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Personal misuse of super-strength botulinum toxin caused a Florida osteopath, his girlfriend, and two of his patients to become paralyzed and hospitalized for months in 2004.
Details of the much-publicized incident—which ended in the practitioner being sentenced to three years in prison—are only now published in this week's issue of the Journal of the American Medical Association.
At the time of the incident, Bach McComb was an osteopathic physician who was continuing to practice in Oakland Park, Fla., after his license had been suspended. In the four cases described, McComb did not use a medical version of Allergan Inc.'s Botox.
Instead, he mistakenly gave himself and the three others four to six injections of a preparation of paralyzing botulinum toxin that was 2,800 times stronger than that typically used on patients, according to the authors of the JAMA article. This formulation was only intended for laboratory work.
The vial's labeling clearly marked the product as not being suitable for human use.
"The fact that clinical practitioners were using an unlicensed product was very disturbing," said Dr. Christopher R. Braden, a medical epidemiologist at the U.S. Centers for Disease Control and Prevention, and an author of the report. "It needed to be highlighted and the issue dealt with so that it does not recur."
"A 100-microgram vial of toxin taken from the same manufacturer's lot as the toxin administered to the case patients contained a toxin amount sufficient to kill approximately 14,286 adults if disseminated evenly," according to the JAMA report.
McComb, his two patients, Eric and Bonnie Kaplan, and McComb's girlfriend, Alma Hall, were each paralyzed by the time they were admitted to a hospital.
All of the patients eventually survived but were hospitalized for months and required assistance for basic functions such as breathing, speaking and walking. McComb was later sent to prison for three years.
The incident does not reflect on the safety of standard treatments of Botox, stressed Dr. John Canady, a professor of plastic surgery at the University of Iowa and vice president of the American Academy of Plastic Surgeons.
"This was clearly not Botox," Canady said. "More than 3 million people got Botox injections in 2005, which is the last year we have statistics on, and I don't believe any reaction such as this has been reported."
The real Botox is carefully packaged by its manufacturer, Allergan, Canady explained. "Botox comes in a vial that does not have an excessive dose, and it is reconstituted in the same vial," he said. "None of these safeguards were in place" in the Florida case, Canady added.
Basic precautions against such misuse are obvious, Canady said.
"It is important to go to a board-certified plastic surgeon," he said. "You should feel free to ask that person what his track record has been in the use of Botox. Probably the biggest take-home message is that it is important to do your homework before any medical procedure, and that includes Botox."
In addition, "It's absolutely fair to ask what material is being injected into you personally," Canady said. "I don't think it's too much to ask to see the container or the material."
And Braden cautioned consumers about bargain-hunting.
The last time he looked at the Internet, he saw advertisements for "Botox-like" medications. "I would be very suspect of those kinds of products," Braden said.
By Ed Edelson, HealthDay Reporter, November 21, 2006
Marathon runners can be proud of their stamina, but all that time outdoors boosts their risk of skin cancer, including the potentially deadly malignant melanoma, according to a study in the Archives of Dermatology.
"We are the first to report this," researcher Christina M. Ambros-Rudolph, MD, tells WebMD in an e-mail interview.
Ambros-Rudolph is a consultant dermatologist at the Medical University of Graz, Austria.
She and her co-researchers, all runners, conducted the study after caring for eight ultra-marathon runners with malignant melanoma over the past decade.
Comparing Runners and Nonrunners
In the study, the researchers evaluated 210 marathon runners, men and women, aged 19 to 71.
They compared the runners' skin cancer risks with those of 210 men and women matched for age and gender who were not long-distance runners.
All participants underwent a skin cancer exam and answered questions about personal and family skin cancer history, as well as changes in skin lesions, sunburn history, sun sensitivity, and physical characteristics such as skin and eye color.
Even though more of the nonrunners had higher sun sensitivity, reflected by their light eyes and sensitive skin types, the runners had more atypical moles and more lesions called solar lentigines—often called "liver spots"—which are associated with a higher risk of malignant melanoma.
Not surprisingly, the more intense the training regimen, the more likely a marathon runner was to have the lesions and moles, Ambros-Rudolph found. While some runners logged about 25 miles a week, others put in more than 44 miles a week.
No lesions suggestive of malignant melanoma were found, but 24 marathoners and 14 from the control group were referred to dermatologists to evaluate growths that looked like nonmelanoma skin cancers (such as basal cell and squamous cell skin cancers).
