Thursday, May 19, 2005

Neuromuscular blocker binders around the corner?

Organon is working on the first of a new class of drugs called selective relaxant binding agents (SRBA). The first drug, called Org 25969, is about to enter phase three trials in the US. These drugs can supposedly reverse neuromuscular blockade at any depth of neuromuscular block by binding the neuromuscular blocker.

Though this news release and the Organon website are short on details, this site has the scoop:

"The novel concept of using a ring-shaped cyclodextrin to engulf a neuromuscular blocking drug is fascinating.2 Cyclodextrins are cyclic oligosaccharides which are recognised to encapsulate lipophilic molecules such as steroids. They are water soluble and well tolerated biologically. Org 25969 consists of eight such sugar molecules in a ring, the outside of which is hydrophilic, and the inside, hydrophobic. The size and shape of the ring is designed to produce a cavity into which a neuromuscular blocking drug such as rocuronium will tightly fit. Org 25969 is capable of forming a binary host – guest complex of high affinity with rocuronium, for two of its externally charged side-chains react with the quaternary nitrogen groups of the muscle relaxant. It is able to encapsulate all four steroidal rings of rocuronium within its lipophilic cavity. This encapsulation or chelation reverses the effect of rocuronium, by preventing its access to the nicotinic receptor and promoting its dissociation from it."

[via Medical News Today]



Saturday, April 2, 2005

DOJ Subpoenas Issued to Orthopedic Companies

Via Medgadget: DOJ Subpoenas Issued to Orthopedic Companies:

" A press release by Stryker

Stryker Corporation (NYSE: SYK - News) announced today that it has received a subpoena from the United States Department of Justice requesting documents for the period January 2002 through the present as follows: "any and all consulting contracts, professional service agreements, or remuneration agreements between Stryker Corporation and any orthopedic surgeon, orthopedic surgeon in training, or medical school graduate using or considering the surgical use of hip or knee joint replacement/reconstruction products manufactured or sold by Stryker Corporation."

Based on an initial conversation with a Department of Justice representative, the Company understands that similar requests have been or will be directed to other companies in the orthopaedics industry. Stryker intends to fully cooperate with the Department of Justice regarding this matter.
Something major is going on. Any ideas?"

Only the rampant attempts to influence orthopedic surgical residents and their attendings with dinners, trips to 'schools' to teach techniques, golf games, and on, and on.



Thursday, February 10, 2005

Coming To A School Near You: Super Size Me

" What happens when a man eats nothing but McDonald's food for 30 days? It's a lesson that schoolchildren across the country are about to find out.

Morgan Spurlock, director and star of "Super Size Me: A film of epic proportions," is releasing an edited version of the film for classrooms. The school version of the Academy-Award nominated film is scheduled to be released after the Feb. 27 Oscars (news - web sites) ceremony. "

Um. Can we show it in hospital waiting rooms?

[via Yahoo News]



Wednesday, February 2, 2005

FDA Approves Generic Fentanyl Patch

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

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

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

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

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

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

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

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

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)



Tuesday, December 7, 2004

Laparoscopy and Ambulatory Surgery Centers in PA

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

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