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Pancreas Tonic, a new herbal treatment for people with diabetes, is drawing conflicting opinions from different quarters of the diabetes community. In 1999, Pancreas Tonic was hailed during an episode of the NBC television program EXTRA as "…the cure for diabetes" by William Taylor, MD, an internist. In additon, testimonials were given by people with diabetes who said that Pancreas Tonic really worked for the treatment of their blood sugars. According to transcripts from the EXTRA episode, Taylor added that Pancreas Tonic could be "one of the biggest medical breakthroughs of the century."
Pancreas Tonic costs almost $30 for a one-month supply. It can be obtained via telephone or the Internet from U.S. Botanicals, based in Bell Gardens, California, the company that manufactures Pancreas Tonic. Despite not having published any human studies, U.S. Botanicals has attracted over 1,500 to 2,000 Pancreas Tonic users in the United States and another 500 to 1,000 worldwide.
On the other side is Steven Edelman, MD, a leading diabetologist and a type 1 himself. He warns, "I would not recommend Pancreas Tonic to my worst enemy." Dr. Edelman, associate professor of medicine, division of diabetes and metabolism at University of California, San Diego School of Medicine, went on to say, "The data are flawed and biased." About the people who manufacture Pancreas Tonic, Edelman adds that they should be "locked up for getting the public high on unsubstantiated data."
In the October 1998 issue of Journal of the National Medical Association, researchers Vijaya Rao, MD, Frank Salem, MD, and Irene Gleason-Jordan, MD, of the Department of Internal Medicine at Charles R. Drew University of Medicine and Science in Los Angeles, investigated the effects of Pancreas Tonic on the serum glucose and HbA1c levels of 20 rats with alloxan-induced diabetes.
During the 12-week study, 10 of the diabetic rats were fed ordinary rat chow and the other 10 were fed rat chow treated with Pancreas Tonic. The researchers discovered that the diabetic group treated with Pancreas Tonic had lower serum glucose and HbA1c levels than the rats in the other group. It was concluded that Pancreas Tonic induced an antidiabetic effect through pancreatic islet cell regeneration in diabetic rats.
What Can Pancreas Tonic Really Claim?
U.S. Botanicals is claiming on their Web site (www.pancreastonic.com/pancreastonic.html) that Pancreas Tonic may reduce the risks associated with high blood sugar, cardiovascular symptoms, kidney failure, blindness and amputations. U.S. Botanicals also says that Pancreas Tonic may function by reducing insulin resistance, lowering insulin requirements and helping to reduce the numbness, tingling and pain in the legs and feet.
Can Pancreas Tonic take credit for these improvements if it is not tested in a multicenter, randomized, placebo-controlled human clinical study, and published in a peer-reviewed medical journal?
Unpublished Human Studies
Mayer Davidson, MD, past president of the American Diabetes Association (ADA), impressed by the earlier rat study, is conducting a multicenter, randomized, placebo-controlled human trial. In addition, Tyron Reece, MD, of Gardena Memorial Hospital in Gardena, California, is conducting another study using Pancreas Tonic. According to U.S. Botanical's Web site, Reece found that in people with type 1 and 2 diabetes Pancreas Tonic helped reduce insulin requirements by 40 percent over six months. This research, however, is unpublished.
Jerry Gerson, MD, medical director at U.S. Botanicals, recently conducted a 12-week study of ten people with type 2 diabetes who took Pancreas Tonic. The results have been submitted to an editor at a peer-reviewed, U.S. medical journal. Gerson, who was unwilling to disclose the results of the human study prior to its possible publication, informed Diabetes Health that Pancreas Tonic was proven to be safe on kidney and liver function in all test subjects. Gerson says that the drop in HbA1c was "significant and remarkable" and "as good as any other study published in the world." Yet, because this study is also unpublished it is of little use.
Do You Buy It?
Richard Bernstein, MD, FACE, FACN, CWS, of the Diabetes Center in Mamaroneck, New York, recently started trying Pancreas Tonic on his patients. He says that he has no idea what the outcomes will be, but is encouraging other investigators to consider informal trials of Pancreas Tonic and Pro Beta, another herbal remedy proven in diabetic rat tests to lower blood sugars.
"If they work," says Bernstein, "my services as a diabetologist would become redundant."
Bernstein adds that the label of "too good to be true" will probably stick to Pancreas Tonic for at least the near future.
Bob Goldstein, MD, PhD, vice president of Juvenile Diabetes Foundation International drafted a position statement on Pancreas Tonic and said that the published rat study needs a lot of clarification and further research before it can be considered for possible clinical application in humans.
"It's a long way from mouse to man," says Goldstein.