What's behind the increased risk?
The study reflects what dermatologists see in practice, says Diane Madfes, MD, a New York City dermatologist and a spokeswoman for the Skin Cancer Foundation.
Among her patients who are long-distance runners, Madfes says she has seen many cases of abnormal moles as well as nonmelanoma cancers, though not much melanoma, she says.
Greater ultraviolet exposure, of course, is one explanation for the increased risk, say the Austrian researchers.
Nearly 97% of the runners studied said they wore running shorts and short-sleeved or sleeveless shirts.
Only 56% said they regularly use sunscreen; nearly 2% never do.
Also, long-term, high-intensity exercise suppresses the immune system, the Austrian researchers write. They note that patients who have undergone transplants and had immunosuppressive therapy have an increase in all types of skin cancers.
Reducing the Risk
Ambros-Rudolph advises runners to cover up, train when sunlight exposure is less intense, and slather on the sunscreen—in spray or lotion form. An SPF of 15 or higher is recommended.
The type of product preferred varies by gender, Ambros-Rudolph has observed. "Men usually hate using lotions, and sprays are quicker to apply and easier to apply on hairy skin, while women often suffer from dry skin and love lotions that moisturize at the same time."
Reapplying a water-resistant sunscreen every two hours is important, adds Madfes.
She suggests runners consider bicycling attire, especially the long-sleeved shirts made of newer wicking materials that draw away moisture from sweat.
About 62,000 new cases of malignant melanoma are expected this year in the U.S., along with more than a million nonmelanoma skin cancers, says the American Cancer Society.
About 8,000 are expected to die this year from malignant melanoma; nonmelanoma skin cancers will claim about 2,000 lives.
By Kathleen Doheny, WebMD Medical News, November 20, 2006
The Australian government has launched an advertising campaign aimed at raising awareness among teenagers of the dangers of skin cancer.
A graphic series of TV ads shows that overexposure to the sun can cause skin cancer in people of all ages.
Australia's chief medical officer, John Horvath, told the Australian Broadcasting Corporation many teenagers are unaware of the facts about skin cancer and they are too young to remember earlier public education campaigns.
"You have to get the message out there again and dispel some of the myths that, 'if you don't get sunburned you'll be all right,' or that a suntan or an olive skin protects you. None of those things are true," Horvath said.
United Press International, November 19, 2006
Finally, there may be something duct tape can't fix: the lowly wart.
Despite claims in an earlier study, covering warts with duct tape may not make them vanish faster after all, say Dutch researchers, including Maastricht University's Marloes de Haen, MD.
The Dutch researchers had heard of a study in which duct tape showed promise as a home remedy for warts -- the skin infections caused by the human papillomavirus.
So de Haen's team conducted their own study, now published in the Archives of Pediatrics & Adolescent Medicine.
The study included 103 Dutch kids aged 4-12 who had at least one wart.
For six weeks, half the children wore duct tape over one of their warts, while the rest wore corn pads over one of theirs.
Once a week, the children uncovered the wart, soaked it in warm water for five minutes, then rubbed the wart gently with a pumice stone.
During the study, the warts covered by duct tape were only slightly more likely to heal than those covered by corn pads.
"After six weeks, the wart had disappeared in 16% of the children in the duct tape group, compared with 6% in the placebo [corn pad] group," the researchers write.
That margin was so slim that it may have been due to chance, de Haen's team says.
Most of the kids in the duct tape group -- 81% -- said the tape didn't stick well to their skin. And 15% reported skin irritations, including rashesrashes.
"Further research with longer follow-up would only be useful with a tape that is better sticking," write the researchers.
By Miranda Hitti, WebMD Medical News, November 8, 2006
Plagued by poison ivy allergy? It might be possible to coax the body to build up immunity to poison ivy.
That news comes from researchers including Mary Morris, MD, of Allergy Associates of La Crosse in La Crosse, Wis.
They studied 115 people with a history of severe skin reactions to poison ivy who were treated at their clinic over the past 15 years.
The treatment was a small amount of poison ivy extract placed under the tongue. The goal was to train the body's immune system not to overreact to poison ivy.
The patients took skin tests to see if the treatment helped.
Those tests showed that after treatment, patients had a much higher threshold for allergic skin reactions to poison ivy.
Ninety percent of the patients said they had "far fewer" skin reaction episodes. Patients who said they still got skin rashesrashes reported milder rashes that were quicker to heal than before treatment.
