Big Pharma: A Real War against Drugs

The news on September 3rd 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 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, all comes to $2.3 billion.

The criminal charge 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 which the FDA had approved for them. 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 3 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. The deal is expected to be finalized before the New Year.

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 this year Eli Lilly coughed up $1.4 billion for its illegal marketing of Zyprexa, an anti-psychotic with the usual slew of side effects; and Bextra being pulled from the market was hardly an isolated case. Since 1992 more than a dozen drugs have been pulled from the market or had strict limits put on their use.

Back in 1976 Henry Gadsden, chief executive of Merck, just before retirement 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 2nd, 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 explains 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 is 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 continue to grow practically exponentially.

Further from the edge of life and death the top selling prescription drug in the U.S. 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 one’s at nonequivalent strengths – to test a higher does 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 and 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 Zyprexa from EliLilly 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.

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 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. Why put all of them under the banner of ‘Neglected’? The WHO webpage puts it thusly:

The misery caused by neglected tropical diseases is largely hidden. Affected people live almost exclusively in remote rural areas and sprawling shantytowns, where lack of safe drinking water, poor education, poor sanitation, substandard housing and where access to health care may be virtually non-existent… Neglect also occurs at the level of research and development. The incentive to develop new diagnostic tools, drugs, and vaccines is low for diseases with a market that cannot pay.

It’s a tale of two worlds: one overmedicated, one 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 librarian and writer who lives in Brooklyn, New York. Read other articles by Joseph.

11 comments on this article so far ...

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  1. David said on September 12th, 2009 at 9:21am #

    Mr. Grosso:

    Thank you for this excellent article. By my reading, it is both valuable and accurate.

    I remain perplexed as to how to solve this dilemna, though. Perhaps the current state of affairs is just what was inevitable here.

    We may have to rely upon the good will of foreign governments to reign in corporate America. It is obvious that our elected officials have no interest in doing so.

    Thanks again for your efforts.

  2. Daniel Haszard said on September 12th, 2009 at 9:35am #

    “FIVE at FIVE”

    The Zyprexa antipsychotic drug,whose side effects can include weight gain and diabetes, was sold for “children in foster care, people who have trouble sleeping, elderly in nursing homes.” Five at Five was the Zyprexa sales rep slogan, meaning 5mg dispensed at 5pm would keep patients quiet.
    Google * Eli Lilly Zyprexa * and read the links,this is for a product that we put in our children’s bodies.
    Awful stuff and $10 a pill
    ——-
    Daniel Haszard

  3. Daniel Haszard said on September 12th, 2009 at 9:36am #

    Eli Lilly has made $38 billion on Zyprexa and it was way oversold and caused diabetes and in some cases sudden death.

    Lilly still criminal on Zyprexa
    Please do a report on Lilly’s (NOW up to $4.6 billion) Zyprexa setllement payout is being stonewalled. 8 Lilly employees who are supposed ‘whistleblowers’ are getting $ 10 million each the real victims like me are being ignored.

    I am a living example of Zyprexa gone/done wrong was given it 1996-2000 off-label for PTSD got sudden high blood sugar A1C 14.7 in January 2000.The stuff was worthless for my condition PTSD and cost me thousands in co-pays gave me diabetes.

    Daniel Haszard

  4. John Pollard said on September 12th, 2009 at 4:57pm #

    THis is SUCH an important issue, and completely ignored.

    I left the US in 1995 and when I got back all I saw on TV anymore were drug ads, which had been banned before. That was a big moment in the “boiling frog ” analogy that I’ve never seen addressed either.

    There are SO many examples of this. I saw some in Australia with the “drug to stop smoking.” Oh really? It had killed hundreds in the trials, and yet they were pulling vitamins off the shelves for a “possible” incident.

    Unfortunately, I think our collective frog was boiled long ago.

  5. C.C. said on September 12th, 2009 at 9:46pm #

    It’s interesting to note that law enforcement, while running recent numerous stings on medical cannabis outlets in California, runs no such stings targeting doctors and pharmacies and manufacturers in the pharmaceutical industry – at most, they respond to complaints. Likewise, the FDA banned lovastatins produced from fungus grown on rice because dietary supplements couldn’t be sold as pharmaceuticals – thus, they banned a natural source of statins and ensured that only the patented product was available – that was the FDA in 1998.

    This is the same FDA that kept Vioxx and Celebrex on the market for years longer than they should have, earning Big Pharma and extra $2 billion dollars at the cost of thousands of damaged hearts. Most of the ‘regulators’ at the FDA either came from Big Pharma and plan to return or hope to get an foot in the door via their corporate-friendly FDA credentials.

  6. john andrews said on September 13th, 2009 at 2:11am #

    Dear Dr. Grosso,

    Thank you so much for diagnosing my problem. I’ve suffered with it since I was a child and now, at last, I know what it is: I’m ODD – Oppositional Defiant Disorder. That’s me! Thank you so much.

