By Morgan Statt, Guest Columnist
It’s 2005, and the National All Schedules Prescription Reporting Act (HR 1132) is on President George W. Bush’s desk ready to sign. With one fell swoop he signs the bill into law, and it grants all states $100 million in funding to aid prescription drug monitoring services. Shortly after, former Louisiana representative Billy Tauzin abandons his post in the House of Representatives and accepts a job as President and CEO of PhRMA, a major lobbying group for pharmaceutical companies. Instead of celebrating the bill being signed into law, Tauzin finds a way to dismantle the allocation of funding.
Now, let’s bring it back to present day. Today, there is an almost daily snippet of news on America’s opioid epidemic, one that has ravaged nearly every area of the country. In 2016, more than 63,600 opioid overdose deaths were reported, the highest number ever, and new reports show that the crisis is lowering the average American life expectancy.
What’s being done to combat the crisis that either directly or indirectly affects millions of Americans?
For one, states are strengthening their prescription monitoring programs, the very thing Rep. Tauzin dismantled funding for in 2005. Although these programs have been in place for a number of years, only a limited number of providers have taken advantage of their ability to detect and deter abuse. Additionally, cities and states across the country have filed lawsuits against pharmaceutical companies for their role in the crisis.
And Louisiana is one of them.
In September 2017, the Louisiana Department of Health filed a lawsuit against 16 drug manufacturers, among them OxyContin maker Purdue Pharma, at the 19th Judicial Court in Baton Rouge. The suit claims that the named companies used aggressive marketing tactics and encouraged physicians to prescribe opioids under the guise that they were not addictive.
Louisiana Attorney General Jeff Landry has said that “Louisiana is one of eight states that has more opioid prescriptions than residents.” Despite the fact that Big Pharma played a role in the opioid epidemic, will these lawsuits actually make a difference? Even if there was an astronomical payout, will these lawsuits help to end the crisis and prevent future epidemics?
The short answer is: no.
Big Pharma is like that rich, popular kid in high school we all knew. They used their money and status to manipulate peers and played off students’ desires to be a part of their inner circle.
Similarly, Big Pharma uses status and influence to get what it wants. Its targets for manipulation span multiple areas of the industry, which include the current regulations in place and clinical trials.
Before we can even have a sliver of hope that a hefty payout will change its ways, we have to tackle the pharmaceutical industry’s influence head-on to see any real impact on its actions. We can start by addressing these two areas of influence.
Drug companies have the ability to fund clinical trials.
Imagine you come out of surgery and are placed on a blood thinner to prevent any clotting from happening once you’re off the operating table. You’ve been told of the internal bleeding side effects, but there just so happens to be no known antidote on the market yet to serve as treatment if such complications arise.
This was the case for the anticoagulant Pradaxa. In 2010, the medication was met with FDA approval and put on the market without an antidote. But then severe internal bleeding incidents took place, and over 1,000 people died as a result of being prescribed the medication. Since then, manufacturer Boehringer Ingelheim has had a slew of Pradaxa lawsuits filed against it for its role in patient harm.
I bring up Pradaxa as an example because it points to issues with the clinical trial process that exist today. In a recent study conducted by Johns Hopkins University, clinical trial funding that has been traditionally provided by the National Institute of Health has fallen dramatically over the years. To supplement the lack of funding, pharmaceutical companies sponsor the trials. But, this presents the opportunity for companies with financial interest in the trial outcomes to favor positive results over any negative side effects that could occur.
In the case of Pradaxa, its industry-funded clinical trial RE-LY was met with criticism from drug safety groups for generalizing the medication’s potential population and failing to be carried out as a double-blind study. Skewed trial results led to hasty FDA approval and ultimately the creation of a $650 million settlement fund in 2014 that Boehringer Ingelheim used to settle over 4,000 claims.
Laws & regulations favor Big Pharma.
Despite legislators’ best attempts to protect consumers, certain laws & regulations currently in place often aid pharmaceutical companies’ business ventures, rather than prioritizing patient safety. One such law that has faced criticism in recent years is the 21st Century Cures Act, which loosened regulations on the drug and medical device approval process.
Although put in place to encourage innovation and quicken the ability for life-saving drugs to get to market, critics argue that the real winners of the bill were the drug companies. As part of the “loosening” of regulations, Big Pharma can now get away with using only “data summaries” instead of conducting full clinical trials to get drug approval. They’re also now able to promote off-label uses for their medications, enabling them to expand their markets – and their profits.
Ironically enough, drug companies aggressively promoted the off-label use of opioids and contributed to the rise in addictions across the country. Look no further than Insys Therapeutics’ push for non-cancer patients to take Subsys, a “powerful, fentanyl-based liquid” originally marketed for cancer patients with pain that couldn’t be treated with any other option.
As much as we’d like to pretend that lawsuits against Big Pharma can play a role in solving the opioid crisis, this isn’t the case. Drug companies’ influence stretches far and wide, and it may be time to strip that influence away little by little.
Let’s scrutinize the laws and regulations in place that give Big Pharma the upper hand. Let’s consider alternative funding sources for clinical trials that would allow little room for bias. But most importantly, let’s find a way to ensure that lawmakers, lobbyists, and other government officials are committed to doing what’s best for the American public rather than chasing that dollar sign.
(Morgan Statt is a Health & Safety Investigator for Consumersafety.org, a consumer information organization which strives to provide information about recalls and safety-related news about drugs, medical devices, food, and consumer products.)
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