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.

NYT series digs into overprescription and developmentally disabled adults

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.

Back-to-the-beat resources on health reform

Aug. 31st, 2011 by Joanne Kenen · Leave a Comment
Filed under: Health care reform 

Since so many of us are in storm (or non-storm) what-are-we-going-to-do-with-all-these-batteries cleanup and back-to-school mode, I thought I’d bring some resources and interesting studies to your attention to help bring your focus back on the beat.

Confusion still reigns

You probably saw the Kaiser poll reminding us once again how confused people remain about the health reform law - including the very people who would be most helped by it, the uninsured. It got a lot of coverage but if you missed it, it’s a must read. It ties into the theme of massive national confusion – and the frustration I feel that the confusion persists despite a fair amount of good reporting – that I wrote about in the first post I did for Covering Health. I think a lot of the confusion stems from the mandate . People hear that they will “have” to buy insurance, and they panic or get angry because they can’t afford it. They don’t hear that they may well qualify for subsidies to make it affordable-and they don’t have to be dirt poor to get the subsidies; many middle class people will also benefit.

kff-graphic-aug2011

Click to enlarge this graph from the Kaiser Family Foundation Data Note found at http://www.kff.org/kaiserpolls/8217.cfm.

Most of the coverage of the KFF poll I heard or saw centered on the uninsured, but there is also a related data note looking at knowledge and expectations of people who have employer-sponsored health insurance. Asked what they would be willing to do to lower health care costs, the answer could be summed up as “not much.” They are OK with participating in a wellness program (although not necessarily actually getting “weller”) but didn’t like the idea of more generic drugs, more restrictive networks of doctors, or higher copays and deductibles.

Eating away at the doughnut hole

An AHCJ member found this report by EBRI, the Employee Benefit Research Institute, useful so I’m sharing. It’s about how the health reform law will slowly (over a decade) close the “donut hole” for Medicare drug coverage, and how repealing the health law would create a savings hole for older Americans who use a lot of prescription drugs. (The doughnut hole is the gap after you use up the basic drug benefit but haven’t hit the “catastrophic” level. Beneficiaries pay monthly premiums through the gap, but don’t get benefits until they burn through the gap. ) EBRI studies health care and retirement issues and does periodic issue briefs.

What questions do you have about health reform and how to cover it?

Joanne KenenJoanne Kenen is AHCJ’s health reform topic leader. She is writing blog posts, tip sheets, articles and gathering resources to help our members cover the complex implementation of health reform. If you have questions or suggestions for future resources on the topic, please send them to joanne@healthjournalism.org.

Staff physicians on the rise

The Center for Health System Change has been tracking health care developments in 12 communities and found that hospitals are hiring more staff physicians. In policy circles, the talk has been that the staff-physician model is a tool in creating more clinical integration, care coordination, higher quality and lower cost – but this study found that the hospitals are in it primarily for market share. Physicians like it because it’s fewer hassles. It doesn’t necessarily bring down overall health care costs. Now, this is a snapshot in a fee-for-service world; new payment models being developed by private insurers, and Medicare and Medicaid may change the dynamic. But it’s an attention-worthy snapshot. The HSC Issue Brief, “Rising Hospital Employment of Physicians: Better Quality, Higher Costs?” is available online.

Who applied to be ACOs?

There was a lot of coverage a few months back about all the health systems that were not going to apply to become Medicare Accountable Care Organizations, at least not under the original shared savings model. We aren’t hearing as much about who is applying – worth checking in your community. Medicare also created an alternative, called the pioneer ACO, to attract more plans. We won’t know until around November how many applied to be pioneers, or who they are, but here’s the story of one plan that’s ready to go.

Behind the drug shortage

There was a lot of discussion on the AHCJ electronic discussion list recently about drug shortages, particularly chemotherapy shortages. I was out of town for a few days (helping care for a relative and learning, among other things, that Medicare pays for oxygen concentrators but not for the batteries) and I haven’t caught up with all of the messages, but this essay in the Sunday New York Times a few weeks ago by Ezekiel Emanuel taught me lots I didn’t know about generic chemo drugs, pricing and shortages, and proposed solutions.

