In October of last year, California Governor Jerry Brown signed SB 17 into law, a bill that mandates drug manufacturers to now publicly provide justification for any big drug price hikes. It was both a rebellion against Big Pharma practices and an effort to inject transparency into the controversial industry.
The legislative decision comes as a response to the massive price hikes of life-saving drugs over the past few years. It’s hard to forget Turing Pharmaceuticals’ CEO Martin Shkreli deciding in 2015 to raise the price of Daraprim by a shocking 4,000 percent, an ill-fated move that catapulted him into the national spotlight.
With California leading the way, more states are taking drug price transparency bills into consideration. But, they certainly won’t be met without some pushback from Big Pharma. In fact, the industry hired 45 lobbyists to try and defeat the Golden State’s legislation.
As states continue to work on efforts to reform various healthcare issues, the pharmaceutical business (Big Pharma) itself is a lucrative industry with problems that extend far beyond the practice of price hikes. Just look at the number of states and local entities who have filed lawsuits against drug companies for their involvement in spurring today’s harrowing opioid crisis.
To further advance healthcare reforms, let us recognize other questionable practices within the industry in the hopes of making even more progress.
Despite recent legislation that has defied the pharmaceutical arena, other laws and regulations in place are actually skewed in its favor. Take, for example, the 1984 Drug Price Competition and Patent Term Restoration Act that has also affected the cost of medications. Although this decades-old law was passed to give pharmaceutical companies patent protections over innovative drugs brought to market, it has since spurred on industry efforts to game the system. Once a drug patent expired, companies began bringing “pay for delay” agreements to the table; brand-name companies simply paid off generic manufacturers not to release their version of a drug.
With generic manufacturers now accepting monetary incentives to stall the release of cheaper medications, the regulation’s intention of keeping drug prices low through increased market competition has failed to be as effective as originally hoped.
Then, there’s the issue of clinical trial funding. A Johns Hopkins study published in the Journal of the American Medical Association (JAMA) found that from 2006 to 2014, the number of independently funded clinical trials has drastically declined. Instead of organizations like the National Institutes of Health sponsoring drug studies, manufacturers themselves started to provide the financial backing.
On one hand, industry-funded clinical trials help to bring more innovative drugs to the market because they’re receiving the necessary monetary support to do so. But on the other hand, drug companies with financial interest in a trial’s outcomes are presented with the opportunity to prioritize the positive results of a study while also masking any negative side effects of a medication.
Look no further than the clinical trial of newer anticoagulant Xarelto. During its industry-funded study, a faulty blood-testing device was used that indicated the blood thinner was less safe than traditional medication warfarin. According to the BMJ (formerly the Brtish Medical Journal) report, knowing the data would highlight Xarelto’s risk of internal bleeding, manufacturers Johnson & Johnson and Bayer withheld this information from the overall results.
After masking this key piece of trial data, the FDA approved the anticoagulant in 2011 without an antidote to reverse its blood-thinning effects. Shortly after it hit the market, thousands of patients who were prescribed the drug suffered internal bleeding complications and even death. This year, Johnson & Johnson and Bayer find themselves in legal hot water after thousands of Xarelto lawsuits have been filed due to the patient harm the medication has caused.
Clinical trial funding sources and regulations skewed in Big Pharma’s favor are just two pain points of the industry that have gotten in the way of proper patient prioritization when it comes to healthcare. California’s latest piece of legislation that addresses the potentially harmful influence of the drug industry is a step in the right direction for our country’s medical care efforts.
We can only hope that more states will follow in its footsteps and reaffirm medicine’s intended focus – a focus that puts patients first.
Morgan Statt is a health and safety investigator who spends her time researching and writing on a variety of topics. Follow her on Twitter @morganstatt.