Wednesday, April 30, 2008

A CME success story

From the Washington Post article:
An intensive educational program for physicians and midwives that stresses giving women the drug oxytocin just after a vaginal delivery resulted in significantly fewer cases of excessive bleeding, according to a study done in two South American countries.
Click here to access.

Monday, April 28, 2008

AAMC report on industry funding of medical education

An excerpt from the Executive Summary:
The Report acknowledges the new policy directions being implemented in many medical schools and teaching hospitals to address industry support of medical education, and it urges all academic medical centers to accelerate their adoption of policies that better manage, and when necessary, prohibit, academic- industry interactions that can inherently create conflicts of interest and undermine standards of professionalism. Although the charge to the Task Force was focused on funding from the pharmaceutical and device industries, institutional policies on conflicts of interest should be comprehensive and encompass providers of equipment and services as well. Concomitantly, industry should voluntarily discontinue those practices that compromise professionalism as well as public trust.
Click here to access the report.

Wednesday, April 23, 2008

Please complete a brief survey regarding my blog!

Click Here to take survey

BPA in your plastics

From the New York Times article:

A draft report from the National Toxicology Program, part of the Department of Health and Human Services, notes that there is no direct evidence that human exposure to BPA harms reproduction or infant development. “I don’t think there’s anything in this brief that should lead to alarm,” said Dr. Michael D. Shelby, director of the Center for the Evaluation of Risks to Human Reproduction, who oversaw the report. “It means we’ve got a limited amount of evidence from some studies that were done in laboratory animals.”

The main concern is the possible risk to infants and pregnant women, although Canada has begun a study to monitor BPA exposure among about 5,000 people to assess any danger to adults.

Click here to access the NYT article.

Tuesday, April 22, 2008

Seroquel "sequelae"?

From the Cincinnati.com Enquirer article:

The University of Cincinnati will increase scrutiny on a psychiatry professor for not reporting all of the hundreds of thousands of dollars in corporate research money she received from a pharmaceutical giant during the last decade.

Melissa DelBello now has to review all of of her interactions with companies with her department chairman, UC vice president of research Sandra Degen said Friday.

Click here to access the article.

Trends in U.S. mortality

Check out the PLoS Medicine article "The Reversal of Fortunes: Trends in County Mortality and Cross-County Mortality Disparities in the United States"; the authors' conclusions:

There was a steady increase in mortality inequality across the US counties between 1983 and 1999, resulting from stagnation or increase in mortality among the worst-off segment of the population. Female mortality increased in a large number of counties, primarily because of chronic diseases related to smoking, overweight and obesity, and high blood pressure.

Click here to access the online article.

Sunday, April 20, 2008

Nepotism

I had to find this myself on youtube.com because my nephew, Erik, would, of course, not let me know this was online. Click here to go to Erik's website.
:)

Saturday, April 19, 2008

Zimmer compliance

Looks like at least one medical device manufacturer is responding just like Big Pharma! An excerpt from Zimmer's recent announcement:
The refined compliance model is designed to aggressively reduce potential or perceived conflicts of interest inherent in consulting relationships between the industry and healthcare professionals—while preserving the best of the collaboration that drives innovation in medical devices and services. The model includes fundamental changes in the areas of product development, marketing, surgeon training, educational and charitable funding, and transparency.
Click here to access.

Friday, April 18, 2008

FDA clarification?

From the Wall Street Journal article:
Drug-industry representatives are descending on the capital to protect their freedom to advertise their wares directly to consumers and to push for looser government restrictions on their ability to promote off-label uses of their medicines.
Click here to access the WSJ article (sub. req.).

Primum non nocere

Check out the editorial in JAMA written by Doctors DeAngelis and Fontanarosa regarding the adverse effects of industry influence. Click here to access (free text article).

Wednesday, April 16, 2008

The Vioxx "haunting"

Senator Grassley sent a letter to Merck asking for lots of information on the latest revelations regarding Vioxx! Click here to access the Senator's letter.

Monday, April 14, 2008

The start of a trend?

Check out the New York Times article "Citing Ethics, Some Doctors Are Rejecting Industry Pay"; an excerpt:
No longer will they be paid for speaking at meetings or for sitting on advisory boards. They may still work with companies. It is important, they say, for knowledgeable scientists to help companies draw up and interpret studies. But the work will be pro bono.
Click here to access.

Saturday, April 12, 2008

Senator Grassley press release

From the Senator's 4-11-08 press release:
Copies of letters that Senator Grassley received from drug makers in response to his request for them to follow Eli Lilly’s lead and disclose financial contributions to continuing medical education are posted with this statement at http://finance.senate.gov. Right now,Senator Grassley does not plan to pursue disclosure legislation separate from the Physician Payment Sunshine Act. He will carefully monitor implementation of the disclosure plans described in these letters and consider additional initiatives, including legislation, if transparency is not achieved.
Click here to read this press release and the response letters from these companies.

Pennsylvania's 2nd annual hospital-acquired infection report

From the U.S. News & World Report article:
Leafing through the report and fizzing indignantly about the performance of some of the hospitals, I was overheard by Bernadine Healty, my next-office physician colleague (a former medical school dean and director of the National Institutes of Health). She reminded me that there could well be reasons for a number that seems outrageous. A hospital might treat a disproportionate number of patients vulnerable to infection because of HIV or old age, for instance. The data are important and impressive, she said, but the primary purpose is to alert a hospital with high numbers that something may be badly amiss. "Before jumping to conclusions, you need to drill down into the data," she said. "Investigate. Find out what's going on."
Click here to access the USNWR article. Click here to access the "Hospital-Acquired Infections in Pennsylvania" Report (98 pages).

