IN SUMMARY: “For the first time ever, I feel like official people in communications and people at the F.D.A. grossly misrepresented data about a therapy,” said Dr. Walid Gellad, who leads the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. That should tell you all you need to know about how bad things are with the FDA and trust in drug approvals.
I spent a lot of time in my career working with and talking to clinical scientists about the “drug approval process”. The more questions I asked the more I learned. I gained an understanding of the need to follow FDA guidelines and let as many people as possible evaluate the data. For the first time, I am now in fear of FDA drug approvals.
Despite what the media portrays drug companies understand that new prescription drugs need to be “safe and effective”. Ethical companies don’t manipulate or withhold data although there have been cases of lack of data transparency in ongoing clinical trials.
According to the Times “many experts — including a scientist who worked on the Mayo Clinic study — were bewildered about where the statistic came from. The number was not mentioned in the official authorization letter issued by the agency, nor was it in a 17-page memo written by F.D.A. scientists. It was not in an analysis conducted by the Mayo Clinic that has been frequently cited by the administration”. This is a HUGE cause for worry.
Dr. Stephen Hahn, the F.D.A.’s commissioner, went so far as to suggest that the plasma therapy could save the lives of 35 out of every 100 coronavirus patients who took it. As STAT News reports, the number is much closer to three to five out of every 100, and even that lower estimate is questionable: The data came from an observational study, not a rigorous clinical trial.
The worry isn’t just around a potential COVID treatment it’s around all new drugs because “The world’s biggest drugmakers and their trade groups have cut checks to 356 lawmakers ahead of this year’s election — more than two-thirds of the sitting members of Congress, according to a new STAT analysis”.
Already in 2020, the companies’ PACs have donated $8.62 million to individual candidates or their affiliated committees. The companies directed another $2.59 million to broader political groups like the Moderate Democrats PAC or the National Republican Senatorial Committee, and to other drug industry PACs, including PhRMA’s.STAT News
While most of the spending is directed at drug pricing I am worried that the money could lead to more political pressure on the FDA to approve drugs. “The Food and Drug Administration is no stranger to political interference. Special interests have played as much of a role as actual data in the approval of questionable cancer drugs and faulty medical devices for almost as long as the agency has existed.”
Where does this leave patients and online health seekers? Should they feel confident that newly approved drugs have been thoroughly tested before being approved?
More importantly, we need to ask “where is the drug industry in this mess?”. Why aren’t they reassuring patients that their drugs are safe and effective? Instead, we have silence.
Our healthcare system relies on every element working together. When one of them fails the whole system is called into question. We can’t let that happen.