Abstracts for 2001

Current Legislation

This bill was passed by both the US House and Senate and signed by the President! HOWEVER - the pharmaceutical industry, which is one of the greatest political contributors to both the House and Senate, was able to substantially alter the bill. The legislation as passed has so much red tape it practically will NOT allow individuals to reimport medicines even if they have been made in the USA by USA companies. The best case is that a large wholesaler in the USA will be able to spend the time and do the voluminous paperwork to be able to reimport and pass on some of those savings to local pharmacies who in turn will pass on to patients.

The FDA says it will take two years to formulate procedures so little relief for USA patients from continued escalating drug costs can be expected in the foreseen future perhaps the 2004 Presidential election will see this issue again brought to the forefront of the politicians and the pharmaceutical industry may not be quite as strong as it is now.

Drugs in the News

Many of the following abstracts result from inquiries we have received from clients and health professionals worldwide.

  • New Drug Campath (Alemtuzumab) Berlex Campath is a new injectable drug indicated for the treatment of refractory B-cell chronic lymphocytic leukemia (B-CLL). It targets the CD52 receptor on the B-lymphocyte (as well as B-lymphocytes and certain other cells). The union of receptor and antibody results in cell lysis and destruction. It can produce objective responses in approximately 30% of treated patients who have become resistant to other drugs used for B-CLL. Side effects are significant with infusion related events occurring in 6% of patients, rigors in 86%, hypotension in 32%, nausea (54%), and depression of white (85%) and red blood cells (80%).
  • Sept. 7 Memantine looks promising for moderate to severe AD (Alzheimers Disease) Memantine, is a promising new drug for Alzheimer¹s disease. It is the first NMDA receptor agonist used to treat Alzheimer¹s. Memantine is believed to stimulate the receptor involved with the thought process. Studies both in Europe and the U.S. show a response rate of 73% compared with a 45% response rate with a placebo. The response rate was divided between those who tolerated memantine well (35%) and those classified as "very well" (60%). Side effects were minimal. Approval in the USA is expected in 2003. It is available throughout Europe. Brown Univ. Geriatric Psychopharm, Update 5:1 (2001).
  • Sept. 7 - L-Propionyl carnitine in chronic limb ischemia (lack of blood supply) to arms and legs is a complication of extensive atherosclerosis. This condition not only is very painful but in its most severe form can lead to permanent damage and necrosis.

