 751 people in 20 states have become ill, and 64 people have died thus far. 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.
- Public Citizen warned readers about compounding pharmacies in Worst Pills, Best Pills News back in 2001, publishing subsequent articles in 2006 and 2007. Even earlier, it tried to get the FDA to act. Since the 2012 outbreak began, Public Citizen has issued several letters to the Secretary of Health and Human Services, the FDA, and Congress, criticizing the FDA and the Centers for Medicare & Medicaid Services for years of oversight failures that led to this public health catastrophe and calling for an independent investigation.
- Public Citizen’s work in this regard 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.” 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 the public safe. In addition to keeping folks informed, Public Citizen also does the following on behalf of the American people in an effort to protect them from bad drugs:
- Public Citizen formally petitions the FDA for stronger drug-safety standards. For example, in 2013, the FDA granted Public Citizen’s petition calling for the agency to propose new regulations to allow generic drug manufacturers to promptly update their product labeling to include newly acquired safety information. When finalized, the rule will provide added protection to the tens of millions of people who regularly use generic drugs, which make up 84 percent of all dispensed prescription drugs.
- Public Citizen formally petitions 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!
- Public Citizen closely monitors the FDA and its drug-approval process that is, unfortunately, heavily dependent on industry financing. For fiscal year 2014, the FDA budget provides the agency with more than $1 billion in total drug industry user fees, which now include fees for generic drugs. This means that more than 60 percent of the total FDA budget for the review and oversight of drugs comes directly from drug companies. Because of this unhealthy financial relationship, we have had to further increase the speed and intensity with which we petition the FDA to ban or relabel drugs, pointing to the urgent need to supplement the inadequate FDA (and congressional) oversight of the drug industry.
- Public Citizen staff testify regularly as medical experts 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.
- Public Citizen takes an active role in stopping Congress from destroying Medicare.
These critical, life-saving activities are expensive, and the modest subscription fee for Worst Pills, Best Pills News doesn’t begin to cover the cost. I encourage our readers to support Worst Pills, Best Pills News by making a financial contribution to Public Citizen. It will be a good investment to help to pay for the research behind the newsletter and Public Citizen’s continuing efforts to force unsafe drugs off the market. 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 – its judgment is not clouded by commercial interests. Public Citizen’s only obligation is to the public.
Our readers can help Public Citizen continue its work by making a financial contribution to Public Citizen, publisher of Worst Pills, Best Pills News. Also, by subscribing to Worst Pills, Best Pills News, a person can become an advocate for his or her own health and also an advocate for others.
Whether you know it or not, Public Citizen has been your advocate for safe drugs for years. That will continue. But Public Citizen needs your support. It’s very important for the group to continue working to keep dangerous drugs off the market. You can get more information on Public Citizen by going to www.citizen.org. A contribution to Public Citizen will help Dr. Wolfe and others continue with their work. You can send your donation to 1600 20th St. NW, Washington, D.C. 2003. I also strongly encourage our readers to subscribe to Worst Pill, Best Pills News.
Source: Sidney M. Wolfe, M.D.; Founder, Senior Advisor; Health Research Group at Public Citizen