Alternative medicine on trial

Dr. James Forsythe practices a type of medicine called “integrative oncology” because it uses aspects of both homeopathic (use of vitamins and supplements) and conventional medicine. He has his conventional degrees in medicine and cancer specialty from the University of California, San Francisco. He studied with the British Institute of Homeopathy before passing his oral and written boards in 1995. He’s been practicing in Reno since 1974, taught at the University of Nevada, Reno medical school, started the cancer wards at Sparks Family Hospital, St. Mary’s, and Washoe Med (now called Renown) and was also head of the Veterans Administration oncology department. He built an impressive practice over those years—and then the Food and Drug Administration came calling, which resulted in one of Reno’s biggest criminal trials of 2007, generating massive media attention, dragging Forsythe’s reputation through the mud and hurting his practice. He was found not guilty in U.S. District Court on Nov. 1. This is an abridged interview, which was conducted in the doctor’s office, 521 Hammill Lane, on Nov. 14, in which he talks about his trial and why the FDA attacks alternative medicine practitioners.

How did you get into homeopathic medicine?

I got interested because I was seeing cancer patients from some of the other docs who were practicing this type of medicine. I was seeing good results, but I was taught the old “cut, burn and poison”—surgery, radiation and chemo. I was seeing these good results, but they didn’t match the paradigm that I had learned. I started to go to conferences, the alternative medicine meetings, and got to know people who were doing this.

Tell me about your experience with the FDA agent.

I was practicing as normal in 2004 when we had an employee that had been with us 10 years. She had some personality problems with the girls in the office. They had been friends for a while and then they got into it. Before she quit, she told some of the other people she was going to bring the office down. She was also seen copying charts, which is against the HIPAA rule, which is the Health Insurance Portability and Accountability Act. Before that happened, she facilitated the agent. I went through this whole trial, and I still don’t know who the exact accuser is.

No kidding.

Yes. A criminal trial where I could have been in jail for five years and had a $250,000 fine, and to this day, I do not know who my accuser is. We think it’s the husband of this disgruntled employee. The other possibility is it could be the guy who was head of Homeland Security, Jerry Bussell. He was a neighbor of ours. It gets into the political side. But anyway, he had some motivation to bring me down.

So somebody called the FDA?

The way it worked out, according to the search warrant, was that a lady from ICE, the Immigration and Custom Enforcement, met a guy at the gym who brought a vial over to her. It said Bio-Tropin from Israel. The writing was in Hebrew. She thought it was of interest so she called the FDA, and they put an agent on the case.

I’m completely confused, but go ahead.

I try to make sense out of it, but I know it’s very confusing. This agent came into my office as a patient. He claimed he had heard about my program, which at that time was called an “anti-aging” program. Now this program was not for muscle enhancement. It was not for making athletes stronger. I was not giving it to high school basketball players to make them taller. All of which you could do with this hormone. It was for what’s called “age-related growth hormone deficiency.” As we age, we lose growth hormone on a predictable 10-15 percent decrease per decade. You have your most when you’re 15-25, after that we all start sliding downhill. When you’re my age—I’m 69—you have less than half of what you had at your peak. Replacing it is a natural thing we do in medicine. Let’s face it: We replace menopausal hormones, male hormones, adrenal hormones, if they’re low, thyroid hormones, if they’re low. Why not replace human growth hormone? I belong to the American Academy of Anti-Aging Medicine, which boasts 20,000 members throughout the country and more around the world. There are probably 40 different societies in the world that are into this anti-aging medicine. It’s called New Age medicine. Replacing growth hormone along with other hormones is what we do. This guy came in with what was entrapment. He came in with a phony name, a phony drivers’ license, a phony Blue Cross/Blue Shield card. He had a wire on. I ordered the proper tests, but he did not comply with the testing. He came back a month later, and I said, “You did not do the testing, what’s wrong?” It was October 24 [2004]. The first time was September 14. I said, “If you’re not going to comply with the testing, I can’t give you any more human growth hormone.” At that point, he did get a growth hormone level, and, according to the standards we go by, he was low. What we aim for is a level similar to that in your 20s. I did a full exam, but the FDA never really approved the drug for age-related growth hormone deficiency as being a real reason to give it.

