Friday, August 1, 2008
Not So Fast, Sugammadex
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The U.S. FDA has declined to approve Sugammadex secondary to concerns over rare allergic reactions. From Schring-Plough:
"
KENILWORTH, N.J., Aug. 1 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today announced that the U.S. Food and Drug Administration (FDA) has issued a "not-approvable" letter for sugammadex sodium injection for the reversal of muscle relaxation during general anesthesia.
"We are surprised and disappointed with this action, especially given that sugammadex received a unanimous recommendation for approval by the FDA Advisory Committee on Anesthetics and Life Support in March of this year," said Thomas P. Koestler, Ph.D., executive vice president and president of Schering-Plough Research Institute. "Sugammadex represents the first major pharmaceutical innovation in the field of anesthesia in two decades. We remain committed to bringing this important medical advance to those who are waiting for it in the United States, and plan to work with the agency to address the issues, which are primarily related to hypersensitivity/allergic reactions." There were no issues related to the efficacy of sugammadex."
Thursday, December 27, 2007
NIH-Funded Research to Be Free (After One Year)
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I was browsing the Wall Street Journal Health Blog and ran across this item regarding the new federal budget:
"The results of NIH-funded research must be made available for free online one year after they’re published in an academic journal. That’s a big deal, because the NIH is one of the biggest funders of medical research and subscriptions to the academic journals where that research is published can cost thousands of dollars a year.
Some researchers and academic institutions have been pushing for this for years, and the multibillion-dollar journal-publishing industry hired a PR guy known as “the pit bull of public relations” to fight the change."
Sunday, September 9, 2007
Your History Can Haunt You
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A cardiologist in San Diego is accused of striking a patient during a heart cath:
Dr. Maurice Buchbinder, a prominent cardiologist, and Scripps Memorial in La Jolla are under federal investigation because he allegedly hit a patient several times during a procedure at the hospital, physicians and health officials have confirmed.
Having been called to the cath lab on several occasions to intubate his patients I can say that this report does not surprise me and is completely consistent with past behavior (though he never struck anyone in my presence). I'm quite sure he refrained from striking me only because of my size and ability to fight back.
Sunday, July 29, 2007
Dr. Anna Poe of New Orleans Not To Be Charged
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Grand jury refuses to indict Anna Pou
"Closing one of the most sensational chapters in post-Katrina New Orleans, Dr. Anna Pou said Tuesday that she fell to her knees and thanked God when she learned that a grand jury had refused to charge her with murdering patients in dark, fetid Memorial Medical Center in the nightmarish days after the hurricane struck on Aug. 29, 2005."
Four civil suits are pending so her legal ordeal isn't over yet. As I understand it, the burden of proof in a civil suit requires only that the plaintifs version of the facts is 'more than likely' to be true (ref).
Sunday, June 10, 2007
Pennsylvania Doctor Trap Number Two Proposed
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Pennsylvania has chosen an interesting strategy to keep doctors from leaving the state. Rather than fix the current jackpot medical malpractice system they've decided to try to trap doctors that are already here.
The first example of this was something called the MCARE abatement program. The Medical Care Availability and Reduction of Error (MCARE) Act replaced an existing catastrophic coverage fund with a new fund to cover awards which exceeded the primary coverage provided by professional liability policies. Each physician must pay into the fund a percentage of their primary premium to sustain the fund.
The MCARE abatement program (or Health Care Provider Retention Program) provides some financial relief from paying premiums to the fund. How much relief a physician gets depends on the practitioners specialty. And here we come to trap number one. If you accept the abatement, you agree to practice in the state for the year in which you receive the abatement AND the next year. If you leave early, you have to pay back the full amount of the abatement.
The legislature is now working on trap number two--a physician loan forgiveness program. For a period of ten years, for every year a physician practices in Pennsylvania after completing training the state will pay off ten percent of their student loan debt. If they leave early (say, after five years), they have to pay the state back ALL of the money the state paid toward their loans.
Thursday, June 7, 2007
At risk: vaccines - The Boston Globe
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The Boston Globe
"Certainly there is plenty of evidence to refute the notion that vaccines cause autism. Fourteen epidemiological studies have shown that the risk of autism is the same whether children received the MMR vaccine or not, and five have shown that thimerosal-containing vaccines also do not cause autism. Further, although large quantities of mercury are clearly toxic to the brain, autism isn't a consequence of mercury poisoning; large, single-source mercury exposures in Minamata Bay and Iraq have caused seizures, mental retardation, and speech delay, but not autism.
Finally, vaccine makers removed thimerosal from vaccines routinely given to young infants about six years ago; if thimerosal were a cause, the incidence of autism should have declined. Instead, the numbers have continued to increase. All of this evidence should have caused a quick dismissal of these cases. But it didn't, and now the courthas turned into a circus. The federal and civil litigation will likely take years to sort out."
[Via PointofLaw.com]
Thursday, March 8, 2007
Details On Why We Get Migraines
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"A University of Iowa study may provide an explanation for why some people get migraine headaches while others do not. The researchers found that too much of a small protein called RAMP1 appears to "turn up the volume" of a nerve cell receptor's response to a neuropeptide thought to cause migraines.
"The neuropeptide is called CGRP (calcitonin gene-related peptide) and studies have shown that it plays a key role in migraine headaches. In particular, CGRP levels are elevated in the blood during migraine, and drugs that either reduce the levels of CGRP or block its action significantly reduce the pain of migraine headaches. Also, if CGRP is injected into people who are susceptible to migraines, they get a severe headache or a full migraine.
"We have shown that this RAMP protein is a key regulator for the action of CGRP," said Andrew Russo, Ph.D., UI professor of molecular physiology and biophysics. "Our study suggests that people who get migraines may have higher levels of RAMP1 than people who don't get migraines." "
The abstract is here.
Wednesday, March 7, 2007
Aspirin/NSAIDs For Colorectal Cancer Prevention Discouraged
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"People who are at average risk for colorectal cancer, including those with a family history of the disease, should not take aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) to try to prevent the disease, according to a new recommendation from the U.S. Preventive Services Task Force. The recommendation is published in the March 6 issue of the Annals of Internal Medicine."
"USPSTF assessment: Overall, the USPSTF concluded that harms outweigh the benefits of aspirin and NSAID use for the prevention of colorectal cancer."
[AHRQ]
Friday, November 24, 2006
Anesthesia is safer than ever (even in France)
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Anesthesiology--Survey of Anesthesia-related Mortality in France.
" Conclusion: In comparison with data from a previous nationwide study (1978-1982), the anesthesia-related mortality rate in France seems to be reduced 10-fold in 1999. Much remains to be done to improve compliance of physicians to standard practice and to improve the anesthetic system process."
Thursday, November 23, 2006
On Negotiations With Hospitals, Insurers, and Physicians
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Contract Negotiations Between Insurers, Hospitals Increasingly Acrimonious
" The AP/Arizona Daily Star on Monday examined how contract negotiations between insurers and hospitals increasingly have "taken an ugly turn" as both sides work to control rising costs. Insurers "are under pressure to lower premiums to win business," while hospitals believe that insurers are "skimping on payments to boost their earnings," the AP/Daily Star reports."
The exact same can be said for negotiations between hospitals and physician groups and insurance companies and physician groups. It all reminds me of that scene in Star Wars where the good guys are stuck in a trash compactor after their escape from the brig--all attempts to stop the walls from moving from the inside fail. (what, you were expecting a reference to Greek mythology?)
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Dec Sep
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