Aug 02 2016

Supplements and Contract Research

snake-oilI dislike double standards. They are inherently intellectually dishonest. Sometimes double standards are the result of a deliberate campaign to confuse the public or regulators in order to create special privileges.

Alternative medicine is a great example of a double standard. Proponents want their own special standard for research, for evidence, and for practice. They, in fact, have succeeded in passing laws in many states which explicitly create a double standard for practices arbitrarily deemed “alternative”.

Organic farmers can use toxic pesticides while criticizing their competitors for using less toxic pesticides. They also eschew GMO cultivars, while using those resulting from mutation farming or forced hybridization.

One clear double standard is the marketing of supplements – the industry has successfully created a double standard for their products. They criticize the pharmaceutical industry while being guilty of far worse practices. 

Supplement Research

A recent article highlights the contract research industry and how it is used to market supplements. There are companies that do research for hire. There is nothing inherently wrong with this practice, as long as they are transparent and hold to reasonable academic standards.

Research is an industry, and if you can do it efficiently and cost-effectively, while maintaining high scientific quality, then I have no problem with that model.

The article is by Ingrid Nuse writing originally for ScienceNordic. She details how specific companies work for both the pharmaceutical and supplement industries. While working for the former, they appear to adhere to tight standards. While working for the latter, they appear to offer research results for hire.

These are often referred to as “in-house” studies – when a company either does a study of their own product themselves, or they contract out to a private research company. Either way, the studies are generally useless scientifically.

Ingrid points out that this is almost unavoidable given the system. In the US and many countries, supplements do not require scientific evidence showing safety or efficacy before they can be marketed. Drug companies have to spend tens of millions of dollars and spend over a decade getting a drug to market. Supplement companies (and often they are the same companies) can put just about anything in a bottle and make just about any claims for it (as long as they are a little careful with wording) and market their product without spending a dime on research.

Their only motivation is to maximize the marketing of their supplement. To do this, it is helpful to be able to say that your product is backed by science. You can do this in a couple of ways. The cheapest way is to refer to studies done by actual scientists looking at something which you can tie to your product.

This often means listing basic science studies looking at some effect in a petri dish of one ingredient in your supplement, then extrapolating from that to a hyped clinical claim. They translate – this vitamin increases this one marker of white cell function – into – our supplement cures cancer (which they will probably state as, “our product boosts the immune system and helps your body fight off cancer”).

However, the words “clinically proven” have marketing value, and so sometimes companies calculate that it is worth the investment to do a study of their specific product to show that it has some health benefit. The problem with real research is that it is research – you don’t know the result ahead of time. If they did proper research, it is possible that their product may not work. There is no incentive to roll those dice since showing evidence of efficacy is not required.

So instead of actual research capable of answering the question – does this product work? – they do in-house research guaranteed to show a positive result. Ingrid writes:

The studies are often very small, with few participants and are very short term, from a few weeks to a few months. The studies don’t measure the products’ long-term effects. Researchers almost never find side effects, and they are happy to recommend the products- although the study shows only minor positive results.

Small studies with short term follow up are likely to be false positive. Add to this even a small amount of researcher degrees of freedom, and you can practically guarantee a positive outcome.

This is not research. This is deceptive marketing.

Of course, there are those who accuse Big Pharma of doing the same thing. The reality is more complex. Pharmaceutical companies definitely want to give their investigational drugs the best chance of working, and they design studies to give them the best chance.

This has actually been studied. A 2006 study, for example, looked at cardiovascular research. They found that:

“Of the 104 trials funded solely by not-for-profit organizations, 51 (49%) reported evidence significantly favoring newer treatments over the standard of care, whereas 53 (51%) did not (P = .80). By contrast, 92 (67.2%) of 137 trials funded solely by for-profit organizations favored newer treatments over standard of care (P<.001).”

This difference was largely explained by using secondary marker endpoints (like blood cholesterol levels) vs clinical endpoints (such as heart attack free survival). This is one way pharmaceutical companies can rig the game, by choosing endpoints more likely to be favorable.

But look at the numbers – 67% vs 49%. This shows a bias, but it is not absolute. There are many examples of drug trials which show that the new drug causes kidney damage, ending the drug after tens of millions of dollars were spent doing research.

In fact, according to the FDA only 8% of investigational new drugs ultimately make it to market. Drugs fail at every stage of research. And, once on the market, new drugs are still under surveillance and some get pulled from the market.

It seems difficult to argue that there is not adequate regulation, or that the system is heavily rigged, when only 8% of promising new drugs make their way through the research hurdles. Many drugs fail along the way, after millions were already invested in research. The process also takes 10-15 years – no small investment for any company.

Further, clinical trials in the US now have to be registered, so that pharmaceutical companies cannot bury negative results.

To be clear, the industry definitely looks for ways to put their thumb on the scale, and then regulators have to change the laws to even the scales again. The system is not perfect, and needs constant tweaking, but the numbers indicate it is working to some extent.

I could not find any similar published reviews of supplement research. I have only seen positive studies from companies themselves. There is no FDA oversight of this research, they do not have to register their studies, and the designs are usually terrible. This is truly rigged research, designed to be used for marketing. A good rule of thumb is to completely ignore such in-house studies. They essentially are just a way for supplement companies to purchase the phrase, “clinically proven” for their marketing.

Contrast the reality with the general public perception, however. That is the power of marketing.

Whenever I write about this topic, there are those in the comments who regurgitate the standard pro-supplement industry propaganda, as if they are the critical thinkers and skeptics are the sheep. It’s ironic. They will call me a shill, then link to a dubious site like Natural News that actually shills for supplements and sells them for profit.

This is more than a double standard, this is an alternate reality. It is the power of marketing.

Unfortunately, such marketing feeds on itself. Selling supplements is a multi-billion dollar industry, and that money funds further marketing which further grows the industry. The marketing is also used to trash skeptics and science-based critics. Sometimes they even target individual skeptics and try to destroy their reputation. They also sometimes sue or threaten to sue their critics.

This behavior makes them more of a cartel than a legitimate industry. The worst of them are thugs using their ill-gotten gains to intimidate and attack those just trying to defend high standards of science. They use their money also to lobby the government (Orin Hatch is the best example), who then champion their cause and put through anti-consumer pro-industry laws.

The supplement industry is actually doing what their customers believe the pharmaceutical industry is going.

Just think about the facts out of context for a minute. You have an industry that deals in health care products, is largely unregulated, does not have to produce research, when they do, the research is in-house rigged studies used for marketing, they engage in deceptive marketing, their products often don’t even contain what the label says it does, they attack, smear, libel, and sue their critics, they lobby state and federal governments for anti-consumer, pro-industry laws, and they are making billions of dollars. Add to this the fact that their products are largely worthless and are marketed with blatant deception.

They then promote themselves by weaving conspiracy theories about their competitors, accusing them of doing things which are not even as bad as what they themselves are actually doing.

Even worse, the public largely buys it. Consumer protection organizations are largely silent. There is no political will to change the situation.

We’ll just have to keep plucking away with public education and hope we can turn things around. We are making some progress, but it is glacially slow.

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