Big Pharma: The business of curing what ails you (Part 2)

*Author’s Note: I wrote this for a Sociology class at WSU, but found the issues are still relevant. Furthermore, all of the complaints, regulations and legalities regarding marijuana, tobacco and perhaps even e-cigarette use are hypocritical considering our history of prescribing much more potent substances.

Part One of this post.

FDA Approval

For those wondering where the FDA is in all of this, the simple answer is that they are right there alongside the pharmaceutical reps, working hand in hand. Studies that determine the safety and efficacy of prescription drugs are organized and funded by the major pharmaceutical companies (Mosher, 2007). In 2007, it was estimated that ninety-percent of the clinical research was “sponsored by drug companies” (Murray, 2009, p.18). For example, the majority of researchers on the panel for Paxil development and evaluation were psychiatrists, all of whom had financial ties to major pharmaceutical companies (Burwell &Stith, 2008, documentary).

A study published in 2010 found significant financial gifts (up to 69 percent of overall funding) in the state of Vermont between pharmaceutical companies and specialists in psychiatry (Chimonas, et al. 2010). Although all these are covered by “disclosure laws,” which maintain that it is acceptable to have a conflict of interest in this scenario as long as it’s openly stated, it can and should make the average citizen question the validity of research being done in the field of psychiatry.

Furthermore, while it’s no secret that document review procedures are often inefficient within drug companies (Bernhardt, 2003), the public has it all wrong if they suppose that the studies done on their antidepressants are strictly scientific. When JAMA (Journal of the American Medical Association) evaluated the research quality, they found an overwhelming bulk of medical studies “[contained] false or misleading statistics” (Murray, 2009, p.17).

The Birth, Usage and Expansion of the DSM

It has been argued that the prevalence of psychiatric drugs in particular arose out of the increasing pressure on psychiatrists to produce evidence-based practices for actual diagnosis, in order to be seen as providing “cures” in the same way as most medical practitioners (Burwell & Stith, 2008, documentary). They needed official guidelines for mental illnesses, and they needed viable treatments. Enter the DSM (Diagnostic Statistical Manual). The first edition consisted of just over 100 mental disorders, quite a step up from the vague general label of lunatic. Now, with the release of the DSM-V, we currently have about 300 mental illnesses. With such numerous options for mental maladies, who couldn’t find a disorder for which they might need a pill?

That is why DTC Advertising has become such a hot topic. With television ads telling us to consider “talking to our doctor” about every other human peculiarity, it is no wonder that one out of eight who ask for and receive a medication first learned about it via advertising (Landers, 2001, as cited in Mosher, 2007, p.343). The odds of finding a disorder might also substantially increase with the expansion of what is considered abnormal.

Over-Diagnosis and Its Effects on Vulnerable Populations

Recently, the media has come out with multiple reports about the changes in the fifth and newest edition of the DSM. Some of these changes include: Disruptive Mood Dysregulation Disorder (temper tantrums), Major Depressive Disorder (bereavement following the loss of a loved one), Binge Eating Disorder (eating too much twelve times in three months), and Adult Attention Deficit Disorder, just to name a few. (Frances, 2012). Of course, the implications of the changes are that you may be slapped with a label and medicated with greater ease.

While senior citizens remain one of the most directly affected by over-diagnosis for physical ailments (Murray, 2009, p.11), these changes in psychiatry guidelines and practices have resulted and will continue to result in yet another fragile population, children, being prescribed drugs for everything from over-activity to emotional outbursts.

In 2011, I saw this firsthand while working in a residential home for foster children who were either newly in the system, or had extreme behavioral issues that prevented a family placement. Out of the twelve children from ages 6-12, all but one were on at least two medications. Given that they were all victims of some form of neglect or abuse, I would have expected therapy rather than a medical diagnosis, or at least an admission that therapy would be the preferred method of dealing with their various methods of acting out. The opinion among staff members was to the contrary. In addition, I was trained in how to count, record and track their medication each day, just to make sure that no counselors were stealing and using supposedly “harmless” medication.

