A former FDA commissioner said that an agency had made a mistake in allowing pharmaceutical companies to promote opioids for long-term use – 60 Minutes


Dr. David Kessler, Commissioner of the FDA in the 1990s, when the powerful OxyContin long-acting and long-acting opioid of Purdue was approved, says the FDA would never have had to authorize the drug and have Other similar products to be widely marketed for patients with chronic pain. The agency made a mistake in radically expanding the opioid market despite lack of studies on safety and efficacy for long-term use, he said. The former commissioner said that the label on opioid drugs needed to be amended to limit the ability of pharmaceutical companies to market opioids. "It must be done," he says.

The change of indication labeled by the FDA for opioids such as OxyContin towards long-term use has given big pharma the go-ahead to push opioids to tens of millions of new pain patients in the country. "You have a pharmaceutical promotion system that has changed the practices of medicine and nobody, everything is fine, did not stop it," Kessler said. Marketing has led to an overdose of dangerous drugs and a flora of pills has fueled the deadly epidemic, companies being allowed to sell more and more pills at ever higher doses. Kessler turns to Bill Whitaker for a 60-minute report to air on Sunday, Feb. 24 at 7:00 pm PT / PT on CBS.

In 2001, after Dr. Kessler left the agency, the FDA officially renamed OxyContin, a powerful opioid, intended to be used for an "extended period" by people with chronic pain. Originally approved on the basis of scientific data stating that it was safe and effective only when it was used "in the short term", the label had been modified without adequate scientific study. "We do not know if drugs are safe and effective for chronic use," said Kessler. "The type of rigorous scientific research that the agency should support is not there." The right to market the new indication was finally granted to a whole class of opioids.

Dr Andrew Kolodny, an addiction specialist at Brandeis University, has been trying since 2011 to change the wording of the FDA and limit the commercialization of opioids. He explains to Whitaker that opioids are essential drugs for the treatment of end-of-life pain. long-term pain needs. "[But]If you take them day and night … you become tolerant to the analgesic effect … you will need ever higher doses, "he explains. The treatment becomes more dangerous and the risk of death increases, "says Kolodny.

When Whitaker asked the FDA why she had not acted as the watchdog for which she was created, Kessler partially blamed the under-staffing of the FDA division that oversaw marketing and promotion.

Dr. Scott Gottlieb, the current FDA commissioner, rejected a request for interview, but provided a 60-minute statement. It reads: "Many mistakes were made along the way … While the agency complied with the law by approving and regulating opioids, at the FDA we include ourselves among those who should have been act sooner. "

In its Sunday edition, 60 minutes, Whitaker will also report the role that drug manufacturers have played in changing the label, which has greatly increased the benefits – and the relationship between the drug manufacturers and the FDA .

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