2265 North Clybourn Avenue    Chicago, IL 60614    P: 773.296.6700     F: 773.296.1131

Addyi: Big Pharma Botches a Viagra for Women

I hardly know where to begin. This is all too bizarre for me. If you’re a regular scanner of cash register magazines, you’ll be reading about Addyi, released by Big Pharma and approved for something called female hypoactive sexual desire disorder (HSDD), which is essentially no or low sex drive.

This story is about a Big Pharma match made in heaven. On one side, the psychiatrist editors of the DSM (Diagnostic and Statistical Manual of Mental Disorders) who put names to conditions they deem to be illness (including shyness, social anxiety, childhood bipolar disorder, and hypoactive sexual desire disorder) are playing right into the hands of Big Pharma. And Big Pharma itself is ready with a new, overpriced, minimally useful, and potentially dangerous pill to swallow.

Having made gazillions with Viagra and its cousins Levitra and Cialis (now $40 a pill), Big Pharma desperately wanted a little pink pill, a Viagra for women. But Viagra deals with the mechanics of flaccidity (lacking firmness). Viagra works a man’s plumbing to increase circulation to his penis and…bingo!

Take a Viagra, wait an hour or so, and a guy can manage sex with himself or with his wife, husband, girlfriend, boyfriend, or Venetian blinds. Generally speaking, sexual desire in women is a bit more complicated than sending blood to an appendage to make it rigid (to be fair, men’s sexual desire is also more complex than that). Lack of desire in either gender usually has psychological roots.

But Big Pharma had a drug, flibanserin, which, having failed in its original iteration as an antidepressant, was just sitting there, unused, ripe for some clever company to find a new way to market it.

Hmmm, how about sex?
Sex always sells, and theoretically flibanserin might have had some positive effects. Many women who have taken a serotonin-increasing SSRI drug like Prozac, Lexapro, or Zoloft know that these meds can dampen desire. Sometimes, though not always, this loss of libido can be prevented by taking an antidepressant that raises both serotonin and dopamine.

But what about lowering serotonin and raising dopamine at the same time, the very mechanism of flibanserin? Hey, it might work to boost sex drive. To be the first to leap into the female HSDD breach! Big Pharma could smell the meat a-cookin’.

Just one problem: it didn’t work. Not only did flibanserin not have much impact on sex drive, it made users sleepy, dizzy, and when taken with alcohol caused significant drops in blood pressure with occasional fainting.

In round one, the FDA voted unanimously (11-0) against flibanserin for premenopausal female hypoactive sexual desire disorder. Not losing hope, the drug was acquired by Sprout Pharmaceuticals, which submitted new studies showing minimal benefit and, again, serious side effects. Strangely, the alcohol interaction issues were studied not in women, but in male Addyi-takers, who also got dizzy and fainted.

Round two: the FDA again votes against the drug
Now Sprout was fuming. They’d made a huge investment in a useless and potentially dangerous drug and wanted some return on their investment. So Sprout launched a women’s advocacy group called Even The Score and initiated an intense promotional campaign directed at journalists, women’s groups, Congress, and the FDA.

Even The Score managed to convince the National Organization of Women (NOW) to write letters to the amusingly named director of the FDA’s Center for Drug Evaluation and Research, Janet Woodcock, MD, accusing the agency of sexism, having blessed men with Viagra but leaving women out in the cold.

Fortunately, not all organizations drank Big Pharma’s Even The Score Kool-Aid. The National Women’s Health Network said in a letter to the FDA “The problem with flibanserin is not gender bias at the FDA, but the drug itself.” At least someone was paying attention.

Round three: the FDA approves flibanserin
This time the FDA Advisory Committee, filled with appointed bureaucrats and industry members, voted approval (18-6) for Addyi as long as physician prescribers received special training to educate patients about Addyi’s  risks. The physician members of the FDA committee remained adamantly opposed to its approval, writing “We do not believe that it is reasonable for the approximately 90% of treated patients who will not respond to the product to be exposed to the numerous serious risks posed by flibanserin therapy.” Thousands of women had been manipulated by Big Pharma into demanding that a useless and potentially dangerous drug become available to them.

Once Addyi was approved, Sprout sold flibanserin to Canada’s Valeant Pharmaceuticals for $1 billion in cash. Valeant is a big player on Big Pharma’s evil team, specializing in buying US companies and making an art form of price-gouging Americans (but not Canadians).

