FDA site tracks post-approval drug dangers
Thanks to new requirements, the FDA is now publishing updates on its safety evaluations of drugs that are already on the market. The evaluations get posted after the drug has been on the market for 18 months, or after 10,000 people have used it. It only includes drugs approved since Sept. 27, 2007.
The site also includes a full list of those drugs flagged by the FDA for various reasons, including ongoing safety alerts. Simply click on any drug in the list to find out what problems were identified and what action has been taken.
(Hat tip to The Plain Dealer’s Diane Suchetka)
Journalist recounts the pressure of GSK clinical trial
Filed under: Health journalism, Hot Health Headline
In the wake of questions about GlaxoSmithKline’s Avandia clinic trials, the Austin American-Statesman’s Ana Cantú talks about her own experience in a different GSK clinical trial five years ago. Her column isn’t long, but she manages to capture the pharmaceutical giant’s desperation and the pressure put on participants. It helps that Cantú was, in some ways, a fulcrum for the study’s success.
I don’t want to spoil the story, but it all revolves around the requirement that seven of the 20 participants complete the study to garner sufficient data for submission to the FDA. After 13 participants dropped by the wayside, a sick and unhappy Cantú found herself on the bubble. She needed a medical authorization to drop out and still receive the $4,800 she was due for her participation, but the physicians in charge of the study were under immense pressure to keep her around and maintain that all-important quorum.
In the end, there’s a reason she refers to it as the “most miserable month of my life,” but at the time Cantú had only scratched the surface of the significance of her participation. Now, her reflections are revealing.
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.
State NAMI chapters got pharma money too
Wall Street Journal health blogger Katherine Hobson writes that, according to an investigation by Sen. Chuck Grassley, state chapters of the National Alliance of Mental Illness received millions of dollars in contributions from pharmaceutical manufacturers in a five-year period. This follows an Oct. 2009 New York Times report which found that “drug makers from 2006 to 2008 contributed nearly $23 million to the alliance, about three-quarters of its donations.”
The group’s state chapters – except for Alabama, Arizona, Connecticut and Hawaii – reported their own donations to Grassley, he wrote in a letter to NAMI’s executive director and president of the board of directors. According to the letter, the California chapter received $632,000 in contributions between January 2005 and October 2009, the most of any state. Ohio NAMI received $623,000 and New York NAMI $448,000. The top ten states received a total of $3.84 million.
Roche linked to doctor praising drug in the media
Filed under: Conflicts of interest, Health journalism
Crikey.com, a news Web site based in Melbourne, Australia, calls our attention to some recent reporting about Mabthera, a drug used to treat non-Hodgkins lymphoma.
Nick Miller, health editor of The Age, recently reported that Mabthera, manufactured by Roche, “has been found to nearly double the number of [leukemia] patients who go into remission.”
In that article, Miller quoted a doctor as saying, “This is the largest single advance in the treatment of this disease in the last 30 years.”
Miller was rebuked by oncologist Dr. Ian Haines, who wrote a letter to the newspaper. Haines points out that the article was “an exaggeration of the benefits of the treatment with no presentation of the downsides … which is that it’s incredibly expensive, it’s not without risk,” according to Flint Duxfield, a student at the Australian Centre for Independent Journalism.
Duxfield goes on to explain how events unfolded and reveals that the promotion of Mabthera is being driven by Roche, which provides financial support to Peter MacCallum Cancer Centre, which employs the doctor who originally touted the drug in Miller’s article.
In fact, sections of the press release issued by the cancer center and the press release from Roche’s public relations company are identical and contain the same comments from the doctor quoted by Miller.
Duxfield also reports that warnings that have been issued for the use of Mabthera that have gone unreported in the print media.
The story says “the engagement of third parties in providing a link between a drug company and the media is all too common in health journalism.”
Veteran health reporter Ray Moynihan agrees: “It happens enormously often because third party endorsements are PR 101 for drug companies.”
Duxfield also points to other examples of these so-called “third=party endorsements” and how they have been reported in the media.
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
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