When an airplane crashes it captures the world’s attention. When two planes crash it instantly becomes a crisis. Such was the case with the Boeing 737 Max 8 airplane. On October 29, 2018, 189 people died aboard a Lion Air 737 Max airplane. On March 10, 2019, 157 people died when an Ethiopian Airlines Max 8 crashed. The FAA (Federal Aviation Administration) was criticized for moving slowly to ground these airplanes. Many other countries pulled this aircraft out of service while the FAA was insisting the plane was safe to fly. A few days later the federal agency reversed course and announced it would ground all the Max 8 airplanes after all. Do these catastrophes underscore fundamental flaws at the FDA (Food and Drug Administration)?
Adverse Drug Reactions vs. Airplane Deaths:
Between October 29, 2018 and March 10, 2019 a total of 346 people died while flying on the Boeing 737 Max 8 airplane. The world focused its attention on the FAA, Boeing and airplane safety. There are ongoing investigations into the regulatory behavior of the FAA. Many people are concerned about the close relationship between this federal agency and the company it was supposed to be regulating.
Over that same period of time it is likely that 38,860 died from adverse drug reactions (ADRs). According to the best data we have, 290 people die daily from ADRs (JAMA, April 15, 1998; FDA presentation on ADRs, updated 3/6/18).
That’s the equivalent of a jumbo jet crashing daily. It may be an underestimate. That’s because these data were based on hospitalized patients. They do not take into account people dying from drug problems in nursing homes, retirement communities or in their own houses.
The world pays very close attention to airplane crashes and the resulting deaths. Almost no one tracks deaths from prescription drugs–not the FDA, the CDC, the NIH or the pharmaceutical industry. There are no headlines and no calls for action or oversight. People die daily in hospital beds, nursing homes and in their own houses and no one seems to care.
That may seem harsh, but here is what the FDA itself states (updated by the FDA on 3/6/2018):
“If these estimates are correct, then there are more than 2,216,000 serious ADRs in hospitalized patients, causing over 106,000 deaths annually. If true, then ADRs are the 4th leading cause of death—ahead of pulmonary disease, diabetes, AIDS, pneumonia, accidents, and automobile deaths.”
“These statistics do not include the number of ADRs that occur in ambulatory settings. Also, it is estimated that over 350,000 ADRs occur in U.S. nursing homes each year. The exact number of ADRs is not certain and is limited by methodological considerations. However, whatever the true number is, ADRs represent a significant public health problem that is, for the most part, preventable.”
Despite acknowledging that there are serious problems with adverse drug reactions, the FDA does not appear to take any responsibility for any of those deaths. We think it is past time for the agency to acknowledge that there are fundamental flaws at the FDA.
Why the FAA Has Been Criticized:
When the Boeing 737 Max 8 airplane crashed in Ethiopia, the FAA was criticized for moving slowly to ground these airplanes. Why was the FAA slower than other countries? The FAA has also come under harsh criticism for not adequately overseeing safety at Boeing. Instead, the company was responsible for a lot of its own safety surveillance.
What are the Fundamental Flaws at FDA?
Are there lessons to be learned from this debacle that might apply to the FDA and pharmaceuticals? The airline industry has one huge advantage over the pharmaceutical industry. That’s because there are two federal agencies that oversee air traffic.
One is the FAA, which approves aircraft. The other is the National Transportation Safety Board, or NTSB. This is the agency that springs into action when something has gone terribly wrong, such as an airplane crash. Consequently, the approvers are not put in the awkward position of having to determine that they might have made a mistake.
China was the first country to ground the Boeing Max 8 airplanes within less than a day of the crash. Other countries rapidly followed suit. It was more than two days later when the U.S. FAA took action.
The FDA Moves Far More Slowly:
Even though the FAA took a few extra days, it still moved a lot faster than the FDA often does. Sometimes it can take months, years or even decades for the FDA to act after it learns about a serious drug problem. We have no independent investigative agency equivalent to the NTSB that can look into drug safety.
The result of this bureaucratic boondoggle is that the same organization that approves medications is also responsible for investigating problems. If it discovers a serious adverse reaction after a medicine has been on the market for awhile, the FDA might not move as fast as a neutral organization.
We’re also concerned that the FDA relies upon the pharmaceutical industry for virtually all its drug approval data. If a clinical trial is not favorable the data can be ignored. Sometimes an FDA safety officer makes a recommendation not to approve a new drug, but upper level management overrules its own reviewer.
Examples of Fundamental Flaws at the FDA:
The Rezulin (Troglitazone) Misadventure:
Take troglitazone (Rezulin), for example. It was approved in 1997 over the objections of the FDA medical reviewer. He worried that this diabetes medicine would harm the liver and the heart. British regulators removed it from their market in December of that year.
In the U.S., however, the FDA did not take action to withdraw Rezulin until 2000. That was despite one of its own safety officers sounding the alarm about liver failure.
The Avandia (Rosiglitazone) Example:
A similar drug, rosiglitazone (Avandia) was approved for treating type 2 diabetes in 1999. However, problems soon piled up, as the drug appeared to cause heart attacks and death.
By 2010, the manufacturer had settled more than 11,000 lawsuits. Other countries pulled it off the market, but the FDA never did.
The PPA Catastrophe:
Another example of the FDA’s slow reaction time includes the decongestant phenylpropanolamine (PPA). This drug had been included in cold remedies and diet pills for half a century.
On Dec. 21, 2000 an article was published in the New England Journal of Medicine titled, “Phenylpropanolamine and the Risk of Hemorrhagic Stroke.”
The authors reported:
“In conclusion, the results of the Hemorrhagic Stroke Project suggest that phenylpropanolamine in appetite suppressants, and possibly also as a cold and cough remedy, is an independent risk factor for hemorrhagic stroke in women.”
The FDA requested its removal in 2000 because it estimated that PPA was responsible for up to 500 strokes each year. If you multiply 500 times 50 years you end up with a very big number of drug-induced bleeding strokes. It took until Dec. 22, 2005 for the FDA to finally announce:
“The Food and Drug Administration (FDA) is taking steps to remove phenylpropanolamine (PPA) from all drug products and has requested that all drug companies discontinue marketing products containing PPA. In addition, FDA has issued a public health advisory concerning phenylpropanolamine. This drug is an ingredient that was used in many over-the-counter (OTC) and prescription cough and cold medications as a decongestant and in OTC weight loss products.”
Remember, this is after PPA was on the market for at least 50 years. There are lots more examples of FDA foot-dragging. You can read about others at this link:
How to Correct Fundamental Flaws at the FDA:
Perhaps it is time to separate the FDA’s drug approval process from the process of investigating drug safety. We think there is a fundamental conflict of interest when the same agency that approves a new medicine also investigates adverse drug reactions. Think airplanes! That is why there is an FAA that approves airplanes and a National Transportation Safety Board that investigates crashes.
Shouldn’t there be a completely independent organization, like the NTSB, to monitor medication safety? It just might help protect the public from future drug disasters. And it should not be funded by the pharmaceutical industry the way the FDA is!
What do you think? Do you perceive any fundamental flaws at the FDA or do you think the agency is doing a great job? Please share your thoughts below in the comment section.