Addyi is available by prescription
It’ll cost you about $800 a month and you need to take it every day. In order for me to prescribe it, I need to pass a four-question self-test called the Addyi Risk Evaluation and Mitigation Strategy (REMS) Prescriber Training Program (quoting the website) “to ensure the benefits of Addyi outweigh the risk of hypotension (low blood pressure and fainting to due an interaction with alcohol).” My guess is they’re trying to protect themselves from the class-action lawsuit that’s sure to be filed in a few years, long after they’ve pocketed billions in profits.

As you might imagine, any physician who doesn’t need to move his or her lips when reading can pass the Addyi test.

Does Addyi do anything? For the highly complex issue of low sex drive in women, clinical trials measured something called “satisfying sexual experiences” (SSEs) as recorded in diary form by women who were either taking the drug or taking a placebo (a dummy pill). There are all sorts of warnings about potential drug interactions, the most significant being that if you want to take Addyi you can’t drink alcohol in any form or amount, period.

At that romantic candlelit dinner, he can sip a flute of champagne while you drain your Big Gulp. The most common adverse reactions linked to Addyi are dizziness, sleepiness, nausea, fatigue, insomnia, and dry mouth.

Good times!

What you’ll gain for this sacrifice is minimal. The placebo-taking group reported 5 SSEs per month and the Addyi group 5.5 SSEs per month. I swear I am not making this up. For the risk of side effects you gain just one-half a Satisfying Sexual Experience (I cannot help you with what that means, exactly).

The physician FDA members called these results “meaningless,” “zero,” and “statistically insignificant.” The non-physician members gave a thumbs-up.

If you’re inclined to accuse me of insensitivity toward sufferers of hypoactive sexual desire disorder, understand this. Men experience HSDD, too, and more frequently than you might think. For both sexes, low libido is very, very complicated and can stem from relationship problems, including good old-fashioned boredom. There can be all sorts of chronic medical problems (underactive thyroid, adrenal fatigue, vitamin deficiencies, low testosterone in both sexes), longstanding psychological issues (gender identification issues, history of abuse or rape), or side effects from numerous prescription meds.

Big Pharma wants you to believe it’s fixable with a pill they’ll sell you for $25 a day. Take it with a glass of Cabernet and you might find yourself in an emergency room getting a CT scan to rule out concussion.

This bizarre story was brought to you courtesy of Big Pharma and the FDA.

Be well,
David Edelberg, MD    

Leave a Comment


  1. Dr. David W Bailey, DC Chicago says:

    I’m struggling to make a humorous comment. Alas, my moral/ethical-o-meter done went and got itself broke. I’m horrified at the audacity of the non-physician, non-science oriented, tongue-in-cheek Big Pharma and FDA bottom feeders that could give a rat’s ass about anything except overflowing coffers.

  2. Phillip says:

    I cannot imagine the political pressures involved at the FDA – the money involved in exploiting patents is just so large. Similar story happened with Provenge for metastatic prostate cancer: treatment involves only 3 infusions over a month, and the cost is now >$100,000. The study showed the treatment group lived 25.8 months vs. 21.7 months with placebo…yet there was no change in disease progression (so people lived a bit longer, but apparently the cancer wasn’t affected…which was weird). But the FDA approved it anyway, and Medicare covers it. Another thing to consider is that you can find at least some evidence for just about anything…

  3. Colin says:

    Thank you again for bringing to light more hypocrisy and greed in the medical industrial complex. It’s so disheartening. Although I feel there is a reckoning coming soon. Peoples pent up rage at the abuses of Wall Street have found a voice and it’s only a matter of time before big pharma falls squarely in the crosshairs.

  4. izzy sizemore says:

    my question is I started addyi about 2 weeks ago. I have been on prozac for almost 3 months for menopause moodiness and depression, I fear that the Prozac is a counter effect to addyi, I need to know if I should take another antidepressant that will not effect addyi’s intended affects, or do I take the Prozac away completely to see if addyi will work?

  5. Dr E says:

    Hi Izzy
    I can’t help here. I have never prescribed Addyi to anyone and no one I know has ever been precribed it. You need to voice your concerns to your prescribing physician

Join our Newsletter

Get health recommendations, delicious and time-saving recipes, medical news, supplement reviews, birthday discounts, and more!

BIRTHDAY

Health Tips

Dr. Edelberg’s Health Tips contain concise bits of advice, medical news, nutritional supplement and pharmaceutical updates, and stress relief ideas. With every Health Tip, you’ll also receive an easy, delicious, and healthful recipe.

