Pity the innocent pomegranate


Those who have been assiduously drinking their pomegranate juice will want to be aware of actions taken today by the Federal Trade Commission (the FTC).

According to a statement made earlier today, “As part of its ongoing efforts to uncover over-hyped health claims in food advertising,” the FTC has charged POM Wonderful LLC (the manufacturers of POM Wonderful 100% Pomegranate Juice and POMx supplements) and three of its principals with “making false and unsubstantiated claims that their products will prevent or treat heart disease, prostate cancer, and erectile dysfunction.”

A Yahoo News report states that POM Wonderful LLC has denied this allegation, but there is no public statement available on the company’s web site at this time.

In defense of the innocent pomegranate and its juice, they may well do wonders for one’s health, but — at the present time — we are not aware of any significant data from clinical trials to support the claims made for their activity in the prevention or management of prostate cancer.

11 Responses

  1. In my opinion, despite what the FTC has concluded, the jury is still out on the effects of pomegranate as regards prostate cancer and other health issues. POM Wonderful is recommended by Medical Oncologists Stephen Strum and Charles E. “Snuffy” Myers.

    Dr. Myers and Dr. Strum recommend the extract rather than the juice because of the sugar content in juice. Good for vascular health, has anti-prostate cancer properties, and some patients have noted that their otherwise high systolic blood pressure has dropped. Levels of nuclear factor kappa B (NF-kappaB) are found to increase during the transition from androgen-dependent prostate cancer to androgen-independent prostate cancer and thus contribute to this transition. An interesting PubMed article describes pomegranate extract having the effect of inhibition of proliferation of NF-kappaB and induction of apoptosis of prostate cancer cells. This is just one study of many regarding the importance of pomegranate to the prostate cancer patient. This particular study can be reviewed here, and there are several other medical papers supporting the importance of pomegranate.

  2. Dear Chuck:

    So let me be very clear. Yes there are published data showing effects of something in pomegranate juice and extract in laboratory models of prostate cancer, but there is no good evidence of a clinically significant effect in men with prostate cancer. (Please see this article elsewhere on this web site.)

    If manufacturers want to claim that their products have medically significant impact on patients (as opposed to some scientifically interesting effects in glass tubes and mice), then they need to demonstrate that in clinical trials.

    Drinking pomegranate juice or extract is a reasonable and safe choice that anyone can make. Promoting the use of pomegranate juice or extract as medically beneficial without the clinical evidence to prove it is just the same as selling snake oil.

    The FTC has made no comment on the actual or potential value of pomegranate-based products. What they have said is that the company has no clinical data on which to substantiate its claims, and so making those claims is potentially illegal. All the company needs to do is prove that the claims are justifiable. There are now 8 clinical trials of pomegranate products in management of prostate cancer listed on ClinicalTrials.gov. There may be as many as 30 such trials actually ongoing. None of them have reported data at this time.

    Without such controls, anyone could start selling ipilimumab or MDV 3100 tomorrow as “nutritional supplements” and claim that they could be used effectively to treat prostate cancer. I don’t think you would advocate that, would you?

  3. Sandy Goldman, who had some experience with claims made for various nutrients, recommended buying pomegranate futures in this bit written some years back.

  4. Here is some evidence.

    Is it “good” evidence? Is it “significant”? It is evident in the UCLA clinic. Thus clinically evident.

    Notwithstanding, the POM people are overselling their product.

  5. Thank you John. I was not aware of this report (interestingly from > 4 years ago). In the conclusion to the report (available in the full text version of the article), the authors mention a new study, started in April 2006 that — as far as I can tell — has never been published and does not appear to be included on the ClinicalTrials.gov web site. There is a trial very similar to the one the authors describe (with Pantuck and Belldegrun as the principal investigators) — but it didn’t start until December 2007

  6. This newer trial you refer to is an extension of the original trial for those men who had success with pomegranate juice. The extension compares juice to extract to placebo and over a longer time. All these trials are underwritten by Roll International which is the organization under which the Resnick family operates its businesses. These businesses include Pom Wonderful and the Pom growers in California and elsewhere. The Resnicks are a very wealthy couple.

  7. Many of us have been aware of the Pantuck trial, mentioned above, for some time now. It looked at men with recurrent prostate cancer and a rising PSA who were given 8 ounces of POM Wonderful pomegranate juice for 2 years. There was only one trial arm and thus no randomization or blinding, so there was the possibility of a placebo effect.

    If the results were due to a placebo effect, I want to have that same effect! LOL. Men whose average PSA was doubling at an average of about every 15 months saw that doubling time extend to 51 months, as I recall. Men who stayed on the protocol, in an official extension of the trial, extended their doubling time to 88 months.