    L-Propionyl carnitine (LPC) was compared to pentoxifylline (PTF) (the current standard available in the USA). Results with LPC were significantly better than with PTF with 78% able to increase pain-free walking distance compared with 30% in the PTF group. A decrease in pain and size of ulcers from the ischema also improved significantly. Clin. Drug invest. 21:555 (2001).
  • Sept. 28 Bupropion (Wellbutrin) may be of value in promoting weight loss a recent study compared bupropion 200 mg twice daily to placebo in a group of non-depressed obese women. Those treated with bupropion lost an average of 4.9% of their body weight in the first 8 weeks of therapy compared with 1.3% on placebo. After 24 weeks of treatment the average weight loss was 12.9%. Obes. Res. 9:544 (2001).
  • Oct. 4 Use of MMR (Measles, Mumps and Rubella) vaccine not associated with autism and inflammatory bowel disease (IBD) despite a few studies suggesting that MMR could increase the chance of a child developing autism or IBD an extensive review of the literature did not show any association with either of the above conditions. Arch Dis. Child. 85: 274 (2001)
  • Oct. 4 Over-the-counter sleep preparations containing diphenhydramine (Benadryl) may increase confusion in elderly A study of a group of hospitalized patients <70 found that the administration of diphenhydramine at bedtime for sleep was associated with an increased incidence of delirium, inattention, disorganized speech and urinary retention. Arch Int. med. 161:2091 (2001).
  • Oct. 4 Inhaled steroids for asthma decreases bone density in females Inhaled steroids are among the most frequently prescribed drugs for asthma. They reduce the inflammation characteristic of asthma and bronchospasm. A recent study found that the number of inhalations/day was correlated with a decrease in bone density and a two-fold increase in the risk of hip fractures. This study suggested that a major effort should be made to reduce the dose of inhaled steroids especially in women past menopause. Adequate dietary intake of calcium and Vitamin D in those women is especially important.
  • Oct. 18 New drug being studied for effect in irritable bowel syndrome (IBS) Dexloxiglumide is a selective cholecystokinin receptor antagonist which has been found to be moderately effective in IBD. In a study in mainly female patients with, ofconstipation-predominent IBS the response rate dexloxiglumide was significantly better than a placebo there was (40% vs. 22%).
  • Oct. 29 Falciparium malaria in Africa becoming resistant to current drug therapy the most common therapy for malaria is the use of a combination of pyrimethamine and sulfadoxine (P-S). A recent study reported that 65% of children who were apparently "cured" (absence of parasites from the blood) one month later had developed clinical disease. Retreatment with the same combination resulted in only 30% showing disappearance of the parasite in the blood. The new drug combination of chlorproguanil-dapasone will replace P-S and will hopefully provide better results until resistance also appears to those drugs. Lancet 358:1218 (2001).
  • Oct. 29 The recreational use of "Ectasy" may permanently affect memory- "Ectasy" also known as MDMA has been found to produce long-lasting impairment of memory as measured by word recall testing. Although other effects of "Ectasy" appear to disappear with time the memory loss effect seems to be permanent. Arch. Gen. Psychiatry 58:901 (2001).
  • Oct. 29 New drug may prevent peripheral neuropathy in diabetics ­ A recent study compared the drug fidarestat to placebo in a group of patients with both type 1 and 2 diabetes. In this small study over 60% of patients in the fidarestat group showed improvement in nerve function and in the remainder there was no further deterioration. In contrast, non of the patients in the placebo group improved. Diabetes Care 24:1776 (2001).
  • Oct 29 Alimta (Pemetrexed) shows promised in malignant mesothelioma (MM) MM although a rare tumor is associated with previous exposure to asbestos. As of today there is no treatment which has produced remission or which can affect the dismal prognosis for this diagnosis. A drug now in early studies, Alimta, has resulted in a 45% response rate. If these early data hold up in additional studies this could be the first drug which can provide at least some positive effects in this now drug resistant malignancy. Medscape News 0ct. 25, 2001
  • Oct 29 Triple therapy for AIDS in children results in decrease in bone density A group of children ages 6-17 who were receiving highly active antiretroviral therapy (HAART) showed a significantly lower spinal bone density than a group of control children and a group of children with HIV who had not been treated. The long-term effects on the development of osteoporosis has not been studied. AIDS 15:1823, 2001.