When you sign up to receive Health Tips, you can look forward to Dr. Edelberg’s smart and very current observations arriving in your in-box weekly. They’re packed with helpful information and are often slightly irreverent. One of the most common responses to the tips is “I wish my doctor talked to me like this!”

Quick Connect

Get One Click Access to our

patient-portal

The Knowledge Base

Patient education is an integral part of our practice. Here you will find a comprehensive collection of staff articles, descriptions of therapies and nutritional supplements, information addressing your health concerns, and the latest research on nutritional supplements and alternative therapies.

Join our Newsletter

Get health recommendations, recipes, medical news, supplement reviews, birthday discounts, and more!

Upcoming Workshops

***WholeHealth for Winter Digestion
Saturday December 1, 2018, 10:30am-12:30pm
An Integrative Workshop with Yoga Therapist Renee Zambo, Dietitian Olivia Wagner, and Occupational Therapist Valarie McConville
Fee: $75.00 (includes take home materials and snacks)

Do you suffer from a sluggish digestive system, constipation, and/or bloating? Does it feel like those symptoms get worse as we head toward the holidays and winter season?  Are you looking for ways to optimize your digestion?  

Join us for two valuable hours of digestive health and cleansing!

Space is limited and registration is required.
Please register online.
Call the Center for additional information at (773) 296-6700
More>>

 

***Healing Touch for Focus, Creativity, and Stress Management
Thursday, December 6, 2018, 5:45-7:30
Katie Oberlin, HTCP/I
Healing Touch Certified Practitioner/Instructor
Fee: $55.00 (includes take-home materials)

Are you feeling overwhelmed and stressed at the end of the year? Want to find a way to feel less scattered and more focused? In this workshop, you will learn how to use energy healing to feel more centered and grounded so you can bring more clarity and creativity to your life and work.

Space is limited and registration is required.
Please register online.
Call the Center for additional information at (773) 296-6700
More>>

 

**Winter Solstice Celebration: Drumming Circle and Shamanic Healing
Wednesday, December 19, 2018, 5:45-7:30pm
Katie OberlinHTCP/I
Healing Touch Certified Practitioner/Instructor
Fee: $55.00

Take a break from the hustle and bustle of the holiday season to enter the stillpoint of the Winter Solstice, reflect on the lessons of 2018, and set intentions for the new year. This will be an evening of individual and group healing, ceremony, and celebration.

Space is limited and registration is required.
Please register online.
Call the Center for additional information at (773) 296-6700
More>>

Recent Health Tips

  • Making Sense of “Controversial” Diagnoses

    I’m warning you in advance. You’re entering a minefield here, with explosive views among seemingly conservative health care professionals. At least wear a helmet. Protective eyewear wouldn’t hurt either. You wouldn’t think a slew of conditions you’ve heard about (including chronic Lyme disease, chronic fatigue syndrome, fibromyalgia, chronic Epstein-Barr, toxic mold syndrome, food sensitivities, intestinal dysbiosis, chronic inflammatory response syndrome, and mast cell activation syndrome) Read More

  • Getting Tough With Your Immune System

    No reasonable physician (I modestly include myself here) can refrain from crowing delightedly when a clinical study confirms the value of a treatment he or she had been using for years, even if that treatment had contradicted prevailing standards. Ever since I learned something about natural medicine, I’ve been reluctant to prescribe antibiotics for respiratory tract infections, such as colds, sore throats, and bronchitis. Many physicians had Read More

  • For A Longer Life…Stand Up Now!

    By far the most common answer to my question, “Exercising these days?” is “Not enough.” This is usually accompanied by the briefest flicker of melancholy regret, as if by such a confession my patient has permanently abandoned the hopes and dreams of both a svelte body and enviable longevity. “Don’t worry,” I say, “It’s just a temporary glitch. You’ll start up again.” (Nod, nod). I Read More

December Sale: 20% Off the UltraLux IV Light Box

Full Spectrum Solutions has been an industry leader for the past 20 years, offering therapeutic lighting that is made right here in the Midwest (Michigan). The UltraLux IV is the first and only LED light therapy unit on the market that is both fully adjustable. Unlike many of their competitors, they boast a high CRI rating (90+) and a lifetime warranty so you never have to purchase replacement bulbs again. Full spectrum light therapy is often recommended in cases of Seasonal Affective Disorder (SAD) to help make up for the sunlight that is missing from these shorter, winter days.

To learn more about and purchase the UltraLux IV, click here.

To see past Health Tips on Seasonal Affective Disorder (SAD) and Dr. Edelberg’s recommendations, including a full spectrum light box like the UltraLux IV, click here.