An uproar has erupted in the scientific community over a decision by the United States Food and Drug Administration to approve a new drug designed to fight Alzheimer’s disease.
The drug, aducanumab, marketed under the brand name Aduhelm, is believed to be the first drug aimed at attacking the mechanism of Alzheimer’s disease. To date, the drugs we have only target symptoms. Unfortunately, they produce limited results, delaying memory loss, on average, by just a few months.
Aducanumab works by destroying the buildup of plaque in the brain. The problem is, although many researchers believe that these plaque buildups play a role in Alzheimer’s disease, this hypothesis is unproven. And things go downhill from there.
Two aducanumab clinical trials were halted in 2019 after researchers concluded that the drug produced no beneficial effects or, at best, negligible results, well within the margin of error.
However, the company that developed the drug, Biogen, reworked the data and told the FDA that cognitive decline slowed in patients who received the highest dose.
The FDA granted its approval on this questionable evidence.
Following this decision, three of the FDA advisers resigned from the expert panel which overwhelmingly advised against approving the drug. “This may be the worst FDA approval decision I can remember,” said Dr. Aaron Kesselheim, professor of medicine at Harvard Medical School, resigning.
He said the agency’s approval of aducanumab was flawed “due to so many different factors, starting with the fact that there is no strong evidence that the drug works.”
Then there is the question of cost. A review body in the UK has determined that, given the limited evidence that aducanumab does good, the highest price that could be justified for a one-year treatment is between $ 2,560 and $ 4. $ 850.
But Biogen is asking $ 56,000 per patient per year.
There is also the reality that the drug has to be infused, which requires monthly hospital visits, followed by an MRI to track the results. It is both a demanding diet for fragile patients and a source of additional costs.
Then the drug can also have serious side effects, including swelling of the brain and bleeding from the brain.
Last but not least, while clinical trials have tested the drug only on patients with early-stage Alzheimer’s disease, the FDA has approved it for all patients with the disease.
About 5.5 million Americans have Alzheimer’s disease. If they all ask for the drug, and many will, the cost could be around $ 300 billion.
A very rough estimate of the costs to Canadian drug plans would be in the order of $ 30 billion.
So what is going on here? When these two clinical trials were abandoned, Biogen’s share price lost 22% of its value.
When the FDA subsequently approved the drug, the company’s share price rose nearly 40%.
Has corporate lobbying played a role?
Its very important. If the FDA had demanded more clinical trials, which would have been the right course, the costs would have been marginal.
So could we see aducanumab approved in our part of the world? It depends on Health Canada, which authorizes the new drugs.
But the story here is not encouraging. Health Canada, whose motto could be “everything for a quiet life”, usually authorizes drugs if they have already been approved by another country.
And the decisions of the FDA carry weight.
I guess as the reluctance to approve aducanumab accelerates, Health Canada will do what the FDA should have done and demand more evidence from clinical trials.
But Alzheimer’s disease is a terrible disease. The pressure to authorize this drug will be immense.
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