Joint Commission issues pediatric medication safety strategies

From the Washington Post article:

"The vast majority of countries utilize the metric system, and the recommendations for pediatric medication use are based on the metric system," said Dr. Peter Angood, vice president and chief patient safety officer for The Joint Commission, which announced the "Sentinel Event Alert" at a teleconference.

"Sadly, there seems to be a lack of widespread appreciation even among health-care providers that children have unique safety and medication needs," said Dr. Matthew Scanlon, assistant professor of pediatrics-critical care at the Medical College of Wisconsin and a member of the Joint Commission's Sentinel Event Advisory Group.
Click here to access the WP article. Click here to access these Joint Commission recommendations.

Friday, April 11, 2008

HelloCME.com?

Check out Dr. Reece's blog entry "Parkinson's Law..." about HelloHealth.com which is scheduled to launch in June 2008. If you don't laugh out loud when you're reading it, then we should never meet. Click here to access the entry.
:)

This mouse is stirring...

Thursday, April 10, 2008

Just say...Yes!

From the CNN.com news article:
One in five respondents to a new survey in the journal Nature say they've used drugs to boost their brain power.

"We were putting our finger in the air to see what our reader response would be. And it was tremendous," said Brendan Maher, an editor with the widely read scientific publication. "What it's suggesting is there are a high percentage of adults using these drugs."

The informal, nonscientific survey, conducted online, polled 1,400 people in 60 countries. Most of the responders, the majority of whom said they worked in biology, physics, medicine or education, reported taking the drugs to improve their concentration.

Click here to access the article.

CDC FoodNet Report

From the WebMD article:
The CDC's Foodborne Diseases Active Surveillance Network, called FoodNet, began tracking cases of food-borne illnesses in 1996 in 10 U.S. states. The idea is to track infection trends for the 10 most important causes of food poisoning.
...
"There is not a particularly important change from the last few years," said Robert Tauxe, MD, MPH, deputy director of the CDC's division of food-borne diseases. "A lot of things have been going on to improve food safety, and we think they are likely to bear fruit ... but we cannot say we have made tremendous progress in the last year."
Click here to access the article. Click here to access the April 11 issue of the MMWR (page 6).

Wednesday, April 09, 2008

AHRQ National Resource for Health Information Technology

Click here to access.

Patient safety survey stats

From the Washington Post article:
From 2004 through 2006, patient safety errors resulted in 238,337 potentially preventable deaths of U.S. Medicare patients and cost the Medicare program $8.8 billion, according to the fifth annual Patient Safety in American Hospitals Study.
Click here to access.

Tuesday, April 08, 2008

The unbranded doctor?

Yep! The National Physicians Alliance has a new campaign entitled "The Unbranded Doctor." Click here to check it out.

The health care economics of prevention

Check out the Washington Post article entitled "In the Balance"; an excerpt:
An ounce of prevention may have been worth a pound of cure in households down through the ages, but in the world of health economics the adage, alas, is not true.

An ounce of prevention is sometimes worth more than an ounce of cure (although rarely worth 16 times as much, or the equivalent of a pound). Usually, an ounce of prevention is worth considerably less. Often it is worth (to mix measures) only a gram of cure. Or even just a milligram.

This is a seemingly illogical truth.
Click here to access the WP article. Click here to access the PLoS Medicine article "Lifetime Medical Costs of Obesity: Prevention No Cure for Increasing Health Expenditure." Ummmmm

Friday, April 04, 2008

Response to CMAJ editorial

Courtesy of notification by Anne Taylor-Vaisey, check out the electronic letters that have been sent in to the CMAJ in response to the editorial "The need for an Institute of Continuing Health Education." Click here to access the letters. Click here to check out Annie's blog.

Psychiatric News article on CME and pharma influence

An excerpt:
Intensifying criticism from academia, the media, and regulators has been directed at perceived bias in the large proportion of CME content that often favors a newly marketed product or off-label use of a product manufactured by the sponsor. The Senate report is primarily concerned about such influence on drug expenditures for Medicare and Medicaid.
Click here to read the article.

Carlat's blog posting on Medical Meetings magazine

Check it out by clicking here!
Happy Friday!
:)

Best practices work when it comes to medication safety!

From the Business Wire article:

A demonstration program at UCSF today reported a 56.8% reduction in medication administration errors – increasing the administration accuracy rate at participating hospitals to 93%. These gains were achieved through adherence to a set of six “best practice” procedures for medication administration identified by CalNOC (the California Nursing Outcomes Coalition). The study also reported a reduction in procedural errors of 78.5% – increasing adherence to these “best practice” procedures to 95.6% after 18 months. This study is the first to directly validate a specific set “best practices” for medication administration.

Click here to access the article.

Saturday, March 29, 2008

National survey of hospital patients

From the New York Times article:
Many hospital patients are dissatisfied with some aspects of their care and might not recommend their hospitals to friends and relatives, the federal government said Friday as it issued ratings for most of the nation’s hospitals, based on the first uniform national survey of patients.
...
The new data, part of a survey of patient experiences and perceptions of hospital care, is posted at a government Web site, www.hospitalcompare.hhs.gov.

