45 Veterinarians and Licensed Wildlife Rehabilitators in 14 northeast Ohio counties are participating in a GCLDSG Education Fund-sponsored tick surveillance study.
When ticks are found on the animals treated and cared for by the participants, they will be removed and sent to the Vector-Borne Disease Unit of the Ohio Department of Health for identification and, if the ticks are live when received,. they will be tested for diseases.
The GCLDSG funding included recruiting the participants and supplying them with the necessary materials to carry out the study.
The study will cover a 20 week period - May 13 through September 29, in order to try to collect ticks in all three stages of life - larval, nymph and adult. The surveillance study will identify what kinds of ticks are found in northeast Ohio and what kinds of diseases they carry.
This is a pilot program in that it has never been attempted in Ohio before. A similar study, sponsored by the Lyme Disease Association of Ontario has been conducted in Ontario, Canada, where ticks collected from dogs have been identified and tested. And in Michigan, the Michigan Lyme Disease Association sponsored a program testing the blood of dogs for the presence of Lyme disease. Both of those studies were valuable contributors to the verification of the presence of Lyme disease.
The investigative arm of Congress is expected to complete a report later this month outlining potential conflicts of interest at government agencies that shaped the diagnosis and treatment of Lyme disease. The General Accounting Office probe�centering on the National Institutes of Health, the Centers for Disease Control and Prevention and the Food and Drug Administration�reflects growing concern that basic research conducted by government and academic institutions is increasingly influenced by a cash-rich pharmaceutical industry.
�We�re looking at federal activities and procedures,� said Marcia Crosse, the GAO�s assistant director for public health. �As part of that, we�re examining financial conflicts of interest among agency employees and advisers.�
Significantly, the probe will be the first to address criticism that federal agencies failed to devote sufficient resources to manage the disease, which infects 16,000 people each year. Whether Congress will follow it up with legislation remains to be seen. Among the issues reviewed by the GAO have been CDC and NIH research spending, the types of grants issued and reviewed by the NIH, and whether federal officials had ties to doctors at state levels, according to congressional sources.
The investigation also explored potential conflicts involving FDA staff and advisory committee members, who in 1998 approved a controversial vaccine that since has been linked to severe arthritic side effects and spawned dozens of lawsuits, according to a GAO source. The disclosure that the GAO is examining potential conflicts among FDA advisers is spawning anger among a growing number of people. Some argue the vaccine, which is called Lymerix, shouldn�t have been approved and now merits a recall.
�If there were conflicts, this unfortunately may account for why this vaccine got approved in the first place,� said Stephen Sheller, a Philadelphia attorney who has filed lawsuits on behalf of more than 200 people against GlaxoSmithKline Plc, which markets Lymerix. Potential conflicts were noted previously among some FDA advisory committee members. According to the transcript of a May 26, 1998, committee meeting to review the vaccine, one member, Robert Daum of the University of Chicago, was granted a waiver for a perceived conflict. In an e-mail note in response to questions from The Star-Ledger, Daum wrote that the potential conflict involved research for a Glaxo rival. However, he added he has not been contacted by the GAO and has not had any ties to the company.
Two researchers at the State University of New York at Stony Brook, who were consultants to the FDA committee and among several experts given voting rights, had consulting ties to the drug maker, according to the transcript. Raymond Dattwyler did not respond to phone calls and e-mails requesting comment. Patricia Coyle denied any conflict.
�A few years earlier, I�d spent two hours reviewing an animal study for the company. The FDA was aware of this,� Coyle said. �There wasn�t anybody on the committee favorable to the vaccine, but there was good data. And you had to go with the data. But there�s no way anybody could say my consultation was a conflict. I think the GAO is going down a dead end.�
Glaxo, the British drug maker, maintains Lymerix is safe. But at an FDA meeting four months ago, several members of the latest advisory committee scolded the agency for not pushing Glaxo to move faster to conduct follow-up studies on Lymerix side-effect issues.
Another avenue being investigated involves patents sought for diagnosing Lyme disease. One example involved a 1992 patent application filed jointly by the CDC and SmithKline, which Glaxo recently purchased. Two years after the filing, the CDC issued a public health notice recommending doctors rely on two of the same diagnostic markers listed in the patent, but never disclosed the agency stood to gain if the patent eventually was licensed and royalties were paid. Ultimately, the patent was never licensed.
