Pretest

Do you know where your medication has been?

Dangerous Doses
A True Story of Cops, Counterfeiters, and the Contamination of America’s Drug Supply

By Katherine Eban

1. True or False: “Pharmaceutical middlemen…buy, sell, sort, repackage and distribute 98% of the nation’s medicine.”

2. Which of the following characters have been granted a license to trade as a secondary pharmaceutical wholesaler:
A. “A convicted heroin seller who had spent years in the Florida prison system”
B. A woman who “pleaded guilty in 2000 to selling stolen medicine through her husband’s wholesale company (and) was still on probation.”
C. “A fellow on federal probation after serving time for marijuana smuggling.”
D. “The eighth grade dropout and heroin addict”
E. Small (big dollar) businessmen that feel threatened with extinction
F. All of the above

3. What methods have been recorded as having been used by secondary wholesalers to buy low and sell high:
A. Parking lot resale. Cancer and AIDS drugs purchased directly from professional patients who sold, rather than took, their medicine.
B. Theft from competitor’s warehouses
C. Theft from hospitals
D. Drug dilution and repackaging
E. The “Puerto Rican” turn, a.k.a. the U-boat diversion, in which wholesalers take advantage of large discounts to overseas buyers, including those in Puerto Rico, by establishing companies in Puerto Rico to buy drugs at a discount. Cargo planes turn around mid-flight and resell drugs to states for a far higher price.
F. All of the above

4. True or False: Kevin Fagan, the father of a teenager poisoned by a counterfeit medication, touched the heart of Laura Bush with this personal letter:
“Today, society is suffering from a moral breakdown where huge companies look only to the bottom line and not to what is the right thing to do…I ask that you, a parent as I, do whatever you can to bring forward legislation to require drug companies to document the shipping locations of prescription drugs from the point of origin to the end user…the general public.”

5. True or False: When Governor Jeb Bush was apprised of the situation, he signed the 1993 Prescription Drug Act. He told investigators (and heroes of this book), “You guys scared the hell out of me.”

6. To research this book, Katherine Eban
a. Conducted over 160 significant interviews with people involved in the problem of contaminated medicine in America.
b. Submitted sixteen Freedom of Information Requests to the Food and Drug Administration, the Florida health department, the Florida Department of Law Enforcement, and other state pharmacy boards
c. Obtained over 13,000 pages of documents
d. All of the above

7. Dangerous Doses
a. Is a fast paced account of the slow pace of the law
b. Is more rigorously documented than the trail of a prescription drug
c. Is the scariest book I’ve ever read
d. All of the above

Answers: 1. True (89) 2. F (72, 140, 82, 340, 183) 3. F. (95,99) 4. False (160) 5. True (266) 6. D 7. D

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Ask About Your Medication

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.