Canserfx170 Marketers Ordered to Halt Brazen Claims

Stephen Barrett, M.D.
December 27, 2004

The Kangniling Pharmaceutical Company (KNL USA) would like you to believe that Canserfx170 is effective against most cancers and has “zero toxicity.” Its Web site falsely describes the company as an international corporation with its headquarters in Great Neck, New York and “research institutes, assemble plants [sic], medical clinics, and stores” with more than 1,000 employees around the world. [1] In May 2004, the FDA ordered KNL to stop marketing Canserfx170 [2]. In response, the company replaced the illegal claims from its home page with a message that the site is “under construction.” However, it did not remove the underlying pages, and its original home page was accessible through the Internet Archive. This article describes some of the statements KNL has made and explains why I don’t believe them.

Illegal Claims

The KNL USA Web site suggests that Canserfx170 is highly effective against a wide range of cancers no matter how advanced they are. The Internet Archive shows that from about August 2003 (when the domain was registered) through February 2004, the home page stated:

 

Frustrated by Ineffective Cancer Therapies?
Suffering from Chemotherapy side effects?
Do not loose Hope! A Safe Herbal Cancer Treatment is here.
Treat Cancer, Naturally With Canserfx170 – The Light of Hope.

Cancer doesn’t have to be a killer disease, not if you understand the various possible causes of it, and learn how to fight it by targeting those fundamental causes. Cancer develops because certain conditions in the body allow it to develop. Once you understand those conditions, and learn how to change the internal environment in the body so that it becomes a place where health flourishes, not cancerous cells. It can be beaten with or without using chemotherapy or radiation. While there certainly are situations where someone is just too far advanced, and doesn t have energy or time to recover, being sent home to die doesn t mean it s too late. Too many people wait too long before getting started on safe and natural supplements to combat cancer, or don t work up to using enough supplement they are taking. Fighting cancer can be a race with time if the cancer is pretty far along. Whole food supplements can’t hurt you. Only help. And they don’t make chemotherapy less effective either. Quite the reverse in fact. Research has shown that when you use Canserfx170, the cancer cells are more susceptible to being killed by radiation & chemotherapy. So why not give a try.

To attract traffic, the home page contained metatags for “Cancer treatment, Cancer cure, Cancer therapy, Cancer alternative, Cancer research, Cancer healing, Cancer herb, Cancer herbs, Cancer medicine, Cancer USA, Tumor treatment, Tumor cure, Tumor therapy, Tumor alternative, Tumor research, Tumor healing, Tumorherb, Tumor herbs, Tumor medicine . . . Herb treatment, Herb therapy, Nature treatment, Chemotherapy, Radiation therapy, Lung Cancer, Esophagus Cancer, Stomach Cancer, Intestine Cancer, Liver Cancer, Pancreatic Cancer, Gallbladder, Bile Duct Cancer, Breast Cancer, Ovarian Cancer, Uterine Cervical Cancer, Nasopharyngeal Cancer, Leukemia, Lymphoma, Kidney, Bladder Prostate Cancer, Brain Cancer Metastasis, Sarcomas, Bone Metastasis, Thyroid Cancer, Oral Cavity Lip Cancer, Professional, Oncology,” and “boosting immune system.”

The ingredients of Canserfx170 are not fully described on the Web site. One passage says that it is “a dietary supplement made from pure herbs to assist to fight all types of Cancer.” [3] Another states that the product can boost cell immunity, promote the cell environment, stabilize its homeostasis, and reduce the side effects and promote response to radiation/chemotherapy.” [4] Another says that the main plants used to make it are “Renshen, Reshi, Dangshen, Sanqi, and Ciwujia” and that the “active components” include: “1. Cell division stimulus: natural cAMP, Genistein, R-interferon, and natural components of membrane, Bisacetamidt, Rh, Rg, Retinoids, Calciferols” and “2. Immunity booster: polysaccharide, polypeptide, terpene, etc.” [4] The stated price is $125 plus shipping for a 20-day supply.

I don’t believe that cells can have their immunity “boosted” to protect against cancer. I don’t know what “promoting cell environment” and “stabilizing homeostasis” are, but I doubt that they have any meaning related to cancer treatment. The Natural Medicines Comprehensive Database contains information about Ren Shen and Ciwujia under (“Ginseng”), Danshen, and Genistein (red clover), but none of the entries suggest effectiveness against tumors. Some ginseng preparations can make people feel more energetic, but whether Canserfx170 contains enough, is safe to use, or would be cost-effective is unclear.

