Abstracts for 2000

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.

  • Jan 1 - Four drug combination for tuberculosis now recommended by the World Health Organization - Who is now recommending that four drugs now be used to treat T.B. instead of previous two drug regimens. Those four drugs are isoniazid (INH), pyrazinamide, rifampin, and ethambutol. This new combination is necessary due to the emergence of resistant strains particularly in developing countries.
  • Jan. 5 - Progress in treatment of pancreatic tumors - Cancer of the pancreas is one of the most rapidly progressing and difficult to treat cancers. A preliminary study in 14 patients where the immune stimulating drug called GVAX was given there were 3 patients whose cancer completely disappeared. Those patients have remained disease free for approximately three years. Boston Globe
  • Jan 10 - Immune system depression for arthritis may lead to tuberculosis - there are two drugs now available for treating arthritis which act by reducing the effect of tumor necrosis factor (TNF) an important mediator of the inflammatory response. Inflammation is also a normal response to an infection in the body and is particularly important as a defense mechanism in the lung. Patients taking either of the two drugs which depress TNF, etanercept (Enbrel) and infliximab (Remicade) are at risk for serious infections. Recently, there appeare to be a relationship between one of the drugs, Remicade, and the development of tuberculosis. European Agency for the Evaluation of Medical Products
  • Jan. 15 - Monoclonal antibodies take spotlight at hematology meeting - at a recent meeting of the American Society of Hematology two monoclonal antibodies were reported to be effective in the treatment of leukemias. The first was Glivic which is being studied for the treatment of chronic myeloid leukemia. In a study of 500 patients after 6 months of therapy Glivic normalized blood counts in 90% of patients and 50% had a significant reduction in marker malignant cells. The other is called CAMPATH-IH. Is use in chronic lymphocytic leukemia as resulted in a 33% response rate in patients with chronic lymphatic leukemia. Drug Topics
  • Jan. - Congenital abnormalities may result from use of valproic acid during pregnancy. Valproic acid is a commonly prescribed drug for seizures. A recent review of the literature found 69 cases of congenital abnormalities in children born to mothers taking the drug. The most common abnormality was in the musculoskeletal system where 625 of the cases had this problem. In addition, 15% of the surviving infants had growth retardation and 29% were Retarded or had abnormally slow mental development. Am. J. Med. Genet. 98:168,2001
  • Jan. 30 - Glucosamine and Osteoarthritis - A recent study found that the long-term use of glucosamine sulfate 1500 mg daily, prevented the narrowing of joint space in the knees in a group of patients with osteoarthritis. They also reported that there was a significant reduction in the symptoms of osteoarthritis in the glucosamine group with no reduction found in the placebo group. Lancet 357:256, 2000 Ed. - Glucosamine is readily available as an over-the-counter non-prescription drug in most countries. It is otten combined with chrondrotin - it is not clear if the combination has any advantage over glucosamine by itself.
  • Feb. 5 - Inhaled insulin moves closer to approval - A recent report in Lancet reported that a new form of inhaled insulin resulted in glucose control similar to that of injected insulin in Type 1 (Juvenile) diabetics . There were no adverse effects on the lung. The insulin powder is aerosolized for delivery to the lung. The preparation may be significantly more expensive that the injectable form since it requires much more insulin to be present to overcome the lower absorption through the lung.
  • Feb. 7 - Interruption of AIDS drug treatment may not be advisable - A number of studies have suggested that interrupted therapy for AIDS may be possible in a limited number of patients. However, over 50% of those in whom the therapy was stopped required the drugs be started again due to growth of the virus. Interrupted therapy appears to work best in patients with new diagnosed disease in whom the drug regimen eradicates detectable virus from the blood. The longer the disease has been present the less likely that interrupted therapy can be continued very long with less than 1/3 able to stop taking the drugs for a prolonged period. The Wall Street Journal
  • Feb 8 - New drug may be effective in treatment of cancer of the large intestine - IMC-225 is a new drug being developed by ImClone. It is a monoclonal antibody directed against epidermal growth factor receptor. Blockage of that receptor is proposed to slow the growth of epithelial cell derived tumors of which colorectal cancer is one. Early results show reduction of tumor size and slowing of tumor growth. The drug has been given "Fast Track" designation by the FDA which is granted only in the case of drugs which represent a potential significant contribution to the therapy of a specific disease.
