A new study published in the Harvard Law & Policy Review painstakingly describes how Big Pharma deception and federal government patenting have brought about the current U.S. opioid epidemic. As lawsuits pile up against pharma companies, this study confirms that for 20 years, the American public has served as the victim in a gargantuan scheme of money and power.
The study, titled The Opioid Epidemic: Fixing a Broken Pharmaceutical Market, gets right to the point in the introduction.
“In this article, we argue that non-rigorous patenting standards and ineffectual policing of both fraudulent marketing and anticompetitive actions played an important role in launching and prolonging the opioid epidemic. We further show that these regulatory issues are not unique to prescription opioids but rather are reflective of the wider pharmaceutical market.”Researchers follow with a primer on the rise of opioid prescriptions and how pain became “the fifth vital sign.” By the 1990s, doctors realized that chronic pain was often ignored, and pain management became a hot topic. Physicians were urged to make greater use of opioids, with experts in the field downplaying the potential for misuse and addiction – a view largely based on experience with morphine.
But this was before OxyContin came along.
Purdue Pharma, recognizing that this newfound view of the medical establishment could be exploited, worked to develop an improved synthetic opioid. Their golden ticket was found with the extended-release oxycodone pill known as OxyContin, patented and approved by the FDA in 1995.However, Purdue’s exclusive patent was based on corporate fraud and government ignorance.
“Purdue was able to patent extended-release oxycodone in the United States despite the fact that its constituent elements—the active ingredient oxycodone and the controlled-release system Contin—had been developed decades earlier...Oxycodone was used in clinical practice in Germany as early as 1917, and was first introduced in the United States in 1939.”Purdue’s angle was to develop a controlled-release version of oxycodone, banking on its success with the patented MS Contin for morphine. Here’s where the feds stepped in to help.
The United States Patent and Trademark Office (USPTO) initially rejected Purdue’s patent request for extended-release oxycodone, citing the combination as “obvious.” But Purdue responded with a statistical falsehood – which the company knew was false – and the patent office made an about-face, granting the 20 year patent for OxyContin.
Since then, the cozy relationship between Big Pharma and government has grown, with the pharma industry spending almost a billion dollars in ten years on lobbying federal and state governments and campaign contributions.
As the Harvard study notes, “low patenting standards” and “a history of tepid enforcement” provided incentive for Purdue to embark on a massive, fraudulent marketing campaign. With the guarantee of no competition provided by government, Purdue spent obscene amounts of money getting American hooked on their newly-patented product.
“Between 1996 and 2000, the company more than doubled its U.S. marketing team…In 2001, Purdue paid forty million dollars in bonuses tied to extended-release oxycodone…Purdue also invested heavily in analytics, developing a database to identify high-volume prescribers and pharmacies to help focus their marketing resources…Patients were offered starter coupons for a free initial supply of extended-release oxycodone, 34,000 of which were redeemed by 2001…Finally, Purdue hosted forty all-expenses-paid pain management and speaker training conferences at lavish resorts. Over five thousand clinicians attended, receiving toys, fishing hats, and compact discs while listening to sales representatives tout the alleged benefits of extended-release oxycodone…Purdue elevated the stakes, spending an estimated six to twelve times more promoting extended-release oxycodone than its competitor Janssen spent marketing a rival opioid…Purdue’s efforts paid off. Between 1996 and 2001, extended-release oxycodone generated $2.8 billion in sales. From 2008 to 2014, annual sales exceeded $2 billion.”
It gets even worse.As the patent expiration for OxyContin approached, Purdue developed an “abuse-deterrent formulation” of the drug, for which FDA granted a patent in 2010. Not satisfied with a simple new patent, Purdue filed a “citizen petition asking the FDA to refuse to accept generic versions of the original extended-release oxycodone formulation on safety grounds.” Incredibly, FDA also granted this to Purdue, “effectively preventing the marketing of low-cost, therapeutically equivalent products that might undercut Purdue’s incentive to continue to widely promote its new abuse-deterrent formulation.”
By the way, the “abuse-deterrent” OxyContin doesn’t really deter addicts, and it has fueled the explosive heroin epidemic as addicts seek out cheaper, black market alternatives. But Purdue is content making its billions off the patented drug.
While thousands of Americans die under a campaign of deception and greed, official Washington pretends to care with the occasional fine levied against pharma companies, including for false marketing by Purdue.
But no one ever goes to jail; no one in top management is ever held to account. The persons in “personhood” conveniently disappear when corporations get in trouble. And the fines? Mere pocket change compared to the revenues already made from the drugs involved.
