As overdose deaths dip, new outrages disclosed on Big Pharma and opioids

drugs-300x179The nation may be hitting an inflection point in the opioid crisis. But Big Pharma, regulators, and politicians have much to answer for prescription painkillers’ terrible toll and their sluggish efforts to reduce the tens of thousands of casualties.

The spare good news about U.S. drug abuse — the first drop in overdose deaths since 1990 — came from the federal Centers for Disease Control and Prevention. The agency also warned its findings were freighted with many “yes, but …” elements, including:

  • The reported 5% decline occurred in deaths from prescription opioids;
  • Fatal overdoses involving other drugs, notably fentanyl and methamphetamines, keep going up
  • The downward tick was so slight it may not represent a sustained downturn;
  • The decline was spotty by geography, with fatal overdoses, many related to fentanyl, continuing to increase in mid-Atlantic states, including New Jersey, Delaware and Maryland, and Western states — which had been less affected — starting to get hit hard now.

But even as Alex Azar, the chief of the federal Health and Human Services Department, expressed guarded optimism that Trump Administration efforts to deal with opioids and overdoses were showing progress, the Washington Post and the  Charleston Gazette-Mail in West Virginia disclosed damning results of their latest deep dig into how Big Pharma fueled the national nightmare that, the news organizations said, resulted in nearly 100,000 deaths from 2006 through 2012.

Big data on the flood of painkiller pills

The Post and Gazette-Mail fought for years to win access to “a database maintained by the Drug Enforcement Administration (DEA) that tracks the path of every single pain pill sold in the United States — from manufacturers and distributors to pharmacies in every town and city.”

As part of lawsuits by more than 2,000 cities, towns, counties, states, and Indian tribes against drug makers and distributors, the news organizations won access to the previously withheld transactional data, finding:

“America’s largest drug companies saturated the country with 76 billion oxycodone and hydrocodone pain pills from 2006 through 2012 as the nation’s deadliest drug epidemic spun out of control … Just six companies distributed 75% of the pills during this period: McKesson Corp., Walgreens, Cardinal Health, AmerisourceBergen, CVS and Walmart, according to an analysis of the database by The Washington Post. Three companies manufactured 88% of the opioids: SpecGx, a subsidiary of Mallinckrodt; ­Actavis Pharma; and Par Pharmaceutical, a subsidiary of Endo Pharmaceuticals. Purdue Pharma, which the plaintiffs allege sparked the epidemic in the 1990s with its introduction of OxyContin, its version of oxycodone, was ranked fourth among manufacturers with about 3% of the market. The volume of the pills handled by the companies skyrocketed as the epidemic surged, increasing about 51% from 8.4 billion in 2006 to 12.6 billion in 2012.”

The Washington Post, to its credit, has gone out of its way to share and to make graphic its hard work on the DEA’s Automation of Reports and Consolidated Order System or ARCOS database.

That makes it possible to see targeted areas, such as Washington, D.C., and how Big Pharma inundated them with painkillers. A database search shows the District flooded with 58,184,205 prescription pain pills between 2006 and 2012, a year in which its population was 623,323. Do a little math (58 million pills/6 years/623,000 residents) and it’s hard to figure how Big Pharma can explain why every man, woman, and child in the nation’s capital was receiving the annual equivalent of 15 painkilling pills each. That was still far lower than the annual per capita breakdowns the Washington Post calculated for the same time in: West Virginia with 66.5 painkillers per person, Kentucky with 63.3, South Carolina with 58, Tennessee with 57.7 and Nevada with 54.7.

Blind to a crisis

The numbers may be daunting but what they show may be worse: Yes, the opioid crisis took time to develop and there is plenty of blame to spread, including with doctors, nurses, hospitals, and insurers. But how did Big Pharma — makers and distributors — never stop to ask what was happening with the potent, addictive product that they were flooding the country with? If federal regulators had this database, why did they never get smacked in the face with the overpowering information it held?

Scott Higham, a Washington Post reporter who worked on this investigation, discussed some of these topics on NPR, saying:

“Look: There are corrupt doctors, and this epidemic wouldn’t have started without them. But up and down the chain, everybody has a responsibility. The doctors have a responsibility. The pharmacists have a responsibility. The distributors have a responsibility. And the manufacturers have a responsibility. It’s a tightly regulated supply chain. And if any of those links in that chain break, the whole thing collapses. And that’s what happened. Up and down the supply chain, there were breaks, and nobody seemed to stop it. And the pills just kept pouring onto the streets of America.”

He observed of federal regulators:

“The DEA said that they decline to comment [on the investigation findings] because of the ongoing litigation. And when you look at this data, you understand why the DEA fought so hard to keep it secret. Firstly, the data was such a mess when the lawyers for the plaintiffs got it, they could barely understand what was in the database because how it was constructed and maintained. And so, DEA agents and others who we know within the agency have complained for years that they couldn’t use this database. They felt like the leadership of the DEA wasn’t putting enough a priority on this. And the men and women who are in … the prescription drug division — it’s kind of a backwater at DEA. These are not the people that do the El Chapo cases, and there’s not many of them, so it’s not a high priority at the DEA, unfortunately.”

Meantime, drug makers and distributors took advantage of the all but nonexistent oversight, “driven by profits and undeterred by the knowledge that their products were wreaking havoc across the country,” Higham and others reported, based on companies’ emails disclosed as part of the suits against Big Pharma.

A judge also ordered the release of a big batch of filings from that case, showing, too, that at least some drug maker employees questioned what was going on. A Walgreen’s staffer, for example, queried her bosses — apparently to no avail — why 3,271 bottles of oxycodone were going monthly (!) to a Florida town with a population of 2,831.

Higham said reporters and editors will keep up their digging to see the root causes of the prescription painkiller mess and how it opened the doors to abuses of even more powerful and lethal legal and illicit drugs like fentanyl and heroin. He noted that Big Pharma and government data still needs to surface from 2012 to now.

Will Uncle Sam end funding to fight opioid harms?

Such disclosures may be helping to stem the prescribing of opioids. Despite the current administration’s insistence that combating the opioid and overdose crisis is a top priority, the New York Times reported that state and local governments, as well as health and mental health organizations, are expressing growing alarm about more than $3 billion in federal grants approved and targeted by Congress and Trump officials to fight drug abuse. The funds, approved in 2017, finally have arrived at local levels and are beginning to show results.

But officials haven’t said if the money will continue after the grants expire next year, when advocates fear that a combative presidential campaign will focus on health care costs, especially for prescription drugs — and not on opioids’ toll.

In my practice, I see not only the harms that patients suffer while seeking medical services, but also the damage that can be inflicted on them by dangerous drugs, especially opioids. It took politicians, regulators, doctors, and public health officials far too long to recognize the scourge of prescription painkillers and for them to even begin to respond. Officials, top to bottom, have acted too slowly and timidly and that persists. It will be yet another black mark for members of Congress and the administration if funding to combat the opioid crisis trickles away, as politicians campaign to keep themselves in office. And, for those who assail the civil justice system and offer false tort “reforms,” there may be a powerful rebuke if some of the major remedies for the opioid crisis — notably Big Pharma’s overdue day of reckoning — comes through lawyers, courts, and lawsuits.

Meantime, as the CDC noted, even with a slight decline in such deaths, “the number of overdose deaths in 2018, more than 68,000, still exceeded the nation’s peak annual deaths from car crashes, AIDS or guns.” We’ve got a lot of work to do on opioids and overdoses and we cannot delay or be deterred.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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