02-000165PL Department Of Health, Board Of Medicine vs. William Hammesfahr, M.D. Status: Closed Recommended Order on Wednesday, November 20, 2002.

Summary: Doctor used alternative medical treatment not within prevailing standards of care. No harm to fully informed patients; thus did not violate Section 458.331(1)(t), Florida Statutes.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, BOARD OF )

MEDICINE, )

)

Petitioner, )

)

vs. ) Case Nos. 02 - 0165PL

) 02 - 02 19PL

WILLIAM HAMMESFAHR, M.D., )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to notice, a formal hearing was held in this case

on May 15 and 16, 2002, in Clearwater, Florida, and on May 24,

2002, by telephonic conference before Susan B. Kirkland, a

designated Administrative Law Judge of the Di vision of

Administrative Hearings.

APPEARANCES

For Petitioner: Shirley J. Whitsitt, Esquire

James W. Earl, Esquire

Department of Health

4052 Bald Cypress Way, Bin C - 65

Tallahassee, Florid a 32399 - 3265

For Respondent: Christopher J. Schulte, Esquire

Burton, Schutle, Weekley, Moeler,

Poe & Robinson

100 West Kennedy Boulevard, Suite 800

Tampa, Florida 33602

Max R. Price, Esquire

Solms & Price, P.A.

6701 Sunset Drive, Suite 104

Miami, Florida 33143

STATEMENT OF THE ISSUES

Whether Respondent violated Subsections 458.331(1)(d),

458.331(1)(n), and 458.331 (1)(t), Florida Statutes, and, if so,

what discipline should be imposed.

PRELIMINARY STATEMENT

On December 11, 2001, Petitioner, Department of Health,

Board of Medicine (Department), issued an Administrative

Complaint against Respondent, William Hammesfah r, M.D.,

(Hammesfahr), alleging that he had violated Subsection

458.331(1)(t), Florida Statutes, in his treatment of M.T.; that

he had violated Subsection 458.331(1)(d), Florida Statutes, by

engaging in false advertising regarding his treatment for

strokes ; and that he had violated Subsection 458.331(1)(n),

Florida Statutes, by exploiting M.T. for financial gain.

Hammesfahr requested an administrative hearing, and the case was

referred to the Division of Administrative Hearings (DOAH) for

assignment of an administrative law judge on January 11, 2002.

The case was assigned DOAH Case No. 02 - 0165PL.

On December 17, 2001, the Department filed an

Administrative Complaint against Hammesfahr alleging that he had

violated Subsection 458.331(1)(d), Florida Statut es, by engaging

in false advertising regarding his treatment for strokes.

Hammesfahr requested an administrative hearing, and the case was

referred to DOAH on January 15, 2002, for assignment of an

administrative law judge. The case was assigned DOAH Cas e

No. 02 - 0219PL.

By order dated January 30, 2002, the two cases were

consolidated. The cases were noticed for final hearing on

March 20, 2002. On February 20, 2002, Hammesfahr filed

Respondent's Motion for Continuance, which was granted by order

dated Fe bruary 27, 2002. The final hearing was rescheduled for

May 7 and 8, 2002. On March 6, 2002, Respondent filed another

motion to continue the final hearing. The motion was granted,

and the final hearing was rescheduled for May 15 and 16, 2002.

The rebutt al testimony was heard by telephonic conference call

on May 24, 2002.

By Order dated April 26, 2002, official recognition was

taken of Section 456.41(1), Florida Statutes, and of the staff

analysis and legislative history regarding the enactment of

Section 456.41, Florida Statutes. At the final hearing,

official recognition was taken of Chapters 456 and 458, Florida

Statutes, and Chapter 64B8 - 8, Florida Administrative Code, as it

existed from May 14, 1998, through December 28, 1999.

At the final hearing th e Department called Dr. Harold

Friend, Dr. David Scales, and Dr. Steven Novella as its

witnesses and presented the testimony of Dr. Thomas Hoffman,

Dr. Steven Novella, M.T., and J.T. by deposition. Petitioner's

Exhibits 1 through 16, 18, and 19 were adm itted in evidence.

Hammesfahr called the following witnesses: Brent Bohne,

Dr. Alexander Gimon, Diane Hartley, Larry Senko, and Dr. William

S. Russell, and presented the testimony of Dr. William Flanagan,

Dr. Jacob Green, Larry Senko, Frank Famiano, Rober t Keys, and

Stephen Putnall by deposition. Respondent's Exhibits 1, 2, 4

through 11, 12A, 12B, 13A, 13B, 14, and 17 through 25 were

admitted in evidence. Respondent's Exhibits 15 and 16 were

proffered. Respondent was given leave to file a clean copy of

Respondent's Exhibit 25 as a late - filed exhibit. Respondent

filed Respondent's Exhibit 25 on October 31, 2002.

The parties agreed to submit their proposed recommended

orders within 30 days of the filing of the transcript. The

final volume of the five - vol ume Transcript was filed on July 15,

2002. The parties requested that the time for filing proposed

recommended orders be enlarged. The requests were granted,

extending the time for the filing of the proposed recommended

orders to August 19, 2002. The pa rties timely filed their

Proposed Recommended Orders, which have been considered in

rendering this Recommended Order.

FINDINGS OF FACT

1. Hammesfahr is a licensed physician in the State of

Florida, having been issued Florida License ME 52212 on

February 8 , 1988. He is board - certified in neurology and pain

management.

