Heartfelt with Dr Melissa Walton-ShirleyView all posts »
Micropharma probiotics lower cholesterol: But does it really matter?Nov 6, 2012 02:55 EST
I had the privilege tonight to witness the birth of what is potentially a multibillion-dollar corporation in a small presentation room at the AHA meeting. "The rise of Micropharma," a catchphrase for some to describe the burgeoning probiotics market, is an apt title for a corporation of the same name. Micropharma's claim to almost certain fame is the ownership of the "intellectual property," Lactobacillus reuteri 30142, a bacterium touted as the only probiotic known to produce consistent improvements in bioinflammatory markers and lipid profiles. It will be marketed under the name of "Cardioviva." With what has been a modest investment by food-additive industry standards of just over $3.5 million, this ambitious company has put its bacterium through rigorous safety and efficacy testing, a practice to be admired. Since all seems so well with this newly developed class of probiotics, why did its purported achievements produce feelings of uneasiness on a magnitude of Grisham-like or biblical proportion?
First let's look at what's to love. A bid capsule supplement and a yogurt vehicle regimen both demonstrated significant reductions in LDL of up to around 11.6 % when compared with placebo. Total cholesterol, apo B, hs-CRP, and fibrinogen levels were reduced as well. It reduced plant sterol absorption by 39%, hinting at yet another mechanism by which lipid levels are affected. There was no significant change in triglyceride levels over the study periods of six and nine weeks, and it was well tolerated. The presenter subliminally connected the imaginary dots for the audience on the potential impact of plaque stabilization, hinting at multiple but unproven cardiovascular benefits. Older research even hints at a lower incidence of Clostridium difficile superinfection, and there are solid benefits on the promotion of comfortable bowel habits that cannot be refuted with probiotics in general.
Further research on the bacterium drove back questions regarding potential issues of antibiotic resistance, pathogenicity, and cancer risk. The presenter was asked, "Are you concerned with higher level of deconjugated bile acid as a mechanism associated with malignancy?" "The cancer risks are with secondary bile acids, not on deconjugates," Dr Mitchell Jones, the corporation's chief science officer with a laundry list of disclosures, replied. But a member of the audience unknowingly voiced my concerns about the lack of hard end points for any of the bacterium's data. He stated that when large numbers of patients are exposed, we still don't know what negative side effects can occur, since large-scale randomized controlled trials have not been performed. Dr Jones countered that the species lactobacillus is already utilized as an additive in many food substances from sourdough bread to sour cream without reports of adverse effects. Undeterred, the audience member repeated his concerns.
What I find disconcerting about this presentation is that soon we will find our population supersaturated with this bacterium. There are plans for everything including ice cream to whipped spreads and tons of other vehicles through which the entity will find its way into our gut. I fear its popularity will explode on the world supplement stage on an even grander scale than that enjoyed by entities such as niacin. I pointed out to Dr Jones that just because an entity is known to affect a lipid profile favorably, it doesn't guarantee a translation into cardiac-event-rate reduction. We are still waiting on hard outcomes on ezetimibe, for instance. When I pointed out that prescribers had learned a hard costly lesson from the AIM-HIGH trial, in which beautiful lipid profiles were no more than mere window dressings put up by niacin, he could only answer that his "product is safe and they have followed the FDA's guidelines for safety" (and marketability).
A massive PR campaign has been unleashed over the past several months that includes the following information: "According to the AHA, nearly 38 million people in the United States would benefit from the combination of diet and drug therapy, and another 30 million from diet and exercise to reduce cholesterol levels. Lack of awareness, fear of side effects, reluctance of otherwise- healthy people to take medication, and cost are the major factors interfering with cholesterol management. The peer-reviewed clinical science behind Cardioviva breaks new ground for probiotics and the potential good they can do naturally through the gut. Cardioviva, as a supplement or ingredient, provides a new solution to consumers and healthcare providers looking for natural ways to help manage high cholesterol as part of a healthy diet and lifestyle."
Show me a reduction in heart attack, stroke, or death rate, and I'll eat a hand full of Cardioviva every single day of my life. But the burden of proof has never been the reality of the supplement and additive industry. We all know that restless investors and scientists eager for the payoff on their hard work won't allow us to wait for the science we are demanding.
In my conversation with the young brilliant cofounders of Micropharma, I asked them to be bold as trailblazers in their field by performing adequate well-designed trials to evaluate for real outcomes. They are frighteningly intelligent and because of that they are worthy of making history, not just millions. In a decade they will find themselves with an opportunity to put their hard work to its best use by proving or disproving their lipid profiles matter by translating that into lower heart attack and stroke rates. It costs around $10 million to perform a good randomized controlled trial on a few hundred patients. In no time, their company's fortune will dwarf that dollar amount, and it will be a shame if they just ride on the coattails and gullibility of those who love all things alternative.
Micropharma, I implore you. Don't just change my gut flora or my LDL. Prove to me that the carefully selected name "Cardioviva" means something. Show me you can change my endothelium and therefore change my life. Only then will the research and your hard work really pay off for more than your investors. What really matters is whether your hard work pays off for the masses.