Did PLoS suffer from COI in ghostwriting article?
Filed under: Conflicts of interest, Health journalism, Hot Health Headline, Pharmaceuticals, Studies
Remember that examination of Wyeth (now Pfizer)’s ghostwriting practices that ran in PLoS Medicine a few weeks back? Well, Pharmalot’s Ed Silverman reports that things got a fair bit weirder, thanks to an accusation from Wyeth/Pfizer that the article’s author suffered from her own undisclosed conflict of interest. The article mentions author Adriane Fugh-Berman was a paid expert witness in the trial against Wyeth through which the documents were exposed, but never discloses that she’s still engaged as such.
Silverman got in touch with Fugh-Berman, who said she would clarify her status.
Things get a bit muddier when company representatives allege that the journal was intentionally using the article fodder for an anti-Pfizer lawsuit. Silverman does a good job of explaining the whole situation.
Related: Say what? Pfizer calls PLoS out on conflict of interest
Anecdotes suggest post-Gulf spill health issues
With the help of Spot.us, Glynn Wilson gathered anecdotes that point to a set of symptoms he’s calling the “BP crud,” affecting residents of the Gulf Coast who were exposed to chemicals in the wake of the BP oil spill. It’s too early for research to clearly demonstrate the health consequences of the spill, and Wilson’s story is as much a tale of locals fighting for recognition as it is one of medical malfeasance. [Update: The full story is here.]
He carefully captures the growing outrage of a local group, as well as the efforts of a small number of pharmacists, physicians and labs, and how it’s all leading to a grassroots effort to bring attention, research and treatment to the post-spill ill.
Canadian government obstructs journalists’ access
Filed under: Government, Health journalism, Hot Health Headline, Public records
Writing in Nature News, Kathryn O’Hara celebrates Right to Know Week by declaring that “the information policies of Conservative Prime Minister Stephen Harper are muzzling scientists in their dealings with the media.” She paints a picture that should be painfully familiar to those who deal with American federal agencies or have followed the recent work of AHCJ’s Right to Know Committee.
Margaret Munro, a science reporter for PostmediaNews, has uncovered that a policy enacted in March stipulates that all federal scientists must get pre-approval from their minister’s office before speaking to journalists who represent national or international media. The pre-approval process requires time-consuming drafting of questions and answers, scrutinized by as many as seven people, before a scientist can be given the go-ahead by the minister’s staff. This is to spare the minister ‘any surprises’.
O’Hara, president of the Canadian Science Writers’ Association, provides some distressing examples, including the systematic burying of climate change research and the odd case of a report on a 13,000-year-old flood that broke outside of Canada, because Canadian journalists didn’t have access to the sources.
Scientists in departments that deal with natural resources, health, fisheries and oceans have also felt the pinch of the muzzle. Consequently, Canadians learn little about the results of their wider government science, at least first-hand. Media clearance can take four or five days — ridiculous in a 24/7 news world. And because of the delays, research led by Canadian scientists is regularly channelled through international collaborators and released through their agencies.
All this message micromanagement is even more remarkable, O’Hara writes, given Harper’s past pledges to maintain a transparent government, and to get Canadians excited about science. Canadian journalists are calling for better access to federal researchers, a position that echoes that of AHCJ’s Right to Know Committee and other American journalism groups.
The Canadian Science Writers’ Association in Toronto is asking for timely access to federal scientists whose research is published in journals or presented at conferences open to the media. Our journalists need to speak with scientists to avoid misinterpretation of research. And, as journalists around the world will testify, scientists usually avoid politics and steer clear of policy-sensitive discussions. Canada’s researchers are no different.
Florida pill mills spread, resist prosecution
Filed under: Health policy, Hot Health Headline, Pharmaceuticals, Public health
With South Florida beginning to crack down, the pain pill mills that fuel the Appalachian drug trade are moving northward. Kate Howard and Paul Pinkham of the Florida Times-Union report that the trade, which has ravaged Appalachia for a decade and exploded in recent years, has hit Jacksonville with a vengeance. There are more than 50 pain clinics in the area, and they even tell stories of 20-something clinic owners and physicians driving sports cars and intimidating each other in competition for the lucrative out-of-state trade. Florida’s first statewide steps to combat the trade haven’t yet taken hold, the duo writes.
