Controversy over breast implants spreads across Europe
Filed under: Europe, Government, Pharmaceuticals, Public health
In the wake of the discovery that a leading international manufacturer was found to be using industrial-grade silicone in its breast implants, questions have emerged about the regulatory process that allowed the implants and who is responsible for removing the substandard implants from women who spent thousands to get them.
John Lister
John Lister, the web coordinator of AHCJ’s focus on Europe, explores the controversy surrounding the implants, including the lack of data on how many women in the United Kingdom received them, how the United Kingdom’s National Health Service has been drawn into the business of removing the implants and the regulatory system that allowed the implants in the first place. Lister reports:
But when it came to ascertaining the numbers of women who may have had PIP implants in British private clinics, it became clear there was no comprehensive or reliable data. A working estimate of 40,000 women potentially at risk eventually emerged, while the private clinics said they were not required to remove the suspect implants or replace them with safe ones. Yet the figures that were available showed that for one clinic as many as 7 percent of PIP implants had leaked, well above initial claims of a failure rate of about one percent.
The Reuters enterprise team has a special report on the breast implant scandal and a piece that shows how the regulatory system may be another scandal waiting to happen. It also looks at how, in the United States, the FDA handled an application from that company in 2000.
The history of breast implants is littered with flawed devices, a colorful cast of intertwined players and billion-dollar lawsuits. Reuters reviewed hundreds of pages of police investigation transcripts and financial documents, and interviewed former PIP employees, the company’s suppliers, customers and health experts, to piece together this latest chapter in that history.
Investigation delves into Wash.’s prescription drug problem
Filed under: Aging, Children, Europe, Government, Health care reform, Health data, Health policy, Hot Health Headline, Pharmaceuticals, Public health, Public records
Everything time we think prescription drug abuse stories have peaked, something comes along to push the story further. This time, InvestigateWest’s Carol Smith sets herself apart by starting from square one and clearly explaining the origins and dimensions of Washington’s particularly nasty drug issues, tracing back each facet of the problem to its source and spotlighting what makes the Evergreen State unique.
Washington has been one of the hardest hit states in the country, in part because of aggressive prescribing practices. That, coupled with lack of oversight of doctors who over-prescribe, has led to the spectacular run-up in the number of deaths from prescription overdoses.
The backdrop for her work is an epidemic that shows no signs of abating, despite a recently implemented state law Smith calls “a bold attempt to reduce overdose deaths by launching the first-ever dosing limits for doctors and others who prescribe these medicines.”
Prescription drug abuse is at epidemic levels throughout the state, and elsewhere in the country, despite lawmakers’ attempts to get a grip on it. Washington now has one of the highest death rates in the nation. Deaths from prescription drug overdoses in this state have skyrocketed nearly twenty-fold since the mid-1990s, and now outstrip those from traffic accidents.
Why caused it to leap so quickly? Smith tracks down several key tipping points. “There’s plenty of blame to go around for what caused the epidemic,” she writes. “Aggressive marketing of opiates by drug companies, nonexistent tracking of overprescribing, lack of insurance coverage for alternative treatments for pain, and demand by patients for quick fixes, to name a few.”
She drills down into many of those causes, with my personal favorites being two key origin stories:
- How marketing by OxyContin maker Purdue Pharma led to relaxed guidelines for chronic pain treatment and a “1999 law specified ‘No disciplinary action will be taken against a practitioner based solely on the quantity and/or frequency of opiates prescribed,’” both of which helped cause a jump in prescriptions.
- How “the rise in the death rates of Medicaid patients tracks along with the state’s cost-saving decision to move many of its poorest residents to the cheapest, most potent pain reliever available: Methadone.”
See the upper right-hand sidebar for more stories from the six-month investigation.
Web outlet pumps out dozens of stories on prescription drug abuse
Filed under: Health journalism, Health policy, Hot Health Headline, Pharmaceuticals, Public health
In partnership with USC’s Annenberg School for Communication & Journalism and a number of other organizations, Santa Barbara online news outfit Noozhawk (about), put together “Prescription for Abuse,” an exploration of the misuse and abuse of prescription drugs in the Santa Barbara area.
