British skeptics rethink drug policy over a few beers
On BMJ.com, guest blogger Annabel Bentley relates the proceedings of a local chapter of “Skeptics In The Pub” (their Facebook page is here) in which they heard the ex-chairman of the UK government’s Advisory Council on the Misuse of Drugs speak in favor of an evidence-based approach to drug policy.
Saying that alcohol is one of that country’s greatest drug problems, the ex-chairman (who lost his job for making similar remarks [PDF]) argued that drugs should be classified based on their relative harms.
Bentley also links to a fun Skeptics in the Pub piece in The Economist, this one about Skeptics coming together in defense of a journalist being sued by the British Chiropractic Association over a piece he did considering the effectiveness of their profession.
Archive offers drug industry documents online
Filed under: Health data, Pharmaceuticals, Public records
In correspondence earlier this month, Kim Klausner, of the University of California, San Francisco Library and Center for Knowledge Management, suggested that reporters should be aware of the Drug Industry Document Archive.
Klausner, the industry documents digital library manager, sent a complete guide to what’s available, the history of DIDA and lots of examples of how reporters and others have used DIDA that is available on HealthJournalism.org.
The archive, available to anyone with access to the Internet, contains about 2,500 pharmaceutical industry documents submitted by “lawyers representing people who file law suits against drug companies and Congressional committees investigating the pharmaceutical industry,” according to Klausner.
William Heisel of the Antidote blog is doing a series of posts that show how the archive can be used to research stories. Heisel’s example uses depositions from a case against Wyeth over side effects of its hormone replacement therapy drugs.
Fla. painkiller industry flourishes, supplies nation
Filed under: Hot Health Headline, Pharmaceuticals
The Miami Herald’s Scott Hiaasen delved into South Florida’s massive painkiller industry, one which, enabled by loose laws and lax oversight, supplies a massive underground distribution network reaching throughout the South and New England. According to Hiaasen, pills flow by the thousands every day through an ever-growing number of clinics offering drugs and prescriptions to walk-in patients at strip malls and nondescript office parks.
In the last six months of 2008, doctors at Broward’s pain clinics handed out more than 6.5 million pills of the potent painkiller oxycodone — almost four pills for every Broward resident, according to federal data compiled by the Broward Sheriff’s Office.
Among Hiaasen’s findings:
- 45 South Florida doctors sold nearly nine million oxycodone pills in the last six months of 2008.
- 33 of the top 50 oxycodone-dispensing doctors in the United States practice in Broward County.
- The number of pain clinics in South Florida grew from 60 to 150 in the past year, the DEA estimates.
- Overdose deaths in Florida caused by oxycodone rose from 340 in 2005 to 705 in 2007.
In a companion story, Hiaasen looks at the other end of the prescription painkiller pipeline: rural Appalachia.
”We’re inundated with it. Florida is killing us,” said Sheriff Bill Lewis of Lewis County, Ky., population 14,000. “There’s a carload that leaves here so often — hell, every week or so — to go to Florida.”
In February, Lewis’ deputies arrested four people returning to Kentucky with almost 1,000 painkillers prescribed by Florida doctors. And last Thursday, they arrested a suspected oxycodone trafficker carrying the business card of a Hollywood pain doctor in his wallet.
Florida is the largest of the 12 states without a prescription drug monitoring plan, a fact some local lawmakers call “embarrassing.”
N.J. psychiatric hospital botches drugs, doses
Jean Mikle of the Asbury Park Press chronicled medication errors at Ancora Psychiatric Hospital, New Jersey’s largest such institution. Mikle pored over public records and found that while hospital officials say they are safer than average, “overdoses, adverse reactions to medicines, and wrong doses of powerful drugs have harmed dozens of patients at Ancora since 2006.”
Since December, two Ancora patients have been hospitalized because of “reactions to medications” they received inside the psychiatric hospital, according to Ellen Lovejoy, the spokeswoman for the state Department of Human Services.
