Saturday, March 31, 2007

Ask Dr Wiki?

Discovered an interesting website -- Dr Wiki -- which "is a collaborative medical website made by physicians for physicians, medical students, and healthcare providers. Its purpose is to serve as a online repository of medical information that can be accessed by anyone." The site's current editors are:

Kenny Civello M.D., M.P.H, Cleveland Clinic Electrophysiology
Brian Jefferson M.D, Cleveland Clinic Interventional Cardiology
Shane Bailey M.D., Cleveland Clinic Electrophysiology
Mike McWilliams M.D., Cleveland Clinic Electrophysiology

The site is pretty cardiology "heavy" but Dr Wiki hopes the site will expand to encompass many more specialties. Click here to access the site.

To stent or not to stent...

Will patients and interventional cardiologists both be slow to embrace the new evidence on the value of drug therapy versus angioplasty? As reported in the Philadelphia Inquirer:

Studies have long shown that angioplasty can save a patient who is having a heart attack.

But the study released online Monday in the New England Journal of Medicine showed that patients who are not likely to have an immediate heart attack fared just as well with drug therapy.

The study found that more than half the patients who get angioplasties - more than a million each year - have heart disease that is stable and would do just as well under medication. The authors said the proportion of unnecessary angioplasties is as high as 85 percent - at a cost of about $30,000 to $40,000 per patient.

David L. Fischman, an interventional cardiologist and codirector of the cardiac-catheterization lab at Thomas Jefferson University Hospital, said patients and doctors should view angioplasty as a quality-of-life decision. The study found that half the 2,287 patients who received a stent had fewer symptoms, such as angina, at the onset. Those numbers narrowed as the study went on.
It will be interesting to see how the payors respond to these findings. Click here to read the entire article.

Friday, March 30, 2007

FDA Announces Discontinued Marketing of GI Drug, Zelnorm, for Safety Reasons

The Food and Drug Administration (FDA) has requested that Novartis Pharmaceuticals Corporation of East Hanover, New Jersey, voluntarily discontinue marketing of Zelnorm (tegaserod) based on the recently identified finding of an increased risk of serious cardiovascular adverse events (heart problems) associated with use of the drug. Novartis has agreed to voluntarily suspend marketing of the drug in the United States.

Zelnorm is a prescription medicine approved in July 2002 for short-term treatment of women with irritable bowel syndrome whose primary symptom is constipation. It was subsequently approved in August 2004 for treatment of chronic constipation for men and women under age 65. Zelnorm is marketed in 55 countries.

FDA is currently advising patients who are using Zelnorm to contact their health care providers to discuss treatment alternatives. Patients who are taking Zelnorm should seek emergency medical care if they experience severe chest pain, shortness of breath, dizziness, sudden onset of weakness or difficulty walking or talking, or other symptoms of a heart attack or stroke.
Click here to read the entire FDA release.

Monday, March 26, 2007

Joint Commission says health literacy a patient safety issue

From the USA Today article:

While cultural and language barriers pose problems for patient-doctor communication, poor general literacy skills can be just as great an impediment, according to The Joint Commission, which accredits nearly 15,000 U.S. health care organizations and programs.

"The implications around all of this are huge if the patient doesn't understand what they have and what they're taking and why. You might be putting the patient in harm's way, and they could be killed," says Dennis O'Leary, president of the commission.

The commission held a news conference in February to present recommendations for health care providers, policymakers and consumers.

The recommendations include specific advice for educating and training health care professionals; using well-trained medical interpreters for patients with English comprehension difficulties; and encouraging a culture of easy-to-understand communication in all facets of medical care.
Click here to read the entire article. Click here to access the Joint Commission's guide "'What Did the Doctor Say?:' Improving Health Literacy to Protect Patient Safety".

Saturday, March 24, 2007

FDA proposes revamp of conflict of interest rules

As reported in the LA Times:

The Food and Drug Administration said Wednesday that it would bar outside medical experts with a financial interest in a manufacturer from voting on advisory panels assessing whether drugs or other products made by that company are safe and effective.

