HHS Secretary Mike Leavitt has offered the most childish, as well as the most mendacious, explanation of his double-cross on Plan B that one could imagine, even in an administration characterized by pathological lying. Senators Patty Murray and Hillary Clinton had blocked the confirmation of Lester Crawford as FDA Director until the Agency promised to issue the ruling on Plan B certification that it was legally required to make, and which had been in limbo for 2 years. They removed their holds on the confirmation hearings when Leavitt personally assured them that HHS would “act on” Plan B by September 1st.

HHS Secretary Mike Leavitt on Monday defended FDA’s action of indefinitely deferring a decision on Barr Laboratories’ application for nonprescription sales of its emergency contraceptive Plan B, saying that he promised senators that the agency would act by Sept. 1 but never guaranteed a “yes or no” decision . . . .

“FDA made their commitment to me, and I made my commitment to the senators. The commitment was they would act. They did.” He added, “Sometimes action isn’t always yes and no.”

Prior to the Bush Administration, it would have been unthinkable for a Cabinet-level officer to say something like this with a straight face. The Senators had specifically said, many times, that they did not demand a particular resolution to the problem but that they insisted on a final decision. Murray’s Web site contains a press release almost 3 months old, making this point clearly enough that even a Bush Cabinet member should have been able to grasp it:

For Immediate Release: Wednesday, June 15, 2005

(WASHINGTON, D.C.) – U.S. Senators Patty Murray (D-Wash.) and Hillary Rodham Clinton (D-NY), members of the Senate Health Education and Labor Committee (HELP), today voted against the nomination of Dr. Lester Crawford to head the Food and Drug Administration (FDA) and placed a hold on his nomination, delaying consideration by the full Senate.

The Senators’ hold will remain in effect until FDA issues a yes or no decision on the over-the-counter application of Plan B emergency contraceptives.

“We are asking FDA to explain why they are delaying an over-the-counter application for Plan B that even their own Advisory Panel overwhelmingly recommended for approval. We are not asking for a specific outcome, but for some final outcome,” Senator Murray said.

Apparently there’s some part of “yes or no decision” and “final outcome” that Mike Leavitt doesn’t understand. But it was in this context that Leavitt promised “action”. He now claims he really only meant that they would do something, not anything useful or definitive. Somehow he never got around to mentioning that at the time, or to explaining that what he was promising was clearly incompatible with what the senators had demanded.

He deliberately issued a vague statement in response to an unambiguous request, and allowed the senators to assume he was dealing honestly with them. I tried that once (“Have you brushed your teeth?” “Yes.” “Have you brushed your teeth today?” “No.”), but even at 10 years old I knew I was lying. To think not only that the agency responsible for the most basic and vital needs of the American public is deliberately obstructing access to an important medication, but that the Cabinet officer overseeing it engages in this kind of childish duplicity, is disheartening. To think that our government has now taken to dealing with its own citizens in this manner is both dismaying and frightening.

What we surely know – though have known it for years already – is that nothing, not the most basic statement or claim of fact, not the most seemingly-ingenuous promise, from anyone in this administration, can be relied upon. Politically-motivated lying, manipulation, and distortion is inbred in them – all of them, apparently, including ones you might hope would have some vestigial feeling of responsibility for the public welfare. None of them is worth anything, and nothing they say is worth listening to.

I’ve said it many, many times already, but: I really, really want the adults to be back in charge.

Hat tip: AJOB/bioethics.net

[First quote above from CQ.com - paid subscription required]

The Washington Post surveys the continuing onslaught against reproductive health rights across the board, concluding that

This year’s state legislative season draws to a close having produced a near-record number of laws imposing new restrictions on a woman’s access to abortion or contraception. . . .

“Every year, we see a lot of legislation introduced,” said Elizabeth Nash, a public policy associate at the Alan Guttmacher Institute, a research group that specializes in family and reproductive health. “This year, we have seen a lot more action than in recent years. The level of bills enacted has been much higher.”

Read the article for the whole dismaying list.

The Post does a good job highlighting the general strategies the right wing is now – quite openly -pursuing: “death by 1000 cuts” and a continuing move to sneak “fetal personhood” into the law.

David Bereit, director of program development for the American Life League, which opposes abortion in all circumstances, supports both the short-term efforts and the long-term strategy aimed at overturning Roe v. Wade .

“People are becoming frustrated more progress hasn’t been made at the federal level and feel they don’t have as much control to change things there,” he said. “If we can’t outright ban abortion, what can we do to make it less prevalent? We see it’s much easier to take up funding and parental notification measures at the state level.” . . .

