State, local, and federal government officials across the U.S. say they’re seeking justice against a corrupt pharmaceutical establishment, but placing blame may not solve America’s drug crisis.
Since 1999, America’s prescription painkiller epidemic has taken nearly 170,000 lives, and that doesn’t include deaths from heroin and other illicit opiates. When they’re added into the mix, the number of deaths is likely to be closer to 300,000. With a crisis so massive, politicians, journalists, and public health experts have long been looking somewhere to place their blame-, and it seems they’ve finally found it.
Until recently, major U.S. pharmaceutical companies have escaped seemingly unscathed from the country’s opioid crisis. Instead, public blame has been focused on criminal gangs and cartels for creating, selling, and distributing drugs, and the government, for the lack of economic opportunities that can often cause addiction and the lack of high-quality, publicly-funded addiction treatment options for addiction sufferers.
However, public opinion recently seems to be swinging in the opposite direction, and many politicians, law enforcement officials, and other public figures are attempting to hold big pharma accountable for its role in America’s addiction crisis. Despite that, drug company profits have never been higher, and other than a few settlements and arrests, little has actually changed in the way that pharma firms create, market, and distribute opioid painkillers.
So, are drug manufacturers really to blame for opioid addiction? If so, what should be done about it? Will holding them responsible actually change anything?
Until 1996, it was relatively unheard of for doctors to prescribe opioids to relatively healthy, patients suffering from chronic pain. That’s the year Purdue Pharma released OxyContin onto the market, and unlike previous opioid painkillers, this drug was aggressively marketed to Americans of all ages and demographics.
Purdue scientists claimed that it’s new drug was considerably less dangerous than other opioids, in part because of the drug’s 12-hour time-release formulation would help make OxyContin’s users less susceptible to addiction. For a time, patients and doctors had no reason to believe otherwise, but that would soon begin to change.
By 2000, communities across the country were beginning to experience serious problems due to OxyContin addiction. Users, many of them teenagers, would abuse the drug in a variety of ways; snorting, injecting, or even taking it rectally. Meanwhile, Purdue’s profits began to skyrocket. Within a few years of it’s release, annual sales of the drug exceeded $1 billion. By 2001, the drug had brought in a total of $2.8 billion in revenue – much of it based upon lies that Purdue representatives told medical professionals about the safety of its products. That same year, however, Purdue, under increasing pressure from patient advocacy groups and the government, completely dropped its claims that OxyContin might be less addictive.
In 2007, Purdue Pharma Settled for $630 Million+ Over Misleading Marketing of OxyContin
In 2007, a federal judge fined Purdue Pharma and three of its top executives more than $630 million for violations resulting from the company’s marketing of Oxycontin. Howard R. Udell, the firm’s chief legal counsel, Dr. Paul D. Goldenheim, the company’s former medical director, and Michael Friedman, Purdue’s president, would plead guilty to charges that they mislead government regulators, medical professionals, and patients about OxyContin’s risk for abuse.
Officials said internal documents from Purdue showed that the firm’s executives believed that OxyContin would be a tough sell to doctors from the start, and to allay the fears of doctors and the
public, they developed a marketing campaign based upon several falsehoods.
When Purdue started to market OxyContin, they received permission from FDA regulators to say that the time-release nature of drug “is believed to reduce” the medication’s potential for abuse. Purdue sales reps, however, did not make this distinction. Instead, they told doctors that the drug actually had a lower potential for abuse, when in reality it was only a theory. To increase sales, pharma reps were even allowed to draw fake scientific charts and distribute them to doctors, in order to help demonstrate the supposedly ‘safer’ nature of OxyContin.’ Sadly, these falsehoods didn’t just increase the sale of OxyContin, they began a sweeping trend of painkiller use and abuse that still plagues America to this day.
Mallinckrodt, Which Once Supplied 66% of Florida’s Oxycodone, Recently Settled a Drug Diversion Case with the Justice Department for $35 Million
OxyContin may have whetted America’s appetite for painkillers, but oxycodone, the generic version of the drug, would end up becoming a much more significant public health problem. New users appreciated the reduced price, and users familiar with OxyContin also enjoyed switching to the cheaper generic to feed their addictions, and nowhere were those addictions worse than in Florida. While the state had been a mecca for cocaine addicts and dealers in the 1980s, by the late 90s, drug abuse rates had leveled off, but they wouldn’t stay that way for long.
By the early 2000s, Florida quickly became the capital for prescription painkiller fraud and abuse. In sunny Broward County, fraudulent pharmacies, commonly known “pill mills” began spreading like wildfire. By 2010, doctors in Florida were buying close to 90% of all oxycodone sold in the entire country.
By 2011, the problem had gotten even worse. One day in February that year, 400 local, state, and federal drug enforcement agents raided a record 11 pharmacies and seized $22 million in assets from doctors and clinic owners. Federal prosecutors say the owners and operators of these facilities were “acting as drug dealers,” by giving prescriptions out to nearly anyone who could afford to pay. Similar enforcement actions in the following months would lead to the forced closure of over 400 pharmacies in the state.
