Washington, DC: The number one goal of drug makers in dispatching sales representatives to meet with doctors face-to-face is to increase sales by convincing doctors to prescribe drugs off-label for unapproved uses, by saying whatever it takes to achieve that goal.
A May 2006, study titled, "Turning Medicine Into Snake Oil," analyzed FDA warning letters sent to drug companies between 2001 and 2005, and found inaccurate statements made by sales reps in meetings with doctors to be the 4th most common source of false or misleading information used in pharmaceutical marketing.
Almost all of the statements were discovered by FDA representatives asking questions of sales reps at conferences, an activity the FDA says, it lacks the resources to do comprehensively. Most troubling, the study found, was that nearly all of the promotional activity between sales reps and doctors occurs without scrutiny by any regulators.
Critics say, these face-to-face meetings lead to bizarre prescribing habits. Knight-Ridder did an investigation into the off-label prescribing habits of doctors in 2003, and found high blood-pressure drugs prescribed for anxiety and headaches and epilepsy drugs prescribed for depression, weight loss, and hot flashes. The investigation also found doctors prescribing antidepressants to treat premature ejaculation and pain, and antipsychotics doled out for insomnia and attention deficit disorder.
It's gotten to the point where Big Pharma has manipulated doctors into prescribing drugs to everybody. According to Dr Marcia Angell, former editor of the New England Journal of Medicine, and author of, "The Truth About the Drug Companies", "What the drug companies are doing now is promoting drugs for long-term use to essentially healthy people.
"Why?" she says. "Because it is the biggest market."
According to attorney, Mark Labaton, of Kreindler & Kreindler, with offices in New York and LA, who handles consumer fraud cases, "off-label promotion of drugs is a form of quackery that victimizes vulnerable individuals who take these drugs with serious and dangerous side effects for purposes never intended."
The situation has gotten so bad in Pennsylvania, that the state's Department of Aging hired an "unsales" force to counter the effects of the false information provided to doctors by drug company sales reps, according to the March 13, 2006, Wall Street Journal.
The "unsales" representatives visit doctors much like drug company reps do to educate doctors about the evidence relating to all treatments, in an effort to shift prescribing patterns to older and cheaper drugs that are just as effective as the new ones.
One of the more recent busts was announced on December 19, 2006, when "The Statesman," reported that Dr E Wayne Sanders, the number one prescriber in California of the antipsychotic, Seroquel, marketed by AstraZeneca, is facing accusations by the state Medical Board of more than a dozen offenses as a result of an FDA sting operation.
According to the Medical Board, in 2003, an undercover agent posing as a mentally ill, patient sought medication from Dr Sanders and he diagnosed the agent, called JZ, with paranoid schizophrenia and asthma, without examining him.
"The suspected offenses," the Statesman reports, "include treating patients without examining them; improperly dispensing prescription drugs; allowing unlicensed staff to perform physician duties; falsely billing Medi-Cal; and mixing patient funds with his own," according to the 51-page accusation, filed on September 29, 2006.
The Board found pharmaceutical sales reps had improper access to Dr Sanders' patients and their records. One sales rep driving a car registered to Zyprexa maker, Eli Lilly, spent several hours looking though boxes of patient records, in violation of patient privacy rules.
Dr Sanders reportedly gave JZ free samples and billed Medi-Cal for the drugs, and during follow-up visits, he gave JZ fewer pills or switched his medication completely. When JZ asked to pick up his prescription at a pharmacy, Dr Sanders' assistant refused the request.
During his undercover investigation, JZ observed Dr Sanders and his assistants, handing out drugs to patients with little interaction, and in one case giving drugs to a patient without checking her chart or asking her name. Another time, he observed one assistant tell a patient to go in a cabinet and get the drugs himself.
In 2006, almost half of Seroquel sales were off-label, according to Datamonitor Plc, a marketing research firm, and Bloomberg.com reports that sales of the drug increased 24% in 2006 to $3.4 billion last year.
Sales to elderly patients even increased after the FDA warned against using the drug with seniors based on an analysis of 17 studies that found that elderly people who took the drug had a death rate almost two times higher than those who did not, and required the drug maker to add a black box warning to the label about the increased risk of death.
In another blatant case of off-label drug pushing, on April 5, 2006, the FDA indicted Maryland psychiatrist, Dr Peter Gleason, who traveled all over the country for Jazz Pharmaceuticals promoting the narcolepsy drug, Xyrem, for off-label uses.
According to the FBI, Dr Gleason was prescribing the drug to about 100 of his own patients for off-label conditions like depression and insomnia, so Jazz asked him to give speeches to other doctors.
The government actually began the investigation a year earlier in 2005, acting on a tip from a whistleblower, according to an affidavit by Darren Petri, a criminal investigator for the FDA, in the case titled, US v Gleason, Cr No 06-229 (EDNY April 5, 2006).
The affidavit claims that a witness taped Dr Gleason saying the drug was even safe for children. In one speech quoted in the indictment, he told doctors that "table salt is more dangerous," than Xyrem, and the FBI likened him to a "carnival snake-oil salesman."
Dr Gleason reportedly was making as much as $3,000 a day off Jazz, and was paid $450 for a face-to-face meeting in a doctor's office, $750 to speak at a luncheon, and $1,500 for a dinner speech. According to the New York Times, he even gave up his medical practice, in order to devote all his time to "hawking" the $600-a-month drug.
The indictment charges Dr Gleason with four counts related to off-label promotion and fraud on an insurance plan. Specifically, he is alleged to have advised physicians to conceal the non-reimbursable off-label uses of Xyrem. The insurance forms were required to list the diagnosis, but Dr Gleason told doctors to leave that part blank, claiming that no diagnosis was required and that most prescriptions would be paid without further scrutiny.
According to the indictment, if an insurance company challenged a prescription, he told doctors to give a secondary code that was off-label but close enough to the approved indication so the prescription would be paid for.
Attorney, Barry Turner, a professor on medical ethics in the UK, says there are hundreds more doctors like Dr Gleason in the US. "Sheer greed motivates this practice," he says, "the same greed that motivates all fraud and theft."
He points out that Big Pharma pays for thousands of speeches by doctors each year because companies can not legally promote off-label uses. So in other words, the law allows drug makers to hire doctors to do the dirty work that would be illegal for the company itself. In 2004, doctors spoke at 237,000 meetings sponsored by drug companies, up from 66,000 in 1999, according to the July 15, 2005, Wall Street Journal.
World-renowned psychotropic drug expert, psychiatrist, Dr Peter Breggin, the author of many books including, "Toxic Psychiatry," is furious with doctors who engage in off-label prescribing of psychiatric drugs cocktails, with no evidence of efficacy or safety, and especially when its done to children.
"Psychiatry," he says, "treats people as if they are broken mechanical devices that can be tinkered with by a person who knows much less about the brain than the average mechanic knows about your car."
"The greatest child abuse of our time," he states, "is the mass drugging of our children."
"And the worst child abusers," Dr Breggin says, "are my colleagues in psychiatry who have led the way."