From noon to 3 p.m. on Monday, ME/CFS patients in the U.K. are staging a virtual and onsite protest to mark the 25th anniversary of London’s St. Bartholomew’s Hospital ME/CFS service. The hospital itself, however, is 900 years old, having been founded in 1123 by a courtier in King Henry I’s court. The hospital’s future seemed precarious 400 years later, when King Henry VIII—the king who beheaded or divorced four of his six wives—ordered the dissolution of the monasteries, thereby depriving the hospital of income, until King Henry VIII reendowed Barts shortly before his death, in 1546.
Many ME/CFS patients believe that the treatment they’ve received at Barts is more appropriate for medieval times than today.
Rosie O’Grady (not her real name) is one of them. The 43-year-old disabled lawyer hails from Ireland but lives in England with a severe case of ME/CFS. Before she became ill in 1996, she reminisces, “I rowed on the weekends on the Thames with a rowing club in Greenwich. I loved traveling and my friends. My life was very full.”
All that changed 14 years ago when she became ill with a flu from which she has yet to recover. She was an outpatient at Barts several times from 1997 to 2005. To get government benefits in the U.K., she explains, there’s “intense pressure to show you’re doing ‘treatment.’ If you had a private income, you would not go there.”
O’Grady says the doctors and rehab team at Barts wanted her to become as physically active as possible. “I was told by the physio there everyone could do 10 percent more activity every few weeks. They told me that any time I felt unwell [I should] go for a walk and the fresh air would wake me up. I completely placed my trust in them,” she says, but like most patients with ME/CFS pushing herself only made her worse. “Some days my power to my fingers was so weak I could not pick up a coin,” she remembers. “I was desperate to get well and would have done anything they said.”
Her ME/CFS case was so severe that she moved into a YMCA where all food and services were provided. “I could not even change the duvet on my bed,” she says. “I was unable to make a cup of tea and stay awake to drink it.” Today she is bedbound or in a wheelchair, unable to work or remain upright for more than few minutes at a time. She believes that her time at Barts contributed to her ill health. Her sojourns there left her physically weaker and “emotionally spun out from the lies and double speak.”
Frustrated by the care at Barts, O’Grady made an appointment with a rheumatologist at a different hospital, who prescribed anti-inflammatories to treat the pain in her back and neck, which proved helpful. When she had given her Barts doctor the same list of rheumatologic symptoms, “he looked bored, said nothing and started cleaning his fingernails,” she recalls. “Another doctor claimed they didn’t need to run many tests on ME/CFS patients because “they would know the results simply by looking at the patients.”
Patients interested in participating in an open-label trial for the experimental ME/CFS drug Ampligen should contact Ali Allen or Kristin Pierce at Dr. Lucinda Bateman's office in Salt Lake City, Utah, for more information. Depending in part upon patient response, Bateman may elect to conduct a trial in 2011. With an open-label trial, all patients receive the investigative drug.
The drug cost will be approximately $6,700 for the first six months, which will include extensive testing to determine eligibility, and $7,200 for each additional six-month period. In addition, there will be procedure expenses (infusion costs, bloodwork, X rays, EKGs and other testing) of approximately $6,900 every six months, plus administrative costs of approximately $1,500 every six months. For six months, expect to shell out more than $15,000 to participate in the study, plus housing costs if you're not from the area.
To qualify for the study, patients must be able to visit the clinic up to six times during the first 10 weeks for baseline testing before receiving the intravenous drug Ampligen. Once you begin the drug, you must reside in the Salt Lake City area and visit the clinic at least twice each week, for one- to two-hour visits, for at least six months.
Dr. Suzanne Vernon, scientific director of the CFIDS Association, recently penneda commentary on three recent XMRV studies. Two of them—the Barnes study in England and the Henrich study in the U.S.—failed to find XMRV. Only the Donaldson study at Baylor College of Medicine in Houston found XMRV, in prostate cancer patients.
Henrich looked at several groups of immunocompromised patients, including those with CFS, HIV, transplants and rheumatoid arthritis. Barnes examined the blood of patients with HIV or hepatitis C.
By email, I asked Vernon to expound on these two XMRV negative studies. Her comments are in green.
CFS Central: In the Henrich and Barnes studies—unlike the Lombardi 2009 Science study—the researchers calibrated the PCR assay with a synthetic clone instead of a clinically positive sample. Synthetic clones have been used to calibrate PCR assays in other studies, including Dr. Myra McClure’s XMRV study done in England last winter. As you know, McClure is also one of the authors on the new Barnes study. Do you believe using a synthetic clone may have contributed to Barnes and Henrich not finding XMRV? Why or why not?
