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Thu Aug 2, 2012, 01:51 AM

Former FDA Reviewer Speaks Out About Intimidation, Retaliation and Marginalizing of Safety

I've been convinced for a while that the FDA's main role is to ensure drug company profits. If they actually do protect the public too, that's a bonus. But like any bonus, don't count on getting it.

MR: Your training as a pediatric clinical pharmacologist has made you especially sensitive to drug risks for children. What are some of the unique drug risks children face?

RK: Pediatric approvals are based on the assumption that children will respond similarly to similar exposures. Yet dosages that are used for studies in children are often based on approved adult dosages rather than a scientific determination of whether children achieve the same or higher exposures than adults. This is because companies don't want to develop lower dosages for children if they don't have to. Thus exposure studies in children are done after the efficacy studies have been begun instead of before when it's needed. The exposure studies then may also use overweight children as well as too few children. Since no allowance is made for race, age, puberty, or actual weight and since there are differences in children's clearance of drugs, there are often higher exposures to active and toxic metabolites in children compared to adults. Thus there are often unnecessary risks with the doses that are approved.

MR: Are there other risks with one-size-fits-all doses?

RK: There are racial differences in drug metabolism that are not taken into consideration. For example, one anticancer drug breaks down faster in African Americans, so patients don't get sufficient exposure to the drug to kill tumors. Yet African Americans were not included in the safety and efficacy studies. When drugs break down faster by one particular pathway, the patients will also sustain greater toxicity and even death from the toxic metabolite that is formed. This is especially true when the company subsequently recommends higher doses to overcome the lower exposure due to faster metabolism. In one case, this occurred with a drug used in pregnant women, where hormonal changes during pregnancy cause a greater breakdown to a metabolite that is suspected to cause mental retardation in children exposed during the pregnancy. Not only does the labeling suggest possible use during pregnancy, the labeling recommends a higher dose during pregnancy. All the while, it appears that the company was aware of the formation of a metabolite that likely affects brain development from well before the drug was ever submitted to the FDA.

MR: That is similar to the FDA's claim with the device reviewers. Why do efforts to silence free speech always seem to be couched as "trade secrets"?

RK: Because much of the information we receive are trade secrets and companies explicitly label everything they provide the FDA as such and explicitly prohibit their dissemination. In spite of this, the Food Drug and Cosmetics Act explicitly allows communication of trade secrets by FDA employees to Congress, but since most people are unaware of this, FDA management can use the threat of jail for violation of the Trade Secrets Act, not only to discourage reviewers, but in my case they got Senator Grassley's staff to destroy the evidence I provided them. The threats, however, can be much worse than prison. One manager threatened my children - who had just turned 4 and 7 years old - and in one large staff meeting, I was referred to as a "saboteur." Based on other things that happened and were said, I was afraid that I could be killed for talking to Congress and criminal investigators.


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Reply Former FDA Reviewer Speaks Out About Intimidation, Retaliation and Marginalizing of Safety (Original post)
MattSh Aug 2012 OP
Ilsa Aug 2012 #1
Zalatix Aug 2012 #2

Response to MattSh (Original post)

Thu Aug 2, 2012, 05:15 AM

1. Damn, this is scary. nt

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Response to MattSh (Original post)

Thu Aug 2, 2012, 06:39 AM

2. "One manager threatened my children" ... "I was afraid that I could be killed"... What the FUCK.


I would have handled him right there and then for threatening my kids. Vaguely or otherwise.

Prison, schmism, once you let predators like this intimidate you with threats, they will eventually make good on it.

America is too weak. We're easy prey for these bastards!

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