The epidemic of opioids in the United States has caused 200,000 deaths since 1999. Its main author, Purdue Pharma, built an economic empire on the sale of painkillers to relieve pain. Now, and after the reduction of its market, they point to Latin America.
A new threat silently stalks Latin America and the world, after two decades of generating havoc in the United States. Known as the opioid epidemic, it has caused more than 200,000 deaths since 1999 due to overdoses. The main reason: the abuse of legal analgesics and illegal drugs with properties similar to opium.
Such is the problem that in 2017, Donald Trump, President of the United States, declared it as a national public health emergency, calling it "the worst drug crisis" in the country. According to the National Institute of Health, more than 90 Americans die every day from an overdose of some type of opioid or opiate.
These figures approximately double the deaths caused by traffic accidents and firearms. Of the 52,404 deaths recorded in 2015 due to substance abuse, 63% involved an opioid. And the trend continues to rise, US Attorney General Jeff Sessions declared an increase to 60,000 in 2016.
In spite of this, the pharmaceutical companies that are responsible continue with the indiscriminate sale of these drugs. Purdue Pharma, author of the crisis, camouflaged as MundiPharma began its strategy in Latin America in 2014. With the same advertising tactics they seek to extend their empire of pain throughout the region and the world.
As explained by Andrew Kolodny, co-director of the Opioid Policy Research Collective at Brandeis University, "the crisis was initially precipitated by a change in the culture of medical prescriptions, a change carefully designed by Purdue." A strategy directed and developed by the Sackler family, its owners.
The Sacklers know how to do two things well: money and analgesics. Since its inception, the three brothers Arthur, Raymond and Mortimer stood out in the field of psychiatry but his greatest achievement would be Arthur, the eldest, in the nascent field of medical and pharmaceutical advertising.
In 1952, they bought a small pharmacy, Purdue. That same year, Arthur was the first publicist to convince the American Medical Association to include pharmaceutical advertising in its scientific journal. His work for years would make him a star in the field of advertising and was one of the first names to be included in the Medical Advertising Hall of Fame in 1997.
Advertising and medicine would be the combination for his great fortune, especially in the pain market. It was in 1972, that Mortimer Sackler ran Napp Pharmaceutical, the branch of the family business in the United Kingdom when they started the research in a timed release system for the application of morphine continuously.
In 1981, Napp introduced the system 'Contin' (continuous) and in 1987 Purdue enter the US market with the painkiller MS Contin. A morphine pill intended for the palliative treatment of cancer patients. A first success, which would not be compared years later with the creation of Oxycontin, one of the opioids causing the crisis.
When referring to opioids, two types of substances are included: legal drugs such as oxycodone, hydrocodone or fentanyl and illegal substances such as heroin. All with chemical characteristics similar to opium, which affect the body by blocking the pain receptors and in turn activate the pleasure zones in the brain causing a release of dopamine.
By the end of the 1980s, the patent on the MS Contin was about to end. In an internal memo, Robert Kaiko, vice president of Purdue's medical research department, said that due to "eventual and serious competition from generic MS Contin tablets, other opioids with controlled-release systems should be considered." That is to say, the monopoly on morphine tablets with the Contin system was about to end and consequently the big profits.
The business plan was to design a new and improved pill and in turn not only market it for cancer patients but expand its market. For 10 years they developed OxyContin, an oxycodone pill. This opioid is a semi-synthetic opium, similar to morphine, but with a greater bioavailability (97%) and 1.5 times more potent.
As Michael Friedman, a company executive, said, what they really wanted to "cure" was "vulnerability to the threat of generic drugs." This is how Oxycontin, would allow them to retake the monopoly of the pain market.
The next step was to obtain the approval of the Federal Agency for the Administration of Drugs and Foods (FDA). Dr. Curtis Wright led a dubious medical review for the FDA. After the approval, he resigned and, according to sworn statements, in less than two years he joined Purdue Pharma. It was so in 1996, the world would know OxyContin with an aggressive advertising campaign that would unleash the epidemic of addiction.
