In 1874, hoping to springboard off the success of a drug it had invented 45 years earlier called Aspirin, German pharmaceutical manufacturer Bayer AG invented a new drug. They began marketing it in 1898 as a cough syrup, taking the name for their new wonder drug from the German word heroisch, or “heroic.” They gave out free samples to doctors and to patients, and soon it became more popular than their best seller, Aspirin. In fact, people seemed almost desperate to buy it. There is a reason; the new drug was called Heroin. Bayer ended the production and sale of Heroin in 1913 and since has carefully deleted all mention of it from the official history of their company. Heroin was outlawed in 1924.
In 1996, Purdue Pharma, a pharmaceutical company based in Stamford, Connecticut, took an existing medication that had fallen out of patent, added a time-release element to it, patented it, and began to market it as a general painkiller. They promoted the idea that, although it was technically a member of a class of opioid drugs so strong that they were usually reserved only for the terminally ill, they could release it widely because it was so difficult to abuse that the risk of addiction was “under 1%.”
That drug was called OxyContin. In June of 2012, a report by the U.S. Senate listed it as one of the biggest drug threats facing America, accounting for hundreds of thousands of cases of addiction, and almost 15,000 deaths. Unlike Bayer, which disavowed itself of Heroin and stopped selling it when its addictive qualities were discovered, Purdue Pharma sold 2.8 billion dollars worth of OxyContin this year. They have also recently commissioned a new series of pediatric clinical trials designed to better enable them to market and sell it to children.
The abuse of OxyContin – by Purdue Pharma and by addicts
It’s not that OxyContin didn’t work as a painkiller. It worked remarkably well, enabling many people suffering from severe chronic pain to deal with the reality of near-constant pain and manage it, sometimes for the first time in their lives. It worked so well, in fact, that Purdue Pharma, hoping to enlarge its market for the drug, began a systematic program of what is called in the pharmaceutical industry misbranding – advertising and promoting OxyContin widely among physicians for off-label use.
That is, rather than encouraging doctors only to prescribe it only for the conditions for which it is certified on its FDA-approved label, Purdue Pharma urged the doctors to prescribe it for lesser conditions, such as ordinary headaches or back pain. This is the same practice for which British pharmaceutical giant GlaxoSmithKline was ordered to pay the largest fine in pharmaceutical industry history –3 billion dollars. In 2007, Purdue Pharma was slapped with a similar – but smaller, a mere $634 million – fine for misbranding OxyContin. This fine was largely looked upon as a “slap on the wrist,” since it accounted for less than half of Purdue Pharma’s yearly sales of OxyContin.
The other problem was that OxyContin was not nearly as difficult to abuse as had been claimed. All that was necessary to do so was to strip off the waxy coating on the pills, crush them up, and then chew or snort the resulting powder or dissolve it in water like heroin and inject it. This “ease of abuse,” together with the ease of obtaining OxyContin from doctors, led to widespread use of the drug by addicts. Purdue Pharma claimed to have “solved the problem” by remanufacturing the OxyContin pills such that they were harder to crush and abuse, but DEA officials and health care professionals say that it hasn’t worked; there is still as large a market for the illegal uses of the drug as there is for its legitimate use. This has led many pharmacies to stop carrying OxyContin altogether, a “solution” that often makes it impossible to obtain by sufferers of chronic pain for whom the drug has legitimately been prescribed.
So the situation is a mess…but what was that you said about children?
That’s the scariest part of this whole thing. OxyContin, although it has its legitimate uses, is an opioid, and thus habit forming. Purdue Pharma has recently begun paying for dozens of clinical trials around the country to perform studies on the effects of OxyContin on children. They claim that this is being done out of their concern for the large number of children who suffer from chronic pain, or even headaches.
Critics of Purdue Pharma point out that the real reason for such pediatric trials may be twofold – first, to develop new markets to enable them to sell more of the drug, and second, to find an “end run” around the fact that their original patent on OxyContin will expire in April of 2013. At that point, Purdue Pharma loses its ability to be the sole manufacturer. By “rebranding” it as a drug for children, they hope to be able to perpetuate their exclusive hold on a lucrative market.
Health care and addiction specialists have expressed their concern about administering an admittedly habit-forming and possibly addictive drug to children. At least one study performed at the University of Michigan found that children who are prescribed opioids early in life are much more likely to abuse painkillers and other drugs as they grow older.
From their side, Purdue Pharma dismisses these concerns as “overblown.” They point to “studies” of dubious authenticity “proving” that addiction to opioids used for pain management is very rare. Then again, Bayer AG said pretty much the same thing about Heroin for over 15 years.