With Ginger Breggin
In April 2001, GlaxoSmithKline:Implemented a marketing effort of unprecedented scale ... with 2,300 sales representatives scheduled to visit some 70,000 US doctors, responsible for writing 80% of asthma prescriptions, in the first week ... This push will be accompanied by a direct-to-consumer advertising campaign on television, aimed at raising the profile of the new drug with patients and maximizing sales of the drug within two to three years.
It worked! The asthma drug Advair became a never-ending blockbuster with sales of $7.8 billion in 2010 and predictions that the COPD drug market, which Advair leads, will reach $13.4 billion worldwide in 2020.
The success is especially remarkable in regard to the limitations of Advair as an asthma treatment. It has a huge array of adverse effects, including adrenal insufficiency, worsening of asthma, and death. It is not helpful in episodes of acute asthma and can even make them worse. It is a combination drug, which can be bought more cheaply and better tailored to the patient's needs when prescribed as two separate drugs.
As described in my previous blog, during this same period of time the U.S. Department of Justice (DOJ) began a lengthy investigation of Glaxo, resulting in recent civil and criminal fines of $3 billion for improper off-label marketing of the antidepressants Paxil and Wellbutrin, and Advair. (Although recording-breaking, the penalty was paltry in comparison to sales for the three drugs, with Advair by itself pulling in considerably more than twice that much per year for several years.)
The Wall Street Journal notes that Advair was singled out for allegedly "promoting the drug for the treatment of mild asthma and other uses [the government] said weren't licensed by the Food and Drug Administration, an illegal practice known as off-label marketing."
Reading the DOJ documents is mind-numbing enough in the documents' disclosures of corporate malfeasance, including Glaxo marketing Paxil off-label to children while withholding or manipulating data that demonstrated the drug's lack of efficacy when used for pediatric patients. But there's something especially impactful about seeing the corporate executives on film "doing their thing."
My wife Ginger found the video excerpts exhibit from Department of Justice website that was used as one piece of evidence in their case against GlaxoSmithKline. The film documents a rollicking in-house sales launch for their asthma drug, Advair, with company executives whipping up fervor among what looks like an audience of thousands of salespersons.
With age and hopefully with growing wisdom, my values have become more traditionally American. I have faith in God as a source of love; I believe my country is unique and special in its principles of liberty and democracy; and I've concluded that the free enterprise system, with all its flaws, remains the best engine of progress. When I watch feature films that ridicule these values, I'm often caught between laughing at the comedy and resenting Hollywood for making such caricatures of what I believe in.
A couple of years ago, for example, there was a hilarious movie about a pharmaceutical sales representative's efforts to woo doctors into prescribing Viagra. Called Love and Other Drugs, it showed a seemingly bizarre in-house launch of the drug with executives regaling the sales teams. Terribly overdone, too exaggerated in its lambasting of corporate America, I thought, but nonetheless funny.
The DOJ's real-life film recording of Glaxo corporate execs exhorting their sales teams to shove Advair down the trachea of doctors and their patients was more bizarrely exaggerated than Love and Other Drugs, or most other Hollywood films that mock traditional American values. The DOJ film clips of the launch of Advair begin with a music and lightshow that rivals a rock band with the executives leaping onto stage with face-splitting grins, theatrical gestures, Blues Brothers sunglasses and sports team-like camaraderie. The giant screen flashes with pyrotechnics. The mood is euphoric. The crowd is urged into waves of applause with predictions of how rich they will all become from selling Advair off-label to "every patient" with asthma in America.
As if scripted by Michael Moore, at 5.5 minutes into the DOJ video, one of the executives brays, "There are people in this room who are going to make ungodly sums of money selling Advair." People squirm in their seats with delight and loudly applaud. "The more you sell, the more you make," he nearly shrieks while using his handheld remote to display a giant simulated slot machine on the huge screen. "God bless America. Free enterprise is a wonderful concept," he crows.
Watching this video, I felt appalled by this misuse and abuse of my values. I felt outraged, as a physician, at the utter contempt with which GlaxoSmithKline holds the medical profession. I felt frightened for all of us who consume the products of these corporations.
It's not that I am naive about corporate evil. I have been a plaintiffs' medical expert in a series of cases against that same company, GlaxoSmithKline. I experienced firsthand how far the company and its lawyers would go to defend the drug against allegations that it could be a cause of violence and suicide. My analysis of Glaxo's internal documents showed how the company hid data about possible links to violence and suicide. My original report was made into a sworn affidavit for the court on July 21, 2001, and hopefully helped inspire the DOJ's later attempts to hold the company responsible.
But I'd never before seen anything like these DOJ video clips showing the executives themselves exhorting their sales teams to make themselves millionaires by pushing these drugs without regard for their alleged adverse effects or therapeutic limits.
Ultimately, it may come down to this, that corporations are no better nor worse than human beings in general, and that capitalism can bring out the worst in some human beings, even while overall providing the best if imperfect environment for individuality, freedom, and productivity to flourish.
But those of us who believe in the free market must never overlook or minimize the dreadful reality of how this system can and will be abused. In particular, some who seem worshipful of corporations call for tort "reform" to make companies less vulnerable to lawsuits. Yet if I had never been a medical expert in product liability cases against a number of drug companies, I would never have discovered, evaluated and published so much information on the potentially harmful effects of psychiatric drugs. And without the Department of Justice suing GlaxoSmithKline, these startling video clips and the treasure trove of other documents would never have seen the light of day.
The capacity of government and its citizens to sue these companies for fraudulent practices is a necessary part of the checks and balances needed to restrain personal and corporate greed.
This is the second in my series of Huffington Post blogs based on the Department of Justice documents about GlaxoSmithKline. More to come.
Peter R. Breggin, MD is a psychiatrist in private practice in Ithaca, New York, and the co-founder with his wife Ginger Breggin of the Center for the Study of Empathic Therapy. He is the author of dozens of scientific articles and more than twenty books. His latest book is Psychiatric Drug Withdrawal: A Guide for Prescribers, Therapists, Patients and Their Families. It is based on a Person-Centered Collaborative Approach to psychiatric treatment with the focus on psychiatric drug withdrawal. It also describes many of the most severe adverse effects of psychiatric drugs that require drug withdrawal. His website is www.breggin.com.
Ginger Breggin, in addition to co-founding and managing the Center for the Study of Empathic Therapy, has coauthored books with her husband, contributes to their mutual research projects, and blogs independently on The Huffington Post.
Disclosure: Peter Breggin, M.D. was a plaintiffs' medical expert in several product liability suits against GlaxoSmithKline.
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