While pharmaceutical companies may not have directly owned or operated any of these clinics, the clinics did get the pills from somewhere, and public health and law enforcement officials say that many pharma firms did not adequately supervise how they drugs they sold were distributed, allowing fraudulent “pill mills” to thrive across the state.
Among pharma firms who may be to blame for Florida’s opiate addiction crisis, one company, Mallinckrodt Pharmaceuticals, stands far above the rest. At one point, the company was responsible for selling 66% of oxycodone in Florida, as well as a large proportion of the drug sold around the country.
The DEA says that Mallinckrodt shipped half a billion oxycodone pills to Florida in the 4 year period between 2008 and 2012. These were the years in which the state’s addiction problems exploded. The drug company said it was prepared to admit that it was responsible for tracking suspicious orders from wholesalers, but said it was not responsible for what happened to it’s products, and effectively, it’s patients, when they reach pharmacies, clinics, and doctor’s offices.
While Mallinckrodt executives may not be happy with their recent fine, many experts believe that they’re being let off easy; some think the true damage caused by the firm is likely to be in the billions. Other public health experts say they’re simply satisfied that the firm was investigated at all, especially since many of them believe America’s opioid epidemic is partially the result of the government’s lax regulation of big pharma.
In 2016, FBI Agents Arrested Five Former Insys Therapeutics Executives for Allegedly Bribing Doctors to Prescribe Fentanyl to Patients Who Didn’t Need It
While companies like Purdue and Mallinckrodt have got into legal trouble involving their role in the improper sales of opioids, they’re far from the pharma industry’s worst offenders. In December 2016, the U.S. Department of Justice (DOJ) alleged that a group of executives from Insys Therapeutics engaged in a “nationwide conspiracy” to bribe doctors and other healthcare professionals.
Executives reportedly bribed medical professionals in order to persuade them to prescribe Subsys, a spray-version of the ultra-potent synthetic opioid fentanyl, regardless of whether patients needed it or not. The employees, which included former Insys CEO Michael Babich, were indicted on a variety of charges, including conspiracy to commit racketeering, and could face serious prison time.
While Subsys was originally intended to help cancer patients deal with severe pain, federal prosecutors say that Insys executives created a “reimbursement unit” specifically designed to provide financial benefits to medical decision-makers in order to persuade them to prescribe the drug off-label. At times, the unit would falsely tell insurers that patients had cancer in order to prescribe them the drug. On other occasions, Insys sales reps would pretend to work for a pain patient’s doctor in order to receive insurance authorization for the medication. In many cases, Insys reps sold drugs directly to patients, bringing bagels and coffee to doctor’s appointments to convince pain patients to try Subsys.
In Pennsylvania, the family of a woman who was convinced to take Subsys by a Insys drug rep in her doctor’s office is now suing the doctor, pharmacy, and Insys for what they say is a major role in her death. And, in a 2015 settlement, Insys paid the state of Oregon $1.1 million after bribing doctors to illegally advertise its drugs for non-cancer pain patients. For Insys, however, these costs are only a drop in the bucket; Subsys alone raked in $462 million in sales during 2015. One former Insys sales rep estimates that only 10% of those prescribed Subsys actually have breakthrough cancer pain, the only condition for which Subsys has been legally approved.
On March 28th, a Senate Committee Opened a Probe of the Five Largest U.S. Opioid Manufacturers, Claiming They Downplayed Risks of Addiction
Law enforcement officials aren’t the only ones who believe that drug manufacturers could be culpable for America’s soaring rates of opioid addiction. This March, a Senate Committee opened an investigation of the five largest opioid manufacturers in the U.S., alleging that they deceived doctors and the public about the risks of their products.
On March 18th, Senator Claire McCaskill, a Democrat from Missouri, sent letters to Purdue Pharma, Johnson & Johnson’s Janssen division, Insys, Mylan, and Depomed to seek information about their marketing practices, internal studies, and historical compliance with legal settlements. McCaskill is the ranking Democrat on the Senate’s Homeland Security and Governmental Affairs Committee.
According to McCaskill, “This epidemic is the direct result of a calculated sales and marketing strategy major opioid manufacturers have allegedly pursued over the past 20 years to expand their market share and increase dependency on powerful — and often deadly — painkillers.”
The Senator continued: “To achieve this goal, manufactures have reportedly sought, among other techniques, to downplay the risk of addiction to their products and encourage physicians to prescribe opioids for all cases of pain and in high doses.”
Stocks in several of the firms fell after news was announced about the investigation. Mylan, however, which received a bout of negative publicity last year after vastly increasing prices for EpiPens, saw its stock price increase by a fraction of a percent.
