There’s a serial killer on the loose, a killer of libidos. No it’s not stress, or overwork, or even relationship difficulties, though all have been implicated in the deaths of desire. This killer is a commonly prescribed medication: Prozac and its cousins the SSRIs.

Consider:

A 35-year-old woman was referred by her therapist for an evaluation of her sadness, irritability, fatigue, and poor concentration despite cognitive behavior therapy. She was happily married and had a fulfilling, enjoyable sex life. She was diagnosed as suffering from depression, and treatment with Prozac was started. At a follow-up visit, she reported complete relief of her depression and irritability. However, she complained about marital problems. Detailed questioning revealed a lack of sexual desire and difficulty in achieving orgasm. It was apparent that the dysfunction was related to the treatment with Prozac. (adapted from Balon, SSRI Associated Sexual Dysfunction)

Stories like these are repeated over and over again in therapists’ offices, or worse, not repeated but kept secret by patients who are embarrassed. And these stories are more common than previously thought. In a 2007 article, Depression, Antidepressants and Human Sexuality, Balon reported that sexual side effects of a class of antidepressants known as SSRIs (selective serotonin re-uptake inhibitors, like Prozac, Zoloft and Paxil) impact anywhere from 30% to 70% of people who take these medications. It is particularly unfortunately that these side effects are often not shared with physicians, because there are ways to prevent, minimize and treat sexual side effects.

Why is it so difficult to pin down exactly how many people are affected by side effects of SSRIs? Part of the problem is that depression itself has many sexual side effects. Approximately 70% of people suffering from depression report some impairment of sexual functioning, particularly loss of libido. Assessing the sexual side effects of SSRIs is further complicated by the fact that many patients have additional medical conditions that effect sexuality or take non-psychiatric medications that can impair sexual functioning.

Nonetheless, years of experience with SSRIs have made it plain that they can and often do cause sexual side effects. Interestingly, the main reason why sexual side effects have risen to the fore in connection with SSRIs is because older antidepressants had many more serious side effects that overshadowed the effects on sexuality. Paradoxically, newer medications with fewer side effects have raised the relative importance of sexual side effects.

What are the sexual side effects of SSRIs? According to Sexual Dysfunction Associated with Antidepressant Therapy:

The major side effect is anorgasmia or delayed orgasm, which seems to occur in 30% to 40% of patients depending on the threshold set for the diagnosis. Clinicians have used this side effect to treat premature ejaculation. These problems usually occur within 1 to 2 weeks of starting the agent and well before the antidepressant effect is evident… Problems with decreased libido and erectile impairment occur less frequently, perhaps in approximately 20% and 10% of patients, respectively

Not all SSRIs are equally likely to cause sexual side effects.

Controlled clinical trials and large prospective clinical series have established that the SSRIs … as a class, are all are associated with sexual dysfunction. There is some evidence that paroxetine has a higher rate of sexual dysfunction than the other SSRIs and that fluvoxamine may have a lower rate of sexual dysfunction …

… Antidepressants with a low incidence of sexual side effects are … Bupropion, Nefazodone, Mirtazapine, [and] Duloxetine.

This variability in the frequency of sexual side effects suggests ways to prevent and treat sexual side effects. To prevent sexual side effects, patients can be started on SSRIs that have a lower incidence of side effects. In the event that side effects develop, switching to a different SSRI may solve the problem.

There are many other strategies for dealing with sexual side effects, including:

          Waiting for the side effect to resolve spontaneously

          Scheduling sexual activity around dosing of the medication

          Temporarily going off the medication

          Adding medications that counteract the sexual side effects of SSRIs (e.g. Wellbutrin)

What do people taking, or contemplating taking SSRIs need to know? First, it is important to be aware, even before starting treatment, that SSRIs can and often do have sexual side effects. Second, it is critical to bring up the issue of side effects with your physician, both before starting treatment, and if any symptoms develop. Third, if the medication is helping with depression, don’t stop treatment because of sexual side effects; they can often be minimized or cured by strategies like those mentioned above. Fourth, if side effects do develop, you can share information with your partner that the side effects are due to the medication and not the relationship itself.

The search is on for newer SSRIs that have fewer or no sexual side effects. In the meantime, for those who need them, SSRIs can be literally life saving. Many sexual side effects can be prevented, minimized or treated, so no one has to choose between a sex life and a life free of depression.

In an ongoing effort to keep readers apprised of the latest, the most interesting, and most unusual stories in medicine, I have come across a medical procedure that fits all three criteria. In addition, this is undoubtedly the grossest medical procedure ever.

Be warned! If you are squeamish, do not read any farther. I say this with a certain amount of authority; I have spent many years immersed to the elbows in people’s internal organs, and covered in bodily fluids, but I was shocked by this. Even the name of the procedure is repulsive, but it is a real procedure that has been successful in treating a very serious problem. What is it?

Fecal transplant … (yes, it’s just what you think it is).

Before we get to the mechanics of the procedure, a digression is in order to explain the disease it is designed to treat. The problem is also unpleasant, but a serious, and growing, danger to our health. The technical name is Clostridium difficile enteritis, but is more commonly known as C. diff infection.

C. diff bacteria are everywhere in our environment, and many of us carry it in our intestines. Normally, it is kept in control by the many other forms of bacteria that reside in our gut. However, when a person takes powerful antibiotics, the majority of bacteria in the gut may be killed off. This allows the C. diff bacteria, which are hardier, to overgrow and produce large amounts of a toxin that inflames the intestines. In effect, this is similar to what happens to many women when they take antibiotics and end up with a yeast infection. The antibiotics kill the normal bacteria of the genital tract, allowing the yeast to take over and cause an infection. Yeast infections, while very unpleasant, are usually not dangerous. C. diff, on the other hand, can be very serious.

Some cases of C. diff infection are mild, causing diarrhea and abdominal cramping. But new strains of C. diff are emerging that produce more powerful toxins and can cause severe, even deadly illness. A severe infection with C. diff can lead to profuse diarrhea, severe abdominal pain, fever and debilitating illness. That’s what happened to Vicki Doriot, profiled in and MSNBC article about the new procedure:

“When those toxins are in your body, you kind of feel like you’re close to death,” said Doriott, 52, an accountant from Eau Claire, Wis., who spent nearly six months battling recurrent bouts of the nasty intestinal bug known as C. diff…

“At its worst, I’d have diarrhea every 15 minutes,” recalled Doriott. “I’d be going for two or three days. I’d have a 103-degree fever. I couldn’t make it two steps from the couch.”

