With less than a month to go before applicable manufacturers must begin reporting payments to physicians and teaching hospitals as required by the Physician Payments Sunshine Act, ProPublica last week launched another series of articles using its Dollars for Docs website and its new Prescriber Checkup database of Medicare Part D claims to publish two stories about improper payments or relationships.
As a reminder to all physicians, Ardis Hoven, MD, president of the American Medical Association (AMA), recently noted that the association had made efforts to ensure that physicians would be able to challenge inaccurate or false information. "We strongly urge physicians to make sure all of their financial and conflict of interest disclosures, as well as their information in the national provider identifier database, are current and regularly updated," Hoven said in a statement. We also urge physicians to ask industry representatives with whom they interact to provide an opportunity to review and, if necessary, correct all information they will report before it is submitted."
In the first article, ProPublica reports on "Top Medicare Prescribers Rake In Speaking Fees From Drugmakers." The article, co-published with NPR, focused on the blood pressure drug Bystolic, which hit the market in 2008 with a "crowded field of cheap generics." The maker, Forest Laboratories, launched the normal promotional efforts that any brand-name company does to educate physicians and prescribers about a new FDA-approved treatment.
For ProPublica, this translates to "flooding" doctor's offices with drug reps, and hiring doctors to "persuade their peers to choose Bystolic." Their concern appears to be that the drug had not "proved more effective than competitors—thus suggesting it was as effective, but likely more expensive—always a concern for ProPublica and the government: costs, not outcomes.
By 2012, sales of Bystolic reached $348 million, almost double its total from two years earlier, the company reported. Using ProPublica's Prescriber Checkup, the authors were able to show that at least 17 of the top 20 Bystolic prescribers in Medicare's prescription drug program in 2010 have been paid by Forest to deliver promotional talks. In 2012, they together received $283,450 for speeches and more than $20,000 in meals—that's less than $1,700 a speaker on average, and less than $1,200 on meals. While the article does not detail how many speaking arrangements per physician, these values appear consistent with fair market value.
To support their assertion that these payments were influencing the speakers, who were thus influencing other prescribers, ProPublica cites industry critic Dr. Bernard Lo, who chaired an IOM panel on conflicts of interest. He told ProPublica that he believed these findings were not a coincidence and that the financial relationships were thus problematic. ProPublica maintains that its project and article are the "first time anyone has matched payment data made public by drug companies with physician prescribing records from the Medicare drug program"—something that is sure to increase once all payments are made public through the Sunshine Act.
The article appears to be criticizing physicians who are being paid fair market value for their services to educate other physicians about new drugs and treatments. In fact, the first physician the article singles out, Dr. Gary Reznik, from Los Angeles. In 2012, he was paid $3,750 for giving talks about the drug. In the two prior years, evidently the most recent for which Part D data exists, he wrote 2,500 (2010) and 2,900 (2011) prescriptions.
Reznik told ProPublica that if patients have blood pressure under control with another beta blocker, he doesn't switch them. But he believes Bystolic is more effective at lowering blood pressure and doesn't cause the slower heart rate and erectile dysfunction of other drugs in the class. He asserted that he "never felt that there were any expectations or pressure on the part of the company that [he] would prescribe it more or at all."
ProPublica cites several other drugs and prescribers, claiming the relationships with industry are problematic because the drugs were new or had new uses, "were expensive and often showed little benefit over existing medications or generics."
However, they do not cite any evidence as to why such drugs had little benefit over generics. Instead, they cite other industry critics, such as Dr. Steve Nissen and another cardiologist who merely use conjecture and anecdotal comments to suggest the drug has little benefits. Further, ProPublica cites a warning letter to Forest for an ad claiming the drug was "novel", but this is not the same as saying the drug does not have benefits over generics.
ProPublica maintains, "If financial relationships influence physicians to choose pricier brand-name drugs that have little benefit over generics, everyone pays the cost – particularly taxpayers, who spent $62 billion last year subsidizing Medicare Part D."
Another top prescriber, internist Mark Barats, of West Hollywood, Calif., said he uses smaller doses of Bystolic to achieve the same effects as higher doses of generic medications. "It has much less side effects, particularly much less side effects on the respiratory system," he said. "I've never seen anything that contradicts what Forest said about Bystolic," said Barats, who was paid $3,750 to speak for Forest in 2012.
Dr. Henry Yee, who was paid $5,000 by Forest, said he chooses the drug for many of the same reasons as Reznik and Barats. The cardiologist, whose office is in the Los Angeles suburb of Alhambra, said he learned about the drug from company sales reps and from reading studies. He started prescribing it "even before I started speaking for the company," he added.
Nevertheless, ProPublica digs on to cite several recent settlements with pharmaceutical companies, citing various disclosures from the unsealed cases about speaker programs. For example, they note that internal documents from such settlements, as well as government analysis show that speaker programs have a high return "on investment in terms of the additional prescriptions for its drugs written by the doctors who participated in the programs, both as speakers and attendees, with the highest return arising from payments to doctors as 'honoraria' for speaking."
However, companies like Pfizer "explicitly prohibit the selection of speakers based on their prescribing behavior ... any inference to the contrary is misleading," a spokesman wrote to ProPublica. Glaxo and Johnson & Johnson also said they do not choose speakers based on prescribing.
ProPublica also cited Boehringer Ingelheim Pharmaceuticals, which makes the blood thinner Pradaxa. The company, which began reporting its payments just last month, spent more on speakers for Pradaxa than any other drug in 2011, according to Cegedim. Of the top 20 prescribers in 2011, only six received speaking fees in the first quarter of this year. Boehringer told ProPublica that it does not pay speakers based on prescribing.