Archives: 11/2005

Guidant logo Guidant Medical Chief to be Probed by SECOh, Guidant. When it rains, it pours. Bloomberg.com reports that Beverly Lorell, Guidant’s medical chief, off-loaded $3.3M in stock (95% of her stake in the company) in the days preceding the first round of letters to doctors regarding the now infamous failures of their difibrillators. While this investigation is into Lorell’s actions (as opposed to the Guidant Corp.), it could provide evidence supporting Johnson and Johnson’s claim that there has been “material adverse change” in the status of the company when a top exec is purging their portfolio.

Guidant, whose $25.4 billion acquisition by Johnson & Johnson is in jeopardy, said Nov. 7 the SEC is investigating trading in the company’s shares and product disclosures. Beverly Lorell, Guidant’s medical chief since 2003, sold the shares in the six days before doctors began to receive letters about the failures. The announcement led to the recall of 109,000 devices and a 14 percent decline in the shares in a month.
“The SEC is always concerned when you have an executive selling a large position in a period immediately before a material adverse announcement,” said Stephen Bainbridge, a University of California at Los Angeles law professor who specializes in securities law, in an interview yesterday.
Lorell, who is on leave from her post as a Harvard Medical School professor, declined in a telephone interview to comment about the sale, referring questions to Guidant’s spokesman Steve Tragash. The sales, which took place on May 17 and 23, amounted to 95 percent of her holdings in the company at that time.
“I don’t have any comment on any of the executives’ stock trades,” Tragash said. “As you know, the SEC has opened up an investigation which we announced Monday, and we’re not going beyond that.”

Link to Guidant’s “Newsroom” Page

red light Red Light Therapy   10News Says it Works!When grading papers, most are marked “good”, given 8/10 and passed on. Some earn lauditory superlatives and extra exclamation points, and some are posted in the teachers’ lounge to be mocked in their horribleness. Today, we’re in the last category.
We all know local TV news stations are hardly bastions of scientific coverage, but San Diego’s 10News is offering some important analysis on red light therapy. Unfortunately, the piece (and what a piece) has nothing to do with red-light induced rage behind the wheel, but is a gold mine of “I don’t understand science” quotes:

“Going into surgery or laser really scares me,” said Rose Alesi, a woman who wants to look younger.

Note the patient’s name, as it becomes important later.

“We are using red light to target fibroblast to energize them and produce collagen and elastic,” explained Ray Mead, CEO of Raymond Anthony International.

We can only hope that this is a horribly transcribed quote, because at last check, fibroblasts are cells, not a substance and no part of your body produces elastic (try elastin).

Lumiere is a light treatment to improve the appearance of skin. Dermatologists have used similar light therapies to treat medical conditions such as psoriasis.

UV light therapy used to treat psoriasis is significantly different from shining a red light on your skin to reduce wrinkles. To their credit, both therapies do contain the word “light.”

The device emits red light wave lengths to wake up cells to replenish skin. When those cells get energized, they produce collagen and elastic. Then, topical products are used to feed the nutrients to those energized cells.

Again with the production of elastic. Apparently this therapy causes your skin to take on properties of rubber and cloth sewn together.

According to 10News, over the course of 60 to 90 days, you can really look forward to surprising good results.

Apparently 10News has their own testing facility for multi-month randomized product trials. Alas, attempts to find this study’s white paper proved fruitless.

But some dermatologists aren’t convinced this type of light therapy can really have that kind of impact.
“Unfortunately, there isn’t any science where a certain wavelength of light that’s non-ablative makes any significant improvements in the complexion,” said Dr. Richard Chaffoo, a plastic surgeon from Scripps.

Bah! Who needs science and evidence-based medicine when you have 10News’ word that the treatment produces results? This also falls into the category of the “requisite arbitrary counterpoint,” key to all bad science reporting as we have reported earlier.

But 77-year-old Aliso is convinced. She said she has noticed improvement after just five 20-minute sessions.
“I’ve noticed a change already,” Aliso told 10News.

Apparently, the therapy also has the power to change your name, as Ms. Alesi has now become Ms. Aliso. Also note we have no idea how long Ms. whatever-her-name-is has been receiving the treatment, only that she’s “already” noticed a change.

Dermatologists said red light therapy like the one used by Lumiere is used widely in Europe but needs further study in this country.