C. diff is caused by powerful antibiotics, but it can be cure by other, equally powerful antibiotics. Unfortunately, a new dimension of C. diff disease has emerged: drug resistant C. diff. Up to 20% of new case of C. diff illness are caused by drug resistant bacteria. There has been some success in treating drug resistant C. diff by using newer antibiotics, but there remain some patients who cannot be cured with antibiotics.

Since C. diff infection is invariably the result of antibiotic treatment that destroys the normal bacteria of the intestines, some scientists and doctors have reasoned that restoring the normal bacteria could allow the body to heal itself. Yet it is not as simple as isolating one or two different kinds of bacteria to use for replacement. It is the complex interaction and interrelationship between many different kinds of bacteria that prevents the overgrowth of C. diff. And where can you find a combination of the right bacteria in just the right proportions? You guessed it … in the gut of someone who does not have a C. diff infection.

That’s how they hit upon the idea of a “fecal transplant.” Not surprisingly, only those patients who are desperately ill are willing to try fecal transplant. That’s what happened to Doriott:

After months of exhaustion and illness, Doriott became desperate enough to consider the fecal transplants she’d heard about through research…

Typically, patients ask a close household member, usually a spouse, to produce a sample of stool, which is tested for disease and infection. In Doriott’s case, her husband, Jerry, 50, a civil engineer, was on tap.

On the day of the transplant, donors provide the feces, which is blended and filtered. A tube is fed through the patient’s nose into the stomach and several teaspoons of the sample are injected through it.

“I refused to look at it,” said Doriott. “All I felt was a coolness. It didn’t smell.”

Doriott said she felt better immediately and hasn’t suffered a C. diff relapse since the treatment…

There have been enough patients willing to undergo the procedure that a formal study has been published:

A 2003 case study of 18 patients who received fecal transplants found that two patients who were very ill died shortly after transplant. But of the remaining 16 patients, only one developed C. diff again, according to the study published in the Journal of Clinical Infectious Diseases.

The use of fecal transplant is reminiscent in some ways to the early treatment of other serious illness. Before insulin was identified as the missing component in diabetes, scientists showed that an extract from ground up pancreas was able to cure diabetes in dogs. Eventually, insulin was isolated from the extract, and that became the standard treatment.

Ultimately, doctors and scientists will probably be able to determine the most important intestinal bacteria that need to be replaced in order to treat C. diff infection, and fecal transplant will be replaced by biotherapy with bacteria grown in sterile culture. Until then, though, this primitive form of biotherapy will have to do. It may be gross, but it is a literally life saving therapy, based on sound biologic reasoning, that allows a body to ultimately heal itself.

 Mothering is marked by transcendent moments. I’ve had those moments while nursing my infants, watching my children in school plays and sports, and looking on proudly as they crossed the stage for graduations. This, however, is not about those moments. This is about teaching children the facts of life.

As a gynecologist, I always vowed that I would not subject my children to agricultural theories of human reproduction. None of that “daddy plants a seed” stuff for us. I planned on anatomically correct, age appropriate, completely truthful answers to any questions about sex. Each of my children learned where babies come from as soon as they asked, and each child got some version of “the talk.”

There were occasional complications; one child received his “talk” in a car at highway speeds. He was so embarrassed by the entire issue of sex that he always ran away when I attempted to discuss it. Only by giving him no option of escape could I make sure he learned the basics.

I was also motivated by my experiences as a practicing gynecologist. I have seen first hand the results of the mistruths, half truths and outright lies that pass for “information” among teens. The staggering toll of this misinformation is measured in unplanned pregnancy and sexually transmitted disease. Often teens lack basic information because no one ever bothered to tell them the truth about sex, about birth control or about protecting themselves.

Whenever I talked about sex with my young children, I had the best of intentions. So why did I often end up answering completely unanticipated questions while struggling desperately not to laugh?

***

While cooking dinner one evening, I was approached by the youngest of my four children. She asked, “Mommy, do you remember all four times you had sex?” I tried to look thoughtful while biting the inside of my cheek in an effort to avoid laughing.

“Actually,” I said, I’ve had sex more than four times.”

Her eyes widened. “Why would anyone do that?”

“Sex is not only for making a baby,” I explained. “Most of the time people have sex because they enjoy sex itself.

She thought for a bit and made a face. “Really? I can’t imagine why.”

***

I wasn’t the only one to have awkward moments. When one son related misinformation he learned from friends at school, my husband pulled out the children’s book “Where do I Come From?” He sat the two youngest children down to read it with him. The book contains excellent explanations that made it clear to my son that what he had heard at school couldn’t possibly be correct. My husband was very proud of how he had handled the situation … or he was until “the question.”

Our son, an angelic boy of eight at the time had a big smile on his face. “I understand now,” he said happily. “I just have one question.”

Pointing to his little sister, he asked: “Can she and I practice this at home, so we’ll know what to do when we get married?”

***

My favorite story, though, is not my story at all. It was told to me by two friends, both physicians, who shared the philosophy that sex should be described truthfully in an anatomically correct way. They carefully planned the “talk” with their youngest daughter and were pleased at how well it had gone. She, too, appeared to understand, and she, too, had only one question.

“I just want to know,” she declared, “how after the man takes off his penis and puts it in the woman to make a baby, how does he stick it back on his body?”

Last May, our small town was roiled by what, for us, was a scandal of major proportions. A new and attractive high school teacher checked her cellphone to find a message from a student. The student was known as a practical joker, but that did not prepare the teacher for what she found: a sexually explicit photo of the student accompanied by a text message that seemed menacing.

The teacher was so frightened that she approached the local police and requested a restraining order against the student. Once that process was put in motion, the high school was forced to act in accordance with legal guidelines. The student, popular and accomplished, was suspended from school and prohibited from attending graduation, planned for the following week. In addition, the college he was planning to attend was notified, as well as the scholarship committees that had awarded him scholarships. Those scholarships were promptly withdrawn.