2. Hammesfahr's office is located in Clearwater, Florida,

where he maintains a practice treating patients who have had

strokes. A stroke is a blockage of an artery in the brain that

causes damage to the brain. As a result of the stroke certain

cells within the brain will die, and the victim will develop a

multitude of deficits, including paralysis, loss of vision,

sensory loss, and memory problems.

3. Between 1998 and 2000, Hammesfahr a dvertised his

treatment for stroke patients and included the following

statements in some of his advertisements:

Using advanced technology, Dr. Hammesfahr

has developed a sophisticated method to help

restore blood flow to the damaged areas of

the brain aft er a stroke. With increased

blood flow to these areas, the brain can

heal.

Dr. Hammesfahr is the first physician to

treat and successfully reverse the effects

of stroke using vasodilators.

These advertisements have appeared in Florida and in airline

mag azines, which travel throughout the country.

4. In some of his advertisements, Hammesfahr indicated

that based on an evaluation of the first 67 patients who went

through the therapy 82 percent had major improvement, 11.9

percent had minor improvement, and 6 percent had no improvement.

He further indicated that the study showing these results was

peer - reviewed.

5. Generally, Hammesfahr's treatment protocol is based on

the concept of dilating blood vessels in the brain to optimize

neurological function a nd neurological recovery. He uses

vasodilator medications to dilate blood vessels in the brain and

to increase blood flow into the brain. Various methods are used

to monitor the therapy and improvement, including ultrasound,

physical examinations, neurop sychological and physical therapy

testing, EEG, transcranial Doppler, and blood pressure

monitoring. Medications used to dilate the blood vessels

include ACE inhibitors, calcium channel blockers, nitrates,

alpha and beta blockers, and sympatholytics.

6. After a stroke has occurred, brain cells in the center

of the stroke are destroyed and cannot be revived. The area

next to the stroke center is called the penumbra and consists of

brain cells that are damaged and might recover. Hammesfahr does

not claim that his treatment protocol can restore the brain

cells that have been destroyed. He does claim that by using his

protocol there may be some recovery in the damaged areas, where

the blood vessels have restricted and narrowed. The medications

dilate the v essels and increase the blood flow to the damaged

areas.

7. The recovery of a stroke patient consists of three

phases: acute, subacute, and chronic. The acute phase occurs

from the onset of the stroke to the next few days or weeks

thereafter. The subac ute phase starts at the end of the acute

phase and lasts for approximately six weeks to three months.

However, in certain cases it might last as long as 18 months.

The chronic phase is the last phase, which commences at the end

of the subacute phase and lasts for an indefinite period.

Hammesfahr usually treats stroke patients who are in the chronic

phase, but has also treated patients in the other phases of

stroke recovery.

8. When a patient contacts Hammesfahr concerning his

stroke treatment, the p atient will be sent a new patient

package, which describes the phases of treatment, contains

articles written by Hammesfahr concerning his treatment, and

includes a fee schedule. Hammesfahr has different treatment

plans from which the patient may choose t o participate. The

costs for the treatment vary according to the plan; the longer

the patient is seen in Clearwater by Hammesfahr, the more costly

the treatment. The average patient seen by Hammesfahr opts for

the three - week plan.

9. If a patient decid es that he wants to be treated by

Hammesfahr, the patient is required to see his primary care

physician, provide the physician with the articles contained in

the new patient package, and obtain his medical records from the

physician. The primary care phys ician is to perform certain

tests on the patient and give a medical clearance for the

patient to travel to Clearwater, Florida, for treatment by

Hammesfahr. The patient is also sent a package of materials,

which includes a medical history form to be fille d out by the

patient and brought to Hammesfahr when the patient comes to

Clearwater for treatment.

10. When the patient initially presents for treatment at

Clearwater, the patient is given an explanation of the treatment

by Hammesfahr and his staff. Pati ents are advised that there

are no guarantees that the treatment will be successful. An

intake is performed to make sure that the needed forms are

properly completed, including a history of the patient to

determine that the patient's primary care physicia n has given

the patient a clearance to come to Hammesfahr for treatment, and

to review the medical records of the patient. A physical

examination is performed on the patient.

11. The patient is given a schedule for the time that the

patient will be in treatment in Clearwater, and Hammesfahr's

staff reviews the schedule with the patient.

12. Tests are performed on the patient in Hammesfahr's

office such as the transcranial Doppler ultrasound to generally

determine the blood velocity.

13. The patient is sent to Diane Hartley, a physical

therapist, for testing of gross motor function, and to

Dr. Alexander Gimon for neuropsychological testing. The tests

given by Ms. Hartley and Dr. Gimon are standardized tests, for

which the patient normally pays additi onal fees. The initial

tests by Ms. Hartley and Dr. Gimon are given to form a baseline

for a comparison with later test results. Those patients who

are three - week patients will also have examinations by

Ms. Hartley and Dr. Gimon at the end of their treat ment period.

The test results are compared with the test results taken at the

beginning of the treatment period.

14. The patient receives an orientation session in which

the patient is informed of the responsibilities that the patient

has during the co urse of treatment. Such responsibilities

include taking blood pressure measurements at prescribed times

of the day, charting the results of the blood pressure test, and

seeing and providing the patient's primary care physician with

the blood pressure read ings. The patient must drink eight

glasses of water a day, unless the patient has a heart disease,

and must avoid certain types of foods that are vasoconstrictors.

