The Opioid Crisis in the United States: Who is to Blame?

There can be no doubt that the United States is in the middle of a severe epidemic; opioid addiction and death. Once rare, drug-induced deaths from opioids has increased greatly over the past two decades killing more than 220,000 Americans between the years 1999-2017.

Recently big questions have been posed as to why we didn’t see this coming and who is to blame. The answers to these questions have rocked the pharmaceutical world and made Americans rethink their trust in big pharma and the medical world.

How Big is the Opioid Problem?

 The problem with opioids is huge with 60 people dying every day from overdoses. The stats are clear that 44 of those deaths are from prescription pain killers while 16 are from heroin.

The United States Centers for Disease Control (CDC), has made information available about the opioid crisis and its causes stating it has been caused and is continues to be fueled by the overprescribing of opioids for chronic pain.

Since the 1990’s, big pharma has been pushing medications like OxyContin, Vicodin, Oxycodone, and Percocet and now the hens have come back to roost as 72,000 people in the United States have died in the past year by accidentally overdosing on opioids. All this just so that the owners of big pharma can continue to rake in billions of dollars every year.

Just in case you think I am exaggerating the danger and big pharma’s sinister part in it, let’s examine the facts.

Fact. Doctors and pharmaceutical corporations have been busy pushing the idea that opioids can be used safely and without addiction for decades. However, this isn’t true. Yes, a person’s history and the length of time opioids are used is vital in determining if you will get addicted and die limits these tragedies, however, there is no way for anyone to predict who will get hooked and who will not. Nor is it possible to say who will abuse their pain medicine and die.

Fact. Open Payments, a federal program that collects information on gifts given to doctors and teaching hospitals where a majority of the research is performed on opioids put out a report in 2005. It stated that $7.52 billion in gifts were given to physicians and teaching hospitals.

The result of all that money has been that doctors and researchers have been compliant with perpetuating myths founded questionable research findings.

Case and point, the letter to the editor issued in 1980, by Jane Porter and Hershel Jick, M.D. from the Boston Collaborative Drug Surveillance Program at the Boston University Medical Center.

Porter and Jick had decided to find out if hospital patients receiving narcotics for pain in short-term treatment with opioids became addicted to them. They did so by reviewing the medical records of around 39,000 hospitalized patients. Nearly 12,000 of the patients they reviewed received narcotics while hospitalized, but only four developed an addiction.

Porter and Jick then reported their findings in a letter written to the editor of the New England Journal of Medicine.

The letter read in part:

“Recently, we examined our current files to determine the incidence of narcotic addiction in 39,946 hospitalized medical patients who were monitored consecutively. Although there were 11,882 patients who received at least one narcotic preparation, there were only four cases of reasonably well documented addiction in patients who had no history of addiction.

The addiction was considered major in only one instance. The drugs implicated were meperidine in two patients. Percodan in one, and hydromorphone in one. We conclude that despite widespread use of narcotic drugs in hospitals, the development of addiction is rare in medical patients with no history of addiction.”

Unfortunately, this letter to the editor was grasped by many people, including prescribing physicians, as proof that what big pharma had been telling them was true. Opioids were not dangerous and did not cause addiction. To make matters worse, the letter was cited 608 times and in 80% of those citations, the authors did not mention that the patients in the letter from Porter and Jick were in the hospital at the time of treatment.

Then in 1986, a study in the journal “Pain” reported they had observed 38 patients and concluded that opioid addiction was extremely rare. This backed up the letter to the editor of Porter and Jick giving a green light to advertise opioids as safe and effective.

The Opioid Crisis and Big Pharma

In 1996, the American Pain Society, a group of health care professionals and scientists were busy promoting changes in public policy and medical practices. In doing so, they declared that pain was the “fifth vital sign” and urged health care professionals to evaluate and address the pain of every patient upon their visit to the office.

There was one critical flaw in this thinking, pain is self-reported and cannot be tested for nor properly diagnosed.

This promotion to doctors that pain must be treated as a fifth vital sign in need of immediate consideration set the stage for the opioid crisis to begin.

Later in 1996, the huge corporation, Purdue Pharma released a new drug, an opioid called OxyContin. To increase sales, they released the video “I Got My Life Back” targeting prescribers.

The video stated that opioid medications were the best pain medicines available and that they had few or no side effects. They went on to state, information straight from the osteoarthritis study, in the video that fewer than 1% of people who use opioids for pain develop addictions to them.

