When it comes to regulation, there are many areas in which the FDA could improve its practices–compounding pharmacies, energy drinks, herbal dietary products, generic drugs,testosterone supplements, plastic water bottles, and cancer treatments–but we can now add diabetes medication like Januvia, Byetta, and Victoza to this list as well. According to a new investigative study from the Milwaukee Journal Sentinel and MedPage Today, the FDA’s approval process for such pharmaceuticals has failed patients.
“The Slippery Slope: Adverse Events and Runaway Diabetes Train”– authored by Elbert Chu, Coulter Jones, and John Fauber–argues that the FDA relies upon a “partial view” of various drugs’ side effects and that many of those it approves are dangerous to consumers. At the heart of their complaint is what they call surrogate testing measures, which occurs when researchers look at limited data sets like blood-sugar or insulin levels rather than “hard endpoints such as reducing heart attacks, strokes, blindness or amputations.”
The problem with this, the article’s authors write, is that blood sugar and insulin are fairly inconsequential if a patient later develops a more aggressive illness, one that may even kill him or her. The three drugs mentioned in the first paragraph–Januvia, Byetta, and Victoza–together were associated with “3,300 deaths and 20,000 hospitalizations” from 2004 to 2014. Despite the fact that these medications represent only seven percent of diabetes prescriptions in this country, “they accounted for more than half of deaths and reported hospitalizations” in 2013 when compared among other diabetes drugs.
Some doctors who are critical of the FDA suggest that their colleagues are too trusting of the agency. One, a Harvard Medical School professor, argues that post-market monitoring needs to take place: “There’s gotta be something better than approving drugs based on a lab test and then losing track of them, which is what essentially is happening.” He continues, “I think most doctors don’t fully understand that the recent drugs approved […] haven’t been proven to reduce organ failure and might actually carry risks.”
What we have seen time and time again in reporting cases of FDA failures is that the organization lacks the resources necessary to pursue dangerous products, but what this investigation has turned up is that adequate records are not even being kept. For example, a report from the U.S. Government Accountability Office (GAO) in 2009 reads: “Although FDA officials told us they received more adverse event reports than staff could review, the agency could not provide data showing the number of adverse event reports staff reviewed during this time period.” The report also explained that the FDA spent about three percent of its budget in 2008 investigating adverse drug events, which is a minuscule amount when we take into consideration how many thousands of people are harmed by FDA-approved medications every year.
The Milwaukee Journal Sentinel/MedPage Today piece ends with a sobering analogy: a runaway train. In short, the FDA’s risk/benefit calculation is based upon surrogate studies and has been for about fifty years. It is “legally bound to ap-prove drugs based on surrogate markers […] as long as drugs appear safe in the early studies,” despite the danger they may pose to patients months or even years in the future. One Canadian researcher explains that instead of forcing a company to prove its products prevent an ailment, the FDA merely asks a com-pany to prove that it does not cause that ailment.
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