Conflicts of Interest in Lyme Disease

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Conflicts of Interest in Lyme Disease:

Laboratory Testing, Vaccination,

and Treatment Guidelines

 

 

 

© 2001 Lyme Disease Association, Inc.

All rights reserved.

Contact: LDA PO Box 1438 Jackson, NJ 08527

 

 

 

Conflicts of Interest in Lyme Disease:

Treatment, Laboratory Testing, and Vaccination

 

Lyme Disease Association, Inc.

 

 

 

 

 

April 2001

 

 

TABLE OF CONTENTS

 

EXECUTIVE SUMMARY

 

PART ONE: A Lyme Disease Primer

Section I Symptoms and Scope of Lyme Disease

Section II The Scientific Debates

Section III History: A Story of Medicine and Politics

Section IV Watershed at Dearborn

Section V The Lyme Vaccine

 

PART TWO: LYME DISEASE AS BUSINESS MODEL

Section VI Why Lyme Had to be Redefined

in Order for Products to Reach Market

Section VII Lyme Disease Products and Companies

Section VIII Lyme Disease Patents

Section IX Size of the Lyme Disease Market in US Dollars

 

PART THREE: CONFLICTS OF INTEREST IN LYME DISEASE POLICY

Section X Defining Conflict of Interest

Section XI Laboratory Diagnosis and Conflict of Interest

Section XII Vaccine and Conflict of Interest

Section XIII Treatment Guidelines and Conflict of Interest

 

CONCLUSION

 

PART FOUR: NOTES AND REFERENCES

 

 

 

EXECUTIVE SUMMARY

 

For more than a decade, Lyme disease has been the object of debate. On

one side are academicians, pharmaceutical companies, and government

agencies, who claim the disease is usually mild and virtually always

easily cured. On the other side are chronic Lyme disease patients and

their doctors, who say that infection may survive the standard four

weeks of antibiotic treatment, and that its impact may be debilitating

and difficult to treat.

 

This report adds another dimension to the debate by focusing on Lyme

disease as a business model. An examination of patents, marketing

agreements, and revenue streams reveals the potential for the

appearance of conflict of interest for many of the individuals setting

Lyme disease policy. These policies, created in part to enable the

analysis of data required for product approval, have also served to

disenfranchise large numbers of infected patients no longer meeting

the official standard for diagnosis with the disease. Untreated by

physicians and uncovered by insurance companies, these patients have

become increasingly ill. In the pages that follow we will detail the

straightforward path of revenue and its relationship to multinational

pharmaceutical companies, venture-backed biotechnology firms,

government agencies, and academicians.

 

LDA hopes that Congress and other officials will study the information

presented in this report as a springboard for their own review. Such

review is of the utmost urgency because Lyme disease is the most

rapidly spreading vector-borne infection in the United States,

prevalent not just in the Northeast, but in California, Wisconsin,

Minnesota, and across the continental US. As long as the status quo

is allowed to stand, large numbers of people exposed to this rapidly

emerging infection will continue to go undiagnosed and untreated for

Lyme disease, and will be placed at severe risk for lifelong health

problems, including arthritis, neurological impairment, psychiatric

illness, cardiac illness, gastrointestinal disease, and more.

 

 

PART ONE: A LYME DISEASE PRIMER

 

 

Section I

Symptoms and Scope of Lyme Disease

 

Lyme disease is a multisystemic infection caused by a spiral-shaped

bacterium, or spirochete, called Borrelia burgdorferi. It is most

commonly transmitted to humans through the bite of an infected Ixodes

scapularis or Ixodes pacificus tick in its ecosystem of choice--the

shaded, woody areas of the suburban United States.

 

Though most people still associate Lyme with the single infection

caused by the Bb spirochete, recent studies show it can be far more

complex. Ticks that carry Borrelia burgdorferi may also carry

co-infections such as Ehrlichia and Babesia, leading to a broader

definition of Lyme disease in recent years.

 

" To me, Lyme disease is not simply an infection with Borrelia

burgdorferi, but a complex illness potentially consisting of multiple

tick-derived co-infections, " says Joseph J. Burrascano Jr., M.D., whose

Diagnostic Hints and Treatment Guidelines for Lyme and Other Tick

Borne Illnesses now form a standard of care for many physicians in the

field. " In later stages, it also includes collateral conditions that

result from being ill with multiple pathogens, each of which can have

profound impact on the person's overall health. Together, damage to

virtually all bodily systems can result. "

 

 

 

Geographic Penetration and Rate of Spread

Still most common in Northeast states like New York, New Jersey,

Connecticut, and Massachusetts, Lyme disease is nonetheless spreading

rapidly nationwide; it is already entrenched in a wide range of states

from California and Wisconsin to Texas, Minnesota, and Florida, and

has established footholds in the rest. Lyme disease is prevalent

across the United States. Ticks do not know geographic boundaries. A

patient's county of residence does not accurately reflect their total

Lyme disease risk, since people travel, pets travel, and ticks travel.