15. Once the patient completes the treatment at

Hammesfahr's office, the primary care ph ysician will take over

the medical management of the patient's treatment. Hammesfahr's

office will confer with the patient's primary care physician

after the patient leaves Hammesfahr's office to discuss the

monitoring of the patient and the altering of t he patient's

medication. One week after returning from treatment in

Clearwater with Hammesfahr, the patient must see his primary

care physician.

16. In October 1999, a friend of M.T. mailed M.T. one of

Hammesfahr's advertisements. As result of receiving the

advertisement, M.T. contacted Hammesfahr's clinic and sought

treatment from him for a stroke which she suffered in May 1999.

Hammesfahr sent M.T. an information package and a videotape.

The package contained articles written by Hammesfahr, a

descrip tion of the different programs available, and a price

list for the programs.

17. M.T. decided that she would try a three - day program

for $3,000. There was a dispute as to exactly which program

M.T. received when she went to Clearwater. The only two

pr ograms which Hammesfahr listed as costing $3,000 were the

Executive Stroke Prevention Program and the One - Week Evaluation

and Treatment Program.

18. The Executive Stroke Prevention Program was described

as follows:

This is a three (3) day program in whi ch

patients will undergo CAT scan and MRI at

our facility, state of the art computerized

EEG, and transcranial ultrasound to look at

the blood vessels of the brain. They will

undergo a comprehensive medical review and

family review, as well as recommendat ions

for lowering one's chances of a stroke or to

treat if there has been a stroke in the

past.

This program is not covered by insurance.

19. The One - Week Evaluation and Treatment Program was

described as follows:

This program is designed for those who want

to start the stroke program and have the

program advanced to a level which makes it

significantly easier for the family

physicians at home and neurologists to

continue the program safely and rapidly.

The first days [sic] involved in the initial

evalu ation, as well as any testing such as

EEG and ultrasound testing, if necessary,

and CT scans and MRIs as well as blood

tests, followed by days two through five

being involved in the initiation of medical

treatment in that either treating the

previous strok e or preventing future

strokes. Recommendations are then made to

the family physician or neurologists for

caring through on this program.

20. There was an additional three - day program, Initial

Evaluation and Treatment, which listed for $2,000 and provid ed

the following:

This is a three (3) day consultation and

evaluation with recommendations for

treatment. This program is designed for

patients who are interested in treatment of

their stroke by their family physicians at

home. A comprehensive evaluation will be

made by our physicians as well as treatment

recommendations. This evaluation will

include review of CAT scans or MRIs and

blood tests, and when appropriate,

computerized EEG testing, neuropsychological

testing, and ultrasound evaluations. The

pr ogram is approximately three days.

21. Prior to traveling to Hammesfahr's clinic, M.T. was

directed by Hammesfahr to obtain medical tests from her primary

care physician, which she did. The tests included a CT scan of

the brain, a CMP, liver profile, CBC with different platelets,

Westergren's sed rate, EEG, CVA, and EKG. She was also required

to take and write down her blood pressure two times a day for a

week before going to Hammesfahr's clinic. M.T. also filled out

a medical history form and a sys tem review checklist prior to

her visit to Hammesfahr.

22. In a letter dated February 12, 2000, to M.T. on

Hammesfahr's letterhead, his office staff described the

treatment that M.T. would receive as follows:

Your first visits with us will be quite

long. So, plan accordingly. On your first

day, you will have a consultation with the

doctor. The second day you will have

diagnostic testing in our office, and an

appointment with Dr. Gimon for a neuro -

psychological evaluation and Diane Hartley

for a physical therapy evaluation. Both of

these doctors will be calling you to set up

these appointments. The neuro - psychological

testing will help us to evaluate any memory

changes. You will probably see Dr. Gimon

again towards the end of your treatment. On

Tuesday s and Thursdays there is an

orientation session outlining what we will

be doing here in the office and [sic]

explaining our treatment program will be

given out. Each new patient must attend one

of these sessions. Every day thereafter,

your visit will be at least two (2) hours

long. As you know, our treatment consists

of sessions in this office each day Monday

through Friday for the duration of your

therapy. Please note: No warranties or

guarantees can be made regarding the time,

the degree, or the dura tion of improvement

with this therapy.

23. On February 20, 2000, M.T. signed a Waiver for Use of

Medications, which stated:

I am, or my caregiver is, aware that I have

had a neurological disease and have failed

to respond to other types of medications

used in the conservative management of my

condition. . . . Options available to me at

this time are those now used at the Florida

Neurological Institute. I am aware that the

medications used in this therapy are

medications that have FDA approval.

Howev er, I am also aware that the FDA has

not approved these medications in the doses

and number of medications used here at the

Institute. I am aware that Dr. Hammesfahr

has published many articles on his therapy.

I am aware of the fact that, during the past

two years, the Institute has treated many

patients with similar conditions and that

most have had at least some improvement in

the symptoms associated with their problem.

I have, and my caregiver has, been counseled

regarding this theory under which this

therapy is being promulgated. Upon arrival

at the Florida Neurological Institute, I and

my caregiver, will see and listen to the

videotapes available regarding this therapy.

