Wednesday, February 2, 2005
FDA Approves Generic Fentanyl Patch
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FDA Clears the Way for Generic Versions of Transdermal Patches to Treat Chronic Pain
" The Food and Drug Administration (FDA) has granted approval to Mylan Technologies, Inc., for the first generic version of Alza Corporation's Duragesic Patch (Fentanyl Transdermal System) used to treat patients suffering from severe chronic pain that cannot be managed with alternative analgesics. When applied to the skin, this patch technology delivers fentanyl, an opioid pain medication that is slowly absorbed into the body through the skin providing pain relief for up to three days (72 hours).
The agency's approval is expected to provide patients with access to a lower cost alternative of this pain management system. At the same time that FDA approved Mylan's generic product, it acted on several citizens' petitions requesting that FDA deny or delay approval of the product." "
[Via Science Blog - Science News Stories]
Sunday, January 30, 2005
A Momentous Day
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The Fox News headline sums it up rather well: "A New Dawn of Democracy".
Iraq, our thoughts and prayers are with you--especially today. Let Freedom Ring!
Wednesday, December 29, 2004
New Genetic Test May Prevent Drug Interaction
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New Genetic Test May Prevent Drug Interaction:
A new DNA microarray test called the AmpliChip Cytochrome P450 Genotyping Test analyzes abnormalities in the gene coding for Cytochrome P450, the liver enzyme involved in metabolizing many drugs. The hope is that testing for the abnormality will allow better use/selection of drugs in these patients. As the list of cytochrome P450-metabolized drugs is long and includes NSAID's, inhaled anesthetics. Are we looking at a standard pre-op test? Perhaps. Polymorphism at this gene may explain some of the bell-shaped curve we see in responses not only to anesthetics, but to many commonly prescribed drugs. What we need now are outcome studies...and to be patient.
More information about genotyping in general is here (thanks, Google).
[Via WebMD Health Headlines]
Donate to Doctors Without Borders
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We've been talking about how best to donate to relief efforts after the tsunami. As I write this, the Doctors Without Borders web site is redirecting to a search page, but you can still reach the donation page directly.
Other choices for helping out are detailed here.
Sunday, December 26, 2004
First cloned pet delivered by a US company
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First cloned pet delivered by a US company:
" "The first cloned-to-order pet has been delivered by a US company, reigniting debate over the ethics of commercial cloning.
The 9-week-old kitten, named Little Nicky, was cloned for a woman in Texas, to replace a 17-year-old pet cat called Nicky, which died in 2003. She paid for $50,000 for her new pet. " "
Fifty thousand dollars for a cat? For a dog, I could see it, but a cat?
[Via Medical News Today]
Sales Rep Pleads Guilty in Federal Court To Bribing Physicians
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Sales Rep Pleads Guilty in Federal Court To Bribing Physicians:
" "A former New York regional sales manager for Swiss biotechnology company Serono on Tuesday pleaded guilty to bribing doctors in New York City to write prescriptions for the company's AIDS-related drug Serostim, the Boston Globe reports." "
And what of the physicians he bribed?
[Via UK Medical News Today]
Radiologists Use iPod for Image Storage
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Via Medgadget:
" "
Radiological Society of North America reports:
The iPod is not just for music any more. Radiologists from the University of California, Los Angeles (UCLA), and their colleagues at other institutions from as far away as Europe and Australia are now using iPod devices to store medical images.
'This is what we call using off the shelf, consumer market technology,' says Osman Ratib, M.D., Ph.D., professor and vice-chairman of radiologic services at UCLA. 'Technology coming from the consumer market is changing the way we do things in the radiology department.'
Dr. Ratib and Antoine Rosset, M.D., a radiologist in Geneva, Switzerland, recently developed OsiriX, Macintosh-based software for display and manipulation of complex medical image data.
Dr. Rosset set up the OsiriX software to automatically recognize and search for medical images on the iPod. When it detects the images, they automatically appear on the list of image data available - similar to the way music files are accessible by the iTune music application.
'It's easy to use and you don't have to worry about how to load and unload it from the iPod,' Dr. Ratib says. 'But the real beauty of it is that I can use the images directly on the iPod. I don't have to take the time to copy them to my computer. The iPod allows me to copy data from work to my laptop, but I don't have to do it if I don't want to.'
Dr. Ratib sees the iPod as a kind of giant memory stick, 'The performance is amazing.'
" "
Sunday, December 19, 2004
Medicaid's fee-for-service drug expenditures increased 18% per annum
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Medicaid’s Reimbursements to Pharmacies for Prescription Drugs (pdf)
This Congressional Budget Office report focuses on the markup paid to pharmacies by Medicaid for buying and dispensing drugs. For example, in 2002 medicaid reimbursed pharmacies an average of $46 per prescription. Of that amount, $14 was for purchase of the drug itself. The $32 difference constitutes the 'markup', which has been increasing at a rate of roughly 10% per year between 1997 and 2002.
" "Between fiscal years 1997 and 2002, Medicaid’s expenditures on prescription drugs in the fee-for-service part of the program increased from $10.2 billion to $23.4 billion. About one-quarter of those amounts went to wholesalers and pharmacies to compensate them for distributing and dispensing the drugs.