  • Oct. 29 Estrogen replacement therapy (HRT) does not prevent age-related decrease in cognition Despite the advantages to the use of estrogens in preventing the symptoms of menopause and osteoporosis, there does not appear to be any preventive effect on the age-related decline in cognitive functioning. Am. J. Epidemiol. 154:733 (2001). There are obviously side effects, some severe, with unopposed estrogen therapy ed.
  • Oct. 31 New form of Paclitaxel may prove tumors unresponsive to conventional therapy a new form of paclitaxel when combined with a polyglutamate polymer appears to have substantial activity in useful in resistant ovarian and peritoneal tumors with 4/9 patients showing either a partial response or tumor stabilization (no progression). Side effects were minimal. Cell Therapeutics Press Release
  • New Indication - Xeloda, a drug active in the treatment of metastatic cancer of the breast has been approved for the treatment of metastatic cancer of the colon and rectum. In recent studies it was found to be more effective than the current standard treatment regimen of flurouracil and leukovorin. Xeloda can be given orally while florouracil requires intravenous therapy.
  • May 8 - Spending on prescription drugs soars - Spending on prescription drugs increased by 18.8% in 2000 compared with 1999. The reason for the increase is that more prescriptions were written for more expensive drugs. Spending on drugs has risen by 40% in just three years with no end in sight. Of interest is the observation that price increases on existing drugs represented 22% of the increase in drug costs. Antidepressants were the most commonly prescribed drug class. The Herald-Sun, Durham p. A2. Ed. Price increases on existing drugs typically will range from 4% yearly to as high as 50% - the higher increases are usually drugs which are prescribed less frequently and those for which no other substitutes exist.
  • May 11 - Vitamins may help to prevent maturity onset diabetes - a recent study found that the use of regular vitamin supplementation was associated with a reduced risk of diabetes with 21% of those who took vitamins regularly developing diabetes compared with 34% of those who took no vitamins or took them on an irregular basis. Am. J. Epidemiol. 153:892, 2001.
  • May 14 - Drug Advances Bring New Hope to Cancer Battle - Two new anticancer drugs are demonstrating sometimes dramatic results against cancers which are poorly responsive to current anticancer agents. One of these is C225 (Imclone Systems) which has been reported in patients with cancer of the colon to reduce tumor size by over 50% in at least 25% of treated patients. The other potential significant addition to the anticancer regimen is Iressa (Astra-Zeneca). Iressa demonstrated dramatic results in a group of patients with resistant lung cancer. Both of these drugs target epithelial growth factor, a stimulant to epithelial cell growth - many cancers including lung and colon cancers are epithelial cell in origin. Despite their dramatic results they are not likely to be generally available until late 2002. The Wall Street Journal p. B1
  • May 14 - Failed heart treatment shows promise with prostate cancer - The experimental drug atrasentan (Abbott Labs), has been found to slow the growth of prostatic cancer in those men who have failed on currently available drugs. The onset of symptoms of progressive disease, particularly bone pain, was delayed by 38%. The main side effect is a stuffy nose. The mechanism of action appears to be blockade of the effects of endothelin, which seems to be a factor in the metastasis of prostate cancer to other sites in the body, The Wall Street Journal p. B1
  • June 6 - Spending on prescription drugs will double in 5 years - By 2006 the amount spent on medications will double with the greatest increase coming in two groups of drugs - cardiovascular medications including cholesterol lowering agents and central nervous system drugs which include those used to treat depression, pain and neurological diseases. The greatest increase in drug use will be in the age group 40-55 - the baby boomers. For those over 65 the average cost of medication in the year 200 was $1400/year. The increase in drug cost is not only fueled by more demand but also from the fact that each new agent is from 5-10 times more expensive than the drug that it replaces. Yahoo Finance
  • June 13 - Old drug effective in preventing Lyme disease - a
    recent study has shown that just 2 capsules of doxycycline taken after exposure to ticks infected with the Lyme disease pathogen reduce the chances of contracting the disease from 3% to 0.4%. The authors stressed that because the chances of contacting the disease is so low that administration of an antibiotic should not be given with every tick bite but that treatment be reserved for those who developed a rash following a tick bite. Herald-Sun, Durham p. A10
  • June 13 - Drug costs for the elderly rising twice as fast than other living costs - The average price of the top 50 medications most often prescribed for the elderly increased 6.1% in 2000 compared with a 3.4% increase in the general cost of living. The greatest increase was for the drug Premarin, taken by postmenopausal women to prevent osteoporosis. The wholesale price of Premarin which is marketed by Wyeth-Ayerst increased by 5 times the rate of inflation (over 15%)! The Wall Street Journal p. B10