Author sees need for more drug safety info for elderly

Jun. 30th, 2011 by Jeff Porter · Leave a Comment
Filed under: Government, Pharmaceuticals 

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.

Factory that made recalled Tylenol was cited

The U.S. House of Representatives’ oversight committee will hold a hearing today about an April 30 recall of children’s Tylenol and other medicines. In advance of that hearing, Alison Young of USA Today reports that the manufacturing place responsible for the medicine “was cited last year by regulators for ‘knowingly’ using a bacteria-tainted ingredient, according to a 2009 inspection report.”

The U.S. Food and Drug Administration also cited the McNeil Consumer Healthcare plant for a similar violation last month. The April inspection, which found serious manufacturing violations and drugs that were potentially too potent, prompted the current recall.

Young also reports that the FDA issued 43 warning letters since January 2009 to drug factories about poor practices that may have endangered patients.

Violations serious enough to prompt warning letters from the U.S. Food and Drug Administration include plants using equipment and ingredients contaminated with bacteria or insects, failing to do proper testing to ensure drug strength and purity, and ignoring consumer complaints that products were making them sick.

Among the cases Young cites are possible bacterial contamination of propofol, reports of bug parts in another company’s medicines and bacteria in calcium carbonate, which is used in antacids and a menopause drug.

That House hearing starts at 10 a.m. ET and will be webcast. To watch, click here.

NPR’s Scott Hensley has been staying on top of the recall story on the Shots blog.

(Hat tip to the Donald W. Reynolds Center for Business Journalism)

Drug companies hit with punitive damages

May. 11th, 2010 by Pia Christensen · 2 Comments
Filed under: Pharmaceuticals 

A jury has decided Teva Parenteral Medicines and Baxter Healthcare Corp. must pay a combined $500 million in punitive damages in a case involving a hepatitis C outbreak in Las Vegas.

The case, expected to be just the first of hundreds, alleged that the re-use of vials of the anesthetic propofol infected patients with the disease.

An attorney for former patient Henry Chanin said the vials provided by the companies were larger than necessary, while “drug company lawyers have maintained that the vials were marked with instructions and warnings, and medical professionals decided what sizes were appropriate.”

Related

Disciplined docs turn up on Pfizer payroll

New Scientist’s Peter Aldhous and Jim Giles created an interesting mash-up of two popular health stories, disciplined caregivers and conflicts of interest, by matching a set of Pfizer disclosures on payments to doctors and researchers in 2009 with discipline records from the FDA and the country’s most populous states. They found 26 matches on the state level and four from the feds, matches which accounted for about one in every 50 Pfizer-paid doctors in the states they’d investigated.

They assembled a number of anecdotes for the story, but the most telling related to a physician who was disciplined for faulty research related to a Pfizer drug, yet still paid by the company to lecture on it.

Other Pfizer experts ran into trouble during their research. Among them is Thomas Gazda of Scottsdale, Arizona, who was paid to lecture about Geodon after being reprimanded by the FDA over irregularities in his conduct of a trial of the same drug’s use in children and adolescents with bipolar disorder – one of whom was given more than the maximum allowable dose for five days. The FDA had earlier told Pfizer to exclude Gazda’s data from the results submitted by Pfizer during its efforts to win approval to use the drug for this purpose.

AHCJ has extensive resources for folks looking to do both sides of the mashup, with tips for investigating conflicts of interest from John Fauber of the Milwaukee Journal Sentinel and recommendations for looking into disciplined caregivers from ProPublica’s Charles Ornstein and Tracy Weber.

Roche linked to doctor praising drug in the media

Crikey.com, a news Web site based in Melbourne, Australia, calls our attention to some recent reporting about Mabthera, a drug used to treat non-Hodgkins lymphoma.