Richard J. Umbdenstock, president of the American Hospital Association, which helped develop the measures, said they allowed “an apples-to-apples comparison” of hospitals at the state, local and national levels.

Click here to access the NYT article.

Friday, March 28, 2008

Culture and health care delivery

Just read a fascinating article that was published Monday in the Boston Globe entitled "Culture Gap"; an excerpt:

Hinton, speaking in You's native Khmer language, told her to taper off her antipsychotic medications, according to his records, and handed her prescriptions for two other drugs - one to help her sleep, another to control her anxiety attacks. He urged her to continue her traditional Cambodian practices to help "wind" flow.

After regular therapy sessions with Hinton, You's emotions stabilized. And she trusted these words from him: You're not going to die from your neck vessels bursting.

Click here to read the article.

A lot more than shrimp on the barbie?

From the Sydney Morning Herald article:

Australian drug companies forked out more than $30 million in six months hosting doctors at controversial "educational" events, a report has revealed.

Pharmaceutical industry body Medicines Australia has been forced to detail spending on doctors' seminars of up to $2,500 a head, often hosted at expensive hotels and in exotic locations.

A report prepared for Medicines Australia by international consulting firm Deloitte shows that 42 companies spent $31 million, including $16.4 million on direct hospitality costs like meals, flights and hotels, in the second half of last year.

Click here to access the article.

Wednesday, March 26, 2008

Self assessment

The newest issue of the Journal of Continuing Education in the Health Professions has been published and it has a wealth of articles on self assessment:
Self-monitoring in clinical practice: A challenge for medical educators
Ronald M. Epstein, Daniel J. Siegel, Jordan Silberman

ldquoI'll never play professional footballrdquo and other fallacies of self-assessment
Kevin W. Eva, Glenn Regehr

Making self-assessment more effective
Robert M. Galbraith, Richard E. Hawkins, Eric S. Holmboe

Self-assessment and continuing professional development: The Canadian perspective
Ivan Silver, Craig Campbell, Bernard Marlow, Joan Sargeant

Self-assessment in CPD: Lessons from the UK undergraduate and postgraduate education domains
Tim Dornan

Self-assessment of practice performance: Development of the ABIM Practice Improvement Module (PIMSM)
F. Daniel Duffy, Lorna A. Lynn, Halyna Didura, Brian Hess, Kelly Caverzagie, Louis Grosso, Rebecca A. Lipner, Eric S. Holmboe

ldquoDirectedrdquo self-assessment: Practice and feedback within a social context
Joan Sargeant, Karen Mann, Cees van der Vleuten, Job Metsemakers
A subscription to JCEHP (and online access) comes with membership in the Alliance for CME.

Ruling on access to JAMA peer review files

From the Wall Street Journal article:
In a court case pitting Pfizer Inc.'s corporate interests against a medical journal's confidential article-review process, a federal magistrate rejected Pfizer's attempt to gain access to documents of the Journal of the American Medical Association.
Click here to access (sub. req.).

Monday, March 24, 2008

Feds focusing on physicians

From the New York Times article:
A long-running federal investigation into the orthopedic device industry’s suspected kickback payments to hip and knee surgeons now has the doctors in the spotlight.

Having reached settlements with the five leading makers of artificial joints last year over the payments, the government has been focusing on the many doctors who receive money as the companies’ paid consultants.
Click here to access the NYT article.

Sunday, March 23, 2008

www.PatientsLikeMe.com

An excerpt from the New York Times article on this website:
But PatientsLikeMe seeks to go a mile deeper than health- information sites like WebMD or online support groups like Daily Strength. The members of PatientsLikeMe don’t just share their experiences anecdotally; they quantify them, breaking down their symptoms and treatments into hard data. They note what hurts, where and for how long. They list their drugs and dosages and score how well they alleviate their symptoms. All this gets compiled over time, aggregated and crunched into tidy bar graphs and progress curves by the software behind the site. And it’s all open for comparison and analysis. By telling so much, the members of PatientsLikeMe are creating a rich database of disease treatment and patient experience.
Click here to access the NYT article. www.PatientsLikeMe.com

Friday, March 21, 2008

IOM committee looks into conflicts of interest

From the Medical Marketing & Media article:
Last week's meeting of an Institute of Medicine (IOM) committee gave some hope for a thaw in attitudes toward commercially supported CME, but supporters and providers remain anxious about the group's inquiry into conflicts of interest in medical research and medical education.
Click here to access the article.

NIH establishes new research center

From the New York Times article:
The Center for Genomics and Health Disparities will be led by Charles N. Rotimi, former director of the National Human Genome Center at Howard University.
...
“By understanding the nature of human genetic variation,” Dr. Rotimi said in an interview, “we can see how that overlaps with group identity and individual identity.
Click here to access the article.

Tuesday, March 18, 2008

Stark introduces new bill on gifts to physicians

From the Kaiser Daily Health Policy Report article:
Reps. Peter DeFazio (D-Ore.) and Pete Stark (D-Calif.) have introduced a bill (HR 5605) that would require pharmaceutical medical device companies to disclose to the public any gifts or payments to physicians valued at $25 or more, CQ HealthBeat reports.

The legislation is a companion to a bill (S 2029) sponsored by Sens. Chuck Grassley (R-Iowa) and Herb Kohl (D-Wis.) (CQ HealthBeat, 3/14). Under the bill, companies with at least $100 million in annual revenue would be required each quarter to disclose gifts or payments exceeding $25 in value, and the information would then be posted on a Web site.
Click here to read the article.