I have, or my caregiver has, read this

waiver and understands its contents. I am,

and my caregiver is, aware that there is no

indicated use for this therapy now. I have

had all questions I may have concerning the

use of these medications answered, I agree

to undergo the use of these medications as

outlined in the material presented to me.

As stated above, I am fully aware of the

fact that this therapy probably will not be

covered by my insurance, but I wish to

continue with this therapy as outlined to me

in my training and information sessions. I

also understand that no physician, or any

other person in this office, can make any

guarantees of success from this therapy.

(Emphasis in the original)

24. On February 28, 2000, M.T., accompanied by her

husband, presented to Hammesfahr's clinic in Clearwater,

Florida, for treatment. On her first day at the clinic, she

received an orientation. She was required to pay $3,000 for her

treatment. A staff member at Hammesfahr's clinic took M.T.'s

blood pressure and directed M.T. to take her own blood pressure

readings thereafter.

25. On the second day of treatment, February 29, 2000,

M.T. was sent to Dr. Alexander Gimon, a neuropsychologist, for a

30 - minute evaluation. A staff member of Hammesfahr's clinic

gave M.T. a transcranial Doppler, a carotid artery ultrasound,

and an electroc ardiogram. A Physician's Office Visit History

and Physical Examination Form was filled out with a date of

"2 - 28 - 00" struck through at the top of the form and the date of

"2 - 29 - 00" placed next to it. At the end of the form appeared a

physician's statemen t signed by Hammesfahr and dated

February 22, 2000, a week before M.T. presented for treatment,

stating that he had "examined this patient, reviewed his/her

history, and consulted with him/her and the caregiver regarding

the treatment planned here at Flori da Neurological Institute."

An Objective (Physical Examination) form was filled out, again

with the date of "2 - 28 - 00" struck through at the top of the form

and the date "2 - 29 - 00" placed next to it. The form does not

indicate who performed the physical ex amination. The form does

indicate that M.T.'s blood pressure and pulse readings were

taken. M.T. met with Hammesfahr, who observed her gait and told

her that he would send her back home and would work with her

physicians. He did not prescribe any medica tions at that time

and did not give M.T. any medications during her treatment at

his clinic.

26. On March 1, 2000, M.T. was supposed to meet with the

physical therapist, Diane Hartley, for evaluation at 8:00 a.m.

When she arrived at Ms. Hartley's facilit y, no one was there to

let M.T. in the building. When M.T. went into the facility, she

did not like the looks of the building, describing it as "shoddy

looking." She decided that she did not want to stay for an

evaluation and left.

27. The fee Hammesfah r charged M.T. included the fees for

Dr. Gimon and Ms. Hartley.

28. On March 1, 2000, M.T. and her husband returned home

with the understanding that Hammesfahr would be contacting her

doctors in Alabama to arrange for the administering of the

medicat ions. M.T. was told to make an appointment with her

primary care physician for the week after she returned from

Clearwater. Hammesfahr first communicated with M.T.'s

physicians by letter, dated April 5, 2000, asking them to

administer the vasodilators an d magnesium sulfate I.V.'s.

29. M.T.'s physicians in Alabama refused to administer the

medications. M.T. did not take the vasodilators, which

Hammesfahr wanted her physicians to administer; nevertheless,

M.T. improved.

30. Based on the rate schedule pre sented to M.T. for

Hammesfahr's various treatment programs, she should have

received either the Executive Stroke Prevention Program or the

One - Week Evaluation and Treatment Program. Hammesfahr was

adamant that M.T. did not sign up for the Executive Stroke

Prevention Program, and the evidence established that she did

not receive this program. M.T. was given an itinerary that

indicated that she would be treated by Hammesfahr for a week;

however the evidence established that she did not receive the

treatment that was supposed to be given in the One - Week

Evaluation and Treatment Program, which promised that the

initiation of medical treatment would be done on days two

through five. Hammesfahr did not administer any medications or

prescribe any medications for M.T. during her stay in

Clearwater. The evidence does show that M.T. received the

three - day Initial Evaluation and Treatment Program, for which

she should have been charged only $2,000.

31. Hammesfahr presented the expert testimony of Dr. Jacob

Green, w ho is a board - certified neurologist, practicing in

Jacksonville, Florida. He has been practicing for over 35

years. Dr. Green has written papers on the use of transcranial

Doppler, and he is experienced in the treatment of acute and

chronic stroke patien ts.

32. Dr. Green is familiar with the protocol and procedure

utilized by Hammesfahr in treating stroke patients. He has read

articles written by Hammesfahr, reviewed patients' records, and

spent a day in Hammesfahr's office observing Hammesfahr's

prac tice and treatment protocol which is at issue in this case.

While he was at Hammesfahr's clinic, Dr. Green observed

Hammesfahr treat patients, reviewed medical records of patients

when they first came to Hammesfahr for treatment, and compared

the findings in those records to his observations of the

patients' abilities. Dr. Green discussed the treatment and

protocol with Hammesfahr. Based on his deposition testimony,

Dr. Green had a good understanding of the treatment and protocol

used by Hammesfahr for s troke patients.

33. Dr. Green described the standard of care for a stroke

patient as "to do good by the patient, do no harm." According

to Dr. Green, Hammesfahr's care and treatment and protocol

complied with the standard of care.

