Thursday, December 15, 2011

Big Pharma Missing From Drug Problem Dialogue

Noise about prescription drug abuses is getting louder, but there's an element missing from the dialogue.

On a national level, an initiative by the U.S. Food and Drug Administration (FDA) to educate the nation's medical providers on the use of opioids is making the rounds and getting support from the nation's industrial medicine constituency.

On Nov. 4, the FDA posted its "Blueprint for Prescriber Continuing Education Program" with a focus on medical providers who prescribe extended-release, long-acting opioids, such as the painkillers oxycodone.

The FDA noted that more than 35 million Americans age 12 and over reported non-medical use of opioid painkillers last year -- up from 29 million in 2002, and that users of opioid painkillers made nearly 342,000 visits to hospital emergency rooms in 2009. Nearly 28,000 people died from use of prescription painkillers in the U.S. in 2007, the FDA said.

The FDA said in a regulatory notice it is developing the training program as part of a risk-evaluation and mitigation strategy (REMS) required by regulation to be developed by the nation's drug manufacturers.

Dr. T. Warner Hudson, president of the American College of Occupational and Environmental Medicine (ACOEM) told WorkCompCentral, "It's the chronic overuse of opioids for underwhelming pain that leads to a death toll that now exceeds motor vehicle accidents in some cases. The problem is setting off alarm bells. It's become a public health emergency."

Dr. Suzanne Novak, a clinical professor at the University of Texas School of Pharmacy and the lead adviser for the ODG Pain Chapter, said in an interview with WorkCompCentral that doctors in general get limited education on drug therapy and basically don't attend any education where workers' compensation is the topic.

"Everybody's working on the same evidence pretty much, and it's been developed over a long period of time," Novak said. "What's ended up happening is that when I talk about workers' compensation, there are a bunch of nurses in the room, but there are no doctors in my audience."

Separately, in Texas where the Texas Labor Code requires the Division of Workers' Compensation to review the quality of health care provided in the workers’ compensation system, Medical Adviser Dr. Donald Patrick has asked for input by Dec. 21 for a plan for auditing utilization review agents, and by Jan. 6 for revising the annual medical quality audit plan for calendar year 2012.

Carriers are seeing this as an opportunity to look at how physicians are prescribing opioids (narcotics) and other drugs.

The Workers Compensation Research Institute (WCRI) reported injured workers in the Texas workers' compensation system are 30% more likely than average to receive prescription drugs, and receive 16% more morphine equivalents than average. The WCRI study also reported Texas has a 44% higher prescription payment per claim than average for the states studied.

Trey Gillespie, senior workers' compensation director, Property Casualty Insurers Association of America (PCI), told WorkCompCentral the association is still reviewing the proposed plan, but he said PCI and its members "are very interested in the review of treating doctors and pain management doctors with regard to drug utilization practices."

In the mean time, Ohio Attorney General Mike DeWine praised the vote by the Ohio State Medical Board to permanently revoke the medical license of James E. Lundeen, Sr., who was alleged to have improperly prescribed narcotic drugs to patients without proper safeguards.

The State Medical Board held hearings in August. During the hearing, the Attorney General's Office presented evidence regarding 26 patients "to demonstrate that Lundeen's practice of medicine fell below the minimal standards expected of care," the office reported.
The office said two of Lundeen's patients testified at the hearing, and said that Lundeen "did not perform even cursory physical evaluations at appointments when he would prescribe ever-increasing amounts of narcotics to them."

Missing from the equation is participation by the drug manufacturers. Drug companies defer to physicians and pharmacists to protect the public because they are already highly regulatory by the FDA.

I believe that there is culpability in the drug industry and that in general that industry does not do nearly enough to protect and educate the public about the significant risk of their agents. Compliance with regulatory notices required to accompany prescriptions is insufficient - does anyone actually read those?

Big pharma won't change its practices until, like big tobacco, they are made to pay for the adverse consequences of failure to adequately protect the public against misuse of their products.

Some attorneys somewhere will bring suit against big pharma, and I suspect, will be successful for stinging that industry for hundreds of millions, if not billions, of dollars in damages to the American public.

If I were heading the pharmaceutical industry, I'd be taking steps now to reduce that risk and put into place as many safeguards as possible (television advertising, physician education, public service announcements, etc.) to limit the exposure to the inevitable suit, because if a case ever gets to a sympathetic jury the damages will be huge.

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