“This year, the pro-life forces united in order to pass some legislation,” Greenfield said. The other measures include stricter parental notification requirements and a provision adding an “unborn child” as a distinct victim to the state’s criminal code for charges of murder in the first and second degree. In its new informed-consent law, South Dakota requires physicians to tell women seeking an abortion about the “existing relationship between a pregnant woman and her unborn child,” and that all abortions “terminate the life of a whole, separate, unique living human being.”

The language in that law was written with the expectation it could be used to “help tear down the wall put up by the Roe versus Wade decision,” Greenfield said. . . .

In its end-of-the-session newsletter, Texas Right to Life hinted at the variety of approaches its side pursued.

Supporters “did not muster the strength to pass any of the multiple freestanding pro-life bills,” it noted. However, “several major pro-life victories came in the form of ‘under the radar’ amendments.” Those included measures to shift state money to abortion alternatives and health care for unborn children, stricter parental consent requirements and a ban on third-trimester abortions “when the abortion is not necessary to prevent the death of the woman.”

The handwriting has never been more clearly on the wall, and the right wingers have become unusually confident during this current – temporary – reactionary swing. Not only are their tactics unmistakeable, but they’re telling us about them. It’s vital to organize to hold the tenuous freedoms that have so far been won.

As Jessica at Feministing says: ‘[S]eeing all of the horribleness i[n] one article is quite something.”

Effect Measure reports on a petition circulated by the American Council on Science and Health, demanding that the EPA reject “junk science” in its determinations of carinogenicity. The “junk science” in question: all tests on animal models.

That’s right – this right-wing lobbying group wants cancer-causing chemicals to be tested on humans – meaning released into the environment without any testing at all, until we just kind of see what happens.

Their argument contains two flavors of bullshit: (a) that animal testing is invalid because it involves “the administration of superhigh doses irrelevant to ordinary human exposure levels”, and (b) this testing is illegal under the “Information Quality Act”, which mandates the “equality, objectivity, utility, and integrity” of information released by government agencies.

The latter point is just nonsense, of course, and Effect Measure deals decisively with the former:

[A]nimals (rodents) are a standard model for biological processes of relevance to humans (which is why drug companies and medical researchers have been using them for a century). They are well understood and are the only sentinels for detecting carcinogenicity of any use to public health. Since chemically induced cancer has a latency period of decades (typically 20 years or more), waiting for it to appear in human populations would meant that once detected, even if exposure would cease instantly (which can never happen), it would take another 20 or more years to eliminate the cancers from exposure (all the cancers induced in the 20 years exposure prior to detection). But even then, the chances of detecting any but the most powerful carcinogens in human populations (via epidemiology) is small. Epidemiology is a very insensitive tool. I say this with some authority, as I am a cancer epidemiologist specializing in chemical exposures and have authored numerous peer reviewed studies in that area over many years.

The main rhetorical lever ACSH employs is the use of high doses in the animal studies, doses that are much higher than usually faced by humans. But as ACSH knows well (but didn’t divulge) there is a technical requirement for using these doses. If one were to use doses in animals predicted to cause cancer at a rate we would consider a public health hazard, we would need tens of thousands of animals to test a single dose, mode of exposure and rodent species or strain. This makes using those doses infeasible. Thus a Maximum Tolerated Dose is used, one that causes no other pathology except possibly cancer and doesn’t result in more than a 10% weight loss. The assumption here is that something that causes cancer at high doses in these animals will also do so at low doses. This is biologically reasonable. . . .

We know of no false negatives with this process. Every chemical we know that causes cancer in humans also does so in rodents (with the possible exception of inorganic trivalent arsenic, which is equivocal). The reverse question, whether everything that causes cancer in animals also is a human carcinogen, is not testable without doing the actual natural experimen: waiting to see if people get cancer on exposure, an experiment ACSH is only too happy to conduct on the American people to make their corporate sponsors happy.

The concept of “dose-responsiveness” is fundamental to environmental health: that the more of a chemical you are exposed to, the greater its effects (or the greater their likelihood) will be. This is not only intuitively reasonable, it is scientifically proven by a vast experimental foundation. And this fact allows for backwards extrapolation from high doses: if certain high dose levels create a certain response in a test population, lower doses can be expected to create a certain (correspondingly lower) response at predictable levels. This allows for testing under pragmatically-possible conditions using small populations exposed to high doses (hundreds, not tens of thousands, of subjects), with results that can be extrapolated to larger populations at smaller doses. The ACSH’s disingenuous suggestion would make it impossible to do safety testing at all – which is precisely their goal, as revealed by their complaints about

health panics, public outcry, activist crusades against chemicals, and waste of resources from unnecessary abatement, cleanup, and product recall/reformulation/replacement.

