Note from the Rat: The medication I refer to as “daclizumab” back in 2011 is expected to be marketed to the public as “Zinbryta.”
It is good to ask questions. Even when the answers aren’t always pleasant—especially when the answers aren’t pleasant.
No one likes to ask questions when things are going well. My first months on daclizumab went really well, so I didn’t bother to ask my nurse about the origin of the clear liquid dripping down the IV tube into my veins. Whatever it was, it was working. My multiple sclerosis symptoms were fading into the background. I couldn’t ask for more than that.
So I didn’t.
Month after month, I had the same nurse arrive at my home for infusions. We took to chatting. The heparin scandal came along, taking the lives of 81 Americans who had assumed—as I’d assumed—that nothing fatal could be lurking in a labeled medication. That month, the nurse told me it wasn’t necessary to flush my veins with heparin. I gave her the go-ahead to use it anyway. I didn’t want to mess with success. Eventually, though, I think we may have agreed to skip the heparin flush. Daclizumab kept on working, either way.
The January 2010 home infusion seemed no different than the others. Neither of us knew it would be our last. As usual, my blood pressure was low, as was my temperature—96.8. As usual, I had no troubling new symptoms to report. The drip itself never took all that long—maybe 15 minutes— and as usual, the nurse and I chatted those minutes away. The nurse mentioned she’d seen me lifting weights at the rec center while she’d been walking the track. I told her it would be OK to interrupt me the next time she saw me there. Neither of us could have guessed there wouldn’t be a next time.
I didn’t start to feel funny until the nurse was gathering her bags to leave. Even then, I didn’t feel funny enough to stop her. My temperature shot up during the interval between the thud of the front door and the clap of the screen door —the screen door hinge is on backward, which makes for a thirty second delay.
I headed straight for the couch, and caught a glimpse out the window of the nurse’s car pulling away. I lay down. Something wasn’t right. At that time in my life, it was unusual for me to lie down while the sun was still shining. I dragged myself off the couch and up the stairs to take my temperature. 98.8.
I wasn’t sure if I should call the nurse. Everybody knows 98.8 is not a fever. But 98.8 was two degrees higher than my temperature of just half an hour before. I was comfortable with that nurse. Even so, I didn’t want her to think I was a big baby. Or a hypochondriac. Or a fool. But then I got to wondering about the contents of that IV bag. Who was to say it wasn’t tainted, like the heparin a while back?
I swallowed my pride. I called the nurse and left a message.
It was a good thing I did.
The high temp resolved itself without any apparent consequence. I felt sheepish when the nurse returned my call that afternoon. But then I heard her news. I quit being sheepish, and shifted into high alert.
Apparently, after listening to my message, she’d called the pharmacist to ask about my drug.
“Guess what he told me? He said I just gave you the last of that medication. It’s been taken off the U.S. market.”
I asked if there’d been another safety scandal. She assured me there had not. “Someone’s bought the entire inventory.”
I wondered aloud, “When was anyone going to tell me?”
The nurse didn’t have an answer for that.
If I hadn’t gotten that little spike on my temperature, I could have easily gone another month without knowing I had to line up a new MS medication. I’d already gone through all the standard MS meds, with no positive results, which was why I was taking an off-label drug in the first place. I didn’t know what I would do without daclizumab. There wasn’t another drug out there I knew of.
There’s a happy ending to this little anecdote.
Yes, it’s true I didn’t get the answer I expected when I asked about my medication. But that unexpected answer motivated me to ask more questions. I managed to track down Bibi Bielekova, the neurologist and researcher who had first put me on daclizumab. She had a new gig at the NIH. I sent her an email on a Saturday, asking for her guidance. She replied almost immediately.
Once again, I didn’t get the answer I expected. Her email contained an offer I couldn’t refuse.
As it turned out, Dr. Bielekova was the one who had gathered all the remaining stock of daclizumab. She’d just negotiated a clinical trial for the next generation of daclizumab, called DAC HYP. She would be switching her patients who’d been on daclizumab long term to this new preparation. She wasn’t sure, but she thought she might have an opening to accommodate one more patient in the trial. My flights would be paid for. Then came the clincher, “The care at NIH, including the drug, is free.”
Now you know how I can afford to make all those trips to DC; I happened to ask the right question of the right person at precisely the right time. I’m going to try to make a habit of that.
My next entry will be a review of the formidable book, Dangerous Doses, written by Katherine Eban, another woman who isn’t afraid to ask questions about medications. The answers she’s uncovered may disturb you. Or they may just motivate you. Dangerous Doses has certainly motivated me. Our drugs are too important to remain a mystery.
“Lies are what the world lives on, and those who can face the challenge of the truth and build their lives to accord are finally not many, but the very few.” -Joseph Campbell
When I first went on daclizumab, I was euphoric. After going through six neurologists, and three MS medications, I finally found a brilliant neurologist who had uncovered an off-label medication that appeared to actually work.
My husband remained unmoved. He girded himself for every outcome, including the possibility that the medication would fail.
I shared his neutrality. At first. But then daclizumab surpassed my expectations. I had wanted nothing more than a medication that would prevent further exacerbations. What I got was a medication that did all that and more. Suddenly, I felt…able. I was able to hike and swim and lift weights. So I did. I pushed my suddenly able body to astonishing new limits. I rode the wave. I soared. My husband stood steadfast, like a beacon on the shore. He appreciated my toned body, but he didn’t expect it to last.
Indeed, it didn’t last.
No body lasts.
Years passed. My physical capabilities became less and less astonishing. I had very much enjoyed becoming super-fit. As my physical parameters kept shrinking, I kept pushing back. It was with great reluctance that I finally learned to stop wanting more of my body than it can deliver.
This week, my hard-won acceptance was put to the test. I would have to also learn to stop wanting more of my medication than it can deliver.
