For the second time in as many decades, one of our most regulated businesses takes the fall for politicians who are supposed to keep an eye on it. In a script right out of the financial crisis, political leaders and regulators encouraged drug companies to develop effective pain killers and made it imperative to prescribe them. When it started to go wrong, they acted like Captain Renault in the movie Casablanca, who walked into the casino saying, “I’m shocked, shocked there is gambling in this establishment.”
There’s nothing like a stiff penalty to arouse the public’s condemnation.
When the government wants to identify the culprit, there’s nothing like a stiff penalty to arouse public condemnation. During the financial crisis, Obama’s Dept. of Justice AG Eric Holder hit the banks with a quarter trillion dollar fine that galvanized people into thinking banks were 100% responsible. By the following day, bankers were pariahs while mortgage securitization cheerleaders Senator Chris Dodd and Congressman Barney Frank walked away with their names embossed on legislation. Now Big Pharma is in the frame after the recent drubbing in the Oklahoma courts, and once again, Eric Holder plays a pivotal role.
Where The Money Is
In the recent case, the State of Oklahoma was awarded nearly $600 million for claims that Johnson & Johnson helped cause the opioid epidemic. It was a litigation win, as the liability could have been as high as $17 billion. But it was an ethical defeat because the company shouldn’t have been a plaintiff or at least at the end of a long line of alternates, including the federal government, the FDA, and the hospital industry. According to the New York Times, J&J accounted for under 1% of the opioid drugs prescribed by Oklahoma’s doctors. But it was hit with the most substantial penalty of any company, including the actual developer of Oxycontin, Purdue Pharma. But as the famed bank robber, Willie Sutton, explained, “the reason I rob banks is that’s where the money is.” Likewise, when Purdue threatened Chapter 11 bankruptcy making it resistant to liability, Oklahoma targeted J&J because of the company’s deep pockets.
There was a widespread belief that the presence of pain eliminated the odds of addiction.
The War On Pain
The opioid problem dates back to several decades ago. It was a time when the medical establishment recognized unmitigated pain is no longer acceptable. It sent the signal to the nation’s drug companies that they had a responsibility to find a remedy, and opioids were the answer. Don’t let the term ‘opioid’ confuse you because of “illegal opioids” like heroin and Fentanyl, which are the source of most overdoses. Legal painkillers like Vicodin and Oxycontin were standard post-surgical care prescribed by doctors. How they went from miracle drugs to a social epidemic is the common refrain about good intentions gone wrong.
During the 1900s the United States shifted from “opiophobia” or a reluctance to prescribe pain-killing medications, according to the National Institute of Health or NIH, to one of pain elimination. Despite two horrific World Wars in which millions suffered from grave and painful injuries, the country continued to treat painkillers as forbidden fruit until around 1985. The medical establishment did an about-face and urged changes in the “state of under-reliance of opioid analgesics and a resultant under-treatment of pain.”
The scientific community urged political leaders to address pain undertreatment, especially in non-cancer conditions. At the time, there was a widespread belief that the presence of pain eliminated the odds of addiction. By 1990, the World Health Organization and prominent medical scientists, according to the NIH, “questioned why opioids were reserved solely for cancer pain and avoided entirely in chronic pain states.” The problem was that fatal cancer pain specialists were influencing decisions about “chronic, non-cancer pain, that equated the etiologies of malignant and non-malignant pain.” The cancer specialists were dealing with palliative care — treatment for pain to enhance the quality of life of terminal patients. Opioid addiction was not something they had to be overly concerned about. Government interference ensured that was about to change.
When doctors meet lawyers, the lawyers always win.
The Veteran’s Health Administration and the Federation of State Medical Boards and the Drug Enforcement Agency also issued statements promising less regulatory scrutiny over opioid prescribers and opioid analgesics. “Physicians were now mandated to provide adequate pain control, resulting in a heavy reliance on opioid medications. The fear among hospital administrators was that if new benchmarks were not met, they were unlikely to receive federal healthcare funds.” If you get a survey every time you see your doctor, this is evidence of the data madness affecting healthcare. Those surveys result in patient satisfaction scores which govern everything from reimbursements to pay raises. It became a simple algorithm: more pain, less patient satisfaction, equals more opioids.
Society then took a fatal step. According to the NIH: “not prescribing opioids for a patient with pain risked being labeled as inhumane, often even to the extent of litigation for the under-treatment of pain.” When doctors meet lawyers, the lawyers always win. The choice of a lawsuit or prescribing more pain killers seemed like an easy decision.
As painkiller medication prescriptions mounted, we began to see a rise in addiction, but also a shift to cheaper illicit drugs like Heroin and Fentanyl, whose potency was uncontrolled. That is what led to massive overdoses and related deaths, rising as high as 64,000 by 2016.
The lawyer for Oxycontin requested that the court seal the settlement records. The lawyer’s name was Eric Holder.
Holder’s Sealed Records
The New York Times reported the crackdown on opioids began about the time awareness of the damage surfaced. In 2007, the maker of Oxycontin, Purdue Pharma, pleaded guilty to felony charges for misleading doctors in its marketing. Allegations suggested Purdue “intentionally” downplayed the risk of addiction posed by OxyContin and misled both physicians and the healthcare industry by overstating the benefits of opioids for chronic pain. The company agreed to pay a total of $634.5 million to resolve Justice Department investigations. For reasons unknown at the time, court records were not made public until the Los Angeles Times unearthed the details in a special report in 2016. “The newspaper found that Purdue had evidence of the problem for more than two decades, but continued to insist the drug lasted 12 hours, in part, to protect its revenue.” The effect of sealing the records from public scrutiny only delayed treatment of this vast epidemic.
Who was the attorney that requested that records were hidden from public scrutiny? According to Kathleen Frydl, a writer on government and healthcare, the Oxycontin lawyer was a partner at Covington and Burling, our future Attorney General, Eric Holder. Then she notes, “While serving as Attorney General of the United States, Eric Holder knew what Purdue Pharma did and he did nothing.” Frydl believes Obama and Holder should “go down in history as oblivious to or complicit in the predations of financial capitalism, and the opioid crisis.”
The opioid epidemic is a drug war — as in drug cartels — not drugstores.
The Cycle of Good Intentions
When the country veers towards a crisis, the scandalmongers look for a scapegoat. The story plays out in much the same way regardless of the era or the sector. The first step is the federal government encourages a sector to respond to its demands, and that ignites the chain of events. In the opioid case, the risk of poor patient satisfaction or liability resulted in hospitals encouraging painkiller relief across a much broader spectrum of cases. The reaction by the pharma industry was to market aggressively, and if scientific evidence confirmed safety was not in jeopardy, more became better. In a regulated business such as healthcare, gatekeepers like physicians felt the same way, and overprescribed painkillers to achieve higher levels of recovery.
The result became painfully obvious: overdosing. It was as true of financial instruments in the mortgage crisis as it is of opioids today.
A further tragedy is that eliminating legal opioid prescriptions will do little to shift the dangers. According to the NIH, deaths by illicit opioid overdose continue to escalate at alarming rates: of the 64,000 people who died from drug overdoses in 2016, 42,000 were opioid-related. Overdoses from illegally manufactured fentanyl represent 20,000 of those; heroin accounted for 15,000. The opioid epidemic is a drug war — as in drug cartels — not drugstores.
Unfortunately, that trend will be unaffected by Oklahoma’s verdict.
*Holder has a background of defending bizarre criminal activity. He defended the NFL’s role in the animal cruelty case against Michael Vick.