The first thing they worked on was changing the attitudes and prescription habits of the doctors. Although opium and its synthetic and semi-synthetic versions are not new -such as morphine-, the 'opiophobia' among physicians meant that the prescription of an opioid was, for the most part, for patients on their deathbed in pain chronic and cancer patients in terminal phases. The Sacklers would change this forever.
This was achieved through a system of selection of medical profiles, which allowed them to filter by doctors with more tendency to prescribe analgesics and for vulnerable areas. That is, areas of middle / lower middle class where workers from factories, construction or agriculture lived since they were the most likely to have chronic pain problems caused by their work.
The funding of research and spokespersons / doctors, who talk about the need to combat chronic pain with the benefits of opioids, was part of the campaign. In a 2003 report from the General Accounting Office of the United States (GAO), between 1996 and 2002, Purdue financed more than 20,000 educational programs related to the subject of pain. Seminars, paid trips, financing for research and marketing were the strategies to engage doctors.
Inclusive, as indicated by a New Yorker investigation, prestigious doctors such as Russel Portenoy, at that time pain specialist in New York, advocated in 1993 on the problem of chronic untreated pain and how opioids were a solution. Portenoy received funding from Purdue but in 2012 he retracted before the Wall Street Journal and admitted that he misinformed about the use of opioids as a therapy for the treatment of pain.
Similarly, medical associations such as the American Academy of Pain Medicine and the American Pain Society in 1997 published arguments in favor of the use of opioids to treat chronic pain. The author was Dr. David Haddox, spokesman hired by Purdue. These techniques and the influence in medical scientific publications caused a paradigm shift.
This caused opioids to become the solution for non-cancer related ailments, which varied from back pain, postoperative pain and even headache. The result, according to an article in the American Public Health Journal, was a 402% increase between 1997 and 2002 in the number of oxycodone prescriptions.
To which was added the ingenuity and ignorance of general practitioners since there was widespread confusion that oxycodone was less risky and potent than morphine. Purdue used this in his favor and used the "most important company" resource: its vendors.
Between 1996 and 2002 he increased his sales team from 318 to 671. All with a memorized speech: "less than 1% of patients become addicted." Scientifically supported by Dr. Haddox who coined the term "pseudo-addiction" in 1989 and also the studies of Porter and Hick / Perry and Heidrich in which there was talk of an addiction lower than 1% and 0%.
The reality was different, several medical studies showed that the percentages of addiction of regular users varied between 18 and 45%. Even Purdue knew it; In a study funded by the company in 1999 it was shown that the percentage of addiction of patients who used OxyContin for headaches was 13%.
One of the main causes that caused this addition was the format of use and doses, a system that 'differentiated' Oxycontin from other analgesics.
There were already oxycodone pills in the market, such as Percocet and Roxicodone, but they lasted six hours. Purdue's value proposition was that his pill would have a release mechanism that lasts 12 hours. That is, patients should only take OxyContin twice a day, improving their lifestyle and reducing pain.
However, the pills never came to fulfill their promise. The 12-hour intervals were "the perfect recipe for addiction," explained Theodore Cicero, a neuro-pharmacologist and expert on the effect of opioids in the brain.
In addition, as demonstrated in a trial against Purdue in 2004, "most patients in the clinical trials required additional medication" since eight hours was generally the time of effectiveness of the drug.
Something that Purdue also knew. In medical tests to obtain permission from the FDA, a later study by the Agency found that one third of patients complained of pain in the first eight hours and about 50% required more analgesics before the promised 12 hours .
The response of the company was to recommend an increase in the doses. Which in turn translated into more profits for the company. A bottle of 10mg pills, the lowest dose, was sold for approximately $ 100 while an 80mg bottle for almost $ 650.
"The higher the dose, the more likely you will die," said Dr. Debra Houry, director of the CDC's National Center for Injury Prevention and Control, told the LA Times. And as more people became addicted, the Sacklers became one of the richest families in the world.
