Untouchable? No equality in sale of drugs

Since when can a defendant plead guilty in a court of law to knowingly misleading the public about a drug that has led to thousands of deaths, hundreds of thousands of addicted people and spawned street sales reaching millions — and the perpetrators count the millions they’ve reaped, rather than the days behind bars?

Such is the beguiling and maddening nature of American laws.

As the nation sinks deeper into the slow nod of the opioid crisis and lawmakers seek solutions to addictions that have destroyed families and financially decimated communities across the U.S., it raises a legitimate question that nobody is talking about: why aren’t the executives and top-level management who are responsible for this crisis not held criminally as well as financially liable?

By their own admission, drug manufacturers misled the public on the dangers of oxycodone, Vioxx and Bextra and a host of other drugs that either enabled or killed users while they reaped billions — and left behind the damage for us to clean up after paying paltry fines that amount to little more than a cheap tip against the health care bill that is being presented to the taxpayer.

And it is a bill that is going to keep on climbing as more people become addicted and more resources are needed, squeezing cities and towns already grappling with deficit budgets and stealing away a generation of workers who will be — at least for a period of time — a drain on the system.

We can debate all day long as to whether or not CEOS and drug manufacturers should be held criminally liable, but what should not be a debate is whether they should be held financially responsible.

Here in Connecticut, where oxycodone was given birth, the opioid crisis is a snapshot of what’s going on around the nation. By now, the numbers are familiar to Nutmeggers but they bear repeating because they keep on climbing and people keep on dying.

More than 917 people in the state died of overdoses in 2016, an increase over the 729 who died in 2015. That is a lot of lost promise.

Overall, in the United States, more than 183,000 have died from overdoses related to prescription opioids during the last 16 years, including more than 33,000 in 2015. More troubling, a 2013 study found 6,973,000 used oxycodone for non-medical reasons and abuse of the drug remains steady.

Much of this could have been prevented.

But since 2002, there appears to be a disturbing willingness by drug manufacturers to put the public at risk, resorting to illegal tactics to see their product in medicine cabinets and their profits rise.

According to the US Department of Justice:

In 2009, Pfizer paid $2.3 billion for claims involving Bextra and other drugs. It was Pfizer’s fourth settlement over illegal marketing activities since 2002.

Whistleblower John Kopchinski, a former Pfizer sales representative, told the Department of Justice “the whole culture of Pfizer is driven by sales, and if you didn’t sell drugs illegally, you were not seen as a team player.”

In November 2011, Merck agreed to pay a fine of $950 million related to the illegal promotion of the painkiller Vioxx, which was withdrawn from the market in 2004 after studies found the drug increased the risk of heart attacks.

GlaxoSmithKline agreed to pay a fine of $3 billion in July 2012 to resolve civil and criminal liabilities regarding its promotion of drugs, as well as its failure to report safety data.

Johnson & Johnson in 2013 agreed to pay a $2.2 billion fine to resolve criminal and civil allegations relating to the prescription drugs Risperdal, Invega and Natrecor.

So, again and again drug executives admitted the public had been put at risk.

So, why are they untouchable? Why aren’t they, too, in handcuffs?

John Thomas, a professor of health care law at Quinnipiac University, said “the big difference is called the Federal Food and Drug Administration.”

“They (drug manufacturers) received approval and the FDA concluded the product was safe for its intended use,” he said.

Thomas said a major problem is how the product is marketed with insufficient information available to the public. He points out while warning labels may call attention to side effects such as drowsiness, they fail to point out the danger the product presents.

“It doesn’t say easily addictive,” he said.

Now police have been turned into medical techs along with friends and family who are armed with naloxone in an effort to prevent people from overdosing. Hospitals are overwhelmed with more than 180,000 addicts in California alone seeking help in emergency room visits a year, according to California-based The Hills Treatment Center.

Last year, the Connecticut Department of Public Heath distributed 9,200 kits with naloxone to its five syringe programs at a cost of $216 per kit, according to Maura Downes, communications director. So far, 140 lives were saved. EMS and police and others get their own naloxone supplies. Some action is being taken. Connecticut Attorney General George Jepsen, who said opioid use has had “a devastating impact in Connecticut,” announced Thursday the state is working with a bipartisan coalition of attorneys general from across the country on an ongoing investigation to evaluate whether pharmaceutical manufacturers have engaged in unlawful practices in the marketing and sale of prescription opioids.

Jepsen said it is unknown “whether our efforts will lead to legal action or relief, but Connecticut residents can be assured that we will pursue this investigation fully.”

Ohio Attorney General Mike DeWine is also going after drug manufacturers for the “thousands and thousands of Ohioans — our friends, our family members, our co-workers, our kids — addicted to opioid pain medications, which has all too often led to use of the cheaper alternatives of heroin and synthetic opioids.”

He has filed lawsuits against Purdue Pharma, Endo Health Solutions, Teva Pharmaceutical Industries and its subsidiary Cephalon, Johnson & Johnson and its subsidiary Janssen Pharmaceuticals, and Allergan. DeWine will argue in part that “these drug manufacturers led prescribers to believe that opioids were not addictive, that addiction was an easy thing to overcome, or that addiction could actually be treated by taking even more opioids.”

And acknowledging the opioid public health crisis, the FDA recently released a statement asking the maker of Opanna to stop selling reformulated Opana ER, or oxymorphone hydrochloride, because “the benefits of the drug may no longer outweigh its risks.” That’s a first. Thomas said our elected officials must take a look at the approval process and the dangers the product presents — and if drug manufacturers continue to sell the products without the necessary safety precautions, “then they should be held accountable.”

Drug manufacturers produce some wondrous products that have saved lives, helped ease the healing of those in pain, and allows many people to cope and function with day-to-day activities. Indeed, the drugs in this column are among them. That is not in question. Misleading the public about the extent of their dangers is.

One of the things people learn early on is that life isn’t fair. How unfair? On my desk is a press release about another street-level drug dealer who was just sentenced for selling fentanyl-laced heroin to someone who overdosed and died. His home is now four walls behind steel doors. Maybe others do, but I see no difference between him and suited-executives who sell their drugs behind the mask of the greater good.

All of them belong behind bars.