Given 10News’ previous history of scientific reporting, this therapy they allude to could be anything. “But needs further study in this country” for what? in order to …what? Obtain the elusive 10News Seal of Scientifc Approval?
Link to San Diego’s 10News
Link to Raymond Anthony International, who in addition to Lumiere technology, specializes in “Tanology.”

condom viag F.D.A.: Condoms Reduce Risks of Pregnancy, DiseaseFrom the New York Times:

Used correctly, latex condoms greatly reduce the risks of pregnancy and disease, the Food and Drug Administration said Thursday in a 63-page report.
Prepared in response to a five-year-old law, the report is to form the basis for labels for condom packaging and provide more up-to-date information about effectiveness.
The federal drug regulators found that latex condoms are “highly effective” at preventing infection by H.I.V., gonorrhea, chlamydia, trichomoniasis and hepatitis B, largely because all of these diseases are spread through penile contact.

No surprises here, indeed. Seems like this has been an undisputed fact for years. The least we can do is reiterate. View the full report here: Class II Special Controls Guidance Document: Labeling for Male Condoms Made of Natural Rubber Latex
More at the NYT

nuchal sm Nuchal Translucency, Blood Tests Show Effectiveness of Screening for Downs in the 1st TrimesterThe Columbia University Medical Center is reporting on some pretty impressive and very important results from a large trial that looked at the effectiveness of screening for Down’s syndrome.
38,000+ pregnant women underwent the Nicolaides nuchal translucency ultrasound test (essentially, a neck skin thickness measurement in the fetus), and blood tests (pregnancy-associated plasma protein A [PAPP-A], the free beta subunit of human chorionic gonadotropin):

The new screening approach uses a blood test that analyzes the level of a protein and hormone in the mother’s blood, combined with an ultrasound or sonogram picture of the thickness of skin on the back of the baby’s neck (known as the nuchal translucency or NT). Results are available within five days, often before starting the second trimester of pregnancy. This combination approach determines the odds that the baby might have Down syndrome, allowing pregnant women the option of prenatal diagnosis for Down syndrome and other chromosomal abnormalities within the first trimester or pregnancy. The researchers found higher detection – 87 percent – in the first trimester compared to the best second trimester screening method – 81 percent detection. Results with this new combination screening approach in the first trimester are a significant advantage over the current standard screening test.
First-trimester screening was performed on 38,167 patients; 117 were found to have a fetus with Down syndrome. If a positive result is found via screening, the woman is given the option to have the finding confirmed with a diagnostic exam: chorionic villus sampling (CVS) or amniocentesis. Both tests carry risks of complication leading to miscarriage.

The press release
The test by KH Nicolaides, et al
More at WaPo…
The study at the NEJM
NEJM’s editorial

contact lense Non corrective Contact Lenses to Require PrescriptionThe Americal Optometric Association (AOA) has achieved success in their tyrannical quest to restrict the decorative contact lens world. Who says your average convenience store or guy-standing-around-outside-the-rave isn’t qualified to sell contact lenses? In all seriousness, S.172, passed into law by the US House of Representatives grants authority to the Food and Drug Admnistration to regulate all forms of contact lenses. According to the AOA press release running on i-newswire.com:

Previously, decorative contact lenses were unregulated and considered a cosmetic, thus consumers could purchase lenses on the Internet, at retail and convenience stores, flea markets and even gas stations.
Rep. John Boozman ( R-Ark. ) led the bi-partisan effort to pass S.172 in the U.S. House on Oct. 26 and close a 2 1/2-year-old loophole that, in spite of warnings by the nation’s eye care providers and federal health officials, has allowed decorative contact lenses to be considered an unregulated cosmetic rather than a regulated medical device. With mounting evidence of grievous harm resulting from the unsupervised use of decorative lenses provided to Congress by the American Optometric Association ( AOA ) and other organizations, the U.S. Senate acted first and approved S.172 in July with strong support from Senators Michael Enzi ( R-Wyo. ), Mike DeWine ( R-Ohio ) and Edward Kennedy ( D-Mass. ).
Decorative contact lenses — often with striking colors or an unusual design — have become increasingly popular and are worn mostly, but not exclusively, by high school and college students. The improper use of decorative contact lenses can cause permanent eye injury or potentially lead to blindness. Since 2003 the FDA has issued warnings to consumers and has acknowledged receiving reports of corneal ulcers associated with wearing decorative lenses as well as other conditions leading to infections and permanent loss of vision. Other risks associated with the use of decorative contact lenses include conjunctivitis ( an infection of the eye ), corneal edema (swelling), allergic reaction and corneal abrasion due to poor lens fit.

