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In yesterday's post on the proposed HHS abortion "conscience" regulation, I overlooked a very important quote from Secretary Leavitt. Rob Stein of the Washington Post relates the following exchange from Leavitt's Aug. 21 conference call with reporters:
But when pressed about whether the regulation would protect health-care workers who consider birth control pills, Plan B and other forms of contraception to be equivalent to abortion, Leavitt said: "This regulation does not seek to resolve any ambiguity in that area. It focuses on abortion and focuses on physicians' conscience in relation to that."
Ambiguity is precisely what pharmacists have asserted in lawsuits demanding the right to withhold hormonal contraceptives. While framing the regulation as neutral, Leavitt is lending support to their position. And, as noted yesterday, the regulation explicitly applies to pharmacies (see page 24 of the PDF) which dispense contraceptives but do not perform surgical abortions.
When it comes to conscience rights, I'm a libertarian. As a pharmacist, you have every right to refuse to fill contraceptive prescriptions. But your customers have every right to boycott your store, and your employer has every right to fire you. If you don't like your employer's policy, open your own pharmacy.
The HHS regulation is not neutral. It uses government leverage to prevent employers from insisting that their employees honor consumer choice. In the name of one freedom, it suppresses another. And in the name of ambiguity, it lends official support to lawsuits that would extend this government intervention from abortion to contraception.
You can add your own views, pro or con, at consciencecomment@hhs.gov.
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HHS Secretary Michael Leavitt has issued a final version of his proposed regulation to protect medical conscience (PDF). As predicted, he has dropped the sentence that originally defined abortion as "any of the various procedures—including the prescription, dispensing and administration of any drug or the performance of any procedure or any other action—that results in the termination of the life of a human being in utero between conception and natural birth, whether before or after implantation."
Leavitt has also chosen to leave open the possibility that the regulation will be applied that way. In that case, it would protect a provider's right to withhold oral contraception, which theoretically could prevent implantation of an embryo. Pharmacists and Catholic hospitals are already waging legal battles to assert this right.
The proposed regulation is 42 pages long. I'm embarrassed to tell you that I read it last week during my vacation. I was looking for a definition of abortion. I'll save you the trouble: There is none. The regulation draws no distinction between abortion and contraception.
In his blog, Leavitt has twice addressed the contraception question. On Aug. 7, he said his intent was to protect the right of conscience, not to define contraceptives as abortion. This left open the obvious next question: Intent aside, does the right of conscience protected by the regulation include the right to withhold hormonal contraception on the grounds asserted by pharmacist litigants: that it might be abortifacient? Two weeks ago, I invited Leavitt to answer that question. He has ignored it.
He has, however, answered a similar challenge from Mary Jane Gallagher, the president of the National Family Planning and Reproductive Health Association. In an Aug. 11 blog post, Leavitt quoted and rebutted her:
"Who's going to provide access to contraceptives services if the administration provides this large loophole to deny services?" [said Gallagher.] CQ reported Ms. Gallagher continued: "Providers are ‘given an oath—now they get to pick and choose what they want to do' if a regulation is issued, she said."
So, according to Ms. Gallagher's ideology, if a person goes to medical school they lose their right of conscience. ... There is something I'd like to point out to Ms Gallagher and the people she represents. It is currently a violation of three separate federal laws to compel medical practitioners to perform a procedure that violates their conscience.
Gallagher is explicitly talking about contraception. And Leavitt's response is to invoke conscience rights.
Last week, Leavitt said some practitioners might "press the definition" in the final HHS regulation and argue that hormonal contraception is abortion. They certainly will. Pharmacists for Life International is already on the case. So is the Christian Legal Society. Concerned Women for America says the equation of hormonal contraception with abortion, explicit in the original draft of the regulation, was right all along.
And when these litigants argue that the regulation implicitly covers contraception, they'll have lots of help from Leavitt. They can cite his response to Gallagher. They can also point out that the regulation explicitly lists pharmacies as a category of "affected entities." (See Page 24.) Last time I checked, pharmacies didn't do surgical abortions.
The argument on the other side will be that Leavitt has said he's not targeting birth control. "This regulation is not about contraception," he said in a conference call last week. "It's about abortion and conscience." But Leavitt has said the same thing about abortion itself. "This is not a discussion about the rights of a woman to get an abortion," he wrote in his blog. "This is about the right of a doctor to not participate if he or she chooses for reasons they consider a matter of conscience." Leavitt's point, in other words, is that the regulation doesn't ban anything; it just protects the right not to facilitate it. As he put it in the conference call, "There is nothing in this rule that would in any way change a patient's right to a legal procedure." But in asserting this right of refusal, the rule doesn't distinguish between surgical abortion and theoretically abortifacient drugs.