The student had a defense; he couldn’t have done it because he had lost his cellphone several weeks before during a trip down South. It contained nude photos he had taken of himself to send to his girlfriend. Whoever had retrieved the phone had sent those photos to his contact list. Why had the teacher’s number been in the student’s phone? He had an answer for that, too. He was the president of a school club and the teacher was the faculty advisor. She had given him the phone number to discuss club matters.

Many parents found the explanation absurd. “Who keeps nude photos of themselves on their cellphones? I asked my college age children. “Lots of people,” was the response. That’s how I learned about sexting.

According to the study, Sex and Tech, released today by The National Campaign to Prevent Teen and Unplanned Pregnancy in collaboration with Cosmogirl.com:

One in five teen girls (22%)—and 11% of teen girls ages 13-16 years old—say they have electronically sent, or posted online, nude or semi-nude images of themselves…

Teen girls are not the only ones sharing sexually explicit content. Almost one in five teen boys (18%) say they have sent or posted nude/semi nude images of themselves. One-third (33%) of young adults—36% of women and 31% of men ages 20-26—say they have sent or posted such images. 

Teens are notorious for their poor judgment, and one reason for this deficiency is the inability to perceive both short and long term consequences of their actions. According to a local Virginia ABC affiliate:

The risque game has very real consequences. “The phones these days are like very good so they can just like send it to the Internet and they can put it on MySpace and other people can save it so it’s like all over the place,” said a seventh grader… 

The kids said very often it starts as a girlfriend sending a boyfriend a picture, but then they break up, he shows a friend and it quickly gets forwarded around…

Who could have seen that coming?

The long term consequences can be even more severe. According to an article in today’s Boston Globe:

Two cheerleaders near Seattle were suspended recently when nude pictures of them spread through their school via cellphone, and last week a Wisconsin teenager was charged with exposing a child to harmful material for showing classmates nude cellphone pictures of his former girlfriend and other girls. At least 10 students were suspended from a Michigan high school in October for spreading a nude cellphone picture of a classmate.

In Salem, principal William Hagen did not discipline any students involved, but warned that future infractions would carry sanctions…

“We educated the kids about the long-term and short-term consequences,” Hagen said. “Once they’re posted electronically, they’re out there forever. They’re available to colleges and universities. They’re available to employers…”

In addition, it’s a felony for children under 18 to receive sexually explicit pictures on their phone, and taking sexually pictures and sending them could lead to charges of pornography production and distribution.

The Sex and Tech campaign has published a list of “5 things to think about before pressing ‘send’.”

1.      Don’t assume anything you send or post is going to remain private.

2.      There is no changing your mind in cyberspace— anything you send or post will never truly go away.

3.      Don’t give in to the pressure to do something that makes you uncomfortable, even in cyberspace.

4.      Consider the recipient’s reaction.

5.      Nothing is truly anonymous.

The resolution of our high school’s sexting incident was sobering. The boy’s family hired a lawyer who obtained the phone company records for the day in question. The call had originated down South several weeks after his phone had been reported stolen, just as the boy had claimed. The principal wrote a public letter of apology to the student; his college was informed and his scholarships were reinstated.

Despite the apparently successful conclusion, there has been a legacy of bitterness. Friends of the student lashed out at the teacher, claiming that she overreacted. The teacher felt that the school had not provided her with support during her ordeal. The student was left angry, embarrassed and in possession of large legal bills.

Sexting exists at the intersection of poor teen judgment, sex and technology. These days, that’s a dangerous place to be.

 In these difficult economic times, it is not surprising that many people are scavenging the basement for goods to sell on E-bay. Most people don’t realize that there are valuable (and renewable) personal possessions available for sale closer to hand: their own cells.

A market for blood components, such as plasma, has long existed because the need is so high. Recently, however, new cellular products have become far more lucrative. These are sperm, and, especially, eggs (ova).  An article on MSNBC highlights the rise in inquiries about paid donation:

…Seeking quick cash in a tanking financial market, would-be sellers of a variety of body products — sperm, eggs, blood plasma, even human hair — are filling waiting rooms and swamping agencies with inquiries.

Increasingly, industry officials say people are hoping to trade spare body fluids, tissues and other parts for payments that can range from $20 to $50 a pop for blood plasma to $60 to $100 for a shot of sperm, $200 for a shiny ponytail and up to $7,000 for a fertile egg.

At the Seattle Sperm Bank alone, donor applications have tripled from 50 to 150 a month during this financially precarious autumn, staff members said, while officials at egg donation agencies from Chicago to Houston estimate that calls are up at least 30 percent over last year.

Organizations that pay for donations insist that donors aren’t motivated by money, or at least not motivated solely by money:

…Christine Kuhinka, a spokeswoman for ZLB Plasma, which operates 66 centers across the country, said she believes more donors are being motivated by altruism.

“There are many reasons to donate plasma,” she said. “At the end of the day, most people recognize that they’re saving lives.”

But blood industry experts said it’s disingenuous to claim that compensated plasma isn’t tied to a faltering economy.

“I am confident that paid plasma increases in tough economic times as a direct result of the economy, and would love to see the data used by plasma companies that says it is not,” said Dr. Louis M. Katz, executive vice president of the Mississippi Valley Regional Blood Center in Davenport, Iowa.

The opportunity to donate plasma, sperm and eggs in exchange for financial compensation highlights an ethical paradox in US healthcare. While sale of cells for money is allowed, sale of organs is strictly prohibited. According to Payment for donor kidneys: Pros and cons by Friedman and Friedman:

…The National Organ Transplant Act states: ‘It shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration for use in human transplantation if the transfer affects interstate commerce.’ Punishment includes fines up to $50,000 and/or 5 years in prison, but has not been meted out. A year after enactment of National Organ Transplant Act, the Ethics Committee of the Transplantation Society issued a supporting Policy Statement: ‘No transplant surgeon/team shall be involved directly or indirectly in the buying or selling of organs/tissues or in any transplant activity aimed at commercial gain to himself/herself or an associated hospital or institute.’

