In the U.S., Genentech markets rituximab (trade name Rituxan). In Canada, it’s Hoffmann-La Roche. And in Japan, it’s Chugain Pharmaceuticals. Unfortunately, as of this week, Genentech doesn’t appear interested in doing a study on ME. Joseph St. Martin, a spokesperson for Genentech, wrote CFS Central in an email on Tuesday: “We cannot comment on the external data you mentioned [the Norway study], but I can say that Genentech has never studied Rituxan in CFS and currently have no plans to do so in the future.”
I sent a follow-up email yesterday: “Given the success of this small double-blind study, and given the fact that CFS is a serious and sometimes fatal disease that afflicts 1 million Americans and 17 million people worldwide, I find it surprising that Genentech would have no interest in doing a study. Why is there no interest? Is there someone at the company who’d be able to enlighten me on this issue?”
St. Martin kindly emailed back that he'd track down the right person for me to interview, but then emailed today after I followed up: “As mentioned, Genentech has never studied Rituxan in CFS and currently have no plans to do so in the future. We will not be disclosing [any] additional information on this topic.”
In my five minutes testifying before the Chronic Fatigue Syndrome Advisory Committee (CFSAC) meeting last spring, I asked for, among other things, a meeting with Dr. Tony Fauci, head of the National Institute of Allergy and Infectious Disease (NIAID), the same Tony Fauci who has said many times that ME is a psychological disease.
I’d love to report that the two of us met over saketinis, where we chatted sotto voce about ME and then braided each other’s hair, during which time the NIAID director finally had the light-bulb epiphany patients have been dreaming about for decades: ya know, that ME is a devastatingly serious and sometimes fatal disease.
Alas, however, I heard bupkas from Dr. Fauci.
As Gordon Gekko might say, summer is over and business is business. I’ve been hearing the usual fretting about the toothless CFSAC committee meetings, the semi-annual snorefest of how to accomplish absolutely nothing while spending beaucoup taxpayer dollars, as suspicious guards eye patients who can barely move as if the patients are Al Qaeda operatives and the guards are Claire Danes in Homeland.
There has been some debate where to hold the CFSAC protest this year, and I say wouldn’t it be great if people could protest everywhere—the hotel where the meeting has been moved, Health and Human Services, at the homes of all government officials involved in the disease, from CDC’s Dr. Beth Unger on up. But since that’s not feasible, in my view a protest outside Tony Fauci’s office is what’s needed most to shake things up. After all, he’s the one who dictates policy; Beth Unger et. al. comprise merely the foot-soldier battalion.
As I’ve blogged before, ACT UP patients addressed Fauci’s indifference to HIV/AIDS 25 years ago; for a time, activist Larry Kramer affectionately dubbed Fauci a “murderer.” Those strong-arm tactics changed everything for the better. Fauci was just one of the government officials ACT UP gutted and served with fava beans and a nice Chianti.
Dr. Stephen C. Joseph, the Health Commissioner of New York City from 1986 to1989, was another. After proposing that physicians be required to report HIV/AIDS patients to the state, Joseph became a favorite target of ACT UP. According to the Wall Street Journal, he also reduced by 50 percent the estimate of the number of New Yorkers carrying the HIV virus, a momentous shift ACT UP believed would result in diminished funding. ACT UP staged sit-ins in Joseph’s office, tortured him with telephone calls, marched outside his house and threw paint on his house. And, in keeping with Godwin’s Law—in which the probability of a comparison to Nazis/Hitler in a heated debate eventually approaches 1—ACT UP denounced Joseph as a Nazi.
And what did Stephen Joseph do? When he resigned at the end of 1989, he told the New York Times that he credited ACT UP with helping change aspects of a system that had been “unfair and constraining.”
When you stand up to bullies, they back down. Eventually. Most recently, we’ve seen this caving in occur with the Occupy Wall Street protests, as the republicans began dialing back their disdain and even showed on-camera sympathy as the number of protestors and media coverage grew.
