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How the Drug Industry Crippled the Investigation Into the Opioid Crisis

The crisis facing our communities and neighborhoods from the over prescription and improper use of prescription opioid pain killers is well known.  Every day in newspapers across the country the stories of those who have died of overdoses of these medications are told.  If you read a newspaper, watch television or get your news from the internet you are bombarded with the daily tragedies of those who have died.

So how did we get here?  How did we arrive a point in time where drug overdoses now kill more Americans than guns? Where it is estimated that 91 Americans die every day from overdosing on opioid medications?

The drug industry’s efforts to smooth the way to ever larger profits is well known in government and regulatory circles.  For example, while the Food and Drug Administration (FDA) is tasked with regulating many products, Big Pharma has long ago discovered that FDA regulation is easily avoided.  Despite its Mission Statement:

 

“protecting the public health by assuring the safety, effectiveness, quality, and security of human and veterinary drugs, vaccines and other biological products, and medical devices. The FDA is also responsible for the safety and security of most of our nation’s food supply, all cosmetics, dietary supplements and products that give off radiation”

 

FDA procedure is rife with loopholes, back doors and ways for Big Pharma to slip its drugs by with very little notice, and more importantly, to hide problems with drugs that cause injury and death.  Medical trials, which are supposed to identify dangerous drugs are often rife with fraud or misconduct.  And if that is not enough, FDA does little or nothing to communicate these errors to doctors or the public.

The opioid crisis had its roots in the late 1990’s and arose out of the perfect storm created, in large part, by Big Pharma to get physicians to prescribe opioid pain relievers for chronic pain.  In the past, opioid prescriptions had been limited to short term use for acute pain, usually post-surgical pain.  Dr. Wilson Compton, M.D. the Deputy Director of the House Subcommittee on Energy and Commerce, Subcommittee on Oversight and Investigations testified about Big Pharma’s role at a Congressional hearing held on June 30, 21017:

 

“The misuse of and addiction to opioids – including prescription pain medicines, heroin, and synthetic opioids such as fentanyl – is a serious national problem that affects public health as well as social and economic welfare.  The Centers for Disease Control and Prevention (CDC) recently estimated that the total “economic burden” of prescription opioid misuse alone in the United States is $78.5 billion a year, including the costs of health care, lost productivity, addiction treatment, and criminal justice involvement.  In 2015, over 33,000 Americans died as a result of an opioid overdose.  That year, an estimated 2 million people in the United States suffered from substance use disorders related to prescription opioid pain medicines (including fentanyl), and 591,000 suffered from a heroin use disorder (not mutually exclusive).

The opioid crisis began in the mid-to late 1990’s, following a confluence of events that led to a dramatic increase in opioid prescribing, including: a regulatory, policy and practice focus on opioid medications as the primary treatment for all types of painan unfounded concept that opioids prescribed for pain would not lead to addiction; the release of guidelines from the American Pain Society in 1996 encouraging providers to assess pain as “the 5th vital sign” at each clinical encounter; and the initiation of aggressive marketing campaigns by pharmaceutical companies promoting the notion that opioids do not pose significant risk for misuse or addiction and promoting their use as “first-line” treatments for chronic pain.”

 

The marketing effort by Big Pharma and allied groups like the American Pain Society was so effective that the sale of prescription opioids nearly quadrupled between 1999 and 2011. Not unexpectedly this was paralleled by a more than four-fold increase in treatment admissions for opioid abuse and a nearly four-fold increase in overdose deaths related to prescription opioids.  And FDA was silent about the marketing, which was unproven and lacking in scientific basis.

And Big Pharma raked in the profits as Americans died at an unprecedented rate from drug overdoses of their prescription pain killers. For example Purdue Pharma, located in Stamford Connecticut is the manufacturer of OxyContin.  In 1996, sales of OxyContin totaled just over $100 million. By 2000, sales had reached 1 billion dollars; in 2010 Purdue Pharma reaped over 3 billion dollars from sales of OxyContin.

But Big Pharma went even further looking for profits.  It began to infiltrate the Drug Enforcement Agency, the governmental agency responsible for enforcing the controlled substance laws by bringing “criminal and civil” actions against those individuals and companies who violate them. In an explosive “60 Minutes”-Washington Post expose reporters discovered how. Beginning in 2005, when the DEA first began to seriously investigate and try to prosecute companies that were distributing excessive amounts of pills and narcotics to doctors and “pain clinics” across the country, Big Pharma  lured away from the DEA as many as 41 employees—31 of whom had worked directly for the division that was responsible for investigating and regulating the industry.

Significantly, President Trump’s nominee for US Drug Czar, Representative Rep. Tom Marino (R-Pa) withdrew his name today  for consideration for the post after the “60 Minutes”- Washington Post expose identified him as the chief proponent and advocate of the  Ensuring Patient Access and Effective Drug Enforcement Act which, according to DEA insiders effectively prevents DEA from bringing criminal enforcement actions against wrongdoers.  Marino was the principle advocate of the bill, and he had received in excess of $100,000 in donations from political action committees tied to Big Pharma. And when, in 2015 the bill stalled in Congress, he went to Big Pharma’s point person:  Linden Barber.  Mr. Barber had worked for—you guessed it—DEA (he was associate chief counsel at DEA until 2011 when he joined Cardinal Health—a major distributor of opioid medications as its Chief Regulatory Counsel) and was the real author of the bill.  With Barber’s help and a complicit, ignorant Congress, the bill passed by “unanimous consent,” without even a formal vote tally and was signed into law by then President Barack Obama.

And then there is the money: between 2014 and 2016, Big Pharma spent 102 million dollars in lobbying monies to get the Ensuring Patient Access and Effective Drug Enforcement Act and other Big Pharma friendly bills passed by Congress.  Big Pharma’s trade organization, the Pharmaceutical Research and Manufacturers of America alone passed 40.8 million dollars around Congress; CVS Health spread 32.5 million.

We at Locks Law Firm have been litigating against Big Pharma for decades. The efforts of our firm and others like us help to shine a light on the devious and mercenary practices of the drug industry whose primary motive is profit, when it should be helping patients achieve wellness. You can do your part, as a consumer of medical services, by staying informed and actively engaging with your elected officials. Demand federal budgetary support for regulatory agencies, instead of the cuts being proposed by the Trump Administration.  Demand rigorous enforcement of laws and regulations geared to protecting patient safety.

 

Democracy demands an informed and engaged populace to survive.