Students at Princeton University finally received meningitis vaccines this week after the Centers for Disease Control ruled that they could be given a vaccine as yet unapproved by the Food and Drug Administration. The strain of the disease affecting the campus, the B serogroup, is rare and no FDA-approved vaccine protects against it. The vaccine is approved for use in the European Union but not in the United States.
So far, seven Princeton students and one guest have fallen ill. Princeton students will be protected by the new vaccine, but many other Americans might contract meningitis—or other diseases—before the FDA speeds up its approval process.
If the CDC circumvents the FDA’s approval process for a group of Ivy League students, then the drug is clearly not dangerous—even for those not receiving an Ivy League education. If it is safe enough for the 500 million residents of the European Union, it should be allowed in America as well.
What if the eight victims were spread throughout the country, or came from less prestigious intuitions? Would the CDC have allowed the use of an unapproved drug?
Asking this question seems ridiculous, but this is a reality faced by millions daily. Cancer patients, diabetics, and those with heart problems or Alzheimer’s are all offered limited treatment options because of the FDA’s refusal to approve promising treatments.
The FDA has existed since 1906—before penicillin. Over that past few decades it has had trouble keeping up with rapid medical innovation and scientists’ understanding of the human body. Everyone has unique DNA, and individuals’ genetic makeups can now be affordably sequenced. Personalized, more effective treatment based on data analytics is possible—that is, if the FDA does not block it.
As Manhattan Institute Senior Fellow Peter Huber argues in his new book, The Cure in the Code, 20th century law is undermining 21st century medicine. A treatment that works for one person may not work for another. Huber says this should come as no surprise. As medicine advances to treat more diseases, the percentage of patients positively affected by treatments will likely shrink.
It is hard to speed up the FDA approval process. AIDS activists accomplished this in the late 1980s, and many remember images of protestors lying with signs that read “Killed by the FDA.” It is disappointing that influential institutions such as Hollywood have not keep reform pressure on the FDA for the sake of those who suffer from other terminal diseases.
Patients with terminal illnesses and their families are desperate. Today, bureaucrats have the legal authority—if not the moral authority—to tell a dying cancer patient they cannot take a one-in-a-hundred chance and try an experimental drug. The Manhattan Institute’s Project FDA recently released a new video that highlights just how devastating such restrictions can be.
What does it matter to those who are otherwise going to die if the drugs they are taking are not proven to be 100 percent safe and effective? Unfortunately, the terminally ill have no other options. Taking experimental drugs at worst provides the sick with hope, and at best saves lives and gives us more data on the drugs’ effectiveness, or lack thereof.
In defense of the FDA, people argue that without regulators, drug companies would market unsafe drugs that bring in profits without cures. The reality is more complex. Some drugs might not work for some individuals, but they might be effective for others. The decision should be left to patients and their doctors.
Drug manufactures, similar to any other company, make money through free exchanges with customers. Consumers would not line up to buy pills from a brand that has a history of creating unsafe drugs. Healthy, happy customers are vital to drug companies’ successes. For this same reason, McDonald’s would not knowingly serve its customers tainted meat. The profit motive provides strong incentives to not harm customers.
That being said, an agency such as the FDA has some advantages. Having impartial certification of a drug’s safety is beneficial, although the market could provide this as well with independent testing services. The benefit of market-based organizations is that competition forces adaption to changing technologies, an incentive the FDA lacks.
The FDA’s outdated ways harm people. It is time to stand up for medical advances and put an end to destructive policies that cause needless suffering. Everyone, not only Princeton students, should be able to take advantage of the latest in pharmaceutical innovation.
Jared Meyer is a research associate for Economics21 at the Manhattan Institute. You can follow him on Twitter here.
[Originally published on e21: Manhattan Institute Blog]