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.
Media must understand, explain changes in European health services
One of the points that stood out for Spanish journalist Esther Paniagua at the first European conference on health journalism was from conference organizer John Lister. “Few journalists understand what [the] health care system’s reforms means,” Lister said during the Health in the Headlines conference at Coventry University in June.
Esther Paniagua
That assertion spells trouble not only for journalists who have to report on this but for all of society. These days, public health systems in Europe are up for debate; only few weeks ago Italy imposed a copayment requiring patients to pay 10 euros (almost $15) each time they visit a doctor and 25 euros (almost $36) if someone goes an emergency room. This may sound normal - even ridiculously low - for an American. However, Europeans are used to “free” and universal care at the point of service and they pay for their systems through diverse taxes. So in effect, copayments make patients pay twice for the same service.
Journalists need to understand the function of copayments and explain all the arguments, for and against. Read more …
Inspired by NHS, Lieberman calls for reporters to spotlight patient safety improvements
Filed under: Europe, Government, Health data, Health journalism, Public health
Fresh off a trip to powwow with health journalists, academics and officials in England as a Fulbright Senior Specialist, AHCJ Immediate Past President Trudy Lieberman writes on CJR.org about what American health systems can learn from the British National Health Service when it comes to patient safety.
In particular, Lieberman looks at the NHS Institute for Innovation and Improvement, which has pushed a few simple changes that have lead to measurable and marked improvements in several key safety measures and are, she writes, embraced by “almost all U.K. hospitals.”
Since 2007 the Institute has fostered nurse-led innovations to improve care in such areas as patient hygiene, nursing procedures, meals, medicines, and ward rounds that frees up more time to be with patients. Now almost all UK hospitals embrace some of these practices. Positive stats from this “Releasing Time to Care” project show a thirteen percentage point increase in the median time spent on direct care; a seven percentage point increase in median patient satisfaction scores, and a twenty-three percentage point increase in median patient observations.
The innovations include little tricks like nurses donning red pinafores to signal “don’t interrupt me, I’m dispensing medication” and charting patient falls with red dots on a hospital floor plan, so that problem areas can be easily spotted.
According to Lieberman, simple changes like these don’t get the attention or widespread adoption they deserve. Thus, she ends her piece with a call to arms for health journalists, asking them to tell the stories of the sort of simple, easy-to-relate-to steps that are saving lives on both sides of the pond (Oregon, in particular, has been quick to follow the NHS lead in these areas).
So where does the press fit into all this? Media outlets in the UK and the US have something in common—they aren’t much interested in reporting good news and what works. It’s in our journalistic DNA to ferret out the evil, bad, and ugly with the hope that press exposure will change practice. But my visit to the NHS showed that positive change does happen and should be reported. Taylor told me she tried to interest British journos in some of the Institute’s achievements but got “not a sniff.”
“Journalists don’t celebrate success,” she said, “but innovation is to be shared.” Nor has there been any interest from U.S. reporters. CareOregon hasn’t sent out any press releases partly because the results are just coming in and because officials fear that the U.S. stereotype of the NHS is so powerful the program might die a-borning. If I were still a local consumer reporter, I would forget about all that ambiguous, hard-to-interpret data about hospital quality and look for concrete improvements patients and families can relate to, like red pinafores and scorecards for reducing falls. Then I would make a how-to comparison chart showing which hospitals were embracing some of the simple technologies that appear to work.
Stark reflects on health journalism in U.S., Europe
The standards of health reporting in the United States are higher than ever before, according to AHCJ Vice President Karl Stark.
Karl Stark
Stark, the health and science editor at The Philadelphia Inquirer, is in England for “Health in the Headlines,” a European conference on health journalism co-sponsored by AHCJ and Coventry University.
While there, he was a guest on “FT Science with Clive Cookson,” a Financial Times podcast.
Stark said this is a time of great opportunity and great foment in U.S. health journalism. When asked about covering pharmaceutical companies, Stark acknowledged that is a challenge and requires training to penetrate and learn the language.
