The Female Sex Pill - An Interesting Article on How Drug Companies Manipulate the FDA

From The Montreal Gazette 8-28-2015

SEDUCED BY THE HYPE

    Montreal GazetteAugust 28, 2015Christopher Labos is a Montreal doctor who writes about medicine and health issues. Christopher.labos@mail.mcgill.ca twitter.com/drlabos

Casanova used oysters and chocolate to put his female companions in the mood. They don’t actually do anything, though. I eat them all the time and have yet to become the ladies’ man I always thought I would be.

So the promise of something that may act as an aphrodisiac would be a financial blockbuster for its manufacturer.

Enter flibanserin (soon to be rebranded as Addyi), which was just approved by the U.S. Food and Drug Administration and seems likely to be approved by Health Canada soon enough. It is the first medication indicated to treat hypoactive sexual desire disorder (HSDD) in women.

Only problem is, many experts contend that HSDD doesn’t actually exist, that the drug is ineffective, has terrible side effects and was approved only because of a successful lobbying campaign. It’s kind of a funny story. Flibanserin was first developed as an anti-depressant and proved to be a flop. But in reviewing the data from trials, investigators found that patients reported improvements in their sex lives. Thus, it was repackaged and became a medication to enhance sexual desire. Studies were done and the data submitted to the FDA.

But the FDA unanimously rejected the drug application in 2010. Undaunted, the manufacturer refiled in 2013. It was again rejected. It appealed and was denied.

The FDA had two fundamental problems with the drug.

First, the FDA didn’t think it worked. To measure what effect the medication had on sexual desire, researchers asked study participants to keep a daily diary. When the results were analyzed, there was no difference between flibanserin and a placebo. The only real difference was in the number of “satisfactory sexual events.” This increased by an average of 0.5 events per month. Obviously, the FDA did not consider one extra orgasm every two months to be a meaningful improvement.

To work around this problem, the manufacturer changed its methodology and asked study participants to use the Female Sexual Function Index, a questionnaire that asks subjects to recall their experiences over the previous four weeks, instead of the daily diary. It is harder to accurately remember things that happened weeks ago, and therefore a daily diary is almost always preferred. On the six-point scale, flibanserin showed a 0.3 point improvement in sexual desire. What this means in real life is hard to say.

The second major problem that the FDA had was that any small potential benefit was outweighed by the side effects. Flibanserin causes a sudden drop in blood pressure and loss of consciousness in some patients. That’s bad. What’s worse is that the symptoms are more pronounced if you mix it with alcohol. Given that alcohol precedes most sexual encounters — at least according to HBO — that particular interaction is somewhat worrisome. It also interacts with a large number of medications including birth control pills. Think about that for a second: a sex pill that interacts with alcohol and contraceptives. And yet, here we are.

Given the significant problems of two FDA rejections, the manufacturer decided to change tactics and launched a media campaign called Even the Score. The message was simple. The FDA is sexist because it approved drugs like Viagra, but not flibanserin. They also rebranded flibanserin as “Pink Viagra” or “Viagra for women.”

The message on their website states that 26 drugs have been approved for male sexual dysfunction and, now, only one for women. This is untrue. First, they have counted several different forms of testosterone (gels, patches, pills, etc.) as different drugs, which is silly. Also worth noting that testosterone has enough side effects (it increases the risk of a heart attack) that no one should be prescribing it simply to treat low libido.

Furthermore, Viagra and flibanserin are completely different medications that do completely different things. They have nothing do with another. Drugs like Viagra and Cialis don’t actually increase sexual desire. They are phosphodiesterase inhibitors, drugs that dilate arteries and improve blood flow. In this case, they improve blood flow to the penis to initiate and sustain an erection. They don’t make you want to have sex. Also, while drugs like Viagra are taken as needed, flibanserin must be taken every day long term. Comparing them is a good marketing strategy, but bad science.

Fundamentally, the difference between men and women is that with men, sexual dysfunction is a problem of ability. Age, smoking, diabetes and high blood pressure all contribute to narrowing of blood vessels, which make erections more difficult. It is a biological problem and these medications provide a biological solution. With women, sexual dysfunction is more complex and is rarely due to a single issue as it is in men. It is a complex interplay of emotional, psychological, social and environmental issues. The old joke that a woman’s sex organ is her brain has some merit.

Sometimes, medical issues can affect a woman’s sexual desire, but flibanserin was specifically studied in pre-menopausal women with no medical problems. It is also contraindicated in women taking a very very long list of medications. As part of its media campaign, many testimonials from women suffering from hypoactive sexual desire disorder were trotted out to sway the FDA. The irony, of course, is that flibanserin would not be indicated for many of them.

The final fly in the ointment is that hypoactive sexual desire disorder doesn’t actually exist. It was removed from the most recent DSM-V, the disease manual that defines medical psychiatric disorders. Many experts consider sexual desire disorders a relic from the 1950s when “frigidity” and “nymphomania” were medical diagnoses. The growing consensus is that there is no such thing as too little or too much sex.

