How Patents Have Contributed To The Opioid Crisis
from the monopolies-make-people-do-fucked-up-things dept
Over at Quartz, there's a very interesting article about how patents may have contributed to the opioid crisis in the US. It's based on a recent paper, May Your Drug Price Be Ever Green, by law professor Robin Feldman (who has done lots of great work about problems in our patent system) and law student Connie Wang.
For many years, we've written about how the pharmaceutical industry has become so overly reliant on patents for their business model, that's it's become destructive. We've argued that the misaligned incentives of the patent system, especially in pharmaceuticals has so distorted incentives that the big drug companies basically have become focused solely on keeping exclusivity that it has lead to a lot of tragic game playing, where the cost has literally been people's lives. This went into overdrive a decade or so ago when big pharma realized that many of their biggest sellers had patents expiring, and their pipeline had failed to come up with new drugs to replace the monopoly rents of the old. This resulted in all sorts of gamesmanship designed to allow big pharma to retain monopoly rights even after a drug should have gone off patent. This included pay for delay schemes, whereby big pharma effectively paid off generic makers to keep them out of the market for longer.
And then there's the trick of making basically the same drug, but with just a slight, non-essential change, and getting a patent on the new drug. Of course, you might wonder why that would stop people from moving to generics. There are all sorts of games played over this, including misrepresenting the "new" drug as somehow better, or even tarnishing the reputation of the old drug for no other reason than to drive people to the new one. Or, a really nefarious trick: stop selling the older drug a little while before it's gone off patent, to effectively force patients who need it onto the new drug, making it much less likely they'll go to the generic copy of the old drug, since there's a big gap in when it was available.
Another trick is Big Pharma threatening doctors for prescribing generics.
Basically, if there's been some sort of sleazy underhanded way to make people pay more for drugs than they really should, Big Pharma companies have probably done it. And that takes us back to Feldman and Wang's study. Basically it puts some numbers to the anecdotes and examples we've talked about over the past few years:
This study examines all drugs on the market between 2005 and 2015, identifying and analyzing every instance in which the company added new patents or exclusivities. The results show a startling departure from the classic conceptualization of intellectual property protection for pharmaceuticals. Key results include: 1) Rather than creating new medicines, pharmaceutical companies are recycling and repurposing old ones. Every year, at least 74% of the drugs associated with new patents in the FDA’s records were not new drugs coming on the market, but existing drugs; 2) Adding new patents and exclusivities to extend the protection cliff is particularly pronounced among blockbuster drugs. Of the roughly 100 best-selling drugs, almost 80% extended their protection at least once, with almost 50% extending the protection cliff more than once; 3) Once a company starts down this road, there is a tendency to keep returning to the well. Looking at the full group, 80% of those who added protections added more than one, with some becoming serial offenders; 4) The problem is growing across time.
And what does that have to do with the opioid crisis? Well, Purdue Pharmaceutical, the makers of OxyContin -- the key drug that's at the heart of the crisis -- has messed with the formulation of OxyContin 13 times to effectively "extend" the patent. Some of these may have good intentions behind the modifications, such as the changing of OxyContin to "abuse proof" pills that are much harder to crush and snort. But, as the Quartz article notes, the constant revamps of the formula and the extending of the patent cliff allowed Purdue to continue promoting the drug. And, famously, Purdue got tons of people hooked on OxyContin by falsely claiming that it was non-addictive. The story of the rise of OxyContin and the false marketing involved in its success is legendary and has been written about in academic papers and the press over and over again. Indeed, the New Yorker just did a giant article on the rise of OxyContin and the dark legacy of Purdue Pharmaceutical's aggressive and misleading marketing. The short summary from that article:
Purdue launched OxyContin with a marketing campaign that attempted to counter this attitude and change the prescribing habits of doctors. The company funded research and paid doctors to make the case that concerns about opioid addiction were overblown, and that OxyContin could safely treat an ever-wider range of maladies. Sales representatives marketed OxyContin as a product “to start with and to stay with.” Millions of patients found the drug to be a vital salve for excruciating pain. But many others grew so hooked on it that, between doses, they experienced debilitating withdrawal.
