Pill Rhymes with Kill for a Reason
Is your medicine doing more harm than good?
Have you ever thought about the medications you take and where they come from? Every month, we fill our prescriptions, and every day we swallow our pills.
Next time you get that bottle from the pharmacy, look at the label, locate the manufacturer name, and do a little Google search. You might be surprised to find out where your drugs are made.
Recently, I read the book “Bottle of Lies” by Katherine Eban. The book was recommended to me by a friend when we discussed anti-rejections drugs, specifically tacrolimus manufactured by a company called “Dr. Reddy’s.” After reading this book, I began to search online for further information on the subject.
Below is an excerpt from the article “These Pills Could Kill You” by Katherine Eban, published in the Boston Globe May 24, 2019.
In late 2013, pharmacists at the Cleveland Clinic made a striking decision: The health system would no longer stock a generic version of an immunosuppressant drug, tacrolimus, made by the Indian company Dr. Reddy’s Laboratories.
The internal announcement surprised Dr. Randall Starling, a Cleveland Clinic heart failure specialist. Starling regularly treated patients who received heart transplants; immunosuppressant drugs were critical to the success of these procedures.
The Dr. Reddy’s version of the immunosuppressant on which his patients’ lives depended