Today’s Flawed and Fake Medical Trials

Recently I was presented with unsolicited lab data ( above) on a patient whom I am not charged to divulge, who is the typical patient I have cared for in the last 18 years and unwittingly poorly throughout my earlier career. This case has what appears to be an unbelievable astounding but in reality not infrequent response, to a single anti-cholesterol medication & vitamins; despite lacking my usual work up which includes inflammatory, absorption and production markers as well as insulin resistance parameters.

I was struck by the upstream effort against the tide of this individual to spread affordable and effective knowledge and experience what I and hopefully many others have been applying for years .
Recently because of the accelerated pricing of Niaspan consistent with gouging, similar to the recent EpiPen scandal, I was at a Walmart pharmacy inquiring about the immediate release form of crystalline niacin which was the vitamin involved in the above patient’s treatment . Thereupon, the pharmacist proceeded to denigrate niacin insinuating that I did not know the literature. Now I did not quite agree with this gentleman and walked out to another Walmart. However, this incident is not stand alone event. I have had many other providers and would be providers even ivory tower institutions disparage niacin, in fact attempting to interrupt successful treatment of the dyslipidemia of some of my patients and I am quite sure others.

In college I started of in the premed program but switched to Physics because I leaned more to analytical thinking. Premed and medical school was mostly about regurgitation of vast amounts of facts with little time devoted to analysis which does require some experience. Unfortunately the medical literature dictum of publish or perish leaves little time for peer- review with correlation & application to the real world.

It is one thing to know what the literature states and another to be able to critically evaluate, usually referred to as peer review. Now peer-reviewers to me are the readers of the articles. Others think that the peer review involves the editors and those who chose the articles for publication. As a Board-Certified Cardiologist since 1973 along with 2005 inaugural year certification in Clinical Lipidology and my recently successful completion of Clinical Lipidology recertification exam in which I am now grandfathered and exempt from any future examination, I believe I have a bit more critical and analytical perspective than the lay public, the vast majority of

physicians and pharmacists who lack peer review capability as well as proponents of big Pharma.

The above pharmacist’s impression emanates from two flawed trials, which in my opinion much like our news media which in last 50 years has generated fake news, has generated data inconsistent , inconsequential or mal-applied in the real world and therefore have drawn false conclusions. Whenever I see data inconsistent with my near 45 year experience I always think of a phrase I learned in medical school about Willie Sutton’s robbing banks i.e. “ Sutton’s law”, ascertain or observe where the money is involved then evaluate who benefits.

Recently upon viewing the Agenda at a National Seminar Symposium, I noticed an interesting discussion about the Niaspan topic; unfortunately not well emphasized because it was on the last day near adjournment. I was unable to attend this session but I decided before the lecture to compose and send to the presenter my peer-reviewed assessment about the status of niacin including Niaspan, in addition to still contemplating about placing this discussion on social media. I never received a response because it may not have been successfully sent. I felt that the data from the relatively recent Mega trials would be emphasized and the older trials would be ignored. Later upon viewing the presenter’s synopsis from another source, my belief was buttressed.

There have been other flawed trials. An example is the Seven Countries Trial( which in my opinion started the obesity epidemic) which is still revered when the history of trials are reviewed at symposiums.

The recent PCSK9i inhibitor trials Odyssey and Fourier are examples of over exaggerated ballyhoo which in short is for a medication that in the future will be vastly underutilized because of its lack of affordability, much less than the statins when they were initially introduced. PCSK9i are set up to be an add-on and not a competitor of the statins. Its powerful LDL-C lowering into the teens results in outrageous cost inefficacy. We should not be concentrating on a transient sojourn of LDL-C into the teens but on the product of ApoB particles over years. Some of PCSK9i other beneficial effects are being glossed over, ignored or relegated to non-significant status. Further discussion an exploration of this topic will be better served in the future



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