Opioid Trail: From FDA to Oxycontin, to MAT & Our Streets | Big Pharma on Blog#42

We’re learning every day, almost, that life has been imitating fiction, from 1984, to Wall Street, to Police State. It was just a couple of years ago that, thanks to Edward Snowden, we learned in a rather spectacular way, that our own government is spying on each and every one of us with Congress’ blessing. We’ve spent the last four or so years witnessing the horrific consequences of the misguided War on Drugs, not only on millions who’ve been caught in the net of criminal justice system gone awry, but we are also finally realizing the extent and scope of our prison-industrial system.

The rise of the police state and prison industrial complex have been taking place within the context of the corruption of the system, with the legalization of money in politics being an outgrowth of the rot, rather than its precursor. Not one of our institutions has been spared from what we now see is generalized corruption. The FDA has long been the subject of discussion and investigation, whether on the process of drug approvals, the revolving door to and from Big Pharma, or the job inspectors are doing when it comes to policing the pharmaceutical industry.

It has barely been three weeks since the Los Angeles Times published its investigation of the makers of Oxycontin. Thanks to their work, we learned about how the drug maker won approval for the opioid, who developed the guidelines followed by doctors in prescribing the drug, the connection to former FDA personnel, and the devastation that has ensued. Oxycontin was touted as the miracle pain drug. “One OxyContin tablet in the morning and one before bed would provide “smooth and sustained pain control all day and all night.”” The trouble with the claim is that, years and several million addicts later, it turns out to have been a lie. The drug not only doesn’t last for that many hours in many who use it, but it is highly addictive. Its maker, Purdue, has made off like a bandit, with $31 billion in revenue and counting, from a cousin to heroin, an illegal substance. From the LA Times’ report:

“The Times investigation, based on thousands of pages of confidential Purdue documents and other records, found that:

  • Purdue has known about the problem for decades. Even before OxyContin went on the market, clinical trials showed many patients weren’t getting 12 hours of relief. Since the drug’s debut in 1996, the company has been confronted with additional evidence, including complaints from doctors, reports from its own sales reps and independent research.

  • The company has held fast to the claim of 12-hour relief, in part to protect its revenue. OxyContin’s market dominance and its high price — up to hundreds of dollars per bottle — hinge on its 12-hour duration. Without that, it offers little advantage over less expensive painkillers.

  • When many doctors began prescribing OxyContin at shorter intervals in the late 1990s, Purdue executives mobilized hundreds of sales reps to “refocus” physicians on 12-hour dosing. Anything shorter “needs to be nipped in the bud. NOW!!” one manager wrote to her staff.”

How did Purdue get this drug approved in the first place? The Times’ investigation further reveals this:

“Dr. Curtis Wright, who led the agency’s medical review of the drug, declined to comment for this article. Shortly after OxyContin’s approval, he left the FDA and, within two years, was working for Purdue in new product development, according to his sworn testimony in a lawsuit a decade ago.”

Dr. Wright waited two years before he joined Purdue in 1997. Fast forward eighteen years and we now have an opioid addiction epidemic of epic proportions, with an estimated 7 million Americans having abused this drug. Now, in the wake of these revelations, months of media reports about the addiction epidemic, deaths due to overdose, perhaps even including artist, Prince, regulatory agencies at the state and federal level are rushing to finally deal with the catastrophe that is Oxycontin.

Is the way this new crisis is being dealt with any different than how it started in the first place? We are about to jump in with both feet and eyes blindfolded into the age of Medication-Assisted Treatment (M.A.T.). In, Addicted To a New Treatment For Addiction, a new op-ed in the New York Times, Beth Macy writes:

“Like methadone, Suboxone prevents “dopesickness” and reduces cravings, without getting you high. It is now the gold standard for opioid addicts in medication-assisted treatment, or M.A.T. A combination of the opioid buprenorphine and the anti-overdose drug naloxone, Suboxone is supposed to give addicts a chance to get their lives together before they taper off it.”

Suboxone is one of two drugs in Probuphine, a new drug delivery system that was just given approval by the FDA, for treatment of opioid addiction. This delivery system is an implant that delivers the drug throughout the day, over a period of months. Back to Macy’s article:

“But Suboxone can get you high if you inject it or snort it or take it in combination with benzodiazepines, a sometimes fatal blend.”

Given what we know about the way Oxycontin became an epidemic and, given what we know about what goes into Probuphine, how wise is the decision to approve the implant for general use without very strict policy guidelines? How likely is it that we are about to compound a disaster with a new one?

The parallels don’t stop with the drugs themselves. In a press release by the maker of Probuphine we learned that:

“Braeburn Pharmaceuticals, today announced that former FDA Commissioner Frank E. Young, M.D., Ph.D., has joined the management team as Executive Vice President, Clinical and Regulatory Affairs. If approved, Braeburn’s first product will be Probuphine®, a buprenorphine implant for the maintenance treatment of opioid addiction, currently under review at the U.S. Food and Drug Administration (FDA).”

Dr. Frank E. Young, Braeburn Pharmaceuticals’ new recruit, is no stranger to controversy. The New York Times, in an article way back, during the Bush administration, reported on problems with Young:

“The Bush Administration has shifted Food and Drug Commissioner Frank E. Young to a less influential job created for him at the Department of Health and Human Services. … Dr. Young’s immediate supervisor, said he asked the commissioner to leave his position and to accept the new job, citing a variety of reasons, including discovery of corruption in the agency’s regulation of generic drugs.”

History appears to be repeating itself, exactly in the same manner as in 1997. How will those who opt for the implant be kept safe from the risk of relapsing into addiction and giving into urges they cannot control? How can we prevent implant recipients from taking drugs, both legal and illicit, in addition to the drugs released by the implant? How do we ensure that implant recipients are not prescribed contraindicated medication by a doctor who is unaware of the implant, in a medical environment in which there rarely are communications between treating doctors? Is treating opioid addiction in this manner wise, given everything we know?

The treatment of pain is a serious issue. Treating pain without inflicting addiction in the process is now an emergency. Problems with Oxycontin were known about two years after its approval. We need to find a way to ensure the FDA no longer is a part of the problem of dangerous drugs being approved for general use due to greed and corruption. While pain management must be provided, particularly for those with chronic and terminal conditions, powerful and addictive drugs should never have been approved for wide use. Pharmaceutical companies are in their business to make money. The FDA should be in its business to make sure the population it serves isn’t harmed by Big Pharma and unscrupulous board executives. The ability to move in and out of the revolving door between Big Pharma and agencies like the FDA, the CDC and many others, must be removed. There are many disciplines in which the professional track is either private industry or civil service. Service in the medical areas of government should preclude taking a sabbatical to fill one’s pockets and then resume a civil service career. The corruption window needs to be hermetically shut.

Let’s not turn the current opioid emergency situation into an unrecoverable disaster. Let’s think this through.