4 Times FDA Was Dead Wrong About an ‘Approved’ Drug

Via The Defender

As history shows, the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention don’t always get it right the first time they declare a drug “safe” — in fact, sometimes they’re dead wrong.

Throughout the pandemic, health officials have urged the public to “trust the science,” reassuring people that “the science” is the basis for any recommendations originating from the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA).

Dr. Anthony Fauci, chief medical advisor to President Biden on COVID-19, at one point even went as far as to tell the media if they criticize him, “They’re really criticizing science because I represent science. That’s dangerous.”

In the U.S., the FDA approves new drugs, including vaccines — or, as is the case with COVID-19 vaccines, grants them Emergency Use Authorization. The CDC then recommends them.

Once that process is completed, it’s assumed the public — and the mainstream media — will unquestionably trust that the drugs or other treatments are safe and effective.

But as we’ve seen recently — when Newsweek last week broke with mainstream media and published two opinion pieces criticizing the U.S. government’s response to COVID-19 and claiming Americans don’t trust the CDC — not everyone buys everything the FDA and CDC are selling.

As history shows, the FDA and CDC don’t always get it right — in fact, sometimes they’re dead wrong.

Whether they err because they allow pharmaceutical companies to deceive them, or because the agencies are populated with “experts” whose financial conflicts of interest cloud their judgment, the results are the same.

There is a lack of a firewall between the FDA and drugmakers who pay much of the agency’s fees.

For example, the current FDA commissioner, Dr. Robert Califf, who had previously served in that role and was again nominated by President Biden, has 50 conflicts of interest.

After leaving the FDA in 2017, Califf became head of medical strategy at Google’s parent company, Alphabet Inc. He also presided over a discredited drug trial of the blood thinner Xarelto, which was linked to at least 370 deaths, according to the Chicago Tribune.

Discussing the Vioxx scandal on PBS, Califf said, “Many of us consult with the pharmaceutical industry, which I think is a very good thing. They need ideas and then the decision about what they do is really up to the person who is funding the study.”

As the FDA and CDC unleash risky, experimental COVID-19 vaccines on babies and toddlers, it’s worth looking back at some of their deadliest mistakes.

Vioxx: FDA’s ‘poster child’ for getting it wrong

Vioxx (rofecoxib), manufactured by Merck, is probably the poster child for a drug the FDA said was safe — but then had to withdraw from the market.

Approved by the FDA in 1999, Merck’s “super-aspirin” pain reliever was heavily advertised by celebrity athletes like Dorothy Hamill and Bruce Jenner and used by 80 million people worldwide — before it was abruptly withdrawn from the market in 2004 after a study showed it doubled the risk of heart attacks and strokes.

It was estimated Vioxx caused 140,000 additional heart attacks in the U.S. alone.

Merck voluntarily withdrew Vioxx in 2004, after disclosures that the drugmaker deliberately withheld risk information from the FDA, medical journals and the drug-taking public and its doctors.

In 2007, Merck agreed to pay $4.85 billion in a settlement with heart attack and stroke plaintiffs. The company made $2.5 billion from Vioxx in 2003.

Vioxx is hardly the first drug to be used by millions after FDA approval, sometimes for years, only to be withdrawn because of surfacing health risks.

Drug safety advocates have observed that a drug’s health risks or “safety signals” are often not acknowledged until the patent has expired and the majority of the profit has been netted.

For example, months after the patent expired on Lipitor — a statin that was the best-selling drug in history — the FDA added a label warning that Lipitor and other statins could cause diabetes, liver injury, muscle damage and memory impairment.

Belviq: What’s wrong with this picture?

The saga of the diet drug Belviq (lorcaserin), withdrawn by the FDA in 2020, should reassure no one of the FDA’s commitment to protecting consumers and resisting pressure from drugmakers.

In 2010, the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted against approval of Belviq, citing questions about cancer and heart disease risks.

FDA advisory committees make non-binding recommendations, which the agency generally follows.

In response to the rejection, Michael Murphy, a chartered financial analyst, in 2010 wrote an open letter to then-secretary of the FDA, Kathleen Sebelius, and senators and government officials decrying the decision on behalf of Arena Pharmaceuticals, the drug’s developer.

“Due to an erroneous analysis of benign tumors in rats at extremely high dosages, the Advisory Committee voted 9-5 against recommending lorcaserin for approval,” the letter notes. “The dramatic elevation of concern over rat cancer” could “result in irreparable damage to the bio-technology and pharmaceutical industry as a whole.”

Two years later, in 2012, after Arena provided more data to the FDA, the agency approved Belviq as a weight-loss drug. But it wasn’t until 2020 that the FDA officially requested the drug’s withdrawal from the market because the “potential risk of cancer outweighs the benefits.”

Diet drug combo fen-phen caused fatal pulmonary hypertension

The diet drug fen-phen, a combination of the two medications fenfluramine and phentermine, was immensely popular for weight loss in the 1990s — until the FDA received reports of potentially fatal pulmonary hypertension and more than 100 reports of heart valve problems.

After issuing warnings, the FDA withdrew the drug in 1997. Legal damages exceeded $13 billion.

However, the withdrawal cast the FDA in a bad light. In 2009, the top FDA reviewer of fen-phen, Dr. Leo Lutwak, told the press he believed the manufacturer, American Home Products (which later became Wyeth and then Pfizer), knew and hid the risks.

When the revelations occurred, the FDA’s former commissioner, Dr. David Kessler, said, “I have some concerns that we may be losing sight of what the FDA is all about … The question is, who’s the agency’s customers? Who’s the agency partner?”

But the FDA would not let Lutwak testify about the issue.

At the time fen-phen was withdrawn (before Lutwak’s accusations), The New York Times wrote:

“The tale speaks to the limitations of current methods of evaluating drug safety…. It also raises questions about the Food and Drug Administration’s standards for approving diet drugs, as well as about the way that drugs are monitored after they are on the market.”

The statin Baycol: 100 deaths, more than $1 billion in settlements

The FDA also had to withdraw Bayer’s Baycol, a statin competing with Lipitor, after approving it.

Baycol was approved in 1997, but Bayer soon after added a warning about the concomitant use of the cholesterol medication gemfibrozil with Baycol.

But that hardly covered the risks. Soon, more than 50 people had died and more than 6 million patients were at risk from the deadly side effects of rapidly dissolving of muscle tissue.

Most of the deaths were attributed to rhabdomyolysis, a muscle-destroying condition, and its related kidney failure.

When another 385 cases, all non-fatal, of rhabdomyolysis were reported, it became apparent Baycol posed a risk 5 to 10 times higher than other statins.

Baycol voluntarily withdrew the drug in 2001.

According to the Organic Consumers Association:

“Bayer removed the drug from pharmacy shelves in the U.S., Europe and Japan, and U.S. and German lawyers announced they are planning an amended class-action lawsuit in the U.S. that would allow European victims to seek damages.

“As the number of deaths grew, Bayer stuck to its story that ‘there is currently no proof that the drug is the cause of the deaths’ and assured shareholders that ‘our sales this year will increase even though Baycol will now be absent.’”

After Baycol’s withdrawal, reports indicated that the drug giant knew of the risks, including the risk of myopathy, a disorder of the skeletal muscles, but did not disclose them.

The FDA allowed the sale of two higher Baycol doses after initial approval and said it did not see an increase in deaths until 2001, when it raised its concerns to Bayer, which withdrew the drug.

There were approximately 100 deaths and 1,600 injuries from Baycol worldwide, reported in 2003, The New York Times reported.

In 2005, Bayer paid $1.143 billion to settle 3,058 Baycol cases, paying an average of $373,733 per case.