Nick Miller, health editor of The Age, recently reported that Mabthera, manufactured by Roche, “has been found to nearly double the number of [leukemia] patients who go into remission.”

In that article, Miller quoted a doctor as saying, “This is the largest single advance in the treatment of this disease in the last 30 years.”

Miller was rebuked by oncologist Dr. Ian Haines, who wrote a letter to the newspaper. Haines points out that the article was “an exaggeration of the benefits of the treatment with no presentation of the downsides … which is that it’s incredibly expensive, it’s not without risk,” according to Flint Duxfield, a student at the Australian Centre for Independent Journalism.

Duxfield goes on to explain how events unfolded and reveals that the promotion of Mabthera is being driven by Roche, which provides financial support to Peter MacCallum Cancer Centre, which employs the doctor who originally touted the drug in Miller’s article.

In fact, sections of the press release issued by the cancer center and the press release from Roche’s public relations company are identical and contain the same comments from the doctor quoted by Miller.

Duxfield also reports that warnings that have been issued for the use of Mabthera that have gone unreported in the print media.

The story says “the engagement of third parties in providing a link between a drug company and the media is all too common in health journalism.”

Veteran health reporter Ray Moynihan agrees: “It happens enormously often because third party endorsements are PR 101 for drug companies.”

Duxfield also points to other examples of these so-called “third=party endorsements” and how they have been reported in the media.

OPM: Don’t restrict our pharmacy contracts

Mar. 1st, 2010 by Andrew Van Dam · Leave a Comment
Filed under: Government, Hot Health Headline 

“Nearly 30 percent of the government’s $39 billion health plan goes to cover prescription drugs,” writes Stephen Losey of Federal Times, a publication directed at federal managers. Perhaps that’s why there has been such a strong reaction to the “Prescription Drug Integrity, Transparency and Cost Savings Act” (H.R. 4489), especially from the federal Office of Personnel Management.

medsPhoto by jypsygen via Flickr.

(The bill), sponsored by Rep. Stephen Lynch, D-Mass., would require PBMs [pharmacy benefit managers] to return to the government 99 percent of all rebates, market share incentives and other savings they receive. It would place new transparency requirements on PBMs and cap drug prices to make sure the government doesn’t pay more than the nationwide average. PBMs would also be prevented from switching federal employees’ drugs to cheaper alternatives without their physicians’ prior approval.

The bill would restrict how the government contracts with pharmacy benefit managers because, Losey writes, “critics say PBMs have opaque pricing methods, retain most discounts or rebates prescription drug manufacturers give them, and receive little oversight from OPM.”

A subcommittee hearing on the bill was held Tuesday.

Survey looks at use of leftover pain meds

Feb. 18th, 2010 by Pia Christensen · Leave a Comment
Filed under: Health data, Public health 

One in five people in Utah have been prescribed pain medication in the past year, according to new figures from the Morbidty and Mortality Weekly report from the Centers for Disease Control and Prevention.

While the survey only takes into account the use of pain medications in Utah, the CDC notes that “This percentage is comparable to the 18.4% of insured persons aged ≥18 years who reported receiving a prescription for opioids in a national study in 2002.”

The report says that deaths in Utah as a result of  “poisoning by prescription pain medications” increased nearly 600 percent from 1999 to 2007.  It also looks at the problem of leftover medication and people using medications not prescribed to them:

An estimated 72% of respondents who were prescribed an opioid had leftover medication, and 71% of those with leftover medication kept it; during the same period, 97% of those who used opioids that were not prescribed to them said they received them from friends or relatives.

The state has set out some recommendations for health care providers aimed at reducing the availability of unused medications.

The data comes from the Behavioral Risk Factor Surveillance System, an on-going telephone survey system that collects information about health risk behaviors, preventive health practices and health care access. Utah is apparently the first state to include pain medication questions in the BRFSS, “although Kansas added a module of questions regarding chronic pain in 2005 and 2007 with one follow-up question asking how the pain was treated.”

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