    Any idea what the cure is?

    Don’t tell me, let me guess…

    Keep on taking the tablets?

  7. Don Hawkins said on September 13th, 2009 at 5:20am #

    John so that’s what I have too. Odd. I saved that John Oppositional Defiant Disorder.

  8. Edward Murray said on September 13th, 2009 at 6:39am #

    We could stop this nonsense.

    We could change the drug approval rules at the FDA to require that new drugs only be approved if they are proven scientifically to be better than other drugs already on the market, or are less expensive. If that is too much of imposition on the “freedom” of drug manufacturers, then we can allow the FDA to approve them, but with a label that says they are no better than existing drugs.

    We could have a public alternative to insurance companies that refuses to reimburse for many of these drugs that are outrageously overpriced or being promoted off label.

    We could not only allow, we could actively encourage overseas purchase of drugs that are overpriced in the US.

    Or we can just pop another pill and make the Big Pharma feel better.

  9. United-Socialist-Front said on September 13th, 2009 at 3:39pm #

    ONLY SOCIALISM CAN SAVE U.S.A. BUT MOST AMERICANS ARE STILL CONFUSED ABOUT CAPITALISM AND SOCIALISM.

    Read these comments by a former americanized USSR citizen who came to USA and became americanized, and how she deffends US plutocratic-fascist imperialism with a passion, even though we all know that USSR was a lot better as a socialist system than USA:

    Larisa Alexandrovna said in reply to United-Socialist-Front…
    Um, I am from the former USSR. Please don’t try to sell me products I so vehemently scream against. It is all well and good to call basic human rights Socialism, but the term has come to be far too associated with a political system for me.
    Reply September 13, 2009 at 12:21 PM

    United-Socialist-Front said…
    hi, u are just biased like most americans. You gotta learn what socialism is, instead of judging it. Read what socialism is, reading won’t bite you.

    And when was USSR socialist? If you call USSR a socialist system it means that you are “faute de lecture” (Lack of book reading)

    Go to http://www.marxist.com to learn what socialism is

    Reply September 13, 2009 at 06:31 PM

    United-Socialist-Front said…
    Oh by the way i am trying to create a United Socialist Front for the 2012 elections, by amassing and uniting, most of the small socialist parties in USA, in a single front for 2012. We need socialism in USA, because if USA doesn shift toward socialism this country could collapse totally.

    Capitalism can only lead us straight to hell !!

  10. Joseph Putnoki said on September 13th, 2009 at 3:40pm #

    A great article! Congratulations! And some excellent posts as well. We must treasure and protect our right of free speech so facts and truth can not be suppressed absolutely. Politicians, their advisors, corrupt industry personnel, doctors, lawyers, judges and law enforcement personnel and others who touch our lives and cause harm or grave risks need to be weeded out and made accountable. Severely so. But the public need to be educated and not apathetic for this effort so as to demand reforms that kills these evil practices the article depicts. Some whistle-blowers from toxic industries and media reporters often pay the ultimate price. Killed in revenge or in anticipation as they poise a threat to the evil interests.
    How strange: Islamic suicide bombers murder innocents as well as targets not based on rational convictions (even if erroneous) but with the illusion of brainwashed afterlife rewards and temporal hero status. And look at us the public: to lazy to demonstrate, to become politically active to remedy this terrible state of affairs! We don’t seem to value our safety and health and in denial! Our active conviction and commitment to action lacking we are complicit in our demise!! The development of our fore brain gave rise to culture, rationality, and the intellectual, technological, ascent of our species. But gave rise also to insanity, and evil. And to CORRUPTION. We need to choose and install leaders who are capable, willing, dedicated TO LEAD we need ongoing education so we can care for each other as well. Not beyond our capacity. Are we willing?
    Be well!

    joseph.

  11. United-Socialist-Front said on September 14th, 2009 at 7:51am #

    BEWARE OF CAPITALISTS OF THE ULTRA-RIGHT WING TEA PARTY. THEY ARE DANGEROUS PEOPLE. ANTI FOOD STAMPS, AND ANTI-TAXES. TAXES ARE NECESSARY, EVEN HUGO CHAVEZ INCREASED TAXES TO FACE CRISIS. RON PAUL AND LIBERTARIANS ARE ULTRA-RIGHT WINGERS.

    Don’t believe in the ultra-right wing, libertarian conspiracy theorists. The Tea Party, libertarian, ultra-right wing movement is funded by Republican Party corporations like Wal Mart to destroy the American Socialist Parties. And socialism, welfare-state is the only solution to reduce poverty levels in USA.

    http://martinkelly.blogspot.com/2008/03/why-libertarianism-is-wrong-and-will.html

    http://web.inter.nl.net/users/Paul.Treanor/libertarian.html

    .