Federal officials will work with 17 pharmaceutical companies — including Johnson & Johnson, Merck, Celgene, and others based in New Jersey — to expedite the development of new nonaddictive pain treatments and medicines to help drug addicts better manage their disease as part of a national effort to curb the opioid crisis.
Gov. Chris Christie, chair of the White House’s opioid panel, announced the public-private partnership yesterday after a two-hour meeting in Trenton with drug company leaders, the head of the National Institutes of Health, officials from the Federal Drug Administration, presidential advisor (and Garden State native) Kellyanne Conway, and other federal representatives.
The collaboration is rooted in past efforts through which pharmaceutical companies worked together to more quickly provide new drugs to treat HIV/AIDS and various cancers, officials said. While an AIDS diagnosis once essentially ensured a patient’s mortality, treatments developed through this same kind of partnership mean that today the disease is “treated as a chronic disease, not a death sentence,” Christie noted.
There is no set timeline for this effort to combat addiction, but officials said the process would reduce the traditional competition between drugmakers and enable the NIH to act as an intermediary as they share knowledge, fast-track the review process, and get products to the public sooner than would otherwise be possible.
New nonaddictive drugs
The group will focus on creating new nonaddictive drugs to combat pain, reducing the potential for substance use disorder; developing additional medication-assisted treatment options for addicts in recovery; and crafting stronger formulations to reverse opioid overdoses. The most common product now in use as an antidote to opioid overdoses — naloxone or Narcan — is not strong enough to overcome the deadly power of some substances, like Fentanyl, which are becoming more popular.
Christie underscored the urgency of what he called a “national emergency” by noting that in 2015, opioids killed some 52,000 people, the equivalent to the death toll of 17 separate 9/11 events; last year, some 64,000 people lost their lives to these substances, he said.
In January the governor declared it a public health crisis in New Jersey, where an estimated 2,000 people were killed by opioid addiction last year, and he has dedicated much of his efforts this year to prevention, treatment, and harm-reduction programs. Over the next few days, Christie said he would outline $200 million in additional state programs aimed at expanding treatment to poor patients, beefing up healthcare services for babies born addicted, and investing more in housing and other support services.
The pharmaceutical partnership comes six weeks after the President’s Commission on Combating Drug Addiction and the Opioid Crisis released an interim report that called for better education for prescribers in an effort to reduce opioid use, the creation of far more treatment beds, strengthening prescription-monitoring databases nationwide, and expanding access to medication-assisted treatment — prescribed drugs that can help patients avoid a relapse — and overdose antidotes like naloxone, among other things.
Trump has yet to act
The report, which was delayed several times, also urged President Donald Trump to officially declare opioid addiction a national emergency, but Trump has yet to act despite pledging to do so. Christie defended the president’s commitment to the issue yesterday and insisted his staff was working carefully to get the order right. (The president extended the panel’s mandate by a month, to November 1, after Christie requested more time to complete a final report and other aspects of their mission, before the group disbands.)
Christie said it has been clear all along that the pharmaceutical industry had to play a role in reversing the potentially deadly trend of opioid addiction, and Trump was supportive of the collaboration when the two spoke about it in late July. The NIH, which oversees medical research, has also been working with the Federal Drug Administration, pharma leaders, and other stakeholders on the concept since early June.
The agreement “takes what has been gathering a lot of momentum — this idea of a public-private partnership — and turns it into reality,” said NIH director Dr. Francis S. Collins. “I heard nearly unanimous agreement” during yesterday’s meeting “that this is an idea whose time has come,” Collins added. “The scope and magnitude of the addiction and overdose crisis in our country requires all hands on deck.”
Collins said the first step is to draft a work plan with timelines, goals, and key decision points, following steps used in the past to collaborate effectively with pharmaceutical companies to identify cures for other diseases. The FDA’s cooperation means these products will still undergo a safety review, but the process can be fast-tracked, the group noted. “It’s an unprecedented partnership that has the goal of getting things to happen much faster than they would otherwise,” Collins said.
‘No silver bullet’
Stephen J. Ubl, president and CEO of the Pharmaceutical Research and Manufacturers of America, the trade group for drugmakers, who also attended the meeting, praised the “comprehensive nature of the response” outlined in the panel’s interim report. Opioid addiction is a “complex public health challenge — there’s no silver bullet,” he said.
While dozens of new products are now under development, Ubl said companies traditionally operate in “silos” that don’t encourage information-sharing, something the collaboration should help overcome. “Our industry stands ready to work in any way we can with the commission going forward,” he added.
This was good news to Jim Curtin, the president and CEO of Daytop New Jersey, a recovery center with seven locations, who praised the governor’s leadership on the issue; Christie has served on the Daytop board for nearly two decades.
Currently, medication-assisted treatment (MAT) depends on three substances: methadone, which has existed for decades, and the relatively newer options, suboxone and vivitrol.
But as treatment becomes increasingly patient-centric — and as patients come from diverse backgrounds and cultures — there is a growing need for additional MAT formulations, Curtin said.
“As a treatment provider, having a tool belt that is a little wider, and having more options, is certainly something we would embrace,” he said. “There are so many different pathways to addiction and substance use disorders, so there have to be many different pathways to recovery.”
The pharmaceutical partnership also includes New Jersey-based firms Eisai Inc., Otsuka, Pacira, Chromocell, and Amicus Therapeutics; other companies involved include BMS (Bristol-Myers Squibb), Perdue Pharma, and Pfizer, among others.
Several firms — including Johnson & Johnson and Perdue — now face class-action lawsuits from the attorneys general of a number of states hit hard by opioid addiction, alleging they were irresponsible in how they marketed and promoted the highly addictive pain medicines that have helped fuel the crisis. New Jersey has not joined this litigation.
When asked about the litigation yesterday, Christie said it would be resolved through the legal process and would have been inappropriate to raise the issue in the meeting with pharma leaders. “They wouldn’t have talked about it anyway,” he noted.