Local Officials in Everett, Washington and Two California Counties Sue Pharma Firms, Say They’re Responsible for Increasing Rates of Opioid Addiction
Criticism of big pharma’s role in the opioid crisis extends beyond law enforcement and congress; local government officials around the country are speaking up as well. In Everett, Washington, city lawmakers say they believe that pharma firms are directly responsible for the area’s rapidly growing addiction crisis. As a result, the city recently decided to sue Perdue Pharma for what it claims is the firm’s ‘aggressive distribution’ of Oxycontin. Specifically, the suit alleges that the company supplied suspicious doctors and pharmacies with the drug, and even monitored the illegal trafficking of its products without informing law enforcement.
Three years ago, two California counties filed a similar lawsuit against major drugmakers, accusing them of responsibility for the increasing rates of heroin use among local residents. In May 2014, Orange and Santa Clara counties filed a suit against Actavis, Endo Health Solutions, Johnson & Johnson’s Janssen Pharmaceuticals, Purdue Pharma, and Teva Pharmaceutical Industries, specifically claiming that they broke California law by engaging in false and deceptive advertising of prescription opioids. When the case reached a judge in August 2015, he dismissed it, ruling that regulating the marketing and sale of opioids would best be left to the FDA.
New Research Shows That Prescription Drugs May be Less Responsible for Addiction Than Previously Believed
Are prescription medications really causing addiction? The answer might sound like obvious ‘yes,’ but the reality of the situation may be much more complex. Results from SAMHSA’s annual NSDUH survey indicate that 75% of prescription opioid abuse begins with an individual using medication that was not prescribed to them. In addition, research shows that being an abuser of other drugs is the biggest risk factor for an individual becoming addicted to opioids, far more so than being medically treated with opioid painkillers.
These aren’t the only facts that begin to shed some doubt on the true relationship between painkiller prescriptions and addiction. A study of more than 100,000 victims of opioid overdose victims indicated that only 13% actually suffered from a chronic pain problem. A similar study of pain patients prescribed opiates found that fewer than 1% of individuals who were effectively screened for drug issues developed new addictions during the duration of their pain treatment.
Americans May Benefit from Greater Oversight of Pharma Companies, but Stricter Regulation Won’t be Enough to Contain the Nation’s Growing Opioid Epidemic
Now, let’s return to our original question: Are pharma companies really to blame for the opioid addiction crisis? Evidence seems to indicate that the answer is yes, but only partially. In general, all known prescription opioids carry serious risks for abuse and addiction, no matter their content, release-method, or dosage. Many companies, starting with Purdue Pharma, mislead many doctors and patients about the truth of this matter, As a result, doctors prescribed patients opioids when they likely shouldn’t have, and some of them went on to become addicted.
However, that doesn’t mean that the prescribing of opiates is truly leading to addiction, or an increase in use of ‘harder’ street drugs, like heroin. Many point to the statistic that 75-85% of heroin users reported using prescription opiates before turning to heroin. While dramatic, that statistic does not say how many of those individuals were actually prescribed the drugs by a doctor. It’s likely many heroin users simply purchased pain pills on the street or stole them from friends or family members.
In addition, only a small fraction of individuals who abuse painkillers switch to heroin abuse. The NSDUH survey shows that less than 4% of who abused prescription opioids abused heroin in the next five years. The survey research also shows that individuals who use heroin are much more likely to be users of many drugs, so it can be hard to accurately pin down a certain substance as the true instigator of their heroin abuse. All this means that drug companies are only partially, not fully to blame for the opioid epidemic– especially when it comes to the abuse of street drugs like heroin and carfentanil, which would likely occur regardless of prescription opioid use and abuse.
In asking and answering our question, we’ve determined that companies are partially to blame, but maybe we’re not asking the right question. Pharma companies are to blame, but does it actually matter? And, perhaps most importantly, What can we do about it now?
By all accounts, it couldn’t hurt to regulate pharmaceutical companies more strictly. Billions of pain pills have been distributed across the country in recent decades, many of them to seemingly suspicious doctors offices, clinics, and pharmacies. While more regulation could certainly prevent the problem of prescription drug abuse diversion, alone, it won’t be enough to combat opioid addiction in the U.S.
Experts Believe True Root Causes of Opioid Crisis Include Mental Illness, Unemployment, and Childhood Emotional Trauma
Unless these highly influential contributors to the drug crisis are properly addressed, America’s addiction epidemic is likely to remain unsolved or even get worse. While it’s true that pharma firms have contributed to the problem, many think that putting more public resources toward fighting drug companies may not be the best use of taxpayer dollars. These are funds that could instead be used to address the true root problems of opioid addiction.
Unfortunately, the issues that really cause opioid addiction aren’t simple, they’re extremely complex, and there’s no one person, organization, or company to blame. That means that fixing the root causes of addiction won’t happen overnight. Even with a massive effort from our political leaders, it’s going to take decades for the U.S. to reform its economy and its healthcare system to protect the country’s most vulnerable residents from the dark spectre of addiction. So, despite big pharma’s sinister role in America’s addiction epidemic, better regulation and stricter oversight of prescription drugs won’t be a one-shot solution to the nation’s growing drug crisis.