But doctors prescribe drugs off-label all the time.

Every drug in the Physician’s Desk Reference can be prescribed off-label—except for one drug: human growth hormone. I did not know that. That never taught us that in the meetings I went to. It was hidden in the steroid law. Incidentally, human growth hormone is not a steroid.

In oncology, 80 percent of the drugs we use are off-label. That means if you have a lung cancer, and you fail the first round of chemo, I would put you on a second round of chemo, and that would probably be off-label because studies usually only cover the first round. So when I prescribe the second, third and fourth round, it’s off-label. Let’s take a simpler example. If you take aspirin for your heart, instead of for a headache, that would be taking aspirin off-label.

OK, so tell me about the raid.

My wife and I were sitting at the table having breakfast. She was sitting facing me, looking at the driveway. She saw three dark cars in the driveway and a bunch of people exiting them. She said, “There’s a bunch of people on the driveway. Did you order something?” I said, “No, but I’ll go see.” So I ran down to the back door. They were pounding on the door. I opened the door, and I saw about a dozen people. They had flak jackets on. One had a helmet on. One had a door buster. They all had guns drawn. I opened the door. I said, “Is this a joke?” I just paled.

Everybody pales when the guns come out.

They said, “No, it’s no joke, and they pushed me back into the house. They put me down on my hands and knees and held a gun to my head. They asked me, ‘Do you have any guns in the house?’ I had a couple pistols, a pellet gun, no rifles. I told them where they were. About that time my wife was coming down the hall, and they held a gun to her chest. They took us, separated us, put her in one room, the dining area, and put me in the family room area. If we went to the bathroom, we had to have accompaniment. Right there, I asked one of the agents to read me my Miranda rights. He said, “No, we’re not going to read you your rights.”

You weren’t under arrest.

No, we weren’t under arrest, but we were in custody. If you are held, you can’t do anything. They watch you go to the bathroom, that’s called custody. We were not handcuffed. We were to sit there and be quiet and behave ourselves. They proceeded to search the house from about 8 o’clock in the morning til about 3-4 in the afternoon. About seven hours.

What were they looking for?

Contraband. The search warrant said we were engaged in smuggling, money laundering, using a new unapproved drug in interstate commerce, and they called it Bio-Tropin.

By new drug, they meant one that the FDA hadn’t approved. It was approved. It’s been approved since ‘95. It was in the FDA’s own Orange Book. The Orange Book is the book of approved drugs. They didn’t bother looking in it. They didn’t bother looking on the internet.

It doesn’t sound much like they cared that it was legal.

They ended up taking our computers, our hardware, went through my financial files, went through all the drawers, they took the weapons. They went around and measured the outside of the house to see if there were false walls. But they never looked under the house or in the crawlspace. They never looked in the garage. They never looked in our storage units. He asked me, “Do you have any Bio-Tropin in the house?” Because I was on growth hormone at the time, I said, “Yes, I have one vial in the house I was prescribed by another doctor.” He said, “Where is it?” I walked over to the refrigerator, opened the door and handed him the vial. He said, “Oh my god, this is just what I wanted. This is it.” The guy was actually going frothy at the mouth.

They never looked in the fridge?

No they didn’t. So anyway, while the raid was going on in my home, unknown to me, the office was being raided by another dozen agents. They took all the employees—we have about 10 employees—put them in one room and started pulling them out individually and interrogating them without the benefit of a lawyer, without their Miranda rights. They had guns. They took 100 patient charts without permission, violating all HIPAA rules. They took computers, software, they took billing information, and they were in this office until about 7 at night, loading up trucks.

You turned yourself in later?

