Drug firms turn to private doctors for promotion
Filed under: Conflicts of interest, Hot Health Headline
Pharmaceutical companies are turning to doctors in private practice to promote their products as universities have developed conflict-of-interest policies that limit their doctors’ activities, according to the latest report from John Fauber of the Milwaukee Journal Sentinel.
Fauber, who has been covering conflicts of interest in medical research for more than a year, reports that “So much money is at stake that in January one academic doctor resigned his job at Harvard rather than give up his speaking income.”
Medical schools can restrict doctors who work for them from advocating particular drugs and can require that they inform patients of their ties to drug companies, but private physicians have no such obligations.
In previous articles, Fauber has reported on University of Wisconsin doctors who were making six-figure sums from drug and medical firms by serving as consultants or doing promotional speeches.
Critics say the talks can be biased and contribute to spiraling health care costs by promoting the use of expensive brand-name drugs over generics. The practice, according to critics, also leads to more non-approved and potentially harmful use of those drugs, so-called off-label prescribing.
PR specialist: Health journalists have critical role
Health journalists may be surprised to find support from Paul Oestreicher, a marketing communications consultant and adjunct professor at New York University with experience in the pharmaceutical industry.
Oestreicher makes the case that the health care industry has a vested interest in increasing the public’s health and science literacy - something he says will be supported by “news outlets being repopulated with professional journalists to help carry information forward.”
Though the pharmaceutical industry has suffered from behavioral, communication and performance missteps that have lowered reputation, it is low health literacy among consumers and the decline of science journalism that are fundamental to this problem.
Oestreicher cites numbers that show the pharmaceutical industry is suffering from a poor reputation that will only be helped by the public’s ability to evaluate medical facts and evidence. He also cites articles and a survey done by AHCJ and the Kaiser Family Foundation about the critical need for journalists who understand scientific studies and statistics.
Professional health and science journalists must help to communicate the progress and the failures, and to differentiate the facts and evidence from the frauds and junk science. Unfortunately, we’ve seen surveys confirm what we already know about the state of health and science journalism over the past few months. It’s a shrinking, wounded profession. We know the symptoms – they’ve been well documented. Like the global economy, journalism needs a recovery plan.
Feds take aim at off-label marketing
Filed under: Conflicts of interest, Pharmaceuticals
The Wall Street Journal’s Jeanne Whalen writes that a recent string of charges against drug companies, including heavyweights like Pfizer, Eli Lilly, AstraZeneca, Johnson & Johnson and Novartis, shows that a decade of aggressive prosecution hasn’t deterred them from some shady marketing practices. [Article require subscriber access]
Whalen says the promotion of off-label prescriptions is still at the core of the most common offenses, and that, according to says Patrick Burns, director of communications at Taxpayers Against Fraud, problems are most likely to crop up “when drug companies are promoting therapies that are similar to others on the market.”
Whalen reports that the Justice Department, which often relies on corporate whistleblowers to spark investigations in this arena, has made such cases a priority.
“Combating health care fraud is a top priority of the Department of Justice,” said Tony West, Assistant Attorney General of the Justice Department’s Civil Division
Drug companies have apparently taken notice. GlaxoSmithKline recently started “capping its annual payments to U.S. doctors at $150,000 and publishing the figures” while AstraZeneca’s CEO said the crackdown had made pharmaceutical companies “more sensitive than we’ve ever been” when it comes to preventing illegal drug promotion. Whalen writes that these steps may not be enough.
But Shelley Slade, a former Justice Department lawyer who now represents corporate whistleblowers through the firm Vogel, Slade & Goldstein LLP, in Washington, D.C., said large criminal monetary penalties and civil settlements don’t appear to deter companies sufficiently. “It’s not going to stop until the government puts some of these executives in jail,” she said. “Many of these companies view the fines as a small fraction of what they have gained through illegal schemes, and just a cost of doing business.”
GAO looks at ‘extraordinary’ drug price hikes
Filed under: Government, Pharmaceuticals, Studies
In a new report (pdf), the Government Accountability Office looks into what caused hundreds of extraordinary increases in prescription drug prices during the past decade. The GAO defines an “extraordinary” price increase as a single hike that more than doubled a drug’s price, an event that occurred regularly throughout the past decade. In their summary of the report (pdf), the GAO summarizes the relevant numbers thus:
From 2000 to 2008, 416 brand-name drug products—different drug strengths and dosage forms of the same drug brands—had extraordinary price increases. These 416 brand-name drug products represented 321 different drug brands. The number of brand-name drug products that had these extraordinary price increases represents half of 1 percent of all brand-name drug products. The number of extraordinary price increases each year more than doubled from 2000 to 2008 and most of the extraordinary price increases ranged between 100 percent and 499 percent. Almost 90 percent of all brand-name drug products that had an extraordinary price increase sustained the new higher price—by either having another increase in price or remaining at the increased price.
More than half of the these extraordinary increases came in drugs in the central nervous system, anti-infective, and cardiovascular classes. According to the report, limited competition and a lack of equivalent drugs (either from generics or brand-name competitors) may be to blame for the price increases. Industry consolidation is also an issue, analysts said, as several drugs jumped in price after their parent company’s acquisition had been finalized.
Related: FDA approval causes drug price to skyrocket
FDA approval causes drug price to skyrocket
In a collaboration between The Philadelphia Inquirer and Kaiser Health News, Harris Meyer looks at the case of colchicine, a drug used to treat gout that has been on the market so long that it predates the FDA approval process, and thus had never been approved. 
Like thousands of drugs it existed in a sort of grandfathered generic state. That ended in 2009 when URL Pharma earned FDA approval for a branded version of the drug, which it sells for 50 times more per pill than the generic.
The drug company convinced the FDA that its version was safer than the generic, a claim disputed by many physicians. Now, Meyer reports, it’s likely that the generic colchicine will be forced from the market over the coming months, driving customers of the centuries-old drug (a natural version was first mentioned by the ancient Greeks) into the arms of URL Pharma. According to Meyer, the case is just one of several that have resulted from post-2006 FDA efforts to gain control and approval over all those grandfathered-in unregulated drugs.
BMJ wants raw data for all drug trials to be shared
Filed under: Hot Health Headline, Pharmaceuticals, Public records
Under the headline “We want raw data, now,” BMJ editor Fiona Godlee recounts the story of how BMJ had to pressure a drug company into releasing full study reports verifying their claims as to the effectiveness of oseltamivir (Tamiflu).
Godlee says that researchers updating their Cochrane review of the drug “failed to verify claims, based on an analysis of 10 drug company trials, that oseltamivir reduced the risk of complications in healthy adults with influenza. These claims have formed a key part of decisions to stockpile the drug and make it widely available.”
Only after Roche was questioned by the BMJ and Channel 4 News did the manufacturer commit to making “full study reports” available. Godlee says that some questions remain, including how patients were recruited and why some neuropsychiatric adverse events were not reported.
Godlee argues that “it can’t be right that the public should have to rely on detective work by academics and journalists to patch together the evidence for such a widely prescribed drug,” saying that “Individual patient data from all trials of drugs should be readily available for scientific scrutiny.”
Report: Prescription drug prices doubled in 10 years
Prescription drug prices doubled from 1996 to 2006, according to new inflation-adjusted numbers from the Agency for Healthcare Research and Quality.
In the report, Trends in Health Care Expenditures for Adults Ages 18-44: 2006 versus 1996, (PDF) AHRQ also reveals that health-care expenses were about $40 billion more in 2006 than 10 years before and the average expenses increased significantly for visits to doctors offices, emergency rooms and dentists.
The analysis did not find a significant difference in how people were paying for their medical expenses; in both years, more than half were paid by private insurance, about one-fifth were paid out of pocket, and most of the
remaining expenses were paid by Medicaid.
How the pharma research ’sausage’ is made
Filed under: Health journalism, Hot Health Headline, Public records, Studies
Reporting on Health’s William Heisel has posted the latest installment in his series highlighting the spiciest entries in the Drug Industry Document Archive, this time focusing on the cold mechanics of the drug industry’s research paper assembly line, and its intimate relationship with pharmaceutical marketing.
Again, Heisel focuses on the deposition of Wyeth ghostwriter Karen Mittleman and related documents and memorandums. He lists the names of some key ghostwriters to look out for, then details a number of specific cases when production and marketing concerns clearly outweighed science, at least as far as the pharmaceutical manufacturers were concerned.
Archive offers drug industry documents online
Filed under: Health data, Pharmaceuticals, Public records
In correspondence earlier this month, Kim Klausner, of the University of California, San Francisco Library and Center for Knowledge Management, suggested that reporters should be aware of the Drug Industry Document Archive.
Klausner, the industry documents digital library manager, sent a complete guide to what’s available, the history of DIDA and lots of examples of how reporters and others have used DIDA that is available on HealthJournalism.org.
The archive, available to anyone with access to the Internet, contains about 2,500 pharmaceutical industry documents submitted by “lawyers representing people who file law suits against drug companies and Congressional committees investigating the pharmaceutical industry,” according to Klausner.
William Heisel of the Antidote blog is doing a series of posts that show how the archive can be used to research stories. Heisel’s example uses depositions from a case against Wyeth over side effects of its hormone replacement therapy drugs.
Promoting off-label use is too profitable to ignore
Filed under: Government, Hot Health Headline, Pharmaceuticals
In a special report titled “Big Pharma’s Crime Spree,” David Evans of Bloomberg Markets writes that pharmaceutical companies continue to promote drugs for uses not approved by the FDA, despite paying billions of dollars in fines and penalties.
Pfizer and Lilly lead a parade of U.S. companies that have paid $7 billion in penalties after promoting drugs for uses not approved by the FDA. This unlawful behavior may not end until prosecutors force a drugmaker into bankruptcy.
Even as prosecutors extract promises from the companies’ lawyers to never market off-label uses again, the pharmaceutical giants are doing just that because the revenue is so much greater than the penalties.
Harvard professor Jerry Avorn says “Marketing departments of many drug companies don’t respect any boundaries of professionalism or the law.”
Evans breaks down the numbers to show why drugmakers see off-label prescribing as so essential. He also talks to a former “medical liaison” with Warner-Lambert who grew concerned about his own role in pushing potentially harmful uses of drugs and filed a lawsuit against the company.
He writes that “prosecutors and judges have been unwilling to use the ultimate sanction – a felony conviction that would render a company’s drugs ineligible for reimbursement by state health programs and federal Medicare.” That, as one prosecuter says, is “potentially a death sentence for a drug company.”
-
Health Journalism 2010, AHCJ's annual conference, features a world-class program with story ideas, sources, stronger reporting skills, chances to meet newsmakers and network with other journalists.
- Health and education: Covering these intersecting beats
- Reporting on the business of health care
- Health reporting resources for journalists on state and local government beats
- Shortened Lives: How location, lifestyle affect health
- Covering a complex story for the long haul
- Aging in the 21st Century: Presentations and tip sheets
- AHCJ calls for better information from Joint Commission Web site