R. Keith Campbell, RPh, professor of clinical pharmacy at Washington State University College of Pharmacy, says that Pancreas Tonic is a perfect example of how natural products are hyped to individuals promising dramatic improvements in their disease status based on a single animal study.
"The journal in which the [rat] study is published is usually not peer-reviewed but sounds impressive," says Campbell. "The company also gets a physician with an MD behind their name to make a claim and that also adds to the mystery and wonderment of the product."
Claims being made about Pancreas Tonic's antidiabetic effects can be made to these consumers, as well as prospective consumers, under what is known as the Hatch Act or the Dietary Supplement Health and Education Act (DSHEA). This laws state that herbal products are not subject to the same rigorous regulations as drugs.
"DSHEA permits anyone to put on the label a claim that the product will have a particular effect on the structural function of the human body," says Varro Tyler, PhD, ScD, retired professor of pharmacology at Purdue University. "For example, you can say, in general terms, that it 'helps maintain pancreatic health.'"
U.S. Botanicals can claim that Pancreas Tonic has blood-sugar-lowering effects, but cannot say that Pancreas Tonic cures diabetes. The only pre-market requirement that U.S. Botanicals has to comply with is to prove that Pancreas Tonic is safe. The U.S. Food and Drug Administration (FDA) will take action against them only if there are documented reports of health problems associated with the use of Pancreas Tonic.
Making claims on the Internet is subject to the same regulations as promotions through any other media. Because of their shared jurisdiction, the Federal Trade Commission (FTC) and the FDA work closely to ensure that their enforcement efforts are consistent to the fullest extent possible. The FTC is the organization in charge of enforcing advertising claims made by companies about their products. Although DSHEA does not directly apply to advertising, it has generated many questions about the FTC's approach to dietary supplement advertising. The answer to these questions is that advertising for any product, including dietary supplements like Pancreas Tonic, must be truthful, not misleading and substantiated.
According to Tyler, who is author of the books "Herbs of Choice" and "The Honest Herbal," the FTC might not be entirely pleased with the claims being made by U.S. Botanicals on its Web site, citing evidence from "clinical studies."
"If the FTC ever got around to it, they would insist that there were at least two 'substantial' clinical trials that prove Pancreas Tonic does what it claims to do," he says. "The rat trial was a pharmacological trial. Clinical trials are conducted on human beings. By saying these things on its Web site, this company, in my opinion, is overstepping boundaries."
According to the Application of FTC Law to Dietary Supplement Advertising (www.ftc.gov/bcp/conline/pubs/buspubs/dietsupp.htm#Introduction), "The FTC will consider all forms of competent and reliable scientific research when evaluating substantiation. As a general rule, well-controlled human clinical studies are the most reliable form of evidence. Results obtained in animal and in-vitro studies will also be examined, particularly where they are widely considered to be acceptable substitutes for human research or where human research is infeasible."
Tyler says the problem is that so many different companies are making so many different claims about their products that the FTC cannot keep up with the sheer volume.
Hard to Publish Studies Without Pharmaceutical Company Support
The American Diabetes Association (ADA) also feels that Pancreas Tonic is an unproven therapy.
"As with all therapies, proven or otherwise, the Association encourages patients to work closely with their physicians and other health-care professionals to obtain safe and effective diabetes treatment."
The ADA adds that there are insufficient valid clinical and research data that address the safety and benefits of Pancreas Tonic for people with diabetes.
Steven Gordon, ND, a private physician from Montana who specializes in diabetes care, says that it is hard to publish a study, like the one conducted on humans taking Pancreas Tonic, without backing from a pharmaceutical company. Gordon also points out that smaller companies, like U.S. Botanicals, lack the backing that is necessary to get participants for a larger human study.
Campbell argues that it is common, when all else fails, for companies to make the claim that their "cure-all" is being downplayed by some conspiracy of the normal medical community.
"When the company does studies in humans with diabetes that are double-blinded, controlled and randomized, and then gets the article published in a respected, peer-reviewed journal, which, by the way is expensive and time-consuming, then the product would have credibility," says Campbell.
Nonetheless, Gordon has been using Pancreas Tonic for his patients with diabetes for about a year now, and has been impressed with the results.
"Pancreas Tonic is the only supplement I use with patients who have diabetes," says Gordon. "I have patients who took this and it was like the missing link. BGs just went down."
Gordon theorizes that the combination of Gymnema sylvestre, a well-know herb linked to diabetes control, is what might assist in the process of lowering blood sugars. Gymnema sylvestre is also the main ingredient in the herbal supplements Pro Beta and Beta Fast. In the January 1999 issue of Diabetes Health, it was reported that Gymnema sylvestre has demonstrated blood glucose regulation in clinical trials involving people with type 1 and 2 diabetes.
