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Medical reversals – when doctors hurt patients

By Sebastian Rushworth, M.D. | February 26, 2021

I’ve been asked why I’m so skeptical when it comes to health and medical science. My answer is because I’ve spent many hours studying medical history, and I’ve seen how much damage doctors have done over the centuries. If you were to select a patient-doctor consultation at random from all the ones that have happened throughout history, your odds are probably better of selecting one in which the doctor harmed the patient than one in which the doctor helped the patient. That is certainly true if you only look at consultations happening before the year 1900.

It’s a shame that medical history generally isn’t part of the curriculum in medical school. If it was, maybe doctors would be more humble about what they know, and what they don’t know. If I were to design a medical school curriculum, I would make the first five to ten weeks of medical school an in-depth course in medical history, with a particular focus on all the mistakes doctors and scientists have made through the centuries, and why they made those mistakes. To quote a well worn cliché, those who don’t know history are doomed to repeat it.

Personally, I wear my skepticism as a badge of pride. If I were to seek out a doctor for some medical condition I was suffering from, I would want that person to be a natural skeptic. I would want someone who won’t believe something just because that’s what they were taught in medical school, or because it’s what they heard from a salesperson working for a pharmaceutical company.

I’m going to present four different cases from recent history, that I think show clearly why it’s important to be highly skeptical when it comes to the area of health and medicine. Things can often seem to be very beneficial after a few early studies, or because common sense suggests they should be beneficial. Then when more data comes in, sometimes decades after a certain treatment has become the “gold standard” of therapy, it becomes clear that the intervention is actively harmful. In some cases, millions of people have died prematurely as a result of the intervention by this point. When this happens, when something goes from being the recommended therapy to turning around 180 degrees and becoming something that doctors recommend against, it is known as a medical reversal. Unfortunately, medical reversals are common.

Another thing that I think is unfortunate is that scientific methodology is not really something that is taught in school. People even leave university with very limited training in scientific method. This causes the large majority of the population to be unable to weigh scientific evidence themselves, and it makes them totally beholden to the opinions of others. That’s why I try to use this blog to educate in scientific method. Science, just like democracy, thrives when lots of people are able to examine different pieces of evidence and think for themselves.

Anyway, let’s get to the four cases.

Lobotomy was first developed in the 1930’s by Portuguese neurologist Egas Moniz, and further refined by two American doctors, neurologist Walter Freeman and neurosurgeon James Watts. A lobotomy is basically a surgical intervention in which parts of the frontal cortex of the brain are destroyed. It was developed as a treatment for psychiatric disorders, based on the hypothesis that destroying parts of the frontal lobe would allow destructive mental patterns to “reset” themselves.

After his first surgeries in 1935, Moniz presented a case report of twenty psychiatric patients. He claimed that a third were significantly improved in their underlying psychiatric illness, while a third were mildly improved, and a third were unimproved. None were apparently harmed. This claim was immediately countered by the psychiatrist that had provided the patients to Moniz, who responded that all the patients had suffered a “degradation” of personality.

The frontal cortex is responsible for complex goal oriented behavior, self-control, and higher order thinking, pretty much the things that separate humans from other animals. So, knowing what we know today about the function of the frontal lobe, destroying large chunks of it is likely to turn a person in to an apathetic, lethargic zombie. And this is what happened to the people who were lobotomized, as was clear early on to those who cared to look.

In spite of the limited evidence of benefit, and early suggestion of harm, the procedure was taken up enthusiastically in several parts of the world. By 1949, when lobotomies were at their most popular, thousands of people were being lobotomized around the world each year. That same year Egas Moniz was awarded the Nobel prize in medicine for his efforts.

Then the truth started to catch up with the hype. It became clear that somewhere between 5% and 15% of all patients undergoing lobotomy were being killed by the procedure, either dying on the operating table or shortly after surgery. It was not uncommon for arteries in the brain to become accidentally nicked, resulting in major intracranial bleeding and strokes. When this didn’t kill outright, it often resulted in severe physical handicaps.

