The battle between the drug-industry-controlled Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid (CMS) over its’ decision to provide only clinical trial reimbursement for Biogen’s Aduhelm, has highlighted the tentacles of the drug development pipeline in nonprofit advocacy organizations. To refresh your memory, Aduhelm, an aducanumab drug was approved by the FDA under the emergency-fast-track-approval process, without the lengthy normal vetting process for new pharmaceuticals. Biogen’s motivation for this was profit, by capturing the market for a promising, but as yet unproven drug for Alzheimer’s. This is the proverbial pants-wetter for big pharma, like Viagra, the ubiquitous male libido enhancer with universal reimbursement. This articles reviews nonprofit organizations which participate in healthcare advocacy and their funders. Only nonprofit entities are reviewed because it is assumed all for-profit advocacy is conflicted, such as lobbyists paid by their clients. This table shows nonprofit advocacy groups, their funders, and their positions on the Aduhelm approval.
|
Organization |
Funding
Source |
Recent
Positions |
|
American Geriatrics Society |
Professional fees from its 6,000 clinician members |
Submitted a letter to CMS against the approval of
Aducanumab for treatment of Alzheimer’s |
|
Alliance For Aging Research |
100% funded by pharma; 50% of annual budget designated for
marketing |
ACT-AD-for accelerated approval of aducanumab or
similar Alzheimer’s treatments |
|
Alzheimer’s Association |
$485,000 from
Biogen in 2021, the developer of Aduhelm; 1.6 million from other drug
companies; a small portion of gross annual budget |
Wants aducanumab approval for all Alzheimer’s
patients even those with mild symptoms, despite scant evidence it works |
|
National Council on Aging |
Nonprofit funded through grants and donors |
Advocate for evidence-based treatments; adopted the
position that Aduhelm should be used with caution in clinical trials, against
accelerated approval |
|
Pharmed Out |
A Georgetown University advocacy group, funded through individuals
and grants |
Educates individuals on the medical concerns about Aduhelm,
against accelerated approval; advocates for increase rigor and value
analysis before approval of drugs |
|
Right Care Alliance |
Mostly funded by private donors, also Resist Foundation
and Ben and Jerry’s |
Sponsor of petition to withdraw approval of Aduhelm, against
accelerated approval for drug |
The U.S. government is the largest funder of scientific
research through these National Institutes of Health Agencies: National
Institute on Aging, National Institute of Mental Health, National Institute of
General Medical Sciences, and National Center for Advancing Translational
Science. Other federal funding comes from the National Science Foundation,
Veterans Administration, Food and Drug Administration, and the Center for
Medicare and Medicaid Services. This
conclusion was drawn from a scientific literature review and meta-analysis
conducted in 2018
Significant concerns about the FDA working too closely with the drug developer Biogen have resulted in the following investigations; congressional committees, the Health and Human Services department’s inspector general, the Federal Trade Commission and the Securities and Exchange Commission. Such concerns reflect the process by which this drug received accelerated approval despite scant evidence it works, manipulation of research data after it was rejected by the expert review at the FDA, and the director of the FDA’s personal relationship with the drug developer. A drug which had not even completed clinical trials and has been shown to kill patients was put on a direct path to market it as an Alzheimer's cure to the public. This resulted in clinical outcry, outright banning of the use of the drug by most major medical centers, and a public movement to draw attention to the concerns, as previously published.[1] [2] As a result, the independent government agency, the Centers for Medicare and Medicaid called for and received thousands of public comments on the concerns about this drug. Additionally, CMS only approved provisional payment for this drug for patients in clinical trials, which appears prudent. This decision infuriated big pharma because they assumed anything that could be hornswoggled through the FDA was a guarantee of payment by CMS, and thus, the giant wallet of the US government, which would be responsible for most of the cost.
Conclusion, since the government conducts most of the early scientific research, shouldn’t it, as the largest purchaser of pharmaceuticals, have a right to review drug approvals, for this is exactly what private insurance companies do with their pharmacy schedules. It is not in the best interest of tax paying Americans to waste money on specious treatments and CMS is doing all of us a favor by slowing down the approval of Biogen’s Aduhelm. The pharmaceutical industry should consider this a shot across the bow as the American public is awake and livid over the continual pillaging of our pocketbooks for their profits.
References
American Geriatrics Society. (2022, April 6). Where
We Stand-Letter to CMS Commissioner on Aducanumab. Retrieved from
https://www.americangeriatrics.org/:
chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/viewer.html?pdfurl=https%3A%2F%2Fwww.americangeriatrics.org%2Fsites%2Fdefault%2Ffiles%2Finline-files%2FAmerican%2520Geriatrics%2520Society_Letter%2520to%2520FDA%2520Biogen%2520Drug%2520for%2520Alzheimer%
Belluck, P. (2022, April 6). Inside a Campaign to
Get Medicare Coverage for a New Alzheimer’s Drug. Retrieved from
https://www.nytimes.com/2022/04/06/health/aduhelm-alzheimers-medicare-patients.html?smid=url-share
Butler, J. (2022, April 5). The Alliance For Aging
Research-Fronting For Pharma. PharmedOut.org. Retrieved April 6, 2022,
from https://mailchi.mp/georgetown/april-2022-newsletter-update
Cameron, K. (2022, April 6). What you need to
know about aduhelm. Retrieved from National Council on Aging:
https://www.ncoa.org/article/what-you-need-to-know-about-aduhelm
Cummings, J. R. (2018, June 13). The price of
progress: Funding and financing Alzheimer's disease drug development.
doi:https://doi.org/10.1016/j.trci.2018.04.008
PharmedOut.org. (2022, April 6). Aduhelm.
Retrieved from PharmedOut.edu:
https://georgetown.edu/pharmedout/advocacy/aduhelm?authuser=0
Right Care Alliance. (2022, April 6). Withdraw
Approval of Aduhelm Petition. Retrieved from Right Care Alliance:
https://rightcarealliance.org/
Roberta Winter is an independent healthcare analyst who accepts no money from any sector of the U.S. healthcare system. She is the author of a guidebook to the healthcare system which was published in 2013 by Rowman and Littlefield. https://healthpolicymaven.blogspot.com/2021/09/is-fda-too-politicized-to-make-sound.html
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