Women’s Health World Abuzz On ‘Pink Viagra’ Approval, But Are Expectations Realistic?

In this June 22 photo, a tablet of Flibanserin sits on a brochure for Sprout Pharmaceuticals in the company's Raleigh, N.C., headquarters. (Allen G. Breed/AP)

In this June 22 photo, a tablet of Flibanserin sits on a brochure for Sprout Pharmaceuticals in the company’s Raleigh, N.C., headquarters. (Allen G. Breed/AP)

Everyone, it seems, has an opinion on the FDA’s approval this week of the drug Flibanserin, aka “pink Viagra,” to boost women’s sexual desire.

“This is the biggest breakthrough for women’s sexual health since the pill,” Sally Greenberg, executive director of the National Consumers League, told The New York Times.

Others have their doubts. Cindy Pearson, of the National Women’s Health Network, told NPR that approval of the drug “is a triumph of marketing over science” and added: “To have any chance of benefit from this drug they’re going to have to take it every day for months on end, years…We just don’t know what the long-term effects will be of changing brain chemistry in this way.”

Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER), said the approval “provides women distressed by their low sexual desire with an approved treatment option…The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction.”

The drug, which will be sold under the brand name Addyi, is expected to go on sale Oct. 17, according to its maker, Sprout Pharmaceuticals. And along with the potential to ignite a low (or non-existent) libido among some women, the drug comes with a boxed warning, the strongest kind, on contraindications and potential side effects, including low blood pressure, fainting, nausea, dizziness and sleepiness.

Here’s more on the site Throb, about how the drug actually works.

Still others have extreme doubts.

Emily Nagoski, a feminist sex educator and author of the book “Come As You Are,” wrote a smart, thoughtful piece on the site Medium about why Flibanserin isn’t addressing the true nature of women’s sexual desires. Here’s a bit of that piece, called: “Pleasure is the Measure:”

I believe that the folks at Sprout Pharmaceuticals — the company that owns Flibanserin, the so-called “pink viagra” — have good intentions. I believe that they want to help women who are struggling with sexual desire.

And I believe that they feel sure — as most people do— that lack of spontaneous, out-of-the-blue desire for sex is a problem. A disease.

They are wrong — as you now know.

It’s not their fault, really, that they’re wrong. Cindy Whitehead, Sprout CEO, isn’t a sex researcher, educator, or therapist. She’s a marketing professional, and she’s darn good at her job. But why would she believe anything except what mainstream culture taught her?

In fact the drug is designed — they’ve said explicitly — as though responsive desire were a disease, as though spontaneous desire were the only “normal” way to experience desire.

And that’s a problem. Continue reading


Shops Remove Possibly Dangerous Diet Supplements After Study Faults FDA

Following a report this week that the U.S. Food and Drug Administration kept silent about synthetic stimulant contamination in some popular diet supplements, a major vitamin seller announced it will pull products that may be tainted with the chemical BMPEA.

Here’s The Vitamin Shoppe announcement via PR Newswire:

Mike Mozart/flickr

Mike Mozart/flickr

Because the health and safety of our customers is our number one priority, and out of an abundance of caution, we are immediately removing all acacia rigidula containing products, due to the concern that some of them may contain BMPEA, from our stores and website. BMPEA is a synthetic drug-like substance that should not be used in dietary supplements.

We are concerned by the findings outlined in the study published yesterday in Drug Testing and Analysis, which state that some acacia rigidula containing products may also contain BMPEA. If these findings are confirmed by the FDA, these products should not be sold as dietary supplements.

The Vitamin Shoppe requires that all manufacturers of the products we carry comply with all applicable laws. The Vitamin Shoppe decided to remove these products because the safety of these products is now in question and may not be in compliance with FDA regulations. In addition, the Vitamin Shoppe continues to encourage the FDA to use its authority to remove any dietary supplements from the market which it deems unsafe.

