An update to our reporting on recently-approved Alzheimer’s drugs. You may recall FDA advisers and many independent watchdogs said there’s no good evidence the hugely expensive shots make a meaningful difference, and they could cause serious side effects. But the FDA approved them anyway.
The following is a transcript of a report from “Full Measure with Sharyl Attkisson.”
Watch the video by clicking the link at the end of the page.
Sharyl: They approved it even though not one of the advisors they had consulted said it should be approved?
Caleb Alexander: They did.
Dr. Caleb Alexander was one of the FDA advisors who voted against Aducanumab’s approval. He’s an epidemiologist, internist, and professor at the Johns Hopkins Bloomberg School of Public Health.
Alexander: The advisory committee — there was near consensus among the advisory panel that there just wasn’t the evidence to warrant approval.
Sharyl: Did they really want advice from the advisors?
Alexander: Well, it’s a fair question. And, in fact, three advisory committee members of the 10 or 11 or however many were on the committee, three resigned in protest of the FDA’s decision.
Much of the controversy centers on the FDA’s overt advocacy of a medicine that had failed miserably during the test phase.
Drugmaker Biogen stopped its two major studies midstream — determining that Aducanumab performed so poorly, it was futile to go on. But within months, Biogen returned to the FDA, claiming to have found some evidence of benefit within the stopped studies. And the FDA enthusiastically endorsed the drug without a single of the completed, large studies normally required.
Sharyl (on-camera): Now, the maker of both drugs, Biogen, has announced it’s pulling one of them off the market: aducanumab. The watchdog group Public Citizen called the FDA’s accelerated approval of aducanumb against the advice of its advisers, quote, “one of the most irresponsible and egregious decisions in the history of the agency.” The remaining drug, lecanemab or Lequembi, has the most serious black box warning for brain swelling and bleeding risks. Biogen says the drug is safe and that even marginal effectiveness could give a loved one more days with family.
Watch update here.
Watch Sharyl’s Full Measure original cover story Mind Games here.
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Anyone that still trusts the FDA hasn’t been paying attention to the news for the last 4 years, ever since the advent of COVID. In a very-sick way, the FDA has become a kind of Darwinian herd-thinning operation, eliminating the stupid and vulnerable from society.
My 40 yr. old son, a physicist, will not read your articles or newsletters as the phrase, Ï need to fnd some new conspiracy theories-all my old ones came true!” turned him off. I do not think this phrase reflects well on you or your background and experience. It reflects someone digging up controversial information. I like to relate you with an investigative reporter who always does the required homework first, and bases their articles on evidence.
I am a loyal supporter. I thought you’d want to know.
Pick a patient population with little likelihood of later malpractice claims for any harms caused by your drugs, and you have the perfect drug.
Patient is beyond informed consent. Family accepts there is nothing to lose by trying the drug for how ever long. Until it is obvious the drug does not work and/or the patient dies from the drug or natural disease progression, all of which which is a blessing to the family. No hard feelings, Doc.
The perfect drug profile, but it also must be exceedingly expensive and Medicare is required to pay for it.
This is a BigPharm designer drug dream product – pick the most malpractice-free drug market (Alzheimers), recklessly go after it (no harm no foul) , let costs be damned (dump them all on Uncle Sam.).
Brain games make me a lot smarter