Sunday, November 14, 2010

Drug Companies At Work: Inventing Science, Bribing Doctors, Having Consumers Pay Their Fines

Money breeds corruption. There are few places where there is easier money to be had than in the healthcare business, and few groups more adept at capturing those funds than the big pharmaceutical companies. They are not endowed with stellar reputations by any means, yet, it is still amazing to discover the blatant chicanery they are capable of, and the complicity of the entire medical profession.

Carl Elliot has a revealing profile of a “pharma-ghostwriter” in “The Atlantic.” He refers to his subject as “David.”
“The mechanics of the ghostwriter’s job are fairly simple, David says. Early on, a medical-communications agency and its pharmaceutical-company sponsors will agree on a title for an article and a potential author, usually an academic physician with a reputation as a “thought leader.” The agency will ask the thought leader to “author” the article, sometimes in exchange for a fee. The ghostwriter will write the article, or perhaps an extended outline containing the message the company wants to transmit, and send it along to the physician, who may make some changes or simply sign it as written and submit it to a journal, usually scrubbed of any mention of the ghostwriter, the agency, or the pharmaceutical company.”

“Every so often, the issue of ghostwriting moves out of medical schools, where it is generally tolerated or ignored, and into the wider public sphere, where it is treated as a moral scandal. The most recent burst of outrage came in July during an investigation by the U.S. Senate Finance Committee, which has been looking into whether GlaxoSmithKline tried to steer attention away from the cardiac risks of its diabetes drug Avandia (whose use was recently restricted by the Food and Drug Administration). The committee found not merely that GSK had “downplayed scientific findings” to minimize the apparent risks of Avandia, but that it had used a ghostwriting campaign for the drug.”

“Ghostwritten articles surface again and again in litigation (in cases concerning Vioxx, Fen-Phen, Zyprexa, Premarin, Neurontin, and Zoloft, to mention just a few). Years before the Avandia scandal, GlaxoSmithKline paid $2.5 million to the State of New York to settle a lawsuit alleging that it had concealed studies suggesting an increased risk of suicidal behavior in children and teenagers taking Paxil, most notoriously in an article “authored” by Dr. Martin Keller of Brown University. One 2003 study in The British Journal of Psychiatry found that ghostwriters working for a single medical-communications agency had produced more than half of all medical-journal articles published on Zoloft over a three-year period.”
That drug companies would consider such actions is not surprising. What is outrageous is that academics, research scientists, and doctors would accept compensation for being their willing pawns. Make no mistake about it—they are accepting a bribe even if no money changes hands. The drug company picks up the publication charges if they can’t stick the taxpayer with the expense, the “authors” receive the benefit of an additional research paper which provides prestige, enhances their probability of getting grant money, and makes them more likely to have access to bribes in the future. This is serious business. Lives are at stake. I know of no other scientific discipline where this kind of corruption is allowed to exist.
“....spinning data perverts science. It also downplays risks that can lead to serious injuries, and deaths. As David puts it, ‘The moral crime I was being asked to commit was to do with truthfulness’.”
The author includes a great line which lowered, for a moment, my level of indignation.
“Like lobbyists, public-relations consultants, and hit men, medical writers are instruments in a much larger enterprise. Their moral problem lies in the structure of the job itself.”
Maggie Maher summarizes here a study being performed by ProPublica called “Dollars for Docs.” There exists in the recent healthcare legislation an item called the “Physician’s Payment Sunshine Act.” In 2013, drug companies will be required to make public all payments and gifts they provide to doctors for promoting their proprietary pharmaceuticals. Apparently, a few of the companies are already doing this, albeit indirectly. ProPublica has been tracking down this information.

This kind of data is becoming more relevant as doctors’ practices and hospitals have begun to ban industry salespersons from their premises due to past abuses. The drug companies have become more aggressive in buying the time and allegiance of doctors to go out and indirectly perform this sales function. It is hard to ban a doctor from a hospital.
“In their recent ‘Dollars for Docs’ project, reporters from the investigative news organization ProPublica offer a sneak preview of what kind of money we’re talking about. Reporters from the group probed the ‘labyrinthine websites’ of seven Big Pharma companies that are already reporting this kind of data and discovered that between 2009 and 2010 these firms paid a whopping $257.8 million to about 17,700 providers for giving ‘educational’ talks and seminars to colleagues about certain medications. Charles Ornstein, a reporter for ProPublica told NPR ‘In our database we found that there were 384 doctors who, over the course of just the past 18 months, have received at least $100,000 from the drug companies that have reported so far’.”
The doctors chosen for this task seemed to be those most easily motivated by the money.
“Besides ferreting out Pharma payments to doctors, ProPublica investigators went farther; digging deeper and running detailed searches on individual practitioners to find out whether they were licensed or had disciplinary actions taken against them. The most surprising finding: ‘A review of physician licensing records in the 15 most-populous states and three others found sanctions against more than 250 speakers, including some of the highest paid. Their misconduct included inappropriately prescribing drugs, providing poor care or having sex with patients. Some of the doctors had even lost their licenses’.”

“For example, ‘In 2001, the U.S. Food and Drug Administration ordered Pennsylvania doctor James I. McMillen to stop “false or misleading” promotions of the painkiller Celebrex, saying he minimized risks and touted it for unapproved uses.’

‘Still, three other leading drug makers paid the rheumatologist $224,163 over 18 months to deliver talks to other physicians about their drugs’.”
Now you have to worry about whether your doctor is being an honest broker, or if he/she has a conflict of interest because he/she takes funds from the drug companies whose products he/she dispenses. In 2013 there will be a database available so you can check up on your doctor. Has it come to this?

The financial Times reports here that
“Pharmaceuticals companies face escalating fines and criminal sentences in the US from actions triggered by charges of questionable marketing and manufacturing practices, according to lawyers and federal prosecutors in the field.”

“A $750m settlement finalised this week against GlaxoSmithKline in relation to manufacturing failures was the latest in a growing series of recent penalties. They include the record-breaking $2.3bn fine imposed on Pfizer last year for aggressive marketing practices, as well as actions against AstraZeneca, Elan, Novartis, Allergan, Forest, Teva, Mylan and Eli Lilly.”

“Tony West, assistant attorney-general at the US Department of Justice, said on Wednesday that since the start of last year, healthcare fraud investigations alone had resulted in $4.2bn in fines, more than double the value of the previous two years.”
Don’t be encouraged by the fact that these guys may be finally getting slapped around a bit. They will turn a profit and someone will have to pay—the consumer.
“....fines may end up ‘being incorporated as a cost of doing business’, which could lead prosecutors to conclude that criminal action against corporate executives is the next step. Pharmaceutical abuses, therefore, could become yet more painful for companies.”
Well, that last part was a little encouraging.

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