It was a sealed search warrant, so it hit the papers, but my name was never out there. This was back in February ‘05. My practice didn’t really suffer at that time. What happened later was there was a very small raid, just on the office with [Special Agent John] Zalinsky himself and a few agents and some local police. They came in and took my supplements because I was running a cancer study group with certain natural things. During the raid a couple things happened that again I consider unprofessional behavior. They were answering the phone, saying, “Taco Bell,” they thought it was a big joke. Then there were patients here that they herded out. I tried to come back to the office later in the afternoon to call patients to talk about their lab results. I told them I had patients that were sick, and I had to follow up. They wouldn’t let me do anything in the office. They wouldn’t let me practice medicine at all, even though I wasn’t arrested.

Right.

Even though our staff was all shook up by this, nothing happened until the middle of April. They were just here a couple hours. They basically took our whole supply of supplements. They probably didn’t get enough of what they took the first time, and they wanted to pile on other charges. In January of ‘06, I had a 225-patient cancer study where I was giving certain supplements either with or without chemo. They wanted all those charts copied. We copied all the charts, we had to paginate them, we had to stamp all the pages. We had to deliver them. My lawyer at the time said we’d do it voluntarily. So we delivered it, but we had to make a separate copy for our lawyer. It was really expensive.

And then, in May of ‘06, they convened a grand jury. Five of our employees, plus my wife and our office manager were called—I had to hire a separate attorney for each of them. It was like $30,000. They were all told to take the Fifth Amendment. Nothing much happened after that until in the end of September in ‘06, Zalinsky and his forces started pounding on the back door here—it was locked at the time—saying, “We’re going to break this door down if you don’t open it.” They came in, stood right there. He said, “Here’s my badge, you’re under arrest, you’ve been indicted. We could cuff you and take you to jail, but the judge has ordered us to allow you to voluntarily submit tomorrow morning, to go to the federal courthouse, present yourself, get mug shots, get printed, see if there’s bail involved, go before the magistrate and plead your case.”

So I called my lawyer. They came in with me the next morning, about 9 o’clock. They got mug shots, and I sat in the jail for about half a day. In the afternoon about 4 o’clock I was brought in front of the magistrate, he asked how I pled, I said, “Not guilty, your honor.” That was that.

I was told by my lawyers not to talk to the press at all. Then the following day was when the very sour press came out, said a lot of things that weren’t true: One of the five worst doctors; I had misdiagnosed the agent; I was trafficking, hiding drugs in my office. All kinds of things that were not true. A week later, there was a whole inside story, a whole two pages of my history in Reno. There were a couple good things, [but] they were trying to shed a bad light on me, basically.

I have not had, in 33 years of practice, any malpractice suits. My record is quite clean. But very soon after that, the hospitals, right in a row, rescinded my hospital privileges. My malpractice insurance went up tenfold. I lost Blue Cross/Blue Shield PPOs. Had I not had the kind of practice I had, I would have probably had to fold my tent and shut the doors. But I was able to keep up enough of a practice to get through.

Let’s talk about the trial.

The trial started with the opening statements. [Assistant U.S. Attorney] Brian Sullivan got up and his opening statement was very flat. He said things like, “You can’t treat old age; we all get old and die.” He said, “Dr. Forsythe is not a back alley dealer, he does it through his office, he imports illegal drugs and smuggles them in the country and these drugs are not approved by the FDA. And he was giving them off-label, and this drug cannot be given off label.” It was a pretty uninspiring speech, I thought. I’m obviously very prejudiced. Then [my lawyer] Kevin Mirch got up and said, “This trial is not really about Bio-Tropin; it’s not about smuggling; it’s not about money laundering; it’s not about introducing a new unapproved drug. This drug is approved, if the FDA had only done its homework. They would have seen in the Orange Book that it’s an approved drug, and it’s been there since 1995. And he showed them an Orange Book for reference. And then he spoke a little bit about me.

He said, “This is about a rogue agent, impaired himself, who wanted to have a big hit on a doctor who was crossing the line into alternative medicine. The FDA gets a lot of its sponsorship from big pharmaceutical companies—billions of dollars a year. They go after doctors who get out of line. They call them ‘disruptive physicians.'” Doctors like myself are disruptive because we don’t march in a straight line.

