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Did the FDA overestimate the need for the synthetic heroin painkiller Zohydro?

MedPage Today published a letter by Victor Dzau MD on July 14, 2015 that defends the support by the Institute of Medicine (IOM) of the FDA’s release of Zohydro, a pure form to synthetic heroin. The statistic used by IOM to defend the release of Zohydro, which is now the most potent pharmaceutical pain killer, is that 100 million adult Americans suffer from chronic pain. That is about 40% of the adult population.

The high price of pharmaceutical pain killers has led to increased heroin use
Photo by Spencer Platt/Getty Images

IOM wrote the report for the National Institute of Health (NIH) that was released on June 26, 2014 that is titled Advancing Pain Research, Care, and Education. The Affordable Care Act (ACA) directs that IOM is to be used by the FDA to improve the impartiality of FDA drug decisions and to increase the literacy of ACA clients in making medical decisions, including the use of pharmaceutical drugs.

Dr. Drau wrote a letter to MedPage Today to respond to an article by John Fauber of the Milwaukee Journal Sentinel that was published on June 25, 2014. The title of the article by Fauber was Chronic pain statistic called exaggerated, misleading.

Fauber’s article focuses on the correctness of the estimate that there 100 million chronic pain in the US, and the possible conflicts of interests by the members of the IOM committee that supported the FDA’s decision to release Zohydro.

The estimate of 100 million chronic pain suffers originated from the Group Health Research Institute in Seattle. The Institute of Medicine report was titled, Relieving Pain in America, A Blueprint for Transforming Prevention, Care, Education, and Research.

The person that co-authored the original research that was referenced by IOM was pain expert Michael Von Korff, a senior investigator with Group Health Research Institute. Von Korff had this to say about IOM using his information to justify the need for Zohydro.

Nobody asked me about it before they used it. About 20% to 25% of adults are substantially impaired by chronic pain, and a smaller number – about 10% to 15% - have substantial work disability because of chronic pain.

This would reduce the justification to approve Zohydro from 100 million to about 25 million people with debilitating pain. That is still a large number of people needing strong pain killers, but substantially less than the IOM's figure used in the recommendation to release Zohydro. Some pain experts are recommending that the potency of Zohydro be reduced significantly due to overdose potential and the attractiveness of the current formulation for abuse.

The Journal Sentinel/MedPage Today investigation found that nine of the 19 experts on the IOM panel that produced that report had connections to companies that manufacture narcotic painkillers in the 3 years prior to their work on the report. Some were officers or board members of groups that received pharmaceutical company funding, others were drug-company consultants or were paid for educational programs funded by companies that make pain drugs. These connections were criticized by Fauber as compromising the impartiality of the IOM committee's recommendations to release Zohydro.

Dr. Dzau defended the committee members in his letter to MedPage Today.

The nation is fortunate to have so many distinguished experts willing to volunteer their time to serve on dozens of the study committees that the IOM convenes to produce evidence-based, peer-reviewed reports on a variety of critical health policy challenges. We stand by our report, the committee, and the process that produced it. It has drawn the attention of policymakers, doctors, and the public to a serious medical problem -- chronic pain -- that had previously been demeaned or simply ignored.

The abuse of prescription painkillers is at epidemic proportions. Zohydro fills a need for those suffering from chronic pain that occurs in case of injury or debilitating terminal illnesses such as bone cancer. Abuse of opiates and synthetic opiates has reached into all areas of society from doctors to the suburbs of America. Doctors have been abusers and they have made substantial income running pain centers with high volumes of pain killers beyond the needs of legitimate chronic pain users.

This problem of bogus prescription dispensing by “pain doctors” has specifically been targeted by the Ohio attorney general, Michael DeWine. Several doctors have been tried, convicted, sent to jail and had their licenses revoked in Ohio because they were prescribing pain pills that were then sold on the street. Ironically, the growth of heroin use is directly tied to the fact that heroin is less expensive than Oxycodone, Percocet and other prescription pain killers.

Striking a balance between providing Zohydro and other powerful pain killers to those that truly need them has to be weighed against the abuse potential of these drugs and the risk of overdosing of legitimate and street drug users. Tight control of dispensing by doctors and careful monitoring of the users is part of the solution to keeping Zohydro use restricted to its original purpose, which is to reduce pain and suffering in people with extreme conditions.

It is unlikely that 40% of adults are in chronic pain. If the Institute of Medicine based its estimates on the number of prescriptions for major pain killers, that could explain this high estimate. There are a lot of people getting existing opiate-based pain killers that are not in chronic pain.

It is now up to the FDA to determine how to regulate all of the opiates and opiate derivatives to get the pain killers to those that need them and away from those that abuse them. When Zohydro is diverted to the streets, a lot of people are going to die. The challenge is how to minimize Zohydro abuse while making the drug available to those that truly need it.