Pom Wonderful hearing

Pom Wonderful FTC ALJ hearing, opening day
Personal milestone: my very first press pass! They were a bit confused about the status of bloggers, I think.

Complaint counsel’s opening statement: Rubies in the Orchard: a marketing book published by one of the individual defendants, Lynda Resnick, about marketing pomegranate juice and Pomx, a dietary supplement. Claims for scientific peer-reviewed research: there isn’t a man in America who shouldn’t drink 8 oz. per day because it keeps you from getting prostate cancer and keeps PSA from rising. False establishment claims and unsubstantiated health/efficacy claims lacking a reasonable basis.

Ads challenged focused on claims that Pom juice/Pomx prevent/treat heart disease, prostate cancer, and erectile dysfunction. The primary evidence of the claims made is the ad itself. [Showed an ad with a Pom bottle and a stethoscope with the tagline “Decompress.”] Claims and various characteristics can create an impression that claims are based on scientific proof. Intent is not required but if present is relevant to finding that claims were made and that they were material. Creative briefs from in-house ad agency show intent to make claims. Benefits to be communicated as stated in those briefs: general health/live forever and heart health/clean and healthy arteries/“floss your arteries daily”—reasons given were that healthy antioxidants fight free radicals which cause heart disease, premature aging, Alzheimer’s, and cancer. Other campaigns targeted men who are scared of prostate cancer, along with elderly supplement users and young health-conscious women. Strategies included having experts state that Pomx provides the same cardiovascular/prostate benefits as the juice.

Pom’s reasons to believe: backed by $25 million in research conducted using Pom juice; only guaranteed 100% pomegranate juice. Diabetes and other diseases associated with aging came up. Website’s health benefits section: tone was to be authoritative and approachable. Focus on heart disease, results of studies sponsored by Pom showing decrease in arterial plaque: patients who consumed 8 oz. daily for one year saw 30% decrease in plaque, and also improved blood flow. Prostate health: similar claims. Slower PSA doubling time could have a relationship to decreased cancer risk—headline was about “saving” men from prostate cancer.

Email to Linda Resnick about an LATimes article discussing problems with the Pom research—no placebo; article concluded that more research was needed and that eating healthy was better than obsessing over the superfruit of the moment. This shows knowledge of the flaws and the intent to convey the message.

Emails to consumers in response to questions from the public about an ad called “Cheat Death”—a Pom bottle with a hangman’s noose around the neck; controversial. Company’s response: our ad campaign is created with the intent of using imagery that irreverently and boldly conveys to the consumer that drinking our product may prevent disease. Pom has many distinct benefits that sets it apart from other products and research suggests it may reduce heart disease. Since heart disease is a big killer, it’s important to communicate to consumers the powerful benefits of drinking Pom.

Actual ads matched up with creative briefs: “drink and be healthy” has ad copy claiming medical studies show that 8 oz. daily minimize plaque buildup. References to clinical pilot studies reducing plaque up to 30%. Pom as “life support”—Pom bottle in place of IV bottle, with the same “reasons to believe” offered as dictated by the creative briefs. Floss your arteries daily: Pom bottle in the medicine cabinet. Amaze your cardiologist: Pom bottle with stethoscopes on it. “What gets your heart pumping?” Pom bottle in bikini—supported by $23 million of initial scientific research from leading universities which has uncovered evidence of cardiovascular and prostate health. Special “wrapped” editions of Time distributed to urologists’ offices claimed prostate health shown by studies.

Likewise, Pomx ads tracked the creative briefs, emphasizing scientific claims. “Hopeful results for men and prostate cancer.” Pomegranate juice may one day prove an effective weapon against prostate cancer. Another tagline: “Science not fiction.” The only pomegranates backed by $20 million in research. Medical imagery, highlighting the studies. “The only antioxidant supplement rated X”—a preliminary study on erectile function, reporting 50% more likely to get an erection compared to placebo, but that study had no valid endpoint and was not statistically significant. “24 scientific studies now in one easy-to-swallow pill.”

Reception and materiality: Pom’s own consumer research showed this. 86% said they bought Pom because it was good for their health, and over half of those said it was good for their hearts (close-ended/multiple choice questions). High percentage chose prostate claims. Many reported that they learned these claims from the ads. Traditional copy tests: Many reported based on exposure to ads that Pom had “proven” health benefits. Poster in urologists’ offices was also tested and many consumers received the prostate cancer treatment message.

Consumer communications with Pom show materiality. “I’m dosing my husband with your wonderful and hopefully miraculous juice”—he was treated for prostate cancer. (A lot of sad stories of people desperate for hope follow.) One inquiry asked about the 30% plaque reduction claim—if that’s true, if you take it for 4 years will the plaque all be gone? (This produced a rumble of amusement in the gallery, but seems a reasonable one to me.) Pom’s response: that was for people with severe arterial plaque and may not apply to all people, and it only followed 10 people for 1 year and 5 for longer, so it’s hard to extrapolate. Linked to a study but didn’t explain that the study showed no effect on people with mild to moderate heart disease.

The science: the appropriate level of substantiation for health claims is competent and reliable scientific evidence, based on the expertise of relevant professionals, conducted in an objective manner by qualified persons in a fashion generally accepted to yield reliable results. Advertiser must satisfy the relevant scientific community that the claim is true.

