Editorial: Behind the Curtain

This fall was full of industry travel for me and for many of you, too. Besides airports, one thing I kept running into was the word transparency.

CEOs and companies sure do love to throw that word around nowadays. It’s often tied to a promise that a company is being more open about its efforts and practices. But in our industry, what does transparency really mean? And how far does it go?

This is the semi-philosophical discussion I had in October with Anthony Almada, president and CEO of GENr8, after running into each other in the Austin, TX, airport following the Council for Responsible Nutrition’s (CRN) excellent annual conference, for which Almada had been a speaker.

He made a good point: why, if companies say they truly want to be transparent, more do not register the studies they intend to pursue in a public clinical trials registry such as ClinicalTrials.gov? Doing so, he argued, would prevent companies from cherry-picking the science they choose to publicize.

When trials are registered, industry is able to track whether a study was conducted according to its initial design-and not changed to achieve better results. It also dissuades companies from sweeping under the rug the results of studies that didn’t work out.

“It’s a method of accountability,” said Almada.

I asked Duffy MacKay, ND, CRN’s vice president of scientific and regulatory affairs, whether more companies should register their clinical trials. “Registering a trial is definitely one component in increasing the transparency of scientific inquiries,” he agreed. “It is a disincentive for someone running the trial to change course midstream without really good justification. If you did so, any regulator or inquisitive clinician or person could go back to the trial registry to check.”

“That’s the whole incentive of clinical trial registry,” he continued. “It’s really to bring a level of integrity to the clinical trial process.”

Arguably, trial registry could increase public trust in scientific research. Also, in the spirit of collaborative science, it would create a more-robust record of what worked and what didn’t. It would also provide regulators with a better record of a company’s science.
Flipping the coin, why then might companies choose not to register a trial? Competition, certainly.

“I don’t think many dietary supplement companies are registering their clinical trials,” says Larry Robinson, PhD, vice president of scientific affairs for Embria Health Sciences, one of the winners of this year’s SupplySide West Scientific Excellence Awards. “There are certainly good arguments both for and against registration.

“Registration is common for pharmaceutical trials. In this case, the product being studied is patented, and FDA approval is required for the pharmaceutical company to make a return on the investment it has made for the drug. Scrutiny by professionals may in this case avoid the loss of many millions of dollars if a certain design element is not perfect. The big difference for dietary supplements is that in many cases, the supplement is not patented. By keeping the protocol of a clinical trial proprietary until publication, a company may get a return on the investment before a competitor with a similar product can duplicate the research.”

Might trial registry also inhibit companies from refining study designs to make them better?

“When you go golfing, the word mulligan is used when your tee shot really stinks. It means, take a second whack at the ball, and try it again,” says Loren Israelsen, executive director of the United Natural Products Alliance. “Conducting clinical studies can often feel like golfing. You get better with practice.”

He adds, “We need to build a culture of science in the natural products industry that is understood to be a complement to, and not a competitor with, our tradition of belief. Clinical trials are the basis of that culture. Yet, we must be realistic about the general level of scientific competence among our many companies, and encourage what is possible. A registry, while laudable, may require a level of  scientific rigor not yet resident in much of the industry.  It must be our goal to improve this.”