You’d think any of the heinous side effects would really only add to the freaked-out look these kids were going for. Imagine, one eye with a cyborg crosshair and the other swollen and oozing puss…sweet.
Flashback: Millions are now wearing medgadgets

Orac from Respectful Insolence visited the Metropolitan Museum of Art in New York to see The Art of Medicine in Ancient Egypt exhibit. His account, originally published in this Respectful Insolence post, is reproduced below with his kind permission. As you might recall, the Edwin Smith Papyrus has been covered by us on a number of previous occasions. Now we wanted to bring to your attention, dear reader, an account by someone in the medical field who has made it to the exhibit. Thanks, Orac!

separator The Art of Medicine in Ancient Egypt: An Account by Orac

papyrus The Art of Medicine in Ancient Egypt: An Account by Orac… The Egyptian exhibit was far more modest in scale, being contained in one relatively small gallery. However, to me, it was probably more interesting because of the centerpiece of the exhibit, the Edwin Smith Papyrus. This papyrus was named after the American Egyptologist who purchased it in Luxor in 1862 and brought it back to the U.S. The papyrus dates to approximately 1600 B.C. and appears to be a copy of a document that dates back 200-300 years earlier still. What fascinated me is that this papyrus was a practical guide to the treatment of various ailments and embodied the medical thinking of Egyptian physicians of the time. Even more fascinating is that the knowledge contained in the scroll was presented as several cases. Most of the cases were, as might be expected, how to deal with traumatic wounds. There are also included eight magic spells purported to protect against airborne disease, but there is also one for preventing harm from an accidentally swallowed fly. Showing that some things never change, there were also two prescription for cosmetic purposes, one of which was for an ointment to combat a head cold, as well as for “rejuvenation of the skin and repelling of wrinkles, any age spots, any sign of old age, and any fever that may be in the body.”
And you wonder where alties got their ideas from.
13244688 The Art of Medicine in Ancient Egypt: An Account by OracActually, reading the translations for some of the remedies filled me with wonder. Remember: The ancient Egyptians had no idea what caused most diseases (which is probably why a lot of this papyrus dealt with trauma, which had a mechanical cause and mostly mechanical treatments). They had no concept of bacteria, only a very rudimentary idea of the circulatory system, knowing only that it originated in the heart, but having no real idea what its purpose was. Diseases were ascribed to the malign influence of various gods and magic, and physicians were often also priests, usually Sekhmet or Imhotep (Greeks equated Imhotep with their own god of medicine, Asklepios). Because Egyptian physicians were both medical doctors and priests, their treatments often combined the practical and the magical.
However, reading some of these cases was quite instructive. The papyrus presents the cases in terms of diagnosis and practical treatment, dividing the conditions into three categories: “An ailment I will handle” (meaning there was a practical treatment available); “an ailment I will fight with” (for ailments for which the treatment and outcome was less certain); and “an ailment for which nothing is done” (for ailments for which no treatment is known). For ailments falling in the first two categories, the papyrus provides a description of the recommended treatment. Take these two cases, one of a head wound with skull damage (case 3) or a head wound with damage to the plates of the skull (case 4):

Case 3. A head wound with skull damage.
Title: Practices for a gaping wound in his head which has penetrated to the bone and violated his skull.
Examination and prognosis: If you treat a man for a gaping wound in his head, which has penetrated to the bone and violated his skull, you have to probe his wound. Should you find him unable to look at his arms and his chest and suffering from stiffness in his neck, then you say about him: “One who has a gaping wound in the head, which has penetrated to the bone and violated his skull, who suffers from stiffness in his neck: an ailment I will handle.”
Treatment: After you stitch him, you have to put fresh meat the first day on his wound. You should not bandage him. He is to be put down on his bead until the time of his injury passes, and you should treat him afterward with an oil and honey dressing every day until he gets well.