Prepared at the request of the House Committee on Energy and Commerce, this paper examines recent trends in that “markup”—or the difference between the total amount that state Medicaid agencies paid to pharmacies and the amount that pharmacies and wholesalers paid to purchase the drugs from manufacturers. In keeping with the Congressional Budget Office’s (CBO’s) mandate to provide objective, impartial analysis, the paper makes no recommendations. " "
and
" "Overall, the largest single factor contributing to the rapid increase in markups was the use of newer generic drugs, with their high markups. Another factor was the use of newer single-source brand-name drugs, which had somewhat higher average markups than did older brand-name drugs." "
Wednesday, December 8, 2004
Two NEJM Articles on the War
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NEJM: Notes of a Surgeon: Casualties of War — Military Care for the Wounded from Iraq and Afghanistan (free full text)
NEJM: From the War Zone to the United States: Caring for the Wounded in Iraq — A Photo Essay (free full text)
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Tuesday, December 7, 2004
Laparoscopy and Ambulatory Surgery Centers in PA
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The Pennsylvania Department of Health sent a letter to all Ambulatory Surgery Centers in Pennsylvania reminding them that they are not to perform laparoscopic surgeries which:
" 'require major or prolonged invasion of body cavities.' "
Noting that:
" 'the risk of injury to abdominal and other internal organs and structures is not lessened. In fact, there are some reports that the risk of injury may be increased. (Peter D. Jacobson, Medical Liability and the Culture of Technology, PEW Project on Medical Liability, released 9/22/04). ' "
My reading of the Pew report turns up no data implicating ambulatory surgery centers (ASC's) specifically in injuries from laparoscopic procedures. Nothing to suggest that eliminating most laparoscopic procedures from ASC's will improve patients safety. In an era when 'evidence based medicine' is the watchword for practitioners, this kind of blanket policy by the government is difficult for me to swallow.
I suspect (though cannot prove) that hospitals have brought political pressure to bear on the Governor and/or Department of Health to make this policy change in order to bring a very profitable class of surgery back to the hospital setting. The facility fees collected for laparoscopic surgery are considerable, and hospitals feel they've been missing out.
Another example to suggest hospitals have been active in this area is the requirement by some payors that orthopedic implant surgeries be performed in hospitals rather than free standing ASC's. For example, we used to perform rotator cuff repairs (which use an anchor suture) in the ASC, but they can no longer be done here because the insurance company will only pay for the anchors if placed in a hospital. There is just no reason I can think of for this requirement other than to force surgeries back into hospitals and away from ASC's.
12/8/04 update: it is on the state servers at: http://app2.health.state.pa.us/commonpoc/content/facilityweb/FacMsgBoardDetails.asp?msgid=819&msgindex=2&Selection=ALL
Friday, December 3, 2004
Pennsylvania Has Its First Influenza Case
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Type A-Fujian influenza has been confirmed in a Philadelphia resident, the first laboratory-confirmed case of influenza in Pennsylvania. Of note, this strain was included in the vaccine.
Merriam-Webster's Word of the Year 2004: Blog
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Blog noun [short for Weblog] (1999) : a Web site that contains an online personal journal with reflections, comments, and often hyperlinks provided by the writer
Just as interesting to me is number 10 on the list: defenestration: Etymology: de- + Latin fenestra window: a throwing of a person or thing out of a window. I believe its more popular use today is in reference to getting rid of the Microsoft Windows operating system, as described in this book
Monday, November 29, 2004
Cocoa, Flavanols and Cardiovascular Risk
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Cocoa, Flavanols and Cardiovascular Risk:
""The Kuna Indians in Panama, living in their indigenous island home in the Caribbean, do not show the typical rise in blood pressure with age, and hypertension is very rare.[34] In a study that began with the search for protective genes, the observation that migration to Panama City led to a loss of the protection against hypertension made it clear that an environmental factor was involved. Examination of their diet uncovered the fact that they drank large volumes of a flavanol-rich cocoa.[2] Subsequent in vitro studies suggesting that cocoa extracts can induce endothelium-dependent relaxation[4] led to studies in healthy volunteers,[9] and in patients with vascular risk or disease.[1] In the studies of Heiss et al. ingestion of flavanol-rich cocoa led to an increase in flow-mediated vasodilation of the brachial artery following five minutes of ischaemia, a response that correlated with biochemical evidence of increased nitric oxide bioavailability.[8] In the normal volunteers studied by Fisher et al. flavanol-rich cocoa induced striking dilatation of the vessels of the finger, which was reversed completely by an arginine analogue that blocks nitric oxide synthesis (figure 1).[9]""
and
""Endothelial dysfunction with a consequent reduction in nitric oxide production has achieved a central conceptual role in the pathogenesis of atherosclerosis and coronary artery disease, diabetes mellitus and hypertension. Recent evidence that flavanol-rich cocoa activates vascular nitric oxide synthesis in the intact human raises an interesting possibility of a therapeutic potential.""
Potentially very good news for Hershey foods, what, what?
[Via Medscape Headlines]
Friday, November 26, 2004
Common Good Promoting Special Health Courts
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Common Good is planning a brochure for mass distribution to 'advance the concept of a special health court.' I've written about this organization before. Their proposal, which has some pretty big names behind it, calls for the creation of special health courts. Some of the details include:
- Full-time judges
- Neutral experts
- Speedy processing at lower cost
- Schedule for non-economic damages
- Liberalized standard for patient recovery
Common Good is accepting donations (tax deductible) to help with the mass distribution of their brochures.
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