Pharmacovigilance. This should be a completely separate entity within the Pharmaceutical company.

The subtitle to this topic is that with the incoming new administration and their plan to incorporate controversial characters into senior positions... there are common grounds with well-informed experts in medicine. One of the major points that has terrified conventional medicine (maybe a little bit myself) is the opposition to vaccines of a number of the prospective leaders, which at times has been pure conspiracy theory/ magical thinking: alien DNA in vaccines.... Bill Gates inserting microchips in vaccines.

This is however logically, the expected aberration cognitive artifact that arises when companies / governmental organizations do not take seriously adverse events, and attempt to ignore or worse, cover them up, that even highly skilled conventional physicians like myself find objectionable. Who gets panalytical transverse myelitis after Gardasil vaccine? And why? Who gets catastrophic neurodegenerative disease after measles vaccine? And why? My informed suspicion is that it is due to a genetic variant. It is inexcusable and unethical not to study these sufferers, but simply pass it off as rare and therefore not important. Individuals who have the gene, or similar entity, can be tested for it so that they do not receive the vaccine. The same is true for GBCAs, and ofcourse for every ot the medicines created. This type of information is knowable. Because the reactions may be rare, does not mean they should be ignored.

For each of the 35 years I have been a radiologist I have been at the pinnacle of scholarly accomplishment, most of these years with a strong focus on the MRI companies, equipment and the GBCAs. I have worked with them. In all of those years I have never seen a single example of pharmacovigilance taking an independent view of the products their company creates. Instead what I have consistently observed is their interest in investigating bad outcomes to show that it could not be due to the products they make. Ofcourse patients do not trust their intentions. Why should they? Even myself have variable faith in their intentions. One of my favorite quotes from legal work I had done on NSF, is a senior member of an MR contrast agent told a junior employee who observed and wrote that their agent was not that stable: 'why didn't you just destroy the data"' I have toyed writing a book on that entire experience of reviewing company information. We will see.

So what is the answer. It is very simple. Pharmacovigilance should be an entirely separate entity within companies, not beholden in any fashion to the company themselves. If they show any bias, then they should be dismissed. This is not to say they should be acting against the interests of the company. They should be interested in finding out the truth and finding solutions. The problem is, who then should they be responsible to. Likely it would have to be the governmental agencies responsible for oversight, the FDA in the US, European Medicine Agencies in Europe, and so on. Unfortunately there has been a lot of doubt sewn regarding these institutions, some of it overblown, some though accurate. They themselves would need to have their reputation restored as independent governmental organizations acting as fiduciaries for their public.

I had planned this blog some months back with the following subtitle:

Lessons from Boeing's issues. The eyes don't see what the mind does not want to see. I have left that blog below largely intact, so there is repetition.

I have recently used a quotation: "the eye does not see what the mind does not know" in an article on the Splanchnic Inflammatory Syndrome (the imaging findings of conditions from leaky gut, Irritable Bowel Syndrome, and the Metabolic Syndrome) explaining what it has not been recognized until the last year or so by myself and somewhat independently my colleague Miguel Ramalho, MD. Others have used variations of this quotation before, also in Radiology.

Combining this with the observation of Upton Sinclair: " It is difficult to get a man to understand something when his salary depends upon his not understanding it".

I won't get into detail on the Boeing set of issues. On a 2024 John Oliver show Last Week Tonight, he goes into some detail about the issues. I think moist central is that individuals responsible for ensuring safety which are supposed to be employees of the Federal Transportation Agency, actually were employees paid by Boeing// merger with a military airplane company//internal safety inspectors fearful of retaliation// dead Boeing whistleblower from mysterious causes in South Carolina.. add them altogether you get two 737 plane crashes in 2019, and panel blowing off a plane in air.

The core problem: there is little incentive to pay rigorous attention to safety, and considerable disincentive if the safety officers are employed by the company. Gandhi would call this one of the 4 deadly sins/ core evils: Capitalism without Conscience. My experience with pharmacovigilance with MR contrast agents over the 35 years of paying attention to them: they are more focused on showing why a patient's adverse reaction was not due to an MR contrast agent, rather than trying to figure out why this happens, and who are the people who get this.

Last year we published this article in Investigative Radiology (the second highest rated Radiology journal by Impact Factor):

Commentary on the Association of Symptoms Associated With

Gadolinium Exposure/Gadolinium Deposition Disease and Gadolinium-Based Contrast Agents

Richard C. Semelka, MD* and Miguel Ramalho, MD†‡

This was a commentary on an article published in that issue by Shahid, et al, looking at adverse reactions to Gd published by the FDA (FAERS reporting) and European Union (EV). Those authors should also have looked at the Yellow Book by the UK, and ofcourse other countries like Japan.

In our article we described what we did to evaluate adverse reactions. This is what pharmacovigilance should do: study the patients themselves rather than a snap shot complaint by individuals. My recommendation is that Pharmacovigilance should be an entirely separate group. I have been toying with should it be private ventures, like essentially most major pharmaceutical companies use to perform the research studies to pass the 3 phases of FDA approval. There are companies focused just on doing that. The problem with small profit - oriented companies doing pharmacovigilance, is just that: profit-oriented, and the large company that developed the drug wants ofcourse to get it approved. So perhaps the parent organization of Pharmacovigilance should be the FDA. The FDA in charge of pharmacovigilance with separate groups in each of the large pharmaceutical companies, and perhaps shared ones in smaller one. As corrupt as the Federal Government can be, it does have more accountability, and less financial incentive than private companies.

A change with a new government with radically different ideas than conventional mainstream medicine does provide for an inflection point on subjects that basically everyone agrees with. Pharmacovigilance in companies need to be focused on the safety and welfare of the public, and not be focused on towing the party line of the company. A simple and obvious concept. This would make an enormous difference in the quality of health care.

Richard Semelka, MD