Monday, July 09, 2012

Pharmaceutical Greed and Its Consequences

At the end of last week, a major news story remained largely uncovered and unaddressed in the media. The massive British pharmaceutical company, GlaxoSmithKlein, was force to pay $3 billion dollars to rectify flagrant health care fraud. The U.S. Justice Department strongly pushed the prosecution of criminal and civil offenses. Unrepentant to the end, the drug maker made no apologies.

From a period that ran from the late 1990's into the early 2000's, the corporation engaged in extensive, willful deception. It pushed ten of its prescription drugs as treatments for ailments, diseases, and disorders that it simply did not treat. None of these off-label uses were approved by FDA.

Most of the settlement involved three specific medications. Two of them are antidepressants and another, Avandia, was developed to treat diabetes. Major names were paid to promote claims that had no basis in fact. One of these was radio personality Dr. Drew Pinsky, who was reimbursed to extoll the virtues of Wellbutrin.
Dr. Pinsky is only one physician mentioned in the U.S. government's complaint. It also accuses a number of other doctors of taking large payments from the drug maker and improperly plugging its drugs, including one doctor who received $2 million from Glaxo between 2001 and 2003. The complaint says the physician, James Pradko, gave hundreds of talks to doctors and Glaxo sales reps about depression and frequently made "off-label claims" about Wellbutrin's effectiveness against a number of conditions for which it isn't FDA-approved, including weight loss, chronic fatigue syndrome, erectile dysfunction and chemical dependencies.
The 99% devotees will take this news as additional proof of corporate greed and a society dominated by the wealthy. Anti-Romney types will bring up once more the Republican candidate’s assertion that corporations are people. All people are equal, but some are more equal than others. Both of these comparisons hold up under scrutiny, but there are multiple lessons to be learned here; lessons which exceed the same familiar populist arguments predicated on class envy. Time Magazine has broken down what was a complicated decision. On the subject of the antidepressant drug Wellbutrin,
Glaxo used the help of PR firms and the appeal of lavish vacations to convince medical professionals to prescribe the antidepressant Wellbutrin for weight loss, sexual dysfunction, drug addiction and ADHD, even though the drug is FDA approved only to treat depression. Tavy Deming, an attorney for one of the whistle blowers, told the AP that during a regional meeting of sales representatives in Las Vegas in 2000, the reps were told to promote Wellbutrin as the drug that makes patients “happy, horny and skinny,” as part of a national slogan repeated to doctors.
Big Pharma has long been accused of similarly unethical tactics, but for the first time, one of its largest offenders has been caught red handed and forced to pay out as punishment. But the judgment, satisfying though it is, reveals a paradox in my own life. I cannot live without the innovation driven by revenue streams that then develop new and more effective prescription drugs.

I struggle daily with a series of chronic illnesses, and an essential part of my life involves taking medications on a regular, frequent basis. The cost alone for some medications is highly prohibitive and out of the reach of far too many. I am fortunate to have health insurance, otherwise, I’d not have access to the drugs that keep me at an even keel. My health would suffer, and I wouldn't be able to maintain a more or less normal life.

I’ve been prescribed Wellbutrin on a few occasions. It is often given to patients with bipolar disorder, like me, who need to keep depression away but don’t want to be flung into a state of mania. Under the trade name, Zyban, it’s given to cigarette smokers who want to quit. Its effects are relatively mild, though some have experienced significant side effects. To counter some of the more ridiculous claims, it certainly isn’t an aphrodisiac. Any antidepressant by its basic nature will cause sexual side effects, some of them extreme. 

Another example follows: until the last few months, no generic alternative existed for the powerful drug Seroquel. An atypical antipsychotic, it contains an FDA approved antidepressant quality and, more importantly, is sedating enough to allow me to sleep through the night. It has been a godsend for many manic depressives whose illness has transformed them into insomniacs. Sleep aids must be prescribed when natural sleep becomes impossible.

That's the good part of this thorny issue. There's a dark side to all of this, too. Originally released in 1997, Seroquel was owned by AstraZeneca, another huge drug company. It kept sole control of Seroquel for fifteen years. Patents were extended and palms were greased to squeeze out the maximum amount of revenue possible for as long as could be maintained. Accordingly, AstraZeneca set the price of Seroquel around $1,000 for a thirty day supply.

I added it up the other day. Without insurance, my prescription costs could be as high as $2,000 per month. This doesn’t even begin to take into account doctor’s visits, the cost of procedures and tests, and the occasional ER visits. Companies like GlaxoSmithKlein are responsible for driving up healthcare costs for everyone when they insist upon charging excessive prices for their products. The industry has seldom been properly regulated. This court case might signal the beginning of real change, or it may go no further than this.

Because the pharmaceutical industry does trillions worth of business a year, $3 billion dollars in fines can easily be absorbed. That’s chump change to them. As much as I wish the court order might serve as some practical deterrent, I have developed a cynical side over time. This decision may influence behavior for a while, but I fear that it won’t go much farther than that.

I am reminded in this instance of the patent medicine boom of the late 19th Century. Mail-order remedies for a variety of ailments promised immediate and instantaneous relief. Upon chemical analysis, these snake oil curatives were discovered to be comprised mostly of opium or alcohol. Yet, the virtues of these remedies were advertised by hyperbole for decades until formal, effective reform legislation was passed. The Pure Food and Drug act of 1906 sought to eliminate poisonous or addictive elixirs and cure-alls. We are past time for another round of needed reforms. To return to the Time article,
Although the antidepressant Paxil is not approved for patients under 18, Glaxo illegally marketed the drug for use in children and teens, offering kickbacks to doctors and sales representatives to push the drug. A government probe was launched in 2002, and it was discovered that Paxil, as well as several other antidepressants, were no more effective than placebo in treating depression in kids. Indeed, between 1994 and 2001, Glaxo conducted three clinical trials of Paxil’s safety and efficacy in treating depression in patients under 18, and all three studies failed to pass muster.

Children, the most vulnerable among us, are usually handled gently when it comes to medication. That is what makes this particular abuse difficult to swallow. But, neither should this discourage the use of prescription drugs for children when they are needed. Reactionary decisions, for example, those that would deny kids routine immunizations out of fear that they might develop Autism are one such example. I developed clinical depression when I was 15, and was given medication at that age. The meds kept me alive. Talk therapy alone was not sufficient.

Many people pontificate endlessly about a nation inclined to overmedicate. They speak of doctors who over-prescribe with reckless abandon. These alarmist views have some basis in fact, but they don’t often take into account the full picture. It isn’t medication or medical advances that are the issue, it’s the greed that goes in into making such astronomical amounts of revenue. Nor should we forget the private slush funds that are standard practice for these corporations. They have been used so successfully to buy off doctors, manipulate medical data, and hire authoritative, trusted voices to peddle their wares.

I learned a long time ago that pharmaceutical malfeasance was a necessary evil, at least as far I was concerned. I’ve developed my own justification to address a situation over which I have no control. The company that makes money hand over fist will be more financially able and willing to invest in newer, more effective drugs. Or, at least, that’s what I tell myself. In this capitalist wilderness, the contradictions and mutually parasitic relationships evident in the process may always be present.

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