34. Hammesfahr present ed the expert testimony of

Dr. William Scott Russell, Jr., a retired neurologist with 33

years of experience. In his practice, he had treated thousands

of stroke patients. Dr. Russell retired in October 1998.

Dr. Russell had first - hand knowledge of the protocol used by

Hammesfahr when he treated Dr. Russell for an acute stroke.

Prior to Dr. Russell's being treated by Hammesfahr, Dr. Russell

had reviewed a paper written by Hammesfahr concerning

Hammesfahr's treatment protocol for stroke victims using

vaso dilators. Dr. Russell considered the treatment protocol

espoused by Hammesfahr to not be below the standard of care as

of 1998.

35. In 1996, Dr. Russell experienced a stroke. When he

awoke one morning, he was confused. He went to work and had

difficult y with his abilities to speak and write. Dr. Russell

realized that he was experiencing a stroke and had a technician

in his office run an EEG. He had peer - reviewed some of

Hammesfahr's papers prior to his stroke and was impressed with

Hammesfahr's work. So, he contacted Hammesfahr and presented at

Hammesfahr's clinic for treatment the day he experienced the

stroke. Hammesfahr performed a transcranial Doppler on

Dr. Russell and administered nitroglycerine to dilate

Dr. Russell's blood vessels. Ten minut es after the

nitroglycerine was administered, Dr. Russell's symptoms

disappeared. Within a reasonable degree of medical probability,

the cause of his recovery was the use of the nitroglycerine.

36. Nitrates are used for acute stroke patients when the

pat ient has an extremely high blood pressure. The nitrates

lower the blood pressure and are given intravenously so that the

medication can be discontinued immediately if the blood pressure

should fall too low. There was no evidence presented to

determine wh ether at the time that Hammesfahr administered

nitroglycerine to Dr. Russell that Dr. Russell's blood pressure

was high.

37. At the time of the final hearing, Dr. Russell felt

that he had total recovery from the stroke deficits. He has

reduced his int ake of medications prescribed by Hammesfahr and

has not had a return of the deficits.

38. The Department presented the testimony of four expert

witnesses concerning the standard of care for treatment of

stroke victims: Dr. Harold Charles Friend, Dr. Stev en Novella,

Dr. David F. Scales, and Dr. Thomas Hoffman.

39. Dr. Hoffman has been practicing neurology in

Melbourne, Florida, since 1982. Approximately five to ten

percent of his patients have had a stroke or a cerebral vascular

disease. He has read som e of Hammesfahr's advertisements and

viewed Hammesfahr's article on Hammesfahr's Internet web site.

Dr. Hoffman understands Hammesfahr's protocol to be the use of

medications to increase the cerebral blood flow and the use of

the transcranial Doppler to d irect the medication treatment by

measuring the cerebral blood flow.

40. Dr. Hoffman does not agree that the use of

vasodilators increases the blood flow to the brain. There is a

loss of cerebral autoregulation when a stroke occurs. According

to Dr. Hof fman, the use of vasodilators can decrease the blood

flow to the brain and worsen neurological functioning in acute

stroke patients.

41. It is the opinion of Dr. Hoffman that Hammesfahr's

treatment of stroke patients falls below the standard of care

for acute, subacute, and chronic stroke patients.

42. Dr. Steven Novella is a neurologist and an assistant

professor at Yale University. He received his medical license

in Connecticut in 1993 and obtained his board certification in

neurology in 1998. He tr eats stroke patients and is familiar

with the appropriate treatment for stroke patients.

43. Dr. Novella understands that the treatment for stroke

patients which Hammesfahr advocates is the administration of

vasodilators to expand blood vessels which have an insufficient

blood supply due to constriction. He disagrees with

Hammesfahr's theory, espousing that the blood vessels in the

area of the brain that is not receiving enough blood flow will

dilate as far as they can go and that the blood vessels will n ot

respond to the vasodilators because the blood vessels are

already maximally dilated. Dr. Novella is of the opinion that

vasodilators may be used for stroke patients to reduce the risk

of another stroke when the patient is hypertensive, but that the

vas odilators should not be used as a method of reversing

deficits caused by stroke.

44. Dr. Harold Charles Friend is a board - certified

neurologist, who has been practicing neurology for 26 years. He

practices in Boca Raton, Florida. Approximately five to eight

percent of his practice is dedicated to treating stroke

patients. He is currently treating in excess of 500 stroke

patients.

45. Dr. Friend has reviewed the charts of two patients of

Hammesfahr, an article written by Hammesfahr, some of

Hammesfahr 's advertisements, some newspaper articles, and an

article authored by Hammesfahr, which appeared on an Internet

site. Dr. Friend also saw a patient in his office that had

previously been treated by Hammesfahr. Based on the information

from these sources , Dr. Friend incorrectly understood that

Hammesfahr's methodology was to basically lower the blood

pressure of his patients in an attempt to restore dead cells.

He also concluded that the patients seen by Hammesfahr were also

receiving physical therapy at the time of treatment.

46. Dr. Friend opined that Hammesfahr's treatment of

chronic stroke victims did not comport with the standard of care

recognized in the medical community. He further concluded that

given the medications that Hammesfahr administe rs to his

patients, that one would expect some adverse effects or no

effect on the patients.