A variety of ethical principles are invoked to justify this ban, even though it may inadvertently sentence to death many people in need of replacement organs. Thousands die each year for lack of people who donate for altruistic reasons during life or after death. Opponents of paid organ donation argue that compensating people for their own organs violates the principle, articulated by the philosopher Immanuel Kant, of intrinsic human dignity. More prosaically, opponents point out that the need to donate for cash will not fall equally on all members of society. The poor and the socially marginized will be under much greater pressure to donate for financial reasons than other members of society.

Other countries do not share the illogical combination of policies favored by the United States. Canada bans financial compensation for all donations, organs and cells. At the opposite end of the spectrum, many countries pay only lip service to legal bans on organ donation. India, China and Russia, among others, have thriving trades in replacement organs.

In the US, we are even inconsistent about our inconsistency. While donation of eggs (ova) for use by infertile couples is generously compensated, donation of eggs for stem cell research is typically not compensated at all. Partly this is the result of the controversial nature of stem cell research under the Bush administration. However, it also reflects our ambivalence about the various uses of donor cells. The creation of human embryos to treat infertility is viewed very differently than the creation of human embryos for use in research.

Can selling cells be ethically justified within a system that bans selling of organs? Without financial compensation, the supply of donor sperm will drop precipitously, and the supply of donor eggs will likely disappear altogether. Yet that is hardly as disastrous an outcome and the thousands of deaths resulting from a ban on selling organs.

Art Caplan, director of the Center for Bioethics at the University of Pennsylvania, knows where he stands:

“The uptick [in donation for money] gives lie to the system that invokes ‘donors’ when it’s really a system of ‘sellers,’”…

“Altruistic motivation isn’t going up,” he added. “The drive to get paid is going up.”

Caplan worries most about donation of genetic material such as sperm and eggs. People who need cash may not be truthful about their medical background, for instance. Or they might be so desperate for money, they don’t think through the potential for physical and emotional complications.

“In economic hard times, if somebody went out to sell a baby, there would be moral contempt,” he said. “But if you sell the ingredients for a baby — and the oven — we don’t pay attention.”

There was a scandal in my small town several years ago when a respected couple was arrested for hosting an alcohol soaked party for middle school students at their home. I don’t remember the details, but I do remember the parents’ defense. They claimed that young teens were going to use alcohol anyway; therefore, it was better if parents provided it and supervised its use.

I was reminded of that case by a controversial commentary, Toward responsible use of cognitive-enhancing drugs by the healthy, published yesterday in the scientific journal Nature. The opinion piece is sure to provoke a firestorm of protest. The authors argue that everyone, healthy people included, should have easy access to cognition-enhancing drugs like Ritalin because, in the words of author Martha J. Farah, “Almost everybody is going to want to use it.” Indeed, the use of Ritalin and other stimulants by healthy college students ranges from 4% to as high as 25% on some campuses. According to Farah, “It’s a felony, but it’s being done.”

This piece makes no sense to me. The authors publish a call for universal access to brain stimulants in the absence of sound scientific research, in the absence of evidence that this is a problem worthy of societal attention, and based on an inane defense that it should be allowed because people are going to use them illegally any way. As Leigh Turner of the University of Minnesota Center for Bioethics said, when asked to evaluate the commentary: “It’s a nice puff piece for selling medications for people who don’t have an illness of any kind,” Turner said.

What does the piece say?

Today, on university campuses around the world, students are striking deals to buy and sell prescription drugs such as Adderall and Ritalin — not to get high, but to get higher grades, to provide an edge over their fellow students or to increase in some measurable way their capacity for learning. These transactions are crimes in the United States, punishable by prison…

 In this article, we propose actions that will help society accept the benefits of enhancement, given appropriate research and evolved regulation. Prescription drugs are regulated as such not for their enhancing properties but primarily for considerations of safety and potential abuse. Still, cognitive enhancement has much to offer individuals and society, and a proper societal response will involve making enhancements available while managing their risks.

In the opening paragraphs, the authors make several bizarre claims. In addition to the claim that everyone is doing it, the authors insist that cognitive enhancement offers many benefits, and that the only role of regulation is safety. Therefore, we, as a society, should figure out how to provide these “benefits” in a safe manner, while presumably decriminalizing the trade of these drugs by individuals.

Drugs like Ritalin have been used successfully to treat attention deficit disorder with and without hyperactivity (ADD/ADHD). There are also reports of therapeutic benefits in cognition in patients with brain tumors, strokes and traumatic brain injuries. However, when it comes to the use of stimulants among healthy young adults, there is surprisingly little scientific information available.

In discussing safety, the authors mention three issues, long term risks, pressure to self medicate, and fairness, but, surprisingly fail to discuss the most important issue, the fact that stimulants like Ritalin are drugs of abuse. We do not have a clear idea of the long term effects of using Ritalin. The information we have at present suggest that stimulants can be safe for long term use in therapeutic settings, allowing us to balance the known benefits of stimulants in therapeutic settings against the unknown, though probably small risks.

There is no reason to assume that the same calculus applies to using stimulants in healthy individuals. Consider a different class of drugs that may offer a useful parallel, opiates. Opiates are extremely beneficial in a therapeutic setting, and although they have both short and long term risks, those risks are usually justified by the benefits. When opiates are used in non-therapeutic situations, to create a “high,” the benefit risk calculus is very different. The “benefit” is not necessarily beneficial, and the long term risk of addiction is far greater. Stimulants, like opiates, are known to be drugs of abuse and addiction even in therapeutic settings. It is quite possible that they are more likely to lead to abuse and addiction when used by healthy people.

The authors devote far more attention to ethical issues of fairness than to the currently more pressing issues of benefits and risk. Their answers to their own ethical questions are hardly better than the inadequate answers to the empirical issue of safety.

Addressing the issue of the morality of using cognitive-enhancing drugs, the authors say:

Human ingenuity has given us means of enhancing our brains through inventions such as written language, printing and the Internet…The drugs just reviewed, along with newer technologies such as brain stimulation and prosthetic brain chips, should be viewed in the same general category as education, good health habits, and information technology — ways that our uniquely innovative species tries to improve itself.

Are these people serious? Brain stimulation and prosthetic brain chips should be viewed in the same category as education? That is a claim that begs for ethical justification and the authors don’t bother to provide any. Blithely assuming that their claim is self-evident, they proceed to two other ethical concerns.

