News reports this week indicate that the U.S. Department of Justice is investigating Cassava Sciences over the investigational Alzheimer’s disease agent simufilam. An article in Science alleged that the company’s research included altered or duplicated brain images.
Cassava, not surprisingly, denies this. And I’m not going to take sides. Maybe they’ll be exonerated, maybe not.
Dr. Allan M. Block
But the bigger point here is the importance of checking such things. Alzheimer’s disease, beyond being a horrible neurological disease, is also big money. REALLY big money. If a company were to develop a truly effective treatment for it, they’d be poised to reap a worldwide financial windfall.
I’m not criticizing that, either. If such a drug were to be developed, with all of the time and money that goes into such things, they’d have earned every penny.
But the financial incentives certainly do increase the risk of less-than-ethical behavior. This isn’t just in Alzheimer’s disease, but across the board in medicine. The main plot line of the 1993 Harrison Ford flick “The Fugitive” was based on a drug company using falsified data, bribes, and other criminal activities (like murder) to bring a potentially dangerous (but high-profit) drug to market.
Less-than-ethical behavior is not new in research either. In 1926 Paul Kammerer’s attempt to prove Lamarckian evolution was shown to be a fraud. Cover-ups of potentially dangerous drugs have also occurred, or been alleged, and resulted in some being withdrawn from the market.
I’m not sure this is any worse than the multitude of over-the-counter products I see in the store saying they promote brain health, joint health, immune health, whatever ... then, in tiny letters, adding “these statements have not been authorized by the FDA. This drug is not intended to cure, prevent, or treat any disease.” This is no different than guys selling snake oil and other worthless elixirs out of a horse-drawn wagon. Why they aren’t regulated in the same way Pfizer or Lilly are is beyond me.
Even beyond the old method of making up figures, data can still be iffy. We use the phrase “numbers don’t lie” – and generally they don’t – but the ability to “spin” them to suit any narrative has become an art form. If you can’t change the data, make them fit into a better scenario. Somehow.
Which brings me back to why it’s critically important that such studies be open to review by people who don’t have a conflict of interest in the success or failure of the drugs. And there are many: from shareholders, from executives, even from the knowledge that a bad outcome may mean they’re out of a job.
Fraud is nothing new in medicine. I also don’t see it going away anytime in the future. It’s not the nature of medicine, but it is the nature of some people. And a few of them increase the need for legitimacy in everyone else.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.