Kurt Donsbach Arrested on Health Fraud Charges

19 April 2009 Filed under Cancer, Complementary + Alt Med, FDA, Legal, Prostate Cancer Posted by » Comments Off

Kurt Donsbach, 73, who markets supplements including some for conditions of the prostate, was arrested April 8 during his internet radio show “Let’s Talk Health” on a warrant charging him with 11 felonies including treating patients without a license, misbranding drugs for sale, grand theft, unlawfully dispensing drugs as a cure for cancer and falsely representing a cure for cancer. Bail was set at $1,500,000.

A San Diego news site reports: “District Attorney Bonnie Dumanis said that Kurt Walter Donsbach, 73, “preyed on vulnerable patients who were looking for medical help.”

Arraigned April 13, Donsbach plead not guilty in San Diego’s downtown Superior Court. Bail was lowered to $250,00.


SignonSanDiego.com
reports that District Attorney Dumanis “said Donsbach falsely identified himself as a chiropractor and a naturopathic doctor in literature and on his Web site, letstalkhealth.com, where he sold what were described as nutritional supplements.”

The warrant for Donsbach’s arrest, online at Stephen Barrett, M.D.’s casewatch.org, charges:

Kurt DONSBACH identifies himself as a “doctor” in literature and online at letstalkhealth.com. Through this media and during a weekly online radio broadcast from Chula Vista, California, DONSBACH claims to offer “alternative,” “natural,” and “nutritional” remedies for many conditions and ailments including cancer and autoimmune disorders. According to the Medical Board of California, DONSBACH does not have a license to practice medicine in the State of California. According to the California Board of Chiropractic Examiners, DONSBACH does not have a license to practice as a chiropractor in the State of California. According to the Bureau of Naturopathic Medicine, DONSBACH is not licensed by the State of California as a naturopathic doctor. According to the Osteopathic Medical Board, DONSBACH is not licensed by the State of California as a doctor of osteopathy.

Two particular charges in the eleven count warrant involve selling specific drugs, a steroid and a NSAID, under phony labels:

1) A woman purchased “neuropeptide” from Donsbach’s businesses allegedly on his advise treat her arthiritis. In the course of six years, she paid a total of $9,300 for the “neuropeptide.” In 2007, she consulted an endocrinologist in Connecticut. Ms. S. told him that she had been injecting herself with the “neuropeptide” for six years. Dr. LANG discovered Ms. S. had developed severe bone density loss. Laboratory tests found the presence of Dexamethasone, a steroid, in Ms. S.’ blood. FDA laboratory tests showed “neuropeptide contained Betamethasone 21-acetate, a glucocorticoid steroid drug.”

2) The FBI and San Diego DA’s office set up a sting operation in which agents acting as a pancreatic cancer patient and his concerned nephew bought a product labeled “Anodyn,” which FDA laboratory tests proved to contain nimesulide, a non-steroidal anti-inflammatory drug (NSAID) associated with liver damage.

The agents purchased the “Anoydne” as part of a “protocol” after contacting Donsbach on his radio show, by e-mail and in person and as though seeking advise. Donscach is alleged to have replied to email: “Here is the protocol I would give you if you were my patient,”listing:

“Super Enzyme Plus – 3 Capsules with each meal, Symplex C – One ounce ••• hour before each meal (3oz daily), Oncopause III – One Capsule with each meal, Healthy Life Protocol – As directed on box, Oncotox II – 1 Capsule each meal, Cando Plus – 1 Capsule each meal, Anodyn – 2 Capsule in the AM and 2 in the PM. . . . I am going to give a copy of this to my assistant Giselle Sallee whose tele# is: 619-917-1819;” and “I do not promise to cure you but I feel very comfortable that you will live much longer and if you can come to our facility in Mexico, your chances get increasingly better!”

The Mexico facility was where Coretta Scott King, Dr. Martin Luther King’s wido, chose to go toward the end of her battle with ovarian cancer. The US pressured the Mexican government to close the clinic.

FBI agent Mark Kolenda paid $543.06 for the home protocol, which was shipped by UPS. “The protocol contained Super Enzyme Plus, Symplex C, Oncopause III, Oncotox II, Cando Plus, Anodyn, and one box of Healthy Life. The bottle containing Anodyn was labeled as a ‘dietary supplement’ and was said to be distributed by Professional Health Services, Chula Vista, California.” The warrant states:

On August 14, 2008, DONSBACH said in a telephone call with SA HAVERTZ that Anodyn was “better than morphine”…”You just have to take enough.” DONSBACH also said he “gives nine to twelve [Anodyn] a day to my cancer patients.” DONSBACH advised that Anodyn was “safe” and that it was “a natural alternative that has no side effects.”

FDA tested Anodyne and found it contained nimesulide, a non-steroidal anti-inflammatory drug (NSAID). Nimesulide was not listed on the Anodyne label.

In an email March 26, 2009, FDA doctors Dr. Robert SHIBUYA and Dr. Sharon HERTZ advised: “there are no FDA-approved nimesulide-containing drugs nor has nimesulide been approved at any time in the U.S.” Dr. SHIBUYA and Dr. HERTZ state, the “last IND (Investigational New Drug Application) [for nimesulide] was recently placed on clinical hold because of safety concerns associated with nimesulide. In particular, there have been reports of hepatotoxicity with this drug substance and several countries in Europe and Asia where nimesulide was an approved product has (sic) suspended marketing authorization because of high rates of liver failure that resulted in deaths and liver transplantations;” and “…the adulteration of a dietary supplement with an NSAID, even an approved molecule, poses significant public health concerns due to the possibility of adverse events and drug interactions. These concerns include the potential for serious adverse events such as liver toxicity and gastrointestinal toxicity as well as adverse effects on the cardiovascular and renal systems. In addition, since a person taking a dietary supplement would not suspect that they are also self-administering a NSAID, they could be on a concomitant NSAID drug which would increase the chances for a NSAID-related adverse event. Likewise, the patient could be on another hepatotoxic drug that could potentiate the known hepatotoxicity of nimesulide. For all these reasons, the fact that a dietary supplement has been adulterated with nimesulide poses an imminent hazard to the public health and could result in significant morbidity and mortality.”

In 2007 The Irish Medicines Board (IMB) suspended nimesulide from the Irish market and refered it to the EU Committee for Human Medicinal Products (CHMP) for a review of its benefit/risk profile. The referral was made following reports of six (6) cases of possibly related liver failures in the period from 1999 to 2006.

The EMEA concluded in September 2007 that the benefits of these medicines outweigh their risks, but that there is a need to limit the duration of use to ensure that the risk of patients developing liver problems is kept to a minimum. Therefore the EMEA has limited the use of systemic formulations (tablets, solutions, suppositories) of nimesulide to 15 days.

LINKS

http://www3.signonsandiego.com/ (San Diego Union-Tribune)

Drug Saf. 2002;25(9):633-48.Links
Mechanisms of NSAID-induced hepatotoxicity: focus on nimesulide.
Boelsterli UA.
HepaTox Consulting, Pfeffingen, and Institute of Clinical Pharmacy, University of Basel, Basel, Switzerland.

NIMESULIDE: THE END BEGINS pharmbiz.com India
Thursday, June 05, 2003 08:00 IST
P A Francis

Kurt Donsbach Arrested Again
Stephen Barrett, M.D.

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