Obama's Former Drug Czar Calls for Ban on High-Grade Opioids at Center of Epidemic
Barack Obama’s former drug czar, Michael Botticelli, has backed a ban on the high-strength opioid painkillers at the heart of the US overdose epidemic now claiming about 50,000 lives a year.
Botticelli supported a petition to the Food and Drug Administration (FDA) by families of opioid victims, doctors and health organisations seeking the removal of the powerful painkillers from pharmacy shelves.
Activists see the “citizen petition”, which legally requires a response – Congress passed legislation in 2007 that requires the FDA to rule on citizen petitions within 180 days – as a test. It will show whether the FDA is finally turning away from policies that critics contend have contributed to the epidemic by putting the financial interests of pharmaceutical companies ahead of public health.
Among the signatories was Dr Andrew Kolodny, co-founder of Physicians for Responsible Opioid Prescribing, who said that high-dose opioids not only significantly increased the likelihood of addiction but endangered lives when taken accidentally.
He said that 11 million Americans had misused an opioid pill in 2015, and many of them were borrowing pills to deal with aches and pains without knowing how strong they were.
“Borrowing that one pill can lead to a fatal overdose,” he said. “These are not medicines. These are lethal weapons that should be removed from the market.”
The petition says that a person taking high-strength opioids is twice as likely to develop an addiction as a person taking the low-strength version. Botticelli supported the call for their removal from the market but said that it should be matched by an effort to reduce the number of opioid prescriptions. Although the numbers have been falling since the epidemic drew political attention, doctors still wrote 240m prescriptions for opioids last year – roughly equivalent to one for every American adult.
“We clearly know that high dosage increases the probability of addiction. Where we have products that are dangerous, it’s important to call for their removal. It is equally as important as doctor prescribing behaviours,” said Botticelli.
The petition is part of a day of events in Washington and across the US led by an activist group, Fed Up!, to raise awareness of the opioid epidemic and to demand policy changes. Bereaved families rallied at the White House to demand the Trump administration take action to curb the distribution of opioids and fund treatment for those addicted. Victoria Allendorf, who lost both sons on the same day to an opioid overdose, spoke of the helplessness of watching a child struggle with addiction and then slowly dying.
Among the drugs the activists want withdrawn are higher strength versions of OxyContin. Its launch 20 years ago with a marketing campaign claiming that it was neither addictive nor dangerous kickstarted the opioid epidemic, which swept out of Appalachia and across the country. Both claims were false and the manufacturer, Purdue Pharma, has paid out hundreds of millions of dollars to settle legal actions. Three of its executives were also convicted of crimes over the false claims.
Judy Rummler, the chair of Fed Up!, signed the petition on behalf of her organisation. Rummler’s son, Steve, died of an opioid overdose in 2011. Fed Up! has been a strong critic of the FDA, saying that it is compromised by financial relationships with the pharmaceutical industry and has bowed to political pressure from a powerful lobby to approve dangerous drugs.
But Rummler said there were signs the FDA’s policy is shifting. In June, the FDA called for the removal of a high-strength opioid, Opana, from pharmacy shelves as a public health hazard just a decade after it was approved for sale in controversial circumstances. Opana was rejected in 2003 as unsafe but approved three years later after the rules of the process were rewritten amid accusations that pharmaceutical companies had undue influence over the process.
The manufacturer withdrew the drug after the FDA call. The new FDA commissioner, Scott Gottlieb, implicitly acknowledged criticisms of his agency when he endorsed a report by the National Academies of Sciences, Engineering, and Medicine in July that recommended that approval take into account “the public health effects of the inappropriate use of these drugs”.
“We’ve already begun to put this policy to work. Last month, the agency requested the removal of an opioid product from the market based on concern that the product’s risks associated with its deliberate misuse outweigh its intended benefits when it was used as directed and lead to dangerous unintended consequences,” he said.
On Tuesday, Gottlieb phoned Emily Walden, who has been among the strongest critics of the FDA for its approval of Opana after her son died of an overdose of the drug. Walden declined to discuss the details of the conversation but said she was impressed.
“He has given me hope for sure,” she said. “I feel like for the first time in a long time we have an FDA commissioner who is willing to correct some of the mistakes. It seems like he understands this issue.”
Botticelli said he thought the FDA was finally changing course. “It does seem there’s been a significant shift around FDA’s framework on opioids,” he said.
Kolodny called for the federal government to commit $60bn over the next 10 years to provide treatment to people addicted to opioids to bring down the rising death toll. Botticelli was not confident it would happen. He criticised Donald Trump for his failure to follow through on a call by his own opioid commission to declare a national emergency. He said that the president could not say he takes the crisis seriously while at the same time proposing deep cuts to the healthcare funding that provides treatment for people who are addicted.