The authors clearly assume that stimulants for cognitition-enhancement in healthy people can and will be widely available. However, they are concerned that when that great day comes, some people will be left out, either because they don’t wish to self-medicate or because they can’t pay for the drugs.

Those concerns are, not surprisingly, similar to issues raised by performance enhancing drugs in sports. If everyone is using steroids, what happens to those who refuse to self-medicate with steroids or can’t afford steroids? Interestingly, we, as a society, have not chosen to make steroid use legal in athletics, nor are we insisting that athletes must use steroids, and we are not offering free steroids to promising high school athletic stars. Nonetheless, this is the direction that the authors of the commentary are pushing us toward in regard to stimulant use.

Who wrote this commentary, and how did it get published in the prestigious and highly respected journal Nature? Of the seven authors, two are consultants for drug companies and one is an editor of Nature. The other four claim to have no conflicts of interest. However, it is a matter of public record that some of their affiliated institutions have financial relationships with drug companies.

At a minimum, it is distressing that Nature has published an article where three of the authors have a clear conflict of interest, including one of their own editors. I want to emphasize that I have no information that the other four authors have any financial ties to the pharmaceutical industry. However, in light of multiple scandals in which authors of papers in both The New England Journal of Medicine and The Journal of the American Medical Association (JAMA) were subsequently revealed to have concealed financial ties to industry, I can only hope that the editors of Nature did more than simply take the authors’ word on potential conflicts of interest.

This commentary is inexplicable. There is no good science to back up its assertions; it ignores the principle risk of drug abuse; and it encourages us to take action on an issue that should be very far down our agenda. And like the parents who were arrested for providing alcohol to minors, its principle justification is that everyone is going to do it anyway. That’s not even a remotely reasonable defense for providing alcohol to minors, and it is not a remotely reasonable defense for providing cognitive-enhancing stimulants to healthy people

Imagine finding that in your e-mail in box. If sex educator Deb Levine, and Dr. Jeffrey D. Klausner have their way, that will be increasingly likely to happen. Levine and Klausner have created an innovative campaign to make it easier to find the partners of people with sexually transmitted diseases. Levine, Klausner and colleagues have recently published a scientific paper detailing their experience with e-mail notification for sexually transmitted diseases (STDs).

Mandated state reporting of STDs has existed for decades. Mandated reporting was instituted because STDs are easily transmitted, often produce no symptoms in those who are infected, and can cause long term health problems when undiagnosed. The mandated reporting puts the state in charge of making sure that partners are notified and come in for treatment. Doctors are required to report all cases of certain STDs that they diagnose.

The e-mail innovation is a response to rising rates of casual sex, when partners may know nothing more than a first name and e-mail address of a sexual contact. According to MSNBC:

The service is the creation of Deb Levine, a sex educator and author of a book called The Joy of Cybersex, and of Dr. Jeffrey D. Klausner, director of STD Prevention and Control Services for the San Francisco Department of Public Health.

“In 2001 I noticed a big rise in the number of syphilis cases among gay men,” recalls Klausner. “In 1998 it was about five cases. By 2001 we had 150 cases.”

Klausner set out to discover why the rate jumped and learned that men had begun meeting each other online for casual encounters. Those encounters may be anonymous, but usually involve an exchange of e-mails. “That turned on a light for me and I realized we needed to do something online.”

He tracked down Levine … and the two created ISIS, a non-profit community organization to put sexual health information online. One of their first projects was the e-mail notification system.

The service is called inSPOT:

More than 750 people visit the inSPOT site daily. Since 2004, the service has sent more than 49,500 e-cards. Syphilis and gonorrhea cases have each accounted for approximately 15 percent of the total cards sent, followed by chlamydia at 11.6 percent and HIV at 9.3 percent. More than half a dozen other diseases account for the rest, including crabs and scabies; hepatitis A, B and C and trichomoniasis, a parasitic STD.

How does it work? In October, the online journal PLOS Medicine published the paper inSPOT: The First Online Partner Notification System Using Electronic Postcards, detailing the system and the results.

On the rationale for the system:

In the United States there are 19 million new sexually transmitted disease (STD) cases diagnosed each year, including 900,000 reported cases of chlamydia, 330,000 reported cases of gonorrhea, and 55,400 estimated new HIV infections per year. Notifying sexual partners of their potential exposure to an STD has been a mainstay of disease prevention and control since the 1930s…

Traditionally, partner notification has been done in person, by phone, or by mail, with the assistance of a public health investigator. The high number of cases … makes partner notification for all named partners impractical in many jurisdictions. Particularly among gay men and other men who have sex with men (G/MSM), who tend to have higher numbers of partners, online notification may be an effective strategy to increase partner notification.

E-mail notification is sent by the infected person, because he or she often has nothing other than an e-mail address to identify the partner, and therefore cannot identify the partner for state reporting efforts:

… inSPOT is very simple. The two sections are Tell Them and Get Checked. In Tell Them, users follow this path:

·         Choose one of six e-cards,

·         Type in recipients’ e-mail addresses (up to six),

·         Select an STD from a pull-down menu,

·         Type in own e-mail address or send anonymously,

·         Type in an optional personal message.

When an e-card is clicked on by the recipient, users are linked to a page with disease-specific information.

The Get Checked section is divided into STD information, a map of local testing sites, and links to online resources. To ensure the privacy of the user, no database to store e-mail addresses or information about e-card senders or recipients exists.

Since its 2004 launch in San Francisco, inSPOT has been replicated in three countries, ten cities, and nine states…

How well does inSPOT work? The authors are extremely enthusiastic, but, in truth, the results are quite modest:

…[W]e analyzed rates at which e-card recipients clicked a link embedded in the card that connected to STD test site information. Annual “click-through” rates ranged from 20.4% in Los Angeles to 48.2% in Idaho, with an average across all sites of 26.8% in 2006 and 28.5% in 2007. During the period that inSPOT has been active, from December 2005 through February 2008, 29,137 people accessed STD testing information as a result of receiving an e-card…

Only one quarter to one half of recipients clicked through to the information about getting tested for the disease to which they were exposed. There is no information about what proportion actually got tested. Accessing the information does not mean that the recipient got tested, and not clicking through to the information does not preclude the possibility that the recipient sought testing through a private doctor. However, when you consider that none of the recipients could have been notified any other way, even small testing rates are encouraging.

