Controversy over breast implants spreads across Europe

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, 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

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.

With state funds gone, Okla. dental programs still serve needy

Writing for the local NPR StateImpact outlet, Logan Layden looks at how dental programs for the needy are coping in the absence of state funding. In the 2010 state budget crisis, Layden writes, “Funding for several programs, including Dentists for the Disabled and Elderly in Need of Treatment, was totally eliminated.”

Among those was Oklahoma’s D-Dent, which provides a sort of superstructure that takes care of logistics and tests in order to allow dentists to donate their work to the needy and elderly. Since the cuts, the statewide program has gone from supporting about 800 patients a year to about 600. They no longer get state funds, though they still rely on the health department for most of their referrals, as well as a little moral support.

“We here are entirely supportive of this program,” Jana Winfee, Chief of Dental Health Services the Department of Health, said. “They have our support, just no funds.”

For more on NPR’s StateImpact project and a list of current participants, check out their lab.

Share your thoughts on database design for tracking pharma payments to doctors

Curtis Brainard of Columbia Journalism Review reminds reporters that their input is needed on the design of a federal database that will track payments from drug and device makers to doctors.

Investigations and databases, such as Dollars for Docs by Propublica, have revealed payments to doctors who had been accused of professional misconduct, had been disciplined or lacked credentials. Researchers have found evidence that payments can influence doctors’ treatment decisions (PDF).

Provisions in the Affordable Care Act mean that companies will have to report such payments to the Centers for Medicare & Medicaid Services, which will post the data on a public website. CMS has asked for “comments on how to structure this Web site for ultimate usability.”

There are a number of ways to submit your comments, detailed in this Federal Register announcement. Comments must be received by 5 p.m. EST on Feb. 17.

Reuters shows how shell companies hide Medicare fraud in plain sight

Reporting for Reuters, Brian Grow and Matthew Bigg used an analysis of public data to investigate the practice of using shell companies to defraud Medicare of millions while staying a step or two ahead of federal investigators.

While the specific damage inflicted by shell companies has not been tracked, “Last year, ‘improper payments’ resulted in $48 billion in losses to the Medicare program, nearly 10 percent of the $526 billion in payments the program made, according to a Government Accountability Office report last March.”

“Simply by reviewing the incorporation records of Medicare providers in two buildings” in Miami, they write, “reporters uncovered information that one government official said could prompt “a serious criminal investigation” of some of the companies.”

The fraud rings merge stolen doctor and patient data under the auspices of a shell company and then bill Medicare as rapidly as possible. Other shell companies are often layered on top to camouflage the fraud, law enforcement officials say.

Some of the shells purport to be billing companies; they form a buffer between the sham clinics and Medicare. Others pay kickbacks to doctors and patients who sign off on bogus medical claims or sell their Medicare ID numbers to enable the shell company to bill the government. Still other shells act as fronts to launder the profits.

The key to this kind of fraud, known as a “bust-out” scheme, is for each of the fake companies to bill as much as possible before authorities catch on. Shell companies become a tool that helps keep the crooks ahead of the cops.

The Armenian crime ring whose fraud made headlines last year used 118 shell companies in 25 states and bilked the feds out of at least $100 million. Varying incorporation rules make state-hopping and obfuscation “easy,” they write, especially since states don’t check to see if records are legit before they allow a company to incorporate. The reportes found that even a few simple safeguards would go a long way to detecting the boldest frauds.

In Florida, FBI agents say almost every Medicare fraud scheme involves shell companies. There, Reuters scrutinized incorporation documents for firms located in two buildings near the Miami International Airport. In a building with dimly lit corridors, a rickety elevator and almost no one in sight, a host of companies purport to provide services to Medicare recipients. But telltale signs of fraud abound.

Many of the 26 companies in the buildings had replaced corporate officers at least once in the last four years. Some had changed ownership, or their corporate executives represented more than one medical-related company. Law enforcement officials consider such activities to be red flags for fraud.

For its part, CMS told the reporters it simply didn’t have the resources necessary to conduct the widespread audits needed to catch fraud, though the $350 million allocated to such efforts under the 2010 health reform law should help.

Health journalists who will certainly want to review the “methodology” subheading at the end of the story.

AHCJ opposes taking taxpayer-funded research out of public’s reach

Congress should not roll back public access to taxpayer-funded research reports, AHCJ wrote in a letter to members of Congress (PDF).

AHCJ is opposing the Research Works Act (H.R. 3699), which would remove the public’s access to medical journal articles about publicly funded research. They are currently available for free to the public no more than 12 months after their publication in a medical journal.

“Our board of directors believes strongly that more transparency, not less, is vital for the public to assess how funds are spent and to benefit from and learn about the research underwritten by the government,” board president Charles Ornstein wrote in a letter to the House Committee on Oversight and Government Reform. “The recently introduced Research Works Act is a step in the wrong direction.”