Since 1999, two hundred thousand Americans have died from overdoses related to OxyContin and other prescription opioids. Many addicts, finding prescription painkillers too expensive or too difficult to obtain, have turned to heroin. According to the American Society of Addiction Medicine, four out of five people who try heroin today started with prescription painkillers. The most recent figures from the Centers for Disease Control and Prevention suggest that a hundred and forty-five Americans now die every day from opioid overdoses.
That part about how it led many to switch to heroin, because OxyContin is too expensive? Well, that all goes back to patents. Obviously Purdue held the key patent on OxyContin for a while, but that expired in 2013. And yet, four years later, there still aren't generics to take its place. As the Quartz article explains:
The company is still profiting off “abuse-deterrent” OxyContin. Though there are currently “authorized generics” of OxyContin available, these are made by manufacturers with licenses to use Purdue’s formula. In other words, Purdue makes money off them. And there are currently no approved abuse-deterrent generics in the US. In September of this year, FDA commissioner Scott Gottlieb said that soon the agency plans to issue guidelines to assist companies who are trying to file applications for these types of generics. No word on when that document will be published, however.
Obviously, this is not the sole reason -- or perhaps even a major reason -- behind the opioid crisis. But it has clearly contributed to it. Purdue Pharma certainly deserves much of the blame for everything its done. And it took doctors way too long to realize the problems and risks of these drugs. But the artificially inflated prices of OxyContin, driven not just by patents, but by the games played by Purdue and other pharma companies, certainly helped keep the prices ridiculously high, often driving people to heroin or other, even more dangerous opioids.
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Filed Under: connie wang, drug prices, monopolies, opioids, patents, pharmaceutical companies. oxycontin, robin feldman
Companies: purdue pharmaceutical
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Patents and Copyrights make me dissent on Techdirt!
Is there NOTHING you won't blame on Patents? -- INSTEAD OF ON THE RICH AND THEIR MONEY MANIA?
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Re: Patents and Copyrights make me dissent on Techdirt!
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"You call that a knife?"
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Re: "You call that a knife?"
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You are free to come up with your own drug business model and bring antibiotics to market. Go ahead, be the next Jonas Salk.
Also, yes, prescription drugs do play a part in the current crisis, but it is only a small part. Over 80% of overdoes in the US happened to people that have never been prescribed painkillers.
The current crisis is caused by drug use mostly, not by anything the drug industry has done.
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The truth is, healthcare is a public good and should not be run solely for profit. I don't have a problem with for-profit healthcare and medicine provision as long as there's a public option. That drug development has mostly been controlled by pharmaceutical companies is the problem. Getting patents off of drugs and of medical equipment and appliance is the solution.
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Re: Opiod pseudo epidemic
In the case of opiods, the stakes are higher, felonies, celebrities and politicians are involved. The public is better informed and suspicious, so the drama has evolved to a political, ethical and legal nightmare especially for patients.
As always, Big Media is complicit in the marketing of a new drug since a third of their advertising dollar comes from Big Pharma and its related enterprises. When a new drug is approved, Big Pharma immediately purchases large amounts of advertising in the new drug or others to compensate for reporting the new and predictably hugely profitable drug as the greatest scientific break throughs in centuries.
Simultaneously cooperating docs distribute enough samples to relieve symptoms and create temporary relief in patients who will likely become dependent, not necessarily on addictive drugs, but on drugs that are at least temporarily effective. At that point the drugs are sold at huge profits to patients who have become dependent.
If Big Pharma knows of adverse or even fatal side effects, that information is carefully concealed until the most opportune time which is near patent expiration when it is used to villainize the patent expiring drug and make a hero of the newly approved drug conveniently waiting in the wings to be revealed as the "perfect," drug on newscasts and in ads as another world changing scientific break through. Scientists almost always knew the adverse effects of the drugs in advance and corporate budgeted for them, they insured for them and planned the public reveal for the same time they revealed their replacement.
