The pharmaceutical industry isn’t exactly known for its ethical and responsible practices. While it’s irrefutable that modern medicine has significantly improved the quality and longevity of millions of lives, it would also be fair to say that the industry’s sordid history should lend itself to a swift policy reform.
People have become so critical of the pharmaceutical industry that it is often referred to as “Big Pharma” – a name that sounds like it was stolen straight out of The Godfather.
Their reputation is particularly suspect in the mental health arena where chemical imbalances and the efficacy of the drugs prescribed to treat these imbalances can’t really be measured. If you have cancer, a specialist can SEE the disease, MEASURE how much it’s spread, then prescribe medications and PHYSICALLY DETERMINE if said medication is working over time. The same is true with conditions like high blood pressure, eczema, and diabetes – the diagnoses and the treatments are easily quantifiable.
But with depression, anxiety, or bipolar disorder, it’s much harder to get the diagnosis correct because none of these things can be measured through tests. And even if a mental health disorder is verifiable, figuring out a course of treatment is a prodigious undertaking.
The reason pharmaceutical companies get such bad press in relation to mental health is because prescription drugs are often unnecessary, over-prescribed, and can sometimes exacerbate an already precarious situation.
In other words, while there is no denying that certain prescriptions are necessary for certain cases, it DOES seem like anyone who has trouble paying attention is fed Adderall or Xanax at alarming rates.
Even more disturbing is a very common practice carried out by doctors called “prescribing off-label.” In essence, this is the practice of prescribing a drug to mediate or extinguish a symptom that the drug is NOT intended for.
Now, to be fair, many popular and effective drugs that we use frequently today weren’t originally intended to be employed for such purposes. Take Viagra as an example. Originally intended to alleviate symptoms of jet lag, scientists noticed that “unprompted erections” were a commonly cited side-effect. This happy coincidence turned what would have probably been a marginally-profitable business into a multi-billion dollar industry.
And Viagra is just one example of a drug that was discovered by accident, so it’s not uncommon for drugs to have more than one purpose or value.
HOWEVER, it is HIGHLY unethical (and often dangerous) for doctors to prescribe a drug to treat a symptom that the drug hasn’t been cleared for by the FDA. But that’s exactly what’s happening and it’s a big issue.
Generally speaking, the FDA approval process for a medication is very time-consuming, expensive, and involved. Every new prescription drug has to undergo extensive clinical trials showing a direct benefit to the pre-specified condition before it can be made available to the public.
So, let’s pretend you are a pharmaceutical company and you’ve created a drug for gingivitis. You present this drug to the FDA as a treatment for bleeding gums. It finally is approved specifically to treat gum disease, but through the process, you’ve noticed that almost everyone in the clinical studies has noted “loss of appetite” as a side-effect. You realize that this drug might be just as effective as an appetite-suppressant/weight loss pill as it is for helping with gum disease, but you don’t want to spend copious amounts of time and money getting this drug cleared to treat obesity. Instead, you just hint to doctors that, while this little pink pill is great at treating gingivitis, it just so happens that you can also lose a lot of weight while taking it. You know, just an added bonus! *wink-wink, nudge-nudge*
While federal law prohibits a drug company to advertise treatment of any symptoms not established by the FDA, there are no laws that forbid doctors from prescribing the drug for alternative reasons. For years, pharmaceutical companies have encouraged this practice even though the use of their drug for an ailment NOT cleared by the Food and Drug Administration is about as irresponsible as it sounds.
In 1999, a group of Stanford researchers found that 20 percent of all prescriptions were written “off-label”, such as using a popular anti-seizure medication to treat ADHD. The study also estimated that the annual American gross-profits for off-label prescription drugs were in the range of $44 billion (which is probably a conservative number considering it’s almost impossible to get an accurate reading on how and why doctors are prescribing certain medications.)
To add to this precarious situation is the reality that most patients don’t even REALIZE they are taking a drug, “off-label.” We trust that doctors know what they are doing, so if they tell us to take medicine for a problem we’re having, the likelihood of someone saying, “wait, is this drug actually meant to treat my symptom?” is very unlikely.
Shady, off-label implementations have resulted in multiple, class-action lawsuits, but that hasn’t seemed to slow down Big Pharma.
Bottom line: Don’t be afraid to ask your doctor or psychiatrist questions. If they are vague or seem put-off by your inquiries, find someone new. Your health isn’t worth putting in jeopardy because you don’t want to make waves with your medical practitioner. Be vigilant, stay informed, and if you’re ok taking a drug “off-label”, be hyper-aware of any differences in your mood or physical state.