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FDA Pulls Addictive Opioid Pain Med off the Market as Lawsuits Against Pill Manufacturers Pile Up

Posted on: July 18, 2017 | by: Consumer Safety Law August 8, 2017


On July 8 – in a first of its kind decision – the Food and Drug Administration (FDA) requested a pharmaceutical company to pull off the market one of its opioid products “due to the public health consequences of abuse.” In response to FDA pressure, Endo Pharmaceuticals has said it will voluntarily stop selling its addictive pain medication, reformulated Opana ER (oxymorphone hydrochloride).

According to the director of the FDA’s Center for Drug Evaluation and Research (CDER), Janet Woodcock, the abuse of Opana ER is associated with the recent eruption in cases of HIV and Hepatitis C. “The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak.” Removing this dangerous drug from the market, Woodcock believes, “will protect the public from further potential for misuse and abuse of this product.”

Ultimately, however, Opana ER is but one of many such opioid pain medications on the market, and thus far from the only product wreaking havoc across the country.

FDA Commissioner Scott Gottlieb, said the agency “will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse.”

The FDA’s concern for “the misuse and abuse” of opioid painkillers reflects a nation coming to grips with a public health crisis. How did millions of prescription pills end up in the wrong hands?

The truth is these drugs were marketed by pharmaceutical companies, like Endo, to doctors and other medical professionals as a safe and non-addictive form of treatment for chronic pain. This “wonder drug” marketing was a lie. And while this lie generated record profits for Big Pharma (Endo is now worth an estimated $7.5 Billion, for example), it played a leading role in the human devastation recorded every single day in headlines across the United States.

Now, as the communities struggle to pick up the pieces, these same pharmaceutical companies are saying they share neither the burden nor the blame.

Since nothing could be further from the truth, cities, counties, states, and tribes are taking opioid pushers to court. After years of deceitful profits, companies like Purdue, Teva, Johnson & Johnson, Janssen and Endo will now have to answer for their blood money.

The Human Cost of the Opioid Epidemic – Victims, Survivors and Communities

According to a recent and startling New York Times report, there was a 19 percent increase in overdose deaths in 2016 from the year prior, and “all evidence suggests the problem has continued to worsen in 2017.” One foundation-shaking fact? For Americans under the age 50-years-old, drug overdose is now the leading cause of death.

Each of the approximately 91 people who die every day from an opioid overdose leave behind a family and a community that must cope with the loss. The damage is nearly impossible to imagine, but it doesn’t even end there.

In Tennessee, the state reports that there are 14 nonfatal overdoses for every overdose death. If someone survives, their battle with addiction is far from over, and families and communities must subsequently find ways to pay for treatment and care. The number of fatalities is shocking, but in order to understand the true toll of loss, one must also multiply the damage to account for all of those who are left behind.

This is why Tennessee, along with Missouri, Ohio, Illinois, Mississippi, California and several New York counties are striking back against Big Pharma with lawsuits. Without the willfully deceitful marketing of opioids, these dangerous drugs never would have been allowed to destroy the lives of so many.

“You don’t get to this point without the fake marketing,” says Paul Hanly, of Simmons Hanly Conroy, a firm representing counties across New York state in lawsuits against the drug companies. “They promoted this ultimately phony science that is utter bulls—. There is zero science to support it.”

How Big Pharma Misled Doctors

The lawsuits serve as a means to shine a light on some of the nasty, manipulative tricks Big Pharma used in order to make it seem like opioids were a good choice for long-term pain management. Doctors were aware opioids were highly addictive, and so companies like Purdue, the manufacturer of OxyContin, worked hard to mislead them into thinking their drug was different.

For example, a 5-sentence letter, published in the reputable The New England Journal of Medicine (NEJM), was cited hundreds of times by pharmaceutical companies as if it were a peer-reviewed study. Dr. Herschel Jick, the letter’s author recently told the Associated Press that:

“I’m essentially mortified that that letter to the editor was used as an excuse to do what these drug companies did. . . They used this letter to spread the word that these drugs were not very addictive.”

In June, the NEJM included a new letter blasting the pharmaceutical companies for a practice that, “contributed to the North American opioid crisis by helping to shape a narrative” that opioids were somehow safe.

Armed with bogus narratives and outright lies, Big Pharma sent sales reps around the country. As Hanley explains, these “experts” would land like a time-bomb in communities:

“They go to Dubuque, Iowa, and host a lunch for 10 family physicians. . . What do they know about opioids — nothing.

The so-called expert peddles this story. And the primary care physicians go, ‘OK, I learned I can give Oxy to somebody who comes in with a sore knee.’”

Pretty soon, it became normal to have opioids in the community. To compound the damage of opioids, vast amounts of money were given as bonuses to sales reps who could hawk the most pills. Over the last 10 years, as the nation’s addiction spiraled out of control, the Associated Press reported that Big Pharma spent upwards of $880 Million fighting tougher opioid laws.

In perverting the facts, Big Pharma created record profits, but as the death toll climbs, they cannot hide the truth.

If Terrorists Killed This Many People . . .

Mike DeWine, Ohio’s Attorney General, outlined the pharmaceutical companies’ motivations for twisting the truth, and his state’s case against them. Talking about the role Big Pharma played in a recent interview, he said:

“You know, we believe that the evidence will show that these pharmaceutical companies purposely misled doctors about the dangers connected with pain meds that they produced and that they did so for the purpose of increasing sales. And boy, did they increase sales.”

These companies hid the dangers in order to sell drugs. It’s simple. It’s wrong. And they are going to have to pay for it. DeWine Continued:

“I think everybody in public office needs to be talking about this opioid crisis. For example, in Ohio, we think we’re losing 10, 12 people every single day. You know, if we were losing that many people in a terrorist attack and then next day, the same thing, and the next day, the same thing, well, we would be all up in arms. . .

. . . every public official as well as every citizen needs to do everything that they can to try to turn this thing around.”

As families, first responders, and doctors try to save the lives of people suffering from needless opioid addiction, one thing is certain: In order to “turn this thing around,” as DeWine describes, Americans need to hold Big Pharma accountable.

New York Counties Continue to Join Fight

In New York State, eight counties have brought lawsuits against Big Pharma in the last year, with Schenectady, Seneca, Sullivan and Duchess counties filing complaints in June. These counties seek relief for the millions of dollars they spend each year combatting the opioid crisis. Suffolk, Broome, Erie and Orange counties have already filed suit.

These lawsuits point to the increased criminal activity – murder and drug-trafficking offenses – along with increased aid for opioid treatment, which is a direct result of the manipulative marketing of pharmaceutical companies. Seneca county, for example, recently witnessed a 47.5 percent increase in opioid-related emergency room visits.

Hopefully, the FDA will not limit its action to a single opioid drug. Getting Opana ER off the market is a step in the right direction, but this single decision will not stem the tide of the public health crisis.

Without the false perception of opioid risk created by Big Pharma and sold to doctors, many of the patients who are now dead or irreversibly harmed would still be healthy people. For the families and communities that have dealt directly with the crisis, this wave of opioid litigation offers to bring much needed relief from those responsible. For those who have had to bury their loved ones, there is hope that this decades-long deception will at long last come to an end.

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