Stark used an analogy about sports preferences in the United States (high scoring) and Europe (low scoring) to explain the differences in how people in the two places view health care.
It’s worth listening to Stark’s segment; it’s about six and half minutes long at the beginning of the podcast.
International cooperative to share health data
Filed under: Europe, Health data, Health policy, Hot Health Headline, Public health, Public records, Tools
Writing that “the importance of data sharing in advancing health is becoming increasingly widely recognised,” 17 major public health players entities, from the CDC and AHRQ to the Bill and Melinda Gates foundation and the World Bank, have banded together to form a sort of data cooperative around the Wellcome Trust and the Hewlett foundation. In a Lancet commentary announcing the initiative, Wellcome director Mark Walport and Hewlett president Paul Brest write that, while fields such as genetics and molecular biology, a mature data-sharing system has sped up discoveries and increased efficiency, public health is lagging behind.
Much of the infrastructures, technical standards, and incentives that are needed to support data sharing are lacking, and these data can hold particular sensitivities. And some researchers are reluctant to share data. Too often, data are treated as the private property of investigators who aim to maximise their publication record at the expense of the widest possible use of the data. This situation threatens to limit both the progress of this research and its application for public health benefit.
Each organization will work within its own structure and their initial goals include the creation of data standards to facilitate sharing as well as increasing the prestige of creating public data sets. They acknowledge there will be some bumps along the way, but call on other organizations to join the initiative and to pursue the long-term goal of the widespread, fair and privacy-respecting sharing of public health data.
UK’s Dartmouth-esque atlas yields familiar results
Filed under: Europe, Health data, Hot Health Headline, Tools
Writing for NPR’s health blog, Christopher Weaver looks at the NHS Atlas of Variation in Healthcare, which is similar to our Dartmouth Atlas. While they don’t have an interactive map up yet (they promise one will come next year), it has generous helpings of maps and graphs. The full PDF comes out to 100 pages and 19mb.
The most and least surprising thing about the NHS atlas? That, despite vastly different health care systems, it yields much the same results as the American version. I’ll let Weaver explain:
Before you blame … inconsistencies on America’s money-driven health system, take a look at Britain’s effort to anglicize the Dartmouth work: Doctors in some areas such as the college town of Oxford do one type of hip replacement at rates up to 16 times greater than in places like London, according to a November atlas by the National Health Service.
The British atlas is surprising because “doctors are not by and large paid on a fee for service basis in the NHS,” Angela Coulter, director of global initiatives for the Dartmouth Atlas-associated Foundation for Informed Medical Decision Making, said at a Salzburg Global Seminar session this week. “It illustrates the fact… that doctors tend to favor the treatments they’re trained to provide,” even when money isn’t a factor. Most British doctors get salaries rather than payments for each procedure like their American colleagues.
Related
For more European health news, see AHCJ’s Covering Europe initiative.
Lack of vaccination, awareness worsen UK flu season
Filed under: Europe, Government, Hot Health Headline, Public health
The Guardian’s Denis Campbell and Sarah Boseley report that a drop in vaccination rates and a lack of public awareness has made this flu season worse than it should have been, and that there is potential for the NHS to be “inundated” with flu cases. The story has spread quickly in the UK, and may be providing just the sort of public awareness campaign that the reporters found was previously lacking.
Professor Steve Field, who until last month was the chairman of the Royal College of General Practitioners, spoke out as the Department of Health revealed there are more than 300 people in critical care beds with flu and 17 people have died.
Field said the decision not to encourage the public to have a jab to protect themselves was “ill-advised” and needed to be urgently reversed.
The NHS should have acted more decisively to encourage people to have the jab because it was known that H1N1 swine flu was still circulating and that few NHS staff had the swine flu vaccine when it was offered to them late last year.
Related
For more European health news, see AHCJ’s Covering Europe initiative.
EU reviewing limits to physician work weeks
Filed under: Europe, Government, Hot Health Headline
The Telegraph’s Andy Bloxham writes that the European Union’s 48-hour-a-week average working time limit is under review, at least as far as doctors are concerned.