The inSPOT notification system is a high tech response to a distinctly high tech modern problem. The internet has created an unprecedented opportunity for soliciting casual sexual encounters. This has contributed to an increase in sexually transmitted diseases, and an increasingly inability to identify sexual contacts of an infected person. It is fitting that the technology used to fuel the increase is also being used to limit its negative impact.

Some think that the inSPOT e-mails are already outmoded. E-mail is increasingly a tool of older people; teens and young adults have moved on to text messaging. According to Mary McFarlane, a behavioral scientist with the Division of STD Prevention at the Centers for Disease Control and Prevention in Atlanta:

“More and more people are going with mobile phone technology” to facilitate casual hookups she says. “I think it is very important that we in public health pay attention to these innovations and provide health information in those places.”

No doubt a text messaging service is on its way. In the near future, people may retrieve their text messages to find:

Wlcm! Yv gt syphilis!

 A paper by Dr. Mark Heaney and colleagues published in the October issue of Cancer Research revealed a startling finding. When leukemia and lymphoma cells were exposed in the lab to dehydroascorbic acid, they were less likely to be killed by chemotherapy. Cells that had been exposed to dehydroascorbic acid were better able to survive treatment with doxorubicin, cisplatin, vincristine,methotrexate, or imatinib, five widely prescribed chemotherapy agents that act in a number of different ways.

Why should the average person care about this study? This study provides a valuable warning to cancer patients because dehydroascorbic acid is vitamin C.

In interviews, the authors were careful to point out that this is lab research taking place in petri dishes, not clinical research done in humans. However, the findings are disturbing in light of the fact that many cancer patients take vitamin C supplements. Rather than boosting the immune system, vitamin C supplements may actually boost the cancer cells.

As recently as August of this year, alternative health practitioners like Joseph Mercola, were touting high dose vitamin C supplements as highly effective against cancer. At this moment, many alternative health websites still recommend vitamin C supplements as “treatment” against cancer. The “theory” is that vitamin C, an antioxidant, interferes with the action of free radicals, chemicals known to damage cells. Supposedly, since damage to cells causes cancer, and since antioxidants prevent damage to cells, antioxidants “treat” cancer.

The irony is that vitamin C appears to act in precisely the opposite way. Yes, vitamin C is an antioxidant that reduces cellular damage from free radicals, but some chemotherapeutic agents are free radicals that kill cancer by damaging the individual cancer cells. Vitamin C supplements appear to inactivate chemotherapy, either by inactivating the drugs themselves or by interfering with the action of the drugs. Indeed, the authors found that vitamin C reduced the cancer killing ability of chemotherapy by 30-70%, depending on the chemotherapy drug.

What did the authors do in the study? The authors exposed leukemia and lymphoma cells to dehydroascorbic acid, the form of vitamin C that appears in the blood stream after taking supplements. Then they compared the effects of chemotherapy on those cells with sister cells that had not been exposed to vitamin C. They did this in two ways; first by exposing cells to chemotherapy drugs, and second by transplanting cells into mice, generating tumors, and then treating the mice with chemotherapy. In both cases, in the petri dishes and in the mice afflicted with cancer, exposure to vitamin C dramatically reduced the ability of the chemotherapy drugs to kill the cancer cells.

These findings are in keeping with a large number of studies that have shown that vitamin C can neither prevent nor treat cancer, most importantly a recently released, large scale study of vitamin C use among 14,600 male doctors participating in the Physicians Heart Study II. Participants received either vitamin C or vitamin E supplements or placebo for 10 years. The study was undertaken to look at the effects of vitamin supplements on heart disease, but the authors kept careful records of all other medical outcomes in these groups. The principle finding of the study was that vitamin C and vitamin E supplements had no effect on the risk of heart attack or stroke. A secondary finding was that vitamin C (and vitamin E) had no effect on cancer risk, either.

While cautious about the preliminary nature of the study, Dr. Heaney, the scientist who tested vitamin C on leukemia and lymphoma cells, expressed his concerns in an interview with Medscape Oncology:

“Our study is a preclinical model that addresses only the situation when vitamin C is given in the setting of chemotherapy treatment,” Dr. Heaney emphasized. There have been no clinical studies of this topic so far, he said.

However, the finding could be of potential concern because “many people, cancer patients included, take supplemental vitamin C,” Dr. Heaney pointed out. Clinical studies of vitamin C supplementation in patients with advanced cancers have had mixed results. There are conflicting hypotheses, he explained. One theory is that vitamin C supplementation protects the cancer and is therefore detrimental to the patient…

Medscape Oncology interviewed another doctor with no connection to the study:

Asked to comment on this study, Len Lichtenfeld, MACP, deputy chief medical officer at the American Cancer Society said: “Vitamin C has a long history in cancer prevention and treatment. Although there is no evidence to demonstrate that vitamin C improves the outlook for patients with cancer, there are still reported observations that cancer patients continue to believe in the potential benefits of vitamin C. Although oncologists do not routinely recommend that patients with cancer take excessive doses of vitamin C, there are reports that cancer patients are being treated with vitamin C by alternative practitioners…”

… [T]he current report suggests that in laboratory experiments, adding vitamin C to cancer cells may reduce the effectiveness of cancer chemotherapy drugs.

“Clearly, there remains an open question as to whether or not vitamin C supplementation is helpful or harmful in the treatment of patients with cancer. Until those questions are resolved with further clinical studies, it would be inappropriate to recommend that patients take large quantities of vitamin C if they have cancer,”

Many cancer patients explore alternative treatments like vitamin supplementation, reasoning that while they may not be help, they are not likely to be harmful. This study demonstrates that such assumptions may be totally false. Supplements like vitamins and herbs have chemical actions of their own, and those chemical actions may interfere with the effectiveness of conventional treatment, or inadvertently improve the survival ability of the cancer, not the patient.

The most important message to take away from this study is that no one should take alternative treatments of any kind without discussing them with their doctor, to be sure that there are no harmful interactions. It would be tragically ironic if cancer patients were actually supplementing their cancer, instead of fortifying themselves for the fight against the disease.

