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The drug industry is working hard to get this Alzheimer’s drug approved. Here's why it matters.

The drug industry is working hard to get this Alzheimer’s drug approved. Here's why it matters.

Picture of Trudy  Lieberman
(Photo by Sarah Silbiger/Getty Images)
Will the Centers for Medicare and Medicaid Services follow the FDA's controversial decision and approve Aduhelm for Alzheimer's disease in April?
(Photo by Sarah Silbiger/Getty Images)

In the next two months the Centers for Medicare and Medicaid Services (CMS) will decide if the questionable and very expensive drug Aduhelm for Alzheimer’s disease will get the government’s final blessing and merit coverage for those on Medicare. This won’t be just any run-of-the mill decision from CMS. This one will have far-reaching implications not only for those with Alzheimer’s but for all patients who might be enticed to take other costly medicines with questionable efficacy or safety. The CMS decision will be a very big deal whichever way the agency rules.     

Recall that last summer the media, the medical community, and academic drug experts loudly questioned the FDA’s decision to approve the drug. As I wrote at the time, the near unanimity of disapproval of the FDA’s surprising decision was startling. Three members of the FDA advisory committee studying the drug resigned in protest, and 10 members of the committee voted against approval while the eleventh voted “uncertain.” One of those members, Dr. Aaron Kesselheim, a professor at Harvard Medical School, said at the time, “It’s clear to me that the FDA is not presently capable of adequately integrating the Committee’s scientific recommendations into its approval decisions,” and noted the FDA’s action was “probably the worst approval decision in recent U.S. history.”

Kesselheim’s strong comments, however, have not deterred the Alzheimer’s advocacy groups that advocate for new drugs and treatments from mobilizing. The outcome of the war over Aduhelm will provide a clear signal: Is the government serious about attacking super-high drug prices by paying only for those that actually benefit patients?

Who will win or lose: drug companies that make the drugs and collect windfall profits along the way, or Medicare beneficiaries and the millions of other Americans who will pay much more for their health insurance as a result of its approval?

As they’ve done in the past with other Alzheimer’s drugs that did not pan out, drug companies are working hard to make sure that CMS approves coverage in April. “Political pressure to approve tacrine (another Alzheimer’s drug) was massive, just as it was with Aduhelm,” recalled psychiatrist Susan Molchan, a former program director for clinical trials at the National Institute on Aging. “And as with Aduhelm, the Alzheimer’s Association — aligned with its corporate donors — pushed for approval despite questions about whether it actually helped people with Alzheimer’s disease or just slightly bumped up some numbers on a test.”

The outcome of the war over Aduhelm will provide a clear signal: Is the government serious about attacking super-high drug prices by paying only  for those that actually benefit patients?

Indeed, the industry has been working hard to gin up support for widespread use of Aduhelm, and no doubt journalists will return to covering the drug in April. So it’s important to understand the lobbying campaign that drug maker Biogen and disease advocacy groups are waging to make sure the decision goes their way. In the summer of 2018, Kevin Lomangino, who was then managing editor for HealthNewsReview.org, wrote that when the site went out of business later that year for lack of funding, “our independent expert assessment of health care claims looms as one of the biggest deficits.” That of course, meant fewer critical stories of drug industry practices would reach ordinary Americans who don’t read STAT News, since many journalists covering such stories had relied on the HealthNewsReview site. But the need persists. Knowing that it’s in the drug industry’s DNA to mount full-fledged public relations campaigns whenever there’s a whiff of regulatory oversight or direct threats to its business model, I looked at the current campaign to persuade CMS to fully approve Aduhelm.

First off, there’s a new twist to the drug industry’s usual message about the need to approve life-saving drugs no matter the evidence. It’s an emphasis on marginalized groups in the health care system — the disparities exposed by the pandemic and now receiving much public attention. In December the Alzheimer’s Association, one of the big kahunas in the patient advocacy world, issued a press release noting that Biogen had reduced the price of the drug by half to $28,200 from $56,000, and that the group “continues to advocate for equitable access to treatment for those in the earliest stages of the disease and who may benefit.” “We know that lack of coverage will further deepen health inequities,” said the group’s president Joanne Pike. In mid-January, the Association sent out another press release arguing that CMS’s draft decision “is shocking discrimination against everyone with Alzheimer’s disease, especially those who are already disproportionately impacted by this fatal disease, including women, Blacks, and Hispanics.” Users of the release were told to attribute the comments to Harry Johns, the Association’s CEO. Johns argued that CMS’s proposed decision meant “access to treatment would now only be available to a privileged few, those with access to research institutions” and would exacerbate and create “further health inequities.”

George Vradenburg, chair and co-founder of another Alzheimer’s group, UsAgainstAlzheimer’s, also traded on the health equity theme. “If CMS denies coverage, it would limit access to this class of drugs to the wealthy,” Vradenburg argued in a January press release urging CMS to cover the drug,

There’s a new twist to the drug industry’s usual message about the need to approve life-saving drugs no matter the evidence. It’s an emphasis on marginalized groups in the health care system. 

“Health equity is not gaining access to dangerous drugs,” said Dr. Adriane Fugh-Berman, professor of pharmacology at Georgetown University Medical Center, in an interview. “They’ brought up the issue of health equity, but what is ironic and sad is that because the drug was not tested in Black people. Fewer than 1%of black people were in these trials.” According to STAT, only 11 blacks and 67 Hispanics were enrolled in the trial for Aduhelm, which included 1,285 white participants. Furthermore, when the drug maker Biogen gave an investor presentation in 2019 about a trial evaluating patients with early Alzheimer’s disease, it listed only white and Asian participants. Furthermore, Fugh-Berman said that the Alzheimer’s Association “has been touting a cure with no results and has taken money from drug manufacturers.” That, she added, “calls into question whether they have the best interests of Alzheimer’s patients at all.”