It�s not clear if the patent containing diagnostic markers will be cited by the GAO in its report, but a GAO source indicated the agency has reviewed it as potential conflict. The patent, which resulted from a cooperative research agreement between the CDC and SmithKline, listed several diagnostic markers, or bands, that doctors might use to identify the rashes characterizing Lyme disease. In 1993, an international application was filed. During that period, scientists were trying to better understand Lyme disease in the hopes of finding a workable treatment. Toward that end, a conference was held in Dearborn, Mich., in October 1994 to identify diagnostic markers to be used by the medical community. As it turned out, Barbara Johnson, a CDC employee who also was listed as an inventor on the patent, was a member of the conference planning committee. She also was involved in setting the agenda for the meeting, according a conference organizer.
That committee �came up with the agenda and points of issues to be addressed,� said Eric Blank, a physician who was a member of the Association of State and Territorial Public Health Laboratory Directors, the conference sponsor. �And several of them were in work groups or led the work groups.�
However, Johnson�s involvement wasn�t disclosed by the CDC in its August 1995 public health notice to physicians. The notice, which included the pair of diagnostic markers, was made in the CDC�s Morbidity and Mortality Weekly Report, a widely read and influential compendium of health alerts and recommendations.
Reached at her CDC office in Fort Collins, Colo., Johnson declined to comment.
In a telephone interview, Andrew Watkins, who heads the CDC�s Technology Transfer Office, said the two diagnostic markers mentioned in the original patent and the 1995 MMWR notice aren�t necessarily the same, due to the quirks of scientific analysis.
�I don�t think you can say they are,� he said. �They may or may not be.�
However, sources in the scientific community who are familiar with the patent, but who asked not to be identified, maintained the markers are similar.
In any event, Watkins argued the MMWR recommendation wasn�t influenced by the patent and CDC ethics rules didn�t require the agency to disclose any potential gain that could have been derived from licensing. He also said CDC employees are permitted to benefit from patents in which they are listed as inventors.
He also noted that in early 1995, several months before the MMWR was issued, Pfizer Inc. bought the SmithKline unit that filed the patent application. And shortly afterward, he indicated, the patent was abandoned, suggesting a potential conflict of interest may not have existed by the time the MMWR was issued later that year. Nonetheless, patent filings continued to be made in other countries throughout 1995 as an �economic defense� against other companies that might have wanted the scientific data, according to one scientist, who is familiar with the patent and events surrounding its filings.
One medical ethicist suggested the CDC should have disclosed the potential for profit when the MMWR was issued. �The interesting thing is, they didn�t disclose the patent applications, when those would be worth money if they�re licensed,� said Jon Merz, an assistant professor of bioethics at the University of Pennsylvania.
�Did it really influence the MMWR recommendation? I don�t know. It�s a formality for the institution and the individual. But it�s important to know people on such a panel shouldn�t have patent interests. It would�ve been useful to have a disclaimer. The agency should have been aware of those issues.�
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Quote of the Month
�Physicians of the utmost fame |
(Thank you to Jeri Wright of Indiana for her efforts in inspiring the Governor and for a copy of the Proclamation.) �To All To Whom These Presents May Come, Greeting:
WHEREAS, according to the Centers for Disease Control, Lyme Disease is the most common vector-born infection in the United States; and
WHEREAS, since 1990, Indiana has had 195 confirmed cases of Lyme Disease; and
WHEREAS, the Indiana State Department of Health advises Hoosiers to take precautions when they plan outdoor activities in order to avoid contact with ticks, a known carrier or Lyme Disease; and
WHEREAS, the Indiana State Department of Health is dedicated to increasing public awareness of the severe health problems associated with Lyme Disease and to providing information on how Hoosiers can prevent getting the disease; and
WHEREAS, Lyme Disease is of greatest threat to both humans and domestic animals during the spring and summer months; and
WHEREAS, it is appropriate to set aside time to increase the public�s awareness of the dangers of Lyme Disease-carrying ticks;
NOW, THEREFORE, I, FRANK O�BANNON, Governor of the State of Indiana do hereby proclaim May, 2001 as
IN TESTIMONY WHEREOF, I have hereunto set my hand and caused to be affixed the Great Seal of the State of Indiana at the Capitol in Indianapolis on this 26th day of April, 2001
(signature)
BY THE GOVERNOR Frank O� Bannon Governor of Indiana
ATTEST: (signature)
Sue Anne Gilroy, Secretary of State�
Two men who passed themselves off in Aurora as doctors with cures for multiple sclerosis, Lyme disease and other serious illnesses were arrested Thursday on charges of practicing medicine without a license.
