How dangerous mistakes and industry bias lead to bad medicine

I’ve written here before about the outrageously high prices most Americans pay for the medications their lives depend on.

Aggressive marketing campaigns keep you coming back for more, whether those drugs actually work… and you’re the one funding those campaigns every time you refill.

Even worse, the “fast track” approval that the FDA provides to drug manufacturers, and the behind-the-scenes connections between Big Pharma and some physicians puts you at risk of taking a medication that can actually do you great harm.

Even medical devices, things like pacemakers and artificial hips that remain in our bodies for years and that keep us alive or maintain our quality of life, are not always subject to approval processes that ensure their quality and safety.

So, what happens when someone discovers that, in fact, a drug or device doesn’t work as its makers claimed, or worse, is a threat to the people using it?

Medical reversals: Expensive and dangerous mistakes

When a medical device, procedure or treatment is found to be no better than previous alternatives, it becomes known in the medical field as a “medical reversal,” and may be taken off the market at the drop of a hat.

But wait, you say… how could an inferior treatment pass muster in the first place, replacing something that was actually better?

I’m all for do-overs, but when lives hang in the balance, there really should be a better way.

A recent review of fifteen years of randomized control trials from across the United States and the United Kingdom revealed nearly 400 medical devices and treatments that were deemed medical reversals.

Medication was the most common reversal seen, at 33 percent.

One example is the “new generation” of antiarrhythmic drugs.

When sudden cardiac deaths started to skyrocket, pharmaceutical companies developed and quickly dispersed these medications.

But in the late 1980s, the Cardiac Antiarrhythmic Suppression Trial (CAST) was conducted to assess the safety of those drugs. This randomized trial study found that these medications were even more deadly than a placebo.

Another example is Avastin, a metastatic breast cancer medication approved in 2008 at a cost of $88,000 per year to the patient.

In 2011, the FDA removed its approval for this drug when studies showed it did not increase survival rates.

Biased studies lead to bad results

Dr. Vinay Prasad is a world-recognized expert in the phenomenon of medical reversals. In fact, he’s written a book on the subject: Ending Medical Reversal: Improving Outcomes, Saving Lives.

Dr. Prasad is also one of the authors of the study mentioned above. He has some definite thoughts about why these “mistakes” occur, and what the medical field can do to make them less common.

The way drugs and devices are tested before going to market is one big problem.

Only 9.1 percent of the 396 reversal studies Dr. Prasad and his colleagues found were funded by industry sources that might have had a bias in favor of the medication or device.

However, a review of ClinicalTrials.gov showed that, between 2006 and 2014, funding for one-third to one-half of the products in question came from an industry source.

In other words, the original approval of the drug or device was most likely influenced by those who manufactured it and their desire to get it to market for a quick profit.

Medical devices: Untested, and modeled on old failures

In 1976, medical devices came under the control of the FDA. At the same time, the FDA provided a huge loophole through which device companies could bring their products to market without testing them on actual people, often without any clinical trials at all.

If a device is “substantially equivalent” to one already on the market, it passes muster.

But what if that old device was recalled years ago? Doesn’t matter.

In 2018, based on this “substantial equivalent’ loophole, the company DuPuy was given approval for its ball-in-socket hip replacement. The company soon had spent over $3 billion settling lawsuits from consumers whose device began to fail due to metal-on-metal grinding.

As it turns out, the approval of this device was kind of like a “hall of mirrors.” Six previous “equivalent” devices had been approved, based in turn on similarities to others that had been removed from the market due to high failure rates.

So, who’s looking out for you?

In a nutshell, you’ll need to look out for yourself.

Since 2016, with the FDA’s knowledge, over a million medical device failures have been recorded in a “secret” database, instead of being entered into the public database known as MAUDE.

So, if you or someone you love is using a medical device, here are a few proactive steps you can take to protect yourselves.

Talk to your doctor. Find out what he or she knows about the device.

Be informed.  Make sure you know about all the possible adverse reactions to your device, as well as any restrictions or cautions you should be aware of while using it.

Keep track of how you feel. If you are carrying a medical device in your body, or have had one used on you during surgery or other procedures, keep careful track of how you felt before, during and after the procedure.

Talk to people. Do you know anyone who’s had a similar procedure with your device? Talk to them and find out what they’ve experienced. Online groups can also offer insight into other people’s experiences.

Sources:

1. Study Finds Nearly 400 Medical Devices, Procedures And Practices That Are Ineffective — ScienceAlert
2. John Oliver on Dangerous Medical Devices, Flawed FDA Clearance System — Rolling Stone
3. Medical devices for pain, other conditions have caused more than 80,000 deaths since 2008 — STAT
4. Vinay Prasad, MD, on ‘Medical Reversal’ — Medpage Today
5. Hidden FDA Reports Detail Harm Caused By Scores Of Medical Devices — Kaiser Health News
6. Meta-Research: A comprehensive review of randomized clinical trials in three medical journals reveals 396 medical reversals — eLife