Then the drug companies launched an aggressive campaign of promoting their products using drug reps that were sent nationwide to doctors and clinics. They offered doctors gifts like expensive all-expense paid medical conferences if the doctor would visit the booth of the company at the conference.

Physicians and medical clinics were being bribed to prescribe opioid medications as the only pain remedies available and to support the claim that opioids are not addictive.

While the pharmaceutical companies were selling junk science to physicians, the medical schools in the United States were offering little or no training on the management of chronic pain. In fact, in 2010 it was reported that only 1 in 5 medical schools had any formal instruction on the topic.

In the void left by this lack of training pharmaceutical companies entered the picture, offering messages that stated opioids were without a doubt safe and effective.

The truth is that opioid painkillers aren’t the only pain relievers available and they aren’t safe.

The fact is that opioids aren’t the only effective medications for chronic pain, they are only more aggressively marketed.

It has been proven in study after study that over-the-counter medications such as Ibuprofen and Acetaminophen when given in combination might relieve pain much better than opioids. There are also drugs that help depression called SNRI’s and some nerve medications like Gabapentin that were found to be effective against chronic pain as well.

The Dark History of Big Pharma and the Opioid Crisis

In 1995, the Food and Drug Administration (FDA) approved OxyContin permitting Purdue Pharma to claim that the drug was a long-acting formulation and was believed to reduce its abuse by drug abusers. This claim was based on the theory stated that drug abusers favored short-acting narcotics because they could get a faster “hit” than their product OxyContin would deliver.

So, it became the belief that drug abusers preferred short-acting painkillers like Percocet or Vicodin and would not abuse OxyContin.

Thus, Purdue Pharma used the FDA’s decision as valuable and used it as their principal marketing tool.

In 2007, Purdue Pharma was confronted with evidence they had gathered that they had trained their sales representatives to tell doctors that OxyContin was less addictive than other opioids on the market.

The drug maker admitted summarily admitted the allegations. The report went on to state that because of their aggressive sales tactics, they had received approximately $2.8 billion in sales from OxyContin as of 2007.

More on this litigation later.

What Did Purdue Pharma Know About the Addictiveness of Their Product?

In 1998, just as OxyContin marketing was beginning to take off, Purdue Pharma received word that a study published in  The Journal of Canadian Medical Association by researchers from the University of British Columbia in Vancouver was reporting that OxyContin was neither safe nor unattractive to drug abusers.

The study used interviews from local drug dealers and abusers to learn what prices legal drugs sold for on the black market. They found that MS Contin, another medication related to OxyContin that was also being aggressively marketed by Purdue Pharma was bringing a huge price for black marketers of the drug. A 30-milligram tablet that cost $1 at the pharmacy was demanding $40 on the street.

An editorial written by a Canadian physician, Dr. Brian Goldman stated that the findings of the report in the Journal of Canadian Medical Association should alert people to the idea that long-acting opioids like OxyContin were on their way to being highly “coveted” by drug dealers and users. In fact, he added in one paragraph that the study should “ring alarm bells.”

However, Dr. Goldman was a paid speaker for Purdue Pharma and his “warning” wasn’t meant to end widespread overprescribing of the pharmaceutical company’s hit medication OxyContin. Instead, he went on in his editorial to state, “The publication of these findings will undoubtedly lead some to call for more action to stop the diversion of licit controlled substances.

But it’s important not to overreact. Although Sajan and colleagues have given us a fascinating window on the world of prescription drug diversion, their study provides no perspective on the scale of diversion, without which we risk overreacting to what may be an extremely limited phenomenon.”

What happened to the study showing OxyContin is dangerous? Purdue Pharma did not alert either the FDA or its sales representatives that it existed. Instead, a sales official who worked for Purdue Pharma testified later to a federal grand jury that the company insisted he distributed a different report that concluded that drug abusers were not at all attracted to time-release opioids.

In his testimony, Mr. Josephson, the above-mentioned Purdue Pharma sales official, stated that Purdue Pharma said it was not required that the drug company inform the FDA about the Canadian study because the study was small and its results insignificant.

Misleading Information by Purdue Pharma Goes Big Time

As has already been starting, in December 1995 and going on until June 2001, Purdue supervisors and employees, meant to defraud. They marketed OxyContin as less addictive and less attractive to drug abusers.

These supervisors and employees then instructed Purdue Pharma sales reps to tell health care providers that Oxycodone was difficult for intravenous abusers to extract from OxyContin and thus was much less attractive to people who shot up drugs.