The proposed restrictions — which would also apply to experts with ties to competing firms — would significantly strengthen the FDA's conflict-of-interest policy. One recent study suggests that more than one-fourth of FDA advisors may be prohibited from voting.
Click here to read the entire article (registration required).

Friday, March 23, 2007

Joint Commission Annual Report

Check out the annual report recently released by the Joint Commission. While things seem to be on the upswing, looks like there's still room for improvement in hospital quality of care:

Hospitals are currently achieving a national average of 90 percent performance or higher on only about half of the measures tracked since 2002. Hospitals are performing at less than 65 percent nationwide on two measures tracked since 2002: providing pneumococcal screening and vaccination to pneumonia patients, and providing discharge instructions to heart failure patients. The Joint Commission encourages all hospitals to strive for 100 percent performance on all measures.

On measures tracked for the first time in 2005, performance is generally lower and more variable than on the performance for measures tracked since 2002, showing a correlation between performance measurement and quality.

Significant differences exist in the performance of hospitals by state. For example, the performance of hospitals in different states on the measure of providing smoking cessation advice to heart attack patients ranged from a high of 96.8 percent performance in the highest-performing state to a low of 67.6 percent in the lowest-performing state.
CME Providers in health care delivery institutions, check out your hospital's quality performance at

Wednesday, March 21, 2007

Collateral fire damage

Fascinating epi study published in the New England Journal of Medicine on firefighters and death from heart disease in the United States. One of the study findings:

Fire suppression, which represents only about 1 to 5% of firefighters' professional time each year, accounted for 32% of deaths from coronary heart disease and was associated with a risk of death from coronary heart disease that was approximately 10 to 100 times as high as the risk associated with nonemergency duties. We think that the most likely explanation for these findings is the increased cardiovascular demand of fire suppression.
Click here to read the entire free article.

Two new books by physician-writers

Health care professionals (e.g., CME professionals) might be interested in two new books authored by physicians. They are "Better: A Surgeon's Notes on Performance" by Atul Gawande and "How Doctors Think" by Jerome Groopman. From the Washington Post article:

The authors' hopes for medical practice based on greater self-scrutiny will be a tall task as well. We live in an era of evidence-based medicine, in which population-based studies, Bayesian analysis and clinical guidelines increasingly dictate medical care. Both authors bemoan this development insofar as it makes physicians into technicians. Doctors, Gawande writes, need to stop to "wonder" and reconsider the paths they have taken. Groopman's best physicians arrive at judgments by assessing not only their patients' complaints but their characters and by paying attention to their own emotional responses to patients.
Reflection is a good thing and part of the improvement process. Click here to read the entire article.

Tuesday, March 20, 2007

And the results are in...

JAMA just published an article on the early results of the Vermont and Minnesota laws requiring pharmaceutical companies to disclose payments to physicians:

In Vermont, 61% of payments were not released to the public because pharmaceutical companies designated them as trade secrets and 75% of publicly disclosed payments were missing information necessary to identify the recipient. In Minnesota, 25% of companies reported in each of the 3 years.
Click here to read the article (subscription required).

Monday, March 19, 2007

Following doctor's orders...NOT!

A recent survey by the Wall Street Journal and Harris Interactive reveals that 27% of Americans who responded do NOT fill a precription because they don't feel it is warranted. More from this interesting survey:

About 52% of Americans believe doctors overtreat patients because of concerns about malpractice lawsuits, while 41% say doctors do so "to make more money" and 44% say "to meet patients' demands."

Still, Americans seem to believe that undertreatment is a problem, too. When asked how often they believe patients are undertreated, 29% said often and 55% said sometimes.
Click here to read the WSJ article (subscription required).

Errors in diagnosis

According to Dr. Jerome Groopman, misdiagnosis occurs in 15 to 20 percent of cases. Why? Because of how doctors think:

Only very recently have medical educators begun to focus squarely on the problem of misdiagnosis, why it occurs, and what might be done to prevent it. It turns out that errors in thinking do not occur in isolation, but usually arise from a cascade of sequential cognitive mistakes.

