Dr. James W Forsythe, MD

In February of 2005, Dr. James Forsythe, MD was sitting in his kitchen having breakfast with his wife when he saw a fleet of cars pull into his yard and men and women empty out of those cars armed with guns and a battering ram. The front of their bullet-proof vests had the initials of FBI and FDA.

Dr. Forsythe opened the door before they knocked it down and said, "Is this a joke."

The FBI agent answered, "This is not a joke." And it wasn't.

Dr. Forsythe was made to get down on his knees and a gun was held to his head. Another agent thrust a gun to his wife's chest and she was escorted to another part of the house.

They searched his home for 7 hours (including measuring inside and outside walls to make sure there was no secret hiding places). Simultaneously, they were searching and questioning the staff at his office and taking charts away. The agents took over the office, sent the patients home, and even on one occasion answered the phone, "Taco Bell."

So, what was his offense?

Before I tell you what Dr. Forsythe was accused of let me tell you that he is board certified in oncology and internal medicine, served in Vietnam, and started the oncology wards in the hospitals in his town (Reno, Nevada), and never had a malpractice case against him in his practice of oncology. He was mostly practicing oncology; but, he had read the data about growth hormone and thought the benefits note worthy. So, he had been prescribing growth hormone to some of his patients (and was taking it under the prescription of another physician).

That was why he was held at gun point in his own home; because he was writing growth hormone prescriptions "off label."

We may smile and say that nothing like what happened to Galileo could happen now (remember he was sentenced to hell for saying that moons revolve around Jupiter instead of the Earth). But, here is a man who was held at gun point and threatened with five years in jail and a $250,000 fine if convicted: for using growth hormone. In testimony at Dr. Forsythe's trial, the FDA expert admitted that he knew of not one--THAT IS NOT ONE--death from the off label use of growth hormone. People routinely die from blood pressure medication, cholesterol medicine, Tylenol, Advil, aspirin, and diabetes medication---even BOTOX at very high doses. But, even with all the abuse by professional ball players, not one death from growth hormone.

Yet, growth hormone is the only medication for which the FDA will send a physician to jail for writing prescriptions for off label use.

Here's a photo of Dr. Forsythe's attorney, Kevin Mirch with his wife (also an attorney who works with him on every case)

Mr. Mirch (also from Reno) was unable to speak well or walk when Dr. Forsythe asked him to take the case. Mr. Mirch credits growth hormone with helping him recover function and avoid the depression of stroke; therefore he is very passionate about defending physicians' rights to prescribe off label.

In this photo, which I also took while at a conference about the law concerning growth hormone, you see Dr. Forsythe, Mr. Mirch, and Eugene S. Peiser (who was the FDA compliance consultant who advised Dr. Forsythe and Mirch and Mirch on this case)...

1. On November 1, 2007, Dr. Forsythe was declared "not guilty" in a verdict by a 12 member federal district court jury (after less than an hour's deliveration).

2. The FDA investigator for the case was fired and was on probation when he took the case (so the FDA does seem to be making some effort to keep things reasonable).

3. Dr. Forsythe's case set a standard (since he won the case). He was asked by the FDA during the trial to offer a protocol for diagnosing growth hormone deficiency. He presented this protocol to the FDA and it became part of the legal record.

At LifeStream Medical, we follow a protocol at least as stringent as Dr. Forsythe. This is important to me and my patients, of course. If you are my patient, I want you to know that our current practice is at least as stringent as what what presented in this winning case.

One last note. Dr. Forsythe was offered the chance to walk away with no penalties (after some technicalities came up that made the FDA look not so great) without going to court and just quit prescribing growth hormone. He took a chance on going to jail for 5 years to win this case. Now there is a winning case on record (this was in federal court) which seems to open up a ray of hope for those whose lives have been changed so dramatically by growth hormone replacement.

Thank you Dr. Forsythe for your courage to stand for what you thought was the right thing for your patients, even when you had a gun to your head.