FDA’s Zantac Fail is not the agency’s first

The Zantac drug recall by the FDA is not the first time the agency has recalled a drug it had formerly approved for human use. In fact, the agency’s safety record is living proof that FDA approval of a drug does not necessarily mean that drug is safe or effective.

Long List of FDA Regulation Failures

The long list of drugs which were approved by FDA and later pulled from the market is long. The list includes Accutane, Baycol, Belviq, Bextra, Darvon / Darvocet, DBI (Phenoformin), DEZ, Fen-Phen, Lotronix, Meridia, Palladone, Propulsid, Permax, Pondimin, Propulsid (Cisapride), Quaalude (Methaqualone), Raptiva, Raplon (Rapacuronium), Rezulin, Seldane, Trasylol, Vioxx (Rofecoxib), Zalmid, Zelnorm. . . and the list goes on and on. The FDA’s safety record for drug approvals is, to say the least, concerning.

Why do so many FDA-approved drugs prove to be unsafe?

The list of recalled drugs is long enough to ask the question: Why do so many FDA-approved drugs prove to be unsafe? One person who can answer that question from experience is Marcia Angell, M.D. She edited one of the most famous medical journals in the world for two decades, the New England Journal of Medicine. Dr. Angell later wrote a story for the Boston Globe detailing what she learned while editing the NEJM.

Related: FDA-Approved Drugs Later Pulled

Marcia Angell’s piece for the Globe was titled, “Talking Back to the FDA” (February 26, 2007). Among the bombshells in her article is the way in which FDA works with drug makers as a virtual business partner instead of performing its congressionally-mandated task as a drug regulator:

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“The FDA also refuses to release unfavorable research results in its possession without the sponsoring company’s permission…It’s no wonder that serious safety concerns about drugs such as Vioxx, Paxil, and Zyprexa have emerged very late in the day—years after they were in widespread use.”

The serious safety concerns she mentions include heart attacks, strokes, cancer, suicides, psychosis, and more.

FDA creates Sweetheart Deal for Drug Companies

Most people have no idea that the drug companies with vested interests in the drugs they make perform the human studies on those new drugs before they are submitted to the FDA. Agency officials then decide whether to approve those drugs for public consumption. Even fewer people understand that FDA officials also have a vested interest in approving drugs. FDA salaries are virtually tied to drug approvals.

Among the sleight-of-hand tricks available to the agency to assuage its drug industry partners is that a drug company might submit four studies on a new drug to the FDA. However, the FDA might choose to give the drug a thumbs up based on just two of those studies.

Related: FDA sued by Doctors, Scientists for Plan to Conceal CoVax Data for 95 Years

While she was editing the New England Journal, Dr. Angell would approach the FDA and say, “We want to see all (emphasis ours) the study-data you have on this new drug. Not just the most positive findings.”

The FDA would refuse to show her all the studies, claiming that those studies were the “property” of the drug companies. So the FDA could essentially play the man behind the curtain for its drug industry partners. Neither Dr. Angell nor any other “outside party” could see all the studies to make their own data-informed determinations regarding safety.

Recalled Drug Lawsuits

That is, of course, unless the drug company were later sued in a court of law over a particular drug, as companies were sued in Vioxx, Rezulin, Trasylol litigation; or, as Pfizer is being sued in Zantac lawsuits. In those cases, plaintiffs’ lawyers demand, and sometimes get, access through the discovery process to even those studies which the drug companies refused to show Dr. Angell and other investigators.

Dr. Angell’s column in the Boston Globe was a shocker that should have provoked action from the Department of Justice, which is more interested now in surveilling parents speaking at school board meetings than holding drug companies to account. After all, if withholding evidence of a dangerous drug’s causing heart attacks, strokes, and other injuries isn’t a crime, then what is?

Sadly, Dr. Angell’s revelations brought virtually no change to business as usual between the FDA and drug companies. Which is one more reason why the agency approved a dangerous drug like Zantac only to later have to pull it from the market.

Conceal the dangers. . . ignore the human destruction

As the former NEJM editor said, we have a hidden definition of pharmaceutical science: “Conceal the dangers, get the drug on the market, ignore the human destruction, and at worst pay a fine.”

This broken system revealed by Dr. Angell and others helps explain how, in the US every year, roughly 106,000 people die as a direct result of ingesting FDA-approved medications, according to Dr. Barbara Stanfield.

Writing in the Journal of the American Medical Association (JAMA) in July 2000, Dr. Stanfield asked, “Is US health really the best in the world?”  Dr. Starfield, called the 106,000 deaths a conservative estimate; others have since put the number at least twice that.

At some point, do the citizens of the country need to hold the FDA accountable for its failures or incompetence just as they are sometimes able to hold the drug companies accountable in the civil courts?

One thing is certain: history proves that one might be wise to think twice before assuming that an FDA-approved drug is safe or effective.



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