Further tests are needed. If those tests go well, the treatment may help people whose jobs and hobbies expose them to poison ivy, the researchers note.
The findings were presented in Philadelphia at the American College of Allergy, Asthma, and Immunology's annual scientific meeting.
By Miranda Hitti, WebMD Medical News, November 14, 2006
The Abbott Laboratories drug Humira (adalimumab) has been given expanded approval by the U.S. Food and Drug Administration to slow structural joint damage in people with psoriatic arthritis. The condition affects people who have skin psoriasis.
Humira was initially approved for overall treatment of psoriatic arthritis in October 2005. It's also been sanctioned to treat moderate-to-severe rheumatoid arthritis, and an inflammatory disease of the spine called ankylosing spondylitis.
Psoriatic arthritis combines symptoms of arthritis—including joint pain and inflammation—with those of psoriasis, including painful red lesions on the skin. Clinical testing on 313 people who hadn't responded to NSAID therapy found that people given Humira had significantly less joint damage than study participants who took a non-medicinal placebo, Abbott said in a statement.
People who took Humira also demonstrated increased ability to perform daily functions such as getting dressed, walking, and climbing stairs, the company said.
HealthDay News, November 14, 2006
Acupuncture and an extract of turmeric—the spice that gives curry its kick—may both offer significant pain relief to some arthritis patients, two new studies suggest.
Reporting in the November issue of Arthritis & Rheumatism, a German team says a combination of acupuncture and conventional medicine can boost quality of life for patients suffering from osteoarthritis.
And in a second study in the same issue, American researchers say the ingestion of a special turmeric extract could help prevent or curb both acute and chronic rheumatoid arthritis.
The findings should be heartening to the roughly 40 percent of arthritis patients in the United States who say they've turned to some form of alternative medicine.
"If I had arthritis, I would be very excited about this," said Dr. Janet L. Funk, the lead author of the turmeric study and an assistant professor of physiological sciences at the University of Arizona in Tucson.
According to the Arthritis Foundation, nearly one in five Americans (46 million) suffers from one of the more than 100 various joint diseases that constitute arthritis. An additional 23 million have chronic joint pain that has yet to be formally diagnosed.
Osteoarthritis is caused by a progressive degeneration of bone cartilage and is the most common type of arthritis in the United States. Rheumatoid arthritis is an immunological disorder characterized by a painful inflammation of the lining of the joints.
In her study, Funk built on earlier research she had conducted with rats. Those efforts suggested that turmeric might prevent joint inflammation.
In her current work, she first broke down the specific contents of commonly sold turmeric dietary supplements.
In the lab, she and her colleagues then isolated a turmeric extract that was free of essential oils and structurally similar to that found in commercial varieties. The extract was based largely on curcuminoids—a compound they believed to be most protective against arthritic inflammation.
Funk's group administered the extract to female rats both before and after the onset of rheumatoid arthritis. They then tracked changes in the rodents' bone density and integrity.
The turmeric extract appeared to block inflammatory pathways associated with rheumatoid arthritis in rats at a particularly early point in the development of the disease. The extract had a beneficial impact if given three days after arthritis set in, but not if given eight days after disease onset.
Investigations in the laboratory revealed that turmeric stops a particular protein from launching an inflammatory "chain reaction" linked to swelling and pain. The expression of hundreds of genes normally involved in instigating bone destruction and swelling was also altered by the turmeric.
Funk stressed, however, that the findings are preliminary, and the extract needs to be tested in people.
"I feel an obligation to make clear that people should not run out to buy and consume turmeric powder," she cautioned. "First of all, a very small percent of the ground-up root that we buy in the grocery store is the protective part of the root, so it's not going to get you anywhere." In fact, the compound used in the study probably makes up only about 3 percent of the weight of current store-bought turmeric supplements, Funk said.
"That means that if this pans out in further studies, patients will be taking a purified extract, and this is all really exciting," she said. "But we still need conclusive proof that this extract is safe and efficacious."
In the second study, researchers led by Dr. Claudia M. Witt of Charite University Medical Center in Berlin spent three years tracking the treatment results of 3,500 male and female osteoarthritis patients suffering from either knee or hip pain.
For six months, all the participants were permitted to continue whatever conventional western medical treatments they had been undergoing prior to the onset of the treatment trials.
However, in addition, over 3,200 of the patients also received up to 15 sessions of needle-stimulation acupuncture during the first three months of the study. The remaining 310 patients received no acupuncture in the first three months. They were offered such treatment in the final three months of the study period, however.