In the extensive, online-only series, the reporters take a look at the problem and its underlying causes, then go a step further by exploring possible solutions as well.
In a uniquely meta twist, the series even looks at how journalism such is advancing public health goals and explains how the project came together. The series features at least 36 individual articles, by my count, and every health journalist who takes the time to browse the full catalog will come across at least a few easily localizable ideas, but in this space I’ll just highlight those stories that deal directly with the series itself:
- USC, California Endowment Unite to Support Health Journalism at the Source
- Bill Macfadyen: Prescription for Abuse Project Is a Series of Opportunities
- Santa Barbara Teen News Network Adds Another Dimension to Prescription Drug Abuse Series
- Annenberg Fellowships Take a Diverse Approach to Community Health Journalism
- Bill Macfadyen: Noozhawk Earns a USC Annenberg Health Journalism Fellowship
- Noozhawk Journalists Recount Lessons Learned from Prescription Drug Abuse Series
NYT series digs into overprescription and developmentally disabled adults
Filed under: Health journalism, Health policy, Hot Health Headline, Pharmaceuticals, Public health, Public records
In the series Abused and Used, New York Times reporter Danny Hakim and a host of his colleagues have been investigating how public resources are used to treat developmentally disabled New Yorkers. The series is ongoing, but hit an inflection point with the publication of Hakim’s piece on the few-strings-attached use of very powerful drugs to treat some of the state’s most vulnerable adult residents.
Developmental disabilities, Hakim writes, often manifest themselves in ways that are easily mistaken for mental illness, and these misdiagnoses can lead to unnecessary or improper medication. “In fact,” Hakim writes, “developmentally disabled residents of group homes in New York are more likely to be given Ativan, an anti-anxiety drug that has a tranquilizing effect, than multivitamins, the records show.”
Hakim’s reporting is rich with both anecdotes and data. These paragraphs from the series will give you an idea of how he approached the issue.
Tens of thousands of powerful pills created to treat serious mental illnesses like schizophrenia are given to developmentally disabled people in the care of New York State every day.
…a review by The Times of previously unreleased records, as well as interviews with state employees, clinicians, family members and outside experts, reveals that the psychotropic medications, which alter the brain’s chemistry, are often dispensed sloppily, without rigorous or regular review, by general practitioners with little expertise in the area.
And low-level workers at state group homes are frequently given discretion to increase the medication “as needed,” despite their lack of significant training.
Psychologists who have worked inside the system describe a culture in which the drugs are used to control the disruptive behavior of the developmentally disabled — people with conditions like autism, Down syndrome and cerebral palsy — an approach increasingly discredited in the field.
Tsouderos looks at federal funding of alternative medicine
Filed under: Government, Health care reform, Health policy, Hot Health Headline, Pharmaceuticals, Public health
In her latest series, Chicago Tribune reporter Trine Tsouderos, whose award-winning reporting has brought her hard-nosed approach to investigating less-proven areas of medicine, which will be familiar to many members, to bear upon the federal government.
This time, her target is the National Center for Complementary and Alternative Medicine, which she calls “a small, little-known branch of the National Institutes of Health … launched a dozen years ago to study alternative treatments used by the public but not accepted by mainstream medicine.” According to Tsouderos, the center has spent $1.4 since its inception, some of it on curious projects.
A Tribune examination of hundreds of NCCAM grants, dozens of scientific papers, 12 years of NCCAM documents and advisory council meeting minutes found that the center has spent millions of taxpayer dollars on studies with questionable grounding in science.
You’ll want to read it for yourself, but highlights include sentences such as “The cancer treatment involving coffee enemas was based on an idea from the early 1900s, and patients who chose to undergo the risky regimen lived an average of just four months” and “Thanks to a $374,000 taxpayer-funded grant, we now know that inhaling lemon and lavender scents doesn’t do a lot for our ability to heal a wound.”
It’s not all just cherry-picking wacky studies, of course. Tsouderos also looks deep into the powerful alternative medicine industry as well as the scientific rigor, or lack thereof, that sits at its core.
