Evidence shows a drug already on the market might treat Alzheimer’s — but Big Pharma hid the data

Mark Sumner
and
Daily Kos
05 June 2019

As the headline above suggests, this is a story that offers some incredibly hopeful information that could change the lives of tens of millions of people in America alone. It’s also a story that contains some information tailor-made to generate white hot rage. And, finally, it’s a story of genuinely baffling decisions, for which the real reasons are probably still hidden.

The Washington Postreports that drug giant Pfizer found some extraordinary information in the insurance records of people who took its widely prescribed arthritis drug, Enbrel. Researchers combing over the data found that Enbrel users appeared to have a 64% lower incidence of developing Alzheimer’s. And then, Pfizer took this hint of amazing, life-altering, life-saving potential … and buried the information for the next four years.

Of course, there was the possibility—even the strong possibility—that this was nothing. It had a big dataset to work with, but connections like this emerge from almost any big set of data. Maybe there was a connection to the drug. Maybe people who go in for arthritis treatment are less likely to develop Alzheimer’s. Maybe people who were developing Alzheimer’s were less likely to complain about joint pain. Maybe it was all noise, no signal.

Pfizer had a scientific basis for believing that was the case. Its research showed that the effective compound in Enbrel doesn’t cross the blood-brain barrier. So it seemed unlikely that it could directly affect a neurological condition. Unlikely—but not certain. After all, the mechanisms of Alzheimer’s are still poorly understood. Maybe Enbrel interfered with the production of proteins associated with Alzheimer’s plaques. Maybe it worked in some wholly unexpected way. The researchers at Pfizer didn’t know. Couldn’t know. Not without testing.

And here’s where the rage comes in. Because when this data turned up in 2015, Enbrel was only a few years from the end of its patent protection. The conducting of clinical trials carried an estimated cost of $80 million. Asking for approval of the drug for use in a new area was considered “heavy lifting.” So Pfizer didn’t pursue the data. And it told no one.

With generics on the way, and a suspicion that the magical effect would disappear on close examination, Pfizer simply decided to skip it. In fact, it had its own neurological unit that had been looking into Alzheimer’s, rather unsuccessfully, but rather than route Enbrel that way, it closed the unit, laying off 300 researchers.

And this is where we come to the genuinely awful part of the article. Because, according to the experts cited by the Post, the solution to this issue is to make it easier for drug companies to extend patents by applying for use in new areas. That, they suggest, would give companies like Pfizer incentive to check out things like, “Does this drug we already have on the market perhaps work to halt the world’s most insidious and heartbreaking disease?” Let’s break that down.

If Pfizer had decided to pocket only 96% of what it raked in from Enbrel in 2018, it could have paid for those clinical trials. But that’s just one year. The statistical data was noticed in 2015. So just 1% of the returns over that period would have covered it. But wait. Most drug patents run for 20 years, and are often extended when the company makes a minor tweak in formulation or dosage. If 2018 was a typical year, Pfizer might have easily made $40 billion from Enbrel over the life of the patent. The cost of checking its effectiveness for Alzheimer’s would be 0.2% of what the company has already raked in.

So, what the experts are saying is that paying out $80 million on a drug that’s already pulled in billions is too much to ask. Not unless the company is given new incentives. Because preventing Alzheimer’s is apparently not enough of an incentive to hand over a tiny fraction of profits.

Then there’s the genuinely inexplicable part: Pfizer didn’t tell anyone. Maybe it thought the numbers were a fluke. Maybe it thought the cost of checking it out was too high. Maybe its arms were just too tired for that “heavy lifting,” but … why not tell someone? $80 million might well have fallen in the range for financing by a research organization. Or a government agency. For a potential Alzheimer’s cure, Senate Republicans might even climb off their asses long enough to pass a bill.

The story certainly seems to suggest that the system around drug companies, data, and testing needs to be changed. But “make it easier to lock things down for decades longer so they can monopolize potential profits” doesn’t seem like the intuitive answer.