Brick resident Derrick Raymond, 28, who has been a patient at Ancora several times since 2002, said he could easily have been given the wrong medication because, he said, patient files were frequently in disarray.
“I’ve had my files mixed with other people’s,” Raymond said. “I could have been given the wrong medication. You start to feel like a guinea pig for medications in there.”
Mikle found cases where patients were given the wrong medication, the wrong amount of medication, no medication when some was needed, expired medication and medication intended for other patients.
Newer technology not always more effective
Joe Rojas-Burke reported in The Oregonian on what he called “a widespread problem in the health care system: the tendency to embrace new technology without waiting for proof that it’s better than older, cheaper, time-tested solutions.”
Some examples from Rojas-Burke’s report:
- A Duke University study found that men who received robot-assisted prostate surgery experienced about the same rate of harmful side effects as those who went under a traditional surgeon’s knife and that, furthermore, the men who received robotic surgery felt three to four times as much post-surgery regret as those who chose the traditional option, probably due to heightened expectations.
- Two Finnish researches reported in the British Medical Journal that falling, not osteoporosis, was the greatest risk factor for bone breaks among the elderly, casting doubt on the effectiveness of scanning bone density and prescribing drugs. “By one estimate, more than 80 percent of low-impact fractures occur in those who don’t have osteoporosis, which means that bone-density tests can’t reliably predict which patients are likely to break bones,” Rojas-Burke reports.
- He cites the use of electronic fetal heart monitoring, computer-aided mammography devices, blockbuster drugs such as Vioxx, Zelnorm and Avandia as other cases in which newer may not be better.
The Columbia Journalism Review’s Trudy Lieberman blogged that Rojas-Burke’s findings are particularly important when considered alongside the government’s proposed stimulus package, the Senate version of which “includes $1 billion for research on the comparative effectiveness of medical treatments.”
Lieberman, president of AHCJ’s board of directors, said the proposed “bill has already sparked concern that some patients may not get expensive treatments that they or their doctors want,” and recounted the cautionary tale of the National Center for Health Care and Technology, created in 1978 with a similar purpose. Lieberman said the center met an early demise during the Reagan administration thanks to the efforts of the American Medical Association and the Health Industry Manufacturers’ Association, which “argued that the Center was redundant because doctors were the ones best equipped to evaluate new technology.”
Reports shed light on FDA oversight problems
When we talk about FDA oversight, what might we mean? Not too much, according to a pair of new reports from the Office of the Inspector General in the Department of Health and Human Services.
One report assessed the process by the FDA’s Center for Drug Evaluation and Research for selecting information technology contractors and monitoring their performance between fiscal years 2004 and 2007. The findings: CDER’s actions demonstrated “limited IT planning and increased risk for the government” by using broad language and relying primarily on acquisition methods that emphasize speed and flexibility over planning. CDER also used quality assurance and monitoring plans inconsistently. For instance, 21 of 28 ‘contract actions’ didn’t have documented quality assurance plans. And of seven contract actions that did include quality assurance plans, three contained identical plans with generic language, no pun intended, for inspections.
A second report, which got some notice earlier this week, found that oversight was lacking of financial conflicts of interest involving clinical trial investigators. For instance, only one percent disclosed at least one financial interest, and this represented 206 of the 29,691 investigators listed in financial interest forms. Of the 206, almost all disclosed only one financial interest, with a few disclosing two or three.
A few other problems - the FDA can’t determine whether sponsors have submitted financial info for all clinical investigators; 42 percent of FDA-approved marketing applications were missing financial info; the FDA didn’t document a review of any financial info for 31 percent of marketing applications, and neither the agency or sponsoring drug makers took action for 20 percent of marketing applications with disclosed financial interests. And when the FDA did action, the agency was inconsistent.
And how did the FDA respond? The agency told the OIG that the extra effort to collect such info “would not be worthwhile because financial interests are only one form of potential bias and not all clinical trials are presented in the marketing applications. That may be true, but the FDA is slow to realize that bias among investigators similarly may pose perceived or real problems.
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