Biden Opposing Alzheimer’s Progress

More than six million Americans are living with Alzheimer’s Disease. It is a devastating disease that typically affects middle-age adults with symptoms of dementia before their elderly years. President Biden says his Administration is leading the fight against the disease, but at the same time it is restricting access to breakthrough treatments. Members of Congress in both parties and Alzheimer’s experts are calling out this contradiction.

The Wall Street Journal editorial board tells us The Centers for Medicare and Medicaid Services (CMS) took the unprecedented step last year of limiting coverage of novel Alzheimer’s drugs. Normally if the Food and Drug Administration approves a drug, Medicare pays for it. But CMS said it wasn’t convinced that a new class of Alzheimer’s drugs is “reasonable and necessary” for seniors.

Since we know CMS doesn’t do anything without the approval of the White House, one has to wonder why the Biden Administration is opposing progress for this devastating disease. WSJ calls this “back-door government medical rationing.” Since we know progressives favor socialized medicine, it would seem this is another indication of their intent to implement that form of healthcare without Congressional approval.

Medicare’s coverage restrictions of these new drugs were a political response to the FDA’s controversial approval of Biogen’s Aduhelm, a monoclonal antibody that removes amyloid plaque in the brain. The cause of Alzheimer’s isn’t known, but amyloid is a feature of the disease.

Neurologists posit that removing amyloid could slow progression, A high-dose of Aduhelm removed 71% of plaque buildup. Patients in one trial who received the highest dose also showed 25% to 28% less decline in memory and problem-solving. A second trial showed unclear benefits in part because patients were on the highest dose for less time. FDA, to its credit, showed regulatory flexibility and approved the drug through its accelerated approval pathway based on amyloid clearance. This prompted progressive howls. “It’s unconscionable to ask seniors and taxpayers to pay $56,000 a year for a drug that has yet to be proven effective,” Oregon Sen. Ron Wyden tweeted. (I wonder how he feels about taxpayers paying off loans for student borrowers?)

Biogen later slashed Aduhelm’s price by half, but CMS ensured that Medicare patients couldn’t get it – or other similar future FDA-approved treatments. Medicare said it would only pay for anti-amyloid monoclonal antibodies that win accelerated approval if patients enroll in randomized controlled trials. The CMS decision limits Alzheimer’s treatments to a small number of patients who live near large medical centers capable of conducting trials. Some patients would also receive a placebo. Even treatments that receive regular FDA approval would be available only through CMS-approved studies that would still restrict access.

To justify its restrictions, CMS claimed that no large randomized controlled trial on anti-amyloid treatments had shown a “clear (non-conflicting) improved health outcome” and that it could reconsider its position if one does. Well, now one has – and yet CMS still refuses to budge.

The FDA in January approved an anti-amyloid treatment (Leqembi) by Biogen and Eisai that slowed progression by 5.3 months over an 18-month trial. Even some neurologists who were skeptical of Aduhelm say Leqembi could be a game-changer. The Alzheimer’s Association and more than 200 researchers have asked CMS to revise its restrictions. In addition, 20 Senators, including Democrats Gary Peters and Amy Klobuchar, plus 74 House Members including 38 Democrats have joined the fight. The House Members said in a letter to CMS that “access to disease-modifying therapy for Alzheimer’s disease will be extremely limited, nearly nonexistent,” resulting in “irreversible disease progression” and “added burdens for patient caregivers.”

CMS is unmoved. The agency told the Alzheimer’s Association that it hasn’t received “new evidence that meets the required criteria” for reconsideration, and it wants to study how the anti-amyloid treatments work in the “real world.” CMS Administrator Chiquita Brooks-LaSure told reporters the agency wants to “learn what these products are going to do.”

CMS has apparently forgotten that evaluating the safety and efficacy of drugs is the job of the FDA, not Medicare. For unknown reasons, CMS is discriminating against Alzheimer’s patients by rearranging the deck chairs and assuming a role they don’t have. This seems to be a classic case of government being more interested in saving money than saving lives. This is one of the hallmarks of socialized medicine systems.

Those who understand how new drugs are developed realize the Biden Administration is talking out of both sides of their mouths.  WSJ editors say, “In his State of the Union address, President Biden touted a new government research agency “to drive breakthroughs in the fights against cancer, Alzheimer’s, diabetes, and so much more.” Yet it makes no sense to fund treatments while restricting patient access to them and discouraging private investment. We’re glad to see Congress and disease experts pushing back.”

Marriage Lengthens Life for Women

I have always thought marriage made for happier lives – at least in most cases. But I never realized it could mean longer lives.

A new study now reports that marriage is linked to significantly better physical and mental health – at least for women. Brendan Case and Ying Chen, writing in The Wall Street Journal, report a new study in the journal Global Epidemiology that makes this unexpected claim. They examined 11,830 American nurses, all women, who were initially never married, and compared those who got married between 1989 and 1993 with those who remined unmarried. They assess how their lives turned out on a wide range of important outcomes – including psychological well-being, health and longevity after about 25 years. The results may surprise you.

They say that in most cases they were able to control for the nurses’ well-being and health in 1989, before any of them had gotten married, as well as for a host of other relevant factors, such as age, race and socioeconomic status. This helped them rule out the possibility that, for example, happiness predicted marriage rather than being predicted by it, or that both happiness and marriage might be predicted by some hidden third factor.