I only learned this recently when I realized I did not know how I think; in fact, when I asked other clinicians how they succeeded or failed in making a diagnosis, very few could explain how their mind works to decipher a patient's problems.
Click here to read the Boston Globe article. What implications do you think this might have for CME?

Friday, March 16, 2007

A piece of Dr. Reece's mind

Great essay by Richard Reece, M.D. published today in HealthLeaders Media. Doctor Reece discusses the complex issues that arise with pay for performance (P4P). He presents, methinks, very valid questions and truths relative to this whole issue of P4P, an excerpt:

Compelling doctors to follow guidelines and enforcing their compliance is not as easy as it might seem. Whose guidelines? Keep in mind there are more than 2,000 guidelines floating around out there. You may find them at the National Guideline Clearinghouse website ( These guidelines depend on both evidence and opinion and are neither infallible nor a substitute for clinical judgment.

Doctors are mortal and may have a hard time keeping all these guidelines in mind. Small wonder that adherence to guidelines and outcomes vary. As I outline above, patient behavior outside of the office and hospital settings is an important factor in healthcare outcomes. Doctors can’t be held solely--or even primarily--responsible for outcomes, and rewarding or punishing them for outcomes may be overly simplistic. Doing so in the confined hospital setting may make P4P advocates “feel good,” and it is a good place to start, but P4P may not lead to better long-term outcomes.
We all know those people who won't quit smoking, who won't exercise, etc., even after they've endured life-saving procedures. Click here to read this important essay (you have register).

ACCME news release

The Accreditation Council for Continuing Medical Education (ACCME) is implementing a new system to recognize non-U.S. CME accreditors:

At the ACCME, "Recognition of non-US continuing medical education accreditors" will be based on substantial equivalency of accreditors. Our engineering colleagues[1] state that "substantial equivalency means the program is comparable in educational outcomes, but may differ in format or method of delivery" and that "substantial equivalency is not accreditation."
And the question that comes to everyone's mind is "will they have to comply with the ACCME Standards for Commercial Support of CME"? Click here to read the news release in its entirety.

Wednesday, March 14, 2007

New label warnings for sleep disorder medications

The FDA has ordered manufacturers of 13 drugs used to either treat sleep disorders or used as sleep aids to revise their "product labeling to include warnings about the following potential adverse events":

Anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling), which can occur as early as the first time the product is taken.
Complex sleep-related behaviors which may include sleep-driving, making phone calls, and preparing and eating food (while asleep).
The 13 drugs are:

Ambien/Ambien CR (Sanofi Aventis)
Butisol Sodium (Medpointe Pharm HLC)
Carbrital (Parke-Davis)
Dalmane (Valeant Pharm)
Doral (Questcor Pharms)
Halcion (Pharmacia & Upjohn)
Lunesta (Sepracor)
Placidyl (Abbott)
Prosom (Abbott)
Restoril (Tyco Healthcare)
Rozerem (Takeda)
Seconal (Lilly)
Sonata (King Pharmaceuticals)
Click here to see the FDA news release.

"Questions Are the Answer"

The Agency for HealthCare Research and Quality has launched a new national public awareness campaign to encourage patients to become more proactive and assertive in their medical care. The idea is that if patients ask the right questions at the right time, then medical errors might be reduced. Here are a few of the questions they suggest asking:

What is the test for?
How many times have you done this?
When will I get the results?
Why do I need this surgery?
Are there any alternatives to surgery?
What are the possible complications?
Which hospital is best for my needs?
How do you spell the name of that drug?
Are there any side effects?
Will this medicine interact with medicines that I'm already taking?
Honestly, I can't get my Mom to ask any questions of her health care provider, much less these. Click here to access the general website; click here to access "20 Tips to Prevent Medical Errors."

Friday, March 09, 2007

FDA black box warning on anemia drugs

The FDA issued an advisory today on erythropoiesis-stimulating agents (ESAs) which are "approved to treat anemia in patients with chronic kidney failure, and in cancer patients whose anemia is caused by chemotherapy." From the SCIENTIFICAMERICAN.COM article:

"Recent reports of studies with erythropoiesis-stimulating agents (ESAs) have shown a higher chance of serious and life-threatening side effects and greater number of deaths in patients treated with these agents," an FDA public health advisory said.

