Thursday, May 10, 2007

Guilty Pleas for Purdue Pharma's Deceptive Marketing of Oxycontin

One of the most striking cases of deceptive pharmaceutical marketing has just reached sort of a resolution. Purdue Pharma and its top executives have just plead guilty to "misbranding" the potent narcotic drug Oxycontin. As reported, for example, in the New York Times,

The company that makes the narcotic painkiller OxyContin and three current and former executives pleaded guilty today in federal court here to criminal charges that they misled regulators, doctors and patients about the drug’s risk of addiction and its potential to be abused.

To resolve criminal and civil charges related to the drug’s “misbranding,” the parent of Purdue Pharma, the company that markets OxyContin, agreed to pay some $600 million in fines and other payments, one of the largest amounts ever paid by a drug company in such a case.

Also, in a rare move, three executives of Purdue Pharma, including its president and its top lawyer, pleaded guilty today as individuals to misbranding, a criminal violation. They agreed to pay a total of $34.5 million in fines.

Those executives are: Michael Friedman, the company’s president, who agreed to pay $19 million in fines; Howard R. Udell, its top lawyer, who agreed to pay $8 million; and Dr. Paul D. Goldenheim, its former medical director, who agreed to pay $7.5 million.

OxyContin is a powerful, long-acting narcotic that provides relief of serious pain for up to 12 hours. Initially, Purdue Pharma contended that OxyContin, because of its time-release formulation, posed a lower threat of abuse and addiction to patients than do traditional, shorter-acting painkillers like Percocet or Vicodin.

That claim became the linchpin of the most aggressive marketing campaign ever undertaken by a pharmaceutical company for a narcotic painkiller. Just a few years after the drug’s introduction in 1996, annual sales reached $1 billion. Purdue Pharma heavily promoted OxyContin to doctors like general practitioners, who had often had little training in the treatment of serious pain or in recognizing signs of drug abuse in patients.

Federal officials said that internal Purdue Pharma documents show that company officials recognized even before the drug was marketed that they would face stiff resistance from doctors who were concerned about the potential of a high-powered narcotic like OxyContin to be abused by patients or cause addiction.

As a result, company officials developed a fraudulent marketing campaign designed to promote OxyContin as a time-released drug that was less prone to such problems.

Purdue Pharma acknowledged in the court proceeding today that 'with the intent to defraud or mislead,' it marketed and promoted OxyContin as a drug that was less addictive, less subject to abuse and less likely to cause other narcotic side effects than other pain medications.

For instance, when the painkiller was first approved, F.D.A. officials allowed Purdue Pharma to state that the time-release of a narcotic like OxyContin “is believed to reduce” its potential to be abused.

But according to federal officials, Purdue sales representatives falsely told doctors that the statement, rather than simply being a theory, meant that OxyContin had a lower potential for addiction or abuse than drugs like Percocet. Among other things, company sales officials were allowed to draw their own fake scientific charts, which they then distributed to doctors, to support that misleading abuse-related claim, federal officials said.

Both Purdue Pharma and the three executives acknowledged that the company fraudulently marketed OxyContin for six years as a drug that was less prone to abuse, as well as one that also had fewer narcotic side effects.


The case seemed particularly egregious among cases of deceptive drug marketing and the creation of pseudoevidence because:
  • The drug involved was a potent narcotic, hence a member of a class of medicines known to be addictive and subject to abuse.
  • Prescription drug abuse, particularly of narcotics, benzodiazepines, and central nervous system stimulants, seems to be rising, and causing more acute problems resulting in Emergency Department visits. [McCarthy M. Prescription drug abuse up sharply in the USA. Lancet 2007; 369: 1505-6.]
  • The marketing efforts were designed to create pseudoevidence (like fake data charts) that would counter physicians' and patients' worries about the drug's abuse potential.

We have posted before (e.g., here) about drug companies pleading guilty to criminal offenses. Yet the penalties up to now have mainly been fines. Although the fines were large, they have not been large in relation to the companies' total profits. (See relevant BrandweekNRX post here.) Furthermore, simply fining a company ultimately penalizes the stockholders, but not those who actually were involved in the actions that lead to the fines.

At least in the Purdue Pharma/ Oxycontin case top company leaders were prosecuted, plead guilty, and will personally have to pay substantial financial penalties. Maybe this will convince the leaders of health care organizations that deceptive marketing practices may not be in their long term interests. Up to now, it may have been too easy to be swayed by the enormous profits deceptive marketing can bring, and regard fines paid by the company as just a cost of doing business.

As we have noted ad infinitum, if pharmaceutical (and other health care) company leaders want to regain physicians' and the public's trust, they ought to start by telling the truth, the whole truth, and nothing but the truth.

See also posts on PharmaGossip, Pharmalot, and the WSJ Health Blog.

5 comments:

Anonymous said...

Corporate removal from the ranks of "citizenship" would be a start; criminal/civil liability for the PEOPLE who act in behalf of the corporation would be a good second step. Criminal penalties for people who DECIDE to harm others in the pursuit of profit seems quite appropriate; and a "death penalty" for repeat (corporate)offenders would also be helpful. (I'm speaking to an analogous form of punishment used by collegiate sports regulators. NCAA violators have on rare occasions been given the death penalty. It impacts the entire institution--not just the offending sports paradigm. Returning to the land of the living is tedious and of long duration . . . and even then, the stench remains.)

BigPharma and medical professionals are forever touting their ability to self-police. I'd sure like to see some of this self-policing. Alternatively, maybe government is the only entity powerful enough to legislate such policies.

Melody

MedInformaticsMD said...

As former Medical Programs Manager, Medical Review Officer and liasion to the EAP for drug and alcohol abuse in the third-largest public transit authority in the U.S., I saw firsthand the damage to individuals and to the public (accidents) caused by illegal drug use. This included employee and passenger injury and death. Opiates were one of the "big 5" that came up in the testing.

What these executives are responsible for is reckless disregard for the health of the population and facilitation of a menace to the public's well being. The 'fines' are a small price to pay for these sins.

Can anyone tell me why they are still employed?

Anonymous said...

MedinformaticsMD--

I know this is not the appropriate place to pose the question--but as a layman, I would like to understand the definition of medinformatics.

After reading the latest post on this site, I assume it is the compilation, access to, analysis potential for, and use of the wide variety of scientific/medical/research literature available?

Melody

MedInformaticsMD said...

I know this is not the appropriate place to pose the question--but as a layman, I would like to understand the definition of medinformatics.

Medical Informatics is the integrative discipline that arises from the synergistic application of computational, informational, cognitive, organizational, and other sciences whose primary focus is the acquisition, storage, and use of information in the health/biomedical domain. (William Hersh, OHSU)

Also see "Training the Next Generation of Informaticians: The Impact of BISTI and Bioinformatics—A Report from the American College of Medical Informatics" at this link for a definition and a diagram of the various subspecialties in informatics.

Anonymous said...

Thanks for the link . . .such awesome possibilities.

Melody