After years of trying, Florida became the 39th state to pass a prescription monitoring bill last year, but it wasn’t funded. Amid lingering questions about its potential effectiveness, the database was slated to launch in December with $500,000 raised through grants and private funding, but is now on hold because of a bid dispute.
Even if Florida does succeed in stopping the pill mills, there are fears that tough legislation will just push the problem into neighboring (and less regulated) Georgia.
Why is it so hard to crack down on pill mills?
Across the state, Letitia Stein and Susan Taylor Martin of the St. Petersburg Times explore what makes it so impossible to shut down the handful of rogue doctors who can each put thousands of pills a day into the hands of abusers. In some ways, it’s similar to other disciplined doctors stories we’ve been seeing lately, as it carefully details the administrative wasteland that stands between local doctors and actual punishment for their actions. Cases languish for an average of 18 months, there is not always consistent communication between enforcement agencies, and disciplinary board members say they don’t have the legal power to search for problem doctors.
“The biggest problem is. we can’t discipline anybody unless a complaint is filed,” said Rosenberg, a West Palm Beach dermatologist on the Board of Medicine. “And drug addicts aren’t about to complain about their drug dealer.”
Stein and Martin looked at about 200 Florida doctors who had been disciplined or investigated for inappropriately prescribing pain pills in the past five years, and found that more than a quarter still have active licenses. Most of them are experienced doctors with specialty certifications, and some practice despite being convicted of crimes or linked to fatal overdoses.
And Florida’s new legislative crackdown on pill mills? The reporters say it specifically targets pain clinics, yet rogue physicians often operate out of other settings.
(Hat tip to Carol Gentry of Health News Florida)
GAO examines competition in hospital purchasing
Group purchasing organizations are intermediaries which theoretically group hospitals together to give them more leverage in purchasing negotiations. In 2009, they accounted for an average of 73 percent of hospitals’ non-labor purchases and were used by 98 percent of American hospitals. There are more than 600 of them in the United States, but the six largest account for 90 percent of the business.
In 2002, they came under fire for anti-competitive practices such as product bundling, excessive administrative fees and sole-source contracting. These practices also may limit access to innovative devices, a problem Washington Monthly’s Mariah Blake investigated earlier this year.
Photo by House of Sims via Flickr
At the time, the GPOs promised to institute codes of conduct to prevent such practices. A new GAO report (24-page PDF) aimed to see how much of a difference such codes had made, among other things (pages 18-22, all page numbers are based on the PDF). It also sought to answer questions like “what exactly do GPOs do, anyway?” (page 12), and “how do they make money?” (page 13).
The report relies heavily on interviews and self-reporting, all of which seem to indicate that the industry has voluntarily made progress toward curbing exclusive contracts and conflicts of interest, though a deeper independent investigation would be needed to produce any truly conclusive answers.
The industry’s primary trade group, the Health Industry Group Purchasing Association (HIGPA), heralded the GAO’s findings.
“The GAO report clearly demonstrates the group purchasing industry’s firm commitment to remaining the most transparent industry in health care. The report affirms that our aggressive efforts have yielded increased transparency and low administrative fees in health care contracting, the second largest expense for hospitals after the cost of labor,” HIGPA President Curtis Rooney said in a press release.
HIGPA, which cooperated with the GAO investigation and says it has helped review codes of conduct across the industry, has a membership list that might come in handy for reporters looking to localize this story.
Ky. program a model for improving rural access
Filed under: Health care reform, Hot Health Headline, Public health
As part of his series on rural health, the Wisconsin State Journal’s David Wahlberg traveled down to Appalachian Kentucky to see how state-funded “navigators” had helped improve access to health care in the region with the lowest life expectancy in the nation. There, they help guide the rural poor through the byzantine system and toward free or low-cost care. They’re part of a program called Kentucky Homeplace.
…lay workers live in the communities they serve, which includes most of Appalachian Kentucky. The workers, who receive basic medical training and earn about $25,000 a year, make home visits and address a variety of needs, such as finding low-cost prescription drugs, arranging transportation to doctor’s offices and helping patients follow up on medical tests.
