Noose Tightens Around Thiopental Supply

European and domestic objections to the death penalty in the U.S. are making it increasingly unlikely that sodium thiopental will continue to be available for surgical anesthesia.

On Thursday, the Sandoz generic drugs unit of Novartis — a major thiopental supplier globally — said it had told its distributors to stop selling the drug to other customers who have been importing it into the U.S., whether for use in lethal injections or in surgical patients.

“Sandoz and Novartis support only the authorized use of injectable thiopental, which is primarily indicated for the induction of anesthesia, and do not support the sale or use of this or any product for use in nonapproved treatments,” the firm said in a statement.

“Sandoz has also advised all of its subsidiaries with locally approved marketing authorizations for sodium thiopental to not export or sell the product to the U.S., or supply it to distributors or third parties that may be selling it into the U.S.”

In addition, a federal lawsuit filed last week seeks to force the FDA to prevent any thiopental imports intended for use in capital punishment.

The moves, if successful, could dash anesthesiologists’ hopes that the drug will stay on the U.S. healthcare market.

Contacted by MedPage Today for comment, the American Society of Anesthesiologists (ASA) reiterated a statement it issued last month when Hospira, the last U.S.-based supplier of thiopental, announced that it would no longer make the drug anywhere.

“The ASA certainly does not condone the use of sodium thiopental for capital punishment, but we also do not condone using the issue as the basis to place undue burdens on the distribution of this critical drug to the U.S. It is an unfortunate irony that many more lives will be lost or put in jeopardy as a result of not having the drug available for its legitimate medical use,” the group said.

Surgical use of thiopental has declined in recent years as anesthesiologists have increasingly favored propofol and other agents, but the ASA pointed out that it is still the anesthetic drug of choice for certain patients and procedures, including those involving geriatric, neurologic, cardiovascular, and obstetric patients.

But it has become a focus of controversy because it is also used in lethal injection procedures in 33 states that have capital punishment.

Thiopental has been in short supply domestically after Hospira stopped U.S. production in 2009. Some states reportedly have had to delay executions because prison authorities couldn’t get the drug.

Last month, Hospira announced that it would no longer attempt to resume production overseas. Its plans to produce the drug in Italy ran afoul of local authorities’ insistence that Hospira prevent the drug from being used in U.S. executions.

Sandoz does not market thiopental in the U.S., but it sells the drug into a multi-link supplier chain that apparently extends into this country.

That chain was the focus of a lawsuit filed last week on behalf of a group of Death Row prisoners. The suit, which named the FDA as defendant, asked a federal district court in Washington to order the agency to stop imports of the drug for nonhealthcare purposes.

The suit specifically cited a customer of Archimedes Pharma, an authorized U.K.-based wholesaler of Sandoz’s thiopental, as having imported the drug and sold it to state governments for use in executions.

According to Sandoz, for its thiopental product to make its way into the U.S., it must pass through at least three sets of hands after it leaves its Austrian factory.

The plant manufactures the drug under contract for an unnamed British company, which, in turns, sells to Archimedes. The latter firm does not itself do business in the U.S., but it sells thiopental to a range of still other suppliers who may.

Archimedes “is solely responsible for the product’s marketing and supply under its respective U.K. marketing authorization,” Sandoz said.

On the other side, the ASA has lobbied the FDA to make it easier for thiopental to be imported.

“The ASA urges FDA to exercise its authority and work collaboratively with foreign governments to import thiopental from foreign manufacturing sites to alleviate the critical shortage within the U.S., and to ensure that patients have access to this important medication when it is clinically indicated,” the ASA said in a letter to the agency last month.

 

 

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