I don’t trust the FDA anymore is going to lead to major issues
By: Richard A Meyer
Tags: FDA, Pharmaceutical

Health experts, including those on an external advisory committee to the FDA, are skeptical that Biogen’s drug will even successfully slow the progression of Alzheimer’s after late-stage clinical trials yielded mixed results and are angry the FDA approved the product.

The FDA’s recent approval of aducanumab (Aduhelm) shows just how badly the agency has failed the public.

In late April, the FDA’s Oncologic Drugs Advisory Committee reviewed six accelerated approvals — a provisional pathway — involving a group of cancer immunotherapies where clinical trials had failed to confirm that the drugs extended survival or improved quality of life. Yet, in four of the six cases, the advisory committee voted to keep the accelerated approvals intact. (source: Medpage)

In response to the FDA’s approval, three members of the Peripheral and Central Nervous System Drugs Advisory Committee who opposed approval of the drug quit the panel in protest.

Physicians are signaling that they now want to see the “complete date” regarding new drug approvals.

According to Medpage Today “In the last 3 months we have seen that the FDA does not have the ability to revoke accelerated approvals, even when the drugs and their sponsors fail to meet the promises made. And to wash that down, the FDA has now approved another uncertain drug for people suffering from Alzheimer’s, against the wishes of a different advisory panel”. That is a serious problem for drug makers and patients.

Many observers don’t fully appreciate how the FDA has taken a position that is indefensible. The agency does not guarantee that drugs that come to the U.S. market actually help Americans live longer or better lives (beyond what could be achieved without these drugs). At the same time, the FDA insists on interfering in the market and sets arbitrary standards for approval. The combined effect is the worst of all possible worlds: we don’t know if drugs work, and the companies can charge massive prices for them! Medpage Today

The establishment of the FDA intends to protect people. That should be the goal of the FDA, but somewhere that train derailed. The result is that physicians can’t rely on FDA approval to prescribe drugs, and they are going to be asking drug companies for a lot more information when it comes to an understanding the drug’s benefit.

I decided to call some physician contacts that I have worked with over the years to get their input on the FDA and the Beige approval. Not one HCP I spoke to thought the approval of the Biogen drug was warranted. Here are some the quotes;

“The approval of aducanumab has put me in a very difficult position. How can I tell a caregiver or patient that there is a 99.6% chance this drug won’t work”.

“Aducanumab didn’t even register one point on a 15 point scale for cognitive improvements and I’m supposed to tell patients it could work?”

“I won’t be prescribing this drug. Plain and simple, it doesn’t work”.

I couldn’t find one doctor (I spoke to six) who was excited about aducanumab. In fact, some said they would flat out refuse to see a Biogen rep if they come to their office. The feeling around the FDA is that there is a profound lack of scientific guidance within an agency that’s supposed to follow the science. Approving a drug that has a minimal chance of working is not what the FDA should be doing.

A Urologist talked to me about the accelerated approval of a new drug for prostate cancer. She said, “at this point, I need to see the data behind the trials and not just cherry-picked data; I want to see it all.” Thank you, FDA.