Pfizer-funded workshop raises questions of ethics
Filed under: Conflicts of interest, Health journalism, Pharmaceuticals
Christopher Weaver, in a piece from Kaiser Health News and NPR, writes about a Pfizer-funded seminar for journalists. To attend the annual seminar about cancer, hosted by the National Press Foundation, 15 journalists get an all-expenses-paid trip to Washington, D.C.
Health care journalists, including HealthNewsReview.org’s Gary Schwitzer and AHCJ president Charles Ornstein, say reporters need to be careful and avoid even the appearance of a conflict of interest.
Foundation president Bob Myers says the pharmaceutical company does not have input on the meeting and an attendee of last year’s meeting, AHCJ member Joy Robertson, says she doesn’t remember Pfizer ever being mentioned at the event.
Commenters on the KHN/NPR include AHCJ members Ornstein; Andrew Holtz, M.P.H. (also a board member); Elaine Schattner, M.D.; and Schwitzer. Schattner, a licensed, non-practicing physician and medical educator, says “This is precisely how Pfizer and other companies try to influence physicians who, in their sometimes-arrogance, tend to think they’re “above” subtle persuasion. Are journalists any better?”
Journalist Merrill Goozner also has written about the seminar and says that that Pfizer has dictated the overall agenda:
Pfizer didn’t make an unrestricted grant to a journalism training organization. The money is being spent to train journalists in how to cover cancer.
Goozner points out, as does Holtz in his comment on the NPR/KHN piece, that “journalism spends less on training than almost any other profession” and that journalists have few opportunities to get out of the newsroom for professional education.
Covering Health wrote about this seminar and this issue last year. It’s worth noting, as we did then, that the Association of Health Care Journalists and the Center for Excellence in Health Care Journalism seek to minimize the possibility and appearance of inappropriate influence from outside parties. Pharmaceutical companies, insurance companies and medical device makers are examples of organizations with with AHCJ will not partner. Read AHCJ’s complete fundraising policies.
AHCJ’s Statement of Principles, which identifies challenges that health care reporters face and suggests how to meet those challenges, addresses the topic:
- Refuse gifts, favors, and special treatment. Refuse meals from drug companies and device manufacturers and refuse to accept unsolicited product samples sent in the mail.
- Weigh the potential benefits involved in accepting fees, honoraria, free travel, paid expenses from organizers of conferences or events against the desire to preserve our credibility with the audience and the need to avoid even the appearance of a conflict of interest.
- Also weigh the potential benefits of accepting awards from organizations sponsored by an entity with a vested interest in health care against our need for credibility.
- Weigh the potential conflict in accepting support from public, private, or foundation sources.
Foreign trial data used in 4/5 of approved drugs
Filed under: Health data, Health policy, Hot Health Headline, Pharmaceuticals
FairWarning’s Lea Yu and The New York Times‘ Gardiner Harris drew our attention to a report from the HHS Office of Inspector General which reviewed 2008 data and found that “Eighty percent of approved marketing applications for drugs and biologics contained data from foreign clinical trials.” Furthermore, the OIG found, “Over half of clinical trial subjects and sites were located outside the United States.”
The OIG expects the trend to grow in the future, writing that “Western Europe accounted for most foreign clinical trial subjects and sites; however, Central and South America had the highest average number of subjects per site.”
The FDA only inspected a minuscule percentage of these foreign test sites, but says it has taken the OIG’s advice and is stepping up efforts to put together agreements with its foreign counterparts and to figure out other methods to standardize and evaluate these foreign trials.
Pharma starts disclosing sample numbers
Filed under: Health care reform, Health data, Health journalism, Hot Health Headline, Pharmaceuticals
The health reform law will require drug makers to disclose the amounts of free samples they distribute, a requirement which promises to shed light on a practice whose scope could previously only be estimated. The Wall Street Journal’s Jared Favole has found some preliminary disclosures; the resulting numbers can be found in the graph below. The numbers should only be treated as the roughest of estimates, as some companies disclosed the market value of the drugs while others gave wholesale numbers. Likewise, some measured the number of samples based on the number of doses, while others counted larger units. 
Samples, Favole writes, are a key weapon in pharma’s war against generics as they can be a gateway to brand-name medicines.
A 2008 study in the Southern Medical Journal found that doctors in a clinic were more than three times more likely to prescribe generic medications to uninsured patients after drug samples were removed from that clinic. “Free drug samples may lead to higher costs for uninsured patients by encouraging physicians to write prescriptions for brand-name drugs only,” the study said.
A PDF of that study can be found here.
Factory that made recalled Tylenol was cited
Filed under: Government, Hot Health Headline, Pharmaceuticals
The U.S. House of Representatives’ oversight committee will hold a hearing today about an April 30 recall of children’s Tylenol and other medicines. In advance of that hearing, Alison Young of USA Today reports that the manufacturing place responsible for the medicine “was cited last year by regulators for ‘knowingly’ using a bacteria-tainted ingredient, according to a 2009 inspection report.”
The U.S. Food and Drug Administration also cited the McNeil Consumer Healthcare plant for a similar violation last month. The April inspection, which found serious manufacturing violations and drugs that were potentially too potent, prompted the current recall.
Young also reports that the FDA issued 43 warning letters since January 2009 to drug factories about poor practices that may have endangered patients.
Violations serious enough to prompt warning letters from the U.S. Food and Drug Administration include plants using equipment and ingredients contaminated with bacteria or insects, failing to do proper testing to ensure drug strength and purity, and ignoring consumer complaints that products were making them sick.