Indeed, it is well known among journalists, though not necessarily among the public, that groups like the Alzheimer’s Association, the American Diabetes Association, and the American Heart Association, despite their altruistic reputations and “good guy” images, actually receive gobs of money from pharmaceutical manufacturers. They are hardly neutral sources, as recent annual reports for these groups show. The 2021 annual report of the Alzheimer’s Association reveals that Biogen gave between $250,000 and $499,999 to the group. So did Eisai, Biogen’s Japanese partner, and Eli Lilly, which also has an Alzheimer’s drug in the pipeline. The 2020 report of the Alzheimer’s Foundation of America also notes large contributions from Biogen ($100,000 to $999,999) and Eisai ($50,000 to $99,999). The 2020 annual report of UsAgainstAlzheimer’s indicates that Biogen, Eisai, and Eli Lilly each contributed more than $200,000. Biogen and Eisai are also listed as “premier sponsors” of the group’s 2021 National Alzheimer’s Summit.

Those patient groups in return have been working members of Congress to gin up their support and help in pressuring CMS to fully approve Aduhelm. Earlier this year, Vradenburg of UsAgainstAlzheimer’s told Politico, “On the Hill a lot of people care about Alzheimer’s. There will be letters. There will be meetings. There will be everything we can muster to turn that decision around.” Last week  it looked like that’s happening. Politico reported that 78 House Republicans sent a long list of questions to HHS asking about Medicare’s interim decision to limit use of Aduhelm. The letter signers expressed concern that “a decision to prohibit coverage … could unnecessarily deny to patients and their families the hope of breakthrough AD treatments and further eroding Americans’ trust in their public health institutions.”

While Republicans’ letter to HHS may be the latest pressure applied to the agency for approval without restrictions, comments from the public are another. Many of those commenters also seemed to call for full approval for the drug, which is not surprising since some of those commenting had links to Biogen, which illustrates the too-often cozy relationship between physicians and pharmaceutical companies documented so well by ProPublica’s Dollars for Docs website. To get a sense of some of the physicians’ financial ties, especially those connected in some way with Alzheimer’s disease, I looked at 2020 drug company contributions to four of the 25 signers of one of the comment letters to CMS. One doctor, according to the CMS open payments database, received $33,255 from Biogen in 2020; a second doctor got $24,945; a third, $10,735, and a fourth got $4,275. The signers, physicians or academics connected in some way with the disease, “strongly” supported allowing these patients with early-stage disease and their clinicians the option of “effectively treating the amyloid accumulation before irreversible neurodegeneration progresses.”

The public interest group Public Citizen also submitted comments. “We said the approval of this drug will raise false hope for patients and families,” said Dr. Michael Carome, who heads Public Citizen’s health research group, in an interview. “The false hope generated by the FDA approval is reflected in the comments.” 

Last week Biogen announced a new proposal, as reported by Nick Florko in a paywalled STAT article. The company proposed collecting new data about the drug, setting up a registry of patients receiving the drug, and analyzing 50,000 patients taking and not taking the drug. Florko wrote that the proposal is the “clearest hint yet that the company could pursue a legal challenge to Medicare’s proposal.” His STAT colleague Ed Silverman noted in his column that the Adhulem episode confirms the worst suspicions about drug makers. “If the Biogen CEO were truly ‘courageous’, he would live with the Medicare decision,” as the headline read.

When the FDA announced its decision last summer, it gave Biogen nine years to obtain confirmatory data that Aduhelm really worked. Dr. Rita Redberg, a cardiologist at UCSF and medical technology expert, told me. “Nine years is a long time to wait to see if a drug has more benefit or harm.” 

Veteran health care journalist Trudy Lieberman is a contributing editor at the Center for Health Journalism Digital and a regular contributor to the Remaking Health Care column.

Comments

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Letters to CMS to fully approve Aduhelm "expressed concern that 'a decision to prohibit coverage … could unnecessarily deny to patients and their families the hope of breakthrough AD treatments and further eroding Americans’ trust in their public health institutions.'” Would a useless and expensive drug with serious adverse effects on the market "erode" trust in the FDA? Quite the contrary. It would be seen as doing its job. Families should still have hope for a breakthrough treatment, but it is not Aduhelm. The $26,200 annual cost of the drug is only the beginning of the cost of treatment. Then there are costs for determining patient eligibility, for monitoring, infusions, cerebral imaging for detecting the ARIA adverse effects, and treating the common adverse effects such as cerebral edema and brain bleeds. Furthermore, the drug was given conditional approval based on the surrogate endpoint of removal of beta-amyloid, whereas the originally stated endpoint of the trial was based on benefits in terms of cognition. There was a slight signal of cognitive improvement in one trial and none in another trial. Finally, giving Biogen nine years to report results is absurd. Yes, measuring cognitive effects takes a while, but Aduhelm adds to the pile of failed monoclonal antibodies to remove amyloid, e.g., solanezumab and bapineuzumab. Haven't these trials proven that amyloid removal is not the way to go? Is amyloid a surrogate marker for some other pathogenic molecule or process? The nine-year trial will require millions of dollars in government payments for those patients being treated. Would Biogen be willing to enter into a risk sharing agreement, i.e., to refund the tens to hundreds of millions of dollars that the government will have paid for the drug if Aduhelm fails in that trial?

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