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.
Author sees need for more drug safety info for elderly
Writing a guest blog item for Scientific American, AHCJ member Laura Newman profiled the case of her mother to argue that health regulators and Congress should “back drug safety initiatives in the elderly,” noting that “people over age 75 are under-represented in clinical trials, leaving physicians in the dark as to safety.”
The particular case involved an often-prescribed drug to treat high cholesterol:
Even as my mother was in crisis, doctors told me that they were astounded that such a high-dose statin was given to a low-risk, frail, elderly women. By low-risk, she had no history of cardiovascular disease and she met the widely used and time-tested Framingham Risk Factor criteria. She did not smoke, had low-level, well-controlled hypertension, but a high cholesterol. I sensed deterioration months before she was diagnosed with rhabdomyolysis.
Her mother died within eight weeks after doctors diagnosed her with rhabdomyolysis, a life-threatening condition, and acute kidney failure.
Baby’s death illustrates how health IT can introduce complexity, error to system
Filed under: Health care reform, Hospitals, Hot Health Headline, Pharmaceuticals
Chicago Tribune reporters Judith Graham and Cynthia Dizikes explore the pitfalls of health information technology through the story of an infant boy who survived despite being born months early and weighing just 1.5 pounds, only to be killed by a sodium chloride overdose when a pharmacy tech entered information into the wrong field of his electronic medical record.
Photo by Christiana Care via Flickr
The tech’s fatal clerical error was compounded by disabled alarms on a compounding machine, incorrect labeling on an IV bag and an ignored lab test. The heart of the errors, the reporters write, seems to be that all the different systems involved don’t communicate.
Almost all medication requests at Advocate are transmitted by a doctor’s keystroke to the hospital pharmacy’s drug-dispensing system. But in this case, there was no electronic connection with the automated compounding system that prepared the IV bag for baby Burkett, a specialized device that handles low-volume, highly individualized orders.
So a technician transcribed the order by hand, and an error was introduced.
Electronic communication gaps are common at large hospitals, which typically use upward of 50 to 100 different information systems at their facilities, with different technologies used in emergency rooms, labs, pharmacies and other medical departments, said Ross Koppel, a sociologist at the University of Pennsylvania who studies health information technologies.
“To some degree these systems talk to each other, but mostly they don’t, so hospitals have to design custom-made software ‘bridges’ to make this happen,” Koppel said. With each jury-rigged software solution comes the potential for new software bugs, transcription errors and other problems.
Series, inquest illuminate Canada’s pill problem
Filed under: Hot Health Headline, Pharmaceuticals
Writing for the reader-funded site rabble.ca with the help of a Canadian Institutes for Health journalism award, Ann Silversides is devoting a four-part series to Canada’s prescription drug problem, declaring the country to be a “world leader in prescription drug abuse.” Canada’s pill problem hasn’t hit the headlines with the vehemence it has in the states, but Silversides says evidence points to Canadian drug abuse that’s every bit as damaging as what’s happening south of their border.
Photo by jypsygen via Flickr.In the U.S., prescription opioids have been the leading cause of unintentional overdose deaths — far surpassing cocaine and heroin — since about 2001. The same is true in Canada, if the statistics from Ontario hold true for the rest of the country. (There is a striking lack of research in the area of prescription drug misuse in Canada, especially about the progression from use to abuse of these drugs.)
Yet in 2008, Canada had the highest rate per capita consumption of oxycodone in the world, surpassing even the United States, according figures from the International Narcotics Control Board.
The second installment in the series zeroes in on a specific Ontario inquest into two opiate overdose deaths, one which promises to shine a bright light on the nation’s broader struggle with the prescription drug abuse epidemic. Other articles in the series:
- Prescription opiate abuse now a public health crisis in Ontario
- Fractured health-care system sets scene for drug deaths
Horgan finds reasons to be optimistic about science writing
In yet another sign of the much-discussed science writing renaissance which may or may not be upon us, Scientific American’s John Horgan blogs that – despite the still-dire economics of reporting on health and science – the young folks entering the profession give him ample reason to be optimistic about the future.
The occasion? The Columbia University Graduate School of Journalism’s science writing awards, for which he has often been a judge.
This year [Columbia staff] sent me more submissions, 35, than in any of the previous dozen years I’ve served as a judge. The admissions were also better than ever. And as I told the J-school grads last week when I handed out the awards, I’ve never said that before — or if I did, I was lying. Some of the submissions were so well-written and reported that it was hard to believe rookies produced them, not seasoned pros.
Horgan was particularly gratified to find that so many of the entries were in a critical vein, revealing the limits and consequences of technology rather than simply trumpeting the triumphs of science. Of this year’s three winners, AHCJ members likely will be most interested in Elliot Ross’ work on ghostwriting in the pharmaceutical industry, which was picked up in a condensed form by the Guardian.
Medtronic, researchers failed to report known link to complication
Filed under: Conflicts of interest, Hot Health Headline, Pharmaceuticals
Medtronic, a medical device maker, and researchers with financial ties to the company have known for years that a “biological agent used in back surgery was linked to sterility in men,” reports John Fauber of the Milwaukee Journal Sentinel.
The doctors, who have received millions in royalties from Medtronic, failed to include the information in journal articles and instead claimed the sterility was caused by surgical technique, not the product. Information linking the product to the complication was included in what the company sent to the FDA as part of the approval process in 2002. But the doctors linked to Medtronic claimed there was “no relationship” as recently as last year.
Several independent doctors contacted by the Journal Sentinel say that while the surgical technique may be a factor in the development of the complication, the Medtronic authors should have stated Infuse also was linked to the condition.
The Journal Sentinel uses Document Cloud to share the documents – journal articles, letters of concern and commentaries – that explain the history of the product, Infuse. The documents are annotated, with key points highlighted and comments explaining the conflicts.
A study done by independent researchers, published today, links Infuse to retrograde ejaculation, a condition that causes sterility in men. Fauber reports the study was prompted in part by the Journal Sentinel’s earlier articles about Medtronic.
“To have such strong evidence that a life-changing complication of sterility exists and then cover it up in my opinion is obscene,” said Charles Rosen, an orthopedic surgeon and president of the Association for Medical Ethics who has read the Stanford study.
Update
Read about the little -known Croatian doctor who pursued concerns about Infuse. Medical journals dismissed his concerns, including one reviewer who told him “as a Croatian he did not have the standing to make comments about Infuse.”
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