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Aldara “Approvable” for Basal
Cell Carcinoma
3M Pharmaceuticals has received an “approvable” letter
from the FDA for its patient- applied cream, Aldara, for the treatment
of superficial basal cell carcinoma; this announcement comes shortly
after the regulatory body approved Aldara for actinic keratosis (AK).
The new medication is an immune response modifier, the first of this
drug class to be approved for AK. The earlier approval was based
on research revealing that nearly half of all patients treated with
Aldara experienced complete lesion clearance, with still more experiencing
lesion clearance of 75% or better.
www.3m.com/profile/pressbox/2004_index.jhtml
Alefacept Leads to Treatment Free Periods
for Psoriasis
A recent study has found that treatment
with the biologic therapy Alefacept “offers an effective and safe opportunity for 'treatment
free' periods for patients suffering from chronic plaque psoriasis.” These
periods of remission may last up to seven months, the authors noted.
These findings are especially relevant in light of a second study,
published in the Journal of Investigative Dermatology, which found
that even a very small amount of psoriasis can negatively impact
daily life; if Alefacept can eliminate the need for treatment, even
for a brief period of time, it could be tremendously beneficial for
psoriasis sufferers.
www.docguide.com
Canvaxin Improves Survival in Stage II Melanoma
At the recent Annual Meeting of the American
Association for Cancer Research, a team of investigators headed by
Mark B. Fairies, MD,
announced study results suggesting that a polyvalent vaccine that
covers most human leukocyte antigen types can help improve survival
among patients with stage II melanoma. The medication in question,
CancerVax Corporation’s Canvaxin, was initially tested in an
11,000-participant prospective trial; the present results were obtained
by studying a subset of this population.
www.docguide.com
Enbrel Approved to Treat Psoriasis
Amgen Inc.’s arthritis drug Enbrel can now be used for the
treatment of a fifth disease, following a late April approval from
the FDA for the treatment of adult patients with chronic moderate
to severe plaque psoriasis who are candidates for systemic therapy
or phototherapy. “Both physicians and patients have expressed
a desire for new options to treat psoriasis,” said Vice President
and General Manager of Amgen’s Inflammation Business Unit Laura
Hamill. “Enbrel rapidly cleared psoriasis in many patients
and was generally well tolerated in two large clinical trials.”
www.amgen.com/news/viewPR.jsp?id=521767
FDA Announces Measures to Improve Generic Drug Access
In early March, FDA commissioner Mark
McClellan, MD, announced a series of measures designed to “spur the development and availability
of generic drugs.” The FDA will provide additional information
helping generic manufacturers determine whether they are eligible
for the 180-day period of exclusivity usually granted the first generic
form of a patented drug (by posting the date of the first generic
application). Moreover, the agency will step up efforts to implement
reforms required by the Hatch-Waxman portion of the Medicare Modernization
Act of 2003.
www.fda.gov/bbs/topics/NEWS/2004/NEW01030.html
FDA Considers Additional Accutane Restrictions
Scientific advisors to the FDA are currently
considering whether additional restrictions should be established
to determine patient
eligibility to receive the antiacne drug Accutane. Accutane substantially
increases the risk of birth defects when taken by pregnant women;
the current system, under which women are asked to voluntarily refrain
from using the drug if they are or plan to become pregnant, has proven
largely ineffective in reducing misuse of the drug. The proposed
restrictions would “allow the drug's use and distribution only
by patients, doctors and pharmacists who are tracked on a national
registry.”
www.intelihealth.com/IH/ihtIH/WSIHW000/333/7228/376535.html
New Report Tells How to Avoid Swimmer’s
Itch
Thanks to a new report appearing in
the American Journal of Public Health, an explanation can now be
given to those patients who have
intense itching of unknown origin, and who have spent time swimming
in lakes. Not much can be done, however, to relieve the suffering
of those with “swimmer’s itch,” a condition formally
known as cercarial dermatitis that tends to last about a week. The
itching results from flatworm larvae that leave snails in search
of a more lasting host—ducks—and instead end up on
humans. Patients should be advised to stay out of shallow water
and be wary
of onshore winds.
www.nytimes.com/2004/05/18/health/18HAZA.html
Pediatric Burn Survivors Benefit from Low-Dose Growth Hormone Therapy
Researchers from the Shriners Hospital for Children and the University
of Texas Medical Branch in Galveston have found that children who
survive severe burn injuries may benefit from the administration
of low-dose growth hormone (GH). The study that led to this conclusion,
which enrolled 154 children with burns covering at least 40% of the
body, found that the use of GH at 0.05 mg/kg/day improves lean muscle
mass and metabolic state in this patient population. Doubling the
dose yielded no additional benefit.
www.medscape.com/viewarticle/470470
President of AAD Addresses Feared Antibiotic–Breast
Cancer Link
Dermatologists nationwide were understandably
concerned in mid-February, when a report in the Journal of the
American Medical Association
found evidence of a possible link between long-term antibiotic use
and risk of breast cancer. In response, American Association of Dermatology
(AAD) President Boni E. Elewski, MD, appointed a task force to review
this study and its implications for the practice of dermatology.
On April 12, Dr. Elewski published this letter, addressed to AAD
members, stating that the task force had concluded “that the
[JAMA] study contained many design flaws that need to be addressed,” and
that until they are, “the judicious use of antibiotics is safe
regardless of the patient’s individual risk of breast cancer.” www.aad.org/PresMessage041204.pdf
Well-Supported CPOE Systems Can Greatly Reduce Prescribing Errors
The results of a study designed to “describe the epidemiology
of medication prescribing errors averted by pharmacists and to assess
the likelihood that these errors would be prevented by implementing
computerized prescriber order entry (CPOE),” are published
in the April 12 issue of Archives of Internal Medicine. Highlights
include the finding that of all verified prescribing errors under
consideration during the study, more than 64% would likely have been
prevented through the use of a CPOE system.
archinte.ama-assn.org/cgi/content/abstract/164/7/785
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