They also make sure homes have heat and running water — and people have food and clothing.
The lay workers get 40 hours of training, and specialize in navigating the local culture and translating medical terminology into words and concepts the locals find more familiar. Their primary role is helping residents find more affordable prescription drugs. According to one of Wahlberg’s sources, “The program, which operates on $2 million in state money a year, helped clients get $28 million worth of free or discounted medications last year.”
The program, started in 1994, “has linked tens of thousands of rural Kentuckians with medical, social and environmental services they otherwise might have done without,” according to the National Rural Health Association, which named Kentucky Homeplace its outstanding rural health program of the year in 2008.
HHS, CDC campaign to encourage flu vaccinations
The Department of Health and Human Services and the Centers for Disease Control are ramping up the campaign for flu vaccinations, judging by the subject lines in my e-mail.
At noon ET on Tuesday, HHS Secretary Kathleen Sebelius; Howard Koh, M.D., M.P.H., HHS assistant secretary for health; and Anne Schuchat, M.D., director of the CDC’s National Center for Immunization and Respiratory Disease; will convene for a webcast about the flu season.
Schuchat, in a blog post, reminds us that this year, the CDC recommends that everyone older than 6 months get vaccinated.
You might remember that H1N1 seemed to hit pregnant woman especially hard during the last flu season. So HHS joined with a number of medical organizations for a letter to pregnant women explaining that getting vaccinated is “safe during any trimester” and can protect women and their babies from the flu.
Members of AHCJ can see eight PowerPoint presentations from the CDC’s two-day influenza briefing in August, including information on how the agency tracks influenza and information about the vaccine.
FDA, device makers, patient advocates lock horns
Filed under: Government, Health data, Health policy
In MedPage Today, Joyce Frieden breaks down the FDA’s day-long town hall meeting that brought together device makers, federal officials and patient advocates last week. Frieden’s report points to more contention than consensus, with the debate crystallizing around a few key issues, most of them related to the FDA’s device approval process.
Predictably, the device makers’ griped about the FDA approval process, one which patient advocates say is lacking in clinical trials, especially long-term ones.
“The overall tone is that the predictability and certainty of our interactions with the FDA are worsening,” Paul LaViolette, venture partner at SV Life Sciences, said at the session, which was part of the Transcatheter Cardiovascular Therapeutics meeting. “Where is the problem? It’s at the review level.”
LaViolette, who is also a member of the board of directors of AdvaMed, a trade group for the medical device industry, said he had “a sense that turnover at the reviewer level is intensifying. Companies report that four out of every 10 submissions experience turnover at the reviewer level. So we have reviewers that are less confident in making a decision, and more meetings are required.”
The FDA blames the slowing approval process in part to the increased reliance on clinical trials conducted outside the U.S., which introduces a swarm of additional variables which regulators must take into account. The recession and an accompanying blow to the venture capital supply and investor confidence also helped reduce the number of devices approved, an industry representative said.
Other topics of discussion included the industry’s request that the FDA’s approval for use and CMS’ approval for Medicare reimbursement be “harmonized,” as well as the FDA’s request that industry look into ways to increase minority patient participation in clinical trials, which is disproportionately low at present.
Everyone reacts to Avandia roller coaster
Filed under: Europe, Health policy, Pharmaceuticals, Public health
First, the background: Avandia, also known as rosiglitazone, is an anti-diabetes drug that helps patients control their blood sugar. It made billions of dollars for GlaxoSmithKline until it became associated with higher risks for cardiovascular issues. On Sept. 23, the FDA and European regulators issued their verdicts on the drug. In America, it will still be available, though with much stronger restrictions than before. In the European Union, regulators are looking to stop sales entirely and steer patients toward alternatives.
If you’re looking for the official lines and basic news, start with CardioBrief, where Larry Husten recapped a few of the highlights and then provided each agency’s press release, as well as the official take of Avandia maker GlaxoSmithKline.
Then, it’s time for the reactions. On the NPR health blog, Richard Knox examined the dueling story lines that have emerged since yesterday’s announcements. This larger framework makes all subsequent reactions a little easier to contextualize.