The origins of Pancreas Tonic are in Ayurvedic medicine, a traditional system of holistic healing from India. Ayurvedic practitioners believe in treating the "root cause" of the disease, not the symptoms. Pancreas Tonic mixes together the following herbs:
Gerson, who was a practicing diabetes clinician for 27 years, says that he is uncertain as to which ingredient, or ingredients, in Pancreas Tonic work best.
"I've asked myself that question 16,000 times and the answer that I got is that there is a synergy between these herbs," says Gerson. "I asked them to take [one of the ingredients] out and check how well it worked. It ended up not working as well, so it appears to be a synergy."
Rats Were Not Diabetes Models
Campbell points out that he is always very suspicious of studies that are done in mice or rat models when the animals are given alloxan to destroy their beta cells.
"Thus, these animal models are not really diabetes models that simulate real-world diabetes," he says.
Gordon agrees with Campbell and other detractors who feel that rat studies do not correlate well with human studies. In Gordon's clinical observation, however, Pancreas Tonic has demonstrated positive results.
"If I see it helping people, that's all I care about," says Gordon, a type 1 himself who testifies to taking Pancreas Tonic. "In some, it hasn't helped, so I just back away. It's different for all people with diabetes. I have found that it tightens up my extreme highs and lows. I saw results in the first week. Other people have seen results within the first month."
Going to the Root of the Problem
In a transcript from the EXTRA episode, Paul Dhaliwal, MS, president of U.S. Botanicals and the chemist who developed Pancreas Tonic, said that he got the inspiration for Pancreas Tonic one day while he was meditating.
"I got a message from the almighty God to help heal people," said Dhaliwal, who adds that the ingredients for Pancreas Tonic came to him gradually over several months. Dhaliwal then went back to India and worked out the exact formula.
In 1994, Dhaliwal brought Pancreas Tonic to the United States and started selling it through mail order. He came up with the name Pancreas Tonic because he wanted to focus people's attention on the pancreas instead of controlling their sugars.
"Some people who have had diabetes for years don't know that the pancreas is the root of their problem."
The Path to Credibility
According to Dhaliwal, "...we saw that people were reversing their neuropathy and cutting back their meds after taking Pancreas Tonic, and we wanted to find out why."
That was when researchers started conducting the rat studies.
"Then, we were featured on EXTRA, before we even started testing Pancreas Tonic in humans," says Dhaliwal. "The human study helped us get to the next step."
That next step was Mayer Davidson. Dhaliwal feels that Davidson's support will help further validate Pancreas Tonic.
"Dr. Davidson is well-known and he will get a human study published somewhere," says Dhaliwal. "Just for him to look at the product and spend his time is incredible because it means he saw something in Pancreas Tonic's data that made him feel that it was worth his time to spend a few months on this product."
Davidson responds by saying that he has no opinion of Pancreas Tonic's potential antidiabetic effects until he sees the results of the more carefully designed, multicenter, randomized, placebo-controlled human study that he will be conducting.
"The first human study that is now awaiting publication was too small a study to comment on," says Davidson. "I wanted to see those results before I embarked on a more complicated study. They were positive in the sense that the people who were taking Pancreas Tonic did have falls in HbA1c and the people on placebos did not. But, the numbers were very small so they weren't definitive."
Davidson hopes that his study will have 50 people at two centers. The goal is to get 25 on Pancreas Tonic and 25 on placebo. It will be limited to people with type 2 diabetes.
Campbell says that until a study like that is published, it is simply "hype and quackery."
In a survey of Diabetes Health readers, 40 percent said they felt that Pancreas Tonic was "snake oil." However, almost 100 percent of respondents said they would try Pancreas Tonic if positive results of a human study were published in a peer-reviewed medical journal.
"If there were well-designed, double-blind clinical trials, showing efficacy when compared to a placebo, and there was a reasonable expectation of not having adverse effects, then I would definitely try it," says Alastair T. Gordon, president of The Islet Foundation in Toronto. "Such clinical trials do not absolutely guarantee efficacy and safety, but at least the claims are not just wishful thinking."
Roy Vanro, a type 2 from Newport, Tennessee, had blood sugars in the 400 mg/dl range when he started taking Pancreas Tonic. He took two capsules before every meal for four months without modifying his diet or exercise regimen.
"My blood sugars dropped to 88 mg/dl," says Vanro. "I continued taking it for one month after I started getting normal and then I stopped. My BGs have remained normal ever since then."
Gary Mason emails that he has also tried Pancreas Tonic.