This creates a dynamic situation with many opportunities for exposure

for each individual. Almost 15,000 new cases a year are reported in

the United States, but those numbers are deceptively low, according to

estimates from Yale University and elsewhere that some 90% of the

cases meeting CDC research criteria are not reported, bringing the

number of reportable cases to more than 1, 500,000 since 1980 and

more than 130,000 in 1999 alone.

 

The Numbers at a Glance

 

Lyme Disease Cases Reported by State, 1995 – 1999 [1]

 

1995 1996 1997 1998 1999

Alabama 12 9 11 24 19

Alaska 0 0 2 1 0

Arizona 1 0 4 1 2

Arkansas 11 27 25 8 7

California 84` 64 147 135 141

Colorado 0 0 0 0 0

Connecticut 1,548 3,104 2,205 3,434 2,302

Delaware 56 173 109 77 64

District of Columbia 3 3 10 8 6

Florida 17 55 56 71 57

Georgia 14 1 7 5 0

Guam 0 0 0 1 0

Hawaii 0 1 0 0 0

Idaho 0 2 4 7 5

Illinois 18 10 13 14 12

Indiana 19 32 33 39 21

Iowa 16 19 8 27 20

Kansas 23 36 4 13 12

Kentucky 16 26 18 27 19

Louisiana 9 9 6 15 11

 

Maine 45 63 12 78 41

Maryland 454 447 482 659 826

Massachusetts 189 321 290 699 999

Michigan 5 28 27 17 1

Minnesota 208 251 195 261 253

Mississippi 17 24 21 17 13

Missouri 53 52 28 12 28

Nebraska 6 5 2 4 11

Nevada 6 2 2 6 2

New Hampshire 28 47 37 45 26

New Jersey 1,703 2,190 1,933 1,911 966

New Mexico 1 1 1 4 1

New York 4,438 5,301 3,326 4,640 4,091

North Carolina 84 66 34 63 74

North Dakota 0 2 0 0 1

Ohio 30 32 40 47 78

Oklahoma 63 42 35 13 8

Oregon 20 19 20 21 14

Pennsylvania 1,562 2,814 2,062 2,760 2,312

Rhode Island 345 534 409 789 464

South Carolina 17 9 3 8 7

South Dakota 0 0 1 0 0

Tennessee 28 24 44 47 57

Texas 77 97 50 32 35

Utah 1 1 1 0 5

Vermont 9 26 8 11 24

Virginia 55 57 63 73 119

Washington 10 18 10 7 11

West Virginia 26 12 10 13 19

Wisconsin 369 396 478 657 117

Wyoming 4 3 3 1 3

1995 1996 1997 1998 1999

Totals by Year 11,700 16,455 12,289 16,802 13,306

 

*Montana will not accept reports until the B. burgdorferi spirochete

has been isolated from two stages of infective tick.

 

According to Dr. Robert Schoen, clinical professor at Yale University

School of

Medicine, " the significant increase of cases of Lyme disease …

beginning in the early 1980s " [2] represents the spread of Lyme

disease from longtime endemic areas to adjacent geographical regions.

" For example, in Connecticut in a 12-town region around Lyme, which is

highly endemic for the disease, the number of cases over the past five

years or so has been fairly stable. But throughout the rest of the

state, we see many more cases in other counties, such as Fairfield

County, Litchfield County, and New Haven County. And it is this

geographic spread of the disease, " says Schoen, " which seems to result

in these additional cases. "

 

" Several lines of evidence suggest that Lyme disease is very much

underreported, " Yale University's Robert Schoen told an FDA panel in

1998. [3] " Data from Maryland as well as ... from Connecticut all

point to the fact that perhaps only about 10 percent of cases ... are

actually reported by physicians .... In a study done by Matthew Carter

and associates at the Connecticut Department of Health, you can see

that through an active surveillance, they identified about 1,000 cases

among 400 physicians who maintain an active Lyme disease surveillance.

With almost 11,000 practicing physicians in Connecticut, the number of

cases reported was only about 10 percent of the expected reporting. "

 

Misdiagnosis

In addition to the 90% of Lyme cases Yale's Dr. Schoen says are

diagnosed but never reported to the CDC, there are those that simply

go unrecognized. Many, including frontline medical professionals,

consider the patient report of a tick bite and a definitive " bull's

eye " rash as prerequisite for diagnosis. But fewer than 50% of

patients with Lyme disease recall a tick bite. In some studies this

number is as low as 15% in culture-proven Lyme borrelial infection.

