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H. Clark Adams

H. Clark Adams

Cathy Bacquet

Cathy Bacquet

Local biomedical device maker Valor Medical and four employees admitted yesterday (January 30) that they did not provide the Food and Drug Administration (FDA) with required information that would have cast doubt on Neucrylate, a product the company was developing to treat aneurysms.

According to documents introduced in court, two preliminary tests contained unfavorable information. Upon hearing of unfavorable news, boardmember H. Clark Adams (later chief executive) sent an email to certain officials in the company stating, "Let's huddle and determine how we can overcome this obstacle."

The unfavorable results were not sent to the FDA, which, fortuitously, turned down the application despite not having the failed results. Adams and clinical manager Cathy Bacquet were given one year of probation. The fate of two other officials will be decided later.

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Comments

rehftmann Jan. 31, 2014 @ 11:28 a.m.

How about this for a fate… Those involved in the exclusive truth get a an exclusive Rx for the treatment, meaning only they can get Neucrylate and they can only get Neucrylate. ("Put the 'late' in Neucrylate" could be their self-marketing slogan.) They would henceforth be exclusively employed as speakers at Libertarian events.

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Don Bauder Jan. 31, 2014 @ 11:42 a.m.

rehftmann: This isn't the first San Diego biotech caught cheating to get a product to market. Sequenom hyped the efficacy of its pregnancy test for Down Syndrome and got in deep trouble. Best, Don Bauder

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Burwell Feb. 1, 2014 @ 11:22 a.m.

These two pieces of shit got off light. Both are still listed as executives with Valor Medical. They did not even lose their jobs. They should be in jail for at least 10 years and subject to 100% asset forfeiture. These two sociopaths would likely put defective drugs on the market that would kill people in order to meet next quarter's profit projections. They can't be trusted to run a drug company and should be barred from the industry for life. The game plan was probably to have the FDA approve the test, giving both of them enough time to unload Valor on a big drug company for $500 million. When the big drug company later finds out its been screwed, the whole thing is covered up to avoid embarrassing the executives at the big drug company who bought the company.

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Don Bauder Feb. 1, 2014 @ 7:15 p.m.

Burwell: These are the risks for anybody who buys a biotech stock. There is always a chance the tests will be rigged and a worthless product will get past the FDA. This gives plenty of time for insiders to unload their shares, which they probably got for a penny or two a share. This is also true of some tech stocks, and other kinds, too. The initial public offering market is often a racket.

The wildness of the IPO market in the late 1990s was one tipoff that the whole market was going to crash. A stock would go out at $10, the first trade would be at $50, and the stock would close the first day at $90. I got in trouble at the U-T trying to warn readers about these IPO scams. Best, Don Bauder

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rehftmann Feb. 2, 2014 @ 3:24 p.m.

Getting busted for rigging the game is a low risk in the profit-driven healthcare system (or utilities or legal system, but whoa, I don't want to come off as a raving socialist, just a socialist).

It's more of a symptom than the underlying ill in our healthcare economy. Even if a therapy works, its value is not based on public health. For example, we could have a sane policy regarding antibiotics but it would be miserably unprofitable in proportion to its effectiveness relative to long-term management drugs such as those used for psychopharmacology or cholesterol control. Imagine criminalizing cigarettes and medicalizing drug and alcohol problems.

So, oddly enough, if you balance the books, this failed treatment is a model of the free market applied to healthcare. Everybody dies eventually, some get rich first.

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Don Bauder Feb. 2, 2014 @ 5:11 p.m.

rehftmann: Market forces work well in some industries. Healthcare is not one of them. One problem with Obamacare is that the pharmaceuticals and insurance companies influenced the final package egregiously. Best, Don Bauder

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