Is the FDA Too Politicized to Make Sound Decisions-The Aduhelm-Alzheimer’s Debacle?

 

Six million people have been diagnosed with Alzheimer’s in the U.S. and though it does impact the elderly at a significantly higher rate (30% are over 80 years old), about 11% of the diagnoses are under the age of 65. (Alzheimers.org, 2021)Recently, the US Food and Drug Administration (FDA) approved a new drug treatment for this disease, Aduhelm, which was based on inadequate proof of any meaningful benefit. In fact, the decision caused such an uproar most of the experts who sat on the review panel resigned because of the decision, which they had not recommended. Briefly here is a timeline and the current state of this drug approval which would cost taxpayers $56,000 per patient per year: (Maddipatla, 2021)

 2007-Biogen purchased the worldwide rights to aducanab from a Swiss pharmaceutical company.

 2014-Biogen started late-stage clinical trials on aducanumab’s effectiveness to reduce amyloid plaque build-up in the brain, which is found in people with Alzheimer’s disease.

 2019-Biogen’s clinical trials on aducanumab were halted after showing no clinical benefit from the drug. (Melillo, 2021)

 August 20, 2020-Despite the lack of evidence in their drug treatment to mitigate dementia Biogen requested accelerated approval from the FDA. Accelerated approval was used to create and disseminate the Covid-19 vaccines, for which the regulatory exemption was intended. 

The use of accelerated approval for a nonlife threatening treatment is motivated by profit, not public health.

 November 2020-A panel of outside clinical experts voted NOT to approve aducanumab as an Alzheimer’s treatment as there was no evidence to support the claim it improved patient outcomes to slow the disease. The panel went against the recommendations of the FDA in their recommendation. 

It appears the FDA did not heed the advice of independent experts and overruled the panel to assuage Biogen.

 June 7, 2021-FDA approved Biogen’s aducanumab (Aduhelm) even though two randomized controlled clinical trials (the gold standard for research) failed to show this drug provided any clinical benefit, including delaying progression of dementia or improved cognition.

 June 11, 2021-Panel members Dr. Aaron Kesselheim, Harvard Medical School, Dr. David Knopman, Mayo Clinic, and Joel Perlmutter, Washington University all resigned in protest of the FDA’s decision. (Chappell, 2021)

 Clinical researchers, physicians, and healthcare advocacy groups were aghast at the FDA’s decision to accept specious evidence and use accelerated approval for this unproven Alzheimer’s treatment causing an explosion of conversations started throughout the country. One such organization, the Right Care Alliance.org, a part of the Lown Institute based in Massachusetts, immediately reached out to its members through its president, Dr. Vikas Saini.

 September 21, 2021-The Right Care Alliance provided a position statement on the FDA’s approval of Adulhelm. (Response to FDA Approval of Aduhelm, 2021)Their group of experts worked for free to break down the complexities of this decision and develop a clear summary of the issues and an action plan for everyone.  Here are the key points:

 1.  Diagnosis of Alzheimer’s is quite imprecise when tested against progressive cognitive failure. The two randomized control trials cited by Biogen as clinical evidence for improved cognition did not work.

2, FDA officials, who should be representing the public, partnered with Biogen to cherry-pick parts of the clinical trial data and changed the basis of the approval after the original submission . The drug was approved on the basis of a reduction in amyloid plaque deposits in the brain, but there was no improvement in patient’s symptoms.

3. Despite the lack of scientific consensus about the drug’s effectiveness the FDA approved it, which will open the door to a host of other unproven treatments with the same hypothesis. Linking something which is correlated  to a disease does not indicate causation, which is far from proven in the case of Aduhelm.     

4.  The Wall Street Journal estimates Biogen will make 40 billion dollars off Aduhelm, while it is undergoing further scrutiny in the next nine years, all at the expense of Medicare, a publicly financed healthcare program and of course, the patients, at a minimum cost of $56,000 per head.

The FDA is allowing Biogen to make money while it experiments on the public to hone their drug. FYI-the drug does have adverse side effects including bleeding and other complications. And we are going to experiment on Alzheimers patients with this-where is the ethics review?

5. Aduhelm approval needs to be withdrawn immediately and a new randomized control trial should be run by independent industry experts, before market approval. The Centers for Medicare and Medicaid should refuse to authorize this treatment or to pay for it until this is done. 

This would effectively shut down the distribution of the drug until further study as all private insurance companies and self-insured healthcare plans in the U.S. rely on CMS approval before they will accept a treatment as well. 

6.  FDA needs to be overhauled to prevent manipulation by well-heeled pharmaceutical companies bent on making a killing at the expense of us all. Dr. Janet Woodcock, current heath of the FDA should be replaced as she overruled the experts on her own panel. Clear conflict of interest was shown by Billy Dunn, head of the FDA neuroscience division, who met with Biogen privately and a lack of understanding about the principles of basic scientific evidence by Patrizia Cavazzoni, which were ignored.

Take Action With Unbiased Information

The Right Care Alliance has been on the frontline of the pharma-wars, including an effort for which I have been involved, reducing the high cost of insulin in the U.S. Recently, Eli Lilly announced it was cutting the price of insulin by 40% in the U.S. This grassroots organization is responsible for the fast and thorough analysis of yet another drug approval issue, Aduhelm. I have participated in multiple Right Care Alliance Conferences and advocacy initiatives and strongly urge you to follow them in your social media. For a copy of their easy-to-understand white paper go to their site.

 https://rightcarealliance.org/article/the-rca-position-statement-on-aduhelm/

For a clear path on what you can do as a citizen advocate who is interested in taking control of our health care and making it more effective, I strongly urge you to join or donate to the Right Care Alliance. Here are links to their organization:

https://rightcarealliance.org/

And since it is a nonprofit consider making a contribution to an organization that is working to make sure you have access to quality information and affordable health care to inform your decisions.

 https://secure.everyaction.com/uCm8ND9g80GwjQSmla5WMw2

And this is the healthpolicymaven signing off encouraging you not to sign blanket releases when you are admitted for procedures. This column does not provide any medical advice.

Roberta Winter is an independent journalist and healthcare advocate based in Washington State. This column has been in continuous publication since November 2007 and accepts no payments from any healthcare industry or insurance company.

References

Alzheimers.org. (2021, September 30). Alzheimer's Facts and Figures. Retrieved from Alz.org: https://www.alz.org/alzheimers-dementia/facts-figures

Chappell, B. (2021, June 11). 3 Experts Have Resigned from an FDA Committee over Alzheimers Drug Approval. Retrieved from NPR.org: https://www.npr.org/2021/06/11/1005567149/3-experts-have-resigned-from-an-fda-committee-over-alzheimers-drug-approval

Maddipatla, M. (2021, June 7). TIMELINE-The long road to approval of controversial Alzheimer's treatment from Biogen. Reuters, p. 2. Retrieved September 30, 2021, from https://www.reuters.com/article/biogen-alzheimers-fda-history-idCNL3N2NL3GJ

Melillo, G. (2021, July 14). How Biogen’s Aduhelm Approval Marks a Precipitous Turning Point for the FDA. AJMC.com. Retrieved September 30, 2021, from https://www.ajmc.com/view/how-biogen-s-aduhelm-approval-marks-a-precipitous-turning-point-for-the-fda

(2021). The F.D.A.'s Aduhelm Approval: Position Statement of the Right Care Alliance. Needham: Right Care Alliance.org. Retrieved September 21, 2021