  • Ed. - Estradiol, which can be purchased as a generic drug has the same effects as premarin and is five fold less expensive if 100 tablets are purchased at a time!
  • June 15 - Substandard medicines common in developing countries - recent reports found that almost 50% of drugs sampled from pharmacies in Nigeria and Southeast Asia contained either too much or too little drug compared with the labeled amount. Importantly, 38% of antimalarial drugs sampled contained NONE of the labeled amount. In the case of Nigeria, the drugs were made in 12 different countries. There was no pattern as to the origin of the substandard drugs as just as many came from developed countries as from developing ones. The Herald-Sun, Durham p. A-12
  • Increase in drug costs exceeds inflation - Families USA recently published data which reported that the cost of the 50 most prescribed drugs for the elderly increased by 6.1% in 1990 compared with the inflation rate of 2.7%. Thus, the costs of drugs ALREADY ON THE MARKET increased by over 200% more than the cost of other goods and services received by those over 65. The biggest increase was in Synthroid at 22.6% followed by Glucophage (which will go generic in next year) at 12.8%. These are usually products which have been on the market for years and for which all the research to enable the drug to pass the FDA were conducted years (sometimes >10 years) ago. In a separate report the same group reported that the pharmaceutical industry spent twice as much on advertising and promoting their drugs as they did on research.
  • 6/19 - Ginsing Not Found To Have Psychological Benefit - Ginsing is a herbal product often claimed to enhance the feeling of "well-being". A study was conducted on 83 young healthy men and women with no problems comparing ginsing with a sugar placebo copy. In the 8 week study no difference in variables of mood were found between the ginsing and the placebo. This study was conducted on normal, healthy individuals. A similar study needs to be conducted on an older population as well as one with some degree of depression - ed
  • 6/19 - Change in HIV Drug Therapy Recommendations Designed to Reduce Problems with Patient Compliance (Adherance) - One of the major problems in the treatment of AIDS is the inability of many patients to adhere to strict regimens frequently using more than three drugs at varying dosage schedules. These strict regimens must be adhered to for years on end. As a patient takes these drugs they frequently begin to skip doses which can lead to the emergence of resistant strains. In order to reduce the time that a person will be on these drugs the CDC recently revised their guidelines on when therapy for AIDS should be begun. This marks a radical departure from previous guidelines that had a person started on triple therapy as soon as HIV positivity was detected. The new guidelines urge treatment not be started until there is clear evidence that the disease had progressed to the point where the manifestations of clinical AIDS would be expected to occur in the immediate future. - The AIDS Reader 11:177 (2001).
  • 7/17 - Melatonin helps sleep quality older adults - Melatonin is a natural substance produced in the brain which appears to be related to the normal sleep cycle. Its release appears to be related to the onset of darkness. It is believed to syncronize sleep with darkness. A recent study compared melatonin to placebo in maintaining sleep in a group of older diabetic patients. The time awake decreased from 63 to 31 minutes in those taking melatonin. In another study melatonin was found to be able to reduce the dose requirement for other prescription drugs used to treat insomnia. Melatonin has also been suggested to be of value in reducing the effects of jet lag by helping a traveler crossing many time zones to rapidly adjust to normal sleep patterns in the new time zone. - ed.
  • 7/17 - Thalidomide effectiveness for multiple myeloma persists - Investigators recently reported that the use of thalidomid resulted in a 2-year survival rate of 48%. This survival rate was seen despite the fact that many of those patients had become refractory to other therapies. However, the more the disease had progressed before treatment was initiated the less likely the response. Significant toxicity was experienced by over 55% of treated patients. Blood 98:492, 2001.
  • 7/5 - Parents overtreat fever in their children - a recent survey of 340 parents found that over 90% worry when their child had a fever and approximately 35% believed that a fever > >100oF could seriously harm their child. As might be expected there was a tendency for sometimes overly aggressive treatment of the fever with fever taking on the aspects of the disease itself rather than a symptom of an infectious process. Pediatrics: June 2001