The Purdue Pharma supervisors used Purdue’s own study to show their reps and their customers that a drug abuser could extract only 68% of the Oxycodone from a single 10-milligram tablet by crushing it, stirring it into the water, and then drawing it through cotton into a syringe.

The problem with this claim is that OxyContin was distributed in 30-milligram tablets, not 10 as described in the study. The difference in the milligrams per tablet means a lot more could be extracted and abused.

They then told their sales reps to state to health care providers that OxyContin creates less chance for addiction than any other immediate-release opioids on the market at that time. They were also taught that the drug resulted in less euphoria and thus had a less potential for abuse.

Further, the company told some health care providers that they should not stop their patients from taking OxyContin abruptly as they would experience withdrawal symptoms.

The Osteoarthritis Drug Study

The misinformation campaign continued.

A study, drafted by some Purdue Pharma supervisors and employees then published in a medical journal in March 2000 claimed in the results section three misleading statements about the withdrawal syndrome and symptoms experienced by patients.

One. “One patient was hospitalized “for withdrawal symptoms…The patient who was hospitalized with withdrawal symptoms had completed the study on the previous day and had been receiving CR oxycodone, 70 mg/d; symptoms resolved after 3 days.”

Two. “A second patient, who was receiving 60 mg/d CR oxycodone, experienced withdrawal symptoms after running out of study medication. The patient had not reported withdrawal symptoms during scheduled respites from doses of 30 or 40 mg/d.”

Three. “Withdrawal syndrome was not reported as an adverse event for any patient during scheduled respites. Adverse experiences reported by more than 10% of patients during scheduled respites were nervousness (9 patients) and insomnia (8 patients).”

Since dubbed the osteoarthritis study, it also included the following information in its comment section to summarize the information given in the results section. It suggested that patients taking low doses could have their OxyContin treatment suddenly ended without experiencing withdrawal if their condition called for its discontinuance.

“There were 2 reports of withdrawal symptoms after patients abruptly stopped taking CR oxycodone at doses of 60 or 70 mg/d. Withdrawal syndrome was not reported as an adverse event during scheduled respites, indicating that {OxyContin] at doses below 60 mg (per day) can be discontinued without tapering the dose if the patient’s condition so warrants.”

From between June 2000 to June 2001 Purdue supervisors and employees distributed copies of the osteoarthritis study article widely, including to its sales representatives to use as marketing tools. They distributed 10,615 copies between February 2001 and June 2001 alone.

In June 2000, some Purdue Pharma supervisors and employees distributed the osteoarthritis study article with a marketing tip added to its sales force. The marketing tip that the pharmacy reps should use the reprint of the article as a tool for marketing success. With this tip came a list of 12 key points they were to use including:

“There were 2 reports of withdrawal symptoms after patients abruptly stopped taking CR oxycodone at doses of 60 or 70 mg/d. Withdrawal syndrome was not reported as an adverse event during scheduled respites indicating that CR oxycodone at doses below 60 mg. It can be discontinued without tapering the dose if the patient condition so warrants.”

It is obvious that the pharmaceutical company wanted its salesforce and their customers to believe the lie that their product was safer and better than alternative treatments.

The Legal Action Taken Against Purdue Pharma

In 2001, Connecticut Attorney General Richard Blumenthal announced that Purdue Pharma needed to take steps to end the abuse of OxyContin. He went on to state in his statement that the actions that had already been taken by Purdue Pharma were “cosmetic and symbolic.” He also noted after the pharmaceutical company announced plans to reformulate the drug that the move would take time,

“Purdue Pharma has a moral, if not legal obligation to take effective steps and address addiction and abuse even as it works to reformulate the drug.”

Then in 2004, West Virginia sued Purdue Pharma for reimbursement of “excessive prescription costs.” The state claimed it had paid these funds because patients were taking more of the drug than prescribed because the effects of the drug wore off many hours before the twelve-hour threshold claimed by the company.

West Virginia charged Purdue Pharma with deceptive marketing and took them to court.

The judge presiding over the case wrote in his ruling that, “Plaintiff’s evidence shows Purdue could have tested the safety and efficacy of OxyContin at eight hours and could have amended their label, but did not.”

This litigation never went before a jury and Purdue Pharma agreed to settle, paying the state of West Virginia $10 million for programs to help discourage abuse of their drugs.

It is interesting to note that all the evidence given during the court hearing remains sealed by court order and is labeled confidential.

In October 2007, it was Kentucky’s turn to sue Purdue Pharma for the widespread of abuse of OxyContin in Appalachia. The suit demanded millions in compensation and eight years later Purdue Pharma settled paying $24 million.