Anyway, so Kevin Mirch painted the picture of a rogue, over-zealous, physically impaired agent who was looking to hit a home run with his superiors by getting an alternative doctor and putting him away. And I think the jury bought it. And then the trial proceeded. It was a six-day trial, three days on the first week, and then two days the second week and then Wednesday was closing statements, and Thursday was the verdict. The prosecutor had his chance first to present his expert witnesses. The expert witnesses were all endocrinologists. There’s a huge fight in medicine today between the field of endocrinology—glands, diabetes and thyroid and adrenals and growth hormone—versus the anti-aging, which also does hormones, but the endocrinologists don’t think they’re qualified because they never took their fellowship in endocrinology. This is kind of the New Age versus the Old Age, and it’s a turf battle.

I remember this battle with the chiropractors versus conventional medicine.

The endocrinologists only want certain few things that legitimate for giving HGH—traumatic brain injury, pituitary injury, radiation, chemo and certain other things. They have not bought into the fact that we are all deficient, and we should all be treated after a certain age. Well, the anti-aging group feels strongly that way. We should all be enhanced in our aging processes and have a more high quality of aging. Who doesn’t want to have more muscle mass, thicker bones and thicker skin and look better and have more exercise tolerance? Our expert witness was Dr. Pieser, who was a captain in the Public Health Service. The Public Health Service oversees the FDA. He said that he looked at all my work, and he thought that I did a fine job; I practiced a high quality of medicine. At that point, we found in their evidence box 14 vials of Bio-Tropin that were partially redacted. They had Mark Gunderson, a doctor down the street who was doing anti-aging medicine, his name on it. So somehow they had gotten hold of his drugs, put it in my evidence to make me look bad. Well, the jury, I think that was the coup de gras with the jury.

That’s very interesting.

And then Kevin had a wonderful closing statement to the jury. The prosecuting attorney kept trying to hinge it all on the fact that there are certain indications that were for growth hormone, and anti-aging was not one of them. He did not go over big.

[The jury] called the judge at 9:30 [the following morning]. I was in the office seeing patients, so I had rush over there. The judge said, “Have you reached a verdict yet?” “Yes, we’ve reached a verdict, your honor.” “May I see the verdict?” So they brought the sealed envelope to the judge, the judge opened it, read it, handed it to the clerk and said, “Please read the verdict.” You get a little tight, because you never know about juries. She said, “It was a unanimous decision, not guilty.” Tears came to my eyes. I still get a little teary just thinking about it. It was very dramatic.

Why does the FDA have such problems with alternative takes on medicine?

The main reason is money. When doctors start using natural things, it takes money out of Big Pharma’s pocket. The FDA is the enforcement arm for Big Pharma. And Big Pharma does not want any natural products. If I give a high dose of vitamin C to a cancer patient, that’s taking away from a $5,000 to $10,000 treatment for that patient that goes to Big Pharma. My vitamin C infusion may cost the patient 100-200 bucks instead of 5-10,000.

But what difference does it make to conventional doctors if there are other ways of perceiving healing people?

You never learn about alternative medicine in medical school. I didn’t hear the word “homeopathy” once in medical school that I can recall. It was always about disease intervention. Those pharmaceutical companies really court the physicians; they really pimp the physicians. They have lunches for them. They have dinners at night. They give you presents. They’re pimping you all the time.

I understand Pharma’s problem with it. What I don’t understand is this pissing match between the conventional doctors and the alternative doctors.

I have never fully understood that either. We shouldn’t be threatening them. There’s plenty of work out there for all of us. They always revert to the thing, “it’s not scientific. You have not done a thousand patient, double-blind, crossover placebo-controlled study to prove that it works.” Well, in conventional medicine, it’s true that only about 20 percent of things that conventional doctors do have ever been subjected to those kinds of studies. But they still say it’s not scientific; they don’t believe that a thousand years of Oriental medicine has any meaning at all—that they’ve learned anything. They don’t want to believe that nutrition and vitamins and supplements help you.