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When pharmaceutical companies create a new drug, they are always looking for compounds that treat specific profitable disorders, especially if they have the potential for blockbuster status. Patent life is 20 years after the drug has been identified as viable in clinical trials – this means that no one else can make or sell the medication during that time.1

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For this reason, pharmaceutical companies prep the marketplace for years prior for a successful launch with maximum impact and profit.

By the time a drug launches, doctors are ready to write prescriptions for that drug, and patients are primed to ask their doctors for it. Because it’s a name brand drug, the price is high, and pharma will want to keep that price point by protecting and extending their patent exclusivity as long as possible.

Pharma protects their patents in a number of ways. One option is to negotiate with generic drug manufacturers, asking them not to release their own versions for a set amount of time and money. Another way is to extend a patent by finding a new indication for it, thereby buying it another lifecycle as a brand name drug that sells at full premium price. In order to find this new indication, pharmaceutical companies have to get creative.

Pharma has found it profitable to create new illnesses to treat with successful existing drugs. An example of this phenomenon is Eli Lilly’s selective serotonin reuptake inhibitor (SSRI), Prozac. Prozac was originally launched and achieved blockbuster status with an indication for depression. The target market was doctors who specialized in central nervous system (CNS) disorders, Family Practitioners, and on the patient side, anyone who suffered from depression. As the first SSRI on the market, Prozac was hugely successful and widely prescribed for mild, moderate, and severe depression. In the USA, annual sales were $350 million in the first year alone and peaked at $2.6 billion a year.2

Doctors were also encouraged by Lilly’s pharmaceutical sales reps to prescribe Prozac for other “off label” uses. Off label uses are any symptoms that the drug is not indicated for and that haven’t been tested in clinical trials. Examples of off label use of an anti-depressant would be obsessive-compulsive disorder (OCD), posttraumatic stress disorder (PTSD), premenstrual dysphoric disorder (PMDD), social anxiety disorder, and panic disorder. It is interesting that prior to Prozac, there was no such “disease” as PMDD. Prozac was also recommended to be prescribed for shyness, fear of public speaking, and other non-medical conditions. And, patients were encouraged to ask for Prozac for these types of mild social phobias, making the drug very successful and profitable.

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Because Prozac impedes sexual function, it is also recommended for premature ejaculation. Now that Prozac (fluoxetine) has gone generic, it is also prescribed off label for bulimia, post-partum depression, premenstrual syndrome, fibromyalgia, body dysmorphic disorder, pathological laughter or crying, narcolepsy, agoraphobia, trichotillomania (hair pulling disorder), seasonal affective disorder (SAD), and many other ills that plague the “worried well.”

“Nothing is as lucrative as a product that someone is desperately dependent on. And, nothing is better than getting those on board who aren’t even ill.”

– John Virapen, in his whistleblower book, “Side Effects: Death Confessions of a Pharma Insider” 

Merck developed a drug treatment for benign prostatic hyperplasia (enlarged prostate, commonly referred to as BPH) named Proscar. Interestingly, Proscar was found to grow hair, and was launched as a brand new drug called Propecia for male pattern baldness which was now being positioned as a treatable “disease.” In reality, male pattern baldness is not a disease, it’s a common genetic condition. Gradual hair loss is a normal part of the aging process for many men. But, if repositioned as a disease that can be cured, it presents a huge market to be exploited for Merck.

Unfortunately, growing hair with the use of medication carries risks. In clinical trials, Propecia was found to cause sexual side effects such as decreased libido, erectile dysfunction, and ejaculation disorder. The drug launched anyway to a prepared eager-to-grow-hair target market. What the manufacturer failed to disclose in the prescribing information (PI) was that those adverse events often lingered even after patients discontinued use of the drug. At least 700 lawsuits are pending in New York State with more to come in New Jersey. The issue is that Merck knew that the adverse events would persist after patients ceased use of the drug, and they hid that information from the public.3

Pharmacia (now Pfizer) created a compound that would later be marketed as Genotropin. This drug is a human growth hormone that is targeted at “slow growing” children.4 The brand team primed the marketplace for the drug by appealing to parents of small children, essentially insinuating that being short was, in fact, a disease. Stats were gathered and a case was built that taller adults have more confidence, enjoy more advantages like promotions and raises, and generally earn more money than their shorter coworkers. What parent would want their child to miss out on those advantages? What the manufacturer failed to disclose is that there are serious side effects that come along with the use of growth hormone in a child’s developing body.

The off-label use of Genotropin was supposed to be the real cash cow. The goal of the Product Managers was to tap into the beauty market by promoting human growth hormone as an anti-aging breakthrough, attempting to relabel the entire process of aging as a disease process in need of pharmaceutical treatment. Researchers had hopes that clinical trials would demonstrate the compound stimulated the growth of muscle mass and decreased fat. Those trials never bore fruit, and Pfizer was unable to push that off label use. But it doesn’t mind promoting Genotropin to orthopedists to inject into the joints of injured athletes who are looking to recover quickly from sports injuries. Using human growth hormone may cause such side effects as pain in joints and muscles, arm and leg swelling, carpal tunnel syndrome, and gynecomastia in men (breast enlargement), and may also lead to heart disease and diabetes.5 These side effects were seen in older people rather than younger, but isn’t it older people who are more likely to take the bait of aging as a disease?

The trouble with prescribing any drug for off label use to treat a newly created disease, such as aging, is the potential for adverse events and even death. This is especially risky if that drug is prescribed by a General Practitioner who isn’t monitoring the patient for a specific disease the way a specialist would. Creating pseudo-diseases to increase profits isn’t about patient health. It’s about pharma wealth.

SOURCES

1 http://www.drugsdb.com/blog/how-long-is-a-drug-patent-good-for.html

http://archive.fortune.com/magazines/fortune/fortune_archive/2001/08/13/308077/index.htm

3 https://www.drugwatch.com/propecia/

4 http://www.genotropin.com/

5 http://www.mayoclinic.org/healthy-lifestyle/healthy-aging/in-depth/growth-hormone/art-20045735


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