Congress Quashes Drug Reimportation Mandate
By William T. Elliott, MD, FACP
Forget reimportation of drugs from other countries as a way to control drug costs. Congress has failed to reverse a mandate barring drug reimportation proposed by Tommy Thompson, secretary of Health and Human Services. Pharmacies and pharmacy benefit management companies (PBMs) had hoped to purchase American-made drugs in Canada or Mexico where prices are substantially lower, then reimport them here for sale. Secretary Thompson, under strong pressure from the pharmaceutical industry, cited safety concerns for his ban, especially the risk of counterfeit drugs. However, patients in border states are not banned from purchasing drugs in Canada and Mexico where the prices are often 50% less than those in neighboring pharmacies across the border.
Deep Venous Thrombsis (DVT)
Oral anticoagulation for the treatment of DVT may be safely discontinued after 3 months according to Italian investigators. In this study, 267 patients with a first episode of idiopathic proximal DVT were randomized to oral anticoagulant for 3 months or 12 months. Most cases of recurrent thromboembolic events occurred in the first year after discontinuing the medication, but the rate of recurrence was the same regardless of the duration of treatment. After 2 years of follow-up, there was no difference in the rate of recurrent thromboembolic events between the 3- or 12-month treatment group. There were 4 nonfatal major hemorrhages in the 12-month group. This study implies that recurrent thromboembolic events after DVT are delayed, but not prevented, by prolonged treatment with an oral anticoagulant (Agnelli G, et al. N Engl J Med. 2001;345:165-169).
Lipids
The FDA has issued an approvable letter for a new lipid-lowering drug that combines lovastatin and niacin. The drug will be marketed under the name Advicor and is indicated for mixed dyslipidemia where either niacin or a statin alone may not be effective. Formal approval of the drug awaits the expiration of the exclusivity patent for Merck’s lovastatin, which is expected later this fall.
Antidepressants for Headache Treatment
Tricyclic antidepressants (TCAs) have been a mainstay of headache prophylaxis. Now there is good evidence that selective serotonin reuptake inhibitors (SSRIs) may work as well as TCAs with fewer side effects. A large meta-analysis going back more than 30 years revealed that antidepressants in general are highly effective in preventing both migraine and tension headaches, and the effect was similar with all classes of antidepressants. Specifically, SSRIs were as effective in preventing headaches as tricyclics, generally with less side effects (Tomkins G, et al. Am J Med. 2001;111:54-63).
Pulmonary Emboli
Patients with massive pulmonary emboli (PE) represent a therapeutic dilemma. Should these patients receive thrombolytic therapy or standard heparin therapy? A new French study suggests that although short-term clinical markers may be improved with thrombolysis, long-term outcomes are worse. Davidson and colleagues performed a retrospective review of 128 patients with massive PE with evidence of right ventricular dysfunction, but normal hemodynamics. Half of these patients received heparin and half received thrombolytic therapy. The patients given thrombolytic therapy had a marked, rapid, improvement in lung perfusion compared to heparin patients, as has been shown in other studies. Despite this, all patients in the heparin group survived, while 4 patients in the thrombolytic group died, 2 from cerebral bleeding, 1 from shock following the thrombolytic infusion, and 1 from recurrent PE. Davidson et al conclude that patients with massive PE and normal hemodynamics will not benefit from thrombolytic therapy. Patients in shock or who are hemodynamically unstable should continue to be evaluated for thrombolytic therapy (Davidson B, et al. Chest. 2001;120:6-8).
Urinary Tract Infection (UTI)
Women with a history of UTIs can accurately diagnose and treat themselves according to a new study from the University of Washington. In this study, 172 women with a history of recurrent UTIs were followed. None had recently been pregnant and women with chronic diseases were excluded. During the study period, 88 women self diagnosed 172 cases of UTI. All were then treated with antibiotics after a urinalysis and culture was done. Only 5% of women had no pyuria or bacteriuria. Cure was achieved in more than 90% of women, and there were no adverse outcomes. Gupta and colleagues conclude that women with a history of UTI can accurately self diagnose and treat UTI, thus avoiding an office visit (Gupta K, et al. Ann Intern Med. 2001;135:9-16).
Oxycodone given "Black Box" Warning
The FDA has taken the unusual step of adding a "Black Box" warning to OxyContin, Purdue Pharma’s brand of oxycodone, a long-acting Schedule II narcotic. The warning is intended to help prevent diversion of the drug, which has a become a popular drug of abuse. Nicknamed "Oxy" on the street, the drug sells for an average of $1/mg or $40 for a 40-mg pill. Abuse has become a particular problem in rural America as described in an article in the July 29 New York Times. Several deaths have been reported associated with misuse of the drug, which is commonly crushed and injected or snorted. The Black Box warning stresses the problems of abuse and diversion hoping that awareness will reduce the likelihood of inappropriate prescribing. Last May, Purdue withdrew the 160 mg strength, the highest dose form of OxyContin, because of increasing reports of abuse.
Prozac’s Patent Expires
After more than a decade of immense popularity and astounding sales, Lilly’s fluoxetine (Prozac) has seen its patent expire, opening the door for generic forms of the drug. Barr Laboratories, the first generic manufacturer to develop a generic, prevailed in more than 5 years of lawsuits with Lilly. Barr shipped their generic fluoxetine on Aug. 2, and will likely retain 180 days of exclusivity as the first generic filed under the Hatch-Waxman act. The cost of fluoxetine to consumers is expected to plummet. Lilly posted more than $2.5 billion sales of Prozac last year.
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