Medicinal drugs in the U.S. are in short supply. Some are so scarce — medicines for heart problems, arthritis, diabetes, cancer, Lyme disease, and tuberculosis as well as antibiotics and crucial saline solutions for patients too sick to eat or drink — that patients are dying because they can’t get access to them.
The shortage goes back at least a decade and shows disturbing trends.
In 2007, the Food and Drug Administration listed 154 drugs that were in short supply or no longer available. That figure exploded to 456 in 2012. Today there are more than 300 drugs listed in short supply by the FDA.
The situation is pressuring U.S. hospitals to pay at least $230 million more a year than they ordinarily would to find alternative treatments, according to Michael Alkire, COO of Premier, an alliance of hospitals and health care providers.
“Hospitals have been scrambling to continue to provide outstanding patient care while there are short supplies,” he said.
More importantly, the shortage may have caused the deaths of 15 people in 2011 when substitute drugs were used instead of first-line treatment medicines that were in short supply, according to one news report.
And a 2012 study discovered that when drug shortages forced doctors to switch medications in a clinical trial for Hodgkin lymphoma, the number of patients who were cancer-free after two years fell from 88 percent to 75 percent.
“I think we’re at a point that some hospitals and doctors may not have what they need to treat a patient,” said Erin Fox, a professor in pharmacotherapy at the University of Utah and a leading expert on drug shortages.
What’s the cause?
One reason for the drug shortages is spikes in demand for treatments when disease breaks out.
But according to the Government Accountability Office (GAO) which did a study in 2013 on the drug shortage, other reasons include a lack of materials to make the drugs, as well as delays in getting government approval for new and experimental drugs.
Add to that the simple fact that fewer pharmaceutical companies are making drugs these days.
According to the GAO report, 71 percent of all generic injectable cancer drugs sold in 2008 were produced by just three manufacturers, while 91 percent of the market share of injectable nutrients and supplements was held by just three pharmaceutical firms.
This may seem contradictory, as the U.S. biopharmaceutical industry is the world’s leader in drug research and has a total economic impact of $790 billion a year on the U.S. economy.
But producing new drugs isn’t necessarily easy. That’s because pharmaceutical companies go through the process of creating a treatment from beginning to end without any guarantee a drug will be effective and produce revenue.
Dr. David Vaughn, head of pharmaceutical giant GlaxoSmithKline’s GSK external research and development, North America, said that the average cost and time — nearly a decade — to get a new drug on the market “has pushed the bigger pharmaceutical firms away from making them.”
Add to that the difficulty in drug production, said Dwight Kloth, director of pharmacy at Fox Chase Cancer Center, in Philadelphia, Pennsylvania. “It’s a lot more complicated to make these types of treatments than making aspirin or cholesterol tablets,” Kloth said.
He said a contamination slip-up somewhere in the process can cause drug makers to shut down production and delay getting medicines on the market.
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