“Do no harm” is NOT Enough

computer-1149148_1280By Beth Russell

“If it ain’t broke, don’t fix it, right,” my granddad used to say, right before he would wink at me, chuckle, and say “let’s see if we can figure out how to make it better.” This type of ingenuity is at the root of American innovation, invention, and process evolution. Observation, experimentation, and a national drive for optimization are part of our culture. As we have moved from the 20th century into the 21st, there has been a fundamental shift from “one size fits all” solutions, towards more personalized solutions.

The Precision Medicine Initiative is one of the great goals of our time. However, most of our medical treatment is still geared toward the treatment that will usually work, rather than the treatment that is the best for the individual patient. What would the world look like if we could change that in years rather than decades? What if we could do it cheaply, and easily, with information that already exists?

We can. To start the process, we need only to do one thing – to share. Buried within our medical records, our genetics, and our health data, is the information that we need to make our medical treatments better. Our diversity in population, hospital, and practitioner policies, and personal health decisions compose an enormous health data set. If we are willing to share our data with researchers and to insist that the insurers, hospitals, and practitioners make sure that the data is interoperable, we will be well on our way.

We often have widely held medical practices that are not actually supported by scientific data. This is illustrated by a recent decision by the Department of Agriculture and the Department of Health and Human Services to remove daily flossing from their guidelines. Apparently, there was no actual scientific data behind it. Such practices are often low-risk procedures or treatments that do not warrant the expense of a clinical trial. Many of these will probably turn out to be accurate for most people, but not necessarily for everyone. I for one don’t plan to stop flossing anytime soon.

These sorts of medical practices are typically adopted based upon observation and consensus. This approach is cheap but relies on practitioners detecting a pattern of good or bad results, is highly subject to human bias, and is much more geared towards safety than efficacy. There will always be room for common sense and human observation in the medical process but they will miss both small, and rare effects.

For over a century the arrow has been shifting away from simple observation towards data-based decision making. Large observational studies like the Framingham Heart Study and the Nurse’s Health Study have had outsize impacts on medical practices but they are still too small. Only with many observations from numerous patients can we detect the variations in efficacy and safety that are needed for precision medicine.

Today, clinical trials are the gold standard for medical treatments. These experiments are expensive, time consuming, and often suffer from low subject numbers and a lack of diversity. They also can run into ethical issues, especially with vulnerable populations. Even when the results of clinical trials are excellent, their results aren’t always adopted initially by practitioners. Medicine tends to be slow to adopt change. Data sharing will allow scientific analysis to extend beyond the length of time and number of subjects that are used in any “trial” and will allow us to better evaluate drugs and treatment after they go to market, not just before they are approved.

Data sharing is also important for areas of medicine for which traditional clinical trials are difficult or impossible to run. One of these areas is surgery. Most surgeries are not subjected to clinical trials and there is great variation in the methods for even relatively common surgeries from hospital to hospital. How does a patient decide where to get a life-saving surgery? Recommendations from friends and family are the number one method for choosing a doctor. There is no place to look to find out whose favorite method is the best one overall, nor the best for the individual patient. This needs to change. Sharing our medical data will make this possible.

Medical practice is poised for a revolution. We are beginning to move from treating the symptoms to treating the person. This can only happen if enough of us are willing to share. So let’s practice our earliest kindergarten lesson already.

Democratizing Science: From Peer-Review to Public-Review

Charles Mueller and Jennifer Buss

It’s time to change the way we validate and communicate science. The golden standard within the scientific community to facilitate the communication of knowledge is peer-review. Unfortunately, this process becomes more dysfunctional with each passing day.  Earlier this week, a major publisher of medical and science articles, BioMed Central, found itself in a peer-review scandal. They were forced to retract 43 papers because the papers appeared to have been approved through a fabricated peer-review process. This is just more evidence that we have spent more than enough time trying to perfect a system that is archaic and easily abused. The definition of insanity is trying to do the same thing over and over while expecting a different result.  We are insane to think traditional peer-review can still work. It is time for a change. That change should be to create an open-source, public-review system for science. We need the Wikipedia for science publications.

Whenever we have let a select few individuals or groups determine what is right and wrong the power has been abused. Every single time. It was only when individuals or groups gave the power back to the people could the situation improve. When Martin Luther nailed the Ninety-Five Theses to the door of the All Saints Church in Weitenberg in 1517, he gave power back to the people and away from the Catholic Church. The Napster revolution signaled to the world that people wanted to decide what was good music rather than the major record labels. Now artists can create and distribute their own music through a variety of avenues such as iTunes or CD Baby. Major publishing houses used to tell us what was worthy of publication, but this has changed since the emergence and growth of the e-book market. Now, authors connect to their audiences through blogs and e-books, meaning we decide what is worth reading and should be published.

Let’s give the power back to the people to analyze and review science. Let’s bring democracy back to America when it comes to science. In all the other democratic processes we have, the people have a voice. Why are we refusing to give them a voice in science? People want to have a say in science. This is evident by the recent rise in popularity of crowd-funded science. Furthermore, the government has already seen the value in crowd-sourcing parts of science (data-gathering) and the federal agencies actively promote the input of all US citizens during their rulemaking processes. We clearly understand there is value in the opinions of the masses and this is part of the reason the science community is pushing so hard for open-access to scientific information: an educated society is a better society. An open-source, public-review system for science creates an open-access forum for spreading knowledge, essentially giving the science community what they want. Yes, there will need to be a lot of important discussions about how we make this happen, but we should be spending our time working on this solution rather than just trying to fix the peer-review problem.

Fixing the peer-review process by opening it up to the people will only help improve the veracity of all information in the digital age. It empowers the people with the message that they are part of the scientific process and encourages them not to be afraid of it. The more people we have thinking scientifically, the more honesty we will have when it comes to our information. The golden standard, peer-review, is corroded and falling apart. Let’s give the power back to the people and create an open-access, public-review system for validating and communicating our scientific knowledge.