Saturday, March 2, 2019

Did patients get risky cancer pain drugs?

Documents given to N.Y. Times describe federal failure to block restricted opioid prescriptions

When risky cancer pain drugs were prescribed for patients of other diseases who couldn't tolerate them, the federal government did little or nothing to stop the practice.

That, at least, is the conclusion of  a recent story by Emily Baumgaertner in The New York Times.

Baumgaertner's piece maintains that although the fast-acting class of fentanyl drugs had  been approved only for cancer patients with high opioid tolerance, it was "prescribed frequently to patients with back pain and migraines, putting them at high risk of accidental overdose and death, according to documents collected by the Food and Drug Administration."

The FDA had established "a distribution oversight program in 2011 to curb inappropriate use of the dangerous medication, but entrusted enforcement to a group of pharmaceutical companies that make and sell the drugs," the article asserts.

The Times also notes that "some of the companies have been sued for illegally promoting other uses for the medications and in one case even bribing doctors to prescribe higher doses."

Some 5,000 page of documents were provided the Times after being "obtained by researchers at the Johns Hopkins Bloomberg School of Public Health through the Freedom of Information Act."

The story about the so-called offline prescribing quotes Dr. Andrew Kolodny, an opioid policy researcher at Brandeis University who wasn't involved in the investigation, as saying, "They had the fox guarding the heinous, people were getting hurt — and the FDA sat by and watched this happen."

FDA officials counter that stance by claiming they had only piecemeal data, which "made it difficult for the agency to measure potential harm to patients."

Dr. Janet Woodcock
One official — Dr. Janet Woodcock, the director of the Center for Drug Evaluation and Research at the FDA, was specifically quoted as believing a stricter oversight program "would be 'extremely onerous.'"

She contends, furthermore, that "all drugs have risks and cause harm."

The class of  drugs in question "contain a narcotic up to 50 times stronger than heroin and up to 100 times stronger than morphine," the Times story indicates.

The drugs are expensive. One prescription for a month's worth, Baumgaertner's story says, "can cost more than $30,000."

Details on investigations into other drugs can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book I, Woody Weingarten, aimed at male caregivers.

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