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Big Pharma: A Real War against Drugs
by Joseph Grosso
The news on September 3 didn't even receive a front page headline in the New York Times. In fact it didn't even flash across the headlines of the Times Business Section. This is strange if only due to the fact that the news did have the novelty of involving the largest criminal fine of all time. That was what the pharmaceutical giant Pfizer, the world's largest drug maker, agreed to pay in a settlement with the Justice Department over unlawful prescription drug promotions. The fine itself came out to $1.2 billion. Plus Pfizer must pay another $1 billion to compensate Medicaid and Medicare which, along with a criminal forfeiture, totals $2.3 billion.
The criminal charge is related to a painkiller called Bextra, considered a Cox-2 inhibitor, which was pulled from the market back in 2005 due to mounting evidence that it increased the risk of heart attack, stroke, and death. According to the government, Bextra and several other drugs were promoted as treatment for medical conditions beyond the conditions for which the FDA had approved their use. It was the fourth such illegal marketing settlement for Pfizer in the last decade, and much like the other three it hardly put a dent in its fortunes - $2.3 billion amounts to less than three weeks of Pfizer sales - as its stock declined a mere 14 cents on the very day of the settlement, and the company announced plans to acquire rival drug maker Wyeth for $68 billion.
In the pharmaceutical industry, Pfizer may be the largest shark but it's hardly a solitary rogue when it comes to this sort of thing. In January of 2009 Eli Lilly coughed up $1.4 billion for its illegal marketing of Zyprexa, an anti-psychotic with the usual slew of side effects. Since 1992, more than a dozen drugs have been pulled from the market or had strict limits put on their use.
In the pharmaceutical industry, Pfizer may be the largest shark but it's hardly a solitary rogue.
Back in 1976, Henry Gadsden, chief executive of Merck, lamented to Fortune magazine the tragedy that his company's market was limited only to those who were afflicted with illness when his dream had long been to sell to healthy people, therefore having a market that potentially included every person in the world. Well one can imagine the internal chuckle Mr. Gadsden would have enjoyed scanning the New York Times front page on September 2, 2009 (a day before the Pfizer settlement was announced) where it was gloriously revealed, this in a headline of course, "Taking Big Risk for Big Payoff, Industry Seeks Cancer Drugs." The article bluntly explained that, after years of the industry ignoring the fatal disease, recent scientific breakthroughs and the opportunity to charge people dying from cancer outrageous amounts of money was finally too tempting to resist.
It's ironic that the Times alludes in passing that drug companies have become perhaps the most powerful force in the country by fulfilling Gadsden's utopian vision of treating the healthy. Through infinite amounts of marketing and promotion, including consumer advertisements in the form of countless TV ads the kind of which are illegal in all other industrial nations (except New Zealand), and even more effort aimed at co-opting the medical establishment through high paying consulting jobs and "continuing education" seminars for doctors as well as an army of sales people pushing their wares all over the country, drug companies have built vast empires selling mostly the same potentially dangerous drugs of questionable effectiveness under different brand names for allegedly chronic, so-called "lifestyle" conditions, the number of which continues to grow practically exponentially.
Further from the edge of life and death, the top selling prescription drug in the US in 2008 was Pfizer's anti-cholesterol drug Lipitor, which brought in $7.8 billion according to IMS Health. Lipitor was far from the only cholesterol drug, known as statins, to reap billions as AstraZeneca's Crestor saw its 2008 sales jump 30% to $3.6 billion. Such cholesterol drugs were the most profitable class of pharmaceuticals in the world for the past decade. While guidelines for what should be considered "normal" levels of cholesterol were continuing to be lowered, often by medical panels full of doctors with numerous financial ties to pharmaceutical companies, the companies saw gold. In her book The Truth about the Drug Companies, former New England Journal of Medicine editor Marcia Angell explained the process:The original statin, Merck's Mevacor, came on the market in 1987. It was a truly innovative drug, based on research in many university and government laboratories throughout the world... Other companies were quick to produce their own statins. Mevacor was joined by the same company's me-too drug Zocor, Pfizer's Lipitor, Bristol-Myers Squibb's Provachol, Novartis's Lescol, and now Crestor... There is little reason to think one is any better than another at comparable doses.