“Rather than deterring fraudulent marketing, the penalties simply became a cost of doing business.”
The Harvard study provides much more insight into the fraudulent marketing practices of Big Pharma, the patent schemes enabled by federal government, how generic drugs are routinely stifled, and possible ways to address the injustice.Some of the more sinister effects of the system include “hard switches” which force patients to go from one costly patented drug to another instead of generics. The use of “citizen petitions” by pharma corporations to slow generic drugs and keep prices high is a particularly insidious scheme.
The study notes that today, “Over four million Americans misuse opioids each month” at a societal cost of $80 billion annually. 300 million prescriptions were written in 2015 in the U.S., which has a population of 323 million. This is reflected in the fact that 80 percent of the world’s opioids are consumed in the U.S., which has 5 percent of the world’s population.
The misuse of opioids is a not a simple issue, and personal choice is of course involved. But the above numbers point to something much bigger going on.
As the Harvard study confirms, Big Pharma has exploited the enormous addiction potential of opioids to prey upon the American populace for decades -- made possible by a federal government with blatant disregard for the well-being of citizens.
I've had a few friends in the past who had a horrible opioid addictions. They had a normal life, job, and income. Overtime their addiction grew worse, and lead to even worse decisions. Some found unconscious and barely lived through their addiction. Opioids aren't a solution for most people and doctors use it as "an easy way out".
This shouldn't be a surprise. Big Pharma will do anything to continue to make money, including putting innocent lives at risk. They have no intentions of curing diseases nor do they want to help those in need to get well. Their main objective is to make as much money as possible. Anyone who believe that Big Pharma is in the business to help them will be disappointed. Do the research, they have destroyed countless lives, such as people who had found cures for numerous diseases. They will do anything in their power to keep disease alive and most of all to create new ones simply to strengthen the Big Pharma empire.
Many drugs are created for pennies on the dollar, but check the prices of these drugs. No one can afford them. There are people I know who lost their lively hoods trying to keep a love one alive. Some even had to refinance their house in order to be able to buy certain drugs, such as cancer drugs. Meanwhile there love ones still perish. "There have been scientists and others who have found cures for many diseases, Big Pharma went after these individuals by discredit them as well as threating their lives." We the people have to do our research and stand together as a team to fight these big organizations that have nothing to do with helping the public. It will not be easy, but trusting these organizations and doing nothing about it is far worse.
I believe it. We're a 'corporatocracy.' None of our regulations have any teeth because the politicians who make the laws and interpret them are all on the payroll of Big Pharma and the other multinationals that run our world. No politician would dare say "boo" to one of these companies, let alone propose legislation that would allow single payer health insurance that uses collective bargaining to get the prices of prescriptions down out of the stratosphere. And they won't propose legislation to regulate or in fact stop dangerous drugs from being released to the market. The amount of damage these opiods have done to our people and society and continue to do now, unchecked by any government force, is beyond staggering. This alone could be what future civilizations say about us when we're written up in history books.
what you think @tft on the swiss market for the pharma industry? It great to know and have some insights from an expert!
thanks and keep posting great content!
Best
Francesco
I have the same earphones as you :P
Virtually every heroin addict was addicted to Oxy's first, half of them legally prescribed. I'm over a year clean now! I made it out alive. I have lots of friends that didn't though...
I do not think it's an exclusive problem for the United States. Here in Spain there has been an increase in the consumption of opiates after almost two decades of decline in consumption. Could we be living the 2.0 wave after the 80s-90s? The years ahead will tell us if it is as deadly as the previous one. Very good article. Thank you.
Pills pills pills.. Everybody on pills
It all goes back to "He who has the gold, makes the rules"! And politicians will do anything to get re-elected (i.e. bribes (both under the table and over the counter in this case)).
On top of all this, they legalize pot so they can generated TAX revenues!
And Obama increased the number of people receiving foodstamps to over 50 Million in a nation of 325 Million people.
The government wants us dumbed down, drugged and dependent on them for food and so scared of them that when they come for our guns, we will bend over and take it with no lube!
Welcome to America!!! Our founding fathers would spit on us!!!
upvoted for the simple fact, this needs to be debated!!!
Part of a article I just posted
https://steemit.com/news/@deanlogic/entitlement-fraud-it-will-make-you-sick-to-your-stomach
You are forgetting about the green men guarding the poppy fields in Afghanistan. Why would they be doing that? For money?