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OpinionEditorial

Tougher regulation is needed to put people before profits

So many tragic deaths to opioids testify to the failure of government

Photo Credit: Getty Images/iStockphoto/VladimirSorokin

In 2001, scientists hired by Johnson & Johnson informed the drugmaker that its marketing messages to promote opioids in general, and Duragesic, the company’s high-strength opioid painkiller, were false, dangerous and should not be used.

The company, which produced about 60 percent of the ingredients in all opioid medications in the United States, including its own line of painkillers, ignored the advice and increased its sales and marketing efforts. It created the Let’s Talk Pain Coalition and website to convince doctors and patients that pain was undertreated and opioids were not an addiction danger. Johnson & Johnson also encouraged doctors running “pill mills,” who already were prescribing vast streams of opioids to addicts and black-market resellers, to prescribe even more.

Johnson & Johnson even pushed the concept of “pseudo-addiction,” an unsupportable argument that patients exhibiting tendencies like drug-seeking, craving and erratic behavior did so because they were undermedicated and needed more high-powered pain medication. It was an astonishingly deadly tactic, one that other opioid producers like Perdue Pharma and Teva Pharmaceuticals also pursued even as their own advisory panels told them not to.

An Oklahoma judge awarded that state $572 million on Monday, to be paid by Johnson & Johnson, as compensation for damage from the company’s conduct. Earlier this year, Perdue Pharma agreed to pay Oklahoma $270 million and Teva Pharmaceuticals agreed to pay the state $85 million. The court ruling prompted Perdue’s controlling Sackler family on Tuesday to make a $12 billion universal settlement offer to end thousands of lawsuits filed against 22 opioid manufacturers by states and localities, including New York and Suffolk and Nassau counties. The awards, whatever they end up being, should prove helpful in getting a handle on the prevention and treatment of addiction.

An awful toll of lives lost to opioids

But more than 6,000 Oklahomans have died since 2000 of opioid overdoses, and more than 400,000 Americans have died from overdoses related to opioids since 1999, 25,000 of them in New York State. If the way our nation handles regulatory oversight doesn’t change dramatically, such tragedies will continue.

The division of the Food and Drug Administration responsible for approving opioids gets 75 percent of its budget and nearly all of its information on drug danger and effectiveness from drug companies. It has ignored its own scientists and approved dangerous drugs under heavy lobbying from the companies. That’s not so different from the Federal Aviation Administration letting manufacturers take lead roles in certifying that their own aircraft are safe, a practice that’s been criticized in the deadly crashes of faulty Boeing 737 Max 8 aircraft, or from the Environmental Protection Agency’s reliance on polluters to police themselves.

Companies frequently pursue profits at all costs. Too often, those costs are counted in caskets. When companies like Johnson & Johnson endanger people in pursuit of profit, they should be heavily fined and criminally charged if the facts warrant.

But preventing deaths is better than responding to them. To do that, U.S. regulatory agencies must demand extensive information and evaluate it independently, valuing safety over the influence of corporations.

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