Against the recommendation of an independent advisory committee, the Food and Drug Administration approved a new therapy for Alzheimer’s disease earlier this month. The drug, aducanumab, will be sold by Massachusetts-based company Biogen under the name Aduhelm. The drug will be sold at an expected annual cost of $56,000—Per. Patient.
That’s despite the fact that two large clinical trials haven’t demonstrated that it is clinically effective in slowing the decline of Alzheimer’s patients. Which is why the advisory panel said it shouldn’t be approved—that, and side effects. In those trials, 41% of participants had a range of side effects, including painful brain swelling, headaches, and dizziness, while 10% of participants getting the placebo reported these effects. Another, smaller group experienced small brain bleeds. Some Alzheimer’s physicians are blasting the decision because they believe it will give false hope. Which is precisely what Biogen is counting on—that patient hope—with its $56,000 price tag. They’re probably already working on their soft-focused, pastel-colored television ad campaign.
There are just so many things that have to happen to reform how prescription drugs are sold in this country, but one of the low-hanging ones that the Biden administration and/or Congress could and should deal with ASAP is just that—television advertising of prescription drugs. Like, end it. Get those things off our TVs.
All this started in 1997, when the FDA authorized direct-to-consumer (DTC) advertising of prescription drugs on television. From 1997 to 2016, DTC prescription drug marketing budgets jumped from $1.3 billion to more than $6 billion—a 361% increase. Advertising works. In 2008, the House Commerce Committee found that every $1,000 spent on a drug ad gained 24 patients for the industry. That doesn’t sound like a great return until you think about how much prescription drugs cost you and your insurance company (which comes back to costing you). More proof that the advertising works: “a 2003 research report found that rates for prescription drugs with ads were almost seven times greater than for those without ads.”
That is costing all of us a lot of money. It’s driving up costs for insurance companies, for employers purchasing insurance for groups, for individuals purchasing their own insurance, and for Medicare, which all of us taxpayers are paying for. It’s also not necessarily better for our health.
In 2015, the American Medical Association voted for a ban on all direct-to-consumer advertising for drugs and medical devices and urged the FDA to end the practice. At the time, AMA board chair-elect Patrice Harris said they took the vote because physicians are concerned “about the negative impact of commercially-driven promotions and the role that marketing costs play in fueling escalating drug prices.”
Back to those doctors, Rachael Bedard and Adam Gaffney, who treat Alzheimers patients and their concerns:
Once a drug is approved, physicians may feel compelled to offer it, and desperate families will have difficulty saying no to a new therapy advertised as the first (and only) to slow Alzheimer’s progression. But the FDA’s (and Biogen’s) satisfaction with improvement in surrogate markers means patients and families will end up focusing on surrogate markers, too. And if they experience a disconnect between what the drug is said to accomplish and what they’re experiencing at home—a loved one who continues to deteriorate, even as amyloid levels presumably fall—it will be difficult to give up the “hope” that is attached to the drug, even when it doesn’t offer anything meaningful in the life of the patient.
That is the particularly painful part for them. “And at the end of the day,” they write, “the consequences of offering false hope—at great personal expense, with all the confusion, discomfort, risk and disappointment that implies—are going to fall most squarely on patients and their families.” Behind every single drug ad on television is that: the offer of hope that may or may not be false. But also behind it is the greed of the pharmaceutical companies that are gaining thousands of new patients and billions of their dollars.
So while Congress and the administration are talking drug pricing, here’s some low-hanging fruit for them, delivered on a silver platter by this “unconscionable” decision: At the very least, make sure Biogen isn’t hawking this unproven drug on our TVs.
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