Both men also face charges of receiving fees for representing a cure for an incurable disease.
Police said neither man was ever a physician.
Steven R. Wecther, 48, of the 0-99 block of South Stolp Avenue, Aurora, was being held in the police lockup in lieu of a $500,000 bond. John B. Peterson, 46, of the 400 block of East Pierce Street, Elburn, was being held in lieu of a $50,000 bond. If convicted, each would face up to $250,000 fines and 3 years in prison.
Both men were arrested after a search warrant was executed in their business, known both as LifeCare Systems and Gensys, at 101 S. Broadway. The business has been operating since mid-1998.
Police claimed the men told patients that they could cure them through a 6-month to 2-year antibiotic treatment they had invented.
Charges against the men list five victims from Bartlett, Chicago, Oak Lawn and Prophetstown, Ill. The Illinois Department of Professional Regulation and the Better Government Association initiated the investigation. Aurora police joined the probe earlier this year.
Ticks are the vectors of many zoonotic diseases in the United States, including Lyme disease, human monocytic and granulocytic ehrlichioses, and Rocky Mountain spotted fever. Most known Bartonella species are arthropod borne.
Therefore, it is important to determine if some Bartonella species, which are emerging pathogens, could be carried or transmitted by ticks.
In this study, adult Ixodes pacificus ticks were collected by flagging vegetation in three sites in Santa Clara County, Calif. PCR-restriction fragment length polymorphism and partial sequencing of 273 bp of the gltA gene were applied for Bartonella identification. 29 (19.2%) of 151 individually tested ticks were PCR positive for Bartonella. Male ticks were more likely to be infected with Bartonella than female ticks (26 versus 12%, P = 0.05). None of the nine ticks collected at Baird Ranch was PCR positive for Bartonella. However, 7 (50%) of 14 ticks from Red Fern Ranch and 22 (17%) of 128 ticks from the Windy Hill Open Space Reserve were infected with Bartonella. In these infected ticks, molecular analysis showed a variety of Bartonella strains, which were closely related to a cattle Bartonella strain and to several known human-pathogenic Bartonella species and subspecies: Bartonella henselae, B. quintana, B. washoensis, and B. vinsonii subsp. berkhoffii.
These findings indicate that I. pacificus ticks may play an important role in Bartonella transmission among animals and humans.
Lyme disease can be unrelenting. Even when sufferers feel better after antibiotics, symptoms -joint pain, dizziness, irritability, fatigue-may return. This is chronic Lyme, controlled but not eradicated, in some patients.
Now, Westchester County internist Dr. Daniel Cameron, whose 2,200 Lyme patients since 1997 include 100 Orange and Ulster residents, hopes to determine the best way to treat chronic Lyme. Cameron is recruiting 216 people with recurring symptoms for his Lyme Disease Re-treatment Study.
�Doctors are seeing recurrences but are torn whether they should treat or observe,� said Cameron, of Mount Kisco. �Whenever you have as much Lyme as you do out there, the chances of relapse are quite common. Doctors are puzzled over whether you should treat or not treat.�
Cameron estimates that 30 percent of chronic Lyme patients will suffer a recurrence of symptoms within a year of their initial treatment.
Lyme can be difficult to diagnose because its symptoms mimic those of other ailments. It can go untreated for years, become chronic and respond poorly to antibiotics. The bacteria hides, sufferers test negative, and those who complain of irritability, depression or neurological woes can be misdiagnosed.
Some doctors say patients with recurring symptoms are suffering from �post-Lyme syndrome� and argue the pain is caused by depression, fatigue or other problems, Cameron said.
�Some articles out there say you should not over-diagnose and over-treat Lyme,�� he said �With those warnings, some doctors say they don�t have enough studies to show the benefit of treatment.�
Judy New of Goshen, who has Lyme disease, along with her husband and son, supports the study. She says the medical profession needs to show insurance providers that Lyme can require extensive and lengthy treatment.
�It also should prove that Lyme disease could return and can have just as strong an impact on a person�s health and quality of life the second or third time around,� New said. Cameron is recruiting 108 people who�ve had Lyme and have tested positive again for the illness. The other 108 recruits will be people who�ve had Lyme and are still suffering from symptoms, even though they�ve tested negative.