The moment of truth arrived on Tuesday. I finally received the news my husband has been girding against ever since I started taking daclizumab, shortly after Tysabri was pulled from the market in ‘05. In all that time, my MRI’s have always come back with no further lesions. I’ve been lucky.
I’ve kept up on the preliminary results of the daclizumab trials, and while they are impressive, I couldn’t help but notice there hasn’t been a 100% cessation of disease activity across the board. Something had to give.
Now finally, something has.
My latest MRI came back with one enhanced lesion.
Just one little lesion, located in the so-called “silent area.” My local neurologist doesn’t think one lesion would be worth attacking with steroids. (And I must say, I’m relieved.)
The news of the MRI didn’t shock me. It was almost a comfort. I already knew I wasn’t well. It actually felt good to have some confirmation that there was a reason, even if that reason was inconveniently screaming from the “silent area.”
Daclizumab has worked wonders for me. But it is what is. It’s a medication—the best I’ve ever taken. It is not a miracle. It is not a cure.
Daclizumab is fallible. Just like me. That doesn’t mean it’s a failure.
I’m glad I haven’t been afraid to hope. Hope did me no harm, after all. Yes, I was once euphoric, but with good reason. I’d been given a reprieve. When the facts changed, I didn’t break. I changed along with them.
It’s been a good ride.
Yesterday, I blogged about my discontent with the fact that over 80% of the active ingredients in the drugs we take are being made in far-off places with little or no federal inspection. Until more people know this fact, there is no incentive for change. So here’s my proposal: Every bottle of pills, every IV bag, should list the country of ingredient origin in at least 6 point type. When you buy a carton of orange juice, the carton has to list which country the oranges come from in at least six point type. Why aren’t drugs labeled like food? We ought to expect drug companies to list where their drugs come from. And I’d like those labels to say, in at least six point type: MADE IN THE U.S.A.
Author’s note: Little did I imagine as I was writing this that Merck is pulling up to 13,000 jobs out of the United States and other developed nations to employ workers in “emerging markets.”
Yesterday, Big Pharma bankrolled my 7am flight to DC and my subsequent MRI at the NIH. I’ve been feeling wretched, despite the experimental drug I’ve been taking for multiple sclerosis, and I wanted to know why. My return flight arrived six hours late, at 1:30 this morning. A few hours later, I got a call from the NIH. The MRI report is not complete, but so far it shows that I have one new contrasting lesion.
Question: what should I do about this lesion?
It is very likely that a course of IV steroids would zap me back into health. My neurologist claims there’s no long term benefit, but I’ll take a short term benefit if it means I’ll no longer be dizzy and nauseous and fatigued and tingly and struggling with my gait. Besides, in my personal experience, the relapses that I haven’t treated with steroids were the ones that produced the symptoms that persist. I once skipped a round of steroids so I could take a vacation in Maine. The tingling in my fingertips with every tap of the keyboard serves as a suggestion that maybe I should have delayed the trip a couple days.
A course of IV steroids is nothing to take lightly. For one thing, it’s expensive. That’s no problem. We have insurance. We have money. We can afford it.
For another thing, a course of IV steroids is physically and psychologically grueling. I’m likely to get ornery. I’m likely to get hungry. I’m not all that likely to get any sleep. My family and I will have to endure a few days of my feeling like a big fat angry monster. No problem. We’ve survived rounds of steroids before.
We’ve been lucky to survive. Because here’s the real problem: It’s a social, economic, and political matter, and it concerns you, gentle reader, and every person you know who takes or will take a drug.
You may not be aware of this, but the ingredients in our drugs are increasingly manufactured in India and China. What with illness and travel, I’ve been behind the Times, so to speak, and only just now got around to reading Saturday’s front page article, “Deal in Place for Inspecting Foreign Drug Suppliers, A Glimpse at Suppliers in Shadows Abroad.”
Apparently, “More than 80 percent of the active ingredients for drugs sold in the United States are made abroad, mostly in a shadowy network of facilities in China and India that are rarely visited by government inspectors”
This is a problem.
I don’t know where the steroids are coming from. But I do know they are typically flushed with heparin. Does the name “heparin” sound vaguely familiar to you? You might recall the scandal a few years back, when “Chinese manufacturers deliberately substituted a cheap fake for the dried pig intestines used to make the blood-thinning drug heparin. The tainted drug was linked to 81 deaths and exposed tens of thousands of people to danger. The F.D.A. never inspected the plants making the crucial ingredients, a larger problem that only now, more than three years later, may be fixed.”
What if that heparin problem isn’t fixed? Do I unwitting submit to paying for “a cheap fake” coursing through my veins? Or do I not take the drug, and continue to suffer?
Now, the whole purpose of the Times article was to celebrate a “breakthrough” in foreign inspection. There is currently legislation on the table. “The proposed solution to this problem is for generic pharma companies to pay the FDA $299 million/year to send representatives from the FDA all around the world for bi-annual inspections.”
I don’t think too highly of this solution.
There’s one other issue that’s been in the papers lately. Way too many Americans are out of work.
Why not bring the drug manufacturing jobs back to the USA?
Drugs could be more easily inspected. Americans could get back to work again. Patients like me can feel confident that the drugs we are taking will help us, not harm us. Drug companies, generic and non-generic, can avoid further scandal, like the Tylenol debacle that broke out just today.
As a lab rat, I have some inkling of all the care and expense and governmental cooperation that goes into testing a new drug. Why let that work go to waste with a sloppy end product?
I may just use my steroid fueled ornery energy to see what a big fat angry monster can do to get some real change going in the way our drugs are manufactured and inspected. I believe there’s a real opportunity for the first major drug company to tout their drugs as being manufactured and monitored right here in the USA.