Don’t Believe the FDA on New Drugs

         Photo by Diana Polekhina on Unsplash

They say, ‘Follow the science.’ But to find the truth, you also have to follow the money. Science as reported to the public too often follows the money and not the facts.

In 2020, the drug company Biogen applied for approval of their new Alzhheimer’s drug Aduhelm. In early trials, the drug slowed the development of “amyloid plaques” a sign of Alzheimer’s in the brain. The Food and Drug Administration (FDA) applied their “accelerated approval” process for vitally important new treatments.

Unfortunately, Aduhelm completely failed two Phase 3 trials, which test whether drugs actually help people. Both trials were stopped early, because the subject patients were showing no benefit. There were also dangerous adverse effects including brain swelling and bleeding in up to 40% of the patients who took it.

Biogen continued their application process. They set the price for this clinically ineffective, dangerous drug at $56,000 a year per patient. Since Medicare is legally not allowed to negotiate drug prices, if Aduhelm were approved and widely prescribed, Biogen would receive billions of dollars of Medicare’s money.

The FDA’s own advisory committee of expert scientists and doctors voted unanimously against approval in November 2020, but in June 2021, the FDA approved Aduhelm anyway.

Scientists pushed back against this decision. According to Jeffrey Toobin on CNN, three of the expert advisers resigned in protest. They wrote letters and told media that the approval process had been corrupted. One, Dr. Aaron Kesselheim, a professor at Harvard, said. “Usually there’s some distance between the FDA and the company, but on this one the company and the FDA were fully in line with each other in support of the drug.”

Top institutions such as the Mayo Clinic and Cleveland Clinic said they would not prescribe Aduhelm. The Center for Medicare and Medicaid Services (CMS) said Medicare would have to consider more before covering the drug. Biogen meanwhile reduced their price to $28,000/year, although they legally didn’t have to negotiate. Were they trying to reduce the public outcry?

In January 2022, CMS approved the drug for patients with early Alzheimer’s. Even though later stage patients aren’t eligible, if all eligible patients got treated with Aduhelm, it would cost CMS up to $30 billion a year or even more. CMS announced that every Medicare recipient in America will have to pay an additional $20/month in Medicare premiums to cover the cost of this one ineffective drug. (They’ve since stated the actual increase may be less.)

According to an article in BioPharma Dive, Biogen has “earmarked $600 million for commercialization expenses,” for Aduhelm, which I gather means advertising and training, wining and dining doctors who might prescribe it.

According to Dr. Michael Carome of Public Citizen, FDA has been captured by the companies it regulates, a process that has happened in most regulated industries. “We believe that the FDA, starting back in 2019, worked in inappropriately close collaboration with Biogen,” he said.” They became a partner with Biogen; they were not objective.”

Similar stories surround other high-tech drugs such as the muscular dystrophy drug eteplirsen (Exondys 51), which post-approval studies found may cause “serious and life-threatening infections.” The drug costs between $750,000 and $1.5 million a year —How do you justify that? How many malnourished kids could we feed with that money? — and has shown “little long-term effectiveness”, according to a report by the Institute for Clinical and Economic Review (ICER.) It’s easy to conclude that the money these drugs earn their creators sloshes around and helps get the drugs approved. But there is more to the story.

One doctor cited by Toobin said FDA may have felt they had to give Alzheimer’s families something, no matter how expensive, ineffective, or dangerous, to give them hope, even if it’s false hope. Desperate patient and family activism also contributed to the approval of Exondys 51 and other drugs for rare conditions. “We have to give them something” seems a successful argument, as I have seen repeatedly with the condition I have, multiple sclerosis.

MS was one of the first conditions for which expensive — although not so expensive as the ones mentioned here — drugs of limited effectiveness were approved and widely prescribed Some insurers, such as the UK’s National Health Service, refused to cover them because their benefit was so limited and the cost so high. But outcry from the MS community, organized by the drug companies, forced them to back down. By now, between drug companies’ lobbying and patient activism, it seems drugs have become harder to disapprove, no matter how ineffective and even dangerous.

Approving COVID vaccines

Does the Aduhelm story remind you of anything? What about the approval process for the mRNA vaccines produced by Pfizer and Moderna to prevent corona virus disease (COVID-19)? Those were approved very quickly, out of a large group of less-experimental vaccines that were in development at the time. The usual approval process for new drugs takes 3–5 years, but Pfizer was approved in a matter of months.

According to the Centers for Disease Control (CDC), the usual process takes so long because of delays in designing studies and evaluating the results. Because COVID-19 was a crisis, the mRNA vaccines went to the top of everyone’s to-do list and those delays were avoided, so they could “do something” about COVID.

The problem is that bureaucratic delays are not the only reason it should take years to bring new drugs to market. The main reason is that new drugs may look safe in short-term studies, but turn out to cause major adverse effects in a larger population over a longer time. This famously happened with the widely promoted pain reliever Vioxx, which turned out to cause heart attacks and strokes and had to be withdrawn. It also happened with the diabetes drug Rezulin, which caused liver failure, and many others.

That is why I have always refused any new drug until it’s been in use two or three years. They might cause more problems than they fix. But in the case of COVID, we didn’t get that choice. Governments stated a public health emergency as the reason to override safety concerns. They started mandating that everyone take these drugs or face exclusion from work, school and public spaces.

Even though children almost never die from COVID, Pfizer and the FDA are now pulling to approve vaccines for children as young as 6 months. Pfizer is recommending infants get a 3-dose series of their “vaccine” for infants.

Remember, these drugs have not been proven safe and cannot be proven safe until they have been in use for a few years. It is already acknowledged that they increase risk of myocarditis and pericarditis, which mean inflammation of the heart muscle or membranes. Perhaps those conditions are not as serious as they sound, and COVID infection itself also causes heart inflammation. Still, it’s clearly too early to know these drugs are safe or effective in the long term. They already seem less effective against the omicron variant. Why are we mandating possibly unsafe drugs to children, who are at very little risk from COVID in the first place?

Maybe vaccinating everybody in the world is the right thing to do, although data doesn’t seem to support that. Africa, the least vaccinated continent, also has by far the lowest rates of COVID death. Or maybe it’s the vast amount of money Pfizer and Moderna are reaping from these drugs. Or the fact that the FDA receives much of its funding from drug company fees. Is it that regulators and scientists at FDA, the National Institutes of Health (NIH) and the CDC often come from the drug companies and go back to work there when they leave government?

We don’t know. Perhaps, even if drugs like Aduhelm and Exondys 51 are total rip-offs, the mRNA vaccines may turn out a net positive. But my point is, don’t trust the FDA, CDC, USDA or others who claim to speak for science. The system is corrupted in favor of corporations. Study all the information you can, and look into the financial connections before putting new drugs into your body.

— — — — –

Thanks for reading! Please comment, share, or steal. Follow me on Twitter, on Facebook or Hire me for freelancing, editing, or tutoring on Linked In

This entry was posted in Uncategorized and tagged , , , , . Bookmark the permalink.

One Response to Don’t Believe the FDA on New Drugs

  1. Bill Fabrey says:

    There is no question in my mind about the FDA being corrupt. They are corrupted by politics and by financial ties. I have seen that for many years, regarding their approvals of artificial sweeteners and weight loss drugs, even when advised not to do so by their own scientific review boards. The information you have given about the alzheimers drug is consistent with their behavior. I am seriously thinking about discontinuing my Medicare Part D coverage.

Leave a Reply

Your email address will not be published. Required fields are marked *