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FDA Stops Amgen Clinical Trial in Children after Child Death

Written by kwmlaw on . Posted in Kelly & West News.

After the death of a young patient participating in a pediatric clinical trial, the U.S. Food and Drug Administration (FDA) shut down the study Feb. 26.

Produced by Amgen, the drug Sensipar was being tested in a new trial to evaluate its safety and efficacy in children. It is approved for use in adults.

The FDA wrote in a Safety Communication that the agency had not concluded that the drug was the cause of the young person’s death. It said that it was “evaluating the information [surrounding the death] and will communicate our final conclusions and recommendations when our review is complete.”

The Associated Press reported the news Feb. 27, 2013. Sensipar is prescribed to treat overactivity of the parathyroid gland. This abnormality can cause brittle bones, kidney stones and abdominal pain. It has been used in adults since 2004 to treat the symptoms of chronic kidney disease and parathyroid cancer.

The drug company Amgen released a statement saying it is “working as rapidly as possible to understand the circumstances of what happened,” reported CBS News.

The New York Times printed an article Jan. 19 about Amgen lobbyists aggressively urging the addition of a paragraph to the “fiscal cliff” bill. The paragraph, buried in Section 632 of the bill, delayed a set of Medicare price restraints on medications in a class that included Sensipar. The language in the bill effectively allows Amgen two additional years to sell Sensipar without having to reduce its prices.

Those who supported this delay, particularly “leaders of the Senate Finance Committee who have long benefitted from Amgen’s political largesse,” said the extra time was needed to enable regulators to prepare for the change in prices.

However, the company already had won a two-year delay, its critics claimed. They said another delay was an “unnecessary giveaway.”

Among these critics were “Congressional aides who were stunned to find the measure in the final bill,” The New York Times wrote. The newspaper article said that the legislative addition to the fiscal cliff bill “shows the enduring power of special interests in Washington.”

The New York Times pointed out that Amgen has profound political and financial ties to the leaders of the Finance Committee, which has power over Medicare payment policy, including Senate Minority Leader Mitch McConnell (Republican from Kentucky), and Senators Max Baucus (Democrat from Montana) and Orrin G. Hatch (Republican of Utah).

The addition to the bill, The New York Times wrote, “runs counter to a five-year effort in Washington to control the enormous expense of dialysis for the Medicare program by reversing incentives to overprescribe medication.”

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