In the letter, AHCJ rebutted medical publishers’ assertions that the current system doesn’t work.

“We understand the objections of such publishers, who contribute editorial support and fear loss of income,” Ornstein wrote. “But it’s worth noting that much of that support comes from unpaid peer reviewers. And publishers still maintain a year of exclusivity, enabling them to reap profits during the time when interest in research is highest.”

In 2010, AHCJ voiced concerns about a similar bill, which did not become law.

BMJ analysis reveals widespread publication/selection bias in research

Reporting on a study released by BMJ and characterized as an almost existential threat to the medical research system by Dr. Harlan Krumholz, the Milwaukee Journal Sentinel’s John Fauber writes that “Drug research, even from clinical trials sponsored by the federal government, routinely is suppressed, harming patients and increasing health care costs.” The emphasis is mine, the strong language Fauber’s.

The conclusions are based on a survey of meta-analyses of individual participant data, which the authors broke down by data source characteristics and publication status. The work is heavy on statistical analysis, but even lay readers can understand the broad strokes of what appears to be a widespread issue.

Steve Nissen, the lead author of the analysis, said 35 of the 42 studies he looked at were unpublished and were obtained only because a court case required the drug’s maker, GlaxoSmithKline, to turn over the data.

And it isn’t just pharmaceutical companies’ financial concerns driving the suppression, Nissen and his coauthors found. At that point, it may more of an issue of confirmation bias and other problems which have always lurked within academic research.

A surprising finding in the BMJ analysis was that serious lapses occurred even in clinical trials funded by the National Institutes of Health.

That research showed that less than half of NIH-funded clinical trials were published in a medical journal within 30 months of the completion of the trial and after 51 months, one-third of trials remained unpublished.

Why are rural Westerners killing themselves?

Writing for ABC News, Alan Farnham seeks to explain the jump in suicide rates in the rural American West, particularly in Intermountain states such as Idaho, Wyoming and New Mexico.

Historically the suicide rate in rural states has been higher than in urban ones. According to the most recent national data available, Alaska has the highest rate, at 24.6 suicides per 100,000 people. Next comes Wyoming (23.3), followed by New Mexico (21.1), Montana (21.0) and Nevada (20.2). Idaho ranks 6th, at 16.5. Suicide is the second-leading cause of death for Idahoans aged 15-34. Only accidents rank higher.

Farnham focuses on the Gem State, where suicide rates are rising alongside unemployment and related economic hardship. In addition to economic factors, including cuts to Medicaid funding, and a regional lack of resources for the initial diagnosis of mental illness, local experts point to demographic and cultural factors.

Kim Kane, executive director of Idaho’s Suicide Prevention Action Network in Idaho says other factors explain the high rate of suicide in western mountain states. One is the greater prevalence of guns: In 2010, 63 percent of Idaho suicides involved a firearm, compared with the national average of 50 percent.

She and Garrett also say the West’s pride in rugged individualism can prevent people from seeking help. Their feeling, says Kane, is that they ought to be able to pull themselves up by their mental bootstraps. Idaho is the only state not to have a suicide-prevention hotline.

‘Doc fix’ flies in the face of rewarding quality, not quantity, of treatment

One of the last things that Congress did before finally getting out of town a few days before Christmas was the so-called “doc fix” – finding money to stave off a scheduled cut for Medicare physician payments. But they only did it for two months – meaning lawmakers will come back in January and struggle with it all over again.

The uncertainly, coupled with the prospects of what, on paper at least, could be a 27 percent fee cut, raises questions about whether more physicians will start cutting back on the number of Medicare patients they take, or dropping out of the program altogether.

It’s also worth reflecting on what this Medicare payment system (formally known as the Sustainable Growth Rate or SGR) means – because it reinforces the very heart of fee-for-service medicine at a time when the health reform law, and many large employers and insurers, are supposedly trying to nudge the health care system away from fee-for-service, which encourages volume. The goal is to move toward new models of more coordinated and integrated care that are supposed to promote value.  So the irony is that we’re tying ourselves in knots about SGR – which pays doctors for how much they do – when the focus is supposedly on creating a system that rewards doctors for how well they do. Go figure.

The SGR dates back to one of those sprawling congressional budget deals, back in 1997. It is supposed to link Medicare physician costs to larger economic and population trends. But the formula didn’t work. Everyone in Washington has pretty much agreed on that. But they haven’t agreed on how or when to replace it. There’s been a lot of talk about coming up with a “doc fix” for a couple of years to allow time for a transition to a TBD new system. But that’s a tall order, given that all the parties don’t agree on what a new system should look like, or which of the new payment systems and incentives being tested are going to turn out to work well (and how long it may take to get them working.)