It also became more widely known that, although the patients might become more “placid” after the procedure, they were hardly being cured. People who had been institutionalized before the procedure, continued to be institutionalized after the procedure. Few people were able to function independently after undergoing a lobotomy. So lobotomies gradually fell out of favor, although they were still being carried out on patients in some countries as late as the 1980’s.

Let’s move on to our next medical reversal. Starting in the 1960’s, public health authorities around the world started recommending that parents have their babies sleep on their stomachs. The recommendation was not based on any scientific studies, rather it was based on “common sense”, that all too frequent destroyer of lives.

There were multiple hypotheses floating around that together constituted the basis for the recommendation. One was that it would decrease the risk of hip dysplasia, another was that it would prevent scoliosis, a third that it would decrease the risk of aspiration of milk (accidentally getting milk in to the airways), a fourth that it would prevent babies developing “flat heads”.

In the late 1980’s, observational data started to appear suggesting that prone sleeping was causing a huge increase in the number of children dying of cot death, a.k.a. SIDS (Sudden Infant Death Syndrome). Children sleeping on their bellies appeared to be around 500% more likely to die of SIDS than children sleeping on their backs.

Pretty much over night, government health authorities switched from recommending that babies sleep on their bellies to recommending that they sleep on their backs. And virtually over night, the rate of cot death dropped. Dramatically. Here in Sweden, the number of children dying of SIDS decreased by 85% over the course of a few years.

How many children died unnecessarily during the few decades in which prone sleeping was being recommended by public health authorities? Probably millions.

It amazes me how keen government agencies often are to offer recommendations based on little or no evidence, especially when we have such clear examples of situations in which this has resulted in mind-boggling harm. If only public health professionals bothered to follow the first credo of the medical profession, which is “first, do no harm”.

Let’s move on to our next case.

Non-steroidal anti-inflammatory drugs (NSAID’s) have been around for a long time. Aspirin was invented in the 1890’s, and ibuprofen has been around since the early 1960’s. One problem with these drugs, which has been recognized since the early days, is that they can cause stomach ulcers. In fact, over-use of NSAID’s is one of the most common reasons for emergency hospital admissions due to bleeding ulcers.

The reason for this side-effect is that NSAID’s block an enzyme called cyclo-oxygenase, generally shortened to just COX (another name for NSAID’s is COX-inhibitors). There are two different versions of COX, COX-1 and COX-2. All the early NSAID’s are unselective COX-inhibitors. In other words, they block both COX-1 and COX-2.

At some point it was discovered that the entire positive effect that comes from NSAID’s, in terms of decreasing inflammation and pain, comes from their inhibition of COX-2, while inhibition of COX-1 is responsible for the side effect of increased bleeding. This naturally led drug companies to seek to develop specific COX-2 inhibitors, that would decrease inflammation, but not cause stomach ulcers.

In 1999, the first two COX-2 selective inhibitors came on the market, rofecoxib (a.k.a. Vioxx), produced by Merck, and celecoxib (a.k.a. Celebrex), produced by Pfizer. They instantly become some of the best selling drugs in the world. Of the two, rofecoxib was much better at blocking COX-2 specifically, and thus far less likely to cause stomach ulcers.

After a few years on the market, signals started to appear that rofecoxib was associated with a heavily increased risk of heart attack and stroke. In fact, people taking rofecoxib had something like a 300% increased risk of having a heart attack compared with people taking non-selective NSAID’s. Merck’s initial response was, unsurprisingly, to try to put the lid on this information. But by 2004, the cat was well and truly out of the bag. In the face of mounting criticism (and lawsuits), Merck chose to withdraw the drug from the market. By that point, 80 million people had been treated with rofecoxib and around 100,000 people had suffered unnecessary heart attacks.

