TELL THE FDA: What Have Your Experiences Been on Ampligen?

The Food and Drug Administration (FDA) will once again decide this winter whether the experimental drug Ampligen, which has helped many ME patients recover or improve, should be approved.  Should the drug be approved, it will be an ME game-changer. 

Oddly, little has been discussed on the boards about Ampligen this time around—perhaps because the drug’s been up for approval several times before—and that’s too bad, because an approved drug would help legitimize the disease, provide much-needed treatment for patients, and signal to other drug companies that the disease is worthy of effective medications—and not psychobabble.

Eighteen years ago, I wrote a piece on Ampligen for Philadelphia magazine called The AIDS Drug No One Can Have. Back then the drug proved remarkably helpful for both ME and HIV/AIDS.  Many patients went from bedridden to returning to work and school and a few with ME whom I interviewed who’d been ill for only a few years completely recovered. 

Then the FDA pushed for a change to make the intravenous drug easier to administer; it’s not clear if the new formulation is as effective, but many patients have continued to report improvement.

The FDA has tentatively scheduled the review process to begin December 20 and to continue to February 2. 

In the meantime, the FDA wants to hear from patients by November 1 about their experiences with ME, including how drugs like Ampligen have helped in treating the disease. The FDA is also interested in learning about the emblematic endpoints that should be used in reviewing ME drugs for approval. Fatigue, for instance, is a a subjective and often inaccurate marker with ME. Improvement in post-exertional malaise would be a far more significant marker. 

Patients can submit comments about Ampligen to the FDA directly here or send in comments and I'll post them on CFS Central and forward them to the FDA. Pressure needs to be placed on the government so that these agencies will be forced—kicking and screaming—to do the right thing by patients.

Team Science

 

Recently Dr. Dennis Mangan, retired NIH chair of the ME/CFS Research Working Group, penned a problematic piece with the convoluted title “Writing an NIH grant application—Team science: Playing in the same sandbox.”

Mangan delivered the news that ME deserves research. The anticipated “but” arrived in no time with the word “regrettably” as in “Regrettably, Congress is now talking about a decreased budget for non-defense related ‘discretionary’ expenses… such as NIH-supported medical research. The success rate for applications is likely to decrease. Opportunities for additional research on ME/CFS will be lost.”

Pass the potatoes. I should add that I once worked for a boss who couldn’t give me a raise but had a wastebasket worth $14,000.

Mangan went on to discuss how researchers working on a team science project should “know their collaborators,” get input in the early planning stages, decide who should be a “team leader,” and get “everyone fully committed to the project.” Who the hell is this piece for?  Children? You know, when my niece was about 5 years old, she saw a photo of the Backstreet Boys on the cover of my Entertainment Weekly. Pointing to their white T-shirts, she said shrewdly:  “Those boys are on the same team.”  

With what passes for wit in the government, Mangan drove home his point by including a lame T-shirt in his piece:

In a follow-up letter came Mangan's inevitable catch-22:  Until we have a "breakthrough" about ME, the government won't throw any meaningful money at it.

In my view, the only redeeming things about the Mangan missive were the brilliant, piercing letters by ME patient Matthew Lazell-Fairman and CFIDS Association board member Jennifer Spotila. In particular, Lazell-Fairman discussed the concept of “will”—or the lack of it, when it comes to the government’s longtime lip service to ME. 

In her letter, the CFIDS Association’s Kim McCleary hurled a bunch of statistics, always guaranteed to bore readers to death. I have no recollection of any of it, as I had to hold my head to keep it from exploding. Please stop doing this, Kim. See the forest through the trees.

A man I used to sleep next to had the bizarro habit of squirming uncontrollably before falling asleep, making it impossible for me to fall asleep. So we devised a code word for keeping still: “tomato.” And he’d remain blessedly still until I slipped into unconsciousness. I have no idea how we arrived at “tomato,” except that we both loved Jersey tomatoes (with coarse sea salt), so it conjured pleasant thoughts.

Maybe ME patients need a code word for “cut the crap,” when it comes to government mumbo jumbo. What should it be?

The Blood Became Sick

A disease discovered about eight years ago is spreading in Asia and parts of the United States. Its victims, most of whom are Asian, are HIV-negative. Their immune systems are paralyzed due to the body churning out autoantibodies that inhibit gamma interferon, which fights infections. For more:  click here.

The Secret Files

Slogging through the sealed U.K. ME files that have finally been released isn't exactly like combing through Girl with the Dragon Tattoo material. But a few of the many entries--most of which concern disability eligibility--may prove illuminating, despite the fact that the patronizing author of what may be the most problematic entry is unknown: The beginning of the letter and signature are missing. The mystery writer intones, "It is important to avoid anything that suggests that disability is permanent, progressive or unchanging. Benefits can often make patients worse." 

Next, psychiatrist Simon Wessely penned an enlightening letter, writing to the Department of Social Security on June 10 of 1993 that ME is a psychiatric disease but that its "powerful lobby group" has earned ME a coveted slip in the neurological harbor.  Explains Wessely:

"I  regret to say that it seems to me that in order to be fair to the ME Association you have now gone to the other extreme. I am disturbed that this disorder should be listed as a neurological disease. I enclosed an editorial that I had written last year for a neurological journal reviewing the evidence on this subject, and concluding that there was little to point to a neurological origin of symptoms. Since then more research has been published in the leading neurological journals, and nothing has happened to alter those conclusion [sic].

"Instead I feel this decision represents the triumph of an effective lobby over scientific evidence. If CFS/ME is to be listed as a neurological disorder, I for one will begin to campaign via the mental health charities for schizophrenia and manic depression to be also listed under the same heading. Indeed, there is far more evidence suggesting that these disorders have a neurological origin than does CFS/ME.

"I also feel that this decision, if it has been made, reflects an undesirable stigmatisation of psychiatric disorders. The main difference between CFS and the major psychiatric disorders is neither aetiological, nor symptomatic, but the existence of a powerful lobby group that dislikes any association with psychiatry."