On Wednesday, The New York Times offered a detailed account of the tainted supplement study, which was published in the journal Drug Testing and Analysis:

Popular weight-loss and workout supplements on sale in hundreds of vitamin shops across the nation contain a chemical nearly identical to amphetamine, the powerful stimulant, and pose dangers to the health of those who take them, according to a new study. The Canadian health authorities in December called the chemical, BMPEA, “a serious health risk,” and pulled supplements that contain it from store shelves.

The Food and Drug Administration documented two years ago that nine such supplements contained the same chemical, but never made public the names of the products or the companies that made them. Neither has it recalled the products nor issued a health alert to consumers as it has done with other tainted supplements. The F.D.A. said in a statement that its review of supplements containing the stimulant “does not identify a specific safety concern at this time.”

But public health experts contend that the F.D.A.’s reluctance to act in this case is symptomatic of a broader problem. The agency is not effectively policing the $33 billion-a-year supplements industry in part because top agency regulators themselves come from the industry and have conflicts of interest, they say.

Dr. Pieter Cohen, an assistant professor at Harvard Medical School, and the lead author of the study, said in an email that he has some short-and long-term hopes for what happens next in the tainted supplement saga. Cohen, also a primary care doctor at Cambridge Health Alliance wrote:

I would hope the FDA stops hiding their head in the sand and immediately warns consumers that they have found a synthetic stimulant in many supplements. The FDA should use it’s full enforcement capabilities to remove BMPEA from all supplements. The FDA should also clarify that the plant being used as cover for this stimulant, a shrub called Acacia rigidula, has no legitimate place in supplements and all supplements labeled as containing Acacia rigidula should be immediately withdrawn from the market. Continue reading

A Miracle Drug For Binge Eating? Not So Fast, Says Therapist

(Bloody Marty/Flickr)

(Bloody Marty/Flickr)

By Jean Fain
Guest Contributor

For more than 20 years, my binge-eating patients have wished for a magic wand. And for all that time I told them there is no wand — there are only strategies that require awareness and effort to get a handle on their eating.

Last week, when the FDA announced it had approved Vyvanse for the treatment of binge eating disorder (BED), I found myself at an uncharacteristic loss for words. With headlines touting a magical cure for this most common adult eating disorder, I feared there was nothing I could say to stop the stampede for this next, new drug.

The news, in and of itself, is hopeful. Vyvanse (lisdexamfetamine dimesylate) has been the subject of rigorous research, first for ADHD, and now for BED. In two good-sized studies with more than 700 adult participants diagnosed with moderate to severe binge eating, this central nervous system stimulant proved more effective at reducing binge days per week than placebo for three months.

What’s more, the FDA’s approval has proven a good opportunity for a drugmaker, U.S-based Shire, and leading eating disorder associations — the National Eating Disorder Association and Binge Eating Disorder Association — to coordinate a nationwide educational campaign. If even a fraction of the estimated 2.8 million Americans diagnosed with the disorder get help as a result of the campaign’s public service announcements and new website, there’s reason to be hopeful.

There’s also reason to be cautious. Consider some of the issues before you take tennis great and Shire spokesperson Monica Seles’ advice to “talk with your doctor.” To help you do that, here are the pros and cons in my clinical experience and that of my colleagues.

But first, if you’re unclear on what constitutes binge eating disorder, here’s how the Binge Eating Disorder Association defines it:

“Routinely eating far more food than most adults would in a similar time period under similar circumstances.” Binge eaters typically feel out of control during a binge, and afterward, they’re consumed with guilt, self-disgust and embarrassment. Other hallmarks of the disorder: eating extremely fast, in secret, to the point of uncomfortable fullness, even when not hungry. Unlike other eating disorders, people with BED don’t try to “undo” excessive eating by throwing up, taking laxatives and other excessive actions.

OK, so here are a few points to consider…


•More Treatment Options

With the FDA’s first and only approved medication for BED, patients now have another way into treatment: their family doctor. Rather than seeking out a psychotherapist or a nutritionist, which many are reluctant to do, they might feel more comfortable asking their physician about a prescription and other treatment options for this lesser-known eating disorder, which was only recognized two years ago as a distinct disorder by the American Psychiatric Association.