Speaking of other reactions, The Hill’s health blogger, Julian Pecquet, rounded up the thoughts of some Washington heavy hitters involved in the Avandia debate, from the omnipresent Sen. Max Baucus to the consumer group Public Citizen. Another key player, cardiologist and Avandia critic Steven Nissen, spoke to The Wall Street Journal’s Alicia Mundy.
In terms of the big regulatory picture, Avandia is the 30th drug which has been restricted under the FDA’s risk evaluation and mitigation strategy provisions since they began in 2007. Merril Goozner says that the FDA has created a new class of drugs. “They are not exactly safe, but not so dangerous that we would deny them to physicians or patients who really want to have them,” he wrote. Five years ago, he said, Avandia would have been pulled from the market. Now, it just gets restricted. It remains to be see how effective those restrictions really are.
Finally, Pharmalot’s Ed Silverman brings us the thoughts of cardiologist and Yale professor Harlan Krumholz, who you might remember from his recent star turn in Forbes. His take emphasized a principle well-known to health journalists: Marketing matters, and often it matters even more than regulation does.
“The company has announced it will no longer promote the drug,” Krumholz wrote, “and the practical result in Europe and the US may be a lot more similar than the decisions at first appear. Usage will stop in Europe and new use should virtually stop here.”
That said, Krumholz raises some interesting questions, any one of which could form the basis of a follow-up story or two. I’ll paraphrase:
- A long series of fortunate coincidences lined up to produce the evidence that led to Avandia’s delayed near-demise, which begs the question: Why are we relying on luck when it comes to spotting danger in major pharmaceutical products?
- “Why does the FDA believe that the barriers to prescription in new users should be stronger than those for current users? There are no studies that indicate that the excess risk dissipates over time.”
- Will the FDA really be able to effectively implement the regulations and guide physician/patient behavior, especially when it comes to a blockbuster such as Avandia?
- Have we done anything to prevent the next Avandia? How do we even go about doing that?
Update: The European Association for the Study of Diabetes weighs in
AP lawyer: Be aggressive in using FOIA
Karen Kaiser, an attorney who leads the FOIA legal work for The Associated Press, spoke about the importance of the Freedom of Information Act during a gathering of the Iowa Freedom of Information Council in Des Moines today.
Kaiser, as you might expect, advocates for the active use of FOIA and cited several examples in which important news stories were done using data and information gained from FOIA requests.
She also points out that, despite the Obama administration’s public push to post data and records online and be more transparent, “Exemption 5″ was used at least 70,779 times during the 2009 budget year – an increase of 49 percent over President George W. Bush’s last year in office. That is the exemption for “intra-agency documents, such as memos that reflect pre-decisional discussions within an agency.”
Kaiser describes some specific struggles the AP has engaged in with the Department of Homeland Security and reveals the documents it eventually pried loose showed that political staff was involved in revewing FOIA requests:
When Homeland Security failed to respond within the 20-day period required by statute, AP filed an administrative appeal. The agency ignored that too. So we reached out to OGIS, and OGIS was able to help. After several discussions with Homeland Security, OGIS was able to successfully negotiate for disclosure, and AP received nearly 1,000 pages of information. Despite blacked-out passages contained in the release, the information described in remarkable detail a department policy put in place after President Obama’s election requiring a wide range of FOIA requests to be vetted by senior political appointees before being released. The political staff sought information about people who made the requests – where they lived, whether they were private citizens or reporters, and details about the organizations where they worked. If a member of Congress sought documents, employees were told to specify Republican or Democrat. Even AP’s request for Homeland Security emails was itself submitted for review by the agency’s political advisors.
Kaiser offers five specific pieces of advice for news organizations using FOIA, that include actually using FOIA to sensitize agencies to their need to respond and opening up lines of communication with government agencies. Read the full text of her speech for more suggestions.
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Awards for Excellence in Health Care JournalismDeadline: Feb. 3
- How I did it: Falsified charts in nursing homes linked to patient care
- Access Denied: Looking at a lack of health care availability
- Transparency & medical errors: Public reporting of patient harm is a potent force
- Focus on freelancing: Tips for buying liability insurance
- Why do some patients get stuck in hospitals for weeks, months?
- Investigate health professionals and the boards that regulate them
- Presidents of AHCJ, SPJ call for more openness from Obama administration