47. The only mention in the record of a patient's being

harmed by Hammesfahr's treatment was by Dr. Friend. Dr. Friend

reviewed a medical chart of a patient wh o had worsened after

treatment by Hammesfahr and had to go to another physician,

Dr. Nassar Elmansoury, to correct the problem. The patient had

been prescribed Accupril, ten milligrams four times a day, and

nitroglycerine cream. Both medications are vaso dilators.

48. When the patient presented to Dr. Elmansoury, the

patient was feeling worse and experiencing chest pain,

dizziness, and disequilibrium. Dr. Elmansoury eliminated the

nitroglycerine cream and reduced the amount of Accupril. Within

two weeks , the patient was improved.

49. Dr. David F. Scales is a board - certified neurologist,

who has been practicing for 34 years. He currently practices in

the Jacksonville, Florida, area at the Jacksonville Neurological

Clinic. About 50 percent of his in - pat ient practice consists of

stroke patients. Stroke patients comprise about 20 to 25

percent of the entire practice.

50. Dr. Scales has reviewed the medical records of two of

Hammesfahr's patients, articles written by Hammesfahr,

literature provided by Ham mesfahr to his patients, and

Hammesfahr's Internet web site. Dr. Scales understands

Hammesfahr's theory to be that vasodilators are administered to

dilate the blood vessels in the brain so that more blood flows

through the penumbra, reactivating neurons t hat were in a

suspended state of activation. He does not agree with

Hammesfahr's theory because the blood vessels in the penumbra

would be dilated to the maximum and the medications would dilate

blood vessels in other parts of the body, which would in tur n

take away or steal the blood flow from the blood vessels in the

penumbra.

51. After reviewing the medical records of two of

Hammesfahr's patients, M.T. and M.S., Dr. Scales was of the

opinion that the treatment provided by Hammesfahr did not meet

the st andard of care for the treatment of stroke patients.

52. Having considered the testimony of the experts

presented by the parties, it is determined that the standard of

care for the treatment of stroke patients varies according to

the stage, type, and s everity of the stroke. In the acute

stage, the patient is admitted to the hospital. A medical

history is taken and a physical exam is given, followed by

appropriate laboratory and imaging studies to determine the site

and cause of the stroke. For patien ts seen within three hours

of the onset of the stroke, certain intravenous medications may

be given in an attempt to break up the blood clot. For patients

seen beyond the three - hour point, the treatment is maintenance

of their blood pressure, monitoring o f their vital signs, and

treating any complications that may occur such as pneumonia and

urinary tract infections. Patients may be given blood thinners

to improve the flow of the blood, and medication to increase the

blood pressure in the event the blood pressure is too low.

Patients with severe hypertension, generally a blood pressure

over 220 systolic or 120 diastolic, are given medications to

lower their blood pressure. Patients with asymptomatic

hypertension are treated judiciously during their hospi tal stay

with anti - hypertensive medications, and the blood pressure is

gradually lowered.

53. The standard of care for subacute stroke patients is a

continuation of the treatment given in the acute phase.

Patients will be started on rehabilitation therap y, which may

include speech, occupational, and physical therapy.

54. The standard of care for chronic stroke patients, whom

the physician is seeing for the first time, would be to take a

history to determine what happened, review the medical records

and any imaging studies that may have been done, and review the

treatment they have had. The physician should assess the

patients' risk factors for stroke such as hypertension,

hyperlipidemia, diabetes, and smoking and manage those factors

aggressivelyea tment with antiplatelets such as aspirin or

an anticoagulation medication might be indicated. An assessment

of their neurological functional abilities should be done to

determine whether aids, braces, further therapy, or home care

could be beneficial.

55. Based upon the evidence presented, the treatment

advocated by Hammesfahr is not within the generally accepted

standard of care. However, the evidence is not clear and

convincing that the treatment used by Hammesfahr is harmful to

his patients. There is literature in the medical community that

vasodilators can be used in the treatment of stroke as a measure

to prevent future strokes.

56. There is evidence that in over 200 patients seen by

Hammesfahr that a large percentage improved after being treated

by Hammesfahr. Dr. Gimon tested a group of 168 stroke patients

seen at Hammesfahr's clinic during the period of November 1999

to May 2000 and another group of 163 stroke patients seen during

October 2000 through February 2001. The same battery of tests

was administered to both groups. Dr. Gimon evaluated these

patients on nine separate neurological evaluations that are

standard instruments recognized in neuropsychology. The tests

measured identified areas of brain function, including verbal,

visual, vi sual motor, and conceptual thinking.

57. Both groups of patients were tested prior to the

treatment by Hammesfahr. The patients were tested again

approximately 18 to 21 days after they began treatment at

Hammesfahr's clinic. The test results showed that many patients

showed improvements in the areas tested. The improvements noted

were measured as to a statistical difference so that the

findings could not be attributable to testing error. Some

patients showed no improvement in all areas. The test resul ts

revealed that there was no neuropsychological deterioration of

the patients tested.

58. Diane Hartley tested two groups of Hammesfahr's

patients, who were treated at his clinic during the period of

January to December 2000. Her tests were designed to measure

functional motor improvement from a gross motor standpoint. She

performed tests on the patients prior to their beginning

treatment with Hammesfahr and again approximately two and one

half to three weeks after the patients had begun treatment.

59 . Of the 242 patients tested by Ms. Hartley,

221 patients demonstrated improvement in one or more of the

areas tested and 21 patients showed no improvement. Of the

patients tested, ten received physical therapy from Ms. Hartley

while they were being trea ted by Hammesfahr. These ten patients

demonstrated a significant amount of improvement, which Ms.

