What has Science Established ?

by
Robert Waldmann
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I want to try to punch above my weight (and be a troll) and contest this

Dr. Kathryn Hibbert, director of the medical intensive care unit at Massachusetts General Hospital … said it will take weeks or months to get results and doctors and patients will need to wait for the results of the clinical trials before knowing which Covid-19 patients — if any — should be getting remdesivir.

“I think we should be extremely cautious about responding too enthusiastically to early data that has not been thoroughly vetted,” Hibbert said. “In the scientific community, over decades, we’ve established that critical review of clinical trials is the best way to determine if the data is strong enough to inform clinical decisions.”

I think the verb “establishd” is doing a lot of work here. Scientists have established two sorts of things.

One is the set of empirical results, styized facts and well supported theories. It is reasonable to accept that science has established that information can not be transmitted faster than the speed of light and that DNA (and topically for some viruses RNA are genentic materials.

The other is that scientists have established rules for what can be published peer reviewed journals (and rules for peer review) and Congress has established a Pure Food and Drug Act which authorizes the FDA to establish rules for which pharmaceuticals can be sold. There is a difference between natural laws and, you know, ordinary laws. Both are binding and both have been established, but one set is discovered and the other set is made.

Let me take the following claim literlly “critical review of clinical trials is the best way to determine if the data is strong enough to inform clinical decisions.” Notice there is no qualifier on “the data”. Thus the statement implies that, when treating an individual patient, one must ignore data not from a clinical trial. This includes all diagnostic tests of the patient. Taken literally, Hibbert asserts that Doctors should consider only clinical trials and ignore all other data. This is nonsense and clearly she didn’t mean that.

I am quite sure that what she meant was [when considering a new drug] “critical review of clinical trials is the best way …”. I am also sure that she means this because she has the law on her side.

I think this rule was established by Congress (as interpreted by the FDA). It is absolutely not the rule in general. It is not the rule governing off label prescription. It is not the rule governing the design of automobile engines or the writing of computer code. It is the law regulating new drugs.

Now what does “strong enough to inform” mean ? The claim, if it means anything, is that evidence weaker than some threshold should be ignored entirely. This is absolutely inconsistent with any sort of rational forecasting or rational choice.

And here “established” means that those with the power to decide have so decided. It isn’t proven in the way it is proven that penicillin kills (some) bacteria. Now it might be that there is a case which can be made and CcNN didn’t have time for it. Indeed, I think it proven that phase III trials are needed, because roughly two thirds of them fail, that is give disappointing results. This means that hopes based on evidence (usually including small controlled phase II trials) were proven to be false.

However, one chance in three that it works is not always negligible. In particular it sure shouldn’t be neglected when deciding what to do with Remdesivir and Covid 19. When dealing with a pandemic, there is no safe option. Notably, only lunatics demand proof that lockdowns work before ordering them. There are no large sample clinical trials of lockdown vs placebo. In this case, better safe than sorry is correctly interpreted as do what is safer not collect data and do nothing else until you know everything. Deciding to do nothing but collect data is deciding without knowing what to do. This is obvious to everyone but Trump and maniac followers (accepted by 81% of US addults asked in a poll). Yet when the question is whether to use Remdesivir, the answer is that science has established that Remdesivir shouldn’t be used for “weeks or months. ” This makes no sense.

It isn’t even an accurate description of current law and policy. In fact, there is an expanded access program so many patients do not have to wait weeks or months.

Now on the Chicago data. Yes there was no control group. but there are baseline data. It is known that roughly two thirds of ventilated Covid 19 patients die. The data from Chicago are clearly overwhelmingly statistically significant. They would be accepted as solid evidence by economists. It is only because gneuinely controlled trials are possible in medicine that they are considered to be the only evidence strong enough to guide decisions. Also, and always, because they are required by the FDA.

But mainly, Dr Hibbert accepts no difference between proposed treatments of a non fatal disorder, proposed new treatments when existing treatments usually work, proposed treatments when the alterntive is certain death (not the case at all with Covid 19) and proposed treaatments of an contagious disease such that time is of the essence.

The “established” rules include no consideration of costs and benefits and, most importantly, allow no consideration of the cost of delay.

I think the argument about proper medical practice made by the director of the medical intensive care unit at Massachusetts General Hospital is clearly wrong.

I think the problem is, as usual, a false dichotomy: are phase III (that is large) controlled trials pointless or necessary before anything can be done ? If one accepts that weaker data should inform clinical decisions, one does not have to conclude that phase III trials are worthless. It is possible to decide how to treat patients using the weaker data while conducting a phase III trial. This is happening, so it must be possible. It is possible to believe that phase III trials should be conducted without also believing that people with a week to live just have to wait weeks or months because it has been so “established”.