  • Feb. 9 - Canker sores may be treated by disk applied inside the mouth - a new drug, Aphthasol, appears to be effective in treating painful oral canker sores. In a placebo controlled study the use of aphthasol in the form of a disk applied to the sore resulted in an acclerated rate of healing with complete disappearance of the lesion in 5 days. Press Release - Access Pharmaceuticals
  • Feb. 11 - Zovent reduces relative risk of seath from severe sepsis - Zovent is a recombinant form of protein C, a biochemical produced by the body in response to an infection. The mortality rate in patients treated with Zovent was 24.7% compared with 30.8% in patients treated with placebo. Serious bleeding occurred in 3.5% of patients treated with Zovent compared with 2% in those treated with placebo. This difference did not reach statistical significance, Press Release- Eli Lilly
  • Feb. 12 - New policy for treatment of HIV - The USA Public Health Service recommendations for the treatment of HIV positive individuals has been changed. Previously, the use of triple therapy was recommended for nay individual who was HIV positive. This has been changed to delay therapy until there was evidence that the virus was significantly affecting the immune system. The new guideline propose delaying therapy until the level of the CD4 immune cells in the blood falls below 350 per mm3 (the old recommendation was 500). The second change is based on the virus/ml of blood. The new recommendation is that treatment should begin after the virus level exceeds 30,000 (the previous recommendation was 10,000). Raleigh News and Observer
  • Feb. 12 - Dexamethasone use in preterm infants may slow brain growth - dexamethasone is commonly used to prevent the development of hyaline membrane disease in premature infants. Brain volume was measured in infants approximately 10 weeks after birth. Whereas normal birthweight infants has a brain volume of 219 ml, infants treated with dexamethasone had a brain volume of 130 ml, a significant 60% reduction. The effect of this reduction on intellectual development is not known. Pediatrics 107:217, 2001
  • Feb. 12 - Celebrex offers no advantage over other NSAIDS in patients also taking aspirin - this study, reported by the manufacturer of Celebrex, was not able to show any advantage of Celebrex over ibuprofen or diclofenac (NSAIDS) in patients taking low-dose aspirin. (Low dose aspirin is commonly used to prevent or treat strokes or heart attacks). In fact, the data presented showed patients taking Celebrex and low dose aspirin had a greater rate of adverse effects than aspirin with either ibuprofen oor diclofenac.
  • Feb. 12 - Hormone replacement replacement therapy (HRT) does not increase risk of stroke - a recent study from the VA Medical center in San Francisco, California assessed the effect of HRT on the incidence of non-fatal and fatal strokes. This four year study did not find any relationship between HRT therapy and the occurrence of strokes or any other cerebral ischemic event.
