Life Science Compliance Update

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January 22, 2013

Physician Payment Sunshine Act: Many Letters to Encourage Completion of Regulations, Disclosures Use in Malpractice Cases

Crack of dawn
As we continue to wait for the final regulations to implement the Physician Payment Sunshine Act, more groups are writing to the White House’s Office of Management and Budget (OMB) urging the Obama Administration to release the rule.  Last week, AARP, AFL-CIO, and 17 other healthcare advocacy groups issued a letter urging the Obama administration to roll out those regulations ASAP.  “After all, the legislation is aimed at holding the line on healthcare costs--by minimizing pharma influence on brand-name prescribing--and at protecting patients from unhealthy results of untoward financial relationships, the groups wrote,” reported The Hill

"There is a significant consequence for healthcare system costs associated with the ongoing delay in implementation because of the practice by some physicians of over-prescribing certain drugs, or by otherwise prescribing medically unnecessary and expensive treatments," the letter states.  "The Sunshine Act provides patients with the right to know about potential conflicts of interest between their physician and industry, and will help to protect patients from payments or financial relationships that could compromise the quality or cost of their healthcare," 

In addition, Forbes reports that several doctors wrote a similar missive to the White House chief of staff, expressing their disappointment that the sunshine provisions remain unimplemented. "Financial relationships between physicians and drug and medical device companies can create conflicts of interest that threaten the quality of patient care and drive up healthcare costs," states the letter, signed by such well-known doctors as Cleveland Clinic cardiologist Dr. Steve Nissen and former New England Journal of Medicine editor-in-chief Dr. Jerome Kssirer. 

Using Payments to Find Guilt 

While we continue to wait, a recent article from Syracuse.com raises several concerns—some which we have previously mentioned—about the potential impact this legislation will have on the practice of medicine, as well as litigation by Plaintiff’s lawyers. 

The story covered a recent medical malpractice case in which a jury found Dr. William Beals, 61, negligent when his patient committed suicide.  The jury attributed the cause of suicide to the doctor “overmedicating him with psychiatric drugs.”  What makes this case interesting in relation to the Sunshine Act, is that Dr. Beals “was highly paid by pharmaceutical companies to teach other doctors how to prescribe some of the same medications,” the article claims.  Moreover, it appears from the description of these payments that the money was for purely promotional-type education, rather than any form of accredited non-promotional education. 

Unfortunately, however, the article exaggerates “highly paid.”  According to their own research, Dr. Beals was paid “$200,000 in compensation between 2000 and 2009 from pharmaceutical companies to promote their drugs to other physicians.”  In other words, he made less than $20,000 a year, and it sounds like he was paid by multiple—not just one—companies. 

Syracuse.com used ProPublica’s Dollars for Docs database to find Dr. Beals payments, and also noted that “companies paid about $1.5 million to nearly 70 doctors, nurses and other providers in the Syracuse area between 2009 and 2011.”  The money was primarily for speaking, travel and meals, the article noted. 

“Physicians value the opportunity to learn from their peers — other prescribers who have real-life experience with our medicines,” Elli Lilly and Co., one of the drug companies Beals worked for, says on its website.  The company’s website shows it paid him $58,731 from 2009 to 2011 for speaking, travel and meals. 

J. Scott MacGregor, the company’s communications director, would not say why Eli Lilly hired Beals or what specific products he was hired to speak about. He said Beals has not served as a speaker for the company since 2010.  “Lilly strives to hold our contracted speakers to the highest ethical standards,” MacGregor said in an email to Syracuse.com. 

The jury awarded $1.5 million to patient’s family after hearing testimony that Beals prescribed antidepressants and other drugs sight unseen to Mazella for many years and put him on too high of a dose before his death. 

The family medicine doctor was disciplined by New York state in February for prescribing drugs to patients for years without ever seeing them in his office.  In September he was censured by the state for abusing alcohol and drugs.  Beals was placed on probation for five years.  While we do not know the facts of this case, it appears that this physician’s behaviors were not dictated by the relationships he had with industry, but rather the professional and behavioral problems of his own creation and wrongdoing.  