    Ed. - Fever results in a more rapid mobilization of the body's natural defenses and in most cases is a good thing not a bad one to be treated. To be sure, fevers >105o can result in seizures and brain damage but agreeively treating relatively mild fevers (<101o F) may produce more harm than good.
  • 7/24 - The effect of Hydroxyurea on Sickle Cell Anemia - A recent report in Blood found that there was a significant reduction of the need for hospitalization among sickle cell patient receiving hydroxyurea compared with their pre-drug experience. Over 50% of the patients experienced no exacerbations of their disease over the 5-year duration of the study. Blood: 97:3628, 2001
  • 7/30 - The effect of omega-3 polyunsaturated fatty acids(OM3A's) on mental health - one of the possible uses of OM3A's has been proposed to have a beneficial effect on depression and other mental disorders. The brain is composed of a relatively high concentration of unsaturated fatty acids and since brain cannot synthesize all of the needed ones, they must come from dietary sources. Supplementation of a regular diet with fish oil which contains a high concentration of OM3A's has been proposed to be useful in the treatment of a large number of psychiatric disorders. There have been only a few controlled studies evaluating the effect of supplemental OM3A's. In one of those studying bipolar disorder, significantly more patients receiving the supplementation improved compared with those receiving placebo. Smaller studies have purported that OM3A supplementation also improved control of schitzophrenia, attention-deficit hyperactivity disorder (ADHD) and senile dementia has been reported to respond to OM3A's supplementation. Drug Benefit Trends 13:2bh, 2001.
  • 8/13 - FDA Panel backs Tracleer - Tracleer is a new drug indicated for the management of pulmonary hypertension. Currently the only drug approved to treat this difficult to treat disease is Flolan. Flolan requires the patient to carry with them a intravenous pump which constantly infuses a drug to reduce pulmonary blood pressure on a 24-hour basis. The Wall street Journal Monday August 13, p. B2
  • 8/14 - Drugs show promise for Mad Cow disease - Mad Cow disease in humans is called Creutzfeldt-Jakob disease. Currently there is no drug treatment approved for this fatal disease. Two drugs currently on the market have shown promise in animal models are quinacrine, an antimalarial and chlorpromazine, an antipsychotic. Both of these two drugs appear to stop the reproduction of the prions which are characteristic of this disease. The Wall Street Journal Tuesday August 14 - p. B11
  • NATRECOR (Nesiritide) - Scios - this new injectable drug is indicated for the treatment of acute congestive heart failure. It is the first of a class of drugs called B-type naturetic peptides. It acts by producing both venous and arteriolar (small arteries) dilation. This results in a pooling of blood in distal vessels and reduces the amount of blood which is circulating. This in turn lessens the amount of blood flowing to the heart and reduces the amount of blood the heart has to pump thus easing the workload on the heart. The major side effect as expected is low blood pressure thus Natrecor should not be used in the presence of a blood pressure <90 mm Hg.
  • Investigational drug for impotence appears safe in presence of hypertension - Uprima (apomorphine) has been under study for over 2 years for its use in male impotence. Because of ongoing concerns about the safety of this class of drugs in the presence of cardiovascular disease, the safety of Uprima was evaluated in a double-blind cross-over design study in a group of hypertensive patients. With a mean age of 60 years, no significant difference was found between cardiovascular side effects between the placebo and apomorphine. The most common side effects were dizziness and nausea occurring in approximately 10% of subjects.
  • Inhaled insulin appears to be as effective as subcutaneous injections. A study from the University of Vermont reported that inhaled insulin appears to be as effective as the injectable. The insulin is delivered to the lung using a device which relies on compressed air to blow the insulin particles into the lung. The success of this treatment has stimulated an even larger Phase III study to further assess both the safety and efficacy of this route of administration.
  • Herbs for depression - a recent review article in Psychiatr. Serv. Reported on the summarized results of a number of studies which evaluated the effectiveness of four herbal preparations, St. John's wort, kava, gingko, and valarian root. The majority of controlled studies with St. John's wort fount it to be as effective as low doses of prescription tricyclic antidepressants and more effective than placebo. The studies with kava were not able to be evaluated while those with gingko suggested improvement in mental alertness and depression . Valarian appeared to be effective in sleep disorders but the absence of large controlled studies made it more difficult to evaluate its effectiveness compared with placebo.