Not challenging claims about whole fruit or fresh fruit, but about Pom Wonderful juice and Pomx pills/liquid. Q: would they have the same problem with same claims about the fresh fruit? A: Some of the hard-hitting claims related to specific diseases/conditions; the point is that we aren’t challenging claims about the health benefits of fruits and vegetables. Their commercially manufactured juice doesn’t contain, for example, Vitamin C and fiber, two of the key reasons for eating fruits and vegetables. The product claims here must be supported by the testing on these specific products. Supplement claims should be made by testing on supplement; can’t go from whole pomegranate to the supplement, because they’re not the same any more than apples are the same as apple juice, which nutritionists generally agree is of little value.

Four experts in heart disease, prostate cancer, and epidemiology will testify about the level of substantiation they’d expect to support respondents’ claims. Studies are small—10 patients—and there were no controls in the key studies, including the arterial plaque reduction studies. Respondents touted 21% blood pressure reduction though it was actually 12% in 2 weeks. Another study was cut off after 3 months despite 12 month protocol; no change in blood pressure, though change in blood flow. Placebo-controlled test with 73 patients showed no change in blood pressure or plaque. 45-patient study showed no change in blood pressure or blood flow: unable to replicate small study. Largest study with endpoint in arterial plaque: 289 patients. No change in blood pressure. No change in arterial plaque reduction at 18 months. No replication of the 10-patient study used in the ads. Published 2009 (completed 2006). Other biomarkers analyzed: no changes. Another nonplacebo study of Pomx pills showed no change in blood pressure or other markers, except for one (a technical thing I didn’t get, something about T-bars). That’s the only study of Pomx.

Prostate cancer: one study, from UCLA, 48 subjects. Not placebo-controlled. Positive effect on mean PSA doubling time. Our experts: not a recognized biomarker for analyzing whether or not the product treats or prevents prostate cancer. Two ongoing studies are placebo-controlled, but we have no idea about the results. Another nonplacebo study shows increase in doubling time.

Erectile function: one was placebo-controlled, but not statistically significant. The respondents will say they got close to statistical significance, but only on an unvalidated measure, not on the validated one.

Summary of respondents’ own assessment of its science, prepared by respondents’ scientific director from 2005-2009, Mark Dreher. Shared with respondent Stuart Resnick to create strategic plan for medical research. Showed a lot of negative results. “Where do we go from here?” Options: prevent heart disease/lower blood pressure claim—need larger studies. Expensive/risky to do science necessary for it. Health claims: few options for health claims—could try reduce risk of heart disease/hypertension. Their own analysis: they needed 2 studies for either option: costs would be $3-5 million and 2 years for FDA approval. Assessment: probably not worth pursuing in part because claim wouldn’t be specific to Pom. Science risks: our data may not be strong enough. Another option: no more clinical research; publicize what we already have. That’s low risk, but our research has holes. Current research is only 3 on 1-10 scale according to doctors.

Produced similar assessment of prostate cancer studies. Prevent/treat claim would require 2 studies, 1000 patients; PSA wouldn’t be accepted as an endpoint. Pharma-grade manufacturing. Health claims would require 100 patients, with an endpoint of active surveillance of cancer. Another option: stick with what we have.

ED (erectile dysfunction): need a stronger study to get clinical significance. Again, another option would be to stick with what we have.

Respondents repeatedly ignored warning signs indicating that marketing didn’t match science. Had a keen understanding of the level of science required to make treatment/reduction of risk claims. 2 NAD decisions.

Ended with more clips from TV interviews showing the consistent message: there are health benefits, they’re proven by tests on humans, we’ve spent millions of dollars on this research.

Q: the government isn’t claiming that this is snake oil, but that they don’t have the right science.

A: yes, that they don’t have the science that they said they did.

Pom decided to wait for its opening statement until complaint counsel finished presenting witnesses.

Lynda Resnick, first witness (in response to various questions from complaint counsel):
Marketer in the family, building the brand. Opened a small ad agency in her late teens; 38 years ago switched to home-based business, then started running Teleflora. She believes that part of the intrinsic value of Pom is its “power to heal.” (Various statements made in her book.) 8000 year history of pomegranates as medicine, so it’s the entire body of evidence, not just research.

The fact that we’re so serious about our science is what makes us stand out from other fruits and vegetables—rarely see another natural food investing in science, and we want consumers to know about that.

Doesn’t specifically recall Oct. 2010 deposition in Tropicana case. Has been deposed in several Pom litigations. She doesn’t read all the body copy or hang tag or sales marketing sheet for the field force; hasn’t paid much attention to website for years. Her involvement since 2007 has decreased as she had more confidence in management of Pom. Looking at big picture and not minutia. Even before then she didn’t have final say on all marketing materials due to family and other brand responsibilities. Who did have final say over ad content? If she didn’t look at it, there were a couple of other people in marketing. People would sit down as a group and brainstorm big marketing initiatives.

Have a full-service in house ad agency that does PR, creative, and media buying.

Discussion of exhibits—she didn’t remember making various comments on proposed ad copy but considered it likely that they were hers; those comments reflected detailed involvement in the ad copy and in the health claims in particular.

I took off to get home in time for domestic responsibilities; I will probably check back in as the case continues.