 The British government has been trying to answer that question, or rather, a variant: How much should they pay for 6 more months of your life? By explicitly framing the question, let alone answering it, the government has put itself at the nexus of 4 ongoing controversies in medicine: Should medical care be rationed? How much is longer life worth? Does evidence based medicine accurately give us the answer? Should governments deal with drug companies that price drugs without reference to their actual cost?

The United Kingdom came down on the side of rationing healthcare years ago. They were honest enough with themselves, and the people of their countries, to acknowledge that there was not enough money to support unrestricted healthcare for all. Forced to choose between providing unlimited healthcare for some vs. limited healthcare for all, those chose healthcare for all. Both the government and the people understood that the annual healthcare budget was finite, that paying for expensive treatments would reduce money available to meet the needs of everyone else, and that a transparent, rational method must be found to make the necessary decisions. Everyone agreed in theory; in practice there has often been tremendous public outcry.

In an effort to create a transparent, rational basis for limiting care, the British government formed the National Institute for Health and Clinical Excellence (NICE). NICE evaluates all forms of medical care through a very extensive review process, solicitng the opinions of all possible stakeholders in every decision. NICE routinely produces voluminous reports reviewing the scientific literature and issuing guidelines for virtually every aspect of care. For example, the NICE guideline for the care of healthy women during childbirth (excluding pregnancy, excluding high risk women) runs to 332 pages and includes review of 628 separate scientific studies.

Almost every decision of NICE carries some element of controversy, but none more than decisions about expensive treatments that lengthen life but do not cure the terminally ill, the elderly, or those unfortunate enough to have rare diseases. NICE is explicit about the criteria. According to an article in The New York Times:

… Any drug that provides an extra six months of good-quality life for £10,000 — about $15,150 — or less is automatically approved, while those that give six months for $22,750 or less might get approved. More expensive medicines have been approved only rarely. The spending limits represent the health institute’s best guess for how much the nation can afford.

Not surprisingly, many state of the art medications exceed that price. The newest treatments for diseases as diverse as multiple sclerosis, advanced renal (kidney) cancer, and Alzheimer’s disease are not covered. The public outcry has been fierce.

No one disagrees with the fundamental principle of rationing healthcare. No one is challenging the evidenced based claims that the drugs provide only limited extension of life for extraordinary cost. The decisions are acknowledged to be both moral and rational based on the agreed upon criteria. They are challenging the decisions as “heartless.”

Bruce Hardy, interviewed for the New York Times article, is an example:

When Bruce Hardy’s kidney cancer spread to his lung, his doctor recommended an expensive new pill from Pfizer. But Mr. Hardy is British, and the British health authorities refused to buy the medicine. His wife has been distraught.

“Everybody should be allowed to have as much life as they can,” Joy Hardy said in the couple’s modest home outside London.

…A clinical trial showed that the pill, called Sutent, delays cancer progression for six months at an estimated treatment cost of $54,000.

Initially, NICE held firm on its decision to refuse payment, even though only a relatively small number of people need the drug.

Given that fewer than 6,000 people per year in England and Wales are diagnosed with kidney cancer, “Why put ourselves through so much heartache for very little money?” Andrew Dillon, the institute’s chief executive, asked in a September interview. “The answer is that if we don’t apply the same criteria even to small groups of patients, there’s little value to what we do at all.”

In the face of increasing political pressure, NICE has recently backed down. Guess who was among the first to report the turn around: the Pharmaceutical Business Review.

The National Institute for Health and Clinical Excellence in the UK may lift the ban on certain kidney cancer drugs reversing its earlier decision to ban four drugs on the NHS – Sutent, Nexavar, Avastin and Torisel.

Previously, the National Institute for Health and Clinical Excellence (NICE) has refused to approve the kidney cancer drugs as they cost more than $70,000 a year per patient. However, the public outcry against its decision and availability of new data regarding the effectiveness of the drugs has forced NICE to overhaul its previous decision…

Pfizer and Roche, the makers of Sutent and Avastin, are also believed to be in talks with NICE regarding a new a pricing arrangement that would see the NHS paying for a drug if it extended a patient’s life by an agreed time. However, if the patient experienced no benefit and died, the pharmaceutical company would refund the cost.

The decision of NICE to pay for the drugs is a victory for the patients. However, it is also a financial bonanza for the manufacturers. It is a bonanza that many believe the drug companies do not deserve, because it is their extortionist pricing policies that led to the problem in the first place. The Times article offers a shocking example:

…Take the case of Celgene, the maker of Revlimid, a drug for multiple myeloma, a bone-marrow cancer, that in a preliminary ruling on Oct. 28 the institute said was too costly.

Celgene’s first big seller was thalidomide, a decades-old medicine now used as a cancer treatment, which is so cheap to manufacture that a company in Brazil sells it for pennies a pill.

Celgene initially spent very little on research and priced each pill in 1998 at $6. As the drug’s popularity against cancer grew, the company raised the price 30-fold to about $180 per pill, or $66,000 per year. The price increases reflected the medicine’s value, company executives said.

In 2005, the company introduced Revlimid, a derivative of thalidomide that is supposed to be less toxic, but may be no more effective. Celgene priced it at about $260 per pill, or $94,000 per year.

The drug company, Celgene, was already making a large profit when it marketed the treatment at $2,2000 per year. Then it arbitrarily chose to increase the cost of the treatment to $66,000 per year, at the highest price it thought the market would bear. Who was willing to pay for such a massive and arbitrary price increase? The government of the US was willing to pay, because George W. Bush and cronies had forced through an addition to the Medicare bill of 2007 explicitly barring price negotiations with drug companies. Bush made it clear to the drug companies that the US government would pay the highest price that the company could dream up.

These irresponsible give-aways have put tremendous pressure on everyone else. Drugs are deliberately and exorbitantly overpriced for the US market, making them unaffordable for countries whose goal is to provide healthcare, not to line the pockets of drug company executives. The unwillingness of the British government to pay, backed by the evidence based reports of NICE, has led drug companies to negotiate with the British National Health Service.