All acupuncture sessions were administered by physicians who had received a minimum of 140 hours of certified training.
Symptom and pain questionnaires were completed at the onset of the study and at three months and six months of therapy.
Patients with chronic osteoarthritis pain who underwent a combination of routine medical care plus acupuncture demonstrated significant quality of life improvements, the researchers found. This included increased mobility and pain reduction above and beyond that experienced by patients who did not receive acupuncture.
For those who began their acupuncture treatments immediately, osteoarthritis improvement held steady three months after cessation of the sessions. For those patients who had begun acupuncture three months into the study period, comparable improvements occurred by the time they ended their sessions at the six-month mark.
The authors said acupuncture appeared to be a safe medical intervention with minor side effects observed in just over 5 percent of patients.
The study, one of the largest of its kind, demonstrated that acupuncture was a viable therapeutic option for people suffering from osteoarthritis, the German team said.
"I'm not surprised that people can be treated with acupuncture and get better," said Marshall H. Sager, a Bala Cynwyd, Pa.-based doctor of osteopathic medicine, acupuncturist, and past president of the American Academy of Medical Acupuncture.
"Using acupuncture adjunctively with western medicine is very common, because if you can do both approaches, you're way ahead of the game," he said. "Some people are not amenable to medication, either because of allergenic effects or because they just don't want to consume artificial things. And so, this is a way to start the healing process by engaging and stimulating the body's own inherent ability to heal itself."
However, Sager cautioned that American patients who consider this alternative route should choose carefully when they seek out acupuncture care.
"'Medical acupuncture' is acupuncture as practiced by a physician, which is much different than acupuncture as practiced by non-physicians in the east, such as in China," he noted. "And I would most definitely recommend that patients in the west deal with a physician that's properly trained and a member of the American Academy of Medical Acupuncture," Sager said.
By Alan Mozes, HealthDay Reporter, October 30, 2006
The bumps (papules) and pimples (pustules) of rosacea, a poorly-understood facial disorder affecting an estimated 14 million Americans, may be the result of an allergy-like reaction to environmental and emotional triggers, according to new study results presented at the National Rosacea Society (NRS) research workshop during the annual meeting of the Society for Investigative Dermatology and reported in Rosacea Review.
"We are very excited about these findings because they may provide the basis for improving the treatment and management of this condition," said Dr. Richard Gallo, chief of the division of dermatology at the University of California-San Diego and lead investigator of the NRS-funded study. "By defining the process leading to the inflammation, new medications might be developed to block these effects."
Dr. Gallo explained that when the normal immune system is faced with any of a broad range of potential dangers—such as sun exposure, emotional stress, heat and spicy foods, among many others—receptors recognize potential threats and protect the body by prompting the production of protective substances that isolate and neutralize any harmful effects. With rosacea, however, these protective substances turn the body on itself like overzealous guards, leading to inflammation.
Using advanced mass spectrometry technology to analyze the biochemical composition of proteins in rosacea patients, the researchers discovered an abnormality in the production of protective molecules known as cathelicidins, Dr. Gallo said. In normal patients, the cathelicidins are found in a form that is inactive and would not lead to bumps and pimples. In rosacea patients, the forms of cathelicidins are different and lead to skin inflammation. The cause of this abnormality in cathelicidins seems to be due to an equally important problem in rosacea—an overabundance of yet another substance, called kallikrein, which can spur dormant cathelicidins into action.
"It appears that the combination of these two substances at abnormally high levels is a double whammy for rosacea patients," Dr. Gallo noted.
The researchers recently completed the picture when they were able to demonstrate that this process is linked to the actual formation of rosacea signs and symptoms. The skin of mice injected with the cathelicidins found in rosacea patients showed a dramatic inflammatory response—including bumps and pimples—while mice injected with normal cathelicidins showed no inflammation, either visually or under a microscope.
"The next step is to test these findings in human subjects through various therapeutic interventions," Dr. Gallo said. "As we gain a thorough understanding in humans, we can look for new medications that block this process in order to treat or prevent the inflammation associated with rosacea."
Rosacea is a chronic disorder that primarily affects the cheeks, nose, chin or forehead, and is often characterized by flare-ups and remissions. It typically begins as a flushing or redness that comes and goes, and visible blood vessels may also appear. Inflammatory bumps and pimples often develop, and in severe cases, the nose may become swollen and enlarged from excess tissue.