Photo by dimnikolov via FlickrThe limit has been in place since August, 2009, and doctors have a limited opt-out clause. According to Bloxham, European health providers have been hit hard by the rule, which cut back their hours “drastically.” Critics have said that “junior doctors, who used to work very long hours, were being stopped from learning or building up experience as quickly as in the past.”
The EU has committed to either reviewing or overhauling the law, and Bloxham lists a few possible modifications.
One way of altering the rules could see doctors’ hours spent on call at hospital rather than on duty counted differently to the hours spent treating patients.
It might also permit them to return from their breaks sooner than the law currently allows in cases where staff shortages are more severe.
The weekly average for American doctors is around 51, which is down from 55 in 1996.
Related
For more European health news, see AHCJ’s Covering Europe initiative.
Report: Kosovo crime ring executed prisoners, harvested their organs
According to a draft report from the Council of Europe, a criminal network in Kosovo executed prisoners and sold their organs on the black market within the past decade. The network is linked to Kosovo’s current prime minister and victims likely included Kosovo Serb civilians. We learned about the story through Michael Montgomery and Altin Raxhimi of the Center for Investigative Reporting.
The report alleges the organ trafficking was part of a broader web of organized criminal activity including assassinations and drug dealing. The “boss” of the criminal network, according to the report, was Hashim Thaci, Kosovo’s current prime minister and the former political director of the Kosovo Liberation Army.
…
The recent case of illegal transplants conducted at the Medicus clinic in Pristina is not an isolated episode. “We believe that there are sufficiently serious and substantial indications to demonstrate that this form of trafficking long pre-dates the Medicus case, and that certain KLA leaders and affiliates have been implicated in it previously,” the report states.
According to a former U.N. war crimes prosecutor interviewed by CIR, an international investigation will be needed because of the breadth and complexity of the case.
Related
For more European health news, see AHCJ’s Covering Europe initiative.
Barlett & Steele uncover chaos, peril of global drug industry
Filed under: Conflicts of interest, Europe, Government, Health data, Health policy, Hot Health Headline, Pharmaceuticals, Public health
In Vanity Fair, Donald Barlett and James Steele have devoted more than 6,000 words to chronicling the gaping holes in the global pharmaceutical industry, particularly as pertains to the globalization of clinical trials. Even if you’re familiar with many of the specific incidents covered, their cumulative effect, driven home with forceful and authoritative prose, is brutal. Each paragraph holds another tale of trials gone wrong, children killed and bad results that somehow never came to the attention of American regulators.
Photo by amyvdh via FlickrIt used to be that clinical trials were done mostly by academic researchers in universities and teaching hospitals, a system that, however imperfect, generally entailed certain minimum standards. The free market has changed all that. Today it is mainly independent contractors who recruit potential patients both in the U.S. and—increasingly—overseas.
They devise the rules for the clinical trials, conduct the trials themselves, prepare reports on the results, ghostwrite technical articles for medical journals, and create promotional campaigns. The people doing the work on the front lines are not independent scientists. They are wage-earning technicians who are paid to gather a certain number of human beings; sometimes sequester and feed them; administer certain chemical inputs; and collect samples of urine and blood at regular intervals. The work looks like agribusiness, not research.
After neatly setting up each pin with demonstrations of how international the pharmaceutical industry has become, then proceed to knock them all down with examples of industry impunity and FDA weakness.
The F.D.A., the federal agency charged with oversight of the food and drugs that Americans consume, is rife with conflicts of interest. Doctors who insist the drug you take is perfectly safe may be collecting hundreds of thousands of dollars from the company selling the drug. … Quite often, the F.D.A. never bothers to check for interlocking financial interests. In one study, the agency failed to document the financial interests of applicants in 31 percent of applications for new-drug approval. Even when the agency or the company knew of a potential conflict of interest, neither acted to guard against bias in the test results.
Related
WikiLeaks cables: Pfizer used dirty tricks to avoid clinical trial payout in Nigeria
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