Prescription drug costs in the United States are high. They are one of the leading factors that keep health care costs routinely rising faster than the general inflation rate.
As a result, Americans spend more on prescription drugs annually than those who live in other developed nations. The reasons are varied.
The drugmakers say they are just passing on the costs of inventing medicines that keep Americans living better and longer. They estimate that it costs $2 billion to $3 billion in research and development to produce a new drug. Without being able to get this money back plus profit on top of it, the drugmakers would not be inclined to make those kinds of investments.
But there are other primary causes, too, among them being the lack of government regulation on drugmakers’ pricing and laws that actually prevent the biggest purchaser of drugs, Medicare, from negotiating on price. Big Pharma spends a lot of money on lobbying and on campaign contributions to keep the system that way.
In this environment comes a head-scratching decision from the Food and Drug Administration to approve for widespread use a very expensive Alzheimer’s drug that has yet to show it can actually slow the brain-destroying disease.
Alzheimer’s and other forms of dementia are terrible. Losing one’s memory and the ability to cognitively function is one of the biggest fears of aging. With an estimated 6 million Americans afflicted with Alzheimer’s, or roughly 1 in 9 people age 65 and older, there is a huge demand to come up with a miracle drug that can slow or reverse the disease.
Is Aduhelm such a drug?
Early studies would not indicate that it is. The manufacturer of the drug, Biogen, stopped two of its studies early because the medicine did not appear to slow the deterioration of the subjects taking the monthly IV treatments. The drug was successful in reducing the sticky plaque in the brain that’s associated with Alzheimer’s, but obviously there’s a lot more going on than plaque buildup with this disease.
Nevertheless, the FDA came up with a lucrative tradeoff to encourage Biogen to do more research on Aduhelm. In exchange for authorizing the drug to go on the market, Biogen is required to conduct yet another study into its effectiveness. And it’s been given nine years to complete that study — more than twice as long as the drugmaker was willing to spend when it had to foot most of the cost of the research.
The Associated Press estimates that during those nine years, millions of Americans could be put on Aduhelm, which comes with a sticker price of $56,000 a year. Since most of these patients will be on Medicare, that means billions of dollars will be added to its costs, pushing a program that’s already close to insolvency even closer to it. And for what? A drug that may not improve the lives of those to whom it is prescribed.
Rather than spur greater research into Alzheimer’s medicines, this move by the FDA could actually stifle it, critics say. Why sign up for Biogen’s next study and take a 50% chance of getting a placebo when a person with Alzheimer’s can be sure of receiving the real thing by seeking a doctor’s prescription? In addition, with all the undeserved hype going to Aduhelm, and the marketing that’s sure to follow, it could make it harder for researchers into other promising Alzheimer’s drugs to recruit volunteers to test them out.
Even with the global medical emergency created by COVID-19, the FDA required that the drugmakers prove their vaccines worked against the virus before they could roll them out. It did not let desperation overrule scientific common sense.
It’s a bit shocking that it has abandoned that restraint with Alzheimer’s.
- The Greenwood Commonwealth