  • St. John's wort found to be as effective as imipramine with fewer side effects A recent study reported that St. John's wort proved to be as effective as a therapeutic dose of imipramine (a tricyclic antidepressant) in the treatment of depression. Importantly, side effects with St. John's wort were almost 40% lower than with imipramine. The authors (from Germany) felt so strongly about their results that they recommended that St. John's wort should be the first antidepressant prescribed in a primary care setting. BMJ 321:536
  • Drug spending increased by 17.4% in 1999 - the increased spending by patients on prescription drugs set a record in 1999. Importantly, the average cost for a prescription rose by 14% for seniors over the age of 70 and 16.4% for those 80 and older. The average spending per person was $387.09 compared with $329.83 in 1998. Although part of the increase was due to the prescribing of newer more expensive medications, the price of older drugs on the market for a number of years also increased significantly. As examples Premarin, for postmenopausal osteoporosis increased 12% in 1999 and Glucophage for maturity onset diabetes increased 14.5%. the Wall Street Journal June 27, 2000.
  • Gene therapy produces exciting results in head and neck cancer - Researchers at M.D. Anderson hospital in Texas reported that when a genetically modified cold virus (ONYX-015) was administered along with standard chemotherapy a reduction in tumor size occurred in 25 of 30 patients. Of those who responded, 19 had a reduction in tumor size of >50%. Side effects from the virus were minimal. ONYX virus is similar to that causing the comon cold except it has been modified not to inactivate p53, a normal cell protein which must be inactivated by the virus for replication in normal cells. Because ONYX virus cannot destroy the p53 in normal cells it cannot replicate. However, 45-70% of head and neck tumors lack p53 thus are susceptible to viral invasion, replication and eventual destruction. Nature Medicine Vol. 6 no. 8
  • Stopping of AIDS drugs may be possible under specific circumstances - in a very small study involving 8 patients who had been taking AIDS drugs for 1-3 years researchers from Massachusetts General Hospital in Boston found that the AIDS drugs could be discontinued for varying period. Five of the 8 remained off the drugs with one patient not taking the drugs for over 11 months. The Associated Press September 28, 2000.
  • Study questions the use of tamoxifen to lower the risk for breast cancer in healthy women- a recent study the Journal Lancet (September 90 questioned the current practice of giving tamoxifen to healthy women who might be predisposed to breast cancer. The study reported that endometrial cancer increased by 50% in women who used any tamoxifen increasing by 100% (2X)for those using tamoxifen for 2-5 years and 700% (7x) for women using tamoxifen for longer than 5 years.
  • Kidney cancer responds to immune therapy - Physicians at the NIH reported that over 50% of patients with inoperable metastatic kidney cancer responded to immune cells donated from another person. In the responders, the metastases either shrank or disappeared. The technique called stem cell transplant, requires the use of drugs to suppress the immune system so that a reaction to the injected immune cells would not occur. ACS News September 15, 2000.
  • A new class of antibiotics may help in the treatment of antibiotic resistant bacteria - Two new antibiotics from a class called ketolides are currently under study for the treatment of a variety of infectious diseases. This new class, structurally related the erythromycin-like macrolides can be given once a day. One of them, Ketek is currently under review by the FDA for approval. Durham Herald-Sun September 21, 2000.
  • AIDS cases increase in China with an estimated 500,000 infected - AIDs is beginning to spread in China with over 18,000 diagnosed with the clinical infection. The rate of increase has been over 40% per year and shows no sign of letting up. InteliHealth September 8, 2000.
  • Thailand AIDS prevalence continues to rise - After a period of relative stability and some decline in the number of new cases of AIDS, recent data suggest that this positive trend is about to be reversed. The prevalence of the virus presence in pregnant women has increased from 1.74% in 1997 to 2.02 % in 1999. There are an estimated 100 new cases every day. Associated Press Sept. 17.
  • Spiriva (Tiotropium) holds promise in the treatment of chronic obstructive pulmonary disease (COPD). A study recently presented at the 10th European Respiratory Society meeting compared Spiriva with ipratropium (available in the USA) and placebo. All three were given by inhalation. Compared with the other two, Spiriva produced a significant reduction in episodes of shortness of breath and hospitalizations for COPD. Although this medication is not yet available anywhere in the world approval by the EU is expected early next year at which time it would be available to patients in the USA if certain regulations regarding the import of prescription drugs are followed. GLOBALRx specializes in that type of import.
