Factory that made recalled Tylenol was cited
Filed under: Government, Hot Health Headline, Pharmaceuticals
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
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.”
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Disciplined docs turn up on Pfizer payroll
Filed under: Health data, Health journalism, Hot Health Headline
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
Filed under: Conflicts of interest, Health journalism
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
“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.
Photo 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
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.”
Open government directive bears fruit, databases
Filed under: Government, Health data, Hospitals, Hot Health Headline, Public records, Tools
In December, 2009 Peter Orszag, director of the White House’s Office of Management and Budget, issued an Open Government Directive (original PDF here) requiring a number of agencies to “identify and publish online in an open format at least three high-value data sets” on Data.gov within 45 days. That deadline came on Jan. 22, and the resulting data sets have all been posted online. The beefiest and most immediately useful are those from the Department of Veterans Affairs, but we’ve also included other sets which could prove useful for health care journalists. Descriptions are taken directly from Data.gov.
Department of Veterans Affairs
Veterans hospital report cards and safety reports
The VA has divided report cards (11 categories) and safety reports (4 categories) into topic-specific files, from Infrastructure to Nosocomial Infections. The best way to find what you’re looking for is to visit the Open Government Directive site and then scroll down to “Department of Veterans Affairs.”
FY08 Veterans Compensation and Pension by County
The Compensation and Pension by County dataset is a count of the number of veterans receiving disability compensation or pension payments from the Department of Veterans Affairs. The data is reported at the county level, by age group and by % disability rating.
Social Security disability claims
SSA Disability Claim Data
The dataset includes fiscal year data for initial claims for SSA disability benefits that were referred to a state agency for a disability determination. Specific data elements for each year and state include receipts, determinations, eligible population, and favorable determination rates.
SSA State Agency Workload Data
The dataset includes monthly data from October 2000 onwards concerning initial claims for SSA disability benefits that were referred to a state agency for a disability determination.
USDA nutrition data
MyPyramid Food Raw Data
MyPyramid Food Data provides information on the total calories; calories from solid fats, added sugars, and alcohol (extras); MyPyramid food group and subgroup amounts; and saturated fat content of over 1,000 commonly eaten foods with corresponding commonly used portion amounts.
USDA National Nutrient Database for Standard Reference
The USDA Nutrient Database for Standard Reference, Release 22 (SR22) is the major source of food composition data in the United States and provides the foundation for most public and private sector databases. SR22 contains nutrient data for over 7,500 food items for up to 143 food components, such as vitamins, minerals, amino acids, and fatty acids.
Medicare
CY 2009 MTM Contact List
CMS approved contact list of Part D Sponsors in Medication Therapy Management Program (MTMP) which is in their plans’ benefit structure.
Office of Medicare Hearings and Appeals Claims Listed by State
Total count of Claims received by Region, State and fiscal year. Appeals can be found here.
Part B National Summary Data File
The Medicare Part B National datasets are summarized by meaningful Health Care Common Procedure Coding/Current Procedural Terminology, (HCPC/CPT), code ranges. Each dataset displays the allowed services, allowed charges and payment amounts by HCPC/CPT codes and prominent modifiers.
Other
OSHA Data Initiative - Establishment Specific Injury and Illness Rates
Each year the Occupational Safety and Health Administration (OSHA) collects work-related injury and illness data from employers within specific industry and employment size specifications. This data collection is called the OSHA Data Initiative or ODI. The data provided is used by OSHA to calculate establishment specific injury and illness incidence rates.
What else is there?
The “Tools” section of the site includes widgets and data-mining and extraction tools, applications, and other services to “provide the public with simple, application-driven access to Federal data with hyperlinks.” The “Geodata” section includes federal geospatial data with metadata and links to more detailed Federal Geographic Data Committee (FGDC) metadata information.
The site is soliciting comments about what datasets should be made available, so you can suggest more datasets here. The site also offers a tutorial.
Drug data could inform stories about elder care
The 2007 National Home and Hospice Care Survey (NHHCS ) Medication Public-Use File and Documentation are now available for downloading.
One group of researchers used earlier NHHCS data to “examine changes in hospice services over time, as they were collected during the period from 1992 to 2000, paralleling the period of substantial growth in hospice use and spending.”
With recent studies and news about the increase in use of antipsychotics in the elderly, this data might be useful in reporting such stories and documenting the increase, as well as stories about how treatments have changed.
The 2007 NHHCS Medication Public-Use Data File is supported by SAS, SPSS, and STATA input statements. The documentation includes three PDF files: technical notes, a data dictionary, and a PDF file that provides drug name codes, drug estimates and rates, and drug characteristics.
FDA documents for most-popular drugs not online
Filed under: Government, Pharmaceuticals, Public records
Nancy Watzman, writing for the Sunlight Foundation Reporting Group, has found that, because the Food and Drug Administration only makes approval background documents available for drugs approved after 1997, safety and efficacy information for nine of the 25 most-prescribed drugs is not available online.
The article points out that doctors base their treatment decisions on information in peer-reviewed articles, where drug companies have little incentive to publish negative information. The studies the FDA uses to make approval decisions, however, may have more complete and balanced information that would be useful to doctors and consumers.
Watzman reports that the FDA apparently receives such documents electronically, then prints them out, redacts them by hand (using white out!) and then scans them and saves them as PDF documents that are not searchable.
The report includes a list of the 25 most-prescribed drugs and highlights those for which FDA review documents are available online.
NPR to air explanatory Fosamax piece tonight
Filed under: Hot Health Headline, Pharmaceuticals
NPR correspondent Alix Spiegel’s latest piece, an examination of how Merck manufactured a disease (and an epidemic) en route to turning Fosamax into a blockbuster drug, is set to air on All Things Considered tonight. 
We all know how the story ends, but the real focus is the journey. As Spiegel says, “it’s the story of how the definition of what constitutes a disease evolves, and the role that drug companies can play in that evolution.”
In the case of Fosamax, it’s a real humdinger, going all the way from a sweltering meeting room in Rome to the shady backrooms of corporate America and, just in case that isn’t Da Vinci Code enough, it even involves dubious decisions at the highest levels of government.
Update
In a sidebar added to the story after this entry was posted, journalist Gisele Grayson writes about learning that she has osteopenia.
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