This sounds like a description of a serious gaping scalp laceration without an underlying skull fracture, and the treatment here is not all that different than what we’d do today (the raw meat and oil and honey dressings excepted, of course). Contrast this to s more serious head wound:

Case 4. A head wound with damage to the plates of the skull.
Title: Practices for a gaping would in his head, which has penetrated to the bone and split his skull.
Examination and prognosis: If you treat a man for a gaping wound in his head, which has penetrated to the bone and split his skull, you have to probe the wound. Should you find something there uneven under your fingers, should he be very much in pain at it, and should the swelling that is on it be high, while he bleeds from his nostrils and his ears, suffers stiffness in his neck, and is unable to look at his arms and chest, then you say about him: “One who has a gaping wound in his head, which has penetrated to the bone and split his skull, while he bleeds from his nostrils and his ears and suffers stiffness in the neck: an ailment I will fight with.”
Treatment: Since you find that man with his skull split, you should not bandage him. He is to be put down on his bead until the time of his injury passes. Sitting is his treatment, with two supports of brick made for him, until you learn that he arrives at a turning point. You have to put oil on his head and soften his neck and shoulders with it. You should do likewise for any man you find with his skull split.
Explanations: As for “which has split his skull,” it is the pushing away of one plate of his skull from the other, while the pieces staying in the flesh of his head and do not fall down. As for “the swelling on it is high,” it means that the bloating that is on the split is great and lifted upward.” As for “you learn that he arrives at a turning point, ” it is to say that you learn that he will die or until he has revived, since it is an “ailment I will fight with.”

This is a startlingly good description of a head injury with a skull fracture (probably a basilar skull fracture, given the bleeding from the ears), and the examination is not too different from what is done in the trauma bay today: Probe the wound and see if you can feel any fractures. Also surprisingly accurate is the observation that “sitting is his treatment.” Elevated intracranial pressure can occur with fractures of this sort, and keeping the head elevated is one way to minimize the rise in intracranial pressure. Indeed, even today, we often keep head-injured patients in a partial sitting position to try to minimize the tendency to intracranial pressure to rise. Of course, we now have CT scans and MRIs to delineate the full extent of the injury and intracranial pressure monitors to determine the extent of the brain selling. We also have hyperventilation and mannitol as adjuncts to try to lower intracranial pressure, and, if they fail, there is always the last resort of the phenobarbital-induced coma. However, given the primitive resources available to ancient Egyptian doctors, it is impressive indeed that they were able to figure out that sitting the patient upright would be helpful for this sort of injury.
I just love this sort of exhibit, as it lets me indulge my interest in both medicine and history. You know, since I happened to have purchased the exhibit book, which contains the complete translations of all the cases in the papyrus, I might have to make this a recurring series, in which I discuss some of the more interesting cases. Maybe later this week…

separator The Art of Medicine in Ancient Egypt: An Account by Orac

We’ll follow more cases from the exhibit when they become available.
To stroll through an online exhibit: The Art of Medicine in Ancient Egypt.
That’s all for this week. Thanks for stopping by. See you on Monday!

flu chip colorado Flu Chip
Nobody can disagree that the hottest topic these days is the possibility of avian flu pandemic among humans. Well, good news people: researchers from University of Colorado at Boulder invented a new and fascinating method of characterizing flu subtypes, which gets the job done within 11 hours, in contrast to currently employed methods which take about four days. This means that in the case of avian flu pandemic, doctors would know sooner the type of flu virus their patient is carrying, and could administer antiviral drugs sooner to lessen the severity of the illness.
The press release:

Tests last month on the new technology by the Centers for Disease Control and Prevention in Atlanta showed the CU-Boulder Flu Chip can determine the genetic make-up of types and subtypes of the flu virus in about 11 hours, said CU-Boulder Professor Kathy Rowlen of the chemistry and biochemistry department. Current methods for characterizing flu subtypes infecting patients take about four days.
The Flu Chip is expected to be in wide use in laboratories within a year, said Rowlen, who has led the two-year CU-Boulder research effort.
“This new technology should help provide better global influenza surveillance by making it easier for more laboratories to swiftly identify severe flu strains, which in turn may aid health officials to stem potential flu epidemics and even pandemics,” Rowlen said.
The chip, which can be configured to test for all known flu virus strains as well as new variant strains, was evaluated for three primary subtypes of flu in the October CDC test — the avian flu strain H5N1, and two of the most common human flu types worldwide in recent winters, H1N1 and H3N2. The chip was more than 90 percent accurate and will be tested again “side by side” with standard flu-virus culturing methods for accuracy and speed at the CDC’s Atlanta headquarters next month.
The Flu Chip fits on a microscope slide and contains an array of microscopic spots, Rowlen said. Genetic bits of information that are complimentary to known, individual influenza strains are “spotted” robotically in an array, where each row of three spots contains a specific sequence of “capture” DNA. Each spot is approximately one-hundredth of an inch in diameter. The microarray is then immersed in a wash of influenza gene fragments obtained from the fluid of an infected individual.
RNA fragments from the infected fluid bind to specific DNA segments on the microarray like a key in a lock, indicating both a match and that the virus signature is present, she said. The captured RNA is then labeled with another complimentary sequence that also contains a fluorescent dye, and such “hits” light up like a pinball machine when the chip is inserted into a laser scanner.
The Flu Chip also should be able to recognize mutations that might occur in avian flu H5N1, which has been spreading rapidly from bird to bird in Asia, Russia and parts of Europe, said Kuchta. While the avian virus does not now spread effectively from person to person, world health officials are fearful the strain will mutate and become transmittable between humans, possibly triggering a worldwide pandemic.
Rowlen said that within a few years, the technology could be downsized to fit into a hand-held portable device the size of a cell phone or PDA and taken into remote areas around the world to test for lethal strains of flu.
“We can make it small and simple enough to take into rural areas in places like the Congo, Cambodia or Indonesia that may lack lab facilities,” she said. “One of our goals has been to address the needs of developing nations by providing an inexpensive, field-portable test kit for respiratory illnesses to the World Health Organization for global screening of respiratory illness.”

Read more at University of Colorado at Boulder…

Interesting nanotech research to fight cancer is coming out of the University of California, Riverside:

Two engineering professors at the University of California, Riverside are developing devices 100,000 times thinner than a human hair, that can listen to cancerous cells, deliver chemotherapy to them and leave surrounding healthy tissue intact.
Assistant professors, Mihri Ozkan of Electrical Engineering and Cengiz Ozkan of Mechanical Engineering at UCR’s Bourns College of Engineering, are leading research into micro-electrical arrays, or the signals cells emit, and the nanodevices (devices made at the molecular level) to deliver anti-cancer drugs.
The married couple hopes to combine the technologies to “listen” for the subtle electrical cues that cancerous cells emit and deliver chemotherapies with such precision that only the cancerous cells are affected…
Cengiz Ozkan says focusing on the electrical signals cells emit is far more benign process and one that holds a great deal of promise, when coupled with nanofabrication (building things at the molecular scale) techniques.
“You effectively listen to the cells. The ones with cancer emit a different signal than healthy ones,” he said. Using DNA and nanotube technologies, Cengiz Ozkan is also developing a drug delivery system that targets the cancerous cells.

The press release

A Purdue research team recently teamed up with a biomedical group at Vanderbilt to use their streamlining of the mass spectrometry technique to identify cancerous liver cells. According to Purdue’s press release:

The team’s paper appears on the cover of the current issue of Angewandte Chemie, a leading European scientific journal. Members of the team include Purdue’s Justin M. Wiseman and Zoltan Takats, as well as Vanderbilt University’s Satu M. Puolitaival and Richard M. Caprioli.
The wand-like probes are one of the improvements the team has made to the mass spectrometer, an analytical device that in its conventional form has been long established in modern laboratories. But while ordinary mass spectrometry is both time- and labor-intensive, the Cooks team has modified the devices so that not only are they portable enough to be carried in backpacks, but they can also determine the chemical composition of an unprepared sample within five seconds.
Their modified spectrometric technique, which the team has dubbed desorption electrospray ionization (DESI, pronounced “daisy”), involves aiming a fine water mist at a surface with a pencil-sized tube that also sucks up the fluid after the droplets have mixed with the material in the sample.
“This paper shows specifically that DESI can detect cancer in liver tissue, but its medical applications can go beyond that,” said Takats, who is a postdoctoral assistant in Cooks’ lab. “We see DESI as a microscope that can ‘see’ chemicals instead of light. As we move the ‘wand’ across tissue, it can reveal what chemicals are where, and these chemical signatures are clues to what’s happening in the body.”

Link to the press release