  • Glucosamine-chrondrotin (GC) may be effective in relieving the joint pain of osteoarthritis - A recent randomized study compared the GC combination with placebo in the relief of joint pain associated with osteoarthritis. Pain was relieved in 52% of the GC group compared with the placebo group. Osteoarthritis Cartilage 8:343, 2000
  • Thalidomide effective in late stage multiple myeloma - Thalidomide, the sedative implicated in producing multiple congenital abnormalities in the late 1960's has been found to be valuable in the pallative treatment of multiple myeloma. Of 16 patients resistant to other forms of therapy, 4 had a partial response to thalidomide (a 50% reduction in urine m protein) and it stopped disease progression in an additional 6 patients for a median of 5 months. Mayo Clinic Proceedings (Sept. 2000).
  • March 7 - Topical Lidocaine of Possible Value as treatment for migraine Headaches - A placebo-controlled double-blind study evaluated the effect of lidocaine applied directly to the scalp on the area of headache pain. The results showed a significant reduction of pain compared to placebo. Side effects were minimal. Reuters Medical News Both lidocaine jelly 2% and a topical patch of 5% are available in the U.S.A.
  • March 12 - St. Johns Wort (SJW) interacts with many drugs - At a recent meeting, a physician from Canada reported that SJW could reduce the blood levels of a drug metabolized through the liver by 60%. The danger of such a drug interaction occurs under two circumstances 1. If someone is taking a drug affected by SJW and SJW is added to therapy. The blood level of the affected drug will drop, often by 50% thus decreasing its effectiveness. The other problem can occur if a drug affected b SJW is added to therapy and the drug titrated to effectiveness. if the SWJ is then stopped the blood level of the affected drug may increase significantly thus increasing side effects.
  • March 15 - Pulmonary hypertension in newborns linked to use of non-steroidal antiinflammatory drugs (NSAIDS) during pregnancy. A group of researchers from Wayne State Univ. found an association between NSAID (ibuprofen, aspirin, naproxen) in pregnancy and the occurrence of pulmonary hypertension in their newborn children. The mechanism is unclear as is the window where such drugs may cause this potential problem Pediatrics 107:519 (2001).
  • March 15 - Domperidone increases milk production for mothers of low birthweight infants - Domperidone (Motilium) a drug not available in the USA produced a 40-50% increase in milk production in a group of women breast feeding premature infants. A placebo produced a 15-205 increase. The was a measurable amount of domperidone found in the mothers milk. CMAJ 164:17, 2001
  • March 20 - Trisenox and cardiac adverse effects - Trisenox (arsenic trioxide) was release in the Fall of 2000 and represents a significant advance in the treatment of acute promyelocytic where 52-90% of patient achieve complete remissions. However 25-33% of patients can develop significant cardiac toxicity evidenced by the appearance of prolongation of the QT interval and a cardiac arrhythmia called torsades de pointes. In rare cases this has resulted in death. Cell Therapeutics
  • March 26 - Viagra use for men with no known cardiac disease OK - a recent study of 5600 men who took Viagra published in BMJ found that there was no apparent risk of heart attacks in men taking Viagra. When compared with a similar group of men who did not take Viagra no apparent difference was noted. In fact, the mortality from heart attacks was 30% lower in the Viagra group than expected in a similar age population. BMJ 322:651, 2001
  • April 13 - Gabapentin (Neurontin) and migraine headaches - a recent study found that when gabapentin was given to prevent migraine headaches (prophylaxis) approximately 50% of the patients experienced a 50% reduction in the headache rate compared with only 16% of patients who received a placebo. Headache 41:119, 2001.
  • April 16 - Cialis ( mfgr. Eli Lilly), an alternative to Viagra will be submitted for approval in 2002 - This drug, similar in structure to viagra and similar in pharmacology appears to be more selective for the enzyme affecting erectile function and has less activity on the enzyme in the skin and retina. Thus, the side effects of affects on color vision and redness of the skin, both problems with Viagra, are less of a problem with Cialis. Business week Online
  • April 30 - Medication use in the USA - A recent study found that over 51% of USA adults took two or more medications each day. Over 25% took multiple prescription medications each day. Not surprisingly, older Americans (over 65) took the most with 79% reporting they took at least one prescription drug. Of those 55-64, 63% reported taking a prescription drug compared with 28% of those 44 and younger. Of those over 65 who take prescription drugs, they took an average of 4 each day! North Carolina Pharmacist Winter 2001 (p 27)