•Fewer Binge Days

Vyvanse has been shown to markedly reduce, if not eliminate, binge episodes in two studies, both funded by Shire. According to last month’s JAMA Psychiatry study, participants who got a daily dose of 50-70 mg, reduced the frequency of binge days per week from about five to less than one over the course of 12 weeks. By comparison, those taking placebo continued to binge more than two days per week. What’s more, half the participants taking the 70 mg dose stopped binging after four weeks, compared to one fifth of those taking placebo.

•Possible Weight Loss

Because Vyvanse has yet to be studied as a weight loss aid, it’s approved only in the treatment of binge eaters, not the overweight or the obese. That said, study subjects who took Vyvanse lost about 10 pounds. The potential weight loss may come as welcome news to bingers taking an off-label prescription for an antidepressant or anti-seizure medication. A common side effect of most antidepressants is weight gain. While binge eaters are often thrilled with the weight loss that the anti-seizure drug Topomax can facilitate, they’re none too pleased by the mental impairment.


•Greater Risk of Abuse/Dependency

There’s a reason Vyvanse is a controlled substance with a black box warning. The potential for abuse and dependence is a real risk. Take it from psychiatrist Daniel Carlat, editor in chief of The Carlat Psychiatry Report, who expressed his reservations in a recent email exchange:

“I’m concerned that the FDA’s approval of Vyvanse for binge eating disorder is going to worsen our problems with stimulant abuse,” Carlat says. Continue reading

Opinion: New Pregnancy Drug Guidelines A Mixed Bag For Consumers



By Dr. Adam Urato
Guest Contributor

Last week the Food and Drug Administration published a final rule that will change how drug companies present information on the risks of medications during pregnancy. This is considered a very important step as there are approximately 6 million pregnancies in the U.S. every year and the average pregnant woman takes between three and five prescription drugs during the course of a pregnancy.

For decades, the public has relied on the FDA’s Letter Category system in which a Category A drug was considered safe, Category D unsafe, with B and C falling in between, and Category X meaning contraindicated in pregnancy.

This past week the FDA announced that it is scrapping that letter system and replacing it with a new system that will offer descriptions about the effects of the drug during pregnancy and lactation. A third section (the “Females and Males of Reproductive Potential” subsection) will include information about pregnancy testing, contraception and about infertility as it relates to the drug.

So what exactly does all this mean for consumers?

As a Maternal-Fetal Medicine specialist, here’s my read on the changes:

What this means is that men and women are going to have to actually go to the drug information label and read it. No longer will a pregnant woman simply be able to look up a drug and find out that it’s a Category D in pregnancy, for instance, and then avoid it.

And this is a major problem that I see with the new system: many patients and physicians do not take the time to read through the label prior to using a medication. A description-based system risks losing the benefit of warning that the current Letter System provides when the drug is simply listed as Category D or X.

Also, it seems that the drug companies themselves are going to be asked to write these pregnancy sections on the label. This strikes me as absurd. Continue reading

Pregnancy Woes: Why Did The Price Of My Progesterone Skyrocket?

(Photo: Rekha Murthy)

(Photo: Rekha Murthy)

By Rekha Murthy
Guest Contributor

Update: KV Pharmaceutical changed its name to Lumara Health, two days after this post was published.

I’m 34 weeks pregnant and working hard to keep this baby inside me for as long as possible. As with my last pregnancy, there’s a real risk that the baby could come too early. But we’re both holding on so far, thanks to a combination of luck, modified bed rest and medical science.

The science is my biggest concern right now. I will spare you much of it because, man or woman, you will instinctively cringe and close your legs. However, one critical medical intervention that has been proven to work for countless women and babies is again under threat, and I must speak up.

Every week, my husband injects me with 250 mg (1 ml) of 17 alpha-hydroxyprogesterone caproate (“progesterone” for short). Leaving aside what this does to an otherwise tender and loving marriage, these injections have been found to significantly lower the risk of preterm birth.

Two weeks ago, my insurance co-pay for progesterone went from $5.50 per dose to $70 per dose. Just like that. For those without insurance (or with a deductible), the medication went from $32.50 per dose, according to my local compounding pharmacy, to…wait for it…$833 per dose, according to the new pharmacy my insurer is now requiring me to use.