Yet more right-wing fake science – and fake logic, fake law, and fake mathematics.

Hat tip: Lindsay Beyerstein.

Lester Crawford – confirmed as Director of the FDA upon his explicit promise to issue the ridiculously-delayed ruling on certification of “Plan B” emergency contraception by 1 September, 2005 – has announced that the issue will be delayed more than two months further for yet more “public commentary”.

The government on Friday put off its long-awaited final decision on whether to sell emergency contraception without a prescription, saying the pill was safe to sell over-the-counter to adults but grappling with how to keep it out of the hands of young teenagers.

In a surprise move, the Food and Drug Administration postponed for at least 60 days a final decision on how to allow nonprescription sales of the morning-after pill called Plan B just to women 17 or older.

The reason, ostensibly, is that there is no effective mechanism to keep teenagers under 16 from purchasing it if it is made available over the counter.

The agency’s independent scientific advisers overwhelmingly backed over-the-counter sales for everybody, not just adults, in December 2003.

FDA rejected that recommendation, citing concern about young teens’ use of the pills without a doctor’s guidance. Barr reapplied, asking that women 16 and older be allowed to buy Plan B without a prescription while younger teens continue to get a doctor’s note. Downey said the company thought it had satisfied all of FDA’s scientific and legal concerns about how to do that — noting that cigarettes are sold in drugstores with age restrictions.

Friday, FDA essentially boiled the issue down to regulatory precedent: Selling the same dose of a drug by prescription and without at the same time and for the same medical use has never been done. The FDA will allow 60 days of public comment on how to take such a step and enforce an age limit, but Crawford would not say how soon the agency could evaluate those comments and rule.

Why an age restriction at all? Crawford said the issue was at what age teens can understand how to use the pills properly.

It should be noted that Plan B is available in Europe over the counter to women of all ages, and has an excellent safety record there – facts which were taken into account in the FDA’s scientific review 2 years ago. The objection regarding teenagers was raised by lunatic Bush appointee David Hager in a personal letter to Crawford, issued after he was outvoted 23-4 by his colleagues on the safety panel. The objections Hager raised are the precise ones the FDA has since cited as its reason for not proceeding, even though its safety panel considered and rejected them at the time. Hager was appointed to the FDA precisely for his history of opposing contraception and medical abortion – and has made good on the deal not only by fabricating objections but by somehow wielding the clout to see that his personal objections drove agency policy even after his committee’s work was done and Hager himself had been pushed off the committee (following lurid revelations about his personal behavior). Now Crawford has broken his promise – after safely receiving the confirmation he had waited for – and the FDA has yet again acted unilaterally to block a proven medication and to impose an idiosyncratic view of how much – and how little – control women may have over their own reproduction.

Hat tip: Jill at Feministe.

UPDATE: Fred Vincy at Stone Court has the perfect response.

Art Caplan editorializes on the death of SF 49ers lineman Thomas Herrion. Although Caplan admits that “I have no idea what caused this tragic death”, he notes that Herrion weighed 310 pounds at 6’3″ – and that over 300 (!) other professional football players top the scales above 300 pounds. (Caplan also notes that the rise of extreme obesity in the NFL mirrors that in general society: 20 years ago, only 5 NFL players weighed this much.) Caplan assumes that weight is implicated in Herrion’s death and that it is a health problem for the other players as well.

[N]o medical or insurance table would give any indication that weighing 300 pounds or more is healthy for anyone. It is estimated that more than a quarter of all NFL players are morbidly obese, according to the Journal of the American Medical Association.

He has a suggestion, as well:

The only reason for this explosion in weight is the need to keep up with the competition. Set a limit on weight and few players or coaches would probably complain.

The NFL has made a huge effort to get a handle on the problem of performance-enhancing drugs. Drug testing is becoming increasingly common and the use of steroids and other substances is on the decline. But the NFL, as the country’s most popular and prominent pro league, has a bigger problem on its hands: obesity. It is time for pro football to convene a panel of experts, trainers, coaches and players and come up with some strict guidelines on weight and body mass.

The intuitive appeal of his argument is obvious, but it rests on a very slim (no pun) foundation.