The rule is open to public comments until Sept. 20. You can submit your comments to consciencecomment@hhs.gov. Here's mine: Mr. Secretary, if this rule doesn't extend the right of refusal to hormonal contraception, say so.
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Yesterday I asked whether Michael Phelps lost to Milorad Cavic in the 100-meter butterfly final at the Olympics. I took a pretty good pounding in the Fray.
Looks like I deserve it.
The reason I looked back at Phelps-Cavic this weekend is that Omega finally released its pictures of the finish. Because Omega is the official timekeeper and its pictures had previously been withheld, I attributed great importance to them. And the company's characterization of the pictures as proving Phelps won was total garbage.
As many of you point out, the fact that these pictures prove nothing proves nothing, since we had better pictures from underwater to begin with. I'd seen the underwater shots on TV, but I hadn't looked at them closely on the Web. Look at the sequence:
Right before the swimmers touch
The touch
A closeup of Cavic's fingers, cropped from the preceding photo (No. 5):
Phelps has clearly touched at this point. Has Cavic touched? His left middle finger is bent back. But if you look at the first of these three photos (No. 4), you can see that the finger is also bent back slightly as he's approaching.
My eye says the finger isn't touching yet. But my eye, as a judge of Olympic photo finishes, sucks. So here are two ways of resolving the question.
1. Do a CSI-style 3-D analysis of photo No. 6, the close-up. See if you can assess the height of Cavic's fingers relative to the cross on the wall. Assuming the fingers are pretty well below the top of the cross, case closed.
2. Calculate the delay between touch and pad compression using the speed of the race. If the speed is fast enough that the delay can't equal one one-hundredth of a second, case closed. There's already a Fray thread pursuing this calculation.
One fascinating thing in underwater photo No. 5: Even if Cavic is touching, you can see that Phelps is touching harder. Theoretically, thanks to the touch pad, that could be enough to win him the race, even if the touches were virtually simultaneous.
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Can we please stop fussing over every new Olympic record?
A new record means that an athlete using today's equipment outperformed an athlete using yesterday's equipment. It's not a fair fight.
In swimming alone, today's advantages include:
1. LZR Racer suit. It reduces friction (compared with skin) and is structurally designed to compress and streamline the body for maximum speed. Estimated drag reduction: 5 percent to 10 percent. Estimated average improvement in top swimmers' best times: 2 percent. Designed by NASA scientists and computers, among others. Cost: $500.
2. Pool depth. This is the deepest pool ever used in the Olympics. Depth disperses turbulence, reducing resistance.
3. Pool width and gutters. Two extra lanes at the margins disperse waves to gutters, reducing ricochet and resistance.
4. Lane dividers. The plastic ones in Beijing deflect turbulence down instead of sideways, reducing resistance.
5. Starting blocks. Nonskid versions have replaced the old wooden ones, boosting dive propulsion.
6. Video. Recordings and analysis identify target variables such as stroke distance and turns.
7. Medical tests. Swimmers are blood-tested after each race to measure lactic-acid buildup.
8. Sports scientists. They run the monitoring and analysis. The U.S. swim team has four.
And here's a partial list of advances in other sports:
1. Lighter shoes. The latest material is carbon nanotubes.
2. Asymmetric shoes. Stronger carbon base in the right shoe tilts you to the left to increase speed as you round the track. Left shoe is designed to stabilize you.
3. Ice vest. It lowers your temperature before the race so you can delay overheating for better performance.
4. Hypoxic tents. Sleeping in low-oxygen chambers increases red blood-cell levels.
5. Aluminum javelins. They reduce vibration compared with the old carbon ones.
6. Bicycle wheels. Front wheels with fewer spokes (eight instead of 32) reduce weight and air resistance. So do composite one-piece rear wheels. All frames are carbon.
Michael Phelps' coach says the LZR suit is fair. "Everybody is in the suit so it's across the board," he argues. That may be true of today's top swimmers. But it's not true of yesterday's. So comparing today's performances to the performances of 20, eight, or even four years ago—which is what "new Olympic record" means—is generally unfair.
If you want to compare today's athletes to yesterday's, the ideal method would be an inflationary formula. We already calculate how much $1 in 1980 would be worth today, based on price increases. We ought to be able to devise a similar multiplier for each Olympic event, based on average year-to-year improvement among top athletes. Averaging would wash out idiosyncratic ups and downs. The effects of aging could be measured and factored out.
