Pharma Controlled FDA Approves Inadequately Tested Alzheimer’s Drug
According to the Alzheimer’s Association, around 6 million Americans suffer from the degenerative disease.
The number is projected to more than double by 2050.
One in three US seniors dies from Alzheimer’s disease or dementia — more than breast and prostate cancer combined.
In 2021, treating Alzheimer’s and dementia patients cost an estimated $355 billion.
By 2050, the cost is expected to be about $1.1 trillion.
Over 11 million American families have one or more members afflicted by these diseases.
From 2000 – 2019, US deaths from heart disease declined by 7.3% while individuals in the country dying from Alzheimer’s disease rose by 145%.
Professor of Medicine, medical ethics and neurology Dr. Jason Karlawish is board certified to practice geriatric medicine.
Among his extensive credentials, he heads the University of Pennsylvania’s Neurodegenerative Disease Ethics and Policy Program, is associate director of the Clinical Core and co-associate director of the Alzheimer’s Disease Core Center, as well as co-director of the Penn Memory Center.
He’s involved with the Healthy Brain Research Network.
It’s dedicated to surveillance, education, awareness, empowerment and promotion of brain health.
He heads makingsenseofalzheimers.org at the University of Pennsylvania’s Neurodegenerative Disease Ethics and Policy Program.
As part of his research on neuroethics and policy, he investigated issues in dementia drug development, informed consent, quality of life, and treatment decision-making.
On May 30 — days before the FDA’s premature approval of Biogen’s experimental, inadequately tested aducanumab Alzheimer’s drug — Karlawish minced no words saying the following:
If approved, “I won’t prescribe it,” adding:
When asked if any new safe and effective drugs exist to treat Alzheimer’s disease, he unequivocally said, “No.”
He’s been saying the same thing “for the past 18 years,” he explained.
Drugs he prescribes to ease cognitive problems “are only moderately effective.”
No magic bullet otherwise exists.
No drugs slow cognitive impairment to let affected individuals maintain control over their lives.
He and colleagues involved in treating Alzheimer’s patients won’t prescribe aducanumab because “Biogen hasn’t made a convincing case for it,” he explained, adding:
“The consequences of FDA approval are as disturbing as they are vast.”
Millions of “Americans could be prescribed aducanumab, at an estimated cost that ranges from $20,000 to $50,000 per person per year.”
“Biogen claims the benefits of slowing declines in cognition and day-to-day function are worth this price.”
Karlawish disagrees, saying Biogen data are “murky.”
“(T)he drug’s benefits are ambiguous at best and not worth this cost.”
“Putting it on the market will stress Medicare’s resources.”
Dubious benefits will force families of Alzheimer’s patients to decide if the high cost is worth the risks posed by the drug.
One risk “is small bleeds in the brain, a risk that is heightened in those with the APOE4 gene, a gene associated with late-onset Alzheimer’s disease,” Karlawish explained.
“Aducanumab is not the drug to launch a new era of Alzheimer’s treatment.”
“It hasn’t been properly studied…so the FDA has incomplete data to form a judgment.”
What’s going on is “good for business but bad for science and patient care.”
According to investors.com, after aducanumab failed two final-phase studies in March 2019, Biogen’s stock lost a third of its value.
After a phase-three test suggested promise — despite 10 members of an FDA advisory committee recommending against its approval — Biogen’s stock rose over 30%.
According to biotech company Cassava Sciences’ CEO Remi Barbier, the anti-amyloid approach used by Biogen “failed repeatedly…for the past 25 – 30 years, adding:
“Normally, when an approach fails, sometimes you try again.”
“Certainly, three strikes and you’re out.”
“It’s been 20 strikes and they’re still batting.”
Biogen is a troubled company.
According to investors.com, generics are eating into sales of its biggest moneymaker, the multiple sclerosis treatment Tecfidera.”
“In the first quarter, Tecfidera sales plunged 56%.”
In partnership with Ionis Pharmaceuticals, sales of Biogen’s spinal muscular atrophy drug Spinraza fell about 8%.
Is FDA approval of aducanumab more about preventing Biogen’s bankruptcy than treating Alzheimer’s patients safely and effectively?
Before the drug’s approval, macreoaxis rated possible Biogen bankruptcy at 28.56% because of its troubled financial situation.
In Phase 2 clinical trials, the FDA let Biogen “skip a crucial step in drug development…to assure that the final phase of testing (Phase 3) will make a convincing case that the drug should be marketed to providers and patients,” Karlawish explained, adding:
“Biogen’s application for approval divided the FDA.”
Its advisory committee sided with the yeas over the neas even though the latter case was much more convincing.
Company data on aducanumab are “incomplete and contradictory,” said Karlawis.
“Skipping a key phase of research” was a business, not a science-based, decision.
Families with an Alzheimer’s disease member are grasping at whatever may offer hope.
The verdict on aducanumab won’t be known unless “Biogen invests the time and money needed to run well-designed trials and complete them,” Karlawis stressed.
Given premature FDA approval, they’re highly unlikely to be conducted.
Aducanumab users will be playing Russian roulette with their health by volunteering as virtual guinea pigs with an inadequately developed drug that may make a bad situation worse.
My two Wall Street books are timely reading:
“How Wall Street Fleeces America: Privatized Banking, Government Collusion, and Class War”
“Banker Occupation: Waging Financial War on Humanity”