    While this kind of evidence is obviously preliminary and not strong by definition, I am greatly impressed by the findings for several reasons. First, PSA levels, and hence doubling time, are a hard, objective piece of evidence. Second, my impression (as a now savvy survivor with a background in science) is that in men with early recurrence PSA behavior is an excellent indicator of the state of the cancer. Third, the apparent impact was not a wishy-washy few months but an eye popping more than tripling of the doubling time, and that time apparently grew longer for the few men who stayed on the protocol. Fourth, a number of observers, while noting the funding source, have also noted that the UCLA team that did the research is highly talented and highly respected. (Dr. Heber was one of the leaders.) Fifth, a number of expert and observant, thinking doctors specializing in prostate cancer, including Dr. Charles “Snuffy” Myers, have reported informally that they believe they are seeing a benefit from pomegranate juice or extract among patients in their practices. Finally, genetic research has been done on the impact of components of pomegranate on prostate cancer, and a substantial impact has been documented, which is again hard, objective evidence, though the link to actual prostate cancer is not yet fully established.

    At least one, and I believe two subsequent trials of pomegranate and prostate cancer are about to conclude, and others are in progress, as noted. As I recall, at least one of these trials is by M. D. Anderson and is independent of the first trial reported.

    I am eager to see the results of these fresh trials, as I’m sure we all are, but in the meantime I’m taking those pomegranate extract capsules. It looks to me like a very good bet at this point: a low stake for what appears to be a very high payoff.

    As to the FDA, it was quite right to slam POM Wonderful for its extravagant claims. While that preliminary trial was impressive, it clearly was not PROOF that prostate cancer could be treated with the juice, which is what at least one of the ads stated, along with other extravagant and inadequately supported claims. POM Wonderful does have some attractive evidence behind those claims, but it’s just that at this point it is insufficient from a science viewpoint.

    I just hope that prostate cancer patients will see through that FDA mishap and heavy-handed (but understandable) media coverage to what looks like a strong likelihood of a benefit from quality pomegranate juice or extract.

  8. I would like to see a scientific study focused on organic pomegranate juice made from 100% fresh pressed (not from concentrate), serving size 4 oz. per day. An example of such a product is “Lakewood Organic Pure Pomegranate Juice FRESH PRESSED.” Lakewood also makes juice from concentrate. I’m thinking that fresh pressed may increase the effectiveness of pomegranate Juice in general. The downside of this product is that it costs more than juice made from concentrate. POM Wonderful is very high in price for what you get and it is made from concentrate.

    Why not use “fresh pressed” for the full effect? It is no more costly than the over-hyped POM Wonderful. Look for it in your food co-op in the juice section. Seems to work for me. Take it hours before or after your other drugs. It interacts with numerous drugs. Increases potency of some, reduces potency of others. Skews PSA tests so don’t use it for 3 or 4 days before your PSA test.

    I’m not a doctor, but I do have prostate cancer and have had my prostate removed, 38 days of external beam radiation, and CyberKnife radiation over 4 years. That is two times the cancer has returned since original diagnosis and removal of prostate. PSA is currently 0.05 ng/ml

    I do other stuff too but the pomegranate juice is one of the things I feel works best.

    “Hit the antioxidants hard, and become a vegetarian” is the best advice anyone has given me so far.

    Regards,

    rhine

  9. Hi Rhine,

    I’m replying to your post of December 10 on 9:41 AM.

    I too was put off by the high cost of POM Wonderful juice, as well as the sugar content — not unusually high for a juice, but still enough to add some calories and sugar load. However, POM Wonderful refrigerates its juice, in contrast to all the other pomegranate juice options I have seen, which reportedly increases potency. (It’s too bad POM Wonderful was “overhyped”; for prostate cancer patients, the plain result of the Pantuck study was dramatic enough — no need for hype.) My solution has been to switch to high quality extract capsules.

    I’m not aware that pomegranate juice or extract significantly affect the impact of other medications. While it does work through CYP3A4, like grapefruit juice, the effect is much weaker (according to several experts I’ve heard discuss it). Do you have specific research on that issue, or some other credible publication? Similarly, as near as I can tell, the effect on PSA is due to a real anti-prostate cancer effect, which would mean the PSA is not being distorted in a way that would make it less meaningful for PSA monitoring. I just checked PubMed to see if there was something fresh on this, but I found no fresh reports. What is your source about a PSA concern?

  10. is pom wonderfull have any effect on my psa I take it daily and take my psa test the same time I find it is rising can you advise me if I am doing the right thing.

  11. Dear Mr. Shaw:

    If your PSA is rising despite the use of pomegranate extract, you need to talk to your doctor about this.

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