|
IN THE NEWS
Highlights
In
the News:
• June 8.
Sunscreen Regulations Update. FDA announced that it will extend implementation of
comprehensive, final sunscreen monograph until Dec. 31, 2002. FDA Press Release.
The previous, May 21, 1999 monograph is also available here in Text or PDF.
• May 18.
FDA Approves New drug, Mylotarg for the Treatment of CD33 Positive Acute Myeloid
Leukemia. FDA
Talk Paper.
• May 9. Genentech
Warns of Serious Adverse Events with Herceptin (trastuzumab). MedWatch Version of Genentech
Letter.
• May 1.
GlaxoWellcome Makes Important Labeling Changes to Agenerase Oral Solution.
Medwatch Version
of GlaxoWellcome Letter.
DRUGS
IN THE NEWS
Many of the following abstracts result from inquiries we have
received from clients and health professionals worldwide.
May 15, 2000
Potion of Herbs Slows Prostate Cancer - an old Chinese herbal remedy (now named PC-SPES)
consisting of 8 different herbs, produced an 80% decrease in the blood level of
prostate-specific antigen (PSA). {The level of PSA is believed to indicate the extent of
spread of prostatic malignant cells}. Many clinicians believe that over a 50% decrease in
PSA is associated with prolongation of life in men with prostate cancer. Side effects are
similar to what would be expected from estrogen therapy and consist of lowered libido,
breast tenderness and enlargement, occasional blood clots in the leg. - The Wall Street
Journal
NOTE: This medication is
available without a prescription in the USA and is sold by BotanicLab, Brea, California
May 15, 2000
Concerta for Attention Deficit Disorder - Concerta, a new drug for ADD, when given once
daily appears to be as effective as methylphenidate (Ritalin) given every 4 hours or 3
times a day. This drug is under current review by the FDA for approval. - The Wall Street
Journal
May 11, 2000
Ontak (Denileukin difitox) is effective in treating severe psoriasis. Ontak, which is
approved for use as an antineoplastic agent in the treatment of cutaneous t-cell lymphoma,
has been found to be useful in treating severe psoriasis, an often debilitating skin
disease. Investigators at the University of Washington have found that Ontak given for 3
days every other week resulted in a 50% improvement in the severity of their lesions in
8/35 patients. -Ligand Pharmaceuticals Press Release - Yahoo Finance
May 10, 2000
Clinical Trials of Remune, an immune system stimulant, as a component of combination
therapy for treatment of HIV (AIDS) has begun. Based on preliminary data suggesting the
combination of stimulation of the immune response system together with AIDS drugs can
result in greater suppression of the HIV virus, a larger study has been initiated to
determine in Remune can delay the onset of virologic relapse. Immune Response corporation
Press Release - Yahoo Finance
May 8, 2000
Drugs to dissolve blood clots which are producing a heart attacks and strokes are now a
standard of therapy. Recent data showed that 20.1% of patients over 75 years of age died
during their hospital stay compared with 16.5% of those who did not receive drug therapy.
Researchers have estimated that there is a 30% increased risk of death in patients over
the age of 80 who are given these drugs compared with no drug. - The Wall Street Journal
May 5, 2000
Deaths due to Herceptin - Herceptin is used to treat a specific form of breast cancer and
produces a significant remission in 25% of women who are HER2 receptor-positive. There
have been 15 reported deaths due to Herceptin with those due to allergic shock and
respiratory distress. Nine of the 15 deaths occurred within the first 24 hours of
treatment. Approximately 23,000 women have received this drug. - InteliHealth
May 3, 2000
Rwanda says half a million people infected with AIDS - of 6% of the population of Rwanda
is now infected with AIDS. Women 25-29 years of age have the highest incidence of
infection at 21.5% compared with 13.9% of all men. Approximately 70% of the beds in
Kigali's main hospital are occupied by sick or dying AIDS patients.
April 29, 2000
Cancer Pain is Underestimated in Minority Patients - Clinicians from the M.D. Anderson
Hospital in Houston reported that 28% of Hispanics and 31% of African Americans received
analgesics of insufficient strength to manage their cancer pain. Physicians underestimated
pain severity by 64% in Hispanics and 74% of African-Americans. InteliHealth Cancer
88:1929 (2000)
April 10, 2000
Uninsured Elderly Found to Pay Higher Drug Prices than HMO's - HMO's and other
prescription programs for retirees have been found to pay 15% less for their drugs than
the uninsured elderly. This, together with an increase in the uninsured elderly from 8% in
1996 to 15% in 1998 demonstrate that that age group is being impacted more severely by the
continued increase in prescription drug prices. The Wall Street Journal -
NOTE: Lets hope that
Congress finally acts to address this increasing problem this year and that the addition
of prescription drug benefits to Medicare is not election year pandering to we voters
April 5, 2000
New Technique Could Help in Cancer Fight - Antisense technology uses a technique of
producing a mirror image of a strand of RNA. This mirror image attaches to the RNA and
prevents the production of specific proteins, necessary for growth of the malignant cell.
