Availability of drugs should be disclosed by manufacturers

Authors


Availability of Drugs Should be Disclosed by Manufacturers

To the Editor:

Pyramid or reverse pyramid approaches and the timing of initiation and aggressiveness of suppressive/disease-modifying drugs have advocates among conscientious physicians attempting to optimize the quality of care delivered and quality of life for the patients served (1). Central to that process is the growing awareness of the importance of early intervention (2). Prominent among those modalities have been gold and methotrexate (3). Although methotrexate could be considered the drug that is in vogue, the clinical efficacies of intramuscular gold and methotrexate appear to be indistinguishable (4). Although some concern has been expressed about side effects interfering with long-term use of gold, close monitoring (for side effects) appears to limit that problem (4). Methotrexate, in contrast, does increase cancer risk (albeit modestly) and also has hidden liver toxicity, which in patients with nonrheumatoid disease requires that liver biopsies be performed at cumulative dose intervals of ∼1,500 mg (5, 6).

Prescription of any medication, however, assumes its availability, and therein lies a problem. The 2 forms of injectable gold available to US physicians over the past several decades have been Solganal (gold sodium thioglucose) and Myochrysine (gold sodium thiomalate). Solganal has now been removed from the market, and the status of Myochrysine seems uncertain. Patients whose disease is in remission have been placed at risk, because disease can become reactivated, with patients experiencing pain and interference in the activities of daily living (disability) as they await drug availability.

Monthly attempts to secure Solganal received only the response that it was “back ordered,” with the manufacturer (Schering-Plough) declining to provide information on anticipated availability. Schering-Plough eventually issued a mailing, stating that they had ceased production of Solganal in March 2002 because they thought that the product was redundant to Myochrysine. Subsequently, the American College of Rheumatology provided clarification, informing us that the federal government had shut down Schering-Plough's factories and imposed a $500 million fine.

That left only the one injectable form, Myochrysine, which is also available from only a single manufacturer. This product is now on extended (>6 months) manufacturer's back order. The manufacturer of Enbrel (etanercept) (Amgen, Thousand Oaks, CA) demonstrated corporate responsibility by informing all concerned when the supply of that drug was forecast as being problematic. They represent the gold standard for the industry.

I believe that we, as professionals dedicated to the benefit of our patients, and our patients deserve no less than that full public disclosure.

Bruce Rothschild MD*, * Arthritis Center of Northeast Ohio, Youngstown, OH.

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