TheLiberalOC accepts guest editorials on a variety of subjects with authors responsible for their content. We offer this submission from Morgan Statt.
The Influence of Big Pharma: Why Lawsuits Won’t Change the Pharmaceutical Industry’s Questionable Practices
By Morgan Statt
There’s a sense of hope and renewal that comes with the beginning of each new year. Now that 2018 is underway, we’re already starting to see moments of positivity. As of January 5th, North Korea has agreed to peace talks with South Korea, and the bomb cyclone that hit the northeast is finally moving on.
But, there’s one bit of news that has stayed constant the past few years. America is in the midst of an opioid epidemic, and there are no signs of it slowing down. In 2016 alone, there were over 60,000 opioid overdose deaths – and the average American life expectancy has dropped for the second year in a row.
To combat the crisis, there’s one measure that has united cities, municipalities, and even entire states. Areas are suing drug companies for their involvement in the opioid crisis. Counties in New York, Louisiana, and even California’s Orange County have filed lawsuits against Big Pharma for aggressive marketing tactics that suggested opioids weren’t as addictive as we know them to be. Stat News has even named the suits among the top court cases to watch in 2018, and some are questioning whether it will be likened to the massive tobacco suit filed in the 1990s.
If these areas of the country win against the drug companies, the question begs to be asked whether or not a hefty payout will do anything to affect the actions of Big Pharma. The industry’s influence spans far and wide, and critics point out that lawsuits filed for any number of reasons are often viewed as just “the cost of doing business.”
How and why exactly does Big Pharma have the amount of influence that it does? Before we can see an end in sight for the opioid crisis, we must first understand two of the reasons behind the pharmaceutical industry’s major control over healthcare.
Health care fraud is “easier” for larger companies.
To protect consumers from harm that could be caused by any pharmaceutical drug on the market, Congress passed and upholds the Federal Food, Drug, and Cosmetic Act (FDCA). The law also includes a Medicare Exclusion Statute that excludes any individual or entity convicted of criminal penalties from participation in Medicare and other state health programs. Convictions can include patient abuse, violations of controlled substances, and other similar crimes.
Despite the existence of this statute, larger companies have found loopholes within the FDCA that allow them to receive less severe criminal penalties. Pharmaceutical giant Pfizer serves as a prime example for its marketing of Bextra in the early 2000s.
In 2001, Pfizer was ready to market the new painkiller that was originally intended for patients who were in recovery after surgery. But, the FDA soon deemed the high doses needed for surgical pain as unsafe. Sales reps ignored FDA judgement and marketed the drug to doctors specifically within surgical specialties. Although Bextra was removed from the market in 2005, Pfizer had already made a $1.7 million profit on prescriptions that went against the FDA ruling.
Litigation against the pharmaceutical company soon followed because of its illegal marketing tactics. If the FDCA was properly followed, Pfizer would have been excluded from Medicare, Medicaid, and other state programs because of the exclusionary statute. However, prosecutors deemed that this exclusion would have a ripple effect so great that such punishment would upset the entire healthcare system. Pfizer would go under, thousands of jobs would be lost, and the delivery of necessary prescriptions to patients would be disrupted.
The pharmaceutical company instead cut a deal that charged its subsidiary Pharmacia, a shell company that never sold a prescription, with the crime. The shell company took the blame, and Pfizer was able to still participate in federal programs.
With a drug company as big as Pfizer, the extent of its monetary and health-focused influence saved it from facing severe consequences.
Drug companies can fund clinical trials.
Traditionally, clinical drug trials have been funded by independent sources such as the National Institute of Health. But according to a recent Johns Hopkins study, the number of pharmaceutical industry-funded trials increased by 43% from 2006 to 2014. Researchers highlight their concern that companies who sponsor and also have financial interest in the trial outcomes could influence the data and results in such a way that they further the company’s bottom line rather than promote patient safety.
Take, for example, the blood thinner Pradaxa that hit the market in 2005. The drug’s industry-sponsored trial RE-LY faced criticism for a number of procedural issues such as failure to be a double-blind study and a generalization of the population as indicated by the selection of trial participants. Skewed results and data encouraged a hasty FDA approval, and the anticoagulant was on the market without an antidote for five years.
Without an antidote to reverse its blood thinning effects, Pradaxa prescriptions contributed to severe internal bleeding complications and the deaths of 1,000 patients. Although an antidote was released in 2010, it still didn’t stop Boehringer Ingelheim from having to answer to numerous Pradaxa lawsuits. In 2014, the drug manufacturer finally created a $650 million settlement fund to satisfy 4,000 claims.
As Orange County prepares its opioid crisis litigation alongside other areas of the country, we must remember that it may take more than just a massive payout to change Big Pharma’s ways for the better. We need to dig deeper and reevaluate the laws and practices in place to guarantee that patient safety remains a top priority.