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.
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
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
"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,
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.
Now that Prozac (fluoxetine) has gone generic, it is also prescribed off label for,
...and many other ills that plague the "worried well."
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
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.
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 goal of the Product Managers was to tap into the beauty market by promoting human growth hormone as an anti-aging breakthrough, attempting to re-label 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,
...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?
Creating pseudo-diseases to increase profits isn't about patient health.
It's about pharma wealth...