As Big Pharma rivals battled to hype opioids, watchdogs dozed. They slumber still.

cdc-opi-aug-300x227When Big Pharma pursues rapacious profits and regulators snooze, patients suffer terrible consequences, as new revelations about the opioid crisis show.

Kaiser Health News Service , via the Washington Post, and The New York Times both have done excellent investigative digging into drug makers’ role in fueling the prescription painkiller mess that authorities estimate claims 116 lives a day due to overdoses.

Fred Schulte, writing for the independent, nonpartisan Kaiser service, reported that rival makers — seeing how much money Purdue Pharma was making with its powerful and addictive OxyContin drug and that it was encountering law enforcement and regulatory challenges — stepped in with “similarly dangerous painkillers, such as fentanyl, morphine and methadone.”

Based on internal Purdue marketing documents, Schulte says the leading opioid maker at the time saw “its biggest competitors were jockeying for market share. Some of those drug makers’ sales promotions downplayed or ignored the risks of taking opioids, or made false claims about their safety, federal regulators have asserted in warning letters to the companies.”

He also reported:

Purdue’s marketing reports indicate the company was worried about losing business to fentanyl-laced patches called Duragesic, as well as morphine pills and, to a lesser degree, methadone — which some managed-care groups and Medicaid health plans preferred because it cost much less than OxyContin. Methadone and morphine are made by a variety of drug companies.

With Purdue seeking to protect what peaked at $1 billion in 2000 OxyContin sales, the company launched into big-spending advertising, marketing, and promotional efforts to fight off rivals like Janssen Pharmaceuticals, an arm of drug giant Johnson & Johnson.

Regulators from the federal Food and Drug Administration, at various points, looked with some alarm at the drug makers’ escalating claims for the utility, safety, and effectiveness of prescription painkillers and their synthetic variety, fentanyl.

But as the New York Times reported, the watchdogs also slumbered as abuses burgeoned, including with widespread, dubious, off-label prescribing of a potent and “fast-acting class of fentanyl drugs approved only for cancer patients with high opioid tolerance.”

Dr. Andrew Kolodny, an opioid policy researcher at Brandeis University, commented to the newspaper about lax oversight of “quick-absorbing fentanyl sprays, tablets and lozenges called TIRFs (for transmucosal immediate-release fentanyl),” that, “If any opioids were going to be tightly regulated, it would be these. They had the fox guarding the henhouse, people were getting hurt — and the FDA sat by and watched this happen.”

The painkillers packed a wallop and were sold under brand names like Actiq and Fentora, made by Cephalon, and Subsys, made by Insys Therapeutics. They were supposed to be given to cancer patients only, and only under rigorous supervision when individuals suffered jolts of overpowering pain. Instead, the drugs were promoted and prescribed for chronic pain in patients with afflictions other than cancer, such as back injuries.

Patients were not warned about strict safety monitoring and use regimens that were supposed to accompany use of the painkillers, which can cost as much as $30,000 a month.

Overdoses and deaths occurred. Researchers at the Johns Hopkins Bloomberg School of Public Health worked with the New York Times to expose this aspect of the widening opioid crisis.

In my practice, I see not only the harms that patients suffer while seeking medical services but also the calamities that can be inflicted on them by defective and risky products and especially by dangerous and costly drugs. Doctors, hospitals, insurers, regulators, lawmakers, and Big Pharma all bear a share of the shame and blame for the wreckage of the opioid crisis and its consequent wave of deaths due to overdoses of legal and illegal drugs. They all must step up to remedy the harm.

It becomes clearer by the day that, while drug makers raked in giant profits and have largely escaped hardship for the dubious actions, patient continue to suffer in the opioid crisis, including those with chronic pain and now struggles to get legitimate medication relief.

It’s also unacceptable that doctors may be turning to other risky pain therapies, including resuming injections near the spine of Depo Medrol. That’s an anti-inflammatory drug that practitioners long shot up patients with (or its generic equivalents), purportedly to ease their “painful backs, necks and conditions like spinal stenosis,” the New York Times reported. But Pfizer, the medication’s maker, the newspaper reported:

[F]aced with hundreds of complaints about injuries and complications related to the shots, asked the Food and Drug Administration to ban that type of treatment five years ago. The company cited the risk of blindness, stroke, paralysis and death — a request that neither the agency nor Pfizer made public. The FDA declined to issue a ban but toughened the label warning. Other countries — among them Australia, Brazil, Canada, France, Italy, New Zealand and Switzerland — heeded Pfizer’s request.

C’mon, FDA, get it together and protect patients, as the agency’s supposed to. In a situation involving a problem affecting so many Americans (back pain), and as the nation’s in the throes of combatting the opioid crisis, the return of orthopedic “drill mills” to enrich Big Pharma and sketchy practitioners beggars belief.

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