Her takeaway message and warning to the FDA is echoed in many of the articles, that "to approve this drug will set the worst kind of precedent — that companies that spend enough money can force the FDA to approve useless or dangerous drugs.”
PharmedOut's 2015 conference on June 11-12, The Real Risks of Rx Drugs, was a great success. Please see a summary below.
June was Alessandra Hirsch's last month as PharmedOut project manager, and we wish her luck in her new chapter at the University of Illinois-Chicago medical school this fall. Alycia Hogenmiller, a recent graduate of the College of William & Mary and former PharmedOut intern, came on board as project manager this week. Welcome Alycia!
PharmedOut's Resource of the Month: Did you miss the PharmedOut 2015 conference, or want to refer to any of the talks? View the presentation slides on our website.
In Short: The Real Risks of Rx Drugs
June 11-12, 2015
“The Real Risks of Rx Drugs,” the theme of the fifth annual PharmedOut conference, inspired some of the most forceful, indeed outraged, presentations yet in this ongoing series of meetings on the undue influence of Pharma in medical research, medical education, and medical practice.
The interrelated risks of prescription drugs were seen by many speakers as an offshoot of free market dynamics giving industry free rein to boost the perceived need for its products. Successful Pharma strategies to increase sales and profits that have been detrimental to public health were reported, such as:
* Expanding the patient population through the careful introduction into public discourse of new disease entities that can be treated by their products, including redefining common conditions, such as shyness, overeating, or heartburn, as serious disorders, to the point where nary a man, woman, or child is not a candidate for a drug to “normalize” them
* Promoting the safety and effectiveness of drugs that are neither for inappropriate indications in patients vulnerable to serious adverse effects, such as second-generation antipsychotics in elderly patients with dementia-related psychosis; opioids for patients with chronic pain; drugs targeting the glycemic index in the absence of data to support that tight control of sugar levels actually benefits patients with dubiously labeled type 2 diabetes; and warfarin substitutes with no established therapeutic range or monitoring requirements, resulting in widespread over- and under-treatment in patients with atrial fibrillation
* The unbridled exorbitant pricing of new “specialty” drugs with no foreseeable generic alternatives drugs — prices once reserved for orphan drugs but now attached to drugs aimed at large populations of patients with such common conditions as hyperlipidemia, high blood pressure, cancer, rheumatologic entities, and hepatitis C — that threatens to bankrupt state and local governments and undermines spending in other areas of human needs
In addition to Pharma, the FDA and other regulatory entities like the JCAHO were given their due in contributing to the real risks of prescription drugs, as were physicians whose financial conflicts of interest or unfortunate lack of critical thinking have furthered Rx drug misuse.
Over the course of the two days, a consensus appeared to emerge that more than public disclosure of the findings presented at the conference should be undertaken, and like-minded participants interested in working for change met in self-organized clusters during breaks.
The slides of all the presenters – a wealth of information – are posted on the PharmedOut website. A video of the conference proceedings will soon be available.
July's PharmedOut Fodder: More on the Flibanserin Fight
Even the Score continues to purvey wrong information on its website, claiming that 43% of women suffer from sexual dysfunction — not true — and that there are 26 drugs for male sexual dysfunction and zero for women. This statement was vigorously denied by the FDA at the June 4th FDA Advisory Committee meeting that considered flibanserin. In fact, there are three drugs approved for painful sex for women and eight drugs (in only two drug categories) approved for difficulty achieving and maintaining an erection in men. There are zero FDA-approved drugs for either men or women for sexual arousal, sexual desire, or orgasmic disorders.
The FDA Advisory Committee recommends to the FDA whether or not a drug should be approved. None of the FDA Advisory Committee voted for outright approval of flibanserin, but 18 members voted for approval with a risk evaluation and mitigation strategy; six members voted against approval. The FDA will formally decide on the approval of flibanserin by August 18th. The Committee’s reluctance to vote for approval with labeled risks only shows their discomfort with the adverse effects of this drug, which include sudden unconsciousness, dangerously low blood pressure, and sedation in normal use that is equivalent to four drinks. The drug interacts dangerously with alcohol, and adverse effects are more common when used with the birth control pill. A bad deal compared to psychosexual therapy, which works without side effects.
We question the very existence of HSDD, as there is no scientifically established norm for sexual activity, feelings, or desire. Decreased interest in sex may be temporary and can be affected by life stresses, relationship problems, illness, medication, fatigue, or boredom. In fact, medication — especially antidepressants — probably accounts for many case of low libido that are not explained by other factors.
Flibanserin is a potentially dangerous drug. If you're not convinced, check out the FDA slides here. If you want to delve deeper in the subject, you can read the full FDA briefing document here.
*** News Round-Up (for more, please follow @pharmed_out on Twitter!)
Don’t miss the most stimulating medical conference of the year. Eye-opening science, empowering strategies you can put to work in your practice, and hundreds of like-minded colleagues all right in the heart of Washington, D.C. You won’t want to miss Director of PharmedOut Dr. Fugh-Berman speaking on Undercutting Diet and Exercise: The Overpromotion of Drugs in Cardiovascular Disease Prevention and Treatment. Join us for this summer’s International Conference on Nutrition in Medicine: Cardiovascular Disease, and click here for more information!