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Big Pharma, ED Drugs And "Pink Viagra"

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Big Pharma has made a number of breakthroughs over the years with new drugs to treat different forms of cancer, viral diseases, heart disease, diabetes, etc. However, the breakthrough that seems to be in the forefront of the minds of many industry critics has been drugs known as PDE-5 inhibitors such as Pfizer’s Viagra and Lilly’s Cialis, used to treat mainly erectile dysfunction. Recently in a New York Times op-ed piece, Llewellyn Hinkes-Jones said that Big Pharma was “funneling billions of dollars into erectile dysfunction drugs”. Another noted critic of the industry, Nobel laureate Joseph Stiglitz, once said in the British Medical Journal that drug companies spend “more on lifestyle drugs than on life-saving drugs.”

These are pretty damning criticisms coming from people of considerable reputation. But are they valid?

One cannot readily get exact figures across the industry about the amount of R&D being done in different therapeutic areas. However, one can make use of a surrogate: ClinicalTrials.gov. This website is provided as a service by the U.S. National Institutes of Health (NIH). The NIH describes this as “a registry and results database of publicly and privately supported clinical trials of human participants conducted around the world.” This is an invaluable source of information especially for patients and physicians who are seeking new treatment for a particular disease. For example, one can go to ClinicalTrials.gov, type in “diabetes” and a listing of 12,059 different trials will appear. This list is very comprehensive in that it will list not only drug trials but also the use of devices, diagnostics, palliative treatments, etc. all devoted to treating this disease.

ClinicalTrials.gov can provide a gross sense of the research being done in a field by simply looking at the number of ongoing studies. For example, there are 19,322 trials underway for heart disease, 6,437 for breast cancer, and 5600 for lung cancer. Surprising to me was the number of trials listed for erectile dysfunction – 385. However, when one looks at these trials, you quickly realize that few involve new drugs. A large chunk of these studies looks at erectile dysfunction resulting from treating prostate cancer by radical prostatectomies, radiation, or cancer drugs. While there are studies that investigate the PDE-5 drugs (Cialis, Levitra, and Viagra), these tend to be looking at the impact of these drugs in patients with diabetes or hypertension, as well as looking at the interactions of PDE-5 inhibitors with other drugs. What is striking is how few new approaches to erectile dysfunction are being pursued. Beyond new preparations of testosterone, there are things like “extracorporeal shock wave therapy” and “far infrared radiation” being investigated. There doesn’t appear to be anything new in the world’s drug pipeline for new erectile dysfunction drugs. So much for “funneling billions of dollars” into this condition.

However, maybe the industry has decided to invest its R&D resources into female sexual dysfunction (FSD) to find a “pink Viagra”. The idea of finding a drug for FSD is in itself controversial. On the one hand, there are those who believe that the whole idea of FSD is a “sham” and that this is an invention of the pharmaceutical industry designed to amass more profits.  An opposing view is represented by the “Even the Score” campaign that has drawn more than 24,000 supporters who believe that women deserve equal drug choices that are available to men when it comes to sex. The FDA held a two day meeting last October to hear both sides of the argument and to discuss the guidelines and hurdles that needed to be cleared for an FSD to gain FDA approval. 

One might think that this push for FSD drugs is being driven by Big Pharma. Once again, at look at ClinicalTrials.gov is helpful. There are listed 260 studies for FSD. More than a decade ago, PDE-5 inhibitors were studied in women. The rationale was that if drugs like Viagra enhanced blood flow to the penis to facilitate erections, perhaps this same mechanism would work to enhance blood flow to the clitoris, thereby treating FSD. Unfortunately, the PDE-5 inhibitors had no impact on FSD. Other methods to treat FSD are being pursued, such as acupuncture and vaginal electrical stimulation. Even a variety of testosterone preparations are being explored. However, there are drugs in late stage studies for FSD.  The most advanced is flibanserin (Sprout Pharmaceuticals), a drug that modulates select neurotransmitters in the brain believed to be related to female arousal. However, the FDA has twice rejected the New Drug Application for this drug because any modest benefit that it provides is outweighed by the drug’s side-effects. Another FSD drug being studied is bremelanotide from Palatin Technologies. This is an analog of a peptide hormone that activates melanocortin receptors in the brain. However, it must be administered by injection which might prove to be a drawback even if the trials turn out favorably.

It appears, therefore, that Big Pharma really isn’t funneling billions of dollars into erectile dysfunction drugs, nor is it spending more on R&D for lifestyle drugs than on life-saving drugs. Yet, when the pharmascolds make these assertions, they are universally believed. Perhaps part of the reason for this is the preponderance of ads touting Viagra and Cialis.  If true, this is an unfortunate consequence of this type of patient awareness campaigns. But if there are people who would really like to have access to a “Pink Viagra” for FSD, their hopes need to rest in small biotech companies. Big Pharma isn’t devoting much time and effort to this research.