Anthony Almada, B.Sc.05.01.06
Tomb of the Unknown Science: Part II
What would happen if a whistle was placed in the mouth of a seasoned industry scientist—and he blew into it?
ByAnthony Almada, B.Sc., M. Sc.
(The first part of the column appeared in the March issue of Nutraceuticals World.)
Anchorwoman: “We spent over 130 hours performing our due diligence on Dr. X, and on this untold dark side of the nutrition industry. Dr. X’s credentials turned out to be impeccable and all of the other scientists we spoke with attested to his sterling record and scientific acumen. We were surprised to find, not unlike in other industries and even the federal government, that there is a not insignificant number of industry ‘experts’ who have degrees from unaccredited, mail order, and even discredited ‘institutions.’ A number of these have written or co-authored consumer books, are on the public speaking circuit, and even have served as consultants for very high profile celebrities. But what we heard in the last portion of our interview with Dr. X left us agape and transfixed. We return to our biomedical science correspondent, Morgan Nobel.”
Morgan: “What is the prevalence of this practice, of using attorney-client privilege between researchers and a nutrition company to prevent disclosure of unfavorable results from clinical studies sponsored by a company and their product or ingredient?”
Dr. X: “Because it is insulated from disclosure—unless one wants to unleash a legal volcano—it is very difficult to estimate. I can say that through my industry experience, and from discussions with a few of my fellow scientist colleagues, it is not uncommon. I know of at least seven studies that have been ‘gagged’ over the past few years. The other practice that is employed, and which has fostered a new industry, is to contract with a private, for profit, non-academic research center or a contract research organization and stipulate in the agreement that the results, and the right to communicate them in any form, are owned in toto by the sponsor. So a company, in sacrificing the prestige of sponsoring a clinical trial at an academic center of repute—which typically has the right to publish any results from sponsored research—gains the advantage of being able to bury non-positive study results. The consumer, the regulatory agencies, and the competition couldn’t begin to look for the buried bodies because they are wholly unaware they even exist! Only a methane probe could unearth them.”
Morgan: “Those are disturbing revelations. One could assert that you have nothing to gain by these insights behind enemy lines because you are, in effect, on the side of the enemy. But aren’t these omissions just rare aberrations?”
Dr. X: I wish they were rare. I know firsthand of 14 studies conducted over the past three years, some on products that you could find anywhere in the country, the subject of seven and eight figure national advertising campaigns, and enjoying tens of millions of dollars in sales.”
Morgan: “What you’re saying is that it is easy to elude disclosure of ‘non-positive’ research results, that the frequency of this practice and tactic is intolerably high, and that some products consumers have bought en masse are party to this deception?”
Dr. X: “Precisely but I would add that ZERO tolerance for this practice should apply.”
Morgan: “There have to be some exemplary companies who report ALL of the results from ALL of their sponsored research. Aren’t there? How about some of the results from some of their studies?”
Dr. X: “I’m unaware of ANY company that has a full disclosure policy for ALL of the clinical studies they sponsor. To add further complexity to the equation I have witnessed selective reporting and selective omission. Moreover, several of my industry scientist colleagues and two of my academic researcher colleagues have confirmed this practice.”
Morgan: “How does selective reporting and omission work?”
Dr. X: “Let’s say you were a company that sponsored a study attempting to prove that your joint health food, beverage, or dietary supplement product would produce a quicker onset of relief of knee joint pain—due to osteoarthritis. You would compare it to other products, a placebo, and maybe even a prescription drug. Any savvy company—and ethical researcher—would want to assess the persistence of this earlier onset of relief—if it lasted for 4, 8, or even 12 weeks, and be superior to placebo or another nutrition product, and even equal to the drug.
“One company’s nutrition product was the focus of this type of a study. Indeed, they did show superior pain relief very quickly but after a longer period of use it was no better than placebo. Where was THAT report, press release or advertisement? Bury another result by omitting the WHOLE outcome. A few other recent studies have been done, with avidly promoted products or ingredients, but the press releases and the industry communications magically exclude this aspect of the studies. Another practice is to exclude the results of specific subjects enrolled in a study that do not produce the ‘desired’ outcome or effect. This yields a study result that looks very positive but is a composite of one or more small studies where the good data are highlighted and the bad data are excised. The reader of such a study would have NO clue that it was the handiwork of a data cobbler.”
Morgan: “Why doesn’t the Federal Trade Commission (FTC) or the Food and Drug Administration (FDA) step in and take a preemptive and enforcing role?”
Dr. X: “What could they do? First off, they would likely assert that they have a priority in hunting down white whales and not small fry. If they did have the mandate to pursue these research sins they would be at a substantial disadvantage because their ‘fish finder’ would not discern their presence, even if they were right on top of them. These ethical crimes would require insider information. This is compounded by the overworked and understaffed plight of these agencies. It would seem that the strategic move would be to place moles in high profile companies and obtain intelligence covertly…”
Morgan: “What do you see as a solution, if there is one?”
Dr. X: “It is very simple but still fallible. Create a clinical trials registry, where sponsors are obligated to register their trial and the details of the intended investigation before it commences. Increasing numbers of mid to top tier biomedical journals and research funding agencies now require this IF investigators wish to publish the results of any clinical trial in one of these journals or receive a research grant. But it is not compulsory and a sponsor/researcher could easily elect to NOT publish in one of these journals. This calls for a nutrition industry-centric clinical trials registry that captures any and all trials that are described in print, online, on air, or in person—for example, at a tradeshow. If you say in public, in any form or forum, that you are sponsoring a study, or that one is already underway, THAT would be captured with as much detail as possible: a free access registry that places an obligation upon that business to disclose the results. This is the closest thing to putting teeth in the dog without governmental regulation.”NW