Caplan is probably right that many NFL players rank as “morbidly obese” by the BMI standards commonly used – but those standards implicitly assume an average non-fat body composition for each given height. Thus, anyone of a particular height who exceeds a particular weight will be evaluated as obese, on the assumption that the “excess” weight must be all fat – no matter what their actual body composition may be. The BMI (what I assume Caplan means by “body mass”) does not correct for high or low muscle mass. Bodybuilders and other heavily-muscled individuals will routinely rank in the overweight or obese categories even though carrying extra muscle is not nearly as unhealthy as carrying lots of fat.

NFL players follow punishing weight-lifting and physical training regimens (often enhanced by steroids – which Caplan explicitly ranks as a smaller health problem than the bulk they produce). Although they do not always have the chiseled muscle definition of bodybuilders (as most true athletes do not), they are extremely muscular and probably few have the kind of body-fat percentage that the average sedentary “obese” person does. It is not clear that simply being heavy by itself is a health hazard, especially for extremely fit and active athletes – at the very least, it is certainly true that being “obese” by the BMI standard is a very different phenomenon for them than for the average non-active person. I suspect that there is actually little research on the health hazards of high muscle-based body weight for persons with low or normal body-fat percentages.

Caplan seems to have extrapolated from a standard scale to the situations of very much non-standard individuals. To promote a general policy of absolute weight limits without regard to body composition is both a broad-brush solution to a more complicated problem, and a focus on, very likely, the wrong issue. It might make more sense to impose body-fat-percentage limits, to ensure that players maintained a healthy body composition no matter what their size and weight – but, given the demanding training schedules the players keep, a body-fat limit might not wind up excluding anybody other than the coaches. If so – if this herd of 300-pounders coursing down the NFL’s gridirons is really composed of uniformly muscular, moderately-fatted, generally healthy players – then there is likely nothing to worry about in the first place. Caplan ought at least to look into this question before applying the couch-potato standard to professional athletes.

Hat tip: AJOB/Bioethics.net

I just saw Grizzly Man, an enthralling documentary assembled by Werner Herzog from video footage shot by Timothy Treadwell – a self-styled wilderness protection activist who lived in close proximity to a population of grizzly bears in the Alaskan wild for lengthy periods 13 years running. In 2001, Treadwell was killed and his body eaten by one of the bears he idolized.

The movie provides a fascinating, at times heartbreaking, look at a man so clearly obsessed by his idealized notions of good and bad, and of nature and people, that he was led to make extremely questionable decisions. Though he is obviously rational and articulate, Treadwell’s demeanor and language, and the beliefs he expressed about his relationship with the bears, call his competency to evaluate and control his own behavior into question. As a strong autonomy advocate who defends people’s right to make virtually any self-interested decision they like, especially in the area of healthcare, I found the sight of someone who unquestionably would pass any test of mental competency, but was unquestionably reckless literally to the point of death, very challenging. The movie left me worried about the ways in which simple “competency” does not capture the range of human mental capacity and frailty, and puzzled how best to defend autonomy while recognizing that not every decision made by a rational person is rational.

I recommend the movie to those who also puzzle over the nuances of the autonomy/paternalism debate, and in its own right to anyone interested in a fascinating, troubled character following his own dreams in an unimaginably breathtaking – and dangerous – setting.

(more…)

A provocative and somewhat weird article in The New York Times today details men’s post-natal disgust with their wives’ vulvas, after seeing a baby come out of the vagina during childbirth.

You were … there?” he asked me, tentatively. “I mean, for the delivery?” . . .

He couldn’t bear to say it. “You saw more than you wanted to?” I asked.

The smile left his face. “I just can’t get it out of my mind.”. . .

“I mean,” he went on, “how are you supposed to go from seeing that to wanting to be with … ?” He stopped, but his eyes kept asking the question. . . .

[D]ozens of men . . . have confided to me that witnessing the births of their children has made it difficult for them to be attracted to their wives, at least in the short run.

They seem to have trouble seeing them as sexual beings after seeing them make babies, trouble reverting to a mind-set in which their wives’ sexual anatomy is just that – not associated with images of new life emerging through the birth canal. . . .

“Honestly,” one man, married for 12 years, told me, “I think one of the main reasons I don’t feel attracted to my wife is that I saw her give birth three times. It’s like I know too much about that part of her.”

(more…)

I posted a while back that I would be gone for a few weeks. Weird stuff happened while I was away, with the result that I wound up unexpectedly moving to a new apartment as soon as I got back from the West Coast. I’ve been swamped for the last 6 weeks with packing up the unbelievable amount of shit that accumulates in a one-bedroom apartment and compacting it into a 250-square-foot studio apartment (why? – that was the weird stuff that happened).

Still a few bugs in that system, but I’m at the point that I can start to put my head up again and see what’s going on around me. Glad to be back.