New Alzheimer’s Drug Sparks Controversy
One of the biggest items in the news last week that is of interest to so many seniors is about a new drug, which will be marketed as Aduhelm, related to the treatment of Alzheimer’s disease. We are not doctors or scientists so we thought we would relay to you some of the information we have seen about this new drug.
To say the least, it is controversial and there is reason to doubt it works. We know for sure that it is incredibly expensive. Having said that, here is some of the information we have seen.
This is from STAT News, a company that “delivers trusted and authoritative journalism about health, medicine, and the life sciences.
“That [FDA] approval is broad, making no distinction between the mild, moderate, and advanced stages of the memory-robbing disease and setting no requirements for its diagnosis.”
“The FDA’s action came despite a 10-0 vote in November against approval by its panel of expert advisers, who were dubious that data from two clinical trials showed the drug was effective in early Alzheimer’s patients with mild cognitive impairment; three members resigned in protest from the panel last week. The surprising decision leaves doctors turning back to data from those trials, which had conflicting results: One barely met its primary endpoint, and the other did not. As if that is not confusing enough, the mental decline that is considered an early sign of Alzheimer’s disease is also present in other age-related disorders, which makes it hard to discern which patients have the disease.”
“The side effects of the drug, to be sold as Aduhelm by maker Biogen, are troubling and the cost is staggering, at $56,000 per year ‘forever,’ doctors told STAT. More than one-third of trial participants developed brain swelling and 17% to 19% had small bleeds in their brains.”
“’The risks are known. The benefits are still in question,’” said Zaldy Tan, a neurologist and medical director of the Center for Alzheimer’s and Memory Disorders at Cedars-Sinai in Los Angeles. “
“’It’s modest in terms of efficacy. It’s [statistically] significant, but it may not be observable by the family or caregiver or even the physician,’” he said. “’I would tell them this is not a cure — something to set the expectation that this is likely not going to be a dramatic improvement, but this could be something more subtle.’”
And there is this report from Vox News:
“Medicare, the federal health insurance program that covers Americans over 65, is facing an impossible dilemma: Should it cover a new and expensive medication for Alzheimer’s disease, which afflicts 6 million Americans and for which there is no existing treatment, even though the drug might not actually work?”
“But the evidence on whether Biogen’s treatment, called aducanumab, is effective is, at best, mixed; the FDA approved it this week over the objections of its own advisory committee. And with a preliminary announced price of nearly $60,000 annually per patient, covering the treatment could cost upward of $100 billion a year, mostly to Medicare, which would almost double the program’s drug spending. Patients themselves could be on the hook for thousands of dollars in out-of-pocket costs.”
“Independent analysts think the drug is worth more like $8,000, but Medicare has no authority to charge a lower price. Instead, the federal program is likely in effect obligated to cover the new drug now that it has FDA approval. The tools it has to make a determination about whether or not to cover aducanumab and for whom are fraught with legal and ethical risk.”
“The government now finds itself trying to figure out how to satisfy patients who desperately need help, even though scientists think this particular treatment lacks strong evidence for its effectiveness and policy experts warn it is setting up a budgetary nightmare for Medicare in the future.”
TSCL will be keeping a close eye on this subject because we know that so many seniors and their families are desperately hoping there will be some new breakthrough that will effectively treatment Alzheimer’s and other forms of dementia. But the cost of this drug is so expensive, and it could have a major impact on the Medicare budget that already is in critical financial condition.
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Legislation to help “Notch Victims” is Introduced
Many of TSCL’s supporters are older and less affluent. And some of them are “Notch Victims,” individuals who receive lower Social Security benefits because they were born between the years of 1917 and 1926.
Just years before they retired these individuals learned they would have significantly lower benefits than they expected because of amendments to the Social Security Act that were signed into law in 1977 and which have compounded over time.
For many years TSCL has led the fight to provide additional compensation to those affected.