They admit their findings were striking. The women who got married in the initial time frame, including those who subsequently divorced, had a 35% lower risk of death for any reason for the follow-up period than those who did not marry in that period. Compared to those who didn’t marry, the married women also had lower risk of cardiovascular disease, less depression and loneliness, were happier and more optimistic, and had a greater sense of purpose and hope.

They also examined the effects of staying married versus becoming divorced. Among those who were already married at the start of the study, divorce was associated with consistently worse subsequent health and well-being, including greater loneliness and depression, and lower levels of social integration. There was also somewhat less robust evidence that women who divorced had a 19% higher risk of death for any reason over the 25 years of follow-up than those who stayed married. Given how many factors influence health and well-being (genes, diet, exercise, environment, social network, etc.), the fact that marriage could reduce 25-year mortality by more than a third – and that divorce could possibly increase it by nearly a fifth – indicates how important it remains even for modern life.

There are limitations of this study. The study sample was mostly white and relatively well-off professional women deciding about marriage in the early 1990s. The study tells us nothing about the effects of marriage on men. The authors acknowledge these limitations. They say, “Nonetheless, our study’s focus on women offers important insights in view of the continuing hold of feminist critiques of marriage as an instrument of patriarchal domination. Other things being equal (and of course in particular cases they often aren’t), marriage – with the support, companionship and affection it offers – is still a crucial constituent of a flourishing life for many women.”

They also express concerns for new generations, such as Gen-Xers, who seem to live by different social standards. In the past 30 years, norms against extramarital cohabitation have relaxed considerably. As recently as 2001, Gallup found that only 53% of Americans thought sex outside of marriage was morally acceptable, but by 2021 that figure was 76%. The impact these changes in attitudes will have on marriage are undetermined at this time, but the authors say recent research has typically found that unmarried cohabiting couples report less happiness and relationship stability than do married couples.

This is no surprise for students of the Bible, who understand that marriage is an institution created by God for the procreation of mankind and the fulfillment of men and women. That research now confirms that women are happier and live longer when married is only confirming that what God created is a good thing, intended for mankind’s benefit. But the declining appreciation of that fact in our modern culture bodes poorly for our future.

Biden’s Medicare Hypocrisy

President Joe Biden recently attacked Republicans for allegedly threatening to make plans to decimate Medicare. He said in his recent State of the Union address, “If anyone tries to cut Medicare, I will stop them.” This false accusation makes good political theater, but everyone knows Republicans have no intent on decimating Medicare. However, they are concerned enough about the future of Medicare to want to discuss ways to ensure its solvency.

We’ve been talking about Medicare’s future in recent posts. The Medicare board of trustees says that Medicare will be insolvent in six years if changes aren’t made soon. Seema Verma, the former director of CMS under President Trump, made some suggestions to solve the problem (The Medicare Status Quo Can’t Last) and I have made some comments on her ideas and suggestions of my own (Solving Medicare/Medicaid Insolvency).

Senator James Lankford has introduced a bill in Congress to address the problem by making it possible for physicians to own hospitals again, a prohibition under the Affordable Care Act (Doctor-Owned Hospitals). This bill would encourage physicians to own and operate for-profit hospitals, which have been shown to increase quality and lower costs in Medicare patients.

All of these ideas have merit and should be promoted. But the biggest threat to Medicare isn’t actually Republicans; it’s Joe Biden himself. That’s not my opinion, but the opinion of Grace Marie Turner writing for Galen.org. She says Biden has a long record of making deep cuts in Medicare. She gives several examples to support her claims:

  • The Biden administration proposed on Feb. 1 “payment regulations” impacting the popular Medicare Advantage plans where 30 million seniors get their coverage. The proposal affects the higher risk adjustment payments that MA plans get for sicker seniors to cover their more expensive care, as Doug Holtz-Eakin of the American Action Forum explains.
  • A study released by the Better Medicare Alliance showed the administration’s plans would mean a “$540 decrease in benefits per member per year,” or a “Medicare cut” of $150 billionover 10 years.
  • Only six months ago, Mr. Biden spearheaded passage of the Inflation Reduction Act that the CBO calculates decreases Medicare spending by $307 billion to finance a slew of initiatives, including hiring 87,000 new IRS agents.  The cuts already are causing drug companies to halt research on promising new treatments. “The bill would reduce drug industry research and development by about $663 billion,resulting in 135 fewer new medicines. This will amount to a loss of 330 million life-years, about 30 times the loss from COVID-19 so far,” according to Prof. Tomas Philipson of the University of Chicago.  So much for seniors’ quality of life, as Sally Pipes explains.
  • And this is after Biden voted in 2010 to cut $716 billion from Medicare to finance Obamacare subsidies. The Manhattan Institute’s Chris Pope details the history of how cutting Medicare repeatedly is used as a piggy bank to pay for other spending.

 

She says Medicare Advantage definitely needs modernizing but in a thoughtful, data-driven way, as AEI’s Dr. Brian Miller, economist Steve Parente, and former Medicare and Medicaid director Gail Wilensky explain. Heritage’s Bob Moffit writes that Medicare Advantage should be the basis for overall Medicare modernization after demonstrating that seniors enrolled in MA plans during Covid had “fewer hospitalizations, fewer deaths, and a greater ability to receive treatment for routine medical conditions.”

(For links to these other commentators, see her newsletter at Galen.org.)

Everyone wants Medicare to survive and prosper in the future. Anyone who claims their political opponents want to cut Medicare is lying to the American people; perhaps to cover their own sins.