$833. Per. Dose.

Pricing varies somewhat across pharmacies and insurers, but not enough to make this price change any less breathtaking. In fact, the drug’s list price is $690 per dose.

The 12-fold leap in my co-pay sent an epic shock through my (natural and synthetic) hormone-laden system. I immediately called both pharmacies, my insurer, and my doctor, and started digging around online. I soon learned that the price increase came from a new requirement to buy expensive brand-name progesterone, instead of the affordable compounded version I had been getting. A disturbing picture came into focus. Continue reading

FDA Proposes New Restrictions To Address ‘Health Risks’ Of Vaginal Mesh

The U.S. Food and Drug Administration today proposed strict new regulations to address the “clear risks” associated with surgical mesh used to treat vaginal prolapse in women.

Specifically, federal regulators want to reclassify surgical mesh as a “high-risk” medical device (it’s now in the “moderate-risk” category) and also impose more requirements on manufacturers in which they must demonstrate that the device is safe and effective.

The risks and health problems related to this type of surgical mesh, which we’ve detailed here, include infections and nerve damage that can occur when the material erodes through the vaginal lining, as well as excruciating pain, the inability to sit down or urinate without a catheter, multiple hospitalizations and an end to a women’s sex life.

Here’s the full FDA news release:

The U.S. Food and Drug Administration today issued two proposed orders to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse (POP). If finalized, the orders would reclassify surgical mesh for transvaginal POP from a moderate-risk device (class II) to a high-risk device (class III) and require manufacturers to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness.

POP occurs when the internal structures that support the pelvic organs such as the bladder, uterus and bowel, become so weak, stretched, or broken that the organs drop from their normal position and bulge (prolapse) into the vagina. While not a life-threatening condition, women with POP often experience pelvic discomfort, disruption of their sexual, urinary, and defecatory functions, and an overall reduction in their quality of life.

“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products,” said William Maisel, M.D., M.P.H., deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health. “If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair.” Continue reading

Robotic Arm Troubles: Possible Stall During Surgery, Company Says

We’ve written about the aggressive marketing of robotic surgery systems and doctors questioning the benefits of such surgery for certain operations, like hysterectomies.



Now come warnings about possible stalling in the da Vinci robotic surgery system, which is manufactured by Intuit.

Bloomberg reports:

Intuitive Surgical Inc. (ISRG), the maker of a $1.5 million robot surgery system, told doctors that friction in the arms of some devices may cause the units to stall, the second warning issued about the company’s products in a month.

The company sent an “urgent medical device recall” Nov. 11 alerting customers of the issue, which affects 1,386 of the systems worldwide, the U.S. Food and Drug Administration said in a Dec. 3 notice on its website. The stalling may result in a sudden “catch-up” if the surgeon pushes through the resistance, the agency said.

Intuitive is facing growing questions about its marketing strategies, training procedures and the safety of its devices, Bloomberg News has reported. The FDA said last month that the number of adverse event reports, including deaths, injuries and system malfunctions, has more than doubled this year as of Nov. 3 compared with all of 2012.

“Reports of friction within certain instrument arms can interrupt smooth instrument motion,” the FDA said on its website. Continue reading

Meth-Like Stimulant Found In ‘Craze’ Workout Powder; Production Stops

A rock of crystal meth (not found in Craze.) Photo: Psychonaut/Wikimedia Commons

A rock of actual crystal meth (not the analog found in Craze.) Photo: Psychonaut/Wikimedia Commons

In medical research, “impact” usually refers to the number of times that an article or a journal is cited by others going forward. If your findings only ever find their way into, say, three sets of footnotes in other people’s papers, you can be pretty sure your impact is minimal.

In journalism, however, when you’re, say, applying for a Pulitzer prize, you need to show “impact” in the sense that your stories have led to significant change: The corrupt sheriff was ousted, or the systemic injustice corrected.