  • Zidovudine (AZT) short term effective in preventing maternal transmission of AIDS virus to newborns - A recent report found that a short course of AZT can effectively prevent the transmission of the HIV virus from a mother who is HIV positive to her newborn infant. The earlier regimen required AZT to be given beginning at 28 weeks gestation and continued in the newborn for an additional 6 weeks after birth. The new regimen does not start the AZT until week 35 of the pregnancy and the newborn for only 3 days after birth. The cost of the short regimen is approximately 5-fold less than the long-term one. New Engl. J. Med. 343:982, 2000. (November 1, 2000)
  • Herbal remedy PC_SPES effective against prostate cancer - A group of 69 men with hormone-resistant prostate cancer were given PC SPES and the effect on serum prostate-specific antigen (PSA) determined. Serum PSA was reduced by over 80% in the majority of patients tested. No data were available on any effect on survival. J. Urol. 164: 1229 (2000). (November 2, 2000)
  • Ginko does not benefit mild to moderate dementia - the herbal drug ginkgo biloba was compared to placebo in a double-blind cross-over study 123 individuals with mild to moderate dementia. Evaluations at the end of 12 and 24 weeks failed to demonstrate and beneficial effects beyond that of the placebo. J. Am. Geriatr. Soc. 48:1183, 2000. (November 2, 2000)
  • Shark cartliage found of no value in treatment of breast cancer - in Danish trial of 17 patients with advanced breast cancer the women were given 24 capsules/day for three months. After that time 15/17 had progression of the disease, one had a partial but brief response and in the case of 1 patient there was disease stabilization. The patient whose disease stabilized was considered to be coincidental to the shark cartilage and not due to its beneficial effects. (November 2, 2000)
  • Aslera (Prasterone) placed on priority review by the FDA - this drug has been proposed to be valuable in the treatment of lupus erythematosis. This new medication both reduced the steroid requirements in female patients with lupus and also improved symptoms. (November 3, 2000)
  • Drug costs expected to increase by over 20% in 2001 - a number of factors are combining to suggest that the total amount spent in the USA on prescription drugs will increase 20% in 2001. Among the reasons are: 1. A 5-10% increase by the pharmaceutical companies for existing drugs 2. Increase in the age of the population 3. Increased cost of new drugs. (November 3, 2000)
  • Targretin may extend survival in non-small cell lung cancer (NSCLC) - a recent study found that patients with NSCLC given Targretin in addition to the standard chemotherapy regimen experienced increased projected survival at 3 years (32%) compared with the expected 15%. Ligand Pharmaceuticals Press Release (November 8, 2000)
  • New adjunct treatment for hepatitis C - One of the reasons why individuals fail on current hepatitis therapy is due to the occurrence of thrombocytopenia (a decrease in platelets). Recently it was reported that if platelet growth factor is also use along with the drug therapy, the thrombocytopenia side effect can be prevented thus allowing continuation of therapy. Medscape Wire (November 14, 2000)
  • Cerebral palsy increased in newborns given dexamethasone for respiratory distress syndrome - a recent study reported that premature infants given the steroid dexamethasone for respiratory distress have a greater chance of developing cerebral palsy than those infants not receiving the steroid (49% vs 15%). In addition there was a higher incidence of developmental delay in the dexamethasone group (55% vs/ 29%). Arch. Dis. Child. 83:F177, 2000. (November 14, 2000)
  • First monoclonal antibody for asthma on drawing board - A new drug Xolair (Omalizumab) is under current study for the treatment of asthma. This compound is a monoclonal antibody directed toward IgE, a component of the allergic response. This new medication will be a specific value to those whose asthma is triggered by an allergy and whose severity is seasonal. Good to excellent results have been reported in approximately 70% of patients. Drug Topics (November 20, 2000)
  • Stage 4 melanoma responds to a new vaccine - a group of 37 patients with metastatic myeloma were given a new vaccine, M-vax. The median survival of the treated patients, many with a very poor prognosis, was 27 months or longer. This survival duration is over two-fold greater than expected for patients with melanoma which has progressed to Stage 4. Ed. - This is a potentially significant advance in the treatment of a very nasty cancer - it is currently available in Canada. (November 24, 2000)
  • New drug being studied for non-Hodgkins lymphoma - At a recent meeting of the American Society of Hematology it was reported that Bexxar, a combination of an antibody specific for the cell surfact of the abnormal cell with the isotope iodine 131. Current treatment consists of using the antibody alone(Rituxan). The new combination reduced tumor size by 50% in 70% of treated patients and 40% had no signs of residual disease. Press release - Smith Kline Beecham. (December 4, 2000)
