A new study in the Archives of Internal Medicine has been getting a lot of attention for its extraordinary claim that breast cancer can spontaneously disappear without any treatment. If it’s true, it raises a host of important questions: Should some women with breast cancer forgo toxic treatments? How does cancer simply disappear? Should we stop aggressive breast cancer screening?

The operative word, of course, is “if.” The case of the disappearing breast cancers described in the scientific paper is powerful but entirely circumstantial. The authors did not see even a single cancer disappear. They hypothesized that some breast cancers disappeared because they did not find as many cancers as they expected.

The paper is The Natural History of Invasive Breast Cancers Detected by Screening Mammography written by Zahl, Maehlan and Welch. The authors recruited over 200,000 Norwegian women ages 50-64 and divided them into two groups. The tested group had mammograms every other year for 6 years (a total of 3 mammograms). The control group had only one mammogram at the end of the 6 year period. The authors were very careful to make sure that the two groups were as similar as possible.

Over the course of the 6 year interval, 1909 cases of breast cancer were diagnosed per 100,000 women who had screening in every other year. In contrast, only 1564 cases of breast cancer were diagnosed per 100,000 women who had only one mammogram at the end of the 6 year interval. The authors concluded that over 300 cases of breast cancer were “missing” from the control group and they believe that those cancers arose and spontaneously disappeared.

Is that what really happened? First, we must consider the fact that the 1564 cases diagnosed in the control group does not include all cancers in the group. Screening mammography is not perfect and some cancers will be missed that might be detected on a subsequent scan.

Second, the use of estrogen replacement therapy in the study group was substantially higher than in the control group. Since hormone therapy has been associated with increases in breast cancer risk, that may account for part of the observed difference.

Third, the incidence of breast cancer in Norway increased over the life of the study. The women in the study group (1996-2002) had a known higher incidence of breast cancer than the women in the control group (1992-1998).

Even taking these factors into account, there is almost certainly a real difference in the cumulative number of breast cancer cases between the study group and the control group. In other words, routine mammography may over diagnose breast cancer by finding cancers that would disappear on their own if not treated.

That’s not a surprising finding. The body has many mechanisms for controlling the growth of runaway cells that could lead to cancer. The appearance of an actual cancer represents a failure of these mechanisms. It is possible, particularly in the case of small cancers detectable only by mammography, that there is still one last fail safe mechanism that could even then attack the tumor and destroy it. This study may be demonstrating that phenomenon.

There are some serious limitations to this study. The study only looks at incidence of cancer. It does not look at outcome and life expectancy. If it turns out that the women in the study group have a much lower incidence of death from breast cancer, because they are treated early and aggressively, it will justify the apparent over diagnosis of breast cancer. That is a very real possibility, because the data show that although the cumulative incidence of breast cancer in the control group was lower, many cases of breast cancer in the control group were not diagnosed until the mammogram at the end of the 6 years.

Finally, and most importantly, there is no way to tell the difference on mammography, or by any other technique, between the cancers that will disappear and the ones that will go on and kill the woman. Without a practical way to separate those who need to be treated from those who do not, the finding is intriguing and worthy of further investigation, but cannot guide us in determining the best way to screen for breast cancer and the best way to treat it.

 Yesterday’s Washington Post Magazine featured a thought-provoking article on the making of an abortion provider. Leaving aside the personal safety issues, which are large, the author chose to focus on the reality of performing abortion procedures and caring for the women who request them. It turns out that wanting women to have access to abortion and being personally willing to provide the service are two entirely different things.

According to the Guttmacher Institute, the premier advocacy group devoted to reproductive health and rights, the number of abortion providers remained relatively stable, dropping only 2% between 2000-2005. In contrast, provider numbers dropped 14% from 1992–1996 and 11% in 1996–2000. The primary reason why the number of providers stabilized is because the decrease in providers willing to perform surgical abortions was almost completely offset by the increase in providers offering new medical methods of pregnancy termination like RU-486.

Surgical abortions remain the mainstay of abortion provision, however, and increasing numbers of clinicians simply don’t want to perform them. The WaPo profile of a medical student activist committed to providing abortion procedures who ultimately changes her mind offers a unique insight into the difficulty of recruiting a new generation of providers. Simply put, the reality of providing abortions is far more unpleasant than the reality of supporting abortion rights.

Author Patricia Meisol introduces us to medical student Lesley Wojick:

a 24-year-old second-year medical student at the University of Maryland School of Medicine who had helped organize this regional student-hosted, daylong abortion seminar last year. Lesley respected forthrightness and unconventional thinking…

She had joined Medical Students for Choice, an abortion education group with chapters on 135 U.S. campuses, as soon as she arrived at Maryland. The nation’s abortion doctors were graying, and unless a new generation took their place, the right to abortion might be rendered meaningless. Lesley imagined herself being part of that new generation. But would her support for abortion translate into action?

“I won’t know until I’m faced with doing it, but I think I would absolutely be able to provide [abortions],” she said. “It’s walk the walk, instead of talk the talk. I want my actions to be consistent with my words.”

But Wojick finds that the reality of actually performing abortions is different than talking about them. According to the Guttmacher Institute, 1.2 million abortions were performed in 2005, down slightly from previous years. Although medical abortions are now widely available, they are not popular. Many women show up too late in pregnancy to qualify for medical abortions, and even those that are eligible usually choose surgical abortion because it is quicker and less painful.

Abortions rights supporters often portray abortion as a choice of last resort after contraceptive failure, but the reality is very different. Most women who seek abortions were not using birth control. The typical woman seeking an abortion is an unmarried woman in her 20’s who already has one or more children, and did not want another but took no precautions to prevent pregnancy. The grinding reality of abortion is that it is a method of birth control, not a last ditch effort to deal with a contraceptive failure.

The reality of the surgical procedure itself is even more jarring. At first Lesley feels that she can handle it. After watching a second trimester abortion she reports:

“It was definitely gruesome,” she said. “You could make out what a fetus could look like, tiny feet, lungs, but it didn’t look like a person.” She knew this abortion was an act that her friend … considered tantamount to murder. She herself expected to be very upset. She’d felt that way at her first autopsy, that of a teenage boy who’d shot himself in the head. For weeks, she could not shake the image of the boy. But this was different. She didn’t regard the fetus as a person yet. She said she was happy to help the woman: “I feel like I was giving [her] a new lease” on life.

Over time, though, Lesley begins to feel differently:

As for obstetrics … Lesley hadn’t loved very much about it. Even as she’d shadowed the abortion doctor, Lesley knew in her heart that this would not be the right place for her to make a difference. It was a big disappointment, she said. “I really thought I’d love it.”

The things she cared about — taking care of women, seeing them through the process — hadn’t happened. It was the nurse practitioner who cared for the patient. Vacuuming out a uterus and counting the parts of the fetus did not seem like a desirable way to spend her work days. It took a unique person to do that on a daily basis, she said.

The ongoing decline in abortion providers is a serious problem, threatening the access for women to a service that is entirely legal. On the other hand, the reality of abortion itself, used as a method of birth control, not as a last resort, and the unpleasant nature of the procedure, vacuuming out a uterus and counting the parts of the fetus, lead students like Lesley to change their minds. It’s one thing to support abortion rights; it’s entirely different to actually perform abortions.

Early in my internship I cared for a young Southeast Asian man who had a rare collagen disease. Surgery for an aneurysm (weakening in the wall of a blood vessel) in his pelvis left him with a large, poorly healing wound in his lower abdomen. As the lowliest member of the surgical team, it was my job to debride his wound every day. Debriding means cleaning and carefully removing any dead tissue from a wound. It would have been a lot easier for him and for me if I had had maggots.

 Maggots weren’t available then, but they are now. In a sign that maggots have gone mainstream, the government recently announced that Medicare and Medicaid will pay for maggot therapy. This is yet another milestone in the rise, fall and resurgence of maggots in medicine.

For centuries, maggots were an important part of wound care. According to Maggot Therapy: The Science and Implication for Complementary and Alternative Medicine:

… In 1829, Baron Dominic Larrey, Napoleon’s battlefield surgeon, described how men had arrived at his field hospital with healing maggot-infested wounds. The wounds were sustained in battle, but, owing to the presence of maggots, were not infected and showed accelerated healing. Such positive accounts were made by many surgeons who followed, but it was William Baer, Professor of Orthopaedic Surgery at the John Hopkins School of Medicine .., who is believed to be the founder of modern maggot therapy.

… Baer … pioneered the use of sterile maggots as a reputable method of wound therapy, following observations he made about the value of maggots in traumatic wounds on the battlefield in France during World War 1… [B]y the mid-1930s almost 1000 North American surgeons employed maggot therapy and by the end of the decade it was in use in over 300 hospitals in the US and Canada.

Instead of daily wound cleaning and removal like my patient had to endure, wound patients had a “dose” of maggots applied to the wound and the world’s tiniest “surgeons” did the same job, slowly and without patient discomfort, working 24/7 to heal wounds in record time.

Maggot therapy came to an abrupt end in the 1940’s when antibiotics came into widespread use. Antibiotics were easier to use, extraordinarily effective at healing infected wounds, and had greater scientific glamour than the lowly maggot. In an age of increasing antibiotic resistance, and the rise of “superbugs” such as MRSA (methicillin resistant staph aureaus), maggots are making a comeback.

Of course, not any maggots will do. The larvae of Phaenicia sericata, the common green-bottle fly, is the maggot of choice. That’s because maggots can be divided into two types, those that will eat living tissue and those that can only survive on dead tissue. Phaenicia maggots belong to the second type. In a wound, they will only consume the dead tissue that is interfering with healing and leave the live tissue alone. When there is no dead tissue left and the wound is healed, they will simply move on.

Maggots have some terrific advantages in wound healing. First, they seem to be able to do the job when all else fails. In Maggot debridement therapy of infected ulcers: patient and wound factors influencing outcome – a study on 101 patients with 117 wounds, the authors report:

It has been known for centuries that maggots are potent debriding agents capable of removing necrotic tissue and slough. … [W]e performed a prospective study to gain more insight in patient and wound characteristics influencing outcome…

… In total, 78 of 116 wounds (67%) had a successful outcome. These wounds healed completely (n = 60), healed almost completely (n = 12) or were clean at least (n = 6) at last follow-up. These results seem to be in line with those in the literature. All wounds with a traumatic origin (n = 24) healed completely… Outcome was not influenced by gender, obesity, diabetes mellitus, smoking, ASA-classification [wound severity], location of the wound, wound size or wound duration.

Second, maggots are effective when antibiotics fail. In the age of the “superbug,” bacteria that are resistant to multiple powerful antibiotics, maggots can still get the job done. Recent research has shown that maggots are just as effective in cleaning wounds caused by MRSA as they are at cleaning wounds caused by other bacteria. When the maggots remove the dead tissue, the body can heal the infection itself.

Third, using maggots to treat routine wounds instead of the current treatment with antibiotics would slow the rise of new drug resistant bacteria.

Finally, maggot therapy is much less expensive than conventional antibiotic therapy. A supply of “medical maggots” from Monarch Labs costs less than $100, in contrast to thousands of dollars for a course of powerful antibiotics. Maggots often work faster than antibiotics, reducing hospitalization costs. When you consider that maggots can prevent the need for amputation of limbs, a course of maggot therapy can save tens of thousands of dollars.

It’s not everyday that scientists discover a new treatment that is effective, easy to use, impervious to antibiotic resistance and inexpensive. The maggot, only recently relegated to the medical sidelines, is poised regain respect. That’s seems only fitting for what are, in truth, the world’s tiniest surgeons.

The conventional wisdom about healthcare costs is that preventive medicine saves money. Indeed, during the recent primary and general election campaigns, many candidates relied on the assumed savings from preventive medicine to either control healthcare costs or to provide the money to extend healthcare coverage.

Unfortunately, the claims of cost savings from preventive medicine have been vastly overstated. The existing research shows that most preventive measures do not save money compared to treatment and quite a few actually cost more money than treating the illness in question. A recent article in the New England Journal of Medicine lays out the disappointing evidence.

 Does Preventive Care Save Money? Health Economics and the Presidential Candidates, was published in June and evaluated the candidates’ claims about cost saving. The paper represents a collaboration between two professors of medicine and a professor of health policy and management. First, they frame the problem:

Sweeping statements about the cost-saving potential of prevention, however, are overreaching. Studies have concluded that preventing illness can in some cases save money but in other cases can add to health care costs. For example, screening costs will exceed the savings from avoided treatment in cases in which only a very small fraction of the population would have become ill in the absence of preventive measures. Preventive measures that do not save money may or may not represent cost-effective care (i.e., good value for the resources expended). Whether any preventive measure saves money or is a reasonable investment despite adding to costs depends entirely on the particular intervention and the specific population in question. For example, drugs used to treat high cholesterol yield much greater value for the money if the targeted population is at high risk for coronary heart disease, and the efficiency of cancer screening can depend heavily on both the frequency of the screening and the level of cancer risk in the screened population.

The authors reviewed the literature on preventive medicine and cost savings. They identified 599 studies across all areas of medicine. For their analysis, the authors compared the cost effectiveness of prevention to the cost effectiveness of treatment as ratio of cost to QALYs. A QALY is a quality-adjusted-life year. A low ratio is desirable because that indicates that a particular measure is inexpensive compared to the QALYs gained. In contrast, a high ratio indicates that it takes a great deal of money to achieve a relatively minor benefit.

What they found directly contradicts the conventional wisdom. Analysis of the data in the 599 studies showed that the costs of prevention are roughly similar to the costs of treating the disease in question. The authors explain:

… the distributions of cost-effectiveness ratios for preventive measures and treatments are very similar — in other words, opportunities for efficient investment in health care programs are roughly equal for prevention and treatment, at least as reflected in the literature we reviewed. Moreover, both distributions span the full range of cost effectiveness…

… Some preventive measures save money, while others do not, although they may still be worthwhile because they confer substantial health benefits relative to their cost. In contrast, some preventive measures are expensive given the health benefits they confer. In general, whether a particular preventive measure represents good value or poor value depends on factors such as the population targeted, with measures targeting higher-risk populations typically being the most efficient…

The article has several important implications. First, while preventive medicine may be desirable because it prevents illness in some people, it does not save money because screening and other preventive measures cost the same or more than treatment.

Second, all preventive medicine is not created equal. Some preventive measures, like vaccination, are extremely cost effective. Others such as intensive anti-tobacco education for middle schoolers are extremely cost ineffective, with a cost to QALY ratio $23,000/QALY, according to the paper.

Third, restricting preventive measures to at risk populations is much more cost effective than applying preventive measures to the entire population. This is in keeping with what we know about screening tests. They are much more accurate in high risk populations than in the population at large.

This does not mean that we should abandon preventive care. We should continue to provide anti-retroviral prophylaxis to HIV positive patients in order to delay the development of full blown AIDS. Such a policy is ethically mandated, even though it costs approximately $29,000 per QALY.

Preventive medicine is beneficial because it prevents disease, but the evidence shows that it does not save money, regardless of what political candidates and others may claim.

In a tale that could have been written by Kafka, Shirley Justins, a 60 year old Australian woman, will be going to jail because she helped her partner end his life after a two year struggle with Alzheimer’s disease. Graeme Wylie had repeatedly and clearly expressed his wish to die before the disease further eroded his cognition. He had made several unsuccessful suicide attempts and had applied to the Swiss euthanasia organization, Dignitas, for help in ending his life.

The court agreed that Wylie had wanted to die, but contended that this was not a case about euthanasia. Rather, the judge and jury insisted — and here is the Kafkaesque part — Wylie had wasted so much time with his failed suicide attempts and the application process for Dignitas, that is was no longer clear that he was mentally capable of making the decision to die.

This is the ultimate nightmare of the Alzheimer’s patient come true: the wish to live as long as life is meaningful and the fear that waiting until that moment will make it impossible to die with dignity. Who bears responsibility for this tragedy? Not Wylie, who wanted what most people would want. Not Justins, who knowingly risked her freedom to grant Wylie his last and greatest wish. We — the people of first world countries — bear responsibility, because it is our unwillingness to confront the reality of Alzheimer’s disease and our unwillingness to create options for dignified death, that drive people to the desperate measures that led to a jail sentence for a woman who acted out of love.

The case is replete with ironies. Wylie killed himself with a large dose of veterinary Nembutal, which is manufactured for the purpose of compassionately putting down dogs and horses in order to end their suffering. Justins was convincted for buying the Nembutal in Mexico. Her friend Caren Jenning, who had helped her purchase the medication, was tried and convicted along with her. Jenning, who was suffering from breast cancer, committed suicide by taking — you guessed it — a dose of Nembutal. Part of the impetus for the case was the anger of daughter Tania Shakespeare (that is her real name) that Justins had robbed her of the chance to say goodbye to her father, though it was not clear that Wylie wanted to say goodbye to her or wanted to tell her of his plans.

The facts of the case are not in dispute. According to the Associated Press:

Wylie, a former commercial airline pilot and the father of two daughters, was diagnosed with Alzheimer’s in March 2003. Over the next two years, according to the judge’s sentencing report, his mental faculties declined; he stopped reading newspapers and had difficulty making conversation.

By 2005, tests showed he had “severe cognitive impairment.” That September, he tried to cut his wrists, but survived.

That month, he told Justins he wanted to enlist the help of Dignitas, a Swiss organization that helps incurably ill people end their lives. It is legal in Switzerland for foreigners to travel to the country to commit assisted suicide, and dozens do so each year…

But Dignitas rejected Wylie’s application, saying it was unclear whether he had the cognitive ability to decide to die.

Wylie later tried to poison himself on lawnmower fumes, but again, survived. In March 2006, Justins handed him a lethal dose of a barbiturate and watched him drink it. She said he died within seconds.

And no one doubts Justins’ motive:

“I believe that generally the offender was caring and supportive of the deceased and compliant to his wishes,” Justice Howie wrote. “There is little doubt that he was genuine in seeking death through the Dignitas application.”

But, according to The Sydney Morning Herald:

[Justice Howie] expressed the need to denounce the killing which, as the “calculated and unlawful taking of human life, is an affront to … civilised society”.

The Supreme Court jury found Mr Wylie lacked the capacity at the time of his death to decide he wanted to die.

If Justins had not received any prison sentence, many in society would have seen her mere conviction “as a badge of honour”, Justice Howie said. “In this case there appears to be an attitude which found its expression in some of the media coverage … that somehow the conduct of the [women] was justified or at least of a different moral order than other criminal conduct that results in the loss of life.”

I, for one, am willing to go out on a limb and make the claim that the conduct of the women was justified, and was of a different moral order than other criminal conduct that results in the loss of life. By failing to offer Graeme Wylie any option to live as long as life was bearable and then to die in the way he wanted, society left him no other choice than to beg his partner for help.

Add cardiovascular disease to the long list of diseases and conditions for which vitamins have been touted, and then found to be ineffective. This week’s edition of the Journal of the American Medical Association (JAMA) contains the paper Vitamins E and C in the Prevention of Cardiovascular Disease in Men by Sesso, et al. According to the abstract:

The Physicians’ HealthStudy II was a randomized, double-blind, placebo-controlled factorial trial of vitamin E and vitamin C that began in 1997 and continued until its scheduled completion on August 31, 2007. There were 14 641 US male physicians enrolled, who were initially aged 50 years or older, including 754 men (5.1%) with prevalent cardiovascular disease at randomization…

Results  During a mean follow-up of 8 years, there were 1245 confirmed major cardiovascular events. Compared with placebo,vitamin E had no effect on the incidence of major cardiovascular events, as well as total myocardial infarction,total stroke, and cardiovascular mortality. There also was no significant effect ofvitamin C on major cardiovascular events, as well as total myocardial infarction, total stroke, and cardiovascular mortality. Neither vitamin E nor vitamin C had a significant effect on total mortality but vitamin E was associated with an increased risk of hemorrhagic stroke.

Conclusions  In this large, long-term trial of male physicians, neither vitamin E nor vitamin C supplementation reduced the risk of major cardiovascular events. These data provide no support for the use of these supplements for the prevention of cardiovascular disease in middle-aged and older men.

This new information is in line with other studies, which show that vitamins have no effect in improving disease incidence or disease related mortality, beyond treating vitamin deficiency. In the last few years, research has shown that vitamin supplements do not prevent the common cold, do not prevent cancer, and do not prevent Alzheimer’s disease.

This information should not be surprising when you consider what vitamins are and how they work. Vitamins are organic chemicals required for normal growth and development. They work primarily as “co-enzymes,” speeding up vital biochemical processes within the body. Each vitamin has a specific function or functions within the body, and deficiency of a particular vitamin produces a specific disease; for example, vitamin C deficiency leads to scurvy.

Vitamins in the body are like nails in a house. Without nails in all the right places, the house will fall down. However, once the requisite number of nails is in place, adding more nails will not improve the stability of the house. More nails will either do nothing, or in large enough amounts, will actually reduce stability. Similarly, without minimal amounts of each vitamin, the body will stop working properly. Once these minimal requirements are met, however, adding more vitamins will not improve the health of the body. In fact, in large amounts, many vitamins are toxic.

Of course you wouldn’t know that from the overstated claims of the supplement industry. Consumers spend over $20 billion dollars each year on supplements, including vitamins, and almost all of it is a waste. Beyond treating vitamin deficiency, vitamins do nothing to improve health. Herbs are even worse. In addition to be completely ineffective at treating anything (compared to standardized pharmaceutical preparations), they contain widely varying amounts of the purported active ingredients, many containing no active ingredients at all.

The supplement industry is well aware of this. That’s why they lobbied for, and obtained, exemption from FDA rules requiring demonstration of both efficacy and safety before medication can be approved. As the website Quackwatch explains:

Most people think that dietary supplements and herbs are closely regulated to ensure that they are safe, effective, and truthfully advertised. Nothing could be further from the truth…

In the early 1990s, Congress began considering two bills to greatly strengthen the ability of federal agencies to combat health frauds…

Alarmed by these developments, the health-food industry and its allies urged Congress to “preserve the consumer’s freedom to choose dietary supplements.” …

The end result was passage of DSHEA, which defined “dietary supplements” as a separate regulatory category and liberalized what information could be distributed by their sellers…

To date, virtually every touted benefit of vitamin supplements to prevent and cure disease, besides preventing vitamin deficiency, has turned out to be false. Beyond a daily multi-vitamin for people at risk of vitamin deficiency, there is no benefit to taking vitamin supplements.

Lost in the excitement about the impending election, an important alliance has been getting short shrift. Doctors have come to the aid of patients opposing big Pharma in a major Supreme Court case. Yesterday’s Supreme Court argument, Wyeth v. Levine, has the potential to dismantle existing consumer protections. Patients should be worried. Doctors are worried for their patients and themselves.

The legal issue is complex, but the case behind it is simple and tragic. Diana Levine, a professional guitarist, lost part of her arm when she received the right drug, in the wrong way. Ms. Levine received Phenergan by IV push (injected directly into the bloodstream to act fast) to counteract the nausea of severe migraines. Instead of injecting the drug into a vein, it was mistakenly injected into an artery, leading to gangrene and subsequent amputation of Ms. Levine’s lower arm.

There is no dispute about the central facts of the case. Ms. Levine did mistakenly received Phenergan into an artery; the health care provider made the mistake; it is well known that Phenergan (like all medications) should never be injected into an artery; Wyeth had labeled Phenergan with warnings, but no specific warning about the consequences of injecting Phenergan into an artery instead of a vein. Ms. Levine has already won a multimillion-dollar judgment in state court against the clinic where she was treated. Then she attempted to sue Wyeth in state court, claiming that the drug label should have warned specifically about the outcome of injecting Phenergan into the wrong place.

It is Wyeth’s defense that has catapulted the case into the national spotlight. Wyeth argues that it cannot be sued in state court for an error in labeling because the Federal government, through the FDA, had approved the label. Therefore, any claims in state court are preempted by Federal regulation. If the Supreme Court accepts this argument, the effect will be to shut down injury lawsuits, not just those against drugs, but also lawsuits against cars, household products, agricultural products and chemicals.

Patients, indeed all Americans, have a lot to lose if Wyeth wins. Doctors’ organizations have lined up squarely behind patients’ rights organizations. The New England Journal of Medicine has filed amicus curiae (friend of the court) briefs in support of Ms. Levine.

The New England Journal of Medicine explained its position in an editorial in the July 3^rd, 2008 edition:

…. If the drug manufacturer, Wyeth, prevails in a case soon to be argued before the U.S. Supreme Court (Wyeth v. Levine), drug companies could effectively be immunized against state-level tort litigation if their products that have been approved by the Food and Drug Administration (FDA) are later found to be defective…

Previous administrations and the FDA considered tort litigation to be an important part of an overall regulatory framework for drugs and devices; product-liability litigation by consumers was believed to complement the FDA’s regulatory actions and enhance patient safety…

But in the past few years, the government’s views have shifted, and the FDA has reversed its position, now claiming that common-law tort actions are preempted. The FDA argues that tort liability stifles innovation in product development and delays the approval process, and that lay juries are incapable of making determinations about product safety…

… Although frivolous lawsuits should not be condoned, product-liability litigation has unquestionably helped to remove unsafe products from the market and to prevent others from entering it… Preemption will thus result in drugs and devices that are less safe and will thereby undermine a national effort to improve patient safety.

The Journal of the American Medical Association (JAMA) has an editorial in the current edition supporting Ms. Levine and opposing preemption.

…the drug and device regulation process is at best an inexact and incomplete science. Until these deficiencies in the system are remedied, some patients inevitably will continue to experience harm from the use of newly marketed products as well as from use of other approved medications. … If the court rules in favor of Wyeth, endorsing preemption, patients will lose an irreplaceable method for seeking remedies for injuries resulting from pharmaceutical agents that were approved by FDA.

A paper in a previous edition of JAMA laid about the implications of this case for doctors:

Most physicians and patients learn about prescription drugs from publications of clinical trials or case reports, promotional materials or alert letters provided by pharmaceutical manufacturers, and formal documents such as the FDA approved label. These sources, however, sometimes provide a limited perspective on a drug’s benefits and risks…

In both the premarketing and postmarketing stages, lawsuits have helped uncover important and previously unavailable data about major adverse events…

Litigation has also helped the medical community reassess drugs by bringing to light new information about adverse effects…

The paper ends with a rousing, and surprising, endorsement of lawyers and lawsuits:

… [L]imiting legal involvement in the prescription drug arena is likely to increase the nation’s problem of poorly defined or inadequately presented drug risk information… [C]linical trials and routine regulatory oversight as currently practiced often fail to uncover important adverse effects for widely marketed products. In each instance, the litigation process revealed new data on the incidence of adverse events, enabled reassessments of drug risks through better evaluation of data, and influenced corporate and regulatory behavior. In performing these tasks, lawyers and their clients often find themselves serving as drug safety researchers of last resort.

 This case is about a lot more than one woman’s right to sue a drug company because of a drug induced injury. If the Supreme Court accepts Wyeth’s arguments that FDA approval means that drug companies cannot be sued for adverse effects of their drugs, doctors will be deprived of important information, and patients will be left at the mercy of big Pharma and their friends at the FDA.

The front page of today’s Washington Post blares a new and troubling finding, Teen Pregnancies Tied to TV Sex. According to the article:

Teenagers who watch a lot of television featuring flirting, necking, discussion of sex and sex scenes are much more likely than their peers to get pregnant or get a partner pregnant, according to the first study to directly link steamy programming to teen pregnancy.

The study, which tracked more than 700 12-to-17-year-olds for three years, found that those who viewed the most sexual content on TV were about twice as likely to be involved in a pregnancy as those who saw the least.

“Watching this kind of sexual content on television is a powerful factor in increasing the likelihood of a teen pregnancy,” said lead researcher Anita Chandra. “We found a strong association.” The study is being published today in Pediatrics, the journal of the American Academy of Pediatrics.

That claim sounded so improbable to me that I sought out a copy of the paper to read the full study. Does TV watching lead to teen pregnancy? No, and the authors of the study are irresponsible to suggest that it does.

What does the study show? Here’s how the authors of the study, Does Watching Sex on Television Predict Teen Pregnancy, describe their findings:

Data from a national longitudinal survey of teens (12–17 years of age, monitored to 15–20 years of age) were used to assess whether exposure to televised sexual content predicted subsequent pregnancy for girls or responsibility for pregnancy for boys… We measured experience of a teen pregnancy during a 3-year period.

RESULTS. Exposure to sexual content on television predicted teen pregnancy … Teens who were exposed to high levels of television sexual content (90th percentile) were twice as likely to experience a pregnancy in the subsequent 3 years, compared with those with lower levels of exposure (10th percentile).

CONCLUSIONS. This is the first study to demonstrate a prospective link between exposure to sexual content on television and the experience of a pregnancy before the age of 20. Limiting adolescent exposure to the sexual content on television and balancing portrayals of sex in the media with information about possible negative consequences might reduce the risk of teen pregnancy. Parents may be able to mitigate the influence of this sexual content by viewing with their children and discussing these depictions of sex.

The study suffers from so many problems that it is difficult to know where to begin. First of all, the study does not, indeed cannot, show that watching sexual content on TV leads to teen pregnancy. The study only looks at whether there is a correlation between sexual content of TV viewing and subsequent teen pregnancy. As anyone who has studied statistics knows, correlation is not the same thing as causation. Two independent events might appear to be correlated, but that does not mean that one caused the other.

For example, over the past 100 years, recreational use of marijuana among teens has increased dramatically. In the same time period, teen death from infectious disease has decreased equally dramatically. We could draw a graph and perform statistical analyses that show that increased marijuana use is associated with decreased death from infectious disease, but that does not mean that smoking marijuana protects teens from death. Simply demonstrating a correlation does not tell us anything about causation.

Even if the authors had shown a causal relationship between viewing sexual content on television and teen pregnancy, that would not tell us which was cause and which was effect. The authors claimed that viewing sexual content led to pregnancy, but it is equally likely being sexually active led teenagers to prefer sexual content compared to their sexually abstinent peer.

The study suffers from major technical problems. The study was based telephone interviews of teenagers and relied solely on their honesty, accuracy and recall; teenagers are not noted for their honesty, accuracy and recall. Three separate interviews were conducted at predetermined intervals over 3 years. More than ¼ of the participants dropped out of the study, and the authors simply ignored them. However, those who dropped out of the study might have differed in significant ways from those who remained in the study, and their absence may have led to erroneous findings.

Of the 1461 teens who remained in the study, 146 (fully 10%) refused to divulge whether they were sexually active. The authors simply ignored them. Of the remaining 1315 teens, 571 (43%, or almost half) were not sexually active at all. The authors simply ignored them, too. That is a very bizarre way to handle the data. At a minimum, the 571 teens who were not sexually active should have served as a control group for the sexually active group. How much sexual content did the abstinent teenagers watch? Was it the same amount as the sexually active teenagers? We don’t know, although the authors do know and chose to keep that information to themselves.

In the end, the authors looked at the television viewing habits of those teens who did not drop out of the study, were willing to divulge their sexual status, and claimed that they were sexually active. After eliminating those who refused to divulge whether or not they had been involved in a pregnancy, only 718 teens were left of an initial group of 2003 that had started the study. In other words, the authors only looked at 36% of study participants (all of whom were sexually active) and ignored the other 64% (including everyone who was not sexually active).

By deliberately excluding teens who were not sexually active, the authors severely damaged the credibility of their study. Unless they could show that abstinent teens were much less likely to watch sexual content on television, they cannot claim any relationship between television viewing and teen pregnancy. The fact that the authors deliberately left this data out of their study strongly suggests that it does not show that abstinent teens watch less sexual content on television. Indeed, I would not be surprised to find that the authors set out to investigate a connection between watching sexual content and likelihood of sexual activity, but found that there was no relationship at all. Instead, they were reduced to concocting a spurious relationship between sexual content on television and the likelihood of pregnancy among teens who were already sexually active.

Does watching sexual content on television lead to teen pregnancy? We don’t know, and this study certainly does not tell us.

What if pain in childbirth is an unnecessary remnant from human evolution?

Natural childbirth advocates often claim that the pain of childbirth brings a variety of benefits. Indeed, there are some who claim that the pain triggers a hormone cascade that is necessary for maternal infant bonding. Others insist that childbirth is not painful and is actually “ecstatic” and provides sexual pleasure. These varying theories hinge on the notion that the pain of childbirth adds something of value to the experience birth, and that the pain is good and beneficial. However, evidence derived from the study of ancient childbirth suggests that natural childbirth advocates have it precisely backwards. The pain of childbirth is not needed to trigger good things, it is vital to prevent maternal and neonatal death, and is a vestigial response that is no longer needed.

Before we consider ancient childbirth, it makes sense to think about the role of pain in the human body. Pain is almost always a sign that something is wrong, perhaps seriously wrong. Indeed, pain is so important to human survival that it can stimulate reflexive reactions. Put your hand on a hot object and you will actually begin pulling it away before you consciously feel the pain. That’s because there are nerve circuits in the spinal cord that allow you to unconsciously perceive the pain and pull away, skipping the step of consciously noticing the pain so as to save time and limit damage.

When you think about it, there is no instance in which pain is not designed to protect against damage. At the level of the skin, pain tells us what is safe to touch and what is dangerous. At the level of bone, the pain of a broken bone is so great that it forces immobility, and that probably helps the bone to heal properly. The pain of disease makes people search for ways to diminish the pain, and perhaps improve survival from the specific problem. So, at the most basic level, there is no reason to believe that the pain of labor is beneficial in and of itself. Unless labor pain is different from all other types of pain of human existence, labor pain exists to warn.

Human childbirth has existed in its present form for millions of years. During that time, the death rate of both mothers and infants was extraordinarily high. Evolution would certainly have favored strategies that lowered the risk of death. Perhaps labor pain, like all other forms of human pain, existed to warn women to seek assistance.

Seeking assistance in childbirth may have lowered infant mortality by having help in situations like breech birth (which usually cannot be accomplished without some manipulation of the baby’s body) and may have lowered the death rate from postpartum hemorrhage, because the assistant could massage a woman’s uterus after birth. Assistance in childbirth must be very important from an evolutionary perspective because anthrologists report that all human societies have birth attendants.

According to Karen Rosenberg (a paleoanthropologist who studies human birth) and Wenda Trevathan (a biological anthropologist and trained midwife) writing in Scientific American special edition, New Look At Human Evolution, 2003:

… [W]e suggest that natural selection long ago favored the behavior of seeking assistance during birth because such help compensated for these difficulties. Mothers probably did not seek assistance solely because they predicted the risk that childbirth poses, however. Pain, fear and anxiety more likely drove their desire for companionship and security.

Psychiatrists have argued that natural selection might have favored such emotions—also common during illness and injury—because they led individuals who experienced them to seek the protection of companions, which would have given them a better chance of surviving. The offspring of the survivors would then also have an enhanced tendency to experience such emotions during times of pain or disease. Taking into consideration the evolutionary advantage that fear and anxiety impart, it is no surprise that women commonly experience these emotions during labor and delivery.

It would be quite ironic for natural childbirth advocacy if the role of pain in labor was to alert women to the inherently dangerous nature of childbirth, so they would seek assistance. It would also mean that labor pain has outlived its usefulness. Far from being beneficial, labor pain may turn out to have only harmful effects.

Baroness Warnock, a leading British medical ethicist, has publicly asked a question that many people, philosophers and lay people, have been pondering privately: “Is there a duty to die?”

Solidifying her reputation as a “philosopher provocateur”, Lady Warnock, a long time advocate of euthanasia, whose previous work has included investigations of fertility treatments, and special education for disabled students, dares to say what has previously been unspeakable. According to an interview earlier this month in the Times Online:

“If you’re demented, you’re wasting people’s lives – your family’s lives – and you’re wasting the resources of the National Health Service,” she said.

“I’m fully in agreement with the argument that if pain is insufferable, then someone should be given help to die, but I feel there’s a wider argument that if somebody desperately wants to die because they’re a burden to their family, or the State, then I think they, too, should be allowed to die.”

No one could accuse her of being reticent. The Baroness elaborates:

“With 700,000 people suffering, it really is a problem that has got to be faced. The fact is we have to take a fairly unsentimental view. Care may get better, but if so, at huge cost. There’s no point saying we ought to spend more, because we can’t.

“People talk about it as if the only respectable motive for wanting to die is for your own sake. But it seems to me just as respectable to want to die partly for the sake of others, and for the sake of society.”

The Baroness gets to the heart of the matter and does not flinch:

“If society has an obligation to look after them, I really want to know what for? For whose benefit? It’s not for the benefit of society, as the person is not in a position to contribute, and it’s not for the benefit of the person, so it must be something abstract about our being unable to bear saying ‘We can’t do this any longer’.

“If I were in a state of acute misery or pain, or an insufferable degree of dependency, I don’t see why I should feel an obligation to others to let them keep on changing my nappies.

“It sounds very callous, but most people I know dread being kept alive in a state of mental incapacity, more than cancer or anything else. If so, then I don’t see why society should force them to go through with something they fear the most.”

Not surprisingly, Lady Warnock’s comments have ignited controversy. Her comments have been vehemently criticized by Alzheimer’s associations, Right-to-Life groups, and politicians.

I do not agree with the Baroness’ claim that there may be a moral duty to die, but I think she is asking the right questions about the way that the senile elderly are being kept alive at tremendous cost, both financially, and also psychologically, to family members and care givers. She puts is quite succinctly:  “If society has an obligation to look after them, I really want to know what for?”

We need to ask ourselves the same question in the US. Does anyone benefit from our perverse insistence on indefinitely extending the lives of the senile elderly? Are we fulfilling the wishes of the elderly people involved? Would they want to be kept alive, incapacitated, incontinent, and incapable of participating in the most basic tasks or social interactions? It’s difficult to imagine that anyone would want that.

And if we are not keeping these people alive for their own benefit, are we doing it to satisfy ourselves of our own moral values as a society? If so, do we have any right to use other people in an effort to make ourselves feel better?

Does it make any sense to spend a major proportion of the healthcare budget on people who are virtually insensate and will never recover? Does it make any sense, financially or morally, to divert resources from young people, who may not even have access to the healthcare system, to elderly people who have already received a lifetime’s worth of benefits from that same system?

There are no easy answers to these questions, but Baroness Warnock has done a service in raising them. It is long past the time where we should examine the rarely examined principle that the lives of the senile elderly should be extended indefinitely by the continuous use of vast amounts of human and financial resources. The Baroness has gotten to the heart of the matter: “For whose benefit?”