I used to work for an consulting firm that specialized in FDA compliance for pharma and medical device companies, and I can tell you the consultants had no faith whatsoever in the FDA approval process during this administration. Looks like their concerns were warranted:

WASHINGTON (AP) — In an unusually blunt letter, a group of federal scientists is complaining to the Obama transition team of widespread managerial misconduct in a division of the Food and Drug Administration.

"The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk," said the letter, dated Wednesday and written on the agency's Center for Devices and Radiological Health letterhead.

[...] The FDA declined to publicly respond to the letter, but said it is working to address the concerns.

In their letter the FDA dissidents alleged that agency managers use intimidation to squelch scientific debate, leading to the approval of medical devices whose effectiveness is questionable and which may not be entirely safe.

"Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices...have ignored serious safety and effectiveness concerns of FDA experts," the letter said. "Managers have ordered, intimidated and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid."

A copy of the letter, with the names of the scientists redacted, was provided to The Associated Press by a congressional official.

"Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around," the scientists wrote.

The whistle-blowing article by Dr. Adriane Fugh-Berman recounts how the author was approached to serve as the front author on a manuscript already written by a “medical education company” on behalf of a pharmaceutical company. The manuscript purported to be a review of interactions between warfarin and herbal remedies. The manuscript was provided to Dr. Fugh-Berman in essentially complete form, with her name on the first page as first author... the apparent goal of the manuscript was to disparage warfarin, the drug with which the pharmaceutical company’s new product would compete.

[I]s this really more of a conflict than traditional advertisers pose? I tend to think yes, since we're conditioned to be skeptical about ads, but tend to trust what looks like a well-researched article.

Panel members said Nogroski's work contained an alarming number of invalidated claims and irrelevant findings. They were particularly disconcerted by the figures in Nogroski's third paragraph, which begins "How do otters survive? Here are some facts about that."

"He didn't even say how they survive," Glass said. "He was just like, 'Otters are about one to 1.2 meters long. Otters' whiskers are about three inches long.'"

"I know!" Swain said. "It's like, 'Hey Mike, how do sea otters survive?' 'Dur. I'm Mike. Sea otters survive by being one meter long.'"

"Hey Mike," LaMott added. "What do sea otters eat? 'Dur, I'm Mike. Sea otters have whiskers that are three inches long. Also, I don't bathe and my jacket is acid-washed.'"

thoughts on the rise of pay-for-print -- when journals require authors to pay the printing costs. Often, if the authors can't afford it, their paper doesn't get printed. She wonders about conflicts of interest:

[I]s this really more of a conflict than traditional advertisers pose? I tend to think yes, since we're conditioned to be skeptical about ads, but tend to trust what looks like a well-researched article.

Panel members said Nogroski's work contained an alarming number of invalidated claims and irrelevant findings. They were particularly disconcerted by the figures in Nogroski's third paragraph, which begins "How do otters survive? Here are some facts about that."

"He didn't even say how they survive," Glass said. "He was just like, 'Otters are about one to 1.2 meters long. Otters' whiskers are about three inches long.'"

"I know!" Swain said. "It's like, 'Hey Mike, how do sea otters survive?' 'Dur. I'm Mike. Sea otters survive by being one meter long.'"

"Hey Mike," LaMott added. "What do sea otters eat? 'Dur, I'm Mike. Sea otters have whiskers that are three inches long. Also, I don't bathe and my jacket is acid-washed.'"

Alas, manuscripts full of illogical ramblings aren't confined to the realm of acid-washed third graders. And if only reviewers were this mature!

There is bone-snapping pressure of conservative not even to pursue PhDs! I simply don't believe that the "chilling effect" on conservatives can get much worse. Meanwhile, the warm, nurturing, environment for champions of Jackassery couldn't be much more encouraging. Hang Churchill (metaphorically of course). Send a signal...

Studying Churchill like he was a lab rat isn't a good idea precisely because he is exactly that -- a lab rat. Typical in every way; the baseline. No one studies lab rats qua lab rats anymore. You only study them after you've done something to them. The only thing that would make Ward Churchill interesting for study is if you cut him loose. See how the other lab rats react. I'm sorry if I sound to Machiavellian...