The revolving door between FDA and Big Pharma may facilitate the approval of ever more powerful opioids such as Dsuvia. (Pixabay)

Many people claim not to like Big Government. They call it the Nanny State. But private companies and people don’t always act in the

people’s best interests, and No man is an island entire of itself”. Actions have consequences for society as well as for the individual.

Big Pharma—the pharmaceutical giants that develop, manufacture, and market prescription drugs such as OxyContin—have been accused of facilitating the opioid epidemic for profit. Among other things, they aggressively encouraged physicians to prescribe the drugs by claiming they were virtually free of addiction risk. Whether they honestly believed it or lied, they were wrong.

Dozens of US cities and states are now suing Big Pharma for the costs they’ve incurred dealing with the opioid epidemic, including drug rehab treatment, loss of productivity, and deaths. Not everyone believes only Big Pharma is to blame, however. Others responsible parties might include:

  • The doctors who prescribed the medicines, sometimes quite liberally. More than one doctor took advantage of the popularity of these powerful painkillers by becoming “pill mills”, prescribing them to anyone who asked.
  • The people with addictions, not all of whom became addicted to opioids by taking them for doctor-diagnosed pain.

Physicians and patients were eager to believe that truly safe painkillers were out there. It’s been a holy grail since at least the 19th century.

Opium begat laudanum, which led to morphine, then codeine, followed by semi-synthetic and fully synthetic opioids such as heroin. Pain patients, especially chronic pain patients, had long complained that doctors didn’t take their pain seriously and were stingy with their prescriptions.

So the pharmaceutical companies, the doctors, and the patients all had a strong motive to believe and want these opioids to have a low risk of addiction. That’s why the system doesn’t depend only on those three groups. The last guilty party is:

  • The regulatory agencies, such as the Food and Drug Administration, that approved these legal pharmaceuticals.

The regulatory agencies are there to make sure we don’t deceive ourselves about the risks. The opioid epidemic suggests the system has gotten badly out of whack.

How much do you try to “get away with”? That is, how much do you cut corners, seek a loophole in the rules or disregard safety concerns if something is to your benefit, such as more money, less work?

There are at least two answers:

  1. As much as your conscience or sense of ethics allows
  2. As much as you can get away with.

Most of us are not monsters. We don’t want people to die or even suffer much just to derive some benefit for ourselves. The laissez-faire version of business and anti-regulation government oversight supposes that this means most businesses will not want to do anything that will knowingly harm anyone. Fear for the lawsuits or criminal prosecutions they might face would deter them, if not guilty consciences.

Unfortunately, that is not always the case. Humans are capable of convincing themselves of “facts” that may be true in the short term but not the long term. That’s why we have regulatory agencies. Unfortunately, again, these agencies are made up of humans.

Like other government agencies, when FDA workers leave government service they are heavily recruited by the companies they used to regulate. It has been called a revolving door. This is now so well-known that people entering the FDA may be aware that their future job prospects might include a cozy relationship with Big Pharma. It might even temper their regulatory zeal.

Ryan Hampton, author of American Fix: Inside the Opioid Addiction Crisis—and How to End It, charged that “Just last November, the FDA approved one of the deadliest opioids on the market, Dsuvia, which is 1,000 times more potent than morphine and 10 times stronger than fentanyl”, but that is slower to approve medication-assisted treatments for addiction:

  • In December, the FDA shelved an innovative recovery treatment, tentatively approving the medication—finding it safe and effective—but announcing that it could not be marketed or sold in the United States for two years. Over that time, more than 100,000 people will die from an opioid overdose.

Hampton doesn’t specify what treatment he’s talking about. I don’t know how many of those 100,000 lives it might save or how many it might kill. What is clear is that many more new opioids are approved than recovery medications. Sometimes the difference is minor—the same basic drug but with a new delivery system—so that Big Pharma can extend its patent.

Dsuvia is needed, FDA maintains, for battlefield conditions or emergency rooms where IV delivery isn’t practical, and then for only 72 hours max. It will not be available at the local pharmacy and will be so tightly controlled that recreational abuse will not be possible. That’s been said before.

Both ABC News and The White House agree that veterans are twice as likely to suffer an opioid addiction or overdose death. That’s why last October the Department of Veterans Affairs launched “a multi-faceted approach called the Opioid Safety Initiative to reduce the need for opioids”. I hope that approach is considered before Dsuvia.

Big Pharma, physicians, and people, in general, need to be more responsible with addictive opioids, but it would help if the FDA did its job in the first place. Maybe ending the revolving door would ensure that.