Why Do I Love Drug Regulation? Simple: It Keeps Us Safe
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a patient’s symptoms whether or not the drug was given. Sales figures for 2009 were nearly $13 million. If you think that’s a lot of wasted money, just imagine about how many yen the company earned over the 40-year period they sold the drug. Pfizer’s gemtuzumab (Mylotarg) was withdrawn from the market in 2010: it failed to demonstrate any benefits to patients in follow-up studies, and patients taking it were actually dying in greater numbers than those who didn’t.
Another dangerous drug that was pulled from the market was Regulin, as recounted in John Abramson’s excellent “Overdo$ed America: The Broken Promise of American Medicine.” The initial FDA reviewer was of the opinion that the drug should not be approved because it offered no significant advantages over existing medicines, and it appeared to cause liver inflammation. The reviewer was removed, however, and Regulin wound up being approved by the FDA for treating diabetes. However, after mounting reports of liver damage and liver failure, the drug was finally pulled off the market three years and $1.8 billion in sales later. It was suspected of killing nearly 400 people and damaging the livers of many more.
Off-label marketing of drugs for indications for which they have not been approved has resulted in some billions of dollars in profits and billions of dollars in fines for pharma companies in recent years. These fines are widely considered a cost of doing business in the industry. Why is off-label marketing forbidden? Because it results in drugs being used for ailments for which they have not been shown to be either safe or effective, potentially costing consumers their money and possibly their lives.
Many people would classify homeopathy, naturopathy, and similar treatments as modern day snake oil. In his book “Snake Oil Science: The Truth About Complementary and Alternative Medicine,” author R. Barker Bausell convincingly illustrates how rigorous scientific evidence does not support the effectiveness of these therapies, and people using them, while possibly benefiting from the placebo effect, are simply wasting their money.
Pressure on the FDA to approve new medicines increased markedly after the pharmaceutical industry began footing much of the bill for drug approvals as a result of passage of the Prescription Drug User Fee Act (PDUFA) in 1992. The number of drugs approved by the FDA but later withdrawn due to safety reasons more than tripled (from 1.6 percent to 5.3 percent) in 1997-2000 compared to 1993-1996.
I don’t disagree with the viewpoint that says that regulations make it more difficult to get drugs approved. But isn’t this a process that we want to be (at least somewhat) difficult? Shouldn’t there be clear and convincing evidence that the drugs that we (and the government) pay for are both safe and effective? As stated above, I readily concede that the FDA isn’t perfect and could function better in providing clear and timely guidance to the drug industry. However, I am happy that they stand between you and I and the people who would sell us modern versions of snake oil to make a buck.
It is widely agreed that new classes of antibiotics are needed to combat the growing number of drug-resistant microbes. The problem facing the pharma and biotech industry isn’t excessive regulation; it’s a lack of inducements in the midst of a drought of innovation. Let’s create significant new incentives that will reward companies for generating new drugs to combat the problem. Among the possibilities are significant tax breaks, longer patents, and guaranteed pricing tied to effectiveness. Maybe this will help redirect money that the industry is presently committing to acquisitions or biosimilars into new and novel medicines that will someday save millions of lives.