Archives For Medical decisions

PillRandomized controlled trials (RCTs) may have lots of problems, but they remain the “gold standard” to determine whether a drug or treatment works. A recent study published in the BMJ, again raises concerns about trusting clinical trial results. The situation is outlined in an article in the New York Times about the antidepressant drug Paxil (paroxetine) and its safety in teens. The original study was published in 2001 in the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP) and the authors concluded that Paxil is “generally well tolerated and effective” for adolescents with major depression. However, since that time, experts have questioned whether the data really supports this conclusion and whether Paxil is really safe in young adults with depression.

In the recent BMJ analysis, the authors looked at the data from the original 2001 study and also some additional data they were able to get from the drug company that makes Paxil, GlaxoSmithKline. They concluded that Paxil is neither safe nor effective in adolescents with depression.

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Scalpel combinedSeveral years ago a close friend asked me to recommend a surgeon for an elective procedure. I told her I had a colleague with a great bedside manner who also had great technical skills. He was absolutely the person I would go to if I needed general surgery. My friend went to see him but ended up using a different surgeon. When I asked her what she liked about the other guy, she said that he told her that he was “the best” surgeon to perform the procedure. She didn’t like his personality but he instilled her with confidence.

The truth is that there is no single “best” surgeon for everyone. And there are many factors that go into picking a surgeon: insurance issues, convenience, etc. And there are advantages to going to a surgeon who works well with our primary care physician (communication) and in having surgery in a place that has an electronic medical record that our primary care physician can access (coordination of care). But the most important thing is how skilled the surgeon is at performing the surgery we need. How do we figure that out? The short answer is that we don’t.

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N-of-1During my medical training, we were taught that if a patient responds to a treatment, it doesn’t necessarily mean that every patient will respond in the same way. The results in a single patient might be due to chance so it was important to look at the results of well-designed research studies before we could conclude that the treatment really worked.  In statistics, “N” refers to the sample size in an experiment so we referred to these individual observations as “N-of-1” experiments (and we did not look at them very favorably).

Unfortunately, there are lots of problems with research studies – they take a long time to complete, the patients in the studies are very carefully selected and may be very different from you, there is often bias in the way the results are interpreted, etc.

What if doctors and patients had tools that allowed them to design high-quality experiments specifically for the individual patient?

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Vaccines and trust

February 27, 2015 — Leave a comment

VaccinesMany years ago I worked in a travel clinic advising people about the immunizations they needed before visiting other countries. Sometimes shots were required for entry into a country, such as the yellow fever vaccine. But we also made sure that MMR (measles-mumps-rubella) and other vaccines were up-to-date. The reason was that while immunizations have been very successful in getting rid of measles (and other childhood illnesses) in the US, many countries still have outbreaks. The booster shots were not necessary in the US because we no longer had cases of measles. Until now.

We are seeing cases of measles (and other childhood illnesses) again because parents are increasingly refusing to get their kids vaccinated. The current outbreak of measles in California is causing a lot of public debate about how to force people to get their kids vaccinated. While we may need to find new ways to enforce vaccination, we also need to restore trust – people increasingly don’t trust doctors, pharmaceutical companies, government agencies or payers.

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The power of placebos

November 19, 2014 — Leave a comment

placeboLots of people talk about the placebo effect but what exactly is it?

The most reliable clinical studies compare a treatment that is being tested with a fake treatment (called a placebo). Generally, half the people in the study get the treatment and half get the placebo and the then the two groups are compared. In the case of pills the placebo is often a sugar pill. Researchers can even test the effectiveness of a surgical procedure by comparing it with a sham or fake procedure. In these studies (called randomized controlled trials or RCTs), patients (and their healthcare teams) don’t know who is getting the pill or procedure being studied and who is getting the placebo. The reason for this is that patients sometimes get better when they are given a placebo because they believe they will get better (called the “placebo effect”) or because their disease got better on its own.

So can patients get better just by believing they will get better? And can doctors actually prescribe placebos to help people get better?

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Research in real time

October 15, 2014 — Leave a comment

Big Data2This past week, I was reminded of the problem of fraud in medical research when the British courts ruled that the mother of a child with autism had lied about her child’s symptoms. The woman was a supporter of Dr. Andrew Wakefield, the British doctor who published studies connecting the Measles Mumps and Rubella – MMR – vaccine to autism based on “data” he made up.

Published medical studies, especially randomized controlled trials, remain the most reliable way for doctors to make treatment decisions. But, in addition to fraud, there are many other problems with medical research studies including the fact that they cost a lot of money to perform and take a long time to complete. An even bigger problem is that research studies have not been done for most of the questions that doctors and patients want answered. And even if there is a relevant published study, the people in the study may be very different from you.

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If we had a serious disease, we’d like to learn about it before we even had symptoms (so we could get started on treatment). And most of us would like to know if we were at risk of developing a serious disease (so we could make changes to prevent the disease). Right?

Two recent articles in the NY Times point out the problems with screening tests.

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Giving thanks

November 26, 2013 — Leave a comment

Engage with GraceAs Thanksgiving approaches, I am thinking a lot about the death of my father in early November 2011. I am thankful that my mother and I had the strength to bring him home to die with dignity, surrounded by his family. I feel blessed that my father lived a long, productive life and that he did not spend his last weeks or months in a hospital bed receiving treatment to prolong his life but not necessarily prolong the life he wanted to live.

Death is not the enemy of life, it is a part of life. As Steve Jobs said in a commencement address at Stanford University in 2005:

No one wants to die. Even people who want to go to heaven don’t want to die to get there. And yet death is the destination we all share. No one has ever escaped it.

And yet, we often fight it, even when there is little hope of meaningful life.

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judy3_on-300x200Last week was the third anniversary of the death of my lifelong friend, Judy Feder. In 2001, Judy was diagnosed with Stage IV breast cancer at the age of 45.

I was involved in a health internet start-up at the time and knew about Gilles Frydman’s pioneering work in creating a collection of online patient communities called the Association of Cancer Online Resources (ACOR). Judy joined the group for patients with metastatic breast cancer. She embraced online communications (perhaps at least in part because she was a public relations professional) and participated in a second breast cancer online community called BC Mets as well. You can read about her 8-year breast cancer journey in this article in the Journal of Participatory Medicine, the journal of the Society for Participatory Medicine of which she was a founding member.

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Does food cause inflammation?

February 20, 2013 — 5 Comments

I am fascinated by food – what makes us eat the food we eat and how it affects our health. I’m especially interested when there is evidence to support the ideas.

As the American diet has changed in the past few decades, we have been gaining weight. It is also true that we are seeing more diseases – especially those that have an inflammatory component. Inflammation is when the body responds to things that shouldn’t be there – like an infection or a chemical – and the body sends cells to the area to fight them off. This can lead to pain and swelling, among other things. Some diseases caused by inflammation have “itis” at the end – arthritis, colitis, bronchitis, etc.

Is it possible that the food we eat is causing some of these diseases that are due to inflammation?

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