How big pharmaceutical companies endanger our health
This year, one-in-six Americans will decide to go without life-saving medicine, according to Consumerist. And according to a 2015 Wall Street Journal article, last year 10 percent of U.S. blood cancer patients stopped taking their prescriptions due to heightened cost. The culprit? Big pharmaceutical companies that are hiking prices and putting citizens’ health at risk.
Mylan, the producer of the EpiPen, recently made headlines after becoming the latest pharmaceutical company to dramatically raise prices. Fortune magazine reported the company had increased prices 500 percent to a list sum of $608.
The increase has already had an impact on Gillian Clowes, a sophomore at the University of Delaware, who doesn’t know how she’ll afford her prescription. “I’m facing the possibility where I just may altogether stop carrying an EpiPen because I don’t know if it’s financially worth it to pay for something that they will administer to me in a hospital when I inevitably end up there,” Clowes said.
So how do pharmaceutical companies get away with it? One way is through patenting their products. After pharmaceutical companies discover a new medicine, “the drug is covered under patent protection, which means that only the pharmaceutical company that holds the patent is allowed to manufacture, market the drug and eventually make profit from it,” Dr. Ananya Mandal explained in a News Medical article.
Mandal said these patents last an average of seven to 12 years; afterward, generic drugs — copies of brand-name drugs — can begin manufacturing. But during the patent’s lifespan, the manufacturer has a monopoly over the drug, according to Mandal, which allows companies to demand any price for prescriptions.
Timothy Holbrook, a professor of Law at Emory University, said the process of introducing generic drugs is slowed not only by the patent system but also by the Food and Drug Administration (FDA). “The patent system is only about creating and incentivizing new innovations,” he said. “I may discover a new drug, but the patent system doesn’t give me any right to sell it. That means you have to get approval from the FDA for any type of drug, a new drug or a generic drug.”
However, the problem is, as Sydney Lupkin of Kaiser Health News found in July 2016, “the FDA had 4,036 generic drug applications awaiting approval, and the median time it takes for the FDA to approve a generic [drug] is now 47 months.”
Backlogged drug approval could be on its way to being solved, though. The FDA has began charging user fees to generic drug companies in hopes of raising their revenue. Lupkin explained in her article that technology improvements and increased hiring have begun to help mitigate the problem. But until that backlog is solved, it creates an issue. Holbrook said the American economy is based off free trade, and the drug industry is part of that economy. Prices are driven by competition, making costs more affordable for consumers. Without a wide availability of generic drugs stimulating the market, and providing that competition, big brand name drugs can raise prices for their own benefit.
Patents and a sluggish FDA aren’t the only things putting patients at risk, however. Not only are drug companies monopolizing markets, they are also failing in their attempts to be transparent. In a study, New York University professor Jennifer Miller found the results of many phase two and three clinical trials — which distribute pharmaceuticals to large groups to ensure safety and effectiveness — were not published. Additionally, only 20 percent of final trials were posted to the official trial registry ClinicalTrials.gov. Disclosing results is not legally required, so many companies don’t take the risk of being transparent.
Because results are not readily available, doctors prescribing drugs could be inadvertently harming our health. In 2015 alone, there were several multimillion dollar lawsuits against pharmaceutical companies for causing bodily harm to patients. For example, DrugWatch wrote that lawsuits forced Takeda Pharmaceuticals to settle for $2.4 million when their Diabetes drug Actos caused bladder cancer. Takeda put their product on the market even after tests showed a 40 percent increased risk of the disease, according to DrugWatch.
Not only are companies withholding vital information about products, they may also be actively pushing the prescribing of brand name drugs — drugs that were the first to receive a patent — for the sake of profit. An investigation by ProPublica found that doctors who received more than $5,000 a year from brand name drug companies had an almost 10 percent higher rate of prescribing those companies’ patented products instead of generic versions.
Because so many Americans are affected, grassroots efforts to combat Big Pharma’s abuse of the system have started to crop up. One group, Universities Allied for Essential Medicines, organizes students to speak out against big pharmaceutical companies. Alexandra Greenberg, a spokeswoman for the organization, said that Americans have a right to most pharmaceuticals because they were created with taxpayer dollars. EpiPen in particular, she said, was developed completely through a Department of Defense grant.
“It actually is a taxpayer funded invention, in that the government provided the necessary money to develop,” Greenberg said. “And now, down the line it has eventually fallen into the hands of Mylan.”
Whether through FDA improvements or citizen activism, only time will tell where the future of pharmaceuticals will lead. For now, issues still remain with the companies that are in control. But Clowes, the University of Delaware student, said she hopes the EpiPen scandal creates awareness of the issues within the system.
“I’m hoping that this will bring to attention the problem there is with healthcare in America and the apparent problem with people not being able to afford medical treatment.”
Anna Lamb is a sophomore journalism major who is seriously thinking about switching to “alternative medicine.” They can be reached at [email protected].