Among the cases Young cites are possible bacterial contamination of propofol, reports of bug parts in another company’s medicines and bacteria in calcium carbonate, which is used in antacids and a menopause drug.
That House hearing starts at 10 a.m. ET and will be webcast. To watch, click here.
NPR’s Scott Hensley has been staying on top of the recall story on the Shots blog.
(Hat tip to the Donald W. Reynolds Center for Business Journalism)
Study authors don’t always have access to raw data
Filed under: Conflicts of interest, Hot Health Headline, Pharmaceuticals, Studies
John Fauber of the Milwaukee Journal Sentinel reports on outside authors of drug company-funded studies who do not have access to the raw data behind the study.
In the latest installment of Side Effects, a series examining doctors, drug companies and conflicts of interest, Fauber reports that a researcher who co-authored a study of Multaq that led to the drug’s FDA approval “vouched for the accuracy and completeness of the study despite not seeing the raw data.”
The researcher, Richard Page, chairman of the department of medicine at the University of Wisconsin School of Medicine and Public Health, says he trusts the Sanofi-Aventis, the drug’s manufacturer.
Fauber delves into the differing editorial policies of the Journal of the American Medical Association and the New England Journal of Medicine when it comes to studies in which drug company employees perform the data analysis.
In the case of the Multaq trial, published by the New England Journal of Medicine, the FDA got unanalyzed raw data and did its own analysis. Fauber reports that “one FDA panel member questioned differences between the information included in the published February 2009 study and what was submitted to the FDA.”
Related
- Uncovering conflicts of interest in medicine, research
- Health Journalism 2010: Journalists encounter obstacles in identifying conflicts of interest in medical research
Drug companies hit with punitive damages
A jury has decided Teva Parenteral Medicines and Baxter Healthcare Corp. must pay a combined $500 million in punitive damages in a case involving a hepatitis C outbreak in Las Vegas.
The case, expected to be just the first of hundreds, alleged that the re-use of vials of the anesthetic propofol infected patients with the disease.
An attorney for former patient Henry Chanin said the vials provided by the companies were larger than necessary, while “drug company lawyers have maintained that the vials were marked with instructions and warnings, and medical professionals decided what sizes were appropriate.”
Related
- Hep C emerges from dormancy to hit baby boomers
- KQED profiles those who live with disease, injury
- VA hospitals faulted for lax infection control
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.”
Drug data could inform stories about elder care
The 2007 National Home and Hospice Care Survey (NHHCS ) Medication Public-Use File and Documentation are now available for downloading.
One group of researchers used earlier NHHCS data to “examine changes in hospice services over time, as they were collected during the period from 1992 to 2000, paralleling the period of substantial growth in hospice use and spending.”
With recent studies and news about the increase in use of antipsychotics in the elderly, this data might be useful in reporting such stories and documenting the increase, as well as stories about how treatments have changed.
The 2007 NHHCS Medication Public-Use Data File is supported by SAS, SPSS, and STATA input statements. The documentation includes three PDF files: technical notes, a data dictionary, and a PDF file that provides drug name codes, drug estimates and rates, and drug characteristics.
Joint Commission finds improved hospital quality
Filed under: Conflicts of interest, Health data, Hospitals, Pharmaceuticals, Studies
The latest report from The Joint Commission, a hospital accrediting organization, finds that “overall, hospitals are following evidence-based standards for treatment of myocardial infarction, heart failure, and pneumonia,” as MedPage Today reports.
The report, which looks at 31 evidence-based measures, did find decreases in two areas: measuring oxygen in blood for pneumonia patients and administering antibiotics to pneumonia patients in the intensive care unit within 24 hours.
The report, “Improving America’s Hospitals: The Joint Commission’s Annual Report on Quality and Safety 2009,” (PDF) and those from three previous years are available on the commission’s Web site. Among the key findings:
- Hospitals accredited by The Joint Commission have significantly improved the quality of care provided to heart attack, heart failure and pneumonia patients over a seven-year period.
- Hospitals have steadily improved on individual surgical care performance measures – as well as on additional individual heart attack and pneumonia care measures - over a two-, three- or four-year period.
- Hospital performance on two individual measures of quality relating to inpatient care for childhood asthma is excellent after only one year of measurement.
- Improvement is still needed.
- Where a patient receives care makes a difference.
As ProPublica’s Charles Ornstein explains in his tip sheet, The Joint Commission does routine inspections of participating hospitals to ensure they meet the standards required for accreditation. It compiles public reports on each hospital, which are available on the qualitycheck.org Web site. These reports include the hospital’s accreditation status, as well as some data on hospital outcomes and practices.
It does not release its detailed inspection reports to the public, and many states’ open records laws specifically exempt the reports from public disclosure. In the past, these inspections have not been surprises, and the group has been faulted for being slow to act against hospitals with problems Also, The Joint Commission rarely takes punitive steps against hospitals, preferring to work with them to improve.
Tip Sheets
A road map for covering your local hospital’s quality
Study: Hospital quality comparisons are inconsistent
News: Congress requires Joint Commission to re-apply for accreditation privileges (Sept. 17, 2008)
-
Spend a week at the CDC studying public health, meeting sources. Apply for the AHCJ-CDC Health Journalism Fellowships today!
- Reporting on the intersection of health, environment
- Tip sheet: Covering cuts to Medicare reimbursements
- Briefing: Reporting on health reform between now and 2014
- Covering high-risk insurance pools: Tips for reporters
- Health care reform has passed: What's next?
- 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
