Anyone with a heart can understand Lisa and Jack Nash’s desperate desire to do something — anything — that could save their daughter’s life. Six-year-old Molly suffers from Fanconi anemia, a deadly, genetic immune-system disorder, and a bone-marrow transplant from a matching donor is her only chance for survival. Doctors at the Reproductive Genetics Institute, a reproductive technology clinic in Chicago, told the Denver couple that the most effective method for finding a match was to have another baby, whose umbilical cord could then be harvested for the vital stem cells that Molly needed. So that’s what the Nashes decided to do.
It’s how they did it that has raised eyebrows. When Adam was born Aug. 29, doctors at the institute knew two things beyond a doubt: that he didn’t carry the Fanconi anemia gene and that he was a perfect genetic match with his sister. They knew because Adam — or rather, the embryo that became Adam — was selected as the most compatible potential donor from among several eggs fertilized in vitro specifically for this unusual embryo “competition.” Doctors at the University of Minnesota performed the bone-marrow cell transplant on Molly last month. The outcome remains uncertain, but the procedure has a good chance of providing her with a functioning immune system.
This is not the first time parents have had a baby under such circumstances. A decade ago, Mary Ayala of Walnut, Calif., bore a second child in hopes of saving the life of her teenage daughter, Anissa, who suffered from chronic myelogenous leukemia. The case drew widespread media attention and sparked a heated debate about the ethics of the Ayalas’ decision. Today, however, both Anissa and her younger sister, Marissa, appear to be healthy and happy, and they say they share an unusual bond. “If it wasn’t for her, I wouldn’t be here,” Anissa said in a recent interview with the Daily News of Los Angeles. “And if it wasn’t for me, she wouldn’t be here, either.”
Since then, dozens of other families have conceived babies as potential donors for older siblings. But those decisions seem tame when compared with the Nash case, which is believed to be the first in which several embryos have been harvested solely in an effort to choose the best match.
Is the successful search for a satisfactory embryo simply a glorious medical miracle or does it move us dangerously close to a morally questionable realm of genetically designed children? Dr. Joel Frader, a pediatrician at Children’s Memorial Hospital in Chicago and professor of pediatrics and medical ethics at Northwestern Medical School, spoke with Salon about this latest step toward customized kids.
What are your initial impressions about the Nash case?
It’s interesting because if you look at this particular case it’s hard to identify anything that you could clearly describe as a wrong or harmful to anyone. Some people could claim that the embryos not used were harmed, but we’re only talking about groups of eight cells. It’s clear that Baby Adam hasn’t been harmed. I think one has to assume — and I see no reason to believe otherwise — that Baby Adam is going to be loved and cherished in his family, maybe even more, especially if the transfusion works. Decisions to have babies are usually fairly complicated decisions. Among the legitimate reasons to have babies, to help others is not a bad decision.
Is it common for families to bear a second child to save the elder sibling?
We don’t have a lot of good data about it. It certainly isn’t precedent-setting here, as the Ayala case can attest. In fact, there are several companies that are now responsible for harvesting and storing cord blood from normal babies. What happens in these cases is that the obstetrician collects the blood and umbilical cord and then it’s stored. The parents then pay an annual storage fee, and can use it when needed. This may be a resource for others needing a stem cell transplant.
What are the chances Molly Nash’s life will be saved by this procedure?
If you take 100 similar cases, if the siblings are genetically matched, in 80 or 85 out of those 100 cases the bone marrow will establish itself successfully. Now, if a child is born without genetic testing and preselection, there is a 1-in-5 chance that the two siblings will have the same genetic markers. If the markers aren’t the same, the chances of a successful transfusion are about 30 in 100 cases. But we don’t have much research, so it’s hard to say exactly what Molly’s chances are — it will either work for her or it won’t.
There are medical ethicists who argue this case is a harbinger of genetically engineered babies, and that the concept of preselecting desirable traits can be troublesome. Do you agree?
I object to the wholesale use of the term “genetically engineered baby.” One is taking advantage of what is there naturally. They aren’t manipulating anything, they are selecting what is most desirable. The reaction seems to be that this is easy to do, and it’s not: It’s expensive and horribly inconvenient for the woman to have her eggs harvested. You would have to give a woman drugs to induce a ripening of a bunch of eggs at once and then the woman would have to have the eggs removed laproscopically and then you have to go into the laboratory and use the father’s sperm and the eggs that you’ve collected. Then you would have to make a bunch of embryos which you then test. This is not something women are going to do casually. It’s not something you just go and do in the bedroom at night. And I don’t envision it getting much easier in the near future.