Until 2002, payments under the SGR rose modestly. Then in 2002 physician Medicare fees were cut by 4.8 percent. In subsequent years, Congress (heavily lobbied by physician groups) postponed the cuts called for by the SGR formula, or approved modest fee hikes. Now, the cumulative postponements mean that doctors face a 27 percent cut – and erasing it would cost about $300 billion over a decade. payments have grown very modestly for nearly a decade now. On top of the SGR issue, physicians and all other Medicare providers face a 2 percent cut starting in 2013 under last summer’s deficit-reduction agreement.

The Medicare Payment Advisory Commission, or MedPAC, knows a mess when it sees one.

The system … has failed to restrain volume growth and, in fact, may have exacerbated it,” MedPAC wrote to Congress earlier this year, recommending yet again that the formula be jettisoned. To a certain extent, cutting physician payments for specific services only encourages them to offer more services.  There isn’t an expert consensus on exactly how much or precisely how the SGR system stimulates more volume. But a recent New England Journal of Medicine article found that doctors in some states were digging the SGR hole much deeper than others (Florida, Texas and New York being among the major culprits). And some specialties’ “excess growth” is much more than others (these include internal medicine, cardiology, diagnostic radiology, and family practice - some of which I would not have guessed.) This doesn’t mean that fees should be slashed in some states and not others, or that family practitioners should get a pay freeze while neurosurgeons make even higher incomes. But it does suggest, as the Harvard health policy experts that wrote the NEJM piece note, that new systems, less blunt and less arbitrary, are required.

The congressional focus on short-term “doc fixes” – a decade’s worth now – blunts the momentum for permanent change. “If you are always doing a fire drill, and finding a perpetual one-year patch, it keeps you from confronting the larger mega-reform that’s needed,” Tom Miller of the American Enterprise Institute observed.

The AMA and other physician groups have warned for years that more and more physicians will stop treating Medicare beneficiaries. On an online AMA survey in 2010, one in five doctors overall, and nearly one-third of primary care doctors, said they are already limiting Medicare patients.

So while Congress struggles for a way out, it’s probably a good time to look at what physicians are doing in your state. (This AMA guide to choices doctors can make about Medicare participation may be useful.) I suspect a lot of doctors don’t quite understand what’s going on in Congress (because as we saw during the pre-Christmas impasse, Congress didn’t seem to quite understand what’s going on in Congress.)

• Do physicians think they will actually get a 27 percent cut? (They won’t - but they may not get an increase or only a modest one.)
• Are they preparing to drop Medicare patients or at least take fewer new ones?
• Have they begun to understand why the system is unsustainable, and become increasingly open to alternatives including ACOs, bundling, medical homes, etc?
• Are they coming up with any creative local solutions? Or are they just assuming that somehow the system can keep muddling through indefinitely?

Kidney disease kills thousands in sugar cane fields

In The Center for Public Integrity’s iWatch News, Sasha Chavkin and Ronnie Greene write that, “Little noticed by the rest of the world, chronic kidney disease (CKD) is cutting a swath through one of the world’s poorest populations, along a stretch of Central America’s Pacific Coast that spans six countries and nearly 700 miles. Its victims are manual laborers, mostly sugarcane workers.”

Each year from 2005 to 2009, kidney failure killed more than 2,800 men in Central America, according to the International Consortium of Investigative Journalists‘ analysis of the latest World Health Organization data. In El Salvador and Nicaragua alone over the last two decades, the number of men dying from kidney disease has risen fivefold. Now more men are dying from the ailment than from HIV/AIDS, diabetes and leukemia combined.

Unlike in more developed nations, neither diabetes nor hypertension can be blamed for the widespread kidney ailments. Instead, the duo found, scientists suspect possible environmental toxins and strenuous labor conditions, both linked to the cane fields, as well as alcohol abuse and anti-inflammatory drug use. At present, researchers seem to be focusing on heat stress as the most likely culprit, and plantation owners seem to concur

Internal studies by Nicaragua Sugar, owners of one of Central America’s largest sugar plantations, provided by the company to ICIJ, show that the company has long had evidence of an epidemic tied to heat stress and dehydration. In 2001, company doctor Felix Zelaya conducted an internal study on the causes of CKD among its workers. “Strenuous labor with exposure to high environmental temperatures without an adequate hydration program predisposes workers to heat stress syndrome [heat stroke], which is an important factor in the development of CKD,” Zelaya concluded.

Nicaragua Sugar and other companies say they have acted voluntarily to protect workers by improving hydration, reducing work hours, and strengthening oversight of labor contractors.

Chavkin and Greene dig deep into the economic and political factors underlying the global response to the epidemic, as well as the day-to-day impact it all has on workers’ lives. For more, read their full investigation.

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