Friday, November 11, 2005

OF MICE AND MERCK

A reporter for the Los Angeles Times recently wrote of a major development in the treatment of learning disorders. It seems that clinical trials are about to start on protocols for certain learning disabilities, which scientist believe can be alleviated with Lovastatin, a drug used primarily to treat high cholesterol. Lovastatin is marketed by Merck under the name, Mevacor.

What does this story have to do with autism? Nothing. What this story highlights is hypocrisy.

The newspaper story doesn’t mention whether Merck funded the laboratory studies that gave rise to the upcoming trials, but the company will surely participate in the trials. And if all goes well in the trials, Merck stands to make a lot of money. Of course, there is nothing wrong with a corporation making money or helping to develop treatments. But participation in the trials and subsequent profits would be an act of hypocrisy on Merck’s part.

The discovery that Mevacor might be useful for this purpose came about when Dr. Alcino Silva, a neurobiologist at UCLA, was approached by a former student who hypothesized that statins would impede a body’s overproduction of a protein called Ras, which many believe leads to some learning disabilities. So how did they test the hypothesis?
Postdoctoral fellow Weidong Li in Silva’s lab tested the theory using specially bred rats that had the neurofibromatosis 1 mutation and had previously been shown to have learning problems similar to those seen in humans with the disorder.

In one test, he trained adult mice with the mutation to follow a blinking light to obtain a food reward. After the animals received the drug, their performance improved 30 percent so that they outperformed normal mice.

Two other tests provided similar results.

“We think we have a real, fundamental reason to be optimistic,” Silva said. “Now, we are ready to go and treat the human disorder.”

Many of you are probably aware of the ground-breaking study by Dr. Mady Horning, of Columbia University, which showed the impact of thimerosal on immune-suppressed mice. That study provides much of the foundation for proving the connection between thimerosal and autism.

I’m really not certain if Merck promulgated a formal response to Dr. Hornig’s study, but we may safely assume that they did not issue any proclamations using the adjective “ground-breaking.” We do know that various parties, including one doctor with a connection to Merck, criticized the study, with the most common criticism being that mice do not provide a good model for the human brain for things like developmental disabilities.

Now Merck stands to profit from experiments that rely on the reliability of mice brains as being good models for humans. I can only hope that Merck will take one of two actions. They can issue a statement acknowledging that Dr. Hornig’s use of mice in her experiments was valid (I know better than to expect them to agree with the results of the Hornig study). The second option is to insist that language be inserted into the informed consent forms for the trials, telling the patients (or the patients’ parents) that the manufacturer of the drug to be administered cannot vouch for the reliability of the underlying experimental work because they do not believe mouse studies to be valid.

Silence would be hypocritical.

4 Comments:

Anonymous Patrick Sullivan Jr. said...

Ouch! Great argument. Let me know how the CEO of Merck responds to, "Were you lying then or are you lying now?" when you depose him. ;-)

11/19/05, 6:53 PM  
Blogger JP said...

Now Merck stands to profit from experiments that rely on the reliability of mice brains as being good models for humans.

The issue with Horning's study was not that mice brains can't be good models for humans - rather, it was that there's no mouse model for autism.

I think it's a bit of apples and oranges.

11/22/05, 11:13 AM  
Blogger Wade Rankin said...

JP,

Perhaps some critics cite the lack of an autism model (an arguable point in itself) as an issue, but others speak more broadly. Maybe you shuld go back and check out some of Dr. Offit's interviews in which he states, commenting specifically about the Burbacher and Hornig studies, that animal studies do not provide a good model for studying the reactions of humans to specific substances such as thimerosal. But even if you are correct that "the issue" was the lack of a mouse model for autism, is there an adequate mouse model for the learning disabilities targeted in these studies? I don't think the problem with human kids is their inability to travel through mazes for food. The problem is utilizing higher brain functions. It seems to me that mice -- who do function in a social context -- provide just as good a model for studying the social dysfuntion of autism as do the mice in Dr. Silva's study for studying learning disabilities. In both cases, the mice function on a lower level than do humans, but the observable impact on those basic functions can (not a definite "will," but certainly a "can") roughly predict human reactions. That's why animal studies are often performed as a prelimiary step in any basic research on human physiology.

11/22/05, 2:28 PM  
Blogger r.b. said...

We all so love Dr. Offitt. I wonder when he actually finds time to practice, what with his other job of representing the drug industry and all.

1/18/06, 7:15 AM  

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