I couldn’t help but wonder why they were worried about staff members wanting access to medication that was apparently safe for young, developing minds.   If it was potent enough for adults to be affected, it should not have been given to children after the first visit with a child psychologist present, followed by a recommendation to a psychiatrist. Perhaps the most troubling aspect of this particular example is that the children in foster care represent one of the most vulnerable demographics.

As noted in the earlier reference to the DSM-V changes, finding a disorder has not been — and will not be — difficult. Without blood tests that “prove” someone has Obsessive Compulsive Disorder, psychiatrists are obligated to diagnose according to their manual. This obviously influences how quickly and easily a child can be diagnosed with anything from ADHD to Bipolar Disorder. In a study published in 2012, it was found that children undergoing tests for Central Auditory Process Disorder had different results depending on the testing method. In this case, the results ranged from 7.3 percent being diagnosed as positive to 96 percent with a positive diagnosis. When the tests methods were strict, a mere 7.3 percent were diagnosed, whereas with lenient testing, they (obviously) arrived at a much higher percentage. Both testing methods were considered scientifically and medically valid (Wilsona&Arnotta, 2013). It is only common sense that if lenient testing can be applied and yield a higher (aka: more profitable) number, then that is the testing method psychiatrists may be more apt to use.

Defining Legal

It is almost ironic to call pharmaceuticals “legal” drugs. There must be reasons, after all, why such powerful entities would need to pay for faulty research to support their practices.

In 2002, Japanese patients began reporting negative side effects from Zyprexa. Eli Lilly & Co. was then ordered to place warning labels on the drugs. More recently, lawsuits against them in 2006 have shown little positive change within the company. Fearing that this would impact sales, not only did they try to hide the adverse effects of the drug, but they “pursued a strategy of creating a shadow science to drown out noncompany-sponsored (and competitors’) research reports [on the adverse effects]” (Applbaum, 2010).

In 2003, GlaxoSmithKline overcharged Medicaid for two commonly used drugs, resulting in an $87.3 million payment. Bayer also overcharged for an antibiotic, and was fined $257 million for violating federal laws (Petersen, 2003, as cited by Mosher, 2007, p.346-347).

Though no lawsuits were filed, Pfizer was directly addressed by the World Health Organization in 2003 for launching a misleading ad, which Pfizer did not correct (Moynihan &Cassels, 2005, p.14). Pfizer did however end up paying the federal government $430 million after off-label marketing drove Neurontin’s sales up to $2.7 billion, all with inaccurate, partial and misleading information (Murray, 2009, p.19).

And that short list is just the tip of the iceberg in pharmaceutical misconduct.

Death of the Hippocratic Oath

From excessive marketing of prescription drugs to criminal practices such as delaying generic drug release, off label usage, misdirection of profit,and product review ghostwriting, pharmaceutical companies are doing more harm than good.

People are dying at alarming rates due to prescription drug abuse, misuse and overdoses. Annually, over 100,000 U.S. citizens died from known side effects while taking prescribed drugs in exactly the way they were instructed. (Perdomo, 2010) This does not count those who abuse prescription drugs, those who steal a friend or family member’s prescription medication, or those who overdose intentionally. However, the prevalence of those who abuse prescription drugs is another troubling statistic. In a 2009 CBS news report, one in five teenagers admitted to abusing prescription drugs (Couric, 2009). Between 1999 and 2008, the number of deaths attributed to legal drugs rose from 4,000 to 15,000, and the CDC has now labeled prescription drug abuse an epidemic (Sabet, 2012).

To put that in perspective, the number of people dying from prescription drug use or abuse more than doubled, and quite nearly tripled during that short time frame. If the United States is so fervently anti-drugs, and if pharmaceutical drugs are medical and scientific, then either the doctors aren’t paying attention, the patients aren’t paying attention, or the medical field has been dominated by Big Pharma.