by Admin
on Oct 9th, 2006

Doctor indicted in drug scandal

JACLYN O’MALLEY
JOMALLEY@RGJ.COM

September 29, 2006

An undercover investigator with the Food and Drug Administration in September 2004 asked a Reno cancer doctor who was known for alternative therapies if he could help him feel young again.

Federal authorities say Dr. James W. Forsythe twice gave the investigator a vial of human growth hormone from Israel to inject into himself that was not approved for use or distribution in the United States. The label said it was for “anti-aging.”

Forsythe told him it would reverse the effects of aging, restore his sleep quality, improve weight control, enhance libido and improve immune function, according to recently unsealed court affidavits in U.S. District Court in Reno.

On Thursday, Forsythe, 68, of Reno, pleaded not guilty to a federal grand jury indictment handed up Wednesday. It charged him with introducing the drug, Bio-Tropin, into Nevada from Israel without approval of the U.S. secretary of Health and Human Services and distributing Bio-Tropin for a purpose other than treating disease. The indictment said others in Forsythe’s clinic helped distribute the hormones between June 2003 and February 2005.

Forsythe surrendered to authorities Thursday morning. He was released on his own recognizance.

“I am confident we will prevail,” Forsythe said after a court appearance Thursday, declining to comment further.

Human growth hormone is secreted by the anterior pituitary gland, and some children don’t produce enough, causing stunted growth.

In the 1980s, the FDA granted approval for a form of HGH that currently is limited to brands of drugs that are sold and used for treatment of limited medical conditions. Bio-Tropin is not approved for use or sale in the United States.

HGH is marketed as an anti-aging miracle that causes weight loss and increases athletic performance. The hormone is part of a federal inquiry into drugs used in professional sports. The Cancer Prevention Coalition in Chicago said that HGH medications increase risks of colon, prostate and breast cancers.

Investigators also say that Forsythe uses a treatment called Poly-MVA, an intravenous treatment he claims is an unconventional therapy that brings “death” to cancer cells. It also is not an FDA-approved drug.

The treatment is featured on a newsletter on his Web site, www.drforsythe.com/cstc.php, and Forsythe claims it is a dietary food supplement.

He also has numerous people identified as patients on his Web site who give testimonials about his treatments.

Forsythe is also accused in court records, but not charged, of receiving the hormone in the mail from smugglers, insurance fraud by fabricating diagnosis to obtain insurance reimbursement for unnecessary tests and treatments and giving patients misbranded vials with inadequate directions.

The U.S. Attorney’s Office said it is still investigating Forsythe and his practice, and more charges are possible.

Forsythe is the owner and medical director of Century Wellness Clinic in Reno. His wife, Earlene, is a partner in the clinic and a registered nurse. The pair have strong ties to the Republican Party and served as delegates to the Republican National Convention. Earlene Forsythe is the former chairwoman of the Nevada GOP. She also declined to comment.

The FDA had been investigating Forsythe since February 2005, when agents searched his home in connection with a Carson City drug supplier investigated for selling Bio-Tropin.

The Nevada Board of Medical Examiners also has been investigating Forsythe, who is certified in homeopathy, internal medicine and oncology.

“Forsythe represents one of the five most serious physician offenders known in the state of Nevada,” according to an affidavit quoting BME investigator Pamela Castagnola.

The board in 1995 charged him in a 44-count complaint with making “unreasonable additional charges for tests in a laboratory, radiological services or other services performed outside of his office.”

This was related to more than 20 investigations for bad conduct, including excessive billing, according to court records.

Forsythe pleaded no contest to one count and agreed to pay $1,000 as a fine and another $44,000 to make up for improper billing.

Castagnola said that since the 1995 discipline, Forsythe has been under investigation.

In 1996, six investigations looked into allegations of excessive billings and bad medical practices. From 1997 to 2004, at least 12 investigations were opened. But, none of the investigations resulted in discipline and most are closed, she said.

The FDA investigator on Sept. 14, 2004, had an appointment with Forsythe at his clinic. He told the doctor he had a large invasive tumor previously removed from his lungs. He said he was 45 and found it difficult to get back into physical shape.

The investigator told him he saw advertisements for the HGH treatment at the doctor’s office and asked if he could help. He told Forsythe that a friend of his at a gym had received the treatment from Forsythe and recommended him. The doctor charged him $422 for the first visit “” $238 was for the one-month supply of hormones, according to court papers.

On Oct. 27, 2004, the investigator returned, and Forsythe sold him another vial of HGH, according to court papers. The doctor also suggested he take a certain blood test, which the investigator said his insurance would not pay for, documents show. But Forsythe allegedly said if he diagnosed him with “hypopituitarism,” insurance would pay for it.

According to the insurance company, Forsythe had diagnosed the investigator during that visit with having a serious stroke, hypertension and hypopituitarism, a pituitary gland problem.

Doctors consulted by the FDA told the investigator that based on his medical history and symptoms, it was unreasonable for Forsythe to make the diagnosis.

Also, they said the initial blood test Forsythe insisted he take was not necessary.

*****************

Click here to read the search warrant issued for Dr. Forsythe’s Century Wellness Clinic, including list of seized items.

*****************

The original article from the Reno Gazette Journal can be viewed here.

Trackback URI | Comments RSS

Leave a Reply

You must be logged in to post a comment.