As I learned from my now deceased friend, every advancement in pharmaceuticals is a well planned marketing event. And all the intensely analyzed and discussed marketing plans are actually just redesigns of the same model that evolves around the hugely profitable patent period. Marketing triumphs over every other effort of bringing a new drug to market.
Another issue is the corruption of opium for the patents and profitability that has increased the fatal and addictive outcomes.
All medicine is becoming a dirty business.
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H owever, it's orthogonal to this discussion (I know, I do it myself!). What I think he's getting at is that the profit motive, far from improving outcomes for patients via market competition, has increased both marketing and competition, hence the mad rush to eternal youth (or semblance thereof) via elective non-essential plastic surgery.
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Whatever the fine they got for their false advertising clearly isn't enough. The courts need to strike down much harder on them for false advertising.
I'd say revoking their patent on the drug would be a strong enough of a deterrent to send a strong message to ALL drug manufacturers that lying to the public about your drugs is not ok, and you'll be punished severely if you do it.
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Or, possibly you think there is no problem.
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Striking down one patent would sting a little. Striking that patent and issuing two injunctions (worded slightly differently and running consecutively) on the company against filing for any new patents for, say, two 20 year periods ("we'd make it 'just' 20 like normal drug patents, but you might miss the point about what patent abuse really is") would be both a strong deterrent and message to other companies.
They could still probably find a way to weasel their way around the injunction by reorganizing as a new company, forming shell companies, or something similar, but it would definitely be painful. The best case scenario is that they would actually learn to compete on merit and value, and set an example for other companies to follow.
In the best case scenario, they wouldn't even have to fire their lawyers. Instead the lawyers could help fight the legal shenanigans of their competition when they realize that a major drug company selling drugs at competitive prices will fundamentally change the whole big pharma paradigm.
Again, from a current legal framework, this isn't going to happen. First, we'd have to enact patent abuse laws with real consequences. But I can dream.
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This is nothing new.
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The Opioid Crisis = Andrew Kolodny
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Just saying.
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It's not as if the people without the patents are any better, though.
One of the principal manufacturers of generic oxycodone is a company called Mallinckrodt. They make tons of money off of it. And then, when people get hooked on it... you know what else Mallinckrodt makes? Methadone, the leading drug for treatment of opioid addiction.
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Another Fact: Opioids are needed by many people. They allow them to live their lives maybe not pain free, but at least able to live through the pain.
There are doctors that overprescribe yes, but there are other doctors that worry because of the current environment, people are not receiving the drugs that they should be getting.
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Fake news then? ... yeah?
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Citation?
"There are doctors that overprescribe yes, but there are other doctors that worry because of the current environment, people are not receiving the drugs that they should be getting."
So, we have to decide where the acceptable point is, since whichever way we go it will lead to people being under or over-prescribed.
Maybe instead of bleating and whining, you guys might actually want to get into an actual debate about these issues?
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Just like how some groups talked about how AIDS wasn't just a gay problem, even though it mostly was. They knew that a lot of Americans would not care if gays were dying, so they tried to make it seem like everyone was at risk.
There is a drug use problem, but mostly an illegal drug use problem. Patents have very little to do with this.
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Patents really don't have much to do with it in reality. People are dying of overdoses not because of a patent, but because they are addicted to it and are unable or unwilling to get help for it.
Moving from Oxy to heroin may be a price issue, but at that point, you are just down the tube of choosing your own pain. Plenty of people OD and die from oxy. Lower the price (or make it generic and even more widely available) and you will just displace heroin as their death of choice.
Huge numbers of people are taking it without a prescription, mostly though pill mills, prescription diversions, forgeries, and of course armed robberies of drug stores. The number of non-prescription users generally far exceeds the number of legit users.
Making it generic and even more widely available wouldn't fix the issues.
The true issues are (a) the US is addicted to legal and illegal opiods, and (b) the US border is so porous that tons of illegal drugs such as heroin are flooding the marketplace.