Recommended Important Review Articles

These abstracts can be found by clicking on the links provided.

HER2 and Trastuzumab (Herceptin) in breast cancer
This review article describes the testing method for presence of the HER2 receptor, the effect in advanced breast cancer when HER2 receptors are present, effect on the heart as a side effect and its role as adjuvant therapy. This is an excellent update on one of the first anticancer drugs targeting a specific receptor in malignant cells JMCC 8:103, 2001

Therapy Guidelines - Treatment Strategies for Recurrent Oral Aphthous
Ulcers - this review article - this common problem which occurs in 25% of the population produces oral pain and often difficulty in eating. Although topical mouthwashes and steroids can reduce symptoms they are not effective in preventing recurrence. Systemic medication such as levamisole and thalidomide can reduce recurrance and severity but due to cost and side effects should be reserved for only the most severe cases. Am. J. Health-syst. Pharm 58:41-53 to view complete review article.

The effectiveness of Pygeum in Benign Prostatic Hypertrophy (BPH) - This excellent review article published in the Am. J. Health-Syst. Pharm. 58:120, 2001 examines the evidence for the effectiveness of pygeum in BPH. This extensive review of the world's literature provided evidence that it is effective in lessening some of the symptoms associate with BPH. Among the symptoms improved were: reduced frequency of nocturia, less daytime micturations, an increase in average urine flow rate, and decrease in residual urine volume.

Spasticity and Stroke - this is a series of abstracts which focus on the treatment of the spasticity which often follows a stroke. Most of the abstracts dealing with therapy have the use of botulinium toxin as a potential beneficial agent.

  1. Hormone Replacement Therapy (HRT) and Breast Cancer - Abstracts from a number of studies reviewing the relationship between postmenopausal HRT treatment and the occurrence of breast cancer. Complete abstract
  2. Evidence-based outcomes for patients with advanced non-small cell lung cancer - an excellent review of recent advances in the treatment of this common form of lung cancer. Although the disease is still almost uniformly fatal, improvement in both quality and quantity of life can now be expected with newer drug treatments. Complete Abstract
  3. Treatment strategies in osteoarthritis - a review of all of the forms of therapy for osteoarthritis including the over-the counter drug, glucosamine. Complete Abstract
  4. A new look at cancer treatments - An easy to read update on the new areas of research into the treatment of various cancers. Complete Abstract
  5. Adjuvant therapies for women with breast cancer - this is a brief summary of the recommendations of a consensus panel formed by the NIH to address that issue. Complete Abstract
  6. Survival factors as potential therapeutic agents for retinal degeneration - this article reviews the potential for this new form of therapy to slow the rate of retinal degeneration in humans.
  7. Guidelines for the treatment of lice - a working group representing a varied group of health, government and privite organizations has released recommendations on the treatment of lice infestations:
    • Parents should not make the diagnosis by themselves but seek the opinion of a health care professional.
    • If diagnosis is confirmed any over-the-counter preparation can be used for initial therapy.
    • A second treatment should be done 10 days later.
    • If lice a still present a prescription drug, malathion, may be prescribed.

    • A metal nit comb should be used to remove dead lice and nits.
    • Alternative therapies such as olive oil, mineral oil, and mayonnaise should be avoided and under no circumstances should gasoline, kerosine, or industrial grade pesticides.

Drug topics October 2, 2000.