FDA clamps down on Taumark’s claims

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In 2013, a four-letter network touted a company known as Taumark.  In 2015, a three-letter federal agency has essentially shut Taumark down.

According to Alan Zarembo of the Los Angeles Times, the Food and Drug Administration has forced UCLA researchers Gary Small and Jorge Barrio to stop claiming that their experimental brain scan can test for brain conditions like Chronic Traumatic Encephelopathy.  Through Taumark, Small and Barrio had suggested that injections with a radioactive compound followed by brain scans could provide early detection of CTE, dementia, and other brain conditions.  The company reportedly found CTE in Hall of Fame running back Tony Dorsett.

But the FDA has found that this claim violates federal law regarding the promotion of unapproved drugs.  As of Friday, Taumark’s website was taken offline.

When first launched, Taumark had the potential of detecting CTE, a condition that otherwise can only be determined by studying brain tissue directly, in the living.  And it created obvious interest in the potential for football players to know whether and to what extent they may be susceptible to long-term cognitive problems.

This latest development shows how far science has to go, not only to understand what it means to have CTE but to find it in someone who is still at risk of further head injuries.

11 responses to “FDA clamps down on Taumark’s claims

  1. Or, rather than how far the science has to go, it has to show that the company didn’t grease the palms of the FDA the right way, like the rest of Big Pharma does. No promise to sit on the board of directors when your term is up as inspector? Well then no business for you and we shut you down. They will learn and sell to Phizer or someone like that real soon, which was probably the plan all along and why they are getting squeezed like this.

  2. This latest development has nothing, per se, to do with the state of science. It is only about the FDA enforcing its own regulations, and you won’t find many scientists touting FDA decisions as based in fact or in current scientific understanding. Indeed, the FDA didn’t say anything about the veracity of claims by the company, only that their procedure wasn’t approved by them for CTE diagnosis (which, again, has nothing to do with whether or not the procedure is effective, only with current FDA status).

    Indeed, the FDA’s approval process isn’t even concerned with whether or not the drugs do what is claimed…only that they are safe. Which is fine, I suppose, as often the time required to ensure efficacy could result in deaths while people wait for approval…as long as the drug’s side effects are minor (i.e. it is safe), it can be released to the public, and better understanding of its utility will come based on how effective people find it to be.

  3. Another person who has absolutely no idea how drug approvals work or the long term clinical research it takes to prove a drug or medical device is safe and effective.

  4. How does the FDA have anything to do with this? It’s neither food nor drug. I’m sure the science is sound or else they’d have been called out by real scientists. The feds have made it so nobody can do anything healthcare unless you’re a huge multinational corporation or a quack who’s willing to pepper your claims with fudge-words. Very unfortunate.

  5. The FDA takes forever to approve anything even after a drug has been shown to work in large sample sizes in Stage III trials. This decision does not mean Taumark’s claims are not without medical and scientific merit.

  6. Sorry but its not FDA palms that didn’t get greased that caused the problem by Taumark. Its more like the NFL has a huge stake in making this go away and they have more money to grease any palms than any small scientific startup company, just saying.

  7. When you watch late night TV, you get to see all the commercials for lawsuits involving FDA approved drugs.

  8. It comes off as small to take a shot at a competitor for ‘touting’ them when the article alludes to general interest in Taumark’s potential benefit. Once a blog, always a blog.

  9. How does the FDA consider either the scan or the dye to be a drug? They’re diagnostic not therapeutic. The FDA shouldn’t stand in the way of Taumark’s process if it works. If it doesn’t work, that will soon be known.

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