We are pleased and grateful that Rep. Grace Meng (D-N.Y.) has once again introduced legislation, H.R. 3839, to remedy this situation. It would allow workers who reach age 65 after 1981 and before 1992 to choose either lump sum payments over four years totaling $5,000 or an improved benefit computation formula under a new 10-year rule governing the transition to the changes in benefit computation rules enacted in the Social Security Amendments of 1977.
Why is it so Hard to Lower Prescription Drug Prices?
Here is a big part of the answer. An analysis by Stat News of campaign finance records shows that the pharmaceutical industry donated to more than two-thirds of Congress as well as 2,467 state lawmakers during the last campaign cycle -- to the tune of over $25 million.
“According to the findings, seventy-two senators and 302 members of the House of Representatives cashed a check from the pharmaceutical industry ahead of the 2020 election — representing more than two-thirds of Congress, according to a new STAT analysis of records for the full election cycle.
“Pfizer’s political action committee alone contributed to 228 lawmakers. Amgen’s PAC donated to 218, meaning that each company helped to fund the campaigns of nearly half the lawmakers on Capitol Hill. Overall, the sector donated $14 million.
“The breadth of the spending highlights the drug industry’s continued clout in Washington. Even after years of criticism from Congress and the White House over high prices, it remains routine for the elected officials who regulate the health care industry to accept six-figure sums.”
Here is more from the report: “Pfizer, which played arguably the biggest role in 2020’s vaccine race, also had a frenzied year politically. In addition to giving roughly $1 million to members of Congress, Pfizer also wrote checks to 1,048 individual candidates in state legislative races.
While the drug industry gave money to a broad range of candidates, it focused in particular on those on key committees that oversee health care legislation.”
Running for election to Congress has become incredibly expensive and lawmakers spend a great deal of their time all year long raising money to pay for their campaigns.
The largest amounts of money come from corporate and special interest groups who want certain legislation passed or stopped.
When it comes to the big drug companies, they do not want limits on the costs of the drugs they manufacture. That is why they make so many campaign contributions.
TSCL does not make campaign contributions because we are funded by our supporters like you, and we simply don’t have the millions of dollars like drug companies do. Instead, we rely on you and your vote. Elected officials care about money, but they care even more about your vote.
Our job is to represent you to Congress and keep you informed about what is happening. We rely on you to put pressure on your Senators and Representative when it comes to the legislation we need to have passed.
Our voices and our votes collectively are how we counteract all the money the drug companies throw around to influence Congress.
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Federal Government Moves to Guarantee Access to Drugs
Keeping the U.S. drug supply chain secure, robust, and resilient is essential for the health and national security, and economic prosperity of the United States during emergencies like the COVID-19 pandemic and for the provision of day-to-day health care.
Earlier this year President Biden signed an Executive Order to secure America’s critical supply chains. The Executive Order directed the Administration to launch an immediate 100-day review and strategy development process to identify and address vulnerabilities in the supply chains of four key product sectors, including pharmaceuticals
The federal government will work with the private sector and Congress to implement the recommendations and develop a strategy to create a robust and resilient pharmaceutical and active pharmaceutical ingredient supply chain, including facilitating adoption of novel methods for commercial production of pharmaceuticals and biologics.
Last week, as part of the Executive Order effort, the Administration announced a set of actions designed to ensure the U.S. has access to the pharmaceuticals necessary for economic security, health security, and national defense.
- The plan includes fostering international cooperation and promoting research and development that establishes innovative manufacturing processes and production technologies to strengthen supply chain resilience
- The U.S. aims to diversify its drug supply chain, relying on a geographically diverse set of manufacturers
- Another critical feature of the plan is the redundancy of the supply chain, such as the existence of multiple manufacturers for each product and its precursors
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As we continue recovering from the Covid 19 pandemic, TSCL remains constant in our fight for you to protect your Social Security, Medicare, and Medicaid benefits. We’ve had to make some adjustments in the way we carry on our work, but we have not, and will not stop our work on your behalf.
For progress updates or for more information about these and other bills that would strengthen Social Security and Medicare programs, visit the our website at www.SeniorsLeague.org, follow TSCL on Twitter or Facebook.