Monday, March 17, 2008

Senate Special Committee on Aging requests documents from Schering-Plough

Click here to access the press release. Click here to read the letter sent to Schering-Plough.

New book on pharma by former reporter

"Our Daily Meds" was recently reviewed by the New York Times -- an excerpt of that review:

“Our Daily Meds” begins by illustrating the established drug-company practices that have led to this sorry juncture. There is the rigging of studies, so that to be deemed “effective” a drug need only perform better than a sugar pill. There are the promotional strategies that evade the need for F.D.A. warnings by, say, planting logos for the sexual enhancement drug Viagra and the antidepressant Wellbutrin on Nascar vehicles. There is the co-option of doctors and university researchers by aggressive, payola-dispensing drug company representatives.

Ms. Petersen, who has done much of her digging with the help of obscure but gratifying corporate documents, even finds feedback from doctors about the bribe-style amenities offered by drug company junkets. (“Hotel too cold inside,” one said, in an evaluation of a June 1998 drug company program, adding, “Resort places preferred.” From a different doctor, miffed at the lack of a chauffeur at another event: “Hired car would have been much preferable.”

Click here to read the entire review.

Friday, March 14, 2008

A red face for the AAD?

From the MedPageToday article:
The American Academy of Dermatology is locked in a furor with a subset of its membership over whether to sell its name, prestige, and a special seal for endorsement of commercial sunscreens.

The imbroglio has an eerie similarity to the infamous Sunbeam logo-for-sale scandal that rocked the AMA a decade ago.

Click here to access the article.

Wednesday, March 12, 2008

What can CME providers do to promote safe medication practices?

Well, for one thing they can provide guidance to their CME faculty and give them the Institute for Safe Medication Practices' List of Error-Prone Abbreviations, Symbols, and Dose Designations! Click here to access this list.

H&P

Methinks Dr. Brewer over at the Wall Street Journal makes several important points today:
Patients present their doctors with undifferentiated problems, such as fever or trouble sleeping. Sometimes a common disease like a sore throat will present in a striking way. Or worse, a serious problem like lung cancer will present with a common symptom like a stubborn cough.

There's a steep penalty for being mistaken, however. An uncertain diagnosis often leads to expensive defensive medicine in the form of extra X-rays and lab tests. Tests like those can be a crutch. In my experience, they don't always help with diagnosis as much as a thorough medical history or physical exam.
Click here to access (sub. req.).

Tuesday, March 11, 2008

FDA may go further on anemia drugs

From the businessweek.com article:

The Food and Drug Administration has toughened warning labels on the anemia drugs -- Aranesp, Epogen and Procrit -- three times since last March, but now it is considering more drastic action. Amgen manufactures all three drugs, which treat the blood-disorder anemia in kidney-failure or chemotherapy patients, though New Brunswick, N.J.-based Johnson & Johnson sells Procrit.

In documents posted online Tuesday, regulators laid out several options for addressing safety risks, including withdrawing their use for chemotherapy patients.

Click here to access the article.

CT sues Lilly over Zyprexa

From the reuters.com article:
Attorney General Richard Blumenthal, who announced the suit, is seeking to recover "millions of taxpayer and consumer dollars improperly spent on Zyprexa as a result of its illegal marketing, and millions more spent for treatment of serious side effects from Zyprexa," according to a press statement from his office.
...
In the lawsuit filed Tuesday, Lilly is accused of promoting Zyprexa for unapproved uses, including the treatment of children, and of hiding dangerous side effects, such as increased risk of diabetes, weight gain and heart problems.
Click here to access.

Senate hearing on academic detailing set

From the seniorjournal.com article:

“The drug industry’s educational outreach is essentially a marketing program, and evidence shows that doctors’ prescribing patterns can be heavily influenced by pharmaceutical sales representatives,” says the news release from the Senate Special Committee on Aging that announced the hearing...The hearing – Under the Influence: Can We Provide Doctors an Alternative to Biased Drug Reviews? – will be at 10:30 a.m., March 12, in Room 562 of the Dirksen Senate Office Building...The hearing will be Webcast and the link can be found at the committee webpage: www.aging.senate.gov

Click here to access the article.


Oregon Academy of FPs just says no to pharma

From the Register-Guard article:

The Oregon Academy of Family Physicians, representing 1,300 doctors around the state, announced last week that it would no longer accept financial support from the pharmaceutical industry, swearing off unrestricted grants for continuing education seminars, sponsorship of events or advertisements in its publications. But individual members can still see pharmaceutical reps at their discretion.

“This is about taking the institutional view that as a professional medical society, we are committed to decision-making that is based on scientific evidence,” said Kerry Gonzales, the group’s executive director. “We want to avoid even the perception of influence or impropriety.”

Click here to access the article.

One in four female teenagers have an STD!

From the New York Times article:

The first national study of common sexually transmitted diseases among teenage women has found that one in four are infected with at least one of the diseases, federal health officials reported on Tuesday.

Nearly half of African-American teenage women were infected with at least one of the diseases monitored in the study — human papillomavirus (H.P.V.), chlamydia, herpes simplex type 2 and trichomoniasis, a common parasite.

That figure compared with 20 percent of white teenage women.

Click here to access the NYT article.

Sunday, March 09, 2008

It's a small, small, small world?

