Research Process: Facing Adversity

By Douglas Kalman PhD, MS | November 1, 2007

Companies that put solid research behind their products are the ones that will gain significant market share in the long run.

Facing Adversity

Companies that put solid research behind their products are the ones that will gain significant market share in the long run.

By Douglas Kalman PhD, MS, RD, CCRC, FACN

It should come as no surprise that the media often takes pharmaceutical and social sciences research more seriously than dietary supplement studies—that is unless there is a negative finding in a supplement study. While the industry may face adver-sity from several angles, there are many ways it can overcome that adversity and use it to grow consumer confidence, as well as the bottom line.

Start with a Validated Product

If the products that you sell are considered validated—that is they have undergone finished product randomized, double-blind, placebo-controlled clinical trials—then your ability to enjoy branded science is solid. In addition, if a study or studies meet the outcome objectives (even some and not all), then you have the ability to use the results for market gain. You can also use clinical trial results in various forms of patent applications, which will only further strengthen your intellectual property and market value.

So what types of studies are certain to increase consumer confidence in dietary supplements? There are many types of trials that can be considered, including: pilot trials (small group of subjects tested in an open-label setting in order to determine if the product has any effect; the results can be used to determine the sample size for a more robust study); comparator trials (your product compared to another product, such as a weight loss supplement vs. an OTC drug like Alli; these comparator trials may or may not have a control arm—if it does include a control arm, the value is exponentially greater); and the “gold standard” randomized, double-blind, placebo-controlled clinical trials or RCTs (in this study setting the researchers and the study participants are not aware who gets what—real product or placebo).

An RCT can be carried out in “crossover” fashion, which means the subjects first receive one treatment and after a set amount of time switch to the other treatment. RCTs conducted with a crossover can also serve as two studies in one, especially if both results support each other—think of it as double validation because the product or ingredient was tested twice within the same study. RCTs in general are less costly than RCTs with a crossover, but both are considered gold standard by regulatory agencies, as well as the scientific community.

If you are intent in retailing a product that has not undergone the rigor of a clinical trial, then you can use borrowed science (published studies on the raw ingredients in your product) to support your product, as long as you sell or use the exact same raw material (herb, vitamin, etc.), at the same exact dose that was used in the prior published science. It should be noted that using borrowed science to support a product, while being inexpensive (relative to actually investing in your own true R&D), maybe be shortsighted because you have no real ownership in your product (your claims are somewhat based on non-owned research that may have many flaws). In addition, if you solely use borrowed science to support your product, you still need more than two studies that produce the same or very similar findings. These studies must also meet the hierarchy of support as outlined by both the FDA and FTC. Another reasonable approach is to combine borrowed science with some of your own research to support your finished product.

How ‘Big Pharma’ Handles Conflict

Recently, pharmaceutical giant Bristol-MyersSquibb (and its subsidiary Apothecon) agreed to pay the U.S. government $515 million for allegations related to its business practices. According to USA Today:

Bristol-Myers Squibb announced that it would pay more than $515 million to settle federal and state investigations into drug marketing and pricing practices, AP/USA Today reports. The former BMS subsidiary Apothecon, a generic drug maker, also is being investigated. The allegations against BMS, stemming from actions between 1994 and 2005, include:

• Off-label marketing of anti-psychotic drug Abilify for pediatric use and to treat psychoses related to dementia;
• Illegally paying healthcare providers in the form of trips and consulting fees to prescribe its drugs;
• Misreporting to CMS (Medicare) its best price for anti-depression treatment Serzone; and
• Inflating prices for some oncology and generic drugs to increase reimbursement rates.

Apothecon was accused of giving illegal enticements to retail pharmacies and wholesalers to buy its drugs. BMS in a statement said that the settlement would not change its business with any customers, including the federal government (Lavoie, AP/USA Today, 9/29).

So, BMS agrees to pay $515 million in fines for illegal business practices and yet says it will not change them. Where is the uproar from this industry? BMS finally agreed to sign a Corporate Integrity Agreement with the Department of Health and Human Services. But, interestingly enough, there wasn’t a prolonged media review of this and there were no calls for a Congressional hearing (remember the outcries about the perceived non-regulation in the supplement industry?).

The BMS example is important because it highlights the lack of reaction from the media. Dietary supplements, on the other hand, haven’t been so lucky. Case in point: whenever the FTC fines a few dietary supplement companies, the media runs wild with it. Oh, and another thing, BMS stock was virtually unaffected by this case.

Jump in the Pool

Increase consumer confidence in your products by aligning yourself with research, and convey your dedication to product improvement and research to the media. Make sure people know you are getting more involved in research and don’t be afraid to admit when something goes wrong (don’t run and hide, aggressively fix the problem). Research can be used for many different reasons and those in academia and the CRO world are here to help you grow your products, brands and companies. Do not be afraid to jump in the research pool—it is better than being a “me-too” company or one that faces continual regulatory scrutiny.NW
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