Hartley could not attribute solely to the physical therapy they

received.

60. The evidence establishes that Hammesfahr informed his

patients by the use of v ideos, orientation sessions, literature,

and a web site on the Internet of the nature of the therapy and

did not guarantee that the patients would improve as a result of

the treatment. Patients were able to make an informed decision

on whether to try Hamm esfahr' treatment.

CONCLUSIONS OF LAW

61. The Division of Administrative Hearings has

jurisdiction over the parties to and the subject matter of this

proceeding. Sections 120.569 and 120.57, Florida Statutes.

62. The Department has alleged that Hammesfa hr has

violated Subsections 458.331(1)(d), 458.331(1)(n), and

458.331(1)(t), Florida Statutes, which provide:

(1) The following acts constitute

grounds for denial of a license or

disciplinary action, as specified in s.

456.072(2):

* * *

(d) False, deceptive, or misleading

advertising.

* * *

(n) Exercising influence on the patient

or client in such a manner as to exploit the

patient or client for financial gain of the

licensee or of a third party, which shall

include, but not be limited to, the

promoting or selling of services, goods,

appliances, or drugs.

* * *

(t) Gross or repeated malpractice or the

failure to practice medicine with that level

of care, skill, and treatment which is

recognized by a reasonably prudent similar

physician as b eing acceptable under similar

conditions and circumstances. The board

shall give great weight to the provisions of

s. 766.102 when enforcing this paragraph.

As used in this paragraph, "repeated

malpractice" includes, but is not limited

to, three or more claims for medical

malpractice within the previous 5 - year

period resulting in indemnities being paid

in excess of $25,000 each to the claimant in

a judgment or settlement and which incidents

involved negligent conduct by the physician.

As used in this par agraph, "gross

malpractice" or "the failure to practice

medicine with that level of care, skill, and

treatment which is recognized by a

reasonably prudent similar physician as

being acceptable under similar conditions

and circumstances," shall not be const rued

so as to require more than one instance,

event, or act. Nothing in this paragraph

shall be construed to require that a

physician be incompetent to practice

medicine in order to be disciplined pursuant

to this paragraph.

63. The Department must esta blish the alleged violations

by clear and convincing evidence. Department of Banking and

Finance, Division of Securities and Investor Protection v.

Osborne Stern and Company , 670 So. 2d 932 (Fla. 1996); Ferris v.

Turlington , 510 So. 2d 292 (Fla. 1st DCA 1 987).

64. Clear and convincing evidence requires that the

evidence be credible; the facts to which witnesses testify must

be distinctly remembered; the testimony must be precise and

explicit and the witnesses must be lacking in confusion as to

the facts i n issue; and the evidence must produce in the trier

of fact a firm belief or conviction as to the truth of the

allegations sought to be established. Slomowitz v. Walker , 429

So. 2d 797, 800 (Fla. 4th DCA 1983).

65. Petitioner seeks to discipline Hammesfa hr for the

methods that he uses to treat stroke victims. In a similar

case, State Board of Medical Examiners of Florida v. Rogers , 387

So. 2d 937 (Fla. 1980), the Medical Board sought to discipline a

physician for administering chelation therapy for

arter iosclerosis. Chelation therapy is an infusion of a

chelating agent into the blood stream over several hours. In

Rogers , the Medical Board charged Dr. Rogers with a violation of

Subsection 458.1201(1)(m), Florida Statutes (1975) 1 , seeking to

discipline hi s license and to prohibit Dr. Rogers from using

chelation therapy in his practice. After an administrative

hearing, the Medical Board entered a Final Order reprimanding

Dr. Rogers, placing him on probation for one year, and ordering

him to cease and desis t from employing chelation therapy. The

district court of appeal quashed the Final Order. The Florida

Supreme Court affirmed the decision of the district court of

appeal, stating:

Under the particular facts of this case,

we conclude that the Board's a ction

unreasonably interferes with Dr. Rogers'

right to practice medicine by curtailing the

exercise of his professional judgment to

administer chelation therapy. The record

before us fails to evidence a harmfulness as

a reasonable basis for the Board's a ction in

restricting use of this treatment. Cf.

Golden v. McCarthy , 337 So. 2d 388 (Fla.

1976). Furthermore, the evidence

demonstrates that no fraud or deception was

exercised by Dr. Rogers upon his patients

who were fully informed of the nature of the

p rocedure and the possibility of no

improvement. Sanctions were imposed against

Dr. Rogers because he utilized a modality

not accepted by the Board as having been

proven effective, not because the Board

found that the treatment was harmful or that

Dr. Roge rs had defrauded his patients into

believing that chelation treatment was a

cure for their conditions. The Board's

findings do not support a conclusion of

quackery, and the state - imposed limitation

on the administration of chelation treatment

has not been shown by the evidence to have a

reasonable relationship to the protection of

the health and welfare of the public.

Id. at 939 - 940.

66. Based on the Rogers case, Petitioner has failed to

establish by clear and convincing evidence that Hammesfahr has

vi olated Subsection 458.331(1)(t), Florida Statutes. Petitioner

did not establish by clear and convincing evidence that the

treatment harmed Hammesfahr's patients, that the patients did

not make an informed decision to try the treatment, or that

Hammesfahr used fraud or deception to make his patients believe

that they would improve with the treatment he offered.

