The press-release conviction of a biotech CEO and its impact on research

Was this article written by Dr. Harkonen&#x27;s publicist or something?<p>The case seems pretty clear: he knowingly misrepresented the results of a drug trial for the financial benefit of his firm and, by association, himself. He did this at the possible expense of critically to terminally ill patients, and at the further expense of the scientific and medical integrity of his research. And he received 6 months of house arrest at his cushy, 3-story San Francisco home as punishment. Forgive me if I don&#x27;t strain myself reaching for my violin.<p>I sincerely hope this piece is not representative of the journalistic integrity of the <i>Post</i> under its new ownership. The article&#x27;s blatant slant, its casual blending of editorial opinion and facts-based reporting, and its weirdly patronizing tone (ex: &quot;the so-called &#x27;p-value&#x27;&quot;) do no justice to the reputation of the newspaper.<p>The author opens with a rather silly rhetorical question, one with an obvious answer:<p><i>&quot;Is it a crime for a medical researcher to hype his results? To put a heavy spin on the findings when there are millions of dollars, and possibly lives, at stake?&quot;</i><p>Yes. Yes, it is. <i>Especially</i> when there are millions of dollars, and possibly lives, at stake. You don&#x27;t get to cut corners in the scientific method because you <i>think</i> you&#x27;re on to something.

As a trained (and hopefully ethical) statistician, I agree with the interpretation that Dr. Harkonen did mis-represent the results of the trial. This article does a pretty good job describing the controversy to a layperson audience, but I do not feel the result is all that controversial.<p>It is well-known to statistically-minded people that p-values are computations that rely on particular assumptions being made. One of those assumptions is that only a single, pre-specified hypothesis is being tested. By making additional comparisons, the p-value that was reported by Dr. Harkonen mis-represented the true significance of the trial. Perhaps factually the p-value was 0.004, but publicizing the p-value as if it were obtained by a fair trial, as opposed to finding it in a hunt for (quasi-)statistical significance, was a manipulation of the facts to support one&#x27;s personal interests. That&#x27;s not science; it&#x27;s bias, and self-serving bias at that.

&gt; This mild-to-moderate subgroup wasn’t one the researchers said they would analyze when they set up the study. Subdividing patients after the fact and looking for statistically significant results is a controversial practice. In its most extreme form, it’s scorned as “data dredging.” The term suggests that if you drag a net through a bunch of numbers enough times, you’ll come up with something significant sooner or later.<p>He could have just kept that data secret, and ran another trial but specifically targeted at people with mild to moderate illness. That would have protected him legally, and made the numbers look even better.<p>That&#x27;s the kind of thing that many people are campaigning against. Companies should release all the research they do rather than cherry picking the useful (to them) results.

Alternate title: &quot;Man commits fraud to profit from terminally ill patients, gets slap on wrist&quot;?

This is very interesting. In most papers I read during uni, the p-value was always set to 0.10. But I suppose it makes sense to have a more rigorous null hypothesis testing when you are talking about saving lives. I&#x27;m curious to see, on the whole, if all researchers in pharma try to move the goalposts like this guy did.

Here&#x27;s a statistician&#x27;s take on this story:<p><a href="http://wmbriggs.com/blog/?p=9308" rel="nofollow">http:&#x2F;&#x2F;wmbriggs.com&#x2F;blog&#x2F;?p=9308</a>

Who&#x27;s got the Dune quote for this?

This case, like so many others, appears to be the product of an overzealous prosecutor looking to add to his resume before he begins applying to work at much higher paying private law firms. The concept of moral hazard does not exist for prosecutors - they can take all the shots they want at other people with no consequences. Until there are consequences, we will continue seeing blatant abuses of our justice system for the personal gain of those that work within it. Though it will never happen, private law firms should simply refuse to hire former prosecutors - many of these nonsensical prosecutions would vanish overnight.

Thank God R.A. Fisher still had all his toes when he invented the concept, or we could have been stuck with a P-value threshold of 0.052631579...