Which brings me back to rituximab. Pushing for a study on rituximab now is paramount for four reasons: one, the drug appears to work for ME, which after 30 years still has no drug to treat it; two, drug approval for a disease garners respectability for the disease—and if there’s one thing this disease needs it’s respectability. Three, figuring out exactly how rituximab works on ME may shed insight into the immune abnormalities in the disease and generate more research and effective treatments. And four, at circa $20,000 a year, the drug is prohibitively expensive and insurance won’t cover it for most ME patients, unless they also happen to have cancer, an organ transplant or arthritis.
On the down side, hobbling pieces of the immune system with a drug like rituximab may prove more Band-Aid than magic bullet. It may thrust ME into the autoimmune world that quashes symptoms with immune suppressors rather than address the underlying disease process. That’s the world in which lupus, MS and rheumatoid arthritis currently reside. And it’s also possible that if enough ME patients improve on the drug, no one will devote much energy to searching for a cure—not that anyone does now, but one can always hope. Moreover, rituximab isn’t benign. It can be toxic to the kidneys and leave patients vulnerable to infections and cancers, as it depletes the B cells, key players in the immune system.
Most problematic is that it can, in rare instances, reawaken the JC virus, which infects most people in childhood and is benign in healthy people, but in rare instances in immunocompromised patients it can attack the brain and cause progressive multifocal leukoencephalopathy (PML), which leads to death or brain damage. The best way to detect the presence of the JC virus is through spinal-fluid PCR and an antibody test prior to beginning therapy. However, negative tests don't ensure that patients won’t develop PML due to the drug. For now, it's the jumbled luck of the draw.
All that being said, there’s always a risk-reward ratio for medications, and for some patients rituximab may restore life to their lives. After a disappointing summer, rituximab is huge news and certainly worthy of a bigger study. How do you convince a disinterested drug company or the disinterested U.S. government to conduct a rituximab study on ME? Perhaps this would work: Patients could contact Genentech, Hoffman-LaRoche, Chugain Pharmaceuticals, their congressman and Tony Fauci with a clear and singular message: ME patients need and want a drug study on rituximab. Period. That could be a key message at the November CFSAC meeting and at the demonstration outside Tony Fauci’s office.
Which brings me to my final point, Peter Weir’s amazing 1982 film The Year of Living Dangerously, with Sigourney Weaver, Mel Gibson (before he got creepy) and Linda Hunt. It takes place in 1965 during the political upheaval in Indonesia under then-President Sukarno. Hunt, who plays a male news photographer (and won an Academy Award), plasters a huge banner outside a hotel window at the movie’s climax. It screams in red letters: “Sukarno, feed your people.”
Tony Fauci, help ME patients. Fund a rituximab study.
Rebel Satori Press has just published the novel Beatitude by writer extraordinaire (and my good friend) Larry Closs. The book has nothing to do with ME, but it is a great read. You can purchase the book on the CFS Central Amazon.com store. Click on the book's yellow book jacket on the right-hand column on this page.
Larry is also a filmmaker and created a terrific 1 minute 13 second trailer for the novel. If you look closely, you’ll see a quick shot of the Beat poet Allen Ginsberg and a few shots of actor Johnny Depp (in the goatee):
From the book jacket:
Reveling in their discovery of the legendary scroll manuscript of Kerouac’s On the Road in the vaults of the New York Public Library, Harry and Jay embark on a nicotine-and-caffeine-fueled journey into New York’s thriving poetry scene of slams and open-mike nights.
An encounter with “Howl” poet Allen Ginsberg shatters their notions of what it means to be Beat but ultimately and unexpectedly leads them into their own hearts where they’re forced to confront the same questions that confounded their heroes: What do you do when you fall for someone who can’t fall for you? What do you do when you’re the object of affection? What must you each give up to keep the other in your life?
Beatitude features two previously unpublished poems by Allen Ginsberg.