Question: True or False?
Dr. Anne Looker, of the Centers for Disease Control (CDC), could not have made Professor Hector DeLuca, the University of Wisconsin, and certain folks at big pharma, any happier with her recent widely reported analysis of the vitamin D status of Americans, while at least one member of the recent vitamin D Food and Nutrition Board (FNB) hopes that the process the FNB used in their deliberations remains impervious to federal Freedom of Information laws.
What did Dr. Looker say in her report about vitamin D levels and deficiency?
Dr. Looker and her colleagues at the CDC reassured Americans by using definitions of deficiency straight from the recent FNB report, a definition that no vitamin D scientist that I know agrees with, except perhaps the vitamin D legend, Professor Hector DeLuca of the University of Wisconsin. Instead of a lower limit of 40, 30, or even 20 ng/ml, Dr. Looker and her CDC colleagues actually said any American with vitamin D levels below 12 ng/ml were “at risk of vitamin D deficiency.” That’s right, she wouldn’t say “deficient” for a person less than 12 ng/ml, all she said is they are “at risk” of being deficient! Why?
Dr. Looker falsely reassured Americans that everything is pretty much OK because around 80% of white Americans have levels higher than 20 ng/ml (although only 30% of African Americans do). I carefully read her entire paper; why didn’t I see a “CDC Action Plan for African Americans” for the 70% of Blacks with levels less than 20 ng/ml? Probably for the same reason I didn’t see any “FNB action plan for African Americans” in their recent vitamin D report.
A failure of the National Academy of Sciences
Where did Dr. Looker get the idea that 20 ng/ml was OK? From the FNB. Where did the FNB get that idea? Professor Hector DeLuca and the vitamin D analogue scientists, that’s where. What I am about to tell you is a failure of a system, not a person. The National Academy is responsible, as scientist to the USA, to see that the processes that occur in its name are fair, above the appearance of impropriety, and free from avoidable conflicts of interest.
I have been to enough vitamin D conferences to know that about half of the scientists who attend these conferences are looking for the new patent that will secure or extend their financial fortune. They do not need America alarmed right now about the fact more than 80% of Americans are actually vitamin D deficient; no, the government might need to do something now, an action that would threaten the value of something that I have just learned about: an imminent river of new vitamin D knockoff commercial patents.
Vitamin D knockoff scientists want the government to say that 20 ng/ml is fine, at least until all the phase 2 and phase 3 FDA trials are finished on their newly patented vitamin D “analogue” drugs. In a few years it won’t matter because dozens of knockoff analogues will have been approved for treating vitamin D deficiency, yes prescription-only vitamin D knockoff drugs to treat vitamin D deficiency, instead of vitamin D, I kid you not. After these scientists get their analogues past the FDA, I predict the same scientists will change their tune and start crying for 40 ng/ml as the desirable lower limit, ensuring a vast market for their knockoffs.
The creation of vitamin D knockoff patent prescription-only drugs goes something like this: take the cholecalciferol or 25-hydroxy-cholecalciferol molecule, change its structure enough – without changing its actions – and Ola, you can patent it. It must be structurally different enough from natural cholecalciferol to be a unique drug but it must retain its vitamin D efficacy.
Ergocalciferol (Drisdol) – the only prescription drug available to treat vitamin D deficiency in the USA – is an example of an analogue, although the path to its discovery and its patent was quite different. The patent on ergocalciferol made the University of Wisconsin’s Department of Chemistry the richest chemistry department in the world. In some countries, ergocalciferol is still the only vitamin D available. For a detailed discussion of how these patents put the National Academies in a very difficult position, read the following blog: Conflict of Interest at National Academy of Science?
Analogue scientists need time before they can cash in on their patents
As I write this, I understand additional vitamin D patent applications are being prepared (I actually know of one application by a member of the recent FNB committee member). These analogue scientists need time; the nutrient, vitamin D, needs to take a back seat for a while. Vitamin D was getting too hot, too many good things being said about it, and too many press stories about too many Americans being deficient. The analogue scientists want a big market when they finish with the FDA.
