Anybody who has been a regular reader of the Report knows my friend Dr. Sidney M. Wolfe at Public Citizen. He writes in Worst Pills, Best Pills News that each year more than 100,000 people die from adverse drug reactions, and another 2,000,000 people are seriously injured. Public Citizen, a consumer advocacy group, works hard to educate consumers about the dangers of some prescription drugs. It has also worked extremely hard to educate the U.S. Food and Drug Administration (FDA) about dangerous drugs.
Most of you, having read our monthly report, have heard of the diabetes drug Rezulin. This drug was approved in 1997 by the FDA and then banned by the agency three years later. By that time, it had already caused hundreds of cases of liver damage, including 63 reported deaths. Dr. Wolfe, through the publication Worst Pills, Best Pills News, warned of Rezulin’s potential danger a year and half earlier, when Public Citizen petitioned the FDA to ban the medication in 1998.
In fact, the Health Research Group at Public Citizen, the publisher of Worst Pills, Best Pills News, has helped to remove 25 other dangerous drugs from the market. That’s why Dr. Wolfe started the newsletter in an effort to warn consumers about dangerous prescription drugs. Many times his warnings were years before the drugs were pulled from pharmacy shelves. The following are some of the projects Public Citizen has worked or is working on:
• In 2012, the FDA dropped the ball on regulating a large compounding pharmacy company, allowing it to continue manufacturing numerous drugs without following proper safety procedures for ensuring that they were free of contamination. As a result, at least 751 people in 20 states became ill, and 64 people have died after being treated with steroid injections that were contaminated by fungus. 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.
• Since the 2012 outbreak began, Public Citizen 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 Rehem Show” and “NBC Nightly News.”
In December 2014, Dr. Michael Carome, Director of Public Citizen’s Heath Research Group, was appointed to serve on the FDA’s Pharmacy Compounding Advisory Committee. As the consumer representative on the committee, Dr. Carome will aggressively advocate for rigorous FDA safety standards for all compound medications to protect patients from serious harm.
Unfortunately, as Dr. Wolfe points out, the FDA is not the gold-standard agency it once was. For this reason, Public Citizen has had to step up its efforts to keep people safe. In addition to keeping folks informed, Public Citizen also does the following on behalf of the American people.
• Public Citizen formally petitions the FDA for stronger drug-safety standards. For example, in 2013, the FDA granted Public Citizen 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. If finalized, the rule will provide added protection to the tens of millions of people who regularly use generic drugs, which make’s up 86 percent of all dispensed prescription drugs. However, the pharmaceutical industry is aggressively lobbying Congress to block FDA issuing the final rule. Public Citizen is working hard to counter these efforts by the drug industry to undermine drug safety.
• 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 had to be removed from the market or receive a black box warning after FDA approval. One in five!
• Public Citizen carefully scrutinizes FDA proposals regarding the dug industry’s promotion of its products. In 2014, we initiated a campaign against a dangerous FDA proposal that would permit Big Pharma to give doctors information that contradicts FDA-approved labeling about the risks of prescription medications. Such a proposal poses a grave threat to patient safety.
• Public Citizen testifies regularly as medical experts at FDA advisory committee meetings about the safety drugs, trying to stop dangerous drugs from being approved or arguing for them to be banned.
• Public Citizen has taken an active role in stopping Congress from destroying Medicare.
I would encourage any person who wants to learn more about the dangers of prescription drugs to subscribe to Worst Pills, Best Pills News. These critical, life-saving activities mentioned above are expensive, and the subscription fee for Worst Pills, Best Pills News doesn’t begin to cover their cost. Public Citizen needs help to pay for the research behind its newsletter and its 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. Public Citizen doesn’t accept money from the government or corporations and that’s very important. This ensures that Public Citizen can remain independent – its judgment won’t be clouded by commercial interests – which makes Public Citizen only obligated to people.
I hope you will help Public Citizen continue to help folks by making a generous contribution to the organization. You can get more information on the work of Public Citizen and the newsletter by going to Citizen.org. You can make your contribution to Public Citizen, publisher of Worst Pills, Best Pills News, by sending a check to Public Citizen at 1600 20th Street NW, Washington, D.C. 20009.
Source: Public Citizen
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