Two-thirds of the 216 participants will be treated with Amoxicillin, an antibiotic. The others will receive placebos during the 3-month trial. If a patient remains sick during the trial, the patient will be examined and given antibiotics, if they were on placebos. Betty Gross, founder of one of the country�s oldest Lyme support groups, praised the study.
�Re-treatment is the only road out of that jungle,� said Gross, founder of the Westchester Lyme Disease Support Group. �There is no voodoo on the road to wellness.�
If you would like to participate in Dr. Cameron�s study, call 914-666-4665
April 24 (CBS HealthWatch)--They are two doctors: an orthopedic surgeon and a respiratory therapist. Both were healthy. Both volunteered to be inoculated with a Lyme Disease vaccine approved by the federal Food and Drug Administration (FDA). But within 24 hours of getting a second dose of the vaccine, LYMErix, both men had severe swelling and arthritis in their hands.
"And we have no reason to believe that it was anything but the vaccine involved in the development of arthritis," explained Paul Fawcett, MD, Director of the Immunological Laboratory at the Alfred I. DuPont Institute in Wilmington, Delaware, in a speech at the 14th International Conference on Lyme Disease and Other Tick-Borne Disorders, held April 21-23 in Farmington, Connecticut.
�Unless you are in a very high risk group, I would not get this vaccine. Put it this way,� he added, �I could have gotten it for free, but I didn�t.� About 200 listeners -- including doctors, nurses, scientists and Lyme sufferers, some of the latter attending in wheelchairs or aided by canes--applauded his advice.
While LYMErix was not the only topic discussed this past weekend at the international scientific conference on Lyme Disease, it was the prime subject stirring ire for professionals and patients alike. When pharmaceutical giant SmithKline Beecham sought approval in 1998 to distribute the vaccine, several members of the FDA�s advisory board expressed strong concerns that LYMErix could for some people actually cause Lyme-related arthritis and other symptoms. But the vaccine was approved anyway.
�The bottom line is monkey business at the federal level pushed this vaccine through, not giving it fair and balanced and scientific consideration,� claims Karen Vanderhoof-Forschner, founder of the national Lyme Disease Foundation and author of the book, Everything You Always Wanted to Know About Lyme Disease (John Wiley & Sons, 1997).
The U.S. General Accounting Office, an investigative arm of Congress, has launched an investigation into whether some members of the FDA advisory committee that approved LYMErix had �conflicts of interest,� or financial factors that might have motivated their approvals.
�That is one of the issues we are examining,� confirmed GAO Assistant Director Marcia Crosse.
Some already have their minds made up. �Absolutely, it was political. You can make a lot of money with vaccines,� says Janet Humes, a 44-year-old geologist and member of the Massachusetts Lyme Disease Advisory Council to the state Department of Public Health. �We are all lab rats,� adds Humes, who contracted Lyme from a tick 25 years ago.
Distribution of LYMErix began in January 1999. About 1.3 million doses have been sent to doctors� offices. There is no information on how much is still sitting on shelves and how many have actually been vaccinated, but a company spokesperson said it is assumed some 400,000 people have gotten the vaccine, which is given in three doses over a year.
But more than a 1,000 previously healthy people who received LYMErix developed disorders after being vaccinated, experts at the conference say. The complaints range from arthritis to paralysis, partial blindness, fatigue and �brain fog� or confusion.
There's no direct evidence that LYMErix is responsible. Still, some are calling for its removal or a moratorium on its use until long-term studies can be completed.
Lyme Disease, first recognized in the 1970s and traced to ticks, has since become the most common insect-borne disease in the United States. Within days of being bitten, a victim usually develops a bull�s-eye rash at the site. Symptoms include joint pain, nerve palsy, chills, fever, headache and fatigue. In most people, early stage Lyme can be cured with antibiotics. Left untreated, Lyme can lead to conditions including debilitating arthritis and mental disturbances.
Yet, if it is generally treatable with antibiotics, why take a chance with a vaccine? Some tick bites go unnoticed, said James Miller, MD, a microbiology and immunology professor at the University of California at Los Angeles.
�By the time the person comes in and gets a diagnosis, they may already have arthritis,� he warns. But would he line up for LYMErix? �No, I wouldn�t take it,� says Miller.
SmithKline says the concerns about LYMErix are all unfounded, though.
�We have every confidence in the safety and efficacy of this vaccine,� said company spokesperson Carmel Hogan. �There is no scientific evidence� that the illnesses recipients are developing are a result of the vaccine, she added. Indeed, SmithKline has applied for approval to give the vaccine to children. LYMErix is now approved only for people aged 15 to 70.
