Medicare premium fix fails to deal with deeper problems at FDA

eisaibiogenlogo-300x110Seniors had reason to let out a whimper of pleasure when the Biden Administration announced that Medicare’s monthly, part B premiums would go down by 3% next year — the first such decline in a decade.

To be sure, the sums that they will save will be small, with most of those covered on the government insurance program next year paying $164.90 a month for Part B and seeing a savings of $5.20. But over the course of 2023, administration officials say, this sum will help seniors recoup what they were charged in 2022 when they were hit one of the largest, single-year Medicare premium increases in recent times.

So, while the head-spinning fiscal mess of Medicare costs may be straightening out a tad, the underlying debacle that caused it all is still festering and ready to cause more prescription drug regulatory fiascoes.

An FDA fiasco with an Alzheimer’s drug

As seniors know — but which officials at the federal Food and Drug Administration appeared oblivious — a medical and financial bungle shook this country when regulators ignored their own independent advisors and the consensus of doctors, hospitals, insurers, and others in the field by approving, on scant evidence, Aduhelm. It is a medication targeted at Alzheimer’s. (This blog, by the way, has tracked this nightmare for months, with posts that can be read here and here and here and here and here).

Aduhelm’s maker, Biogen, took a tortured path to winning FDA approval of a drug that even its most ardent backers conceded had limited effect, at best, on patients with early Alzheimer’s. Biogen then stuck it to the public, setting a nosebleed price on the drug — $56,000 annually for the medication alone, not to mention that it requires administration in a doctor’s office, clinic, or hospital, and that patients taking it must undergo regular brain scans. That’s because the drug has serious side effects, including reported cases of brain swelling and bleeding.

FDA regulators, in unusually cozy work with Biogen, insisted that so few options existed to treat the progressively worsening and debilitating age-related menace of dementia, and its most common form of Alzheimer’s, that it made sense to allow Aduhelm on the market. Others in medicine assailed the agency and rejected the drug, with doctors, hospitals, insurers, the Department of Veterans Affairs, and Medicare saying they would decline to recommend the drug for patients, except in highly limited use.

This all occurred too late, though, for officials in charge of Medicaid. They set rates far ahead, and they slapped tens of millions of older Americans, many of whom could ill afford it, with a big rate hike in anticipation of the federal government possibly paying billions of dollars for an FDA-approved drug.

Biogen has slashed the price it charges for Aduhelm. But the medication has become a huge flop for the drug maker, which shook up its management and laid of a chunk of its workforce when Aduhelm went from a golden revenue lode to veritable dross.

What lessons were learned?

Well, all’s good now? Nope. Critics point out that the FDA remains rife with big, bad problems, notably in its oversight of wealthy, powerful Big Pharma and the way the agency purportedly safeguards Americans from risky and bankrupting drugs.

Congress, once every five years, examines whether the agency should derive one of the largest chunks of its budget from sizable fees paid by pharmaceutical companies and medical device makers. Critics say these user fees, including those paid to expedite reviews of prescription drugs, give the industry far too much sway over regulators. That longstanding concern hardly caused a flinch among lawmakers, who have re-upped the program as part of a deadline-driven bill to keep funding the federal government until after the midterm elections.

Despite the uproar over Aduhelm, the FDA — which still is supposedly under congressional investigation over the relationships between its folks and agency regulators — also has not responded to criticisms about its drug oversight practices. Indeed, eyebrows are raising again over the agency’s work in now approving a med targeted at treating the rare but debilitating condition known as ALS or Lou Gehrig’s disease. Experts have questioned the effectiveness of the drug, which will be priced at $158,000 a year.

Further, regular folks should brace themselves for yet another tussle over — yes, of course — another drug from Biogen and Eisai targeted at Alzheimer’s. It, too, relies on a theory facing great scientific headwinds these days — that the condition of major cognitive decline in older adults is tied to the amyloid brain protein and plaques (buildups) and tangles of it that damage normal function.

Hype builds for another Alzheimer’s med

The new drug is named lecanemab, and it is getting a wave of attention as the FDA reviews it.

The hype that is building for the drug, though, should cause the tiny hairs on sensible folks’ necks to rise. That’s because the information that is emerging is from the drug’s makers. They have not published the detailed scientific studies and data that not only regulators must see but also that independent experts examine with drugs that media outlets deem to be a “multibillion-dollar blockbuster.”

The buzz around lecanemab is rooted in its purported results and how they support the beta amyloid theory in treating Alzheimer’s by clearing protein plaques and tangles in the brain, the New York Times reported, noting this nugget from the makers’ information provided to the press:

“Cognitive decline in the group of volunteers who received lecanemab was reduced by 27% compared with the group who received a placebo in the clinical trial, which enrolled nearly 1,800 participants with mild cognitive impairment or mild Alzheimer’s disease.”

That sounds impressive, right? Well, sort of. There is this disclosure, again, only in company information and nothing formal, peer-reviewed, or published:

“As with previous anti-amyloid drugs, some patients taking lecanemab experienced brain swelling or brain bleeding, but the prevalence of these side effects was lower than with Aduhelm and other experimental medications.”

There’s also this explanation, which, geez, appears many, many paragraphs deep in the New York Times news article:

“Some experts said the drug’s ability to slow cognitive decline — by 0.45 on an 18-point scale — was modest at best and might not be a difference that patients in the mild early stages of the disease would notice. Dr. Lon Schneider, director of the California Alzheimer’s Disease Center at the University of Southern California, said the effect ‘is small and would not be considered by many as a minimally clinically important difference.’ However, he added, ‘others would strongly disagree and say it’s clinically meaningful.’”

Huh? Could the evaluation criteria be more confusing for the effectiveness and benefit of the drug?

Here, of course, is the giant omission in the corporate tub-thumping for a drug that has not been approved by the FDA and for which zero information has been peer reviewed or published:

The makers have not said what lecanemab will cost.

So, are seniors, taxpayers, regulators, lawmakers, and politicians ready for another expensive, merry-go-round ride with Big Pharma talking up a drug of unknown benefit and cost but with great allure? How many desperate older folks already are asking their doctors about a new treatment that they think will give them a glimmer of hope against what surveys say is one of the most feared and loathed conditions of age?

In my practice, I see not only the harms that patients suffer while seeking medical services, but also the damage that can be inflicted on them by dangerous and bankrupting drugs.

We supposedly have a rigorous, independent, and credible process, handled by accomplished public servants with high expertise, to safeguard the products pushed out at us by Big Pharma and medical device makers. Taxpayers spend billions of dollars on the FDA, knowing that even doctors, hospitals, and insurers must rely on the agency’s wisdom, knowledge, and experience to keep block risky products and get patients life change and lifesaving medicines.

President Biden, Health and Human Services Secretary Xavier Becerra, FDA chief Dr. Robert Califf — as well as members of Congress — must step up to cut out the Big Pharma and medical device maker nonsense. The FDA is supposed to inform the public, based on the toughest, best available evidence, he quality, safety, and effectiveness of prescription drugs. Sick and injured patients and their loved ones, as well as doctors, cannot be expected to sort through gobbledygook to determine if costly nostrums will be helpful.

We cannot see an Aduhelm repeat. C’mon, Mr. President: How embarrassing will it be next year if Medicare premiums, rolled up and down already due to a drug regulatory fiasco, are upended yet again by Big Pharma and FDA tomfoolery? We have much work to do to ensure the safety, access, affordability, efficiency, effectiveness, and excellence of prescription drugs.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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