What doesn't kill me only ...... gives my doctor the opportunity to finish the job?

A recent article published in the British Medical Journal looked into the number of deaths due to medical errors. They found that about a quarter million deaths a year are due to medical errors. That would make medical error deaths more prominent than deaths due to diseases such as chronic lung disease and third to Heart Disease and Cancer.

This is a very curious and scary statistic. In a way it is a great statistic because it brings up an issue that as far as I know has not been well studied and quantified. It also bring to light the different mechanisms of avoiding errors in the hospital. In other words the statistic really is asking: Do the regulatory mechanisms in place actually work? This might also be a good statistic for insurance companies and give them a reason to increase their rates. Of course in general this is a bad piece of information for any of the living and especially those of us planning long hospital stays in the near future. I think this article is a good example of science and statistics influencing the general public. It is a very easy to digest statistic. It is something that everyone can understand and is very understandable due to the common knowledge of the other diseases it is being related to. Hopefully this awareness will translate into reform that decreases these horrible deaths every year.

Welcome to Trump Tower....... Umm I mean the White House?

This is a counter point to the recent blog post discussing the chance of Bernie Sanders winning the White House. In this article, a statistician predicts that Donald Trump will win the election in November. Similar to the blog below, this person has never been wrong. Well, it finally happened everyone. All of the other potential candidates dropped out and now the Trumpster (hybrid of Trump and dumpster) himself is the nominee for the Republican party. All of the odds stacked against him including not really being qualified for the position in the first place.

I can't remember a time where I have hoped for a statistic to be wrong. This prediction was made a few months ago and gives Trump a 100% chance of winning. If I would have read this prediction before today I would have said no way is this possible. But maybe it isnt real. Maybe this is simply a year where the statistics got lucky and picked the outlier. There are a lot of things that I doubt the model can take into consideration. Such as, the other horrible candidates fighting for the Republican nomination and the general populations general IQ. So with that being said. Is there a possibility that Bernie could win it all as an Independent? Crazier things have happened. As a matter of fact that thing happened today.

BIG brother regulating BIG data

http://www.sciencebusiness.net/news/79758/UK-government-plans-ethics-council-to-guide-big-data-researchers

The government in the UK recently passed legislature to regulate what they are calling ‘big data’. This is an umbrella term to describe all of the major meta data being collected recently such as the data that might be collected from Facebook and Microsoft concerning usage of their products by the public. To provide ethics and regulations for this type of data, a new committee will be put into place at the Alan Turing Institute.

I thought this story was an interesting take on ethics. We always talk about ethics in terms of potential (physical) harm to the individual. With the advances in technology and the ability to quickly access and analyze large sets of personal data it makes sense that different countries are attempting to put regulations in place to try and curb misuse. I think it is great that they are trying to put rules in place now before things get out of control. This would be in contrast to the type of bioethics committees in the US that were largely formed due to the public exposure of unethical experimentation such as the Tuskegee experiments. One aspect that I am not sure about is how long these different regulations can last before reform is needed to keep up with the times. Technology is always changing and surely new ways of mining personal data will be developed. It will be interesting how these different committees interpret these new technologies and how the rules are adjusted to protect the public. 

Does Animal Research Count as Unethical?

The lecture about responsible and reliable research presented by LeBreque sparked a lot of great conversation on the blog about unethical research and how much has changed in the past 50 or so years. Studies like the Tuskegee Study of Untreated Syphilis in the Negro Male resulted in better regulation of  things like informed consent in studies involving human subjects in order to try to prevent experimental issues like this in the future. A comment on another blog post how the use of subjects, both human and non-human, is an evolving topic, and it made me wonder whether or not use of animals for scientific research will one day be considered unethical by the majority. I use mouse models in my research, and while I am not happy about it, I understand that they are being used for the greater good of advancing research, even if they are being used without their consent, and regardless of the fact that we are giving them diseases they most likely would not have contracted otherwise. 

I decided to look into some of the current concerns related to use of animal research, and found an article posted by the New England Anti-Vivisection Society (NEAVS). According to the article, 24 of the 30 Institutes and Centers that make up the NIH use animals in their research, and about 40% of NIH-funded grants and contracts involve animal research. We use animal models under the assumption that they recapitulate humans biologically, and while we know animal models can represent human diseases and responses well, in many cases the way animals respond to treatment does not mimic human responses. The article gives examples such as how "forcing dogs to inhale cigarette smoke did not show a link to lung cancer; Flosint, an arthritis medication, tested safe in monkeys but caused deaths in humans; and the recalled diet drug fen-phen caused no heart damage in animals, while it did in humans". More than 25 million animals are used yearly in the U.S. in all areas of research, testing, and education, and the article says that statistically, 92% of drugs tested in animal and approved for human trials fail. Outside of drug studies, I would be curious to see how much of the data obtained through use of animals successfully models outcomes or responses in humans.

The article points to how factors like stress, which is often experienced by animals in labs, negatively influences the reliability of animal research data. According to the article, stress influences heart rate, pulse, blood pressure, muscular activity, and hormone level, and can influence results observed in studies. Cost of using animals in research is another issue addressed by the article. Animal research is a multi-billion dollar industry, with interest from the animal importers, breeders, dealers, cage and equipment manufacturers, feed producers, and drug companies. Additionally, purchase and maintenance of animals is expensive. "Rats, mice, and birds are the main animals used, not because they are necessarily the best or most reliable, but because they are relatively inexpensive to buy, easy to manage and maintain, and because they are disposable without much public clamor or concern."

Another point made by this article was related to the development in the last 10 years of using transgenic models for medical research. While transgenic models are great for attempting to remedy the biological differences between humans and animal models, the NEAVS article pointed out that if transgenic models are needed to genetically improve existing animal models, perhaps animal models really aren't justified for research use, because they really don't have biological and/or clinical relevance.

I agree that animal models are not perfect for researching human conditions, but I also cannot think of a non-animal alternative that is a better solution. I also believe that there should be some sort of in vivo model used after in vitro studies before testing drugs or whatever else in humans. The article blames a lack of alternatives on the investigators, but I don't see them offering any alternatives either. I guess time will tell whether animal research is eventually considered unethical, but I don't think that will come until someone comes up with a good non-animal alternative that does not jeopardize progress made with testing human subjects. 

Did you know that research ethics can be dangerous?

 

The following blog post is in reference to the MMR research performed by Wakefield et al. 

 This is probably the most classic case of a piece of research going wrong. I use the term ‘research’ in the previous sentence very loosely. This is a classic case of fraud that went too far. Basically, the work was done by a now former researcher named Andrew Wakefield. He put together a bunch of data that showed a link between MMR vaccine and a new form of Autism. All of the data was proven to be false and Wakefield lost his license to practice medicine and is no longer a researcher. I would like to use this blog post to comment on some of the more interesting aspects from this case of deception.

One of the most interesting facts of this case is that it was known that the research results were not very good. The study used a very small cohort and it seemed impossible to generate the results that were published in the paper. Even the editor at the time thought that the work seemed very weak. This work was published in the Lancet, which is a pretty good journal. I think this is another good point, top journals make mistakes as well. Although, I have had a few good laughs reading some of the open access journals recently (I’m looking at you PLOS ONE). Of course the most damaging thing that came out of this entire ordeal is the effect it had on the general public. Most work that is published may be retracted for dishonesty but that is where the issue ends. The paper is retracted, researchers shamed and the world keeps spinning. But this case led to a new breed of stupid : the anti-vaccine movement. A group of individuals content with the idea that vaccines are bad for their children and thus vaccination must be avoided at all costs. Vaccine, although with much room for improvement, are probably one of the most important scientific achievements in history. No BS, I actually believe this. The number of lives saved by vaccination s staggering. The fact that most vaccines are made at a low price point has made them available to a majority of the world and led to the successful eradication of several diseases such as small pox. Think about that for a moment. A cheap and efficient method of eradicating a disease agent that would kill tens of thousands of people annually. But with the anti-vaccine crowds they don’t care for this history of events. So what do they do to justify their position? They reference the Wakefield study. This is why the Wakefield study was so damaging. People still believe it even though it is completely and terribly incorrect. So, in the end this study really did damage in the public opinion arena. This work obviously is cherry picked to prove an erroneous opinion and is the major reason why this study never should have been published. I never knew that a journal article could turn out to be so dangerous.

Why not? Nobody said we couldn't do it this way

http://www.cdc.gov/tuskegee/timeline.htm

The study originally started out as the Tuskegee Study of Untreated Syphilis in the Negro Male. The purpose of the study was to bring enough evidence forward to justify treating African Americans with syphilis infections. I think that is kind of strange. Why would you not treat people that have an infection that you know is bad for their health. Unless you are assuming that people of different races have different outcomes from disease because the races are so far apart from a genetic level? 

The study began in 1932 and originally involved 600 subjects. About 400 with disease and 200 without the disease. The men in this study never received informed consent and were given promises of free meals, free medical exams (yeah, I bet) and burial services would be paid for. These people were also lied to about the status of their disease. They were never told that they had syphilis. They were only told that they had ‘bad blood’. This is a phrase used to describe a number of ailments. In 1947, with Penicillin becoming the drug of choice for syphilis, the subjects were still not offered treatment. The study was to be conducted for 6 months but ended up lasting for 40 years.

I think that this case illustrates a number of ethical issues involving medical research. First, is the issue of do no harm. In clinical studies today it is common to give drug to an untreated or alternative treated group the drug under study if the data on the new drug is sufficient to prove that the treatment is significantly better at treating the disease. It is hard to understand why the participants would not be given the drug of choice in 1947. What is also bizarre is that the study in general makes absolutely no sense to me. It was already understood that syphilis was a bad disease so what was the point of the study? I think it is a great example of something that happens in science all too often, but certainly not to the degree of this study, which is basically putting a study together because you can. The lack of regulation in this study is staggering and makes me wonder what things would be like know if science was not heavily regulated. With the advancement of science over the last 50 years there are certainly experiments on certain researcher’s minds that would most likely put the Tuskegee study to shame.

The final outcome for the Tuskegee study was a settlement with the victims’ families. Also, study regulations were extremely modified and set the standards that we currently carry for medical research today. It should also be noted that the Tuskegee experiment did not become public knowledge until the media picked up on the issue. Could this study have continued for another 20 or 30 years without this coverage? Maybe. Overall the Tuskegee study is a primary example of why bioethics are so important for scientific investigation. It is important for keeping study participants safe but it is also good for science itself. What I mean is that it is important for science to be trusted by the general public. Otherwise you end up with stupid people not wanting to vaccinate their children.