Healthy Skepticism Library item: 18762

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Electronic Source

Armstrong W
Pharma Gets the ProPublica Treatment
PharmExec 2010 Oct 27
http://blog.pharmexec.com/2010/10/27/pharma-gets-the-propublica-treatment/

Abstract:

Alternative news organization and media allies investigate the industry’s payments to doctors-launching a fresh assault on the ethical status quo.

Full text:

Last week, Big Pharma’s practice of paying doctors to do medical education, promote its products, or both was the focus of a multimedia blitz launched by ProPublica in collaboration with National Public Radio, the PBS Nightly Business Report, the Chicago Tribune, the Boston Globe, and Consumer Reports. In what must be seen as a wake-up call for the industry on its handling of compliance issues, each of these major media outlets ran its own major story raising questions about the ethics of paying physicians to help increase sales of medicines. Whether the avalanche of data and juicy anecdotes of physician behavior found in ProPublica’s “Dollars for Docs” report actually answered any of those questions l depends on your point of view.

That pharma sales strategies can encompass elements of fraud, kickbacks, and other funny-money exchanges isn’t exactly news. Billion-dollar settlements with the Department of Justice have become so ho-hum over the past decade that the chorus of threats of criminal prosecutions of drug-company executives by officials at Justice, HHS, and FDA is reaching almost credible levels. What is news-and ProPublica’s new contribution to the debate-is the searchable database for consumers containing the names of some 17,700 US doctors and other practitioners who raked in a total of $257.8 million in pharma payments since mid-2009, a considerable technological feat (aided by Google Refiner) given the mix and sloppiness of the data. The list remains far from complete-it records the fees for speaking, consulting, researching, or related activities paid to doctors by only seven of the top pharma firms: Pfizer, Glaxo, Merck, J&J, AstraZeneca, Lilly, and Cephalon. Of the seven, only Merck and Glaxo volunteered the info; ProPublica got the rest from disclosures the other five companies were forced to make as a condition of false-claims and other settlements.

The sharing of its database with other news organizations (and ultimately the public) is central to ProPublica’s alternative business model. The nonprofit Internet news organization’s mission is public-interest investigative journalism-a resource-consuming enterprise increasingly viewed as nonessential by an industry in financial free-fall. Since its launch in mid-2008, the group has earned its credibility, winning many of the nation’s top journalism awards, including a Pulitzer last year for investigative reporting. It counts among its funders the Gates, MacArthur, and Ford foundations; its newsroom is led and staffed by veteran editors and reporters from the New York Times and the Wall Street Journal. By lending its pharma-physician database to other national and local news outlets-and orchestrating a simultaneous delivery-ProPublica ensured that it got maximum bang for its investigative buck. And the investigations into the pharma industry’s financial ties continue this week with a report based on research into its payments to lobbyists and to political campaigns.

In the week since the stories broke, many lines of debate have developed among readers, including physicians, sales reps, patients, and pharma analysts. There is the usual shouting match between the pro- and anti-pharma lobbies, but the conclusions that emerge from ProPublica’s analysis are based on data that has been independently sourced from credible third parties. ProPublica’s analysis contradicts a few of the pharma industry’s most frequent justifications for the practice of putting the very professionals who write prescriptions for its products on its own payroll.

Contrary to drug makers’ claim that they only hire thought leaders and other top specialists to move their message, the sheer volume of names in the database indicates this contingency is broadly framed. Among the 384 doctors who earned $100,000 or more during this period, more than one in nine had no board certification in any specialty at all. A search of physician licensing records in 18 states found that more than 250 doctors who accepted speaker fees, including some very high earners, had been sanctioned for misconduct, not surprisingly including inappropriately prescribing drugs. More than 40 got slapped by the FDA for research wrongs, lost hospital privileges, or had criminal convictions, while at least 20 others had two or more malpractice judgments or settlements.

These numbers inevitably give rise to some unsettling questions. For example, why is pharma paying anything at all to doctors who have been sanctioned for professional misbehavior?

When asked if background checks are done on doctors, only Cephalon and J&J said that they review state websites. Nevertheless, ProPublica data base shows that one physician accused of sexual misconduct with female patients was Cephalon’s third-highest-paid speaker in 2009.

Critics of the ProPublica presentation, including healthcare journalists, point out that the accounting was incomplete, even unfair, because it failed to put the final tally in perspective. Most notably, only 1.5 percent of doctors on company pay had been sanctioned, while the average payment to a physician came to $15,000, not exactly small potatoes but not necessarily an amount worth risking your reputation over. But at the same time, in a survey by Consumer Reports that accompanied its own reporting, about half of all Americans said that they would be concerned about the quality of care from a doctor who took even as little as $500 from pharma.

According to Medscape, pharma paid more psychiatrists than any other specialists-they also had the highest number in the $100,000-plus club, 116 out of 384. This frequency may be explained by the fact antipsychotics topped the 2009 list of best-selling drugs, while antidepressants came in at no. 4. In addition, the off-label use of these drugs is among the highest for any category.

Neither ProPublica nor any of the other news organizations reports in significant detail about the content of the speaking or consulting or researching for which pharma is paying these many thousands of doctors. While PhRMA reps and many physicians have been quick to point out that all materials must strictly conform to the product label and are regulated by FDA and other agencies, it’s an open secret that many of the scripts and slides that doctors rely on are produced by agencies paid by drugmakers and never vetted by any official. Companies invest in such information in order to reach as many prescribers as possible with a message about a brand-name drug that is as positive as possible. Whether you call this medical education or product promotion is beside the point. ]

Starting in 2013, the new US healthcare reform law requires all drugmakers to publicly disclose the amount and date of every physician payment, the name and address of the physician, and the drug or device that the doctor helped promote. This is should help build confidence in the integrity and accuracy of the data, which some experts have questioned as leading to extreme conclusions when accessed by investigative journalists. Until then, the ProPublica-based media blitz will continue to spark controversy and conversation over the ethics of industry practices.

To their credit, both Lilly and GSK responded to the ProPublica revelations that the companies had sanctioned doctors on their payroll by launching their own investigations. In a statement, GSK said “we do have criteria in place to evaluate potential speakers. However, ProPublic has raised issues to our attention that we are investigating further. We will also use this information as we continue to improve the processes by which our speakers are evaluated.” Likewise, Lilly noted that “reporting by ProPublica and other media outlets has raised valid and important questions about some of our processes, which we take seriously.” And over the past week, all seven of the drugmakers featured in the stories have commented on the reporting. The PBS Nightly Business Report has posted these responses on its website. Hence the debate continues-and soomer rather than later, expect the investigations to spread to practices in other countries led by renewed regulator interest in provisions of the 1977 Foreign Corrupt Practices Act.