PC-SPES Makers Plead Guilty

PC-SPES Makers Plead Guilty

BREA, Calif.On Dec. 18, theprincipals of Botanic Labthe company that became known for its prostatecure-all, PC-SPESpled guilty to misdemeanor violations of the California drugacts, while the company as an entity pled guilty to a penal code felony forselling unsafe and dangerous products. In both cases, the defendants agreed topermanent restraining orders from operating similar businesses in the state ofCalifornia. In the civil cases, John Chen and his sister, Sophie, paid a totalof $50,000, and Allan Wang was charged $60,000. In addition, the corporationagreed to pay $350,000 in penalties.

All three principals avoided jail time and are on three yearsprobation after reaching a plea agreement with Orange County district attorney,Byron Nelson. The case was submitted by the California Department of Health andHuman Services (CDHHS) (www.dhs.ca.gov) tothe DAs office in mid-2002.

It was earlier that year the Food and Drug Administration(FDA) instituted a recall for PC-SPES and SPES, Botanic Labs supplement forimmune health, for allegedly containing prescription drugs. A laboratoryanalysis conducted by CDHHS found PC-SPES contained warfarin, a prescriptionblood thinner, and SPES contained alprazolam, better known as Xanax. At thetime, the company claimed the material CDHHS found may have been phytocoumarinacompound naturally synthesized in various green plants that may appear likewarfarin.

Nelson reported that although the Chens and Wang neveradmitted to adulterating the products, If you read what one of their defenseattorneys said in the LA Timeswhich reads like the products becameadulterated through osmosis on a boat coming over from Chinaour position isthat is patently false, he said. We believe they intentionally adulteratedand misbranded these products. He added that considering the expensive natureof the case and the facts that were available to try the case, both sides agreedto a plea bargain.

We are very pleased by the results, Nelson added. Oneof our primary goals was to prevent these products from being sold.

In August 2002, the National Center for Complementary andAlternative Medicine (NCCAM) announced it was still conducting lab studies on anall-natural version of PC-SPES (which contains eight herbs: baikalskullcap, Chinese licorice, Dyers woad, mum, rabdosia, Reishi, san-qi ginsengand saw palmetto). However, the human study it had planned was permanentlyhalted due to the pharmaceutical discovery. At that time, NCCAM stated that although PC-SPES containedpharmaceuticals, data from PC-SPES studies still remain promising. For example,one study indicated a particular herb in PC-SPESbaicalin was found toinhibit the proliferation of cancer cells (Prostate, 49, 4:285- 92,2001). Baicalin is isolated from the traditional Chinese medicinal plantScutellaria Baicalensis Georgi, or baikal skullcap.

No one will argue ... that this product decreased PSAlevels, and it would be great if this were an effective product that wasproperly tested and met the state of Californias and FDAs requirements,Nelson said.

He added that although his office has no proof, he believespeople probably died from the two drugs these products contained due to theirblood-thinning effects.

Botanic Lab is still facing pending class action suits, butinsurance will most likely pay those damages.