Bernard Hoet, MD, a physician for SmithKline, said data show the number of people developing arthritis and other maladies after the vaccine is no greater than it is in the general unvaccinated population. �We do not consider arthritis cases (to be) associated with the vaccine,� said Hoet.
And even some doctors who say they�ve seen recipients develop �what seems to be identical to chronic Lyme� say that doesn�t mean all efforts with LYMErix should be halted.
�I�m not sure we should throw the baby out with the bath water,�said Sam Donta, MD, of the Boston University School of Medicine. �The FDA should have made a decision to be a little more cautious with its recommendations for the vaccine.�
Two years ago, Lori Levesque of Embreeville, Pa., was suffering from an array of seemingly unrelated symptoms that baffled her doctors: pain on her right side, weakness, hair loss, blurred vision and chest pain.
�I had about eight specialists looking at me and had gone through three different family practices in the area,� she says. �I had CT scans, ultrasounds, X-rays � and nothing was being found.�
Worst of all, her children, Ryan, 12, Cara, 10, and Ailee, 7, started showing symptoms. �Ryan would come home from school and sit on the bed and stare. Cara would sit on the floor and say, �I don�t feel good.� My baby was a temper tantrum waiting to happen. We were all becoming so ill.�
A friend suggested they might be suffering from Lyme disease, a tick-borne illness that is common in rural Pennsylvania where the Levesques operate a campground. But, Levesque says, she had been tested three times for Lyme disease, and all were negative.
Her illness progressed. One day, as she walked from her home to the campground, �I turned into a farm area and basically had a breakdown. I didn�t know where I was or how to get home.�
Her alarmed husband, Gary, sought out yet another doctor, who listened to her litany of ills and �after a 20-minute conversation, he said, �Mrs. Levesque, you have Lyme disease.�
�He came back with a paper and read a list of symptoms. I had 90% of them,� she says. �No one ever put it together that they were all part of a systemic illness.�
Lyme disease is caused by a corkscrew-shaped bacterium called a spirochete, which is transmitted by the bite of tiny deer ticks or, on the West Coast, by the western black-legged tick. The ticks feed mainly on white-footed mice and white-tailed deer, along with birds and other mammals. As the deer population has grown and expanded its range, the range of Lyme disease has also expanded, though the risk still is highest in the Northeast and Upper Midwest.
It was first identified in Lyme, Conn., in the mid-1970s in children who were suffering arthritis � one of the most common symptoms � and has since become the most commonly reported tick-borne disease in the USA, according to the Centers for Disease Control and Prevention. The true incidence is probably much higher, scientists say, because in some parts of the country doctors see so many cases that they often don�t bother to report them to the CDC. The Lyme disease season begins in late May, when the ticks are in the nymphal stage. Nymphs account for nearly 90% of infections, although adult ticks also transmit the disease. Adult ticks are active from October through June in warmer areas.
Making matters worse, says pediatrician Peter Krause of the University of Connecticut School of Medicine, is that some patients have more than one tick-borne infection. In one study, he says, about 10% of patients with Lyme disease also had babesiosis, a parasitic disease of the red blood cells, and the same may be true for ehrlichiosis, a disease discovered in 1987 caused by a bacterial parasite of white blood cells. Both are carried by the deer tick.
Yale University researcher Durland Fish recently discovered yet another organism carried by the deer tick, a bacterium similar to the one that causes Lyme, but it�s not yet clear whether it causes illness.
Levesque was diagnosed not only with Lyme disease but with ehrlichiosis and babesiosis. She also had human parvovirus, a common childhood infection.
The children were tested and found also to be infected with Lyme, babesiosis and ehrlichiosis. Ryan also had Rocky Mountain spotted fever, a disease transmitted by dog ticks. Then, husband Gary had a cardiogram that showed he needed a pacemaker to regulate his heartbeat. His blood tests turned out to be positive for Lyme, ehrlichiosis and babesiosis. �He had no other symptoms,� says his wife.
�He probably would never have been diagnosed. He just would have had a heart attack.� Today, after months of antibiotic treatment, all are recovering, she says.
Diagnosing Lyme disease can be tricky, scientists say. The ticks are very small, about the size of a poppy seed in the nymphal stage, and can latch on, feed and fall off without detection. Once infected, many people develop a characteristic bull�s-eye rash that is a sure sign of Lyme disease, but often there is no rash, or it erupts on the scalp or elsewhere out of sight. In such cases, the illness can go undetected only to emerge months, even years, later.