I’m going to end with a slightly more personal example. On my first day of medical school I was told about a fantastic new treatment that had been developed at my new place of study, Karolinska Institutet, and its associated hospital. The developer of the new treatment was a surgeon called Paolo Macchiarini, and the treatment was a stem-cell coated synthetic windpipe. The windpipe could be transplanted in to people who had damaged their windpipes in accidents, or who had to to have their windpipes removed due to cancer. The idea was that the synthetic windpipe would meld with the surrounding tissues and grow in to a fully functioning new windpipe.

Paolo Macchiarini had been head-hunted by Karolinska Institutet in competition with several other top universities. He seemed a shoe-in for the Nobel prize.

The synthetic windpipe transplant surgeries had started in 2010. The first people to be operated on all died relatively soon afterwards, but there was a lot of media hype around them anyway, probably due to the feeling that this was a revolutionary technology, and probably also due to the fact that Machiarini was an excellent salesman.

Since the people he operated on had an annoying habit of dying, Machiarini supposedly felt that he needed healthier specimens to operate on. Thus far, all the people had been suffering from end-stage diseases that would have killed them in the near future even without the surgery. Maybe they were just too sick to begin with to truly benefit?

So he found some people who weren’t actually dying. In 2012 he put synthetic windpipes in to two people who lived with chronic tracheostomies (breathing tubes in the throat) after car accidents, and one in a woman who had suffered accidental damage to her trachea during an earlier surgery. In 2013 he put a synthetic windpipe in to a two-year old who had been born without one. These people were perfectly healthy otherwise, and they were young.

The synthetic windpipes didn’t work. The stem cells didn’t turn in to functional epithelium, as had been hoped. The synthetic windpipes became seeding grounds for bacteria and were attacked by the immune system. They failed to meld with the surrounding tissues. They literally fell apart within months. And the patients died.

What is particularly galling is that there was no need for the synthetic windpipes. Windpipes could have been taken from cadavers instead. In fact, Machiarini had started out doing surgeries with windpipes from cadavers, which had on the whole been successful, but had then chosen to switch over to synthetic windpipes, apparently because it seemed more high-tech and was therefore more likely to generate media attention. The entire exercise was a PR-stunt, primarily intended to speed Paolo Machiarini on the path to a Nobel prize.

By the time I first heard of the synthetic wind pipes, on my first day of medical school in September 2014, things were already starting to come apart. The patients were dying like flies – even the ones who had been healthy before their surgery. Yet Machiarini was continuing to publish articles in prestigious scientific journals, in which he claimed that the stem cell treated synthetic windpipes were holding up well, and integrating with the surrounding tissues, just as planned.

Everything came crashing down very suddenly, in 2016, when Swedish public television aired a documentary that told the truth about Machiarini’s surgeries. Apart from making clear that the surgeries were nowhere near as successful as was being claimed, it became clear that Machiarini had never tested any of his synthetic windpipes on animals before moving on to humans(!), and it also surfaced that colleagues at Karolinska University Hospital had tried to blow the whistle on Machiarini two years earlier, in 2014, but had been threatened in to silence by the leadership at the university and the hospital.

I guess this last case isn’t really a medical reversal, since the synthetic windpipes never actually became standard practice. But I think it’s an interesting cautionary tale. There are lots of charlatans out there, masquerading as serious scientists. Some of them get discovered early on, like Paolo Machiarini, and some of them don’t get discovered until decades have passed and many people have had their lives ruined, like Egas Moniz.

My main point from these cases is that doctors and health authorities harming patients is not even remotely something that is in the distant past. We’re not talking blood letting here, a practice that resulted in millions of unnecessary deaths, but that doctors thankfully stopped doing on a regular basis two hundred years ago. Serious medical reversals have happened in the recent past, and they will happen again. They are particularly likely when new interventions get rushed out based on scant evidence.

February 26, 2021 - Posted by aletho | Science and Pseudo-Science, Timeless or most popular