"Because all ESAs work the same way, the findings from these studies apply to all ESAs; the FDA is re-evaluating the safe use of this drug class," the advisory said.

The FDA will gather further input from a May meeting of a panel of outside experts. More changes to the drugs' labels could follow that meeting, FDA officials said.
Click here to read the entire article. CME Providers might want to review their enduring material lists!

Thursday, March 08, 2007

16 Rules to live by

Thanks to Sue Pelletier, MeetingsNet Web editor, mad blogger (Face2Face), and editor of Association Meetings Magazine for including the link to Bob Parson's 16 rules to live by in her blog. The 16 rules:

1. Get and stay out of your comfort zone.
2. Never give up.
3. When you're ready to quit, you're closer than you think.
4. With regard to whatever worries you, not only accept the worst thing that could happen, but make it a point to quantify what the worst thing could be.
5. Focus on what you want to have happen.
6. Take things a day at a time.
7. Always be moving forward. Never stop investing. Never stop improving. Never stop doing something new.
8. Be quick to decide.
9. Measure everything of significance.
10. Anything that is not managed will deteriorate.
11. Pay attention to your competitors, but pay more attention to what you're doing.
12. Never let anybody push you around.
13. Never expect life to be fair.
14. Solve your own problems.
15. Don't take yourself too seriously.
16. There's always a reason to smile.
The above rules are displayed here with the permission of Bob Parsons ( Copyright © 2004-2006 by Bob Parsons. All rights reserved.

Gosh, could these be applied to CME?

Wednesday, March 07, 2007

ACCME posts clarification on expanded definition

Click here to read this clarification.

Retention of foreign object...

is one of 27 categories of medical errors that the Indiana Medical Error Reporting System utilizes. From the INDYSTAR.COM article:

State health officials said the error-reporting system is designed to give health-care providers useful information in understanding why errors occur and developing systems for preventing future errors. The officials also said they expect the number of reported errors to rise as hospitals become familiar with the program.

“Every health care provider takes adverse events seriously; even one adverse event is too many,” Kathy Rapala, interim director of the Indianapolis Coalition for Patient Safety, said in a statement. “The statewide report provides valuable information that we can use to guide our patient safety actions.”

Gov. Mitch Daniels ordered the Indiana Department of Health to begin collecting the information in 2005. But the preliminary report released today is the first comprehensive look at a full year.
Click here to read the entire article.

Tuesday, March 06, 2007

Congressional committee to look at off-label use issues

As reported today in the Wall Street Journal, a congressional committee will examine "the widespread practice in which doctors prescribe medical products to patients outside the boundaries approved by the Food and Drug Administration." Boston Scientific Corp. and Johnson & Johnson's Cordis unit, have been asked to provide clinical data and marketing materials on their drug-coated stent products to the House Committee on Oversight and Government Reform. In addition:

The committee's chairman, California Democrat Henry Waxman, also asked for marketing materials from three drug companies that have come under scrutiny over whether they promoted their products for unapproved uses: Eli Lilly & Co., whose antipsychotic drug Zyprexa had $4.36 billion in sales last year and was the company's best seller; AstraZeneca PLC, which makes another depression drug, Seroquel; and Cephalon Inc., whose marketing of painkillers has been under investigation by the Connecticut attorney general.
Click here to read the article (subscription required).

Sunday, March 04, 2007

The Boardman Incident

When Dr. Cecelia Boardman, a gynecologic oncologist at Virginia Commonwealth University's Massey Cancer Center, made statements before the Viginia General Assembly regarding the efficacy of the new Merck vaccine to prevent HPV infection, she apparently failed to disclose her financial relationship with Merck (per the newspaper article, she has given "educational talks" to physicians on the new vaccine). While she "didn't violate any disclosure requirement governing witnesses who give input to lawmaking committees" and no one, apparently, questions her credentials, she still ends up in the headlines. From the article:

"I'm most distressed and most apologetic and most concerned that there is any perception of my being dishonest or untruthful," Boardman said. "I have done a lot of public speaking on cervical cancer and cervical cancer prevention in my professional roles. In my mind, I did not feel any conflict in the testimony I provided."