Does Canserfx170 “promote response to radiation or chemotherapy”? To bolster this claim, the site contains a table purporting to show results from clinical trials of more than 40,000 patients. The report does not say how, when, where, or by whom the studies were done and whether they were published. The text accompanying the table states that the criteria used to judge outcome were (1) tumor shrunken, (2) “positive effect with chemo-radiation therapy,” (3) decrease side effect of chemo-radiation therapy, and (4) symptomatic improvement. The effect is said to be “significantly positive” if two of these criteria are met and “positive” if one is met.

I suspect that the data were either made up or represent a misinterpretation of standard studies that did not test the product. The “groups” do not correspond to a science-based classification of cancers. (For example, “Bone Metastasis” can occur with different types of cancer and no proper study would group patients with diverse cancer types that way.) The method used to judge effectiveness makes no sense whatsoever. The standard way to report results in terms of survival time (usually 5 years). Tumor shrinkage is usually related to effectiveness but should be a component of “positive effect with chemo-radiation therapy,” not a separate item. Symptomatic improvement” is too vague to be a meaningful description.

Common sense would suggest that if these numbers reflected effectiveness, or even if so many studies had been performed, Canserfx170 would have been making headlines everywhere.

 

Identity Theft

The KNL USA Web site represents that the picture to the right is the headquarters of the Kangniling Pharmaceutical Co., Ltd., at 58 Hicks Lane in Great Neck. However, 58 Hicks is a residential address, and the pictured building belongs to the Contract Pharmacal Company (CPC), which has no affiliation with KNL and is located in Hauppauge, New York. CPC president John Wolf told me that his company manufactured Canserfs170 about a year ago but had no idea that it would be promoted illegally as a cancer cure. (KNL paid only $1.60 a bottle for which it charges $125 for a 10-day supply.) The KNL site also displays a pirated photograph of Wolf and four family members that it portrays as KNL staff members.

 
Regulatory Action

Even if Canserfx170 works, which I doubt, it would not be legal to sell it as a cancer treatment without FDA approval, which it certainly does not have. In an apparent attempt to suggest otherwise, KNL posted an FDA statement that the product is regulated by the FDA and can be “freely marketed” in the United States provided that it conforms to all applicable U.S. laws and regulations. In other words, it might be possible to sell it as a dietary supplement if it is not claimed to prevent, treat, cure or mitigate disease. But, as noted above, the company has been making blatant treatment claims.

In January 2004, the FDA issued a detention order to stop importation of the product. In May 2004, the FDA ordered KNL USA to stop selling it here [2]. The letter pointed out:

  • The product cannot be marketed as a dietary supplement because it is claimed to treat disease.
  • The FDA statement and other documents are displayed in a manner which implies that FDA has approved the marketing of the product and the claims made for it.

After KNL received the notice, it removed the contents of its home page and posted an announcement that the site was being “reconstructed.” However, the rest of the pages were left intact, including the ordering page, which I located by searching with Google. Curious to see whether the product was still for sale, I phoned the company and was told that it was.

Newsday Investigates

After reading my report, Newsday reporter Jamie Talan located and interviews KNL’s owner Jack Zhang, who said:

  • He was a pharmacist who began marketing his cancer product the 1980s in China, where it was tested in 400 cancer patients. [His Web site claimed that it had been tested in 40,000]
  • He had left China 15 years ago, settling in Queens. In 2002, he moved to Great Neck, where he set up Kangniling Pharmaceutical and a Web site to market Canserfx170. He did not realize that it was against the law to make medical claims for dietary supplements. [I wonder whether he cared.]
  • His family owns a company in China with about 100 employees. [His Web site falsely claimed that the company had 1,000 employees worldwide.]
  • He intends to change his product’s name to CFX170 as a dietary supplement with claims that it will “boost energy and help in the repair of abnormal cells,” but that the company’s China Web site will continue to include cancer-cure claims [5]. [Claims for dietary supplements must be truthful and nonmisleading. I do not believe there is any scientific evidence that “CFX170” can help repair abnormal cells.]

After reading Talan’s report, which was published four weeks after mine, I found that the KNL site still displayed the false and illegal information and the stolen Contract Pharmacal pictures.

Talan also reported that pharmacists at M.D. Anderson Cancer center had recently fed Canserfx170 capsules to animals and found no cancer-fighting properties and that further studies were ended after KNL had failed to provide information on its manufacturing practices or scientific data on the product [5]. No cancer treatment found ineffective in animals has ever been proven effective in humans. I hope that the FDA follows through and puts Zhang out of business.

References
  1. About the company. KNL USA Web site, accessed Nov 29, 2004.
  2. Baca JR. Warning letter to Kangniling Pharmaceutical Co. May 5, 2004
  3. About the products. KNL USA Web site, accessed Nov 29, 2004.
  4. Clinical trials show:. KNL USA Web site, accessed Nov 29, 2004.
  5. Talan J. The missing ingredient. Newsday Dec 27, 2004.