In its first year of sales (1996), the tablet registered 45 million dollars in sales. Four years later (2000), the average per year was 1,000 million and its cap would arrive in 2010 when annual sales reached 3,100 million dollars. By then, the crisis was in full swing and deaths were adding up. In total, Purdue has generated 35 billion dollars thanks to Oxycontin.
However, higher doses and use in less than 12 hours meant that insurance companies were not willing to cover the entire treatment, since morphine was much cheaper.
According to the guidelines of the Center for Disease Control and Prevention (CDC) of the United States of 2014, doctors were asked to "avoid" and "carefully justify" high-potency prescriptions. Despite this, according to the University of Arkansas, in 2014 more than 52% of patients taking OxyContin had been prescribed doses greater than 60mg per day.
Taking into account that oxycodone has classification of narcotic class II, such as cocaine, heroin and opium, high doses and regular use proved fatal. In 2003, the Drug Enforcement Administration (DEA) would find that Purdue's "aggressive methods" "exacerbated the widespread abuse of Oxycontin."
The various civil suits in several states and the increasing number of deaths caused the Department of Justice of the United States to launch a criminal investigation. In 2007, the company and three of the highest-ranking executives pleaded guilty to fraud by consciously minimizing Oxycontin's risk of addiction. There was no prison for anyone, the only punishment was a fine of 635 million dollars, a negligible 2% of all profits of the company.
But sales continued and in 2010, under pressure from the Government and the growing numbers of addicts, the company agreed to change the structure of the pill to avoid crushing and subsequent inhalation. An act that included economic interests and not a commitment to help the crisis.
Because in 2013, the Oxycontin patent was going to end up using this excuse to change the formula of the pills to make them more resistant to crushing and in turn to get the FDA to prohibit generics. The board was ready and Purdue handled the 'chips': the patent was approved until 2030.
However, the 'bad' publicity generated by the evidence of fraud and the cases of deaths at national level, caused that since 2010 the prescriptions of Oxycontin are reduced by 40%. The doctors had new reasons to avoid using these drugs in their patients.
A report from the National Institutes of Health (NIH) found that there is no evidence of the effectiveness of long-term opioid use for chronic pain and there is ample evidence of harm, including overdoses and addiction. "Few drugs are as dangerous as opioids," David Kessler, former commissioner of the FDA (1990-97), told the New Yorker. Despite this, in 2015 the use of Oxycontin was approved for children aged 11 to 16 years.
But it was not enough since Purdue Pharma looked at the rest of the world as a potential market. In 2014, Raman Singh, executive of MundiPharma (Purdue) said that "every patient in emerging markets should have access to our medicines." With the same tactics: travel, seminars, and advertising directed to doctors entered the region.
According to a statement from the company, in Colombia, the investments for 2014 were of 10 million dollars and contemplated the development of its medication portfolio, a strong investment in medical education, as well as research on issues related to pain. In Mexico, 40 million dollars and Brazil 80 million dollars with an investment to establish its base of operations for the region.
"I would urge you to be very cautious about the commercialization of these drugs," said Vivek H. Murthy, former General Surgeon of the United States, referring to the sale of opioids in other parts of the world.
The campaign continues. In countries such as Ecuador, in 2016, a workshop was held entitled 'The relief of pain as a fundamental human right', funded by MundiPharma. This included the participation of 100 internists, anesthesiologists and oncologists. Another example is Ricardo Plancarte, a physician and member of the Cancer Institute in Mexico, who is now a spokesperson for the company. And the names continue, not only in Latin America but throughout the world.
In the words of MundiPharma, "we're just getting started." The example of Purdue shows that the deregulation of pharmaceuticals and capitalist greed have a price, which in this case have been hundreds of thousands of deaths and thousands more families destroyed by the addition.
Something that resembles the strategy of the United Kingdom in 1825 when introducing opium in China. The imperial interests of globalized capitalism seek to place private enterprise on human life and history seems to repeat itself.
Written by: MartÃn Pastor (Ecuador)
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