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Alternative medicine on trial
A successful cancer doctor in Reno comes under federal scrutiny for New Age practices.
Here's the story from his point of view.

By D. Brian Burghart
Dr. James Forsythe, a Reno oncologist and homeopath, was taken to court by the FDA—
and won.
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 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
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.
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."http://www.newsreview.
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.

April 16, 2007

Tears fell in Virginia today.  Sobs were heard across the nation.  A gunman with a Visa has
broken our hearts. Why do we cry?  Why do we feel anger, grief, outrage, and fear? Some
say we need better campus security.  Some say we need gun control. Some say they
understand that the gunman was enraged by his girlfriend. Some were sure it was a
terrorist. Some are certain it will happen again. Some are afraid for their children.  Many,
even those who say they do not believe, thanked God it wasn’t their child, their father,
their sister, or brother. They thanked God it wasn’t them.  And then life goes on.

We check the stock reports to see how oil is doing and if our investments are making us
money.  We watch the news and listen to pundits analyze the reasons and foretell the
next political agenda.  We listen to talk radio as experts rationalize behaviors.  And then
we thank God again that it wasn’t us.  We pray a little.  Cry a little.  And then turn on the
Sopranos or hateful rap music or Howard Stern.  And we wonder why? We wonder how?

How did he get the guns?  Why did he kill others and not just his girlfriend? Why didn’t
the alarm go out sooner?  Who can we blame?  Who’s at fault?

We are.  We have created all that we see and feel.  We are at fault.  We have encouraged
and allowed our children to listen to hate.  We have taught the children of other
countries to listen to our anger, our negativity, our lust for money and love.  We give
them talk radio and television and films and music that depict us as atheistic,
misogynistic, decadent imperialists who only believe in money, sex, and violence. We
interpret the right to bear arms to mean we can all carry guns and use them as we
please.  We interpret the right to free speech to mean we can say anything to anyone,
anywhere we please. We read the words on the Statue of Liberty and interpret the “tired
and poor, the huddled masses,” to mean anyone from anywhere who wants to use us or
abuse us. We interpret the constitution to mean only some of us are in a nation under
God. So what do we do now?  How do we avoid more broken hearts, more senseless
death?  How do we begin to heal?

We cannot heal if we mask the cause.  We cannot begin to balance our lives through
surgery.  If we only put borders on our schools, who have we imprisoned?  If we argue
gun control for another generation and allow only the killers access to weapons, who
have we protected?  If we send our children to the mall with credit cards and give them
computers and the freedom to choose before they have the foundation for behavior,
how will they lead the next generation? If we teach defense and say we can’t stop these
things from happening we can only learn how to respond when it does, how do we teach
our children, our family, our country to move forward and grow?

Americans need to stand up and claim their birthright. Americans need to take
responsibility for what we have created within our boundaries.  It begins at home.  It
begins with the FCC.  It begins with overcoming the fear that someone might not like us if
we do what’s right, instead of what’s accepted by the flock. It begins with the
government, a government that is supposed to be by the people and for the people. A
government that is not supposed to provide funds, but leadership.  A government that
should not have personal agendas, but solutions. A government that should not tax each
solution Americans need and then give freely to those who aren’t or don’t want to be
We, the people of the United States of America, need to reclaim our responsibility as
Americans.  To be an American means we believe in one nation under God.  We believe
that charity begins at home.  We believe and know that hard work made our country great
and that continuing that work isn’t so hard when you love what you’re working for.  We,
the people, need to take our children by the hands and teach them, or reteach them, that
they have been given the gift of life and liberty, and that that gift does not come
unconditionally.  We need them to know that being an American means bearing arms to
defend your country and that free speech means honoring your words and the people
you speak them to.  We need them to learn that are responsible for choosing the people
who work for them, who govern them, and that the right to choose is uniquely American.  

We can only begin to heal when we stop the churning of the melting pot.  We can only
begin to find the cause and change it when we are truthful with ourselves. When we
admit we’ve been lazy about making our government do what’s right for the country and
therefore what’s right for our family.  When we admit that all the people of our country
who have chosen to live by the laws, language, and beliefs of our country are our family.  
When we admit that we haven’t been the parents we should have been, the workers we
should have been, the faithful we should have been, or even the warriors we should
have been.  When we stop the uniquely male energy that always relies on the warrior and
find the balance between male and female that allows for peace and vision and truth and
responsibility to the Earth and its people.

Tears fell in Virginia, and unless we begin with ourselves and begin to teach each other
the ways to live on this Earth, they will fall again.  Whom, then, will you blame?