Olympic inflation indexing wouldn't devalue new records. It would isolate and elevate records that truly stand out. Scores of media reports have boasted that every team in this year's 4 x 100 men's swimming relay beat the time that won that event four years ago. But by inflationary standards, the British, who beat the 2004 winning time by three-tenths of a second in constant time, actually failed to keep pace with it. The Americans, who beat it by five seconds, produced a genuine achievement.
And now, if you'll excuse me, I'm off to watch the latest high-definition broadcast from Beijing on my 46-inch flat-screen TV. It beats the crap out of the 20-inch tube I was squinting at in 2004. But that doesn't make my eyesight any better.
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Last Tuesday, I wrote about a draft regulation, circulated by the Department of Health and Human Services, that would protect the right of private employees to refuse to facilitate any abortifacient chemical or activity. The draft rule defined abortion as "any of the various procedures—including the prescription, dispensing and administration of any drug or the performance of any procedure or any other action—that results in the termination of the life of a human being in utero between conception and natural birth, whether before or after implantation." It would thereby encompass the right to withhold oral contraception, which theoretically could prevent implantation of an embryo.
On Friday, HHS Secretary Mike Leavitt wrote a blog post about the draft rule. According to the Washington Post, Leavitt "denied that [the] draft regulation would redefine common birth control methods as abortion and protect the rights of doctors and other health-care workers who refuse to provide them."
Really? Where's the denial?
Here's the relevant part of Leavitt's post:
An early draft of the regulations found its way into public circulation before it had reached my review. It contained words that lead some to conclude my intent is to deal with the subject of contraceptives, somehow defining them as abortion. Not true.
The Bush Administration has consistently supported the unborn. However, the issue I asked to be addressed in this regulation is not abortion or contraceptives, but the legal right medical practitioners have to practice according to their conscience and patients should be able to choose a doctor who has beliefs like his or hers.
The Department is still contemplating if it will issue a regulation or not. If it does, it will be directly focused on the protection of practitioner conscience.
Leavitt's post says his intent is to protect the right of conscience, not to define contraceptives as abortion. It doesn't deny that the final version of the rule will have the effect of treating some contraceptives as abortion. And there's every reason to believe it will do just that.
Leavitt writes as though conscience protection is a separate issue from the blurring of abortion with contraception. It isn't. A rule that guarantees the pro-life conscience rights of doctors, pharmacists, and other private employees is limited only by what those employees believe. And what many of them believe, as the Post's Rob Stein has documented, is that oral contraceptives are wrong because they can prevent implantation.
If you think Leavitt won't extend conscience protections that far, you haven't met his boss. Nine years ago, when George W. Bush was running for president, Tim Russert asked him: "Do you believe life begins at conception?" Bush replied: "I do." Two years later, as he prohibited federal funding of embryo-destructive stem-cell research, Bush repeated, "I think life begins at conception." Referring to pre-implantation embryos, Bush wrote that "it is unethical to end life," even to save the lives of others.
How can Leavitt fail to extend conscience protections to a pharmacist who refuses to fill a birth-control prescription because, like Bush, he believes that life begins at conception? If that belief is good enough to bar funding of stem-cell research, why isn't it good enough for the pharmacist?
If Leavitt really wants to clarify this question, he can do so by writing one more post in which he stipulates that the HHS rule, if issued, will not extend to drugs or procedures that act prior to implantation. I'm betting a month's supply of birth-control pills that he won't.
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When is a life-threatening disease not worth treating? When something else will kill you first.
This week, the U.S. Preventive Services Task Force issued new guidelines for prostate cancer screening. The New York Times explains:
Prostate cancer often progresses very slowly, and a large number of these cancers discovered through screening will probably never cause symptoms during the patient's lifetime ... Past task force guidelines noted there was no benefit to prostate cancer screening in men with less than 10 years left to live. ... The new guidelines take a more definitive stand, however, stating that the age of 75 is clearly the point at which screening is no longer appropriate.
Well, sort of. The new guidelines do draw the line at 75. But the rationale hasn't really changed. Here's the key paragraph from the report:
In men age 75 years or older, the USPSTF found no direct evidence of benefits of prostate cancer screening. However, the USPSTF was able to establish an upper bound for the potential magnitude of the benefit of treating screening-detected prostate cancer in this age group, by extrapolating from evidence of treatment for clinically detected prostate cancer in this age group. For a population of men with an average life expectancy of 10 years or fewer, the USPSTF determined that the benefits of prostate cancer screening and treatment would range from small to none.
In other words, men 75 years or older aren't worth screening because their life expectancy is 10 years or less. This matches the logic of the previous guidelines ("Older men ... who have a life expectancy of fewer than 10 years are unlikely to benefit") and, as the report notes, similar guidelines issued by professional medical associations. It also matches a study, cited in the key paragraph, that compared "radical prostatectomy" to "watchful waiting" in two groups of men. The study found that with prostate removal, "The absolute reduction in the risk of death after 10 years is small."
