“Have you ever walked along a shoreline, only to have your footprints washed away? That's what Alzheimer's is like,” said famed-basketball coach Pat Summitt. As someone who watched my own grandmother slowly fade away to the disease, I can attest to this feeling.
Alzheimer’s Disease is a (currently) incurable neurodegenerative condition that affects 6 million Americans. Few people are unaware of its devastating impacts on families and elderly populations, but despite the government throwing loads of taxpayer dollars at the problem, remedies have been slow-coming.
In fact, it has been 20 years since a new drug was approved for Alzheimer’s, a trend that was (thankfully) reversed this month as the FDA cleared the way for the drug Aduhelm to enter the market.
Notably, Aduhelm is the first drug aimed at slowing cognitive decline rather than just addressing the symptoms of the disease—making it a potentially life-altering treatment for millions of families. But despite the drug’s potential, it has received surprisingly little fanfare.
Aduhelm on the Fast Track
On June 7th, the FDA fast-tracked approval for the drug, creating much dissension in the ranks and leading to the resignation of three outside FDA advisors. There are some questions over the drug's efficacy and it also carries a pretty steep price tag of $56,000.
Dr. Aaron Kesselheim, a professor at Harvard Medical School who is also director of the Program On Regulation, Therapeutics, and Law at Brigham and Women's Hospital was one of those to resign. He called the FDA’s decision, “probably the worst drug approval decision in recent US history.”
All of these elements put the drug in an interesting place.
On one hand, Aduhelm is a potential "miracle drug" for one of the country’s most heartbreaking diseases — and it’s one patient advocacy groups lobbied heavily for. On the other hand, its high price tag means it will be unaffordable to most Americans.
This is a tricky problem, especially for Democrats who have railed against capitalism, profit incentives, and “greedy” manufacturers in the prescription-drug sector for some time. In fact, the approval comes just as Congress is gearing up for a fight over those drug prices this summer.
Spoiler: Because Australia has universal healthcare. https://t.co/c8BemM1y6h— Alexandria Ocasio-Cortez (@AOC) May 16, 2019
But few politicians want to get caught criticizing what could be a very popular medicine.
All in all, Aduhelm is poised to become a hot potato between the two parties, drawing attention to many of the core problems in our healthcare system that both political parties would rather ignore.
Profit Drives Innovation and Competition
While the Democrats hoped to be able to stump over drug prices this summer, the debate of Aduhelm subtly reveals the true culprit behind sky high drug costs. Government regulation.
Many progressives in Congress may be suspicious of profits, but the profit motive is precisely what brings drugs like Aduhelm and other innovations to the people and ultimately drives their prices down.
The profit motive spurs competition, which leads to more research and development, and more treatments entering the market. A higher supply of treatments, more options, and competition would actually bring prices down. But those economic components are currently being stifled by a tremendous amount of red tape in the healthcare industry tying up the invisible hand of the market.
And much of that red tape comes from the FDA itself.
The FDA serves as a roadblock that impedes competition and increases the cost of developing new treatments. The agency has a notoriously cumbersome and slow process for approving potentially life-saving medicines. The process involves lengthy clinical trials, trial design, approvals, and execution—which take six to eight years on average at a huge cost to drug developers in terms of money and time, and a huge cost to patients deprived of potentially life-changing medicines.
If a company actually manages to get through all that red tape, the FDA then takes another year or more for analysis and possible approval. This is no small matter. The government impedes innovation, produces the sky-high costs politicians then like to grandstand over, and denies freedom of choice to patients who might very well opt for early access to drugs, but who often die waiting instead.
Despite efforts to expand early access through Right to Try legislation and other compassionate use laws, research shows only a small percentage of patients gain that ability. All of this proves that the showdown over healthcare prices ought to revolve around the FDA itself.
People should have access to potentially life-saving measures without the government standing in the way, and developers should have a clear pathway to willing customers to incentivize more innovation. These are the common-sense policies that would actually save lives and bring down healthcare costs.
What does that look like? The Promising Pathway Act is a good model for such legislation.
Under this act, patients with especially serious diseases would be able to make informed decisions, with the advice of their doctors, about the use of new drugs that have passed safety trials and shown preliminary efficacy. These drugs would receive provisional approval, which would enable access five to seven years earlier.
Not only would such legislation allow many more people to access potentially life-saving treatments, it would also produce more and better research and lead to a faster-to-market and broader set of treatment options. Notably, this would also mean reduced costs for the development of new drugs.
And, such measures would also allow smaller, financially-constrained drug companies to develop more drugs under a reduced cost structure. Ultimately, that would mean many promising drugs that were never tested due to insufficient expected revenue could have a second shot at market-entry.
The fact that progressives are largely staying mum on Aduhelm shows that they know profit incentives work despite constantly bashing them in the medical field. Instead of pursuing legislation that would diminish the profit incentive, they should turn their attention to legislation that would make access easier and the pathway to cures smoother.
To learn more about The Promising Pathway Act, see the following slideshow.