Dr. Pieter Cohen (Courtesy)

Dr. Pieter Cohen (Courtesy  Cambridge Health Alliance)

Dr. Pieter Cohen, a general internist at Cambridge Health Alliance who researches dietary supplements, has just crossed the line from the academic sort of impact to the journalistic: On Monday, he and colleagues published a paper warning that they had analyzed the popular pre-workout supplement Craze and found that it contained a little-studied methamphetamine-like substance. Now, USA Today reports: “Driven Sports, maker of the pre-workout supplement Craze, announced Tuesday that it has suspended all production and sales of the product in the wake of tests finding amphetamine-like ingredients.”

In fact, Driven Sports writes on its Website that it stopped production “several months ago while it investigated the reports in the media regarding the safety of Craze” — though it also maintains that Craze is safe and its own testing has found no amphetamine or other controlled substances.

But would we have known that Craze production had been suspended if Dr. Cohen’s study in the journal Drug Testing And Analysis had not appeared? We asked him for his main messages from the Craze tale, and he replied:

• Supplements are all assumed safe until proven otherwise by the FDA.  But the FDA has no effective system to detect hazardous supplements.

• In this setting it’s concerning to find that more and more supplements, like Craze, that contain new, untested compounds.  This can lead to serious health effects: The FDA is currently investigating whether a new ingredient in a weight loss supplement, aegeline, was responsible for one death and dozens of cases of severe hepatitis in Hawaii. Continue reading

FDA’s Reassurance On Arsenic In Rice Not So Reassuring

FDA Commissioner Margaret A. Hamburg and colleagues visited research facilities and rice farms in California on Sept. 4-5, 2013 in an effort to gain a greater understanding of the presence of arsenic in rice. Photo: United States Government Work/flickr

FDA Commissioner Margaret A. Hamburg and colleagues visited research facilities and rice farms in California on Sept. 4-5, 2013 in an effort to gain a greater understanding of the presence of arsenic in rice.
Photo: United States Government Work/flickr

I was a little confused last week when the FDA issued what was portrayed as a reassuring update on levels of arsenic in rice and rice products. After analyzing more than 1,300 rice-containing foods, the agency said, essentially, that the arsenic in rice won’t kill you, at least not today. The headline in The New York Times mirrored most of the media coverage: “No Immediate Risk Found In Arsenic Levels in Rice,” it said.

OK, but what about last year’s Consumer Reports investigation (which the FDA confirmed) that showed “worrisome levels” of arsenic in rice, notably brown rice, in common food products including  “organic rice baby cereal, rice breakfast cereals, brown rice [and] white rice”? Consumer Reports noted that “arsenic not only is a potent human carcinogen but also can set up children for other health problems in later life.”

When I read the updated FDA materials, including an FAQ for consumers and a blog by FDA Commissioner Margaret Hamburg, who went on a fact-finding mission and visited with U.S. rice growers, it became clear that we should still be concerned about arsenic in our rice. The key point in this new flurry of agency news? “We still need to better understand long-term health risks,” Continue reading

Diet Pill Dilemma: Why Is FDA Approving Drugs When Europe Isn’t?

By Karen Weintraub
Guest Contributor

We’ve all dreamt of popping a pill to help us safely lose weight, or at least eat that chocolate cake without guilt. But alas, even though the Food and Drug Administration has approved two new diet drugs in recent months, that dream probably isn’t any closer to reality.



In the current issue of the BMJ (formerly the British Medical Journal), Sidney Wolfe, founder of the advocacy group Public Citizen, slams the FDA for approving the drugs – lorcaserin (US brand name Belviq) and topiramate (called Qsymia). The FDA’s European counterpart rejected both of them because of heart risks that turned up during preliminary trials.

The FDA decided that the risks were relatively small and ordered the manufacturers to look for problems once they are on the market – basically, approving the drugs now and worrying later if they prove dangerous. Buyer beware.

The problem, Wolfe explained in a phone interview from Washington where he is preparing to testify at a National Institutes of Health meeting tomorrow, is that the reasons for hunger are complex and connected to many biological systems.

“When you give a drug powerful enough to effect hunger it is also going to affect other systems of the body,” most often the heart, he said. Continue reading