"I went through one bottle with no noticeable changes whatsoever," says Mason, adding that he would try Pancreas Tonic again if human trials are published in a reputable medical journal.
Hy Hunter of Granada Hills, California, is totally blind and has severe neuropathy pain in his legs. About four months ago, a friend of his wife kept telling him about Pancreas Tonic and said he should take it.
"I never believed in these Mickey Mouse cures, but I took Pancreas Tonic because my wife pushed me to," says Hunter, who took the recommended dosage of two pills before every meal. "Last week, I looked at my wife and I could see an outline of her face for the first time in many years. Also, the pain in my legs went away and I was walking for the first time in months."
Julie Ann Swenson, a type 1 from Portland, Oregon, says she would be "incredibly interested" in something like Pancreas Tonic.
"I would try it, snake oil or no snake oil, and I wouldn't need human clinical trial results to determine whether or not I tried it," says Swenson. "A cure exists. Why not speculate that it lies perhaps in plants or strange methods."
David Chasey emails that a rat study and an unpublished human study with 10 people mean nothing.
"Rat studies are great, if you're a rat," says Chasey. "What other actual evidence is out there?"
Dhaliwal says that U.S. Botanicals wants to validate its product.
"We are submitting the human study to scientific journals so they can validate what we have found," he says. "Also, we have a tremendous number of people who say they have benefited from Pancreas Tonic, but we want to go one step further."
Gerson says that he was also a detractor when he first heard about Pancreas Tonic.
"I said it was voodoo medicine, and that it probably was not real and that herbs don't work," he says. "Then, I realized that most of our medicines come from herbs."
Fear of the Eastern Medical Experience
Gerson adds that practicing endocrinologists seem to be the biggest detractors of Pancreas Tonic.
"Endocrinologists are the people who say, 'don't use herbs, just use insulin, because there is no cure and there is no real treatment for diabetes except insulin and the pills we give you. If you don't take insulin and pills, you are doing the wrong thing.'"
Joseph Prendergast, MD, of Diabetes Advocates in Atherton, California, feels there is some validity in that statement.
"Endocrinologists, like most physicians, are quite conservative and prefer to see exhaustive testing done before anybody accepts a product," says Prendergast. "On the other hand, as we have seen with other botanicals, sometimes people with diabetes can have good effects from them. However, everybody hates to hear a physician say, 'Oh gee, that product sounds like a good thing,' and then find that we have a lot of egg on our face when later testing shows that it is ineffective."
Gerson says that diabetes physicians would never believe in Pancreas Tonic because it is "outside the Western medical experience."
"Anything that is unusual and strange tend to be suspect," says Gerson. "In their favor, I know they are trying to protect their patients from unproven and unfounded claims. However, they have never read the research and they have never looked at the world literature."
Gerson says he knows of only one patient, a young child, whose C-peptide went from 0.9 to 1.5 in a period of two months after taking Pancreas Tonic. C-peptides are the by-product of insulin-producing islets. They are used as a marker for how well a person's pancreas is working.
"We do not recommend Pancreas Tonic to young children for many liability reasons, but the parents of this patient chose to do it anyway and were rewarded with these remarkable results.
U.S. Botanicals says that there is no set therapy duration for Pancreas Tonic because everybody is unique and responds differently. Therapy can take from 3 to 24 months, or even more, depending on the condition of the person with diabetes and "how religiously you take Pancreas Tonic as suggested." At $29.95 per bottle (a one-month supply), taking Pancreas Tonic for 3 to 24 months will cost approximately $90 to $720 for the person with diabetes who is waiting to see if there are results.
Laura, a type 1 from Los Angeles, says that she took Pancreas Tonic for one month and still was not able to reduce her insulin intake.
"I read the material published on Pancreas Tonic which stated that individuals who have had diabetes for many years may have to be on the product for a longer period of time before they see any results," says Laura. "...I started to get discouraged. Due to the fact that it was so expensive, I stopped using it. I don't want to say anything negative about Pancreas Tonic, in case it does work for someone. Maybe I just didn't give it 100 percent."
What if There is Never a Published Human Study?
Leroy Eide emails that he is aware that a lot of money is required to bring a drug to market.
"I am also aware that drug companies will not sponsor anything that will not bring in a lot of income for them," says Eide, adding that if there were better product information and more complete research, he would try Pancreas Tonic without the blessing of the mainstream medical establishment.
Nancy Bohannon, MD, of Monteagle Medical Center in San Francisco says that she would never give Pancreas Tonic to one of her patients.
"I have nothing positive to say about Pancreas Tonic," says Bohannon. "When they have the proper studies done by good investigators and are published in respected peer-reviewed journals, then I'll pay attention."