Healthy Skepticism Library item: 17946

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Publication type: news

Todd S
Drugmakers continue 'off-label marketing' despite large fines
The Star-Ledger 2010 Jun 6
http://www.nj.com/business/index.ssf/2010/06/drugmakers_continue_off-label.html

Full text:

Johnson & Johnson’s epilepsy drug Topamax was approaching $1 billion in annual sales in 2003 when the company began a campaign to persuade doctors to use the medicine as a treatment for bipolar disorder and alcohol dependence.
The drug was never approved by federal regulators as a treatment for either disease, but some doctors found it helped their patients and were willing – for a fee – to help Johnson & Johnson’s Ortho-McNeil subsidary promote Topamax’s other uses.
In industry jargon, the practice is known as off-label marketing, a tactic drugmakers use to increase sales of a medicine by persuading physicians to prescribe it for things other than its approved use. A medicine approved to treat seizures, for example, would be marketed to relieve pain or a epilepsy drug would be pitched as a mood disorder treatment.
In the past year, two giants of the industry, Pfizer and Johnson & Johnson, have pled guilty and paid whopping fines to settle federal charges of illegally promoting prescription drugs. Eli Lilly also agreed to pay $1.4 billion to settle criminal and civil charges related to its off-label marketing of the schizophrenia drug Zyprexa.
And earlier this year, AstraZeneca paid an $18 million fine to settle allegations that it improperly marketed an anti-psychotic drug to children and to dementia patients in long-term care facilities.
“There are very few companies that haven’t had their turn in the wheelhouse to get a spanking,” said Ira Loss, an independent analyst who follows the pharmaceutical industry. “I tend to think the pressure put on these salesmen to hit targets and goals leads to misbehavior.”
The pharmaceutical industry, which is concentrated in New Jersey, has long depended on the development of blockbuster medicines to stay profitable, intensifying the pressure to constantly turn out new, powerful drugs. But drug development is an expensive and risky endeavor, fraught with demanding regulatory requirements and the possibility that years of investment will result in failure.
And the practice of off-label marketing – or persuading physicians to prescribe a medicine for conditions other than what it is approved by regulators to treat – provides companies with a way to hedge their bet by squeezing more money from their top products. Between 1999 and 2004, Pfizer generated $10 billion selling its seizure drug Neurontin for unapproved uses, according to the estimates of a plaintiff’s attorney in a civil lawsuit against the company.
In some cases, off-label marketing is a short cut. While a drug may show some effectiveness at treating other conditions, the company chooses not to go through the arduous, expensive studies necessary to secure the Food and Drug Administration’s approval for another use.
While off-label marketing isn’t usually dangerous to patients, the practice has made drug makers more vulnerable to patient lawsuits over safety problems and has sullied once-pristine reputations of companies such as Johnson & Johnson.
“As long as off-label promotion is more profitable than the fines for punishing off-label promotion, we will have off-label promotion,” said Adriane Fugh-Berman, an associate professor at Georgetown University Medical Center,
Ortho-mcneil fined
In April, federal authorities in Boston accused Ortho-McNeil of creating a management-sanctioned program to promote Topamax among psychiatrists and other physicians. The New Brunswick-based health care giant agreed to pay $6.14 million and plead guilty to a misdemeanor violation of the Food, Drug and Cosmetic Act to settle the charges.
The company declined to comment on the Topamax settlement for this story.
From roughly the start of 2001 through the end of 2003, Ortho-McNeil paid physicians as much as $3,000 plus expenses to accompany their Topamax sales reps on field calls to doctor’s offices to help boost sales of the drug, which was approved by the FDA to treat epilepsy in 1996.
According to documents filed in U.S. District Court in Massachusetts, the sales reps told physicians they were visiting that the doctor accompying them could “talk to you about things I can’t talk to you about.”
Those things included a variety of unapproved uses, including tremors, mood stabilization and a number of psychiatric-related conditions.

Breaking the law
There is nothing improper when a doctor prescribes a medicine for an unapproved use when there is evidence that it may be an effective treatment. Yet, when pharmaceutical sales reps try to persuade physicians to use a medicine for off-label purposes – advocating the use of an epilepsy medicine to treat alcohol dependence, for instance – it does break the law.
In the federal government’s crackdown on off-label marketing, Pfizer became something of a poster child after it agreed to pay a record $2.3 billion fine to settle allegations that it illegally promoted a number of its medicines, including Bextra.
Bextra, which was pulled from the market in 2005 because of safety concerns, was approved by regulators as a treatment for arthritis. Pfizer also promoted it as a pain medicine and a treatment for post-surgical discomfort.
It wasn’t the first time off-label marketing had gotten Pfizer into trouble with authorities. In 2004, Pfizer paid $430 million to settle allegations it marketed the epilepsy drug Neurontin for pain and psychiatric illnesses.
Mike Loucks, who was acting U.S. attorney for the District of Massachusetts last year, said the magnitude of the fine reflected the scope and recurrent nature of the company’s marketing tactics.
In a statement released last week in response to a reporter’s questions, the New York City-based drugmaker said it has taken steps to correct past behavior.
“As we have maintained all along, Pfizer regrets certain actions taken in the past that gave rise to the recent settlement, but we are proud of the aggressive actions we’ve taken over several years to strengthen our internal controls and pioneer new procedures that meet the high standards that patients, physicians and the public expect from a company dedicated to healing and better health,” the statement said.
Industry observers remain unconvinced that drugmakers will be detered by the heavy fines.
Professor Fugh-Berman of Georgetown University Medical Center said there remain lots of ways for the companies to “skirt the law.”
“It’s not just promoting a drug for a (use) that it hasn’t been approved for,” said Fugh-Berman, who is involved with a program called PharmedOut, created to educate doctors about the prescribing influences of big drug companies. “The biggest tool the industry has for off-label promotion is continuing education. Physicians have freedom of speech and aren’t under the same constraints as industry employees.”
But Frank Palumbo, executive director of the University of Maryland School of Pharmacy Center on Drug and Public Policy, said it’s not always a bad thing when drugs are used in ways that go beyond their regulatory approval.
Until recently, the FDA rarely approved a drug as a treatment for children, even though medications were often prescribed for them.
“I’ve never seen a sentiment that says all off-label use is bad,” Palumbo said.
That won’t protect the drug makers from penalities that could have more impact on their bottom lines, including the prospect of having their medicines pulled off formulaires used by agencies such as Medicare and Medicaid.
“I think companies are on notice at this point to make sure they’re in compliance,” he said. “Adopting a corporate integrity agreement puts a company on notice that they need to be more proactive about their sales reps are doing.”