Antipsychotic use booms among Canadian kids
Filed under: Children, Hot Health Headline, Pharmaceuticals
Writing for The Vancouver Sun and Postmedia News, Sharon Kirkey and Pamela Fayerman, report that, in an environment where the rate at which physicians are recommending certain antipsychotics for children has doubled since 2006, a local children’s hospital has launched what the reporters call “the world’s first clinic to help children cope with the side effects of such medications.”
The clinic, which helps children and their parents prepare for antipsychotic use or cope with its side effects, opened in April and has a four-week waiting list.
(Dr. Jana Davidson, a child and adolescent psychiatrist who helped establish the specialized clinic) said she helped create the clinic because of her increasing alarm over the side effects of treatment in her patients. While she believes the medications are sometimes prescribed inappropriately, they are often useful for a range of disorders including severe aggression, mania in bipolar disorder and schizophrenia. But the side effects can be serious.
“I would see kids with psychosis in the emergency department and then I would see them again 10 months later and they would be 30 to 50 pounds heavier,” she said.
Despite sometimes serious neurological side effects, more Canadian families are turning to the drugs and antipsychotic drug recommendations for youth jumped 114 percent in Canada from 2005 to 2009.
The drugs — which have not been approved in Canada for use in children under 18 — are being used for attention-deficit/hyperactivity disorder, conduct disorders, irritability related to autism, mood disorders, physical or verbal aggression and other behavioural problems.
Pharma discloses free meals, ProPublica expands database
Filed under: Conflicts of interest, Government, Health care reform, Health data, Health journalism, Hot Health Headline, Member news, Pharmaceuticals, Public records, Tools
In his latest report, ProPublica senior reporter and AHCJ board president Charles Ornstein explains exactly how, since its founding last October, ProPublica’s Dollars for Docs database of pharma payments to physicians has mushroomed from 30,000 entries to more than half a million. They answer, he writes, has a lot to do with free meals and other perks that pharmaceutical companies are starting to publish ahead of strict federal disclosure regulations which will go into effect in 2013.
Pharmaceutical company representatives say the meals serve an important educational purpose, and they have adopted their own set of rules for such interactions.
A voluntary code of conduct adopted by the Pharmaceutical Researchers and Manufacturers of America says that “it is appropriate for occasional meals to be offered as a business courtesy” to doctors and members of their staffs attending information presentations by sales reps.
In such cases, the guidelines say, the presentations have to “provide scientific or educational value,” and the meals should be “modest” by local standards and not part of an entertainment or recreational event. Meals for spouses and take-out meals are not appropriate, the guide says.
To put it all into perspective, Ornstein demonstrates with numbers from Pfizer that, while the meal numbers have certainly increased the number of entries in their database, they haven’t had as significant an impact upon the overall dollar amounts in question.
Relatively, the meals didn’t add up to much money. Pfizer’s meals amounted to only $18 million last year, compared to $34 million for promotional speakers and $108 million for research.
As with previous installments, Ornstein, Tracy Weber and Dan Nguyen’s database work has spawned follow-up reports around the country. In fact, the response was such that Ornstein and Weber even took the step of re-nationalizing the localizations of their story, with the follow-up “News Reports Cite Drop in Physician Speaking Fees.” Below, I’ve linked to a few notable localizations and follow-up stories. If you’ve got another one to point out, add it in the comments.
- A Dozen Pharmas Make Payments to Physicians Public, Kathlyn Stone, About.com
- Drug firms disclose spending on meals, Liz Kowalcyzk, Boston Globe
- How To Find Out If Your Doctor And Drugmakers Are In A Relationship, Scott Hensley, NPR
Thieves target pharma cargo, cause shortages
Reporting for WBBH-Fort Myers, Fla., Andy Pierotti reports that highly specialized thieves have made an art form of snatching shipping containers in the state, slipping in like ninjas and getting away with the massive haul in fewer than 90 seconds. They’ll take anything they can get, Pierotti writes, but the big prize is a shipment full of pharmaceuticals.
An intercepted shipment, especially one loaded with rare drugs with tight supply chains, can cause nationwide shortages and price hikes, experts say. And, no matter how esoteric the product, the criminals seem to be able to find buyers.