Though political pressure forced NICE to back down on its refusal to pay for Sutent and similar drugs, it did not back down completely. It negotiated a performance based pricing structure for the drugs. If the medication does not provide the promised benefit, the British government will not have to pay.

What are the lessons for the US? First and foremost, as the largest purchaser of drugs in the US, if not the world, the US government must be liberated from its absurd inability to negotiate with drug companies. That will go a long way to making treatments more affordable, and therefore more available, to everyone. Second, we have no choice but to ultimately follow the British in their attempt to ration and rationalize the provision of healthcare. There is simply not enough money to provide everything to everyone. We may choose to make different decisions and create different cut off points than the British have done, but we will not be able to avoid answering the difficult question: How much should we pay for 6 more months of your life?

One of the thorniest ethical dilemmas in medicine is not who to treat, but how to treat. As new treatments become available for life threatening illnesses, patients and doctors are required to make decisions about whether to stick with the tried and true therapy, and its associated risks and side effects, or switch to the new treatment, which may have fewer risks and side effects, but may be less effective.

Prostate cancer patients already have to make a difficult treatment choice between surgery, radiation and watchful waiting. Surgery and radiation have high cure rates, but both also have high rates of serious complications like impotence and incontinence. That’s because both surgery and radiation inadvertently damage delicate structures like nerves, which are so close by that they cannot be avoided.

A new treatment has recently appeared on the scene, the radiation Cyberknife. Proponents of the radiation Cyberknife claim that it is offers treatment that is far easier (days instead of months) and, because the radiation can be targeted extremely accurately, far less likely to cause serious side effects like impotence and incontinence. Theoretically, it should be just as effective at curing prostate cancer as traditional radiation therapy, but in reality, no one really knows. Hence the ethical dilemma: should the Cyberknife be offered to patients before we have accumulated enough data to be sure that it really works?

I have more than an academic interest in the matter. Eight years ago I chose the Gammaknife for treatment of a benign brain tumor growing within the middle of my brain and pressing on vital structures. Today the Gammaknife is often first line therapy for brain tumors like mine. At the time, though, it was the non-standard alternative, and I might not have even heard of it, let alone chosen it, had I not been a doctor connected with other doctors who were aware of state of the art treatments.

The brain surgeon I consulted strongly recommended surgery even as he counseled that I would lose my hearing on that side and might lose feeling in my face as well. I chose the Gammaknife because the data available at that time suggested that it had an even higher cure rate with a much lower risk of side effects. That turned out to be correct. The new treatment was safer and easier than the old, and was just as effective … fortunately.

Is the Cyberknife a similarly effective alternative to conventional treatment? It has worked very well for tumors of the spinal cord. When it comes to prostate cancer, though, there is far less data available. Indeed, there is less data than the amount of information that was available to me at the time I chose my radiation treatment. Expectations are that, because it is a highly targeted treatment, with the radiation beams “sculpted” to match the exact dimensions of the tumor and spare surrounding tissue, it should be just as effective, and lead to fewer cases of impotence and incontinence. But expectations are just that, expectations, and no one really knows what will happen. Only 2,000 patients have been treated thusfar, and they have been followed for only a few years (not long enough to see long term effects). The preliminary data show that the Cyberknife has a similar cure rate, with fewer short term side effects.

Cyberknife for prostate cancer remains essentially an unproven treatment with great promise. Doctors are struggling with whether it is ethical to introduce such a treatment before it has been proven to be effective. On the other hand, many doctors wonder if it is ethical to withhold such a promising treatment that, theoretically, will reduce the risk of serious and dreaded side effects like impotence and incontinence.

As detailed in a recent Washington Post article, Anthony L. Zietman, president-elect of the American Society for Therapeutic Radiology and Oncology (ASTRO) is opposed to offering the Cyberknife at this point:

“This is really pushing the envelope. It might be as good and more convenient. It may be better and more convenient. But it could turn out to be a disaster. No one knows…”

“We just don’t have the data to support treating prostate cancer with five days of radiation,” said Kevin A. Camphausen of the National Cancer Institute, noting that prostate cancer can recur many years or even decades later. And high-intensity radiation, even though it is more precisely focused, might still damage the rectum, bladder and urethra, potentially causing complications years later.

“What I’m worried about is that we might not be curing patients who we know are curable,” he said.

On the other hand:

Proponents argue that enough evidence has accumulated to make them confident that the approach is at least as good as standard therapies and that it can prevent unnecessary deaths by making treatment less daunting. Because the CyberKnife can more precisely target tumors with higher doses of radiation, it could prove even safer and more effective, they say.

The ethical issues are complicated by the financial incentives. Treating prostate cancer with the Cyberknife represents a tremendous financial boon to the doctors who are advocating its use. They stand to make $1200 per treatment course or more. Cyberknife is faster and more convenient for the doctor as well as the patient. That means that doctors can treat more patients, and make more money, by working the same hours that they worked before. It is not difficult to imagine that this financial advantage could cloud the judgment of Cyberknife proponents.

What does the scientific literature say on this topic? From a discussion of new technologies in radiation therapy:

… While equipment is still developing for the accurate delivery of stereotactic radiosurgery for tumors outside the cranium, many fundamental biological and clinical questions remain regarding the use of these technologies in medical practice…

There is no reason to suppose that all patients or tissue organs will tolerate [treatment] equally well. From the science of radiotherapy, it is understood that toxicities to large radiation fractions are predominantly late occurrences… Since these toxicities may occur late, longer follow-up will be required … [T]here is no reason to suppose that all patients will benefit equally … Only through a consistent and monitored approach will optimal groups be identified for cancer treatment.

In other words, while the new treatment for prostate cancer seems promising, more research is necessary to determine if it is as safe and effective as existing treatments. There is simply not enough scientific research available to guide us. In the meantime, industry is pushing a new and unproven treatment that might be far better than the existing options.

There is only one way to solve this ethical dilemma: the decision must be left to the patient. All options should be presented, and special care should be taken in counseling patients about the unknowns involved in the new treatment. As long as patients realize that they are taking a risk, it is entirely reasonable for them to take that risk in the hope of avoiding serious side effects. This ethical dilemma is similar to many other ethical dilemmas in medicine and the “treatment” is the same: more knowledge and increased patient choice usually represent the best way to move forward.