In 2007, The New York Times reported that Purdue Pharma had been taken to federal court and charged with criminal misleading of federal regulators, doctors, and patients about the risks of addiction to OxyContin.

The parent company of Purdue Pharma pled guilty and was ordered to pay $600 million in fines and other payments. At the time, it was the of the largest amounts ever paid by a drug company in any related case. Also, three executives of Purdue Pharma pled guilty to the misbranding of its product and criminal violations of federal laws. They were ordered to pay a total of $34.5 million in fines.

The payments by Purdue Pharma and its employees totaled $634.5 million.

I think it is obvious that the litigation brought in 2007 was only a slap on the wrist to Purdue Pharma.

Then in 2016, the Los Angeles Times reported that the 12-hour schedule told to patients by their doctors to adhere did not adequately control their pain resulting in withdrawal symptoms. The journalists concluded that this information gave, “new insight into why so many people have become addicted.”

Using Purdue documents and other records, the L.A. Times claimed that Purdue Pharma was aware of this problem even before the drug went to market but “held fast to the claim of 12-hour relief, in part to protect its revenue because OxyContin’s market dominance and its high price — up to hundreds of dollars per bottle — hinge on its 12-hour duration.”

By that time OxyContin had become a hugely successful moneymaking drug as Purdue Pharma had increased its revenues from a few billion in 2007 to $35 billion by 2017.

Then the famous magazine The New Yorker brought to light that Purdue Pharma is owned by one of America’s richest families, the Sackler Family, with a net worth of $13 billion. The article’s title is telling, “The Family that Built an Empire of Pain.”

The article infuriated the public of the U.S. and people began to truly take note of the horrendous toll that addiction to the substance that had been marketed as safe was taking on innocent family and friends.

The straw that broke the proverbial camel’s’ back happened this year (2018), when Purdue Pharma patented and began marketing a new drug to control cravings to use in treating addictions to their own drug.

To date there are more than 16 lawsuits by states in the U.S. and Puerto Rico filed against Purdue Pharma and six other states Florida, Nevada, North Carolina, North Dakota, Tennessee, and Texas. All are charging Purdue Pharma for deceptive marketing practices and seeking damages.

The Real Question that Needs to Be Asked

The real question that needs to be asked is this, is big pharma the only reason for the epidemic of death in the US?

The answer is complicated.

Although there can be no doubt that Purdue Pharma covered up the knowledge that OxyContin was a dangerous medication, corporations like Purdue Pharma pursue profits through the principal of supply and demand.

If people keep demanding their products, they will keep supplying to turn a profit.

It is true also that Purdue Pharma used deceptive marketing practices to sell their products and keep doctors prescribing by offering what amounts to bribes.

But those same physicians had to notice that some of their patients were abusing their medications and hospitals also play a role as they did not report to the proper authorities the uptick they were experiencing in drug overdoses for a long time.

So, what can be done to end the opioid epidemic in the United States?

Across the country, there is a surge to work on strategies to end the opioid crisis. The United States Department of Health and Human Services has focused its efforts on five priorities:

  1. Improve access to treatment and recovery services
  2. Promoting the use of overdose-reversing drugs
  3. Strengthening our understanding of the epidemic through better public health surveillance
  4. Providing support for cutting-edge research on pain and addiction
  5. Advancing better practices for pain management

While these are all noble goals, we are still missing one big piece of the puzzle to end the suffering of families who have lost to death someone they love from an opioid overdose. We need to find and implement non-drug ways treatments for chronic pain.

The journal Pain Research and Treatment, in May of this year (2018), reported on how useful and effective peripheral nerve stimulation is in treating chronic pain.

It’s clear that as new technologies come into being, new treatments for chronic pain and many other disorders suffered by humanity will be found and utilized.

The only things standing in the way of finding these better and non-addictive forms of help are the wars being waged by big corporations like Purdue Pharma and the American people who believe that a pill can solve every problem.

It is my sincere hope that you will consider the words written here in this report and heed my warning against overuse of prescription painkillers. It only takes a few days of using these strong medications to become hopelessly addicted, so if it is at all possible, avoid using opioids.

The quality of your life and the possibility of your death from overdose hang in the balance.

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Disclaimer:  The article above may be controversial. As such we wish to state here that the opinions expressed in this post are the personal views of the author. They do not necessarily reflect the views of PatientNextDoor. Any omissions or errors are the author’s and PatientNextDoor does not assume any liability or responsibility for them.

 

 

 

 

 

 

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