Work on B, limit the use of opiods as prescription medication, and work on getting those addicted off the drugs. Then patents aren't even an issue. Worrying about patents in all of this is deck chairs on the Titanic material.
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Addicted out of thin air I suppose? No abuse in prescriptions, no pressure on doctors.
My mother happens to be a doctor. She has been pressured and threatened, in a veiled way of course, because she refused to prescribe medicine. More than once. Good thing she built a solid reputation and could repeal such threats. On medicine that should be public domain.
So, personal experience says you are a moron.
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There will be many other factors, but I think this (along with things like patents that encourage such behaviour) has to be a major factor.
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Really, patents don't have much to do with the way companies use underhanded tactics to get maximum profit during the patented period? Tactics that have a large amount to do with the current problem. You believe that?
"Moving from Oxy to heroin may be a price issue, but at that point, you are just down the tube of choosing your own pain."
Heroin was also a branded drug made by a "respectable" company who claimed it wasn't addictive. Worth thinking about.
"Huge numbers of people are taking it without a prescription... The number of non-prescription users generally far exceeds the number of legit users."
"Work on B, limit the use of opiods as prescription medication, and work on getting those addicted off the drugs."
Most people are taking it without a prescription, and often recreationally so the best fix is to reduce the prescriptions and threat the medical side. Really?
You should read your own arguments sometimes, it might help you see why they're laughable.
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Tighter restrictions on it's use would also go a long way to keeping people from getting addicted. The fewer people with marginal issues or issues that could be addressed by non-addicting medication that don't end up taking it would certainly have longer term implications.
"Really, patents don't have much to do with the way companies use underhanded tactics to get maximum profit during the patented period? Tactics that have a large amount to do with the current problem. You believe that?"
I think that as a more widely available generic, we might be facing an even greater crisis. Prices would drop, usage would likely go up, and more people would be addicted.
The truth is that it's a medication that should be stringently controlled. The government(s) have failed.
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It will help, but I think the boat has sailed there in terms of it being the major solution. People who are already genuinely addicted will still go to the black market, who are very much capable of producing their own drugs.
It's currently easier for them to redistribute officially produced drugs, but the people currently producing other opitates and synthetic drugs will most likely be happy to produce these as well, with the lack of quality control that happens in that market causing even more problems.
It's right that these things have to be done, but it's a folly to suggest that it's the main solution, especially in a profit-driven medical system.
"I think that as a more widely available generic, we might be facing an even greater crisis"
Now, this is where I disagree totally, but I admit I'm not fully versed in the US medical system. I think that the issue isn't patent vs generic at heart, but overprescription and the resulting addiction. Uniquely in the US system, corporations pressure both patients and doctors to prescribe their product, even where it's not medically necessary. Making the product generic removes the major profit motive for a single company to push doctors to prescribe their product, since even if the advertising works, they can't guarantee it will be their brand that the pharmacist provides.
Again, I could be wrong, but in a massively profit-driven medical system (changing that would be the better long-term solution, by the way) removing the profit increase driven by the patent would surely stem some of the overprescription.
"Prices would drop, usage would likely go up, and more people would be addicted."
If the only way you can legally obtain a drug is through a doctor's prescription, I don't see why price should be an issue. But, I do say that as someone who has enjoyed public healthcare for most of my life, so I've rarely paid more than a few pounds/euros/dollars for any type of medication. The problem in my mind is the profits due to the drug manufacturers and the doctor, not the cost to the patient.
"The truth is that it's a medication that should be stringently controlled. The government(s) have failed."
You can say that about most drugs, medically prescribed or otherwise. Thriving black markets exist for all of them, except those that don't sell enough to be worth the effort.
But, it is worth noting that the current opiate epidemic is mostly in the US, where 80% of prescribed opiates are consumed. While you want to pluralise the governments there, this does seem to be a largely American problem, and so you have to look at what makes the medical system different there - which usually includes things like for-profit motives, marketing prescription drugs to patients (illegal in most other countries) and so on.
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