Think sensitivity and specificity, and positive and negative predictive values, folks!! Click here to access the NYT article. If you'd like to learn more about sensitivity and specificity, etc., check out the BMJ article "Understanding sensitivity and specificity with the right side of the brain" published in 2003 (sub. req).“You’ve got industry trying to capitalize on fear,” said Dr. Andrew Berchuck, director of gynecologic oncology at Duke University and the immediate past president of the society. “We’d all love to see a screening test for ovarian cancer,” he added, “but OvaSure is very premature.”
OvaSure’s debut also raises questions about whether greater regulation is needed to assure the validity of a trove of sophisticated new diagnostic tests that are entering the market and are being used as the basis for important treatment decisions. OvaSure did not go through review by the Food and Drug Administration because the agency generally has not regulated tests developed and performed by a single laboratory, as opposed to test kits that are sold to laboratories, hospitals and doctors.
Saturday, August 30, 2008
Ova not so sure?
Thursday, August 28, 2008
Russia an epicenter for MDR-TB
The Siberian provinces of the central Russian plateau—poor, even by Russian standards, with high rates of alcoholism, drug abuse and a large prison population—are among the epicenters of a worldwide epidemic of drug-resistant tuberculosis. Whereas the 490,000 reported cases of MDR-TB account for just a small fraction of the 9.2 million new cases and 1.7 million deaths from TB reported to the World Health Organization in 2006, MDR-TB represents a significant global public health hazard. In parts of Siberia, it accounts for more than 15 percent of all cases.Click here to access the SA article.
Tuesday, August 26, 2008
Another medical school moves to pooled funding for CME
The Stanford University School of Medicine will no longer accept support from pharmaceutical or device companies for specific programs in continuing medical education, as industry-directed funding may compromise the integrity of these education programs for practicing physicians, officials said.Click here to read the entire article.
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Under the new guidelines, the school may accept commercial support for CME only if it is provided for broad areas, such as medical, pediatric and surgical specialties; diagnostic and imaging technologies; and health policy and disease prevention. Funding must not be linked to a specific course, topic or program. In addition, commercial exhibits will no longer be permitted at Stanford-sponsored CME activities on or off campus.
Monday, August 25, 2008
New FDA labeling rule
Government regulators have issued new rules designed to keep drug warning labels clear and concise, though some say the new guidelines would also shield drugmakers from lawsuits.Click here to access the CCNMoney.com article. Also check out Drug and Device Law's blog entry on this rule by clicking here.The regulations from the Food and Drug Administration, which were released Thursday and take effect next month, explain when drug and medical device companies are responsible for rushing out safety updates on their products.
Sunday, August 24, 2008
Ready for some fun?
1. The Stroop Test. A fun test that measures how fast and flexible a thinker you are by using color-coded words.
2. The Worst Sounds. Grab your headset and take this online sound test to find out which sounds bother you the most. You’ll hear snoring, crying babies and nails on the chalkboard.
3. Personality Test. Check out the “I Just Get Myself” personality test. It comprises just 40 easy questions but delivers a surprisingly insightful (at least I thought so) assessment of your personality traits.
Click here to access the NYT article (and more online tests).
Tuesday, August 19, 2008
Monday, August 18, 2008
FDA to mandate special training on narcotic prescription?
Should doctors be required to undergo special education in order to prescribe powerful narcotics? The Food and Drug Administration may soon recommend that they do so, though such a move would most likely prove controversial.
“I think it is a good idea, and it is something we are considering,” said Dr. Bob Rappaport, the director of the division of Anesthesia, Analgesia and Rheumatology Products at the F.D.A. But the agency itself does not have the authority to take such a step, Dr. Rappaport said.
Typically, state medical boards, rather than the federal government, impose licensing requirements on doctors, including the type of continuing education they must receive. A few states, including California, now provide doctors with education about the treatment of pain patients. But nationally, state medical boards have shown little interest in mandating added training in the use of potent pain medications or in screening patients for those prone to drug abuse.
Click here to access.
Wednesday, August 13, 2008
Survey indicates disruptive behaviors impact patient care
Click here to access (sub. req.).
Monday, August 11, 2008
Coalition for Healthcare wants your input
We seek data and information that will support our comments as well as volunteers to help craft the Coalition comment. Please participate in the Coalition effort and support individual comments by your company or yourself. The Coalition comment would be strengthened by position statements supported by compelling data and examples of how commercially funded programs advance clinical knowledge in critical areas and advance patient care.Click here to access the Coalition's commentary on this and how you can provide your input into this debate.
MA Governor signs 2863
Governor Deval Patrick yesterday signed into law one of the nation's strictest limits on gifts given to medical professionals by drug salespeople, the most contentious measure contained in a broad package intended to improve healthcare safety and curb skyrocketing costs.Click here to access the TBG article.
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Still, the limits in the law put Massachusetts at the forefront of states in cracking down on the use of financial incentives to persuade doctors to prescribe particular drugs or medical devices. In addition to banning some gifts and requiring disclosure of others, it calls for the state to develop a code of conduct for industry representatives that includes a $5,000 fine for each violation.
Friday, August 08, 2008
6 rules for providers to keep in mind when they see patients...
Rule 1: They don’t want to be at your office.
Rule 2: They have a reason to be at your office.
Rule 3: They feel what they feel.
Rule 4: They don’t want to look stupid.
Rule 5: They pay for a plan.
Rule 6: The visit is about them.
Do you think any of these link up with the ACGME/ABMS core competencies? Click here to access the NYT article.
FDA alert issued...
Click here to access the alert.
Wednesday, August 06, 2008
Important legislation introduced
Senate Finance Committee Chairman Max Baucus (D-Mont.) and Budget Committee Chairman Kent Conrad (D-N. D.) introduced last night legislation to improve the quality of health care that Americans receive, by creating national priorities for, and conducting and distributing research findings on the effectiveness of different health care treatments. The Comparative Effectiveness Research Act of 2008 will establish the Health Care Comparative Effectiveness Research Institute to review evidence and produce new information on how diseases, disorders, and other health conditions can be treated to achieve the best clinical outcome for patients. The Congressional Budget Office has signaled that national health care spending could be reduced if physicians and patients had more unbiased data on the effectiveness of the treatments available to them.Click here to access the entire news release.
Monday, August 04, 2008
Med com companies take another hit
Trying to steer clear of potential conflicts of interest, two medical industry giants are distancing themselves from a little-known breed of marketing specialists. The recent steps by the drugmaker Pfizer (PFE) and Zimmer Holdings (ZMH), a medical device manufacturer, illuminate subtle promotional tactics other companies continue to aim at doctors, despite mounting concern on the part of some physicians and ethicists.Click here to access. Hat tip to Dr. Carlat.
SACME and NAAMECC release "joint" assessment tool
Sunday, August 03, 2008
Regional differences in health care (and cost)
Saturday, August 02, 2008
New study indicates that U.S. HIV infection rates higher than previously estimated
The United States has significantly underreported the number of new H.I.V. infections occurring nationally each year, with a study released here on Saturday showing that the annual infection rate is 40 percent higher than previously estimated.The study will be published in the August 8th issue of JAMA. Click here to access the NYT article.
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The findings confirm that H.I.V., the virus that causes AIDS, has its greatest effect among gay and bisexual men of all races (53 percent of all new infections) and among African-American men and women.
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Dr. Gerberding said the new findings were “unacceptable,” adding that new efforts must be made to lower the infection rates. “We are not effectively reaching men who have sex with men and African-Americans to lower their risk,” she said.