This approach is showing promise in the treatment of advanced stage melanoma. Using this
technique, a group of 16 patients at the University of Vienna survived for >9 months
with the expected survival of 4-6 months. Durham Herald-Sun
March 24, 2000
Drug Resistant Tuberculosis is Rising in Areas Once Deemed Under Control - The WHO
recently reported that the percentage of tuberculosis patients resistant to conventional
therapy rose by 50% in Denmark and Germany while it doubled in New Zealand. There are now
11 countries where in specific areas the incidence of resistance is over 255 with the
highest being in Estonia where multiple drug resistance is over 40%. -Wall Street Journal-
March 21, 2000
New Technique May be of Value in Heart Pain due to Insufficiency of Cardiac Blood Flow - a
new form of therapy which stimulates the production of new blood vessels around the heart
has proven effective in early trials. This technique involves the direct application of
the substance called fibroblast growth factor -4 into the coronary arteries via a catheter
inserted in the leg and threaded to the heart (a common procedure in cardiac
catheterization). In an early study there was a 30% improvement in the amount of time
patients could walk on a treadmill before experiencing pain. -The Wall Street Journal -
March 16, 2000
Women who use birth control pills have a reduced risk of ovarian cancer and scientists
have assumed that this is due to the prevention of ovulation and the hormonal changes
which accompany that effect. Now, three studies suggest the relationship is more
complicated than previously thought.
March 15, 2000
"Enbrel Follow-up Study in Chronic Heart Failure" - Enbrel, which inhibits Tumor
Necrosis Factor is now being studied for its ability to improve the symptoms of congestive
heart failure (CHF). A study from Baylor reported that patients with CHF on Enbrel showed
sustained improvement in their CHF symptoms compared with another group given placebo
injections. When Enbrel was discontinued, the group showing improvement regressed to their
original baseline status. Press Release- Immunex
March 15, 2000
"Heart Drug Linked to Impotence" - Researchers at the University of Wales, UK
reported that there was a link between men taking the "statin" drugs (Zocor,
Lipitor etc.) and the development of impotence. Normal sexual activity was restored to
approximately 1/2 of the men complaining of impotence following discontinuation of the
statin drug. - New Scientist
March 14, 2000
Nigeria has an estimated 2.6 million adults who are now HIV positive.
March 14, 2000
"Drug Resistant Tuberculosis Strains are Found at High Levels in Mexico" - Two
new reports found more than 28% of newly diagnosed cases of tuberculosis in Orizaba were
resistant to either were resistant to both drugs. A second study which was based in Baja
found 3-50% of cases were resistant to one of the two drugs and 2-22% were resistant to
both.. Adding the drug ethambutol to therapy reduces the incidence of resistance BUT
increases the cost/patient by 30% annually, a potentially unrealistic increase for
developing countries where multi-drug resistant TB is prevalent. -The Wall Street Journal
March 10, 2000
"Drug May Remove Women's Facial Hair" - A new topically applied drug, Vaniqa
which is currently under FDA review appears to be valuable in removing excess facial hair
from women. A 24-week study resulted in 70% of women who used the topical drug showing
marked improvement with the area where Vaniqua had been applied becoming almost clear of
an new hair growth. Associated Press
March 10, 2000
"A Common Side Effect, Dry Mouth, Can Cause Serious Tooth Decay" - There are a
number of drugs which have dry mouth as a common side effect and may predispose to an
increase in tooth decay. Among these are: the antidepressants Prozac and Paxil, Xanax
(alprozolam), the antihypertensives Lopressor and Vasotec, and Zyban (antismoking) and its
sister Wellbutrin, and antihistamines such as diphenhydramine (Benadryl) and
chlorpheniramine (Chlor-trimeton). Thus, a dry mouth, particularly in the elderly is a
symptom which needs to be addressed and not ignored. If caused by medication, an alternate
drug should be considered. - The Wall Street Journal
March 7, 2000
"Industry Said Decade From HIV Vaccine" - US Pharmaceutical company Merck which
has begun testing an HIV vaccine believes that no vaccine to prevent AIDS will be
available before 2010. The reason for the difficulty in making a vaccine is the large
number of variants of the HIV virus and the ability of the virus to mutate over time.
Merck has predicted that the current vaccine under study will fail. - Yahoo News - Reuters
March 7, 2000
HIV in Russia - Registered HIV cases in Russia are rising steeply. There are now more than
30,000 cases with 50% of them contracting AIDS in the last year. For more information
March 6, 2000
"Asthma Drug May Eventually Set Standard" - An new drug for asthma which is an
antibody against IgE appears to offer a new an promising modality for the prevention of
asthmatic attacks. An increase in IgE is one of the components of an inflammatory response
which will ultimately produce bronchoconstriction. In over 500 adults with asthma, 40%
stopped taking steroids with no loss of control of their asthma. This new drug, being
developed by Genentech and Novartis appears to be as or more effective than inhaled
steroids. - The Wall Street Journal
March 2, 2000
"Gene Therapy Research Pays Off" - The use of gene therapy is just beginning to
show promise in opening new approaches to difficult to treat diseases. One of the most
promising diseases being investigated is hemophilia B, where patients with that condition
lack the clotting protein, Factor IX. In an initial study to ascertain safety only,
researchers from the University of Pennsylvania injected a virus containing the gene that
instructs cells to produce factor IX into three boys with hemophilia. Two of the three
began producing Factor IX within eight weeks and continue to do so. That has reduced their
need for supplemental infusions of Factor IX by 80%. - The Herald-Sun, Durham
March 21, 2000 Tourists
Eyed in Tobago AIDS Spread - the twin-nation islands of Trinidad and Tobago have a 20%
increase in AIDS cases with 1200 new cases reported in Jan-Oct. 1999. The increasing
incidence is proposed to come from the numerous parties associated with the tourist
season.
| 