From the mlive.com article:
At least one pharmaceutical was detected in tests of treated drinking water supplies for 24 major metropolitan areas, according to an Associated Press survey of 62 major water providers and data obtained from independent researchers.
Click here to access the article.

Check out Dr. Carlat's blog posting on the two recent journal articles on industry-supported CME

Click here.

Expert witness testifies on Lilly drug

From the New York Times article:
Eli Lilly, the drug maker, could and should have warned physicians as early as 1998 about the link between Zyprexa, its best-selling schiophrenia medicine, and diabetes, an expert witness told jurors Friday in a lawsuit that claims that Zyprexa has caused many mentally ill people to develop diabetes.

Instead, Lilly hid Zyprexa’s risks from doctors to protect the drug’s sales, according to the witness, Dr. John Gueriguian. Lilly waited until 2007 to add strong warnings to Zyprexa’s label to reflect the drug’s tendency to cause severe weight gain and blood sugar changes.

...

A lawyer for Lilly said after Dr. Gueriguian’s testimony that the company had shared all it knew with the F.D.A. and that the question of the link between Zyprexa and diabetes was still a subject of scientific debate.

Click here to access the NYT article.

Wednesday, March 05, 2008

Prescription drug costs rise for seniors

From the Washington Post article:

Drugmakers increased prices by an average of 7.4 percent last year for the brand-name medicines most commonly prescribed to the elderly, according to the advocacy group AARP.

The increase far exceeded inflation, continuing a longtime trend.

...

The trade group representing drugmakers, the Pharmaceutical Research and Manufacturers of America, said AARP's numbers reflect neither the true amounts consumers pay for medicine nor a slowing in the growth of drug prices when taking into account generics.

Click here to access.

Hospitals and drug errors

From the Wall Street Journal article:
Hospitals are taking steps to prevent errors in the use of so-called high-alert medications -- those that, when given in the wrong dose or used incorrectly, have the highest risk of seriously harming or even killing a patient.
...
While there are 19 categories of high-alert medications, according to the Institute for Safe Medication Practices, studies show that about eight medications, including heparin, account for 31% of all medication errors that harm patients.
Click here to access (sub. req.).

Monday, March 03, 2008

Will MA ban industry gifts to physicians?

Maybe -- from the Boston Globe article:

Senate President Therese Murray proposed today a broad measure to control healthcare costs by in part banning all gifts and freebies to doctors from drug companies, saying the perks have helped drive up costs for consumers.

If adopted, the legislation would make Massachusetts the first state in the country to place an outright ban on drug-industry gifts. Prohibited gifts would include any payments, entertainment, meals, travel, honoraria, subscriptions -- and even a pen bearing a drug company logo. Companies would be forbidden from offering the gifts and doctors, their families and employees would be forbidden from accepting them.

Under the proposal, anyone who violates the ban could be fined $5,000, face two years imprisonment or both.
Click here to access the BG article.

"the Jarvik episode"

Check out the New York Times article "Drug Pitchman: Actor, Doctor or Pfizer's Option" by Doctor Zuger; an excerpt:
Years ago, a large poster featuring an appealingly sweaty and smiling young man climbing a mountain appeared in my subway station, directly across from my usual waiting spot. Purportedly he had been invigorated by one of the first AIDS drugs marketed directly to the public. He looked magnificent on top of his mountain, a lot better than my AIDS patients — a lot better than me.
Click here to access.

Sunday, March 02, 2008

The heart of a champion

From the New York Times article:

The high school wrestling career of Dustin Carter ended Friday in defeat but with an ovation from the crowd at the Schottenstein Center in Columbus, Ohio.

Carter, who had an acute bacterial infection in his bloodstream at age 5 and had parts of all of his limbs amputated, battled his way into Ohio’s Division II wrestling tournament as a 103-pound senior for Hillsboro High School.

...

“I told him, ‘Dusty, you went way beyond your expectations,’ ” Russ Carter said by telephone. “ ‘With everything you did, you inspired people out there.’ ”

I've categorized this as "Off topic," but is it really? Click here to access the article.

Saturday, March 01, 2008

Rise in nursery product injuries

From the Wall Street Journal article:

Nursery products were involved in 66,400 injuries that sent children to emergency rooms in 2006, an 11% increase from the year earlier, according to the Consumer Product Safety Commission.

The agency said in a report yesterday that the number of injuries to infants and children under age five involving cribs, high chairs, walkers and other items rose by 6,600 from 59,800 in 2005.

Click here to access the article (sub. req.).

The China syndrome?

From the Wall Street Journal article:

The Food and Drug Administration needs more inspectors and a comprehensive computer database to better track products entering the U.S. from foreign sources, a top drug-safety official told lawmakers.

Click here to access (sub. req.).

FDA Public Health Update

Recall of Heparin Sodium Injection and Heparin Lock Flush Solution (Baxter)

Thursday, February 28, 2008

MDR-TB, WHO knew?

From the WHO website:
Multidrug-resistant tuberculosis (MDR-TB) has been recorded at the highest rates ever, according to a new report published today. The report presents findings from the largest survey to date on the scale of drug resistance in tuberculosis.