The key to getting a toehold in the market, according to Angell, was either to test me-too drugs for slightly different outcomes in slightly different kinds of patients, then promote the statin for those uses, or to compare new statins to older ones at nonequivalent strengths - to test a higher dose of a new statin against a lower dose of another one. The marketing machines, whose budgets within companies far exceed the research ones, take over from there, usually taking the form of paid celebrities leading awareness campaigns (while not acknowledging that they're on the take of whatever drug company patented the drug they're promoting), ghost written essays in medical journals, and saturation of TV and print with advertising both sunny and fearful at the same time.
In Our Daily Meds, Melody Peterson described just how widespread the production of me-too drugs has been:Between 1990-2004 the FDA's Center for Drug Evaluation and Research approved about 1100 new drugs. Only about 40% of them were actually "new," or what the FDA called a new molecule entity. In addition, federal regulators found that most of these "new molecular entities" were not significant improvements over the medicines already being sold. Only 183 drugs, or about 16%, were actually new and significant. The rest were nothing more than me-too drugs or drugs for which there was no need.
The same kinds of shadiness can be seen in the class of drugs that has recently replaced the statins at the top of the sales charts. This year will see the publication of the new edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V), the field bible for mental health professionals. If earlier editions are any indication, the latest one will feature a slew of newly established disorders all to be treated with the latest anti-depressants or anti-psychotics. DSM-IV featured, among others Dysthymic Disorder [defined by the online Mental Health Encyclopedia as "a mood disorder with chronic (long-term) depressive symptoms that are present most of the day, more days than not, for a period of at least two years"], Oppositional Defiant Disorder ("an ongoing pattern of disobedient, hostile and defiant behavior toward authority figures which goes beyond the bounds of normal childhood behavior"), and Schizoid Personality Disorder ("a condition characterized by excessive detachment from social relationships and a restricted range of expression of emotions in interpersonal settings"). Anti-psychotics such as Zyprexa from Eli Lilly and Seroquel ($3.8 billion in sales in 2008) may not yet be the household names that Prozac, Ritalin, Paxil, Zoloft and Sarafem are, but still are mega-blockbusters, a blockbuster being the code word for a drug that pulls in more than a billion in sales.
DSM-V...will feature a slew of newly established disorders all to be treated
with the latest anti-depressants or anti-psychotics.
Other disorders, both mental and physical, conjured up or legitimized in recent years include Social Anxiety Disorder, Premenstrual Dysphoric Disorder, Irritable Bowl Syndrome, Estrogen Deficiency disease, Osteoporosis, not to mention the always stretching boundaries of ADD (see Adult ADD) and ADHD to include more and more drug takers. It can't be said that the effort of branding new disorders and expanding the very concept of what disease is has been a failure for the drug companies. Prescription drug use has skyrocketed over the past two decades. Americans now spend money on prescription drugs in amounts that equal or surpass the amount spent on higher education and automobiles. Their profits enable the drug companies to have a death lock over the country's political process. The predictable flipside being that, according to a 2005 survey by the National Center on Addiction and Substance Abuse, the number of Americans who admitted to abusing prescription drugs doubled from 1992-2003.
While American children living in the suburbs get pumped with medication for all sorts of overstated or marketed illnesses, children living in the planet's rapidly expanding slums perish of preventable digestive-tract diseases rooted in contaminated drinking water and overall polluted conditions. In sub-Saharan Africa alone, neglected tropical diseases (NTDs) are the most common conditions affecting the region's poorest 500 million people. A recent assessment published in the journal PLoS Neglected Tropical Diseases estimates that hookworm, an infection that weakens immune systems and causes anemia, occurs in 40-50 million school-aged children. Schistosomiasis, the second most prevalent NTD, claims 192 million victims and is "possibly associated with increased horizontal transmission of HIV/AIDS." There are many others (Lymphatic filariasis, onchocerciasis, roundworm) often overlapping in the same individuals.
It's a tale of two worlds: one overmedicated, while one is largely left to suffer debilitating conditions in silence due to the fact they can't fill the coffers of drug companies. (Research for NTD treatments, as well as for other deadly diseases like AIDS is often performed under government funded initiatives like the NIH; breakthroughs are later usually licensed to drug companies without any price control requirements.) Perhaps Henry Gadsden just forgot to mention that his dream was not only the sale of drugs to healthy people, but to the well-off; or maybe that was simply implied as an obvious fact. For all the rhetoric about healthcare "reform" shouted in recent months, it seems that real reform would begin with an industry that for years has been making healthy profits by making the rest of the planet sicker.
Joseph Grosso is a writer and librarian living in New York City.
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