She said she did not participate in Gardasil research and that she independently evaluated the drug's performance before coming to her conclusion that it works.

"If I thought the data was crummy, I'd say the data was crummy," she said.
Click here to read the entire article. I'd like to know if these "educational talks" were promotional or CME-certified presentations, one can never really tell from these news articles.

Friday, March 02, 2007

8 Pharma companies receive FDA Warning Letters

The FDA issued Warning Letters to eight (8) pharmaceutical companies regarding the unapproved use of drugs containing ergotamine tartrate for headache relief. From the article:

Like other approved products for migraine and other headaches, the drugs contain the active ingredient ergotamine tartrate. But they have been manufactured and distributed without undergoing review by the FDA, the agency said.

"Doctors and patients often do not realize that not all drugs that are available on the market are backed by FDA approval," said FDA's Deborah Autor, who oversees compliance issues. She added that fewer than 2 percent of prescription medications are unapproved.

"Drugs that skirt the approval process may be unsafe, may not work, and in our experience, often have inadequate labeling," she said in a statement.

The unapproved ergotamine tartrate drugs do not carry necessary cautions against their use in patients also taking the metabolic enzyme inhibitor CYP 3A4 found on labels for similar approved headache drugs, the FDA said.

Such inhibitors can include certain antibiotics, antifungal treatments and protease inhibitors.
Click here to read the article. Click here to access the FDA Warning Letters.

Serotonin Syndrome

Remember the case of Libby Zion? If you don't, then be certain to read "A Mix of Medicines That Can Be Lethal" published in the New York Times. From the article:

In March 2005, two such specialists, Dr. Edward W. Boyer and Dr. Michael Shannon of Children’s Hospital Boston, noted that more than 85 percent of doctors were “unaware of the serotonin syndrome as a clinical diagnosis.”

In their review in The New England Journal of Medicine, Dr. Boyer and Dr. Shannon cited a report based on calls to poison control centers around the country in 2002 showing 7,349 cases of serotonin toxicity and 93 deaths. (In 2005, the last year for which statistics are available, 118 deaths were reported.)

The experts fear that failure to recognize serotonin syndrome in its mild or early stages can result in improper treatment and an abrupt worsening of the condition, leading to severe illness or death. Even more important, in hopes of preventing it, they want doctors — and patients — to know just what drugs and drug combinations can cause serotonin poisoning.
Click here to access the article.

Thursday, March 01, 2007

Prescription drug abuse

In a related International Narcotics Control Board press release on prescription drug abuse:

The demand for these drugs is so high, that it has given rise to a new problem – that of counterfeit products. Strong demand on the illicit markets of Scandinavia for flunitrazepam (Rohypnol®), a sedative, is increasingly met by illicitly manufactured counterfeit preparations. The demand of the illicit market in North America for OxyContin® has lead to distribution of counterfeit products containing illicitly manufactured fentanyl.

An equally serious consequence is that abuse of prescription drugs can have lethal effects. An increasing number of deaths related to abuse of narcotic drugs, including fentanyl and oxycodone have been recorded in North America and Europe.
Click here to read this press release (fyi, they have 2006 on the 1st page...should read March 1, 2007).

Counterfeit drugs a real issue!

The International Narcotics Control Board (INCB) issued a press release today on the dangers of counterfeit drugs:

“Besides the fact that the existence of unregulated markets, the sale of diverted and counterfeit drugs and the purchase of drugs containing controlled substances without prescription contravenes international treaties on drug control, it is important for consumers to realize that what they think is a cut-price medication bought on an unregulated market may however have potentially lethal effects whenever the consumed drugs are not the genuine product or are taken without medical advice. Instead of healing, they can take lives,” said Dr. Philip O. Emafo, President, INCB.
Click here to read the press release.