Congress Blasts the FDA for being Incompetent

This is what oversight is supposed to look like:

(AP) House members chastised the Food and Drug Administration on Tuesday for not doing more inspections of foreign drug manufacturers in the wake of a litany of problems with the blood thinner heparin and other products.

"Last year, this nation's regulatory failures resulted in dead dogs and cats. This year, it has tragically led to the deaths of people," said Rep. Bart Stupak, D-Mich. "If we don't make some rapid progress on fixing the foreign drug inspection program, the next melamine or heparin tragedy will soon be upon us."

FDA Commissioner Andrew von Eschenbach told a House subcommittee that he has asked the administration for more money to conduct inspections, but he did not specify how much. He agreed that more inspections are needed, but not to the lengths Democrats suggested, which is to inspect every foreign firm every two to three years.

"I don't believe that's the solution to the problem," von Eschenbach said. "It's much more complex, and the solution needs to be much more comprehensive than simply inspecting a facility."

Typical spin from a Bush loyalist--regularly checking out firms is costly, time-consuming and makes everyone pull nervously at their collar, but it's virtually the only way to ensure compliance with the law. What do you get when you "trust" the industry or industries to "self-regulate?" You get cost-cutting, corner-cutting, and dead people.

Spare me that "government is the problem" and that "libertarian" bullshit on this one--the only thing that is going to ensure that we even approach having a safe supply of materials is to have a hard-assed inspector with a clipboard and an eye for detail looking into what these firms are up to.

Republican members of the subcommittee were in agreement with Democrats that the lack of foreign inspections is a big problem.

"We have already heard the numbers that show the imbalance in risk priorities, with most domestic firms inspected about every two years, but literally hundreds of foreign firms that have not seen an inspection, if at all, in a decade," said Rep. John Shimkus, R-Ill. "Clearly these priorities need to be brought closer into balance."

The Government Accountability Office testified Tuesday that the FDA was making progress in conducting more inspections of foreign drug manufacturers, but still inspects relatively few facilities.

The agency conducted 30 such inspections in the last fiscal year and plans to conduct at least 50 this year, according to government auditors.

That's not nearly enough for members of Congress, who point out that there are more than 3,200 foreign drug firms listed by the FDA.

Of course the Republicans agreed--they're not THAT batshit crazy. See, it's not about ideology. It's not about letting the market decide or the individual do for themselves. It's about a safe supply of fucking drugs that actually work. So, out of 3,200 firms, we're inspecting 80 over a two year period? How the hell is that supposed to keep the American people safe? How hard is it to actually do the job? You'd think there wasn't a Bush appointee alive who was even remotely capable of showing up for work.

Another Agency Decimated by a Political Hack

Julie Gerberding has trashed the CDC, and spent a few billion of your dollars doing it. She took an agency that worked, that was the global gold standard 0f public health, and demoralized the staff, drove off the top talent, changed the structure of the agency so it now has a centralized command structure, and, in general, ruined it. (This is considered "success" by the Bush cabal.)

And in no department within the CDC has her ham-fisted politicized management style been more acutely felt than in the vaccine safety office. The vaccine safety office was, until 2004, led by a charismatic Taiwanese immigrant named Robert T. Chen.

Chen aggressively expanded vaccine safety measures to include a linked nationwide database of 3 percent of the country’s population that could be used to investigate possible harm from vaccines. The database was key to the 1998 discovery that a new rotavirus vaccine, produced by Wyeth Co., apparently caused a severe bowel disorder in about 1 in 10,000 infants who received it. The vaccine was withdrawn.

Chen rubbed some of his superiors the wrong way, partly because of a blunt speaking style but more fundamentally because of his willingness to put the interests of public health ahead of those of the CDC. It was a combination of personal and philosophical conflicts that led to him being removed from his job. He now works in HIV prevention at CDC. [emphasis mine]

Vaccine safety now goes through Gerberding's office, and consensus seems to be that doing so has been disastrous.

The CDC had always been independent, no matter who was in the White House. It is, after all, the nations public health service. Emphasis on PUBLIC. As in you and me. Us. Our kids, and our neighbors and our friends and our coworkers and the people who work at Costco and the Kansas City Chiefs and the cop on the beat and the bartender and the butcher and the baker. Us. The people. In the past, that is where the CDC's focus was.

And it worked.

When was the last time an epidemic swept this country?

Exactly.

Our relatively disease-free existence didn't just happen, you know. It came about because of the hard work of the public health system, led by the CDC!!! It happened because dedicated men and women have lived very focused lives, concerned only with the health and well-being of the people they serve.

Robert Davis is one of the top epidemiologists in the world, and he only lasted one year at the helm of the safety office. He couldn't abide the politics - or answering to an unqualified political hack of a scientist that Gerberding put in charge because she wanted a "Yes, Ma'am." I will let him have the last word.

“What’s really sad about it is, you had a few people with the power to eviscerate what I think most of the American public wants,” Davis said. “To me that was really, really shocking.”

Policy Trumps Public Health

It should surprise no one that a Surgeon General’s report on global health issues was quashed because it did not advance the Bush administrations rigid, monolithic political agenda. That is the charge leveled by current and former public health officials familiar with the report.

It seems the ideologue-in-charge was put off by the reality of a link between poverty and poor health. The squelched report called on the U.S. to lead an effort to combat wide-spread diseases as an integral part of our foreign policy objectives. It also challenged corporations to help improve the living conditions in the nations where they operate.

Release of the report was blocked by Richard Steiger, a movement-conservative ideologue and god-son of former President George H.W. Bush who was appointed to run the Office of Global Health Affairs in the Department of Health and Human Services.

The report, “Call to Action on Global Health” was commissioned by then-Surgeon General Richard H. Carmona, who recently cited the suppression of this report as evidence that the Bush administration puts an ideological tweak on science to advance their agenda, or the science gets ignored. Camona related an incident to lawmakers: As he was fighting to get the report released, a senior official, apparently exasperated with Camona’s insistence on being grounded in reality finally told him flat-out “You don’t get it. This will be a political document, or it will not be released.”

Thomas Novotny, a former assistant surgeon general who ran the global health office before Steiger, said, "It's embarrassing, just ridiculous that the report hasn't come out." Novotny, who served at HHS in the Clinton and in both Bush administrations, said that many nations have made health issues central to their foreign relations and trade policies, but that the United States has been reluctant to embrace that idea.

"It made perfect sense for the surgeon general to take up the issue because the U.S. used to be a leader in this field," Novotny said. "For the nation's top doctor to be unable to release the report shows that leadership is gone."

A former career official at the HHS, Richard Walling, asserted that the report was directly blocked by Steiger, who “always had his political hat on. I don't think public health was what his vision was. As far as the international office was concerned, it was a political office of the secretary. . . . What he was looking for, and in general what he was always looking for, was, 'How do we promote the policies and the programs of the administration?' This report didn't focus on that."

On June 30, 2006, a Steiger aide sent an e-mail saying that the report should not be cleared for public distribution: "While we believe the subject matter of the draft is important, we disagree with the style, tone and messaging. We believe this document should be focused tightly on the Administration's major priorities in global health so the American public can understand better why these issues should be important to them. As such, the draft should be a policy statement, albeit one that is evidence based and draws on the best available science."

I am always heartened when evidence is treated as an afterthought. Aren’t you?

When these jokers leave, by whatever mechanism they depart, the practical among us know that it is going to take a decade (at least) to root out the Loyal Bushie career hires, and set the departments they have thoroughly fucked up back right.