Suzanne Vernon: Negative results could indicate that assays are not sensitive enough. Positive controls and gold standards for XMRV detection in peripheral blood are needed.
CFS Central: In addition, Henrich and Barnes examined HIV patients for XMRV—and didn’t find it. There is significant evidence to suggest that infection with two retroviruses is unlikely, that infection with one retrovirus helps prevent infection by another, a phenomenon known as retroviral superinfection resistance (http://www.retrovirology.com/content/2/1/52). Would you comment on the possible role of retroviral superinfection resistance and negative XMRV findings in these patients?
Suzanne Vernon: The immune response to viruses that express similar antigens may help prevent dual infection. However, the role of superinfection resistance as it relates to XMRV has not been extensively explored.
CFS Central: Moreover, some of the HIV patients studied had been on ARV [antiretroviral] therapy. Do you believe being on ARVs could have made it more difficult to find XMRV in these patients?
Suzanne Vernon: It is possible although the chronic HIV cohort had not received highly active antiretroviral therapy for an average of 14 months.
CFS Central: Concerning the Henrich study, your article states that 32 patients met the Fukuda definition of CFS. However, in actuality these patients didn’t meet the Fukuda definition; they met the Empirical definition. The work of Dr. Leonard Jason has shown that 38 percent of patients who meet the Empirical definition actually have major depression. I think it’s an important point that Henrich is studying patients who don’t meet the Canadian or Fukuda definition, and who may be suffering from depression, not CFS. Would you explain your point of view concerning the CFS definition in this study?
Suzanne Vernon: Henrich et al used the 1994 CFS case definition criteria which is considered the revision of the 1988 CFS case definition published by Holmes. We have confirmed use of the 1994 criteria with the investigators. No one other than CDC has used the empiric approach in research.
CFS Central: You mentioned in your review that investigators should seek to replicate “as much as possible the features of the CFS patients found to be positive for XMRV and related MLVS in the studies published in Science and Proceedings of the National Academy of Sciences.” Shouldn’t a replication study replicate the patient group selected for the Science or PNAS studies precisely, by using the same definition—particularly in light of the divergent findings published and the resulting confusion that patients and researchers have been grappling with for a year? Thus, in these XMRV studies, shouldn’t patients meet the 1994 Fukuda definition and/or the Canadian definition of CFS, while weeding out the Empirical patients used in the Henrich study? Why or why not?
Suzanne Vernon: Study subjects in replication studies should be as similar as possible to those studied by Lombardi et al and Lo et al and should meet 1994 and/or Canadian.
Dr. Michael Snyderman, an oncologist with Chronic Lymphocytic Leukemia and ME/CFS, started the HIV drug AZT five months ago to treat both diseases. Five days after beginning AZT, he added another HIV drug, raltegravir (Isentress). The third FDA-approved HIV drug shown in test-tube studies to be effective against XMRV is tenofovir (Viread), which he plans on adding to the mix next month. "I haven't started tenofovir yet because I want to collect enough data to sort out what is happening," Snyderman explains. He calls his cocktail a boilermaker.
For the year before he began the HIV meds, Snyderman experienced lower extremity neuropathic pain but couldn't figure out why. And for a few weeks before beginning treatment he became more fatigued than usual and couldn't concentrate by the end of the workday, "which isn't good if you are taking care of sick people, so I started thinking I would have to retire." In addition, his pain had become "agonizing."
During the first two weeks of treatment, there was no improvement, and the only drug side effect was mild nausea. At the third week, however, the pain resolved completely and his concentration and energy began to improve. "I am still tired though maybe 25 percent better," Snyderman says. "I believe it must take a long time to heal the damage done directly by the virus and done by the elevated cytokines. Stopping the virus and lowering the cytokines must be important and should be our initial goal, but there are other issues like dealing with the deconditioning. I am not an expert on CFS so I can't go beyond that."
On the HIV drugs, Snyderman's elevated cytokines have normalized, and his cancer markers have improved as well.
The British advocacy organization Action Now begins its new “Policy Change: NOW” campaign today. The campaign, which will run for two weeks, was inspired by the “Time for Action” campaign started by three ME/CFS patients in the U.S.
The U.K. campaign dovetails with today’s demonstration at the Department of Health in London. Today marks the first day that British ME/CFS patients are banned from donating blood.
A spokesperson says that today’s protest was organized in response to the government position that there is no infectious pathogen associated with ME/CFS and that the British ban is in place for only one reason: to prevent patients’ health from getting worse. For more information on the campaign, click here.
Action Now has developed a foreboding two-color print ad campaign: