Sunday, January 31, 2016

Celebrity surgeon - Something's rotten in the state (university) ....

I had thought about writing something completely different but the story out of my home country that accelerated this week made it quite impossible to think about much more than "WTF is happening". And "what are they doing at Karolinska Institute (KI)"....

It's been a longer story, and then there was a TV documentary (all in Swedish) and an article in the "Swedish Physician journal" (an English translation here) and then things started to unfold pretty quickly. Especially considering that this mostly happened Friday and rolled into the weekend, Swedes don't normally work on weekends as much as the rest of the world. And then Science wrote a piece about it too.

Maybe you have read the Vanity Fair story (found here) about the celebrity surgeon who - when they looked into the CV found some inconsistencies and lies - seems to have made up a bunch of things. They didn't mention the incredible story of investigation that KI made last year when they were investigating possible fraud charges. That story is pretty fantastic. I mean, you have an independent investigator brought in from the "other" prestigious university (forgive the sarcasm, Sweden is small and there are two important old places apart from KI, Uppsala University and Lund University. The latter is not a known medical place so Uppsala it is). To add insult to injury this investigator is a former chair of an ethics committee.

Anyhow, partly what was investigated was a charge that the articles coming out of the research weren't properly showing what the raw data really showed, partly that the informed consent wasn't gathered properly. The independent investigator delivered the verdict that there were discrepancies and that the articles didn't properly show the raw data results. The report suggested more investigation and a full showing of the raw data. KI and their committee decided that this was not what they thought and disregarded the report. So much for "paying attention to the independent outside investigator".

Up until the documentary the vice-chancellor had said "I'm standing by the decisions we have made", of course it's interesting to note that Friday and Saturday the head of the Board (former Minister of Education in case you are interested) decided to come out and say "we need to take a look at this". Hello "welcome to the world is watching you now so maybe not good enough to cover it up internally".

My beef with the whole story? Mainly a few key ethical issues....

1) There was clinical trials in Russia AND in Sweden. The problems? That the inclusion criteria and treatment of the trials were different. The trials in Sweden only touched patients who were terminal and wouldn't have any other choice. The trials in Russia, well not so much. Any time I see these differences in trial protocols (between countries or rich/poor places*) I know that there is something going on. Why would you change the protocols unless there was something that wasn't flying in the stricter country but you "really wanted to try the surgery".....

2) Discrepancy between raw data and published results. Especially after people on your research team are reporting internally that they don't agree with the publication and the interpretation of the data.

3) Telling patients when you are trying to get their informed consent that you have done animal experimental procedures that have work when you haven't done ANY animal experiments at all. (I'm saying this is a no brainer. Seriously? How you even conceive to make this an OK thing, I don't know.)

There are many more, but I'll leave it to you dear reader to look at the articles and see what else there is. I'm mainly concerned with the handling from the most prestigious institution in the country. It's a mess with super prestige and medical doctors.... not to mention the Nobel prize... it will be interesting and I for one, am hoping that the internal process will change and they will be more diligent of not getting tricked by fancy research and showy things. Glam will do you in. Every time.

It can't be asking too much that an university checks credentials of professors. That the ethical committee are diligent with consent forms. That personnel who report discrepancies to publications are being heard and an investigation is performed. It's all about trust and truth and if you don't have that - how are we ever going to perform ethical clinical trials in the future?!

*like some malphalan trials.... a couple of trials running in other countries since they can't be run in the USA. Yep. But the results can be reported in scientific journals and conferences... since their ethical committees have approved the protocols. Not needed that the ethical boards in the other country agree. story for another time.

Thursday, January 14, 2016

Is your advice wanted? if not - be quiet

Part of my job involves having assorted information about projects, planning and science (and quite a lot of behaviour and personal knowledge). I also have some experience in the research and industry field that may or may not be good to share at times when trying to decide priorities and goals. However, as everyone who has worked with people know - the issues are seldom with the project but with dealing with the people in the project. 

"The most important part to manage in a projects are the stakeholders aka people involved in the project."* Also "communication, communication, and documentation of communication

Even if you know "the best way" or have some suggestions that will improve the project and the ideas and goals, there are times when it feels like you are driving your head into a wall. "They simply won't listen to you, they know the way they want to do it"...

Since it's no fun feeling frustrated with people, having alternative strategies to deal with this is imperative. One of these strategies might be what we call ABC.

When in a situation when you have knowledge the other person doesn't, the questions to ask yourself are:
A - Accept ("will they accept it?")
B - Believe ("will they believe it?")
C - Change ("will it change anything/will they change their approach/attitude?")

If answer is No to these three - our solution is to "Let it go" and don't approach it. It is not the correct time or place to spend time and energy trying to convince them**. You will end up more frustrated and, more importantly, the person will be more frustrated with you (mostly since they will feel that you are hindering them and not playing on their team, and _that_ is so very important).

Of course, I know this. It doesn't mean that I always adhere to it. I'm a quite stubborn woman and at times I stick my chin out and dazzle with my knowledge***. And the people promptly go ignoring it but at least "I said something". There's a time and place for everything.... Now, if I could only be more like a duck...

*edit. As mentioned in the comments - you don't really manage people, you manage things. You lead people. I would say though, as a project manager a lot of what you do it manage communications (thus relationship) between people. But point is mostly - it's more complex than short snippets in a blog post.

**Second comment in regards to being quiet. I agree with the "a drop over time will make a hole in a stone" and changing someone's approach or modify it will take time. Building trust and making small comments and nudge them towards the "better" option. And indeed, that is what I try most of the time. Sometime though, it's good to remember to save the fight for another time.

***tongue in cheek, I voice my suggestions in a reasonable way, targeted to their personality.