More to the point, the 75-10 equation matches current U.S. life expectancy tables. The guidelines clearly identify life expectancy as a key factor in setting limits to screening:
The USPSTF found convincing evidence that treatment for prostate cancer detected by screening causes moderate-to-substantial harms, such as erectile dysfunction, urinary incontinence, bowel dysfunction, and death. These harms are especially important because some men with prostate cancer who are treated would never have developed symptoms related to cancer during their lifetime.
According to the latest U.S. government data, remaining life expectancy for a 75-year-old man is 10.8 years. But that number applies only to the most recent year on the table, 2005. If you scan up the column of numbers, looking back in time, you'll see that remaining life expectancy for men at 75 has been edging up. Since 1980, it has increased by two years. And if you look at tables going further back, you'll see that a 75-year-old man today can expect as much remaining life as a 70-year old man could expect in 1975.
In other words, life expectancy is increasing, and as it does, the age at which slow diseases are worth testing and treating also increases. Three decades ago, by the logic of the 10-year limit, a 70-year-old man wasn't worth screening for prostate cancer. Today, he is. We have extended his remaining life to the point at which prostate cancer would shorten it. By preventing and treating other diseases, we have made this one worth preventing and treating, too.
So don't count on the screening line to hold at 75. Over the next few decades, it could easily rise to 80.
One way to look at this trend is that the job never ends. The more we accomplish, the more work we have to do. It's exhausting. Maybe we should back off and respect nature's limits.
The other perspective is that there's nothing more liberating -- nothing more human -- than shattering old expectations. This boring little tweak in the recommendations for prostate cancer is actually this week's episode of the biggest story in the universe: biological emancipation. In the beginning, we accept a cause of death as nature's course. Then we call it a disease and study it. Then we push life expectancy to the point at which the disease is worth treating. The truest measure of progress isn't what we achieve. It's what we undertake.
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If you're looking for interesting bathroom reading, allow me to recommend Urology. The July issue is chock full of page-turners: "Robotic Prostatectomy," "Scrotal Mass with Bladder Outlet Obstruction," "Histologic Comparison of Pubovaginal Sling Graft Materials," "Multi-Drug-Resistant Bacteremia After Transrectal Ultrasound Guided Prostate Biopsies," and my favorite, "Modern Management of Adult-Acquired Buried Penis" (it's "a result of obesity" - don't ask).
Seriously, though, I want to talk about an article in the July issue. It's called, "Does ‘Normal' Aging Imply Urinary, Bowel, and Erectile Dysfunction?" Here are key excerpts from the abstract:
We assessed if urinary, bowel, and sexual dysfunction and associated bother were part of the "normal" aging process in the general male Dutch population. ... Three thousand eight hundred ten (3810) men responded (81%), mean age 67 years, range 58 to 78. ... Bowel dysfunction and bother were not related to age. Erectile dysfunction was reported by 19%, ranging from 12% in the youngest to 26% in the oldest group ...
Conclusions: Urinary and bowel dysfunction were not part of the "normal" aging process. Erectile dysfunction was significantly more prevalent in older men.
And here's the headline on the Reuters write-up: "Erectile dysfunction may be ‘normal' with age."
The curious thing here is the word normal. It's being used in this context to mean age-related. Most men in the sample didn't have erectile dysfunction. But because ED's frequency increases with age, and because we think of aging as a universal process accompanied by physical decline, ED seems normal.
Since "urinary and bowel dysfunction were not part of the ‘normal' aging process," the authors conclude, they "may well be related to prior treatment" in men who have been treated for prostate cancer. This appears to make them logical targets for prevention or remedy. Does the opposite implication follow for ED? Does its "normality" make it a less compelling target?
There are many plausible ways to think about normality and health. Age-dependence is one of them. To me, the authors' framework makes sense: Medicine should focus first on maladies that strike some people unusually early in life. Maladies that accumulate with age are less unfair. They're also less tractable, since they're more biologically inherent.
ED, however, is a confounding example because it's in the process of being transformed from a "normal" to a commonly treated condition. Bob Dole made his famous ad for Viagra in 1999, when he was 76. In the last decade, 35 million men have used Viagra. Millions more have taken similar drugs such as Cialis or Levitra. Modern man has set out to conquer the ancient loss of manhood.
Which brings us back to the question posed in Urology: Does normal aging imply ED? The answer seems to be: It used to. And that's not just a change in the way we think about erections. It's a change in the way we think about aging.