Even so, the Even the Score campaign was successful. It got the support of 11 congressmen in the United States, mobilized feminist groups and put sufficient pressure on the FDA to provide a conditional approval for flibanserin. It is worth noting though that a few feminist lobby groups saw through the ploy and campaigned against the drug’s approval. Nevertheless, third time’s the charm for drug approval, and this will almost certainly open the door to an aggressive media campaign designed to convince women they have a disease.

And so we have a drug that doesn’t really work, with serious side effects, to treat a condition that doesn’t really exist, that was approved not because of science, but because of a media campaign.

I’d like to think Casanova would not approve.

Testosterone Supplements - No Help!

There has been much publicity about low testosterone, mostly from the drug companies producing the supplement. But even in patients with low testosterone (now referred to as "low-T'), does supplementation actually do anything?

In an industry-supported (!) randomized trial, 306 men (age, ≥60) with morning total testosterone levels of 100 to 400 ng/dL or free testosterone levels <50 pg/mL received either testosterone gel or placebo gel daily for 3 years. Doses in the active-treatment group were adjusted to achieve total testosterone levels >500 ng/dL.

They found no differences in erectile function, a total sexual-function score, and a health-related quality-of-life score between the two groups.

Essentially, unless your testosterone level is very very low (less than 100; normal levels are often quoted at about 220) there does not appear to be any advantage of using testosterone gel.

Allan S. Brett, MD Reviewing Basaria S et al., JAMA 2015 Aug 11; 314:570

Viagra for Women - I think not

There has been a lot of publicity for the approval of the new drug - Addyi -purported to enhance sexual desire in women. It is currently only approved in pre-menopausal women. I have addressed this before and now once again am reporting on it.

This can be an issue in certain women and we have no good way to treat it. Some have used antidepressants and even low dose testosterone without much success.

Unfortunately, and contrary to all the hype, this is not the magic answer. In the studies the FDA used to approve it there was an average increase of 0.5 to 1 satisfying sexual event per month, relative to placebo. However, women also reported increased desire and decreased distress with the drug.

And there are major side effects. If taken with alcohol it can cause major drops in blood pressure and fainting; alcohol should not be taken while on this drug. Since it is taken every day this means total abstinence! In my limited experience I find a little wine to be more effective than 1/2 to 1 increased events per month!

Do Fats in Diet cause Heart Disease?

At one time fats were considered the cause of heart disease. Then food producers started making trans-fats as a replacement; and this was discovered to be much much worse.

Now, in a recent study, researchers have found that diets containing saturated fats, which are found in nature, are not associated with heart disease; even in somewhat higher than recommended amounts.

BMJ 2015;351:h3978

Trans fats of course were a major risk factor.

Once again, this confirms that a healthy diverse diet, with moderate intake of all foods, is the way to go.

So if a low fat diet is not going to lower your risk, what can you do. Exercise, maintaining a good weight, a well balanced diet, and treating risk factors such as diabetes and smoking are the way to go. And for those with a genetic predisposition and high lipids I would consider medication.

Coca Cola and Obesity Research

There have been numerous studies showing how unhealthy the refined and excess sugars found in soft drinks are.

This has affected Coke's sales, down about 20% in the US. So I have to wonder when they start to sponsor obesity research whose goal seems to be to show that lack exercise and NOT sugar is the cause of the epidemic of obesity and diabetes.

It's sort of like the coal industry saying that carbon emissions are not responsible for global warming. But doing it by sponsoring an "independent" research agency.

The New York Times has a good article on this:

New York Times Article

Sleep Deprivation and Threat Evaluation!

Emergency personnel, soldiers, physicians and police officers often have to make split second decisions and evaluations of threatening situations; and how they evaluate it can affect their response.

In a recent study, researchers had study subjects look at threatening and non-threatening faces after a full nights sleep, or after being awake for a prolonged time. They used physiological measurements and functional MRI to evaluate how threatened the person felt.

Significantly more faces were identified as threatening and fewer as nonthreatening after sleep deprivation than after rest, and this was associated with changes in areas of the brain associated with such an emotional response.

The need for adequate sleep to reset our threat recognition could have interesting and important implications, especially when we are seeing questionable police shootings and "stand your ground" defenses!

Goldstein-Piekarski AN et al. J Neurosci 2015 Jul 15

Do spicy foods help you live longer?

Maybe. A recent article (cited below) received a lot of publicity which said that eating spicy foods may help you live longer.

In the actual study they followed about 500,000 Chinese for 7 years, and asked them how much spicy foods they ate.

The groups with the highest amounts (mostly Chili Peppers) had a lower mortality by 10-14%.

This is an association, not necessarily a cause and effect. Perhaps healthier people tended to eat spicier food; or the lower levels were related to stomach issues. By looking backwards on their spice intake this picture could be skewed.

The good news, however, is that spicy foods definitely did not lead to more illness. So enjoy!

BMJ 2015; 351 doi: http://dx.doi.org/10.1136/bmj.h3942 (Published 04 August 2015) Cite this as: BMJ 2015;351:h3942