The important distinction to make here is this: What happens in each case? Is there any reason to see harm or wrong? Can we distinguish that from situations where people have less compelling reasons to have a baby? Obviously, having a blond, 7-foot baby who will become a great basketball player isn’t the same thing as the Nash case. It somehow diminishes persons generally, because it doesn’t cherish what would happen naturally. That is troublesome.
What is it about this technology that makes us uncomfortable? Like you said, many people have children for much worse reasons …
We are uncomfortable about the practices in China and India about more boys surviving infancy than girls; or the selective abortion of female fetuses or their infanticide once they are born. We do worry that there is a tendency among people to select for characteristics of children that sometimes seem undesirable or wrong. And this technology opens up the possibility of specifying what we want. There ought to be a difference between ordering from the menu and cherishing that which nature provides.
I think it would not be good for humankind if we were to get to the point of ordering up designer babies based upon our preferences of the characteristics. There is something morally troublesome about that. The question is: Can we as human beings exercise good judgment and say, “We’re not going to do that”?
Do you think we, as a society, will be able to exercise that discretion?
At each point, we have an opportunity to exercise human judgment about how we are going to use available technologies and we don’t always do the wrong thing. We’ve had atomic weapons available for 50 years now and they have been used once — during World War II. There are a lot of things that we don’t employ on a regular basis.
How close are we to having custom-order technology?
I think we are a long way from ordering from the menu — eye color, hair color, body habitus, intelligence, temperament and so on. The important question is how soon will the Human Genome Project reveal information we can use in this way? Within a few years, we will know what each gene is, but it’s many years between having the distinct genes isolated and knowing what each of those genes do. And it’s even more years away from using that genetic information in order to create children that are going to have specific characteristics.
Should we draft policies or laws to curb the more questionable medical technologies?
We don’t have good mechanisms and procedures allowing us to evaluate these cases and we definitely need them. This is far too important to be left up to doctors individually. This should be a matter of policy. It touches upon two areas that provoke much debate: One is the area of reproductive freedom. The other issue is really important, which is that we want to have an atmosphere in society where we respect differences, where we cherish all children who are born regardless of abilities or disabilities that they might have, and what we worry about is situations where we have babies being born because of the characteristics they have. It smacks of slavery and skin color concerns. And it should be discussed.
It’s probably a good idea to avoid specific laws that govern particular medical practices because the world changes and the law has difficulty keeping up. And the law is typically a fairly blunt instrument and doesn’t adapt well to nuances in medical practice.
As you said, parents have kids for all different reasons. Is there a difference between having these kids to save a child’s life or to weed out an embryo that may grow up to have a serious disease?
People are using this technology to avoid having children with diseases. Technology allows us to see the baby that would result with the continued growth of that embryo; if that embryo would have Tay-Sachs disease or cystic fibrosis or some other disease that would entail substantial suffering for the baby. Many people are using this technology in this way already. That doesn’t involve the additional motivation of helping their family member. I don’t see a moral objection to avoid having children with serious diseases.
Why?
Some people object to this destroying of the embryo. They believe it is somehow harmful to those entities, those bundles of cells. I don’t buy that. I don’t believe an eight-cell entity deserves protections. If you identify that the embryo has a serious disease, I have no moral qualms to not use that embryo and permit it to go on to be a baby. Once you have a baby, it seems to me that it’s a whole different circumstance and one has different kinds of obligations toward that live, born baby.
What kind of message does that send to people who have serious diseases or mental disorders?
That’s a claim the disability rights community has been making. I understand it, but I don’t think it makes sense. Because as a parent to choose to not have a cluster of eight cells develop into a particular child with a gene disorder, it doesn’t mean that I won’t be entirely respectful and supportive of people who are born with that problem. I don’t think it’s a necessarily logical question.
Tom battled for years to control his obsessive sexual attraction to teenage boys. It eventually landed him in court for stalking.
“It’s kind of like if you have a big sweet craving, when you think about it all the time,” he says. “I would hang around with teenagers and then things would happen.”
The 47-year-old, who asked not to be identified, isn’t the typical picture of a sex offender. Thoughtful and articulate, he lives with his wife and together they’ve made a commitment to work through his sexual deviance. And so far, he’s proud to report, they’re succeeding. Why? A drug called Lupron gets at least partial credit. The drug decreases testosterone, the hormone that fuels the sex drive. Tom’s desire for intercourse is almost nil now — but along with it has also largely gone the lust for adolescent boys.
“It’s a big help,” he says. “I would be OK without it because I’m committed to working on this deviant behavior, but it would be a lot harder. It would take a tremendous amount of will power.”
Lupron is one of the latest in a series of drugs, called antiandrogens, that trigger a reduction in the production of testosterone. Most commonly used to treat men with prostate cancer — like New York Mayor Rudolph Giuliani — and women with endometriosis, it also serves as a “chemical castration” to treat sex offenders.
In late August the new chemical castration drug surfaced in the news during the professional hearings of sex addict and former family practitioner Dr. Joseph Campanella. He had admitted to more than 200 improper sexual liaisons with members of his office staff, hospital employees, patients and homosexual strangers over the past 18 years. His license was finally suspended in January after he was caught masturbating in front of a church bus. When Campanella went before a Chicago medical disciplinary board, he claimed that he had already been “cured” and was ready to return to his medical practice.
His treatment? Six weeks of therapy and Lupron.
Campanella’s claims that Lupron can catalyze a quick-fix cure for sexual deviants has raised many questions about the use and efficacy of chemical castration drugs and the very essence of sexual deviance itself. The theory behind Lupron is that reduced sex drive results in a greater ability to control deviant sexual urges, but can flipping a testosterone-laden switch really turn off deviant sexual thoughts? Don’t sexual predators and pedophiles prey on vulnerable people and children in part out of a psychological desire to dominate or inflict pain? Can we really transform a person’s ethical system though tinkering with their chemistry? Is immorality in the end a treatable physical disability?
Most medical researchers would argue that sex offenders aren’t “cured” by such a quick-fix solution. They maintain that Lupron is just one part of a complete and complex treatment regimen. But still some clinicians wax enthusiastic about its ability to transform the dangerous but well-meaning perv into an upstanding citizen.
“It’s a wonderful drug,” says Dr. Gabrielle Paladino, a psychiatrist who works in a treatment program for convicted sex offenders at California’s Atascadero State Hospital. “It’s great to see that someone who can’t keep their hands off people is able to control those urges.”
Other doctors, however, remain skeptical of such ringing endorsements. “There are so many misconceptions about Lupron and other drugs like it,” says Dr. Fred Berlin, associate professor and founder of the Johns Hopkins Sexual Disorder Clinic. “Some people respond well to it, others don’t. Each sex offender is different.”
Lupron differs from Depo-Provera, another common antiandrogen, used primarily as a form of birth control for women. Instead of releasing a form of progesterone into the body as Depo-Provera does, Lupron works directly on the brain. By tripping up the hormone in the brain that signals to the pituitary gland to produce estrogen in women and testosterone in men, it has a generalized desexualizing effect.
“In a sense, you can say the sexual drive for both men and women begins in the brain with GnRH [gonadotropin-releasing hormone], which starts working at puberty,” says Dr. Richard Spark, associate professor at Harvard University and author of the book “Sexual Health for Men.”
Studies in Europe and the United States have shown that castration, whether chemical or the old-fashioned surgical kind, does tend to lower recidivism rates among sex offenders, Berlin says. In a report published two years ago in the New England Journal of Medicine, Israeli researchers found that all men studied responded with a decreased number of sexual fantasies and deviant sexual acts when treated with a combination of therapy and triptorelin, a Lupron-like clone medication. Though, interestingly, they noted a lag time of 10 to 11 months between the physical reduction of testosterone levels and reduction of sexual thoughts.
Still, even doctors who’ve had good results with Lupron don’t believe it can help those with violent tendencies. “Of course, some sex offenders don’t need much in the way of testosterone to offend,” says Paladino. “Many of these people have problems in their head, not their genitals.”
Paladino and Berlin deal with patients on different ends of the clinical spectrum. Paladino’s clients are convicted sex offenders identified before the end of their prison term as “sexually violent predators” who must receive treatment before being released, while Berlin generally deals with clients on an outpatient basis, who generally exhibit less extreme pathologies. Still, they’ve both noticed improvements in some of their patients who take Lupron.
“I’ve treated many men who took it and it helps them,” says Berlin. “But I would never recommend using it strictly on its own. It’s not like throwing a switch, it’s more subtle … when I’m hungry, for example, I’m thinking obsessively about food. But absence of hunger is not a presence, and therefore it’s hard to measure. But certainly, with an absence of hunger, I’m less likely to eat.”
Paladino says Lupron works for different reasons on different types of offenders. “It’s a very effective treatment for a psychopath, for example, as an external control or monitor … But for other patients who are tormented by sexual thoughts, Lupron is a godsend. I have a guy who drops his pants in front of female police officers in the hospital. He just can’t help himself on his own.”
Regardless of the effectiveness and understanding of the proper use of Lupron and other testosterone-lowering drugs, the political reaction to castration ranges wildly from horror to blind faith. In 1996, convicted sex offender Larry Don McQuay actually begged for the state of Texas to castrate him before he was released. (State officials refused to perform either a surgical or chemical castration). The same year, California passed a law mandating that certain types of convicted sex offenders on parole be required to take a Depo-Provera injection.
“I’d call myself a moderate,” says Berlin. “I think no one should be forced to take any of these drugs, but certainly, the drugs should be made available to those who want it.”
Tom, one of Berlin’s patients, says he couldn’t maintain his ordinary married life without Lupron. And despite the fact that he’s suffered the drug’s worst side effects — flushing, bone mass density problems and lowered sex drive — he’s become one of Lupron’s biggest fans.
He concedes that his use of Lupron has caused certain problems in his marriage. “I can just barely have sex with my wife,” he says. But, he quickly adds, being free from deviant sexual thoughts is worth whatever sacrifices they have to make. “In a strange way,” he muses, “you could actually say it’s brought us closer.”
Continue Reading
Close
Probably no one knows better than the Bush family about the importance of appearing healthy during an election campaign.
In 1992, President Bush’s reelection bid began badly when he vomited and collapsed in Japan at a dinner party thrown by the country’s prime minister. From then on, the campaign was dogged with mostly unconfirmed rumors of his ill health. It was speculated, for example, that atrial fibrillation medications he took were affecting his mental acuity. What else would explain his pallid and lackluster performance at debates and appearances, particularly compared to the robust physical health and voracious appetite exuded by opponent Bill Clinton? The Bush campaign headquarters vigorously denied every ill health charge but it didn’t change the fact that it wasn’t only the economy that was ailing — it was also Bush’s physical image. His election results were equally anemic.
So when Dick Cheney was officially announced as George W. Bush’s running mate this week, campaign managers went to great lengths to show that Cheney was physically fit. A highly credentialed cardiologist tapped by the Bush family gave the 59-year-old former defense secretary a clean bill of health — despite a medical history that includes three previous heart attacks and quadruple bypass surgery more than a decade ago.
The basis for this medical pronouncement seems thin at best. Denton Cooley, chief surgeon at the Texas Heart Institute, based his assessment not on an actual examination of Cheney but on a review of his records and a telephone call to his cardiologist, Jonathan Reiner, whom Cooley reported as saying: “Mr. Cheney is in good health with normal cardiac function.”
Reiner then gently countered that no one who has had three heart attacks has completely “normal” cardiac function — that is, the three heart attacks had left Cheney with permanent damage to the heart.
So how sick is Cheney? It’s confusing, as Wednesday’s New York Times story on the subject attests. The lead cheerily announces that Cheney is in “excellent health,” then goes on to state that he takes “many drugs for heart disease and other medical conditions.” The laundry list that follows is pretty daunting: besides heart disease, the doctor had him treated for a number of other ailments (including many for which he continues to take medication), from gout to skin cancer to a potentially fatal allergic reaction to pomegranates to metabolic disorders.
Of course, it’s quite possible that Cheney could be relatively unaffected by his past heart troubles. Certainly quantum leaps in the treatment of heart disease, the nation’s No. 1 killer, have dramatically improved the quality of life of those diagnosed, even after surgery. A greater understanding of the disease and what signifies its recurrence also allows doctors to more closely monitor a person’s condition.
Controlling the diet, regular exercise, quitting smoking and taking medication — all things that Cheney practices, according to his doctor — can change the lives of heart disease sufferers profoundly, doctors say.
“The perception is that people who suffer heart disease are not capable of fully functioning,” says Dr. Lynn Smaha, a cardiologist and the past president of the American Heart Association. “But many people go on to live fully productive lives after surgery.”
But campaigns are highly stressful affairs. Earlier this year, New York Mayor Rudy Giuliani was forced to drop out of a high-profile Senate race against first lady Hillary Clinton because of his fight with prostate cancer. And Bill Bradley, who unsuccessfully sought the Democratic presidential nomination, canceled several public appearances because of his irregular heartbeat, a much less serious condition than Cheney’s heart troubles.
“Campaigns are kind of like the first year of law school or med school,” says Kevin Sweeney, who served as press secretary for presidential hopeful Gary Hart’s two attempts to win the presidency. “You are primarily motivated by a fear of failure. If you lose by a close margin, you can spend hours thinking ‘If I had only made a few more phone calls, it might have made a difference.’”
Admittedly, top candidates don’t go through the same rigors as their staff. “I was pulling an average of two all-nighters a week,” says Sweeney. “Gary didn’t do that. The top person works the least. He has to be fresh.”
But back-to-back late night interviews and early morning shows, constant travel and the anxiety of participating in public debates and other functions can take their toll on a presidential candidate, Sweeney said.
Most doctors can’t directly answer the question of how a presidential campaign might affect someone who has heart disease. They do point to other high-stress professions that have loosened their attitude toward heart disease sufferers in recent years: It used to be that airline pilots were permanently grounded at the first sign of heart problems, says Smaha. These days, as long as pilots pass various stress tests, some are allowed to fly again even after surgery.
“That’s an interesting question,” says Dr. Marc Gerdisch, a cardio-surgeon and spokesman of the American College of Cardiology. “It depends on the individual and how they deal with stress. Some stress is good stress. If you love what you are doing, it can be a motivator. If you hate it, that’s a totally different kind of stress.”
Regardless of how well Cheney deals with his stress, it’s highly unlikely the public would hear about any serious health problems even if they did occur. Though it isn’t always rational, human beings associate health inextricably with goodness and strength. The image a powerful leader must have is of good health.
Politicians and their handlers know this, and so political machines often go to great lengths both to bolster images of good health and to downplay illness in the public eye. Why else would Chinese President Jiang Zemin take a widely publicized dip in Hawaiian waters during his landmark 1997 tour of the U.S.? It was widely understood that his hour-long breast stroke was a symbolic attempt to silence rumors that the septuagenarian had heart disease and had experienced a heart attack on his U.S.-bound flight. Jiang’s predecessors, Mao Zedong and Deng Xiaoping, also performed well-timed public swims as a way of putting their physical health on display and to bolster various policy moves. At the onset of Mao’s disastrous cultural revolution in 1966, for example, he swam against the tide in the Yangtze River.
Are such displays of athleticism just a quirk of the East? No way. When seeking the Democratic nomination for the presidency, Paul Tsongas employed the same technique to counter worries about his ailing health. Slick television spots showed him doing laps in a swimming pool.
Predictably, when the health of Mao and Deng began to fail, it took years for any official government pronouncements to acknowledge the facts. By the same token, when the Soviet Union’s Boris Yeltsin began to exhibit enough erratic and unhealthy signs to fill a medical dictionary, the Kremlin constantly soft-pedaled the Russian leader’s physical state. The aftermath of a heart attack he suffered during his successful 1996 reelection campaign was characterized simply as “colossal weariness” until he finally confessed to having undergone heart surgery.
Foreign leaders aren’t the only ones with image-makers eager to gloss over their ill health. Let’s not forget that the many signs that President Reagan’s Alzheimer’s was diagnosed while he was still in office, though he didn’t announce it until 1994, long after his two terms were finished.
Is it better for the politician to fess up when feeling under the weather or maintain face for as long as possible? Given the relentless speculation that most candidates are subject to, it’s not hard to understand why politicians will do whatever they can to maintain some vestige of medical privacy.
On the other hand, in our democracy, there’s at least a presumption that the citizenry should be able to freely elect representatives whose bodies and minds can withstand the excruciating trials of public life. Besides, once there’s even a hint of ill health, it becomes a matter of public debate and no amount of doctorly spin can prevent rumors from spreading.
Could George Bush have stemmed the tide of opinion in 1992 regardless of what information he released about his health? It’s unlikely. And his son’s new running mate, Cheney, may face a similar challenge.
The question is no longer will we see Dick run, but can he run? In answer to this question, don’t be surprised if he suddenly is seen cheerfully jogging in a 10K race.
Continue Reading
Close
The two young women sitting in a Seattle bar one Saturday night are living, breathing examples of modern thinking regarding birth control. In their early to mid-20s, both live with boyfriends they may or may not marry, and both have taken oral contraceptives for years. One of them even took the “morning-after” pill when she was in college. They are savvy, intelligent professionals who are unquestionably pro-choice on the abortion issue.
Yet neither of them is particularly in favor of making birth control pills available without a doctor’s prescription.
“The Pill doesn’t affect everyone the same way,” says one. “What if it made you sick? What if women didn’t go in to get their Pap smears and annual checkups?”
The other nods. “When I took the morning-after pill, it was really, really harsh,” she says. “I’m not sure I would have wanted to go through that alone.”
Their opinions are reflective of the strange debate — or nondebate — surrounding the Food and Drug Administration’s most recent open discussion about whether oral contraceptives, including the morning-after pill, should be available over the counter.
Birth control pills have been available in the U.S. for decades, but only by prescription. Emergency contraceptives — large doses of the Pill that can prevent pregnancy if taken within 72 hours of conception — became legally available more recently. In some parts of the country, like Washington and Oregon, pharmacists are trained and licensed to prescribe emergency contraceptives at the pharmacy, making them effectively an over-the-counter product.
The potential benefits of making the Pill available without a prescription are obvious, though untested: Such a move would increase access and thus reduce unwanted pregnancies, as well as eliminate the hassle of getting prescriptions refilled. While insurance carriers would probably stop covering contraceptives, an open market might force drug makers to lower prices.
“It would be an interesting experiment,” muses Elizabeth Nyman-McHugh, a physician assistant who has worked in clinics serving low-income clientele and the director of health services at Evergreen State College in Olympia, Wash. “In general, the Pill is pretty safe and easy to take. My perspective comes from promoting population control, and anything we can do to reduce unwanted pregnancies is a good idea and is good for public health.”
But in the face of the increasingly pervasive use of oral contraceptives, the debate seems to have swung away from the right to use them toward the safety of using them. At a series of public hearings held at the end of June, birth control was probably the least contentious item in a list of prescription drugs the FDA is exploring making over the counter, from anti-allergy drug Claritin to cholesterol-lowering medications. That’s no easy feat for reproductive rights issues, which usually mobilize the pro-life and pro-choice movements into polemical stances.
“I was appalled, really appalled,” says Judie Brown, president of the American Life League and the only national pro-life organization to testify against over-the-counter oral contraceptives at the FDA hearings. “I would have expected much more … from the pro-life movement.”
The biggest disappointment to Brown? That the National Right to Life Committee, the largest pro-life organization in the country, has backed away from the debate entirely.
“For us, the birth control pill is completely a nonissue,” says Laura Echevarria, an NRLC spokeswoman. “We don’t consider using birth control an abortion.”
Not only have the major pro-life groups, aside from the ALL, largely stayed out of the fray, but the pro-choice groups that testified chose to champion the cause only of emergency contraception, ignoring the birth control pill question. Indeed, pro-choice heavy hitter Planned Parenthood has yet to weigh in with an argument at all — and a spokeswoman for the group says not to expect one for a while.
“There is a difference between the two,” says Elizabeth Arndorfer, senior staff attorney with the National Abortion and Reproductive Rights Action League, one the nation’s most active pro-choice lobbying groups. “Or rather, they are used differently. Using emergency contraception is a one-time thing that many recent studies have shown to be effective. But there are contraindications for some women using the birth control pill long term. It may be better for a doctor to keep an eye on it.”
While the FDA’s consideration of over-the-counter status for most of the other drugs on the list stems from petitions submitted by drug manufacturers or health insurers, no major interests have demanded the same review of birth control pills or emergency contraception. “The FDA process is to wait for petitions from drug or insurance companies,” says an FDA spokesperson. The federal agency might make a request for petitions if it perceived a proven health need or there was a public outcry, but without such interest, it’s unlikely the issue of nonprescription birth control pills will go much further.
So how exactly did birth control pills get added to the list? It’s “an issue that’s been raised over the years, more likely in the form of discussions,” says an FDA spokeswoman. “The FDA meets with many, many different groups all the time, so it has come up.”
And what little back-and-forth there has been on the subject has focused solely on emergency contraception. NARAL and other pro-choice groups firmly support making the morning-after pill truly over the counter, though again in a reactive and not a proactive way. “We and other organizations saw the opportunity to promote the most recent research on emergency contraceptives, and so we jumped on it,” said NARAL’s Arndorfer of the public hearings. “We do feel it’s an important issue.”
The main opposition consists of ALL and the Roman Catholic Church, which views emergency contraception as akin to abortion. Representatives of the National Conference of Catholic Bishops, a major church lobbying group in Washington, didn’t attend the FDA hearings, but it will probably file an opinion before the chance for public comment is closed at the end of August.
Although the Catholic Church has traditionally been viewed as a foe of birth control pills, the method of their dispensation — whether over the counter or by prescription — is an issue modern ecumenicals consider only on a “theological and philosophical” level, says NCCB spokeswoman Helen Alvari.
“That cat is long out of the bag,” says Alvari with a laugh. “We try to tell people to think about what they are doing … but there isn’t the widespread movement to oppose the birth control pill … It’s legal, so we don’t argue over it.”
Whether pharmacy shelves will ever carry birth control pills next to aspirin is unclear. But if that does occur, the two young Seattle women will probably adjust to it as quickly as society adjusted to the idea of a birth control pill in the first place.
Continue Reading
Close
When the Federal Trade Commission publicly reprimanded the makers of Vaseline for falsely claiming that slathering on their “antibacterial” hand lotion would kill all germs — from flu viruses to bacteria — it seemed as though the government was finally cracking down on the booming germ-therapy industry.
“They were saying that if you put this stuff on you, you’d somehow be protected, that the germs would die on contact,” says Kerry O’Brien, the FTC staff attorney who researched the case, which was made public in September. “That was deceptive to consumers.”
Evidence is mounting that the increasingly popular over-the-counter antibacterial cleaners, soaps, lotions and sprays may not, as touted, kill bacteria and other microbes any better than washing with hot water and soap. Indeed, some research suggests such products may do more harm than good by creating resistance in the very microbes those antibacterial agents claim to kill.
The American Medical Association is the latest to jump on the bandwagon and question the health value of antibacterial household goods. The meaty report the AMA released last week detailed the research available, then urged the U.S. Food and Drug Administration to tighten its control over these products. Even with all the controversy around antibacterials and the force of the largest professional doctors organization in the U.S. pushing for regulations, why is it that more than 700 new antibacterial goods have flooded the market in the past few years? And what exactly is being done to regulate this booming industry?
The answer is not much. And until more research is available, not even the AMA is advocating any dramatic regulatory moves.
“In the best-case scenario, we’d want the public to be discussing this issue with their doctor, and making an informed medical decision about when to use antibacterial products,” says Robert Mills, an AMA spokesman. “We should be slaves to science. The best thing that could possibly happen is that this information leads to more research on the subject.”
False germ-killing claims are only the tip of the antibacterial iceberg. Scientists are looking at the meteoric rise in immune disorders such as asthma, allergies, Crohn’s disease and multiple sclerosis in industrialized countries and wondering: Are we making ourselves ill by banishing all germs? A theory called the hygiene hypothesis suggests that in our germ-phobic culture, the obsession to destroy all bacteria, microbes and other small nasties might also rid us of the necessary microorganisms needed to properly stimulate the immune system. It’s a new idea and has yet to be proved, but it’s gaining credibility among scientists, particularly among those concerned that germs not wiped out by antibacterial cleaners will come back meaner and stronger.
“Antibacterials have been developed to prevent the transmission of disease from one patient to another in a hospital setting and they are becoming more necessary as we move patients from the hospital to the home,” says Dr. Stuart Levy, director of the Center for Adaptation Genetics and Drug Resistance at Tufts University School of Medicine. “But there is no place for them in a healthy household.”
Part of the issue is that in our market economy, government regulators are loath to pull products off the shelves, choosing instead to focus on education and consumer choice. There is, for example, nothing healthy about cigarettes, but they are still sold, the packaging plastered with statements acknowledging that smoking them could lead to death.
So it shouldn’t be surprising that the FDA reports it is “monitoring the situation closely,” but has no set time frame for finalizing the rules about household antibacterial products, which have been in the works for years.
While the FDA has warned several companies by letter against making false claims — most notably Bristol-Myers Squibb’s Keri antibacterial solution and Jergens’ antibacterial antiseptic lotion — it didn’t go so far as to yank the products from store shelves. The evidence just isn’t convincing enough that these products are dangerous, says a spokesman.
The FTC’s big case against Unilever’s Vaseline Intensive Care antibacterial lotion, in which the New York company was forced to pull advertising — though not the product — was probably the most public action taken by the U.S. government against a maker of antibacterial products. The Vaseline case is also the only major antibacterial case the FTC has pursued, or at least the only one that has been reported to the public.
“I can’t confirm or deny whether the FTC is investigating any other companies now,” says O’Brien.
Besides the fact that the company’s claims did not stand up to scientific scrutiny, Vaseline Intensive Care’s main antibacterial agent, triclosan, had been shown not to work against the viruses, O’Brien said. But she doesn’t think that information warranted pulling the products from the shelves.
“I’m no scientist,” said O’Brien. “But the evidence was only in the beginning stages. I think in some cases, antibacterials are a good thing.”
The AMA is in agreement with her: Last week’s report says clinical settings where patients with low immunities reside, whether in the home or the hospital, are still considered appropriate locations to use antibacterial cleaners.
Continuous everyday use, on the other hand, is not such a good idea. More recent studies highlight another concern about triclosan, also commonly used as an antibacterial agent in both hospitals and over-the-counter household products. In lab environments, microbes are developing a resistance to triclosan and other antibacterial agents, a trend the AMA report calls “troubling” — particularly if those microbes also prove resistant to therapeutic antibiotic treatments.
“Granted it’s just a laboratory experiment at this stage. But if it can be done in a lab, it can possibly be reproduced in the home,” says Tufts’ Levy, whose lab pioneered the triclosan-resistance studies. “Like the message we give with antibiotics, the same thing goes with antibacterials. To waste them on healthy households means there is great potential to create new microbes in the home which can fight off antibacterial agents when you need them most, that is, when a sick person is present with low immunity.”
Furthermore, Unilever isn’t the only company making false claims about antibacterial products, according to the AMA report. Data gathered from 11 companies also uncovered unsubstantiated claims, according to the Association for Professionals in Infection Control and Epidemiology, a nonprofit research institute in Washington.
But even so, the AMA is careful to say that not enough research has been conducted to justify a full-scale ban on such products. The report itself reflects the AMA’s ambivalence, emphasizing that it “does not say that the use of antimicrobials in consumer products is a significant reason for antibiotic resistance … [But it] does state that such use may be a potential source of antibiotic resistant organisms.” Later, the report adds, “Considering the available data, it may be prudent to avoid the use of antimicrobial agents in consumer products.”
This lack of conclusive data is what the FDA says is the hardest thing about pursuing antibacterial regulations. “In 1997, our advisory board decided there wasn’t a health hazard yet, but there was a theoretical threat, so we decided to keep an eye on it,” says an FDA spokesman. “The evaluation is ongoing, but right now we don’t have enough evidence — though we are watching it.”
One of the strongest proponents for final FDA regulations comes from one of the new players in the antibacterial market.
“The FDA regulations are long overdue,” says David Moll, president of International Laboratory Technology Corp. in Florida, which markets a new antibacterial product called Pure and Clean. He accuses most antibacterials being sold as “not meeting the standards and not passing the tests” set out either by their own claims or by those in the open FDA regulations.
Moll contends Pure and Clean, made not from triclosan but from an ammonium compound of the same stuff that makes up swimming pool chlorine, is “the only product out there that kills all germs for four hours. But I can’t compete, because I don’t have $20 million to market my product.” He claims his company spent 10 years and millions of dollars making sure his product passed all tests in the existing FDA temporary regulations.
Moll isn’t in favor of pulling products from the shelves and he scoffs at the hygiene hypothesis, contending that the right product will kill every germ. “We don’t have to test our product for resistance because we kill everything on contact,” he brags.
But even some of those who may not be looking for tighter regulation of these products think the public should at least be educated about the potential dangers. In the current issue of Consumer Reports, an article on antibacterial cleaning products urged against the “scorched-earth housecleaning” method of sterilizing everything, saving antibacterial products only for “specific, high-risk situations.”
“It’s pretty normal for the institutions to take a while to catch on,” says Levy. “I went through this with antibiotic overuse in the late 1970s. You have to build a foundation of people to say, ‘Hey, we don’t need these products.’”
And that may mean starting with one person at a time, reteaching something we all learned in kindergarten: If you play in the dirt, before sitting down to dinner, wash your hands.
Continue Reading
Close