The Latest Information on New Drugs and New Indications
Jane henney, md, the clinton administration’s candidate to replace David Kessler, MD, as the Commissioner of the FDA, was finally confirmed by the Senate on October 20. Her confirmation had been in doubt recently as her views on RU-486 and the tobacco industry had raised the hackles of the Republican leadership. But, bipartisan support along with lobbying from Donna Shalala, secretary of Health and Human Services, helped to resolve any opposition. Henney most recently held the position of vice president for Health Sciences at the University of New Mexico. Prior to that, she held leadership roles at both the FDA and NIH. The position has been vacant since Kessler left to assume the role of Dean of the Yale University School of Medicine.
The flu has arrived early in some parts of the country and the flu vaccine arrived late, but full supplies should be available by mid-November. Wyeth-Ayerst was in the process of changing its manufacturing process when the CDC announced the antigens for this year’s vaccine, thus, falling behind the normal production schedule. But, other manufacturers, especially Pasteur Merrieux Connaught, are rushing to fill the void. There should be plenty of vaccines available by the end of the month. There actually may be some advantages to vaccinating later rather than earlier, with the effects of the vaccine waning after six months and the flu season generally starting in December and running well into the late spring.
The Diabetes Complications and Control Trial (DCCT) demonstrated the benefits of tight blood sugar control in type 1 diabetes, and to a great extent, changed the standard of care for this disease. Now, the results of the largest study ever done on type 2 diabetes has been published. The United Kingdom Prospective Diabetes Study (UKPDS) followed more than 4000 type 2 diabetics for 20 years. The study was designed as a prospective, randomized trial, with patients randomized to intensive blood sugar control using sulfonylureas and insulin, or conventional care. A separate wing of the study looked at metformin use in overweight diabetics. The results of the study have been published recently (BMJ 1998;317:703-713; Lancet 1998;352:837-853; BMJ 1998:317:13-20). The results of this important study will be interpreted for years to come. The primary findings were that intensive control decreased the incidence of microvascular complications such as retinopathy and nephropathy, but did not seem to affect the rate of stroke or cardiovascular disease. Overall mortality was also unaffected by intensive control. (The Physician’s Therapeutics & Drug Alert supplement contains a reference to help with the prescribing of drugs for type 2 diabetes.)
Children with croup do better with a dose of corticosteroids according to a study published in August (N Engl J Med 1998;339:498-503). One hundred forty-four children with croup were randomized to receive recepinephrine along with intramuscular dexamethasone, nebulized budesonide, or placebo. Both treatment groups did far better, with the dexamethasone group having the most favorable outcomes, including significantly less need for hospitalization (23% vs 71% for placebo).
Paroxetine (Paxil) has been found to be effective in treating social phobia, this country’s third most common psychiatric disorder, following depression and alcoholism. One hundred eighty-seven patients were randomized to paroxetine in doses of up to 50 mg daily or placebo (JAMA 1998;280:708-713). More than half of the treated patients reported improvement after 11 weeks, while only one quarter of the placebo group was improved. SSRI side effects, including sexual symptoms and headache, were common in the treatment group.
The mechanism by which hormone replacement therapy (HRT) lowers cardiovascular risk may be multifactorial. Along with improving lipid profiles, HRT may also lower ambulatory blood pressure. A recent study from the Netherlands (Am J Hypertens 1998;11:1147-1152) showed that blood pressure was lowered an average of 5.5/4.2 mmHg in women taking cyclical HRT for more than one year. The study was performed on healthy women with no history of hypertension or cardiovascular disease.
If your patients are unsuccessful at quitting smoking, remain encouraging and supportive. A recent Gallup survey reveals that the average smoker attempts quitting four times before they finally kick the habit.
The Physician’s Desk Reference is branching out. Medical Economics, the company that publishes PDR, has announced that they will soon release a PDR for Herbal Medicines. The reference will contain information on more than 600 herbal remedies. Much of the information will be based on European data, especially data from Germany.
Alendronate (Fosamax) may cause more GI symptoms than previously suspected. In a recent study based on telephone interviews with women who had filled prescriptions for the alendronate, nearly one-third of women taking the drug experienced gastrointestinal problems, and more than 28% of women discontinued the drug because of side effects. The study (J Man Care Pharm 1998;4:488-492) was based out of Kaiser Permanente in Northern California and was partially funded by Novartis. The study also revealed that many women were not adequately instructed on the use of the drug or did not comply with instructions for taking it, especially instructions about the timing of eating and taking other medications.
The FDA has put two drugs on the fast track approval process. Discovery Labs synthetic lung surfactant SP-B peptide (Surfaxin) is in phase III trials for treatment of acute respiratory distress syndrome (ARDS). The drug replaces lost surfactant in ARDS and is administered via an endotrachial tube directly into the lungs. Advanced Corneal Systems hyaluronidase (Vitrase), which was also given fast tract status, is an enzyme used to treat vitrous hemorrhages. The hyaluronidase breaks up hyaluronic acid in the vitrous, allowing faster clearing of trapped blood and it’s eventual reabsorption.