Big Pharma Captures the FDA

The following is authored by a non-clincian.

The authors of this column are strong supporters of capitalism and the free market, but we become very concerned when there are indications the profit motive is becoming the determining factor in drug and vaccine approval decisions.

Let’s start with the Covid vaccine. The SCIENCE indicates the vaccine is beneficial to the elderly, the obese and those with pre–existing conditions. Government and Big Pharma urging those individuals to take the ‘Fauci Ouchi’ makes perfect sense.

Where we begin to part company with vaccine recommendations is the current drive to vaccinate those in their 20s and 30s who, if they are otherwise healthy, are apparently at very little risk from the virus. And we are opposed to forcing those who have already had and recovered from Covid to take a vaccine for a disease to which they are already immune. We question the medical precedent for this dangerous recommendation.

And we are completely opposed to forcing the vaccine on children and teenagers. The government might as well force them to be vaccinated for lightning strikes, since more children die from being hit by lightning that being hit by Covid.

It looks to us like much of the impetus for this unnecessary push for vaccinating anyone and everyone has its origin in the profit motive.

Big Pharma makes billions more as the total potential market for the Covid shot expands and the government bureaucrats at the CDC and FDA supporting this market share expansion also share in the wealth through grants, speaking fees and consulting contracts both before and after their government career ends.

This is not only unethical. It should be illegal.

The recent uproar over the approval of an Alzheimer’s drug by the FDA only serves to reinforce our suspicions.

Fox News reports a drug developed by Biogen was just granted “Accelerated Approval” status and approved for use on humans even though the drug has only been through a single study with indifferent results. What tipped the balance in favor of the drug was a “surrogate endpoint.” That’s a SCIENCE term that sounds impressive, but the fact is a “surrogate endpoint” is merely a prediction or a theory of what might happen when the drug is in widespread use.

We haven’t seen much in the way of recent evidence that government predictions from either the CDC or the FDA are worth the paper necessary to print the prediction.

The end result of “Accelerate Approval” is Biogen starts making potentially billions of dollars off the drug — it’s been almost two decades since an Alzheimer’s drug was approved so demand is potentially very high, particularly after the advertising campaign starts — while the general public is an unsuspecting collection of guinea pigs.

Three members of the FDA panel were so appalled by this Rush to Profit that they resigned their positions in disgust. First it was Dr. David Knopman, Mayo Clinic neurologist and Dr. Joel Perlmutter, neurologist of Washington University in St Louis.

Dr. Aaron Kesselheim, professor of medicine at Harvard Medical School and faculty member at Brigham and Women’s Hospital, is the latest to resign. He told CBS, “The drug showed no good evidence that it worked because it had important side effects and then the FDA is totally switching gears over the last six months and approving this drug on the basis of a theory relating to the surrogate marker of amyloid plaques that we as an advisory committee back in November were told to not consider.”

Kesselheim also sent a resignation letter that called the approval, “probably the worst drug approval decision in recent U.S. history.”

This is a scandalous decision that only fuels American’s distrust of medical ‘experts’ who have been so disastrously wrong over the past year and a half. It really makes us wonder if the ‘scientists’ who make these decisions are viewing the data or the dollar signs.

Michael Reagan, the eldest son of President Reagan, is a Newsmax TV analyst. A syndicated columnist and author, he chairs The Reagan Legacy Foundation. Michael is an in-demand speaker with Premiere speaker's bureau. Read Michael Reagan's Reports — More Here.

Michael R. Shannon is a commentator, researcher for the League of American Voters, and an award-winning political and advertising consultant with nationwide and international experience. He is author of "Conservative Christian's Guidebook for Living in Secular Times (Now with added humor!)" Read Michael Shannon's Reports — More Here.