Opioids & The Myth of Unintended Consequences

“Science can be Pandora’s beautiful box,” Paul A. Offit, M.D., writes in Pandora’s Lab: Seven Stories of Science Gone Wrong. “Our curiosity about what science can offer has allowed us, in some cases, to unleash evils that have caused much suffering and death.”

In this compelling book, Dr. Offit tells seven nonfiction stories about scientific discoveries that have changed our lives for better and for worse. As he explains, “All of these stories are united by a myth that dates back to 700 B.C. — the myth of unintended consequences.”

In the first chapter, entitled “God’s Own Medicine,” Dr. Offit focuses on the discovery of opium derivatives — opiates and opioids — juxtaposing their immensely important pain-relieving value against the tragic consequences of their highly addictive and potentially lethal qualities.* He writes, “Opioid overdoses [are] now the leading cause of accidental deaths in the United States,” with prescription painkillers resulting in a person’s death every 19 minutes.

Dr. Offit’s main point is that these drugs were developed and marketed broadly to the public without much data on their addictiveness and lethality, concluding: “If you’re going to medicate a nation, at the very least you should base your recommendations on a mountain of evidence, not a molehill.”

In my opinion, the fact that pharmaceutical companies distributed and marketed these drugs without complete data—and then continued to market these drugs as “safe” even when the harm was evident—suggests that the tragedies that have ensued are not merely the unintended byproduct of scientific curiosity. They are the result of intentional conduct, which includes recklessness and willful ignorance.

As my other half (also an attorney) says:

Pharmaceutical companies that make dangerous products are no different from drunk drivers. No one who works at a pharmaceutical company wants a consumer to get hurt, to become addicted, or to die, but their executives ignore foreseeable risks when they use scant and misleading information to develop, manufacture, distribute, advertise, and sell drugs, and when they choose to ignore the consequences. Similarly, a drunk driver doesn’t want to kill anyone. They just want to get home. Both should be held accountable for the tragic consequences that result from their reckless conduct.

In the case of OxyContin, for example, Purdue Pharma intentionally disregarded the risks associated with the drug and misbranded it to make money.

Dr. Offit mentions the 2007 criminal and civil charges against Purdue Pharma, writing:

On May 10, 2007, Purdue Pharma, along with three company executives, pleaded guilty to one count of ‘misbranding’ OxyContin. The court ruled that Purdue had minimized risks, made unsubstantiated claims, and failed to include clear warnings about how, under certain conditions, the drug could be fatal… The three executives were fined $34.5 million (which Purdue paid), barred from working for any company that sold medical products for the next 12 years, and required to perform 400 hours of community service in drug-treatment centers. Purdue also paid an additional $634 million penalty.

The lawsuits against Purdue (and other opioid manufacturers) continue to happen: In 2015, Purdue settled claims with the Kentucky Attorney General and the New York Attorney General. In 2017, New Hampshire joined other states in suing Purdue for its deceptive practices (See complaint here/PDF). The drug companies have asked for the lawsuits to be thrown out, claiming that, even if the allegations are true, they can’t be held responsible for the damage.

But executives in the company have generally avoided prison time, unlike drunk drivers whose conduct is similarly reckless but often less deceptive. Instead, pharmaceutical companies get off easy. They pay a little bit of money for the harm they cause, and then make additional profit by selling drugs to “fix” the epidemic they had a hand in creating, disregarding new risks along the way.

Consider this excerpt from Drugmakers Push Profitable, But Unproven Opioid Solution on the States, Phila. Inquirer (Dec. 16, 2016):

Pilloried for their role in the epidemic of prescription painkiller abuse, drugmakers are aggressively pushing their remedy to the problem: a new generation of harder-to-manipulate opioids that have racked up billions in sales, even though there’s little proof they reduce rates of overdoses or deaths.

[…]

The latest drugs – known as abuse-deterrent formulations, or ADFs – are generally harder to crush or dissolve, which the drugmakers tout as making them difficult to snort or inject. But they still are vulnerable to manipulation and potentially addictive when simply swallowed. National data from an industry-sponsored tracking system also show drug abusers quickly drop the reformulated drugs in favor of older painkillers or heroin.

The drug companies have immense lobbying power, and they’ve managed to convince well-intentioned lawmakers that requiring insurance companies to cover unproven abuse-deterrent opioids is part of the solution to the opioid crisis.

Will this coverage do anything other than line the pockets of Purdue and other companies? Will it cause more harm? Last June, an article in The New England Journal of Medicine noted that the evidence supporting ADFs was ambiguous, that nearly half of physicians wrongly believed ADFs were less addictive, and that ADFs do nothing to stop the most common form of opioid abuse, which is to take a larger dose than was prescribed.

I’d feel more comfortable about turning to our drug manufacturers for a new drug to solve the crisis they created if we had more than a “molehill” of evidence in support of it.

_______________

*On the difference between opioids and opiates, Dr. Offit writes: Opioid refers “to synthetic forms of opium, like oxycodone. Morphine and codeine, which can be purified directly from opium without modification, are called opiates.”

6 comments

  1. I hate how company executives get away with reprehensible behavior and I’m also really not a fan of how often scientists are represented in pop culture by people who make these immoral decisions. I like to think they’re by far the minority!

  2. This is infuriating. I don’t get why these people have so much money that they need so much more that they’re wiling to hurt people to get it. Ugh.

  3. I live in Indiana, and I’m not sure why, but we’re a very conservative state full of addicts. We have some of the worst numbers in Opioid addiction, and there’s a county in southern Indiana in which 190 people (out of a population of 4,000) were found to have HIV thanks to needle sharing. I know one of your other commenters said people should be partially responsible and that she didn’t take a pill marked “may cause addiction,” but then wouldn’t she ask why the doctor prescribed the pills in the first place?

  4. I don’t know, obviously many if not all of of these Pharm companies are just all about money. I guess it’s better than when crack was ignored and looked at as a black people problem, so they just threw people in jail. I’m glad they are looking into opiates/opiods.

    Doctors are really not wanting to give out these kinds of pain meds. They go in this data base to be sure you aren’t doctor shopping. I’m good with that. It keeps me who has almost never been given any pain meds maybe 3-4 from the dentist. And for 2 days after I had surgery on a broken ankle. I have chronic pain. I have been doing physical therapy for years. The doctor for my rotator cuff injuries said I might get pain shots. But even that I doubt I will get. I don’t have ANY problem with better warnings, both from the doctor and on the container itself. I guess we will have to see what happens.

  5. A drug’s addictiveness is only part of the problem. I’ve had Tylenol 3 (codeine) in the house all my adult life. I have never become addicted to it. I’ve always used it carefully and only when I need it. Recently I was given ten painkilling pills that came with the warning, “User may become addicted.” I refused to take them. Patients have to claim some responsibility for their health choices, but Big Pharma needs to do the same.

    The other part of the problem is the massive income inequality in this country. People need affordable, safe places to live and jobs that pay them enough to live on. The system is broken, thanks to unbridled greed at the top. Citizens aren’t getting the help they need to live productive lives. Who wouldn’t want to escape when the future is black and there is no hope?

    1. “Recently I was given ten painkilling pills that came with the warning, “User may become addicted.” I refused to take them. Patients have to claim some responsibility for their health choices, but Big Pharma needs to do the same.”

      It almost sounds like you’re arguing that your doctor prescribed the 10 pills to test you and how responsible you are.

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