Doctors usually make diagnoses based on symptoms and a history of exposure to ticks, followed up by blood tests to detect an immune system response. But the tests are not always reliable, sometimes producing false-negatives, especially early in the infection before the immune response develops.
The wide range of symptoms also can lead to misdiagnoses, says Pat Smith, president of the Lyme Disease Association (www.lymenet.org). In some people, she says, the infection can manifest itself only in brain and central nervous system impairments, ranging from memory disturbance to seizures. Depression, bipolar disorder and tremors are other symptoms, she says, along with disturbances in thought processes. �People call it Lyme fog,� she says.
In such cases, says Smith, only a �very competent Lyme-literate physician� is likely to pinpoint Lyme disease as a cause. The Lyme Disease Association is working with Columbia University to open an endowed research center for study of Lyme and other tick-borne diseases, she says. The association is also part of a coalition of Lyme disease groups backing legislation introduced in March by U.S. Rep. Christopher Smith, R-N.J., that would provide $125 million for Lyme research and physician education. A report from the General Accounting Office assessing Lyme disease research and funding is expected to be completed soon.
Levesque says more research is needed to investigate connections between Lyme disease and other ailments. �In my community, we have people with lupus, multiple sclerosis, Guillain-Barre syndrome,� she says. �They�re getting tested for Lyme and coming up positive. Why not look at the possibility these organisms could be the cause of those diseases?�
David Dennis, a Lyme expert at the CDC�s laboratory in Fort Collins, Colo., agrees with the need for more research. Without clinical evidence, he warns, some patients may latch onto a Lyme disease diagnosis out of a need for an explanation for what is causing them discomfort, not because there�s good evidence of infection. �If we leave it open that Lyme disease can cause anything,� he says, �we give these people false hope and we divert our normal diagnostic pathways, so we may miss another (disease) that can be treated and cured.�
While questions remain about Lyme disease, Dennis says, a great deal has been learned about it.
We�ve been studying this disease long enough under controlled conditions that we know it has a very wide range of manifestations, but we can logically categorize these symptoms of disease based on the stage of infection,� he says. �If we blow it out and say this disease can cause anything without actual clinical studies, we�re straying off into never-never land.�
HARTFORD, Conn., May 31 (UPI) -- A potentially deadly infection carried by the same tick that transmits Lyme disease is emerging along parts of the U.S. eastern seaboard and public health officials are concerned it may be going undiagnosed in many people.
Babesiosis is a parasitic infection carried in mice and other rodents. The disease, carried to humans by ticks, attacks the red blood cells and causes symptoms often mistaken for the flu. Unlike Lyme disease, with its distinctive target-shaped rash, tick bites carrying babesiosis are often undetected. Symptoms appear one to six weeks after a tick bite and can last several weeks or months.
In most people, symptoms disappear without treatment, but in the elderly and those with compromised immune systems -- and especially for people lacking a spleen -- the infection can prove deadly, Dr. Peter Krause, of the University of Connecticut School of Medicine at Farmington, told United Press International.
"Symptoms resemble the flu -- fatigue, appetite loss, fever, chills, muscle pains and headaches," Krause said. "We are concerned that it may be more widespread than we have previously thought."
The disease, once considered rare, is now classified by the federal Centers for Disease Control and Prevention in Atlanta as "emerging" -- meaning that the number of cases is increasing at a steady rate.
[The same tick bite can infect with both Lyme and Babesiosis Ed.] If you would like to receive information on Dr. Shoemaker's FDA-IND, IRB approved study, "Use of atovaquone and cholestyramine in patients with Lyme disease coinfected with Babesia," please call 410-957-1550.
This is a double blinded, placebo-controlled, crossover clinical trial which will enroll thirty (30) patients who have Babesia and Lyme but who are still symptomatic despite antibiotic therapy and cholestyramine, used according to Dr. Shoemaker's complete protocol.
GlaxoSmithKline will provide up to nine weeks of Mepron at no charge for those who enroll. Patients will need to make one trip to Pocomoke, Maryland on the Eastern Shore near Ocean City, Maryland, to enroll. There is no charge for medical services provided.
If you wish to receive an enrollment packet send a self-addressed priority mail envelop ($3.95 postage) to: Ritchie C. Shoemaker, M.D., Chronic Lyme Disease Center 1604 Market Street, Pocomoke, MD 21851
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