An NBC2 investigation discovered over the last four years in Florida, thieves stole at least 24 cargo containers full of pharmaceuticals. From dialysis products to eye medicine, they were valued at $5.6 million.
Erik Hoffer, an expert in pharmaceutical cargo crime, says the evidence disappears fast.
“Those pills can be blended into real and fake, there’s no way to trace it anymore and you’ve eaten the evidence,” said Hoffer.
Local hospital administrators say they can feel the pinch when a shipment goes missing, and that the problem has worsened in recent years. There are possible solutions, but their implementation would likely spell more price increases.
Possible remedies to the problem include putting tracking devices on individual pill bottles or cartons, and a consumer interactive tool on the pill box that allows them find out [if] it was reported stolen.
The problem is, that’s expensive and the cost would likely be passed down on the customer.
The stolen drugs pose a health risk, as well. One expert says the stolen drugs can be blended with other drugs and resold, with consumers none the wiser.
Top docs spar over Medtronic research, Iraq service
Filed under: Conflicts of interest, Hot Health Headline, Pharmaceuticals
Following up on his work on the dangers of Medtronic’s Infuse spine fusion product and the conflicts of interest that appear to have facilitated its approval and adoption, the Milwaukee Journal Sentinel’s John Fauber has the latest on high-profile sniping between two top orthopedic surgeons over the Spine Journal’s recent Infuse issue devoted to the many complications and conflicts of Infuse.
The combatants in this case are frequent Fauber target and University of Wisconsin-Madison orthopedic surgeon Thomas Zdeblick, who has received $23 million from Medtronic since 2002, and Stanford orthopedic surgery professor and Spine Journal editor-in-chief Eugene Carragee, the Iraq veteran whose research helped spark the recent push against Infuse.
The showdown began with Zdeblick’s defiant response to the Spine Journal’s Infuse research, a letter which included an apparent attempt to discredit Carragee’s review because the surgeon wasn’t performing the elective spine fusion surgeries while he was serving with the American military in Iraq. In response, Carragee says he took no extended leaves of absence during the period covered in his study. For the record, Carragee’s second tour of duty in Iraq was cut short in 2008 after he was injured in an attempted suicide attack.
The full text of Zdeblick’s initial letter and the response of Carragee and his co-authors has been published online, and the medical community has rallied around the decorated veteran.
In an email to the Journal Sentinel, Charles Rosen, president of the Association for Medical Ethics, was sharply critical of Zdeblick’s letter.
“Zdeblick’s assertions are so nonsensical that the whole letter strikes me more like the ravings of a guilty man who’s been cornered,” said Rosen, a clinical professor of orthopedic surgery at the University of California, Irvine.
Fauber’s review included a particularly tidy summary of the overall Medronic fracas, and I have included his wrapup below the fold in case anyone still needs to get up to speed on the issue.
Pushback against Medtronic’s Infuse hits boiling point
Filed under: Conflicts of interest, Health journalism, Hot Health Headline, Pharmaceuticals, Public records, Studies
Medtronic’s ongoing woes with its blockbuster spine fusion product Infuse have been a staple of Covering Health for as long as we can remember, but things have reached a crescendo this week.
The first blow came with the publication of John Fauber’s in-depth report (read it at the Journal Sentinel or in MedPage Today) on the conflicts of interest and regulatory weak points that kept Infuse going strong despite serious questions about medical outcomes.
The next day, The Spine Journal made the unprecedented move of dedicating an entire issue to repudiating the failures of science and medical journal publication that made Infuse what it is today. For the record, both those links point straight to journal press releases. If you’re looking for more context, you’ll find it in Fauber’s followup to The Spine Journal’s Infuse issue. HealthNewsReview editor and publisher Gary Schwitzer also blogged his take on the releases.
Fauber’s Medtronic coverage is a joint project between the Milwaukee Journal Sentinel and MedPage Today.
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- Numbers reveal how often, or how rarely, states check doctors’ disciplinary records
- How I did it: Falsified charts in nursing homes linked to patient care
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- Transparency & medical errors: Public reporting of patient harm is a potent force