67. The treatment advocated by Hammesfahr could be

considered an alternative health care treatment, which is "any

treatment that is designed to pro vide patients with an effective

option to the prevailing or conventional treatment methods

associated with the services provided by a health care

practitioner." Subsection 456.41(2)(a), Florida Statutes. In

Subsection 456.41(1), Florida Statutes, the Flo rida Legislature

set forth its intent concerning the use of alternative health

care treatment.

It is the intent of the Legislature that

citizens be able to make informed choices

for any type of health care they deem to be

an effective option for treating h uman

disease, pain, injury, deformity, or other

physical or mental condition. It is the

intent of the Legislature that citizens be

able to choose from all health care options,

including the prevailing or conventional

treatment methods as well as other

tre atments designed to complement or

substitute for the prevailing or

conventional treatment methods. It is the

intent of the Legislature that health care

practitioners be able to offer complementary

or alternative health care treatments with

the same requir ements, provisions, and

liabilities as those associated with the

prevailing or conventional treatment

methods.

68. Subsection 456.41(3)(c), Florida Statutes, provides

that a physician may in his "discretion and without restriction,

recommend any mode of treatment that is in his . . . judgment,

in the best interests of the patient, including complementary or

alternative health care treatments, in accordance with the

provisions of his . . . license."

69. Hammesfahr is offering an alternative treatment. He

has met the requirements of Subsection 456.41(3), Florida

Statutes, by providing his patients with the required

information for the patients to be able to give an informed

consent for the treatment.

70. Petitioner has failed to establish by clear and

con vincing evidence that Hammesfahr's advertising was false or

deceptive. Many of Hammesfahr's patients have improved after

being treated by Hammesfahr. Hammesfahr has had his study of

his first 67 patients reviewed by peers in the medical

community. While the peer review may not be the type that would

be acceptable for many medical journals, it nevertheless is a

study that was reviewed by peers. No evidence was introduced to

show that other doctors are using Hammesfahr's methods; thus, he

is the first phy sician to treat patients successfully to restore

deficits caused by stroke.

71. Petitioner has established by clear and convincing

evidence that Hammesfahr did violate Subsection 458.331(1)(n),

Florida Statutes, as it relates to M.T. The price schedule

f urnished to M.T. indicated several services which Hammesfahr

would perform for a set price. M.T. paid $3,000 for treatment

and did not receive the treatment that would be included for

either the Executive Stroke Prevention Program or the One - Week

Evaluati on and Treatment Program. M.T. received the services

outlined in the three - day Initial Evaluation and Treatment, for

which the cost was $1,000 less that what M.T. paid. Hammesfahr

did exploit M.T. for financial gain by charging her for services

that she did not receive.

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of

Law, it is

RECOMMENDED that a final order be entered finding that

Hammesfahr did not violate Subsections 458.331(1)(d) and

458.331(1)(t), Florida Statutes; finding that Hammesfahr did

violate Subsection 458.331(1)(n), Florida Statutes; placing

Hammesfahr on probation for six months; and imposing a $2,000

administrative fine.

DONE AND ENTERED this 20th day of November, 2002, in

Tallahassee, Leon County, Florida.

_____ ______________________________

SUSAN B. KIRKLAND

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399 - 3060

(850) 488 - 9675 SUNCOM 278 - 9675

Fax Filing (850) 921 - 6847

www.doah.st ate.fl.us

Filed with the Clerk of the

Division of Administrative Hearings

this 20th day of November, 2002.

ENDNOTE

1/ Subsection 458.1201(1)(m), Florida Statutes, provided:

(1) The board shall have authority to deny an application for a

license or t o discipline a physician licensed under this chapter

or any antecedent law who, after hearing has been adjudged

unqualified or guilty of any of the following:

(m) Being guilty of immoral or unprofessional conduct,

incompetence, negligence, or willful misc onduct. Unprofessional

conduct shall include any departure from, or the failure to

conform to the standards of acceptable and prevailing medical

practice in his area of expertise as determined by the board, in

which proceeding actual injury to a patient n eed not be

established when the same is committed in the course of his

practice whether committed within or without this state.

COPIES FURNISHED :

James W. Earl, Esquire

Agency for Health Care Administration

Post Office Box 14229, Mail Stop 39 - A

Tallahas see, Florida 32317 - 4229

Max R. Price, Esquire

Solms & Price, P.A.

6701 Sunset Drive, Suite 104

Miami, Florida 33143

Christopher J. Schulte, Esquire

Burton, Schulte, Weekley, Hoeler,

Poe & Robbins, P.A.

100 West Kennedy Boulevard

Suite 800

Tampa, Flor ida 33602

Shirley J. Whitsitt, Esquire

Agency for Health Care Administration

2727 Mahan Drive, Mail Stop 39 - A

Tallahassee, Florida 32308

Larry McPherson, Executive Director

Board of Medicine

Department of Health

4052 Bald Cypress Way

Tallahassee, Flor ida 32399 - 1701

R. S. Power, Agency Clerk

Department of Health

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399 - 1701

William W. Large, General Counsel

Department of Health

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399 - 1701

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions within

15 days from the date of this Recommended Order. Any exceptions

to this Recommended Order should be filed with the agency that

will issue the Final Order in thi s case.