  • Physician calls new leukemia drug a major breakthrough - At a recent meeting of the American Society of Hematology data were presented that Glivec, a drug which blocks a signal which is responsible for production of many types of cancers is effective in treating chronic myelogenous leukemia (CML). The study reported that that over 90% of patients responded to treatment and 63% went into remission. CML affects 10,000 adults yearly. (December 5, 2000)
  • The effect of thalidomide in cancer - a number of recent studies the drug thalidomide, implicated in the production of multiple birth abnormalities in the late 1960s particularly in Europe, may be effective in the treamtent of many types of cancer. Most thoroughly studied is its usefulness in multiple myeloma, where abnormal proteins in the blood were significantly reduced and in those with resistant disease, after 18 months 55% of patients were still surviving. Chemotherapy Foundation Symposium XVIII. (December 4, 2000)
  • AIDS in eastern Europe - in just one year there has been a significant increase in the number of patients who are HIV positive increasing from 420,000 to over 700,000, a 66% increase. These data continue to demonstrate that AIDS continues not only to be a significant problem throughout the world but also that in may places its incidence is increasing. www.intelihealth.com/enews?304677 (December 6, 2000)
  • Researchers rush 2nd tumor-starving cancer drug to human tests - two drugs are currently under study which "starve" the tumor of blood thus causing death of tumor cells. The one furtherest along is called endostatin which has shown impressive results against breast cancer. The newer drug 2Me2 (2-methoxyestradiol) acts both by preventing the formation of blood supply to the tumor AND also kills the tumor cells. The Durham Herald-Sun (December 7, 2000)
  • New combination provides better protection for prevention of malaria. The newly released combination of atovaquone and proguanil (Malerone) was found to more effective in preventing malarial infection than the combination of chloroquine and proguanil. In addition, patients taking the new combination experienced fewer side effects (particularly gastrointestinal). Lancet 356:1864 (2000). (December 11,2000)
  • Galanthamine effective in slowing progression of Alzheimers disease. Galanthamine (Nivalin) has been available in Europe for some years. A recent study of 653 patients compared the effect of galanthamine with a placebo. After 6 months of treatment patients in the galanthamine group were significantly better than those in the placebo group. Side effects are not severe with increased sweating, nausea, and blurring of vision occurring occasionally. Brit. Med. J. 321:1445, 2000 Note: Galanthamine is not available in the USA but can be imported into the USA based on a prescription and letter from a physician stating the need for the medication. (December 11, 2000)
  • Older treatment for manic illness may be superior - a recent study of 120 patients compared the new drug Zyprexa with an older standard, Depakote for the treatment of the manic phase of manic-depressive psychosis. Although both were effective, the side effects with Depakote (particularily weight gain, sleepiness, and dry mouth) were significantly lower than with Zyprexa. Note: Depakote is approximately 1/3 less in cost than Zyprexa. The Wall Street Journal (December 12, 2000)
  • Drug offers hope for Creutzfeldt-Jacob Disease (CJD) Victims - a recent study in Germany used a new painkilling drug called flupirtine (Katadolon) to slow the progression of the cognitive deficit symptomatic of CJD. It acts by slowing the death of brain cells characteristic of that disease. CJD is the disease which is linked to "mad cow disease". Over 1 million people in the world suffer from this disease - it has a average survival after diagnosis of 4-6 months. The Wall Street Journal (December 18, 2000)
  • New drug for inherited emphysema put on FDA fast-track status - Aventis Behring has submitted a New Drug Application for an intravenous preparation of alpha1 proteinase inhibitor. This is of value in treating emphysema which is due to an inherited deficiency of alpha1 proteinase inhibitor in the lung. Infusion of the inhibitor increases the amount in the lung and lessens the damage produced by the deficiency. (December 20, 2000)
  • Lotronex was withdrawn by the FDA in December 2000. An alternative drug Zelmac should be available in Europe and USA mid-2001.
  • 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 found 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 There is an excellent review article on St. John’s Wort which can be found by
  • 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 prescrbing 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 Nws 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, 2000.
  • 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 uriine m protein) and it stopped disease progression in an additional 6 patients for a median of 5 months. Mayo Clinic Proceedings (Sept. 2000).