safety concerns

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:

FDA Boss Infuriates Patients with Drug Safety Tweet

FDA Boss Infuriates Patients with Drug Safety Tweet

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.

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  1. MFK
    Reply

    I feel the same as Cynthia from Missouri…grateful to be living in good health and, in addition to good food and physical activity, no Rx and rarely OTC medications. Learning about natural remedies for most ailments has given me safe choices for those rare occasions when I need help. Keep moving. Have purpose in life, eat well, and manage stress.

  2. Trish
    Seattle
    Reply

    Right now, we have a mindset in Washington that industry can best regulate itself, that government oversight is terrible (unless it comes to monitoring women’s pregnancy choices). So we can expect our health to continue to degrade as long as public agencies set up to ensure our safety are run by political appointees.

  3. Jen
    Illinois
    Reply

    There should be two separate organizations who receive no monetary input from the companies they are evaluating—either for approvals or adverse reaction investigations.

  4. John
    Baltimore
    Reply

    The comments are very interesting, and some commenters point out correctly that money is the issue here. One thing that is missing though is that for the past 40 years folks have been cheering for and voting into office politicians who want to fight government because “government is the problem”. So people who believe that government is the problem, and the solution is the magic of the free market, and people are happy when their taxes are cut (which helps mainly the rich in the first place) then those folks should not be surprised about the government not helping them any more.

  5. doug
    ny
    Reply

    Pure and simple, it’s all about the money. Prove it’s not.

  6. Elizabeth
    CA
    Reply

    The corrupt incompetent FDA needs a total overhaul!
    My Mom was on Avandia she had several strokes after taking it!
    It got so bad regarding the FDA not doing their job whenever my Mom got prescribed a new medication I would check to see if it was available in the U.K. and the E.U. If it was not allowed there I told her Dr to prescribe something else that was available there.

    Too many times my Mom suffered horribly from side effects of drugs that should not have been available to harm Americans that were already banned in The U.K. and E.U.
    I do not trust or rely on the FDA; it is a corrupt joke!

  7. Sherry
    Redmond, WA
    Reply

    A big reason why I won’t take a new drug until it’s been out for at least 7 years…. It amazes me how many problems are found out about during that time that were never reported after clinical trials.

  8. Cate S.
    Reply

    Amen to the Dr’s comments on the whole medical /pharma industrial complex. The Germans do so much a better job than the USA; everything she said about health systems that exist to restore and maintain the person in health rather than keeping them in chronic illness while squashing symptoms, but producing new symptoms, so that they can sell you more drugs, is right on. The current system is morally, spiritually, ethically criminal.

  9. Ken
    Reading, PA
    Reply

    To both of your considerations, there is one and only one cause for all of these tragedies: Follow the money. Money and those who expect to make more of it from the items cited are the sole reason in our country for most everything that happens. In the final analysis, there is seldom concern for whom will be injured or die.

  10. Betty
    UT
    Reply

    Thank you for this information. I had no knowledge of this.
    I’m pretty healthy, and have always believed doctors when they prescribe something, but then I was prescribed levofloxacin. After two pills, I knew I was in trouble, but stupidly took a third one, because a doctor prescribed it as the first drug option for pneumonia (that was barely visible on an x-ray.) After the third pill (and three sleepless nights, drilling pain in my stomach, hallucinations, and weird thoughts-like climbing up on my roof,) I called the clinic and told them I would never take that drug again, and they prescribed me something milder, which worked. Levofloxacin had been used for decades, but now they are learning (or people are speaking up more about) how dangerous it really is.

  11. Barbara
    spokane
    Reply

    Hello, not everyone is on FB, Twitter etc , nor wants to be. Put the article on FB, but keep it on the net.

  12. Barbara
    Spokane
    Reply

    Great idea. Once someone tackles the FDA, how about the EPA.? Total fraud , i.e. that Colorado mine cleanup/screwup a few years back, and nit-picking rural property owners about seasonal wetlands!! Swamp indeed! I won’t bother to get into HUD.

  13. Linda
    Sun Prairie, WI
    Reply

    Follow the money and the politics. If we the people want an ethical, well-funded government agency, it would be headed and staffed by experts (not political appointments) and funded with taxpayer monies. I don’t see any other way it can work to provide oversight or safety to consumers. We have seen too many privately funded, conflict-of-interest drug studies that have resulted in untold suffering and death.

    I’m sure this goes for every government agency headed by a politically appointed person. There can be no continuity of effort when the direction may be changed every 4 years. There can be no real oversight if a government agency is privately funded by corporate interests.
    What we have now is the wild west of government: Reduced funding for consumer protection agencies and politically motivated “oversight.”

    We can’t have it both ways. Consumer protection can result only from objective, well-funded oversight. And that can’t happen if voters consider government the enemy.

  14. Joan
    Texas
    Reply

    I took levaquin for a bad sinusitis situation. I now have peripheral neuropathy and an abdominal aortic aneurysm. Doctors did not originally believe the neuropathy was due to the levaquin until it was included in the black box warning. Recently the aneurysm was included in the warning which my neurologist also noticed.

    Be careful about taking any fluoroquinolone!

  15. Dr. Susan Zimmer
    FL
    Reply

    Adverse Drug Reactions vs. Airplane Deaths: Why do we call deaths by drugs only adverse reactions to the drugs, and not simply Drug Deaths as we call Airplane Deaths. Airplane Deaths are not Adverse Airplane Reactions. Calling deaths due to prescribed drugs only adverse reactions is blaming the body for reacting badly to the drugs. The intake of drugs are to blame for the incredible number of deaths daily worldwide, not the human body.

    Where is the outrage for this? Why do we seem to protect the drug industry by disconnecting the industry from the deaths? Instead, the FDA blames the patients for interfering with the actions of their drugs.

    Is it partly due to the advertising revenues the media makes from the drug industry? Is it because prescribing drugs is the only medical modality that conventional Allopathy has to offer? Why is it accepted that drugs which harm the body and kill people in the hundreds of thousands are good for the body, are good for health?

    It’s like love that abuses is NOT love; through fear the abused person stays and accepts this treatment, believing there is no other way.

    There are many other ways to real health, and without the deadly consequences from drugs, such as what humans did for thousands of years before the drug makers–Nutrition, Herbs, Exercise, Acupuncture, Chiropractic, Homeopathy, Naturopathy, etc. CDC research shows ZERO Deaths from vitamins ever. The side effect of healthy eating, natural health care is not having to use drugs.

  16. Berge
    Coconut Creek, Fl
    Reply

    I completely concur with your evaluation, that there should be a separate federal agency to evaluate side effects of drugs.

    Any organization that oversees drugs must be independent from drug companies. BTW we should abolish drug company lobbyists who give money to Congress and Senate people, as the drug prices are out of reach of many people; Their profit level is beyond imagination. I know enough about drug prices, as I am retired physician

  17. Pepi
    Harrison, OH
    Reply

    Please public this article on your face book page so that it can be share.

    Thank you

  18. BRUCE H.
    Texas
    Reply

    I well remember when phenylpropanolamine was taken off the market. I thought it was a shame. That stuff worked very well as a decongestant and millions and millions of people used it every year in a variety of products with no problems. I would guess maybe 25 million people …. possibly more ….. used that drug effectively with no consequences every year. So, if 500 people out of 25 million died, that would mean it was 99.998 % safe. Maybe THAT’S why they kept it so long. …. Also, if it was primarily women who died, maybe it should have been taken off the market for dietary reasons and made a prescription drug only for men’s decongestant use. ……….. How many people die each year from peanut allergies? Should peanuts be banned as well?

    • Joe Graedon
      Reply

      Bruce,

      I fear I do not follow your logic. Although I actually doubt that 500 people died each year for 50 years as a result of taking PPA, the FDA did estimate that hundreds might have died annually from this drug. If one were to do the math, that could be as many as 25,000 deaths. BIG number! Even if millions were able to take PPA safely, clearly a lot of people were harmed.

      Put another way, would you find it acceptable if 500 people died each year as a result of airplane crashes if millions were able to fly safely? Even a “small” risk of a plane crash (two or three planes a year) would be unacceptable to most Americans. Over 2 million people fly daily in the U.S.

      So what is an acceptable death rate from a medication? For a decongestant the number should presumably be far lower than for an anti-cancer drug don’t you think. There are other decongestants on the market that presumably are safer than PPA. These are important policy questions and I would like to better understand what you would consider an acceptable risk.

      Joe

  19. Cynthia
    Missouri
    Reply

    I am very fortunate in having wonderful health at the age of 80. I take no prescription drugs and avoid OTC medications if at all possible. But I also realize that I am extremely lucky to live this way as I see many of my friends of similar age struggle with various health issues. Many of them seemed dazed and confused most of the time when they were once vibrant and alert. I believe some of this is caused by over medication. We once believed that the doctor was always right and took his word as absolute gospel. This belief is now dangerous as we know doctors are overworked and understaffed and rely on drug reps for “reliable” information on the drugs they peddle. Big pharma IS NOT our friend and we all must be vigilant about meds we take and those taken by family members.

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