 “It’s one thing to have a physician who is following best practices and guidelines for treatment getting paid a lot of money to represent your product,” said Art Levin of the Center for Medical Consumers, a consumer group in New York City.  “But to be paid a lot of money to be involved in a promotion of a product and inappropriately prescribe and manage treatment of that product, is unconscionable.”  This draws to light the need for companies to thoroughly vet their speakers, including looking closely at complaints and the number of patients they are treating to ensure that they are not writing scripts without visits. 

MacGregor said Lilly regularly “checks to see if any of its physician speakers have been disciplined for professional misconduct or excluded from participating in federal health care programs.  When such problems surface, the company may terminate a doctor’s contract or decide not to renew a contact.”  He declined to say why Beals was removed from its roster of speakers, reported Syracuse.com.  In a pre-trial deposition filed in the Mazella malpractice case, Beals said he stopped working for Lilly because “ ... they no longer asked me.” 

When he was on the speaking circuit, “Beals said he talked to other doctors about antidepressants and drugs used to treat Attention Deficit Disorder, using information provided by the drug companies.”  “ ... what happens is they train you on a product and they bring you into a doctor’s office, usually over lunch or dinner, and you do a program over lunch or dinner and they reimburse you for that,” Beals said in the deposition. 

Beals said in the deposition he also worked for GlaxoSmithKline, which makes the antidepressant Paxil, and Wyeth Laboratories, now part of Pfizer, which makes Effexor, another antidepressant.  During the malpractice trial, Beals was accused of prescribing Paxil to Mazella (the deceased patient) for 10 years without ever seeing him, then doubling the dose of Paxil in 2009 and adding another drug, Zyprexa, an antipsychotic drug made by Eli Lilly. 

Dr. Peter Breggin, an Ithaca psychiatrist who testified during the trial as a medical expert for the family, said Beals’ treatment of Mazella “didn’t fit into any possible kind of acceptable behavior.”  “That’s why I was willing to call it malpractice and negligence,” he said.  He claimed that “most antidepressants are prescribed by family medicine and other primary care doctors, not psychiatrists,” and he said “that’s why it made sense for pharmaceutical companies to hire a family doctor like Beals to promote their products.”  “What better way than to buy a family doctor to go talk to other family doctors?” Breggin said. “They are not concerned about expertise, they are more concerned about promotions.”   From the description, this doctor is undefensible and deserved being fined in court and should be a model to other doctors on what not to do.

MacGregor of Eli Lilly said the company-sponsored educational programs improve the ability of doctors to care for their patients.  “These expert health care professionals have invested years developing their knowledge and experience and bring a critical clinical perspective, which is highly valued by other health care providers and patients,” he said in an email.

 Ultimately, this case marks the beginning of a trend likely to develop at rapid speed by plaintiff’s lawyers across the country—the very reason why physicians are extremely concerned about the 45 day comment period to make corrections to payments, and also why physicians want to have more than just simple descriptions (e.g., travel) next to their names and payments.  This case demonstrates that plaintiff’s lawyers—as we have said for years—will use the Sunshine database to help attack the credibility of hardworking physicians, despite the fact that 1) the payments are legal; and 2) the overwhelming majority of such payments are for legitimate, bona fide services and are fair market value.   

Once the physician is sued, however, and placed in front of a camera for a deposition or jury for trial, the neutrality of such payments and their nature will be almost impossible for the average citizen to discern, particularly after a plaintiff’s lawyer spins his or her web on how those payments may have improperly influenced the treatment their client (the patient) received.  Cases like this should raise even more alarms for physicians and healthcare professionals who are unaware or only slightly familiar with the Sunshine Act. 

Moving forward, the use of this database in malpractice and negligence cases may further chill the practice of medicine, reducing the quality of care physicians give to their patients due to their fear of working with pharmaceutical companies, which unfortunately may result in harming patients further. 

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