In addition to long-term medical therapy to bring the condition under control and maintain remission, patients are advised to keep a diary to identify and avoid lifestyle and environmental factors that may affect their individual cases. Some of the most common rosacea triggers include sun exposure, emotional stress, hot or cold weather, wind, heavy exercise, alcohol, hot baths and spicy foods.
A new combination treatment offers hope to people who have the blistering, potentially fatal skin disease known as pemphigus vulgaris.
By combining the cancer-fighting drug rituximab with intravenous immune globulin, Harvard doctors have discovered a therapy that can effectively treat people with cases of pemphigus vulgaris that haven't responded to other treatments.
"We got a home run with this combination," said study co-author Dr. Marshall Posner, medical director of the head and neck oncology program at the Dana-Farber Cancer Institute and Harvard Medical School.
"These patients were extremely ill and on multiple medications," he said. "This therapy resulted in complete eradication of the disease for nine patients." The remaining two patients in the study required additional doses of the treatment before they, too, went into remission. All of those involved in the study had sustained remissions, some as long as 37 months, by the end of the study.
Results of the study are published in the Oct. 26 issue of the New England Journal of Medicine.
Pemphigus vulgaris is a rare autoimmune disease that causes the skin cells to stop adhering to one another. Blisters and lesions form, usually beginning in the mouth and then spreading to the skin.
"Before the discovery of corticosteroids, it was fatal within five years. People lost the surface of their skin, and died horrible deaths," explained Dr. John Stanley, chairman of the department of dermatology at the University of Pennsylvania School of Medicine. "This is an instructive disease about the power of the immune system. While it's usually used for good, it can actually destroy you."
Stanley co-authored a review article in the same issue of the journal about pemphigus and other dermatological diseases.
Currently, the first line of treatment for this devastating skin condition is prednisone, a corticosteroid. While it's often an effective treatment, it has numerous side effects that can be serious, so people generally can't stay on high doses for a long time. Other medications used are immune-suppressing agents that also carry the risk of serious side effects, such as infection.
Posner said most deaths from pemphigus occur as a result of immune-system suppression. But without suppressing the immune system, people with pemphigus would continue to develop blisters and erosions in their skin, giving bacteria an easy entry into the body.
Another treatment option is intravenous immune globulin. This option is usually reserved for those who don't respond to the other treatment options. Stanley said scientists aren't sure how this therapy works, but it may be that it replaces the immune-system antibodies that are attacking the skin cells with healthy antibodies.
For most people, these treatments options have proved lifesaving, and people with the disease often do well, said Stanley.
However, there are people who don't respond to any of the currently available treatments. And, the 11 people treated in the new Harvard study fell into that category. None of the available treatments had worked for them, and the disease was covering more than 30 percent of their body's surface area.
Each study volunteer received two cycles of rituximab weekly for three weeks. During the fourth week, they received a dose of intravenous immune globulin. Then, they received monthly infusions of both rituximab and IV immune globulin for four months.
During the initial treatment, nine of the 11 study participants went into remission for an average of 32 months. The remaining two required additional treatments about six months after treatment, but subsequently went back into remission.
While previous research on rituximab has sometimes found serious side effects, such as allergic reaction, Posner said there were virtually no side effects seen in this trial.
He said he thinks this drug combination would likely be helpful in less severe cases of pemphigus vulgaris, and he added that it could potentially be useful for treating other autoimmune diseases, such as rheumatoid arthritis, systemic lupus and type 1 diabetes.
"This therapy offers hope for this disease, and it could lead the way to treatment for other diseases that have a big impact on people's lives -- it needs to be investigated in other diseases so we can see how it works in other situations," Posner said.
Stanley said he doubted that rituximab would become a first-line treatment for pemphigus vulgaris anytime soon because the medication is quite costly and insurance companies would likely balk at paying for an expensive drug that isn't FDA approved specifically for treating pemphigus. The problem, he added, is that because pemphigus is so rare, it would be difficult to conduct a large enough trial to get such approval.
But, Posner suggested that while the rituximab/immune globulin combination treatment is more expensive initially, a cost analysis comparing all of the costs, including hospitalizations, might find the combination treatment is the cheaper alternative in the long run.
By Serena Gordon, HealthDay Reporter, October 26, 2006
By: Heather Woolery-Lloyd, MD
Discover the unique skin care challenges of various ethnic skin types and about some treatment options.