Anyway, after you have your new vitamin D molecule and your patent, you approach the FDA, who will require that you do randomized controlled trials, pitting your new vitamin D analogue drug against . . . what? Vitamin D, right? No: placebo. That’s right, placebo. As I understand the process, and I hope I am wrong, the vitamin D knockoffs only have to prove they are better than placebo, which, if they keep their efficacy, will be a cinch.
I even know of a patent application for a drug to treat vitamin D deficiency by inhibiting the 24-hydroxylase (the enzyme that gets rid of vitamin D in the body). If you inhibit the 24-hydroxylase, you will raise 25(OH)D levels and thus treat vitamin D deficiency; this is what big pharma is up to (I kid you not). Can you imagine taking a drug that interferes with a natural enzyme that metabolizes vitamin D in order to increase the amount of vitamin D in your blood, instead of just taking vitamin D? Is this the best that American medicine can do?
Very few people seem to know that the recent FNB committee had an unusual guest, an overseer, an official vitamin D advisor, Professor Hector DeLuca, one of the true giants in the field of vitamin D, both academically and financially. Talk about mother-load analogue patents, he wrote the book. He has created so many activated vitamin D knockoffs that he named one after himself, “Hectorol.”
Why is Hector DeLuca the only vitamin D scientist who is a member of the National Academy of Sciences?
Another fact often gets lost; Dr. DeLuca is the only member of the vitamin D community who is a member of the National Academy of Sciences, an extremely difficult membership to achieve, a shadowy process requiring inside advocates and secret votes. I’m told, but could not confirm by calling the National Academies, that blackballing is still used; if so, one negative vote and, “I’m sorry Dr. Holick,” “I’m sorry Dr. Heaney,” and “I’m sorry Dr. Norman.”
Anyway, Professor DeLuca and his Department of Chemistry at the University of Wisconsin are experts in making knockoff analogue vitamin D drugs. To be fair, his analogues of activated vitamin D have saved thousands of lives, mainly patients with kidney failure, although activated vitamin D itself works in kidney failure. If the new analogues of cholecalciferol and 25-hydroxy-vitamin D effectively treat vitamin D deficiency, they too will save millions of lives. However, there is just a much easier and cost effective way of treating vitamin D deficiency: plain old, cheap old, nutrient old, vitamin D.
As far as the recent FNB report on vitamin D, can you visualize all the scientists on the FNB hard at work, under the watchful eye of their “Special Advisor,” National Academy of Sciences member, Professor Hector DeLuca. I would venture a guess that more than one member of the FNB vitamin D panel dreamt about being in the National Academy himself or herself one day. Then they pondered which lower limit to vote for, the 40 ng/ml opined by most vitamin D scientists or the 20 ng/ml opined by “Special Advisor” DeLuca. Let us see, what will get me into the National Academy of Science the quickest?
I can’t really complain:
- First, this is America and I suspect the quickest way to treat the massive vitamin D deficiency pandemic is going to be through private industry, like it or not.
- Second, it is possible one of the vitamin D knockoff drugs will actually work better than vitamin D; “possible” I said.
- Third, I get royalties on my own brand of vitamin D so I have my own conflicts of interest.
- Fourth, before you get too high on your horse about Dr. DeLuca, ask yourself how many lives have you saved in your lifetime? He discovered activated vitamin D, trained dozens of the top vitamin D researchers, and saved thousands of lives.
Also, I have no way of knowing how exceptional was the FNB’s decision to make secret the critiques of the 12 top vitamin D experts, experts who were asked to review the FNB’s work. Does the FNB invoke such secrecy frequently? When did it do so last? Did the final FNB report change, based on the opinions of the 12 vitamin D experts, or did the FNB Board (most who admit to not being vitamin D experts) simply comply with Professor DeLuca’s judgment?
If the final FNB report did change, what did the report look like before the vitamin D experts’ opinions were weighed? I understand at least one vitamin D expert charged the FNB with racism for its failure to consider the vitamin D plight of African Americans. Is that true? Most members of the Vitamin D Council would like to read all 12 critiques by the 12 top vitamin D experts in the world but – unlike Professor DeLuca or the vitamin D-knockoff pharmaceutical companies – we don’t have the money to legally fight the FNB’s proclamation that the 12 expert critiques by the top vitamin D experts in the world are – and will remain – secret, beyond the reach of Federal Freedom of Information Laws.