Likewise, fewer than 50% of patients with Lyme disease recall citation

any rash; and although the bull's eye presentation is considered

classic, it is not the most common dermatological manifestation of

early-localized Lyme infection. Atypical forms of this rash, taking on

a large variety of forms, are seen far more commonly. It can last a

few hours or up to several weeks. The rash can be very small or very

large (up to twelve inches across), and can imitate such skin problems

as hives, eczema, sunburn, poison ivy, fleabites, and so on. The rash

can itch or feel hot or may not be felt at all. The rash can disappear

and return several weeks later. For those with dark skin the rash may

look like a bruise.

 

But most practitioners, even those in endemic areas, simply are

unaware of the complexity and diverse presentation. Addressing a

recent FDA hearing on antimicrobials for early Lyme disease, [4] SUNY

Stony Brook rheumatologist Raymond Dattwyler noted that in the heavily

endemic area of Long Island where he himself works, practitioners,

including pediatric infectious disease experts, regularly fail to

recognize the EM. " One guy at our hospital was teaching the house

staff that erythema migrans was always a flat lesion, " Dattwyler told

the FDA, and " that if there was any edema in the lesion that it

couldn't be erythema migrans. " Dattwyler pulled out some

culture-positive lesions to show his SUNY Stony Brook colleague that,

indeed, the EM rash could be raised as well, hopefully preventing any

more young physicians in his charge from mastering the wrong set of facts.

 

Often, Dattwyler added, patients remain ill because physicians fail to

recognize or diagnose " other tick & #64979;borne infectious diseases that are

in these endemic areas. Certainly, Babesia and Ehrlichia (HGE) are

becoming more common. HGE and Babesia carriage rates in our ticks are

quite high in the Northeast, so that it is not uncommon that 20 to 30

percent of the ticks that are infected with Borrelia have another

pathogen, as well. " If the co-infections are untreated, patients

treated for Lyme alone may not get well.

 

The Great Imitator

When, due to these diagnostic errors, patients are treated

insufficiently or not at all, they become extremely ill. Since the

Lyme spirochete can infect virtually any organ in the body, it can

mimic many other diseases. Called " The Great Imitator, " it has been

misdiagnosed as multiple sclerosis, Parkinson's disease, lupus,

Alzheimer's, arthritis, amytrophic lateral sclerosis (Lou Gehrig's

disease), fibromyalgia, Guillain-Barré, and chronic fatigue syndrome,

among others.

 

 

Several days or weeks after a bite from an infected tick, a patient

usually experiences flu-like symptoms such as aches and pains in

muscles and joints, low-grade fever, and/or fatigue. But no organ is

spared. Other possible symptoms include:

· Jaw -- pain, difficulty chewing

· Bladder -- frequent or painful urination, repeated " urinary tract

infection "

· Lung -- respiratory infection, cough, asthma, pneumonia

· Ear -- pain, hearing loss, ringing, sensitivity to noise

· Eyes -- pain due to inflammation, sensitivity to light, sclerotic

drooping of

eyelid, conjunctivitis, blurring or double vision

· Throat -- sore throat, swollen glands, cough, hoarseness, difficulty

swallowing

· Neurological -- headaches, facial paralysis, seizures, meningitis,

stiff neck,

burning, tingling, or prickling sensations, loss of reflexes, loss

of coordination,

MS-like syndrome

· Stomach -- pain, diarrhea, nausea, vomiting, abdominal cramps, anorexia

· Heart -- weakness, dizziness, irregular heartbeat, myocarditis,

pericarditis,

palpitations, heart blockage, enlarged heart, fainting,

inflammation of muscle or

membrane, shortness of breath, chest pain

· Joint -- arthralgias or arthritis, muscle inflammation and pain

· Other Organs -- liver infection, elevated liver enzymes, enlarged

spleen, swollen

testicles, irregular or ceased menses

· Neuropsychiatric -- mood swings, irritability, poor concentration,

cognitive loss,

memory loss, loss of appetite, mental deterioration, depression,

disorientation, sleep disturbance

· Pregnancy -- miscarriage, premature birth, birth defects, stillbirth

· Skin -- single or multiple rash, hives

The symptoms may occur in any combination, in any sequence, and over

any time frame.

 

Neuroborreliosis

Over the years doctors have discovered that Lyme disease, if not

treated early or sufficiently, can trigger a host of neuropsychiatric

symptoms as the spirochete disseminates throughout the central nervous

system and the brain. Dr. Brian Fallon, [5] an associate professor of

clinical psychiatry at Columbia University and director of the Lyme

Disease Research Program at the New York State Psychiatric Institute,

explained that the spirochete is quite efficient and can spread to the

brain even before the " bull's eye " rash appears (if it does at all.)

 

contimued......

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