The report, "Anti-tuberculosis drug resistance in the world", is based on data collected between 2002 and 2006 on 90 000 TB patients in 81 countries. It found that extensively drug-resistant tuberculosis (XDR-TB), a virtually untreatable form of the respiratory disease, has been recorded in 45 countries.
Click here to go to the WHO website:

America's Health Insurance Plans on the offense

From the Wall Street Journal article:

The health-insurance industry is racing to defuse a growing furor over retroactive policy cancellations that have saddled some patients with big medical bills and sparked lawsuits.

America's Health Insurance Plans, an industry group, is pushing a proposal with state regulators that would give consumers the right to appeal such policy cancellations, known as rescissions, to an external panel, whose decisions would be binding. Some insurance companies, eager for even quicker action, are preparing to roll out their own independent review programs.

Click here to access (sub. req.).

Wednesday, February 27, 2008

Surgeons as consultants to device companies under more scrutiny

From the Wall Street Journal article:

The Senate Special Committee on Aging plans to discuss the practice of device manufacturers retaining surgeons as paid consultants in today's hearing. Sen. Herb Kohl, a Wisconsin Democrat who is chairman of the committee, has proposed legislation that would mandate disclosure of consulting payments by medical-device makers and drug companies.

Click here to access (sub. req.).

Sunday, February 24, 2008

Health insurer's action called "egregious"

From the Los Angeles Times article:
One of California's largest for-profit insurers stopped a controversial practice of canceling sick policyholders Friday after a judge ordered Health Net Inc. to pay more than $9 million to a breast cancer patient it dropped in the middle of chemotherapy.

The ruling by a private arbitration judge was the first of its kind and the most powerful rebuke to the state's major insurers whose cancellation practices are under fire from the courts, state regulators and elected officials.

Calling Woodland Hills-based Health Net's actions "egregious," Judge Sam Cianchetti, a retired Los Angeles County Superior Court judge, ruled that the company broke state laws and acted in bad faith.
...
Earlier, Health Net had defended its actions, saying it never would have issued Bates a policy in the first place if she had disclosed her true weight and a preexisting heart condition on her application.
Click here to access the article.

Friday, February 22, 2008

"Google this'

From the New York Times article:
For 18 months, Google has been working to come up with a product offering and a strategy in the promising field of consumer health information. Until now, the search giant hasn’t had anything to show for its labors other than bumps along the way — delays and a management change.

But on Thursday, Google’s technology for personal health records, which is still in development, is getting a big endorsement from the Cleveland Clinic. The big medical center is beginning a pilot project to link the health information for some of its patients with Google personal health records.
Click here to access the NYT article.

Monday, February 18, 2008

Study delineates cancer dx disparities

From the New York Times article:
A nationwide study has found that the uninsured and those covered by Medicaid are more likely than those with private insurance to receive a diagnosis of cancer in late stages, often diminishing their chances of survival.

The study by researchers with the American Cancer Society also found that blacks had a higher risk of late diagnosis, even after accounting for their disproportionately high rates of being uninsured and underinsured. The study’s authors speculated that the disparity might be caused by a lack of health literacy and an inadequate supply of providers in minority communities. The study is to be published online Monday in The Lancet Oncology.

Click here to access the NYT article.

Sunday, February 17, 2008

Perhaps he's never heard of pharmacists?

Check out the Forbes.com article "A Free Lunch" by Paul H. Rubin, Professor of Law and Economics at Emory University and former Chief Advertising Economist at the Federal Trade Commission and Chief Economist at the U.S. Consumer Product Safety Commission; an excerpt:
Drug company reps offer overworked doctors useful, lifesaving information in an efficient manner. The drug companies are of course motivated by profit, but economists have known since Adam Smith that the profit motive is the best way to induce someone to do something useful.
Click here to access the article.

Friday, February 15, 2008

Will off-label uses have another avenue besides CME?

Maybe...from the Wall Street Journal article:
The Food and Drug Administration wants to allow drug companies to give doctors information about unapproved uses of prescription drugs, a controversial move that is already drawing objections from Capitol Hill.

Companies generally aren't allowed to advertise or market such "off-label" uses, though doctors can prescribe drugs for any condition. The FDA has proposed guidelines allowing manufacturers to give physicians reprints of medical journal articles about uses of drugs and medical devices that haven't won the agency's approval.

The regulator is stepping into a high-stakes business issue, because off-label uses of prescription drugs are a mainstay of the industry -- an estimated 21% of drug use overall, according to a 2006 analysis published in the Archives of Internal Medicine.

Click here to access the WSJ article (sub. req.).

ACCME news release re: partnership between ACCME, ANCC, and ACPE

Click here to access.

Wednesday, February 13, 2008

Institutional conflicts of interest

Interesting survey results just published in JAMA on academic institutional conflicts of interest relating to research (upstream of CME). Click here to read the abstract.

Saturday, February 09, 2008

The patient's perspective...what a concept!

Check out the New York Times book review of "When Doctors Become Patients"; an excerpt:
When doctors get sick, they discover fissures in the health system that they didn’t know existed. They learn that seemingly small annoyances they never paid attention to as doctors — like long waiting times or a broken television in a hospital room — really are a big deal when you are the patient. Even doctors who thought of themselves as compassionate recognize they can do better once they experience life as a patient.
The book's author is Columbia University psychiatrist Dr. Robert Klitzman. Click here to read the entire review.

Friday, February 08, 2008

Merck settles whistleblower suit

From the New York Times article:
A sales manager who ''just couldn't abide'' by the way Merck wanted him to market the drugs Vioxx and Zocor to doctors took the lonely step of filing a whistleblower suit against his employer.

Seven years later, Merck & Co. will pay $671 million to settle complaints it overcharged government health programs and gave doctors improper inducements to prescribe its drugs.

Click here to read the article.

Thursday, February 07, 2008

Does body double spell double trouble for Dr. Jarvik?

From the New York Times article:
Dr. Robert Jarvik is best known for the artificial heart he pioneered more than a quarter-century ago. Since then he had toiled in relative obscurity — until he began appearing in television ads two years ago for the Pfizer cholesteral drug Lipitor.
...
Some of the questions may involve his credentials. Even though Dr. Jarvik holds a medical degree, for example, he is not a cardiologist and is not licensed to practice medicine. So what, critics ask, qualifies him to recommend Lipitor on television — even if, as he says in some of the ads, he takes the drug himself?

And, for that matter, what qualifies him to pose as a rowing enthusiast? As it turns out, Dr. Jarvik, 61, does not actually practice the sport. The ad agency hired a stunt double for the sculling scenes.

Click here to access.

Wednesday, February 06, 2008

"Never pay" PA policy for never events...

From the Philadelphia Inquirer article:

In 2006, 11 hospital patients in Southeastern Pennsylvania died after getting transfusions with the wrong blood type. An additional 40 died after medication errors, and four more after being accidentally burned during their stays, according to an Inquirer computer analysis of hospital billing records.

Such deaths, nearly 1,500 all told, are a rough estimate of what the Rendell administration would initially find if it applied its new Medicaid policy on medical errors to all 708,657 hospital admissions in 2006 from Philadelphia, Bucks, Chester, Delaware and Montgomery Counties.

Under that policy, the state will stop paying hospitals for the added costs of care for Medicaid patients that result from serious, avoidable medical mistakes.

Click here to read the entire article.

NJ AG issues subpoena to ortho device makers

From the New York Times article:
The New Jersey attorney general’s office issued subpoenas Monday to two companies involved in the development of the Prodisc, an artificial spinal disk for the lower back.
Click here to read the NYT article.

Tuesday, February 05, 2008

Review article published on herbal extract

From the New York Times article:
Dr. Pittler said it makes him uncomfortable that hawthorn is available without a prescription. “We don’t really know the mechanisms by which hawthorn works,” he said, “and it is important to caution that patients should not self-diagnose, and then self-treat with hawthorn.”
Click here to access the NYT article.

Nurses and pharma

Interesting article "Soft Targets: Nurses and the Pharmaceutical Industry" over at PLoS Medicine; an excerpt:
But it is not only prescribing nurses who must be the focus of these strategies. As we have described above, non-subscribing nurses play an under-appreciated role in prescription and administration choices. One of us (AJ), an experienced staff nurse, recalls guiding new house staff in the choice of treatment; the other (DBM) was grateful for such guidance as a medical intern.
Click here to access.

Monday, February 04, 2008

SafeRX Amendment Act of 2008 in D.C.?

From the AMNews article:
The measure, dubbed SafeRx, would require detailers to pay a licensure fee, adhere to an ethics code, receive continuing education and refrain from misleading doctors about drugs. Sales reps could be fined up to $10,000 for operating without a license.
Click here to access the article.

Saturday, February 02, 2008

The heat is on...

Just came across the 1-22-08 entry "Variations on a Theme of Sleaze" at the Health Care Renewal Blog -- an excerpt:
Medical journals are not the only compromised medium. Continuing Medical Education (CME) is a second front in the campaign to expand the AAP drug market. The standard formula calls for corporate sponsorship channeled through an “unrestricted educational grant” to a medical education communications company (MECC). The MECC employs writers to prepare the “educational content,” and academic KOLs are recruited to deliver this content.
Click here to read the entire posting. Fasten your seatbelt!

NAAMECC and Coalition for Healthcare Communication Response

to the Macy conference summary on CE. Click here to access.

Friday, February 01, 2008

Venous thromboembolism prophylaxis gap

From the medpage today article:
Hospital patients at risk for venous thromboembolism don't receive appropriate preventive care, no matter how developed a country they live in, researchers here said.

More than 40% of surgical patients and 60% of medical patients at risk for venous thromboembolism in a large international study failed to receive prophylaxis as recommended by the American College of Chest Physicians, reported Alexander T. Cohen, M.D., of King's College Hospital, and colleagues in the Feb. 1 issue of The Lancet.

Some 5% to 10% of overall inpatient mortality is attributed to pulmonary embolism. It is the leading preventable cause of death in hospitals, Dr. Cohen and colleagues said.
Click here to access the article.

FDA issues Public Health Advisory on Chantix (varenicline)

Click here to access.

Hospitals making the grade...

From the Washington Post article:
Patients admitted to the top-rated hospitals in the United States have an average 27 percent lower risk of dying than patients admitted to other hospitals in the country, a new study shows.

Released Thursday by HealthGrades, an independent health-care ratings organization, the analysis of 27 procedures and diagnoses also found that patients who have surgery at the top-rated hospitals have an average 5 percent lower risk of complications during their hospital stay.
Click here to access the article.

Thursday, January 31, 2008

Leaky MD?

From the New York Times article:
A leading member of the Senate said Wednesday that a prominent diabetes expert had leaked an unpublished and confidential medical journal article to GlaxoSmithKline last year, tipping the company to the imminent publication of safety questions involving the company’s diabetes drug Avandia.
Click here to access the article.

New and updated health status stats by state

The website Statehealthfacts.org has added new and updated data on Medicaid and SCHIP, Managed Care and Health Insurance, Health Status, Providers and Service Use, and Demographics and the Economy.

Monday, January 28, 2008

IOM says HHS should establish effectiveness database

From IOM Press Release:
A new report from the Institute of Medicine offers a blueprint for a national program to assess the effectiveness of clinical services and to provide credible, unbiased information about what really works in health care. The report recommends that Congress direct the U.S. Department of Health and Human Services to establish a program with the authority, expertise, and resources necessary to set priorities for evaluating clinical services and to conduct systematic reviews of the evidence. This program would also be responsible for developing and promoting rigorous standards for clinical practice guidelines, which could help minimize the use of questionable services and target services to the patients most likely to benefit, said the committee that wrote the report.
Click here to read the press release.

"Wither CME?"

Encourage y'all to read this cleverly titled article (starts on page 13 of the newsletter) in the latest issue of Pharma Marketing News.

Anatomy of a medical error...

From the Los Angeles Times article:
A technician mistakes an "a" for an "o" in a drug name. A doctor misplaces a decimal point in a prescription order. A nurse reaches for a vial in a cabinet as she's done hundreds of times before, only this time the light is dim and she fails to notice that the powder-blue label is more of a sky blue. The slip-ups are often simple, and always human, and all have happened in U.S. hospitals.

Each simple mistake is supposed to be countered by a recommended backup, a second or third set of eyes -- in other words, guidelines to reduce human error. A lot has to be overlooked in the cascade of errors that result in serious patient harm.
Click here to access the article.

Saturday, January 26, 2008

The cost of diabetes

From the Forbes.com article:

The economic costs of diabetes in 2007 were estimated to be $58 billion, a figure that includes reduced productivity of both people in the labor force and unpaid workers, unemployment from diabetes-related disability, and increased absenteeism.

It's believed that about 6 million people in the United States have undiagnosed diabetes, which means the actual total cost of diabetes in 2007 may have been much more than $174 billion, the study said.

Click here to read the entire article. Might CME Providers collaborate regionally and nationally on this topic? And what about Big Pharma -- would they fund such an effort?

"FDA Warns Public of Contaminated Syringes"

From the FDA News Release:

The U.S. Food and Drug Administration (FDA) today announced a nationwide recall of all lots of heparin and saline pre-filled flush syringes manufactured by AM2 PAT, Inc., of Angier, N.C. Two lots have been found to be contaminated with Serratia marcescens, a bacterium that can cause serious injury or death.

These syringes are manufactured by AM2 PAT under the brand names Sierra Pre-filled, Inc. and B. Braun. They are sold in fill sizes of 3mL, 5mL and 10mL and syringe sizes of 6mL and 12mL.

Consumers and health care facilities with any of the recalled, pre-filled Heparin Lock or Normal Saline IV Flush syringes should stop using the product immediately. Health care facilities should immediately quarantine the products in their inventory and return them to their distributor. Individual consumers should return them to the location from which they were received, such as a pharmacy or hospital. They should also let their health care providers know that they have been exposed to syringes recalled by FDA.

Click here to access.

Friday, January 25, 2008

Are brand name "cholesterol" drugs more effective?

From the Wall Street Journal article:

Merck & Co. and Schering-Plough Corp. defended their actions Friday involving a recently released study that raised questions about the effectiveness of cholesterol drugs Vytorin and Zetia.

The Food and Drug Adminstration, meanwhile, said it will review the partially completed study once it has been finished.

The companies are being sued in several states over allegations they misled consumers into thinking the drugs were more effective than generics. In a statement Friday, the companies said they acted "with integrity and good faith."
Click here to access (sub. req.).

A side effect of the Pill

From the New York Times article:

British researchers found that women taking the pill for 15 years halved their chances of developing ovarian cancer and that the risk remained low more than 30 years later.

The findings were to be published Friday in The Lancet.

“Not only does the pill prevent pregnancy, but in the long term, you actually get less cancer as well,” said Valerie Beral, the study’s lead author and director of the Cancer Research UK Epidemiology Unit at Oxford University. The study was financed by Cancer Research UK, a charity, and Britain’s Medical Research Council.

Click here to access.

Thursday, January 24, 2008

New FDA rule for clinical trials

From the New York Times article:
After decades of inattention to the possible psychiatric side effects of experimental medicines, the Food and Drug Administration is now requiring drug makers to study closely whether patients become suicidal during clinical trials.

The new rules represent one of the most profound changes of the past 16 years to regulations governing drug development. But since the F.D.A.’s oversight of experimental medicines is done in secret, the agency’s shift has not been announced publicly.
Click here to access the article.

Wednesday, January 23, 2008

And another COI headline (research)

From the New York Times article "Researchers Go Unchecked, Report Says":

Universities are increasingly seeking other sources of income to support research, and drug and device makers have become an important resource. But blending these sources of financing can often present researchers with troubling conflicts of interest, and managing such conflicts has become dizzyingly complex.

Indeed, academic medicine has become so rife with conflicts of interests in recent years that the Food and Drug Administration has complained that it has difficulty finding experts for its advisory boards who do not have a conflict.

Click here to access the NYT article; click here to access the OIG report.

Do the conflicts of interest ever end? Further comments on the Macy Report

Check out yesterday's posting on Dr. Carlat's blog; click here.