Also, Patents Lead to Corruption

It appears that the research which showed that the drug simufilam had promise in treating Alzheimers patients, Cassava Sciences may have submitted dubious data in an attempt to secure regulatory approval and funding.

A number of journals have already retracted articles using this data:

A small biotech company that trumpeted an exciting new treatment for Alzheimer’s disease is now under fire for irregularities in its research results, after several studies related to its work were retracted or questioned by scientific journals.

The company, Cassava Sciences, based in Austin, Texas, announced last summer that its drug, simufilam, improved cognition in Alzheimer’s patients in a small clinical trial, describing it as the first such advance in treatment of the disease. Cassava later initiated a larger trial.

………

But many scientists have been deeply skeptical of the company’s claims, asserting that Cassava’s studies were flawed, its methods opaque and its results improbable.

Families of some trial participants have said they see improvements. But critics noted that the trial reporting better cognition due to simufilam lacked a placebo group, and asserted that the Alzheimer’s patients were not followed long enough to confirm that any improvements in cognition were genuine.

Some experts went further, accusing the company of manipulating its scientific results.

………

On March 30, another scientific journal, PLoS One, retracted five papers by Dr. Wang after a five-month investigation into “serious concerns about the integrity and reliability of the results,” according to a spokesman for the journal. Two of the papers, co-written by Dr. Burns, were about a brain protein targeted by Cassava’s drug.

The New York Times contacted nine prominent experts for comment about the scientific underpinnings of Cassava’s trials. All said they did not trust the company’s methods, results or even the premise underlying the drug’s supposed effectiveness.

As Dean Baker notes, the enormous profits generated as a result of being granted a patent encourages fraud and fabrication, and the solution to this is to make revoking a patent when fraud is used:

The New York Times had an editorial about the corruption of the patent system in recent decades. It noted that the patent office is clearly not following the legal standards for issuing a patent, including that the item being patented is a genuine innovation and that it works. Among other things, it pointed out that Theranos had been issued dozens of patents for a technique that clearly did not work.

As the editorial notes, the worst patent abuses occur with prescription drugs. Drug companies routinely garner dozens of dubious patents for their leading sellers, making it extremely expensive for potential generic competitors to enter the market. The piece points out that the twelve drugs that get the most money from Medicare have an average of more than fifty patents each.

The piece suggests some useful reforms, but it misses the fundamental problem. When patents can be worth enormous sums of money, companies will find ways to abuse the system.

We need to understand the basic principle here. Patents are a government intervention in the free market, they impose a monopoly in a particular market.

………

We should think about patents in the same way. While patents can be a useful tool for promoting innovation, when huge sums are available by claiming a patent, we should expect there will be corruption, in spite of our best efforts to constrain it. This means that we should limit their use and try to ensure that we only rely on them where patent monopolies are clearly the best mechanism to promote innovation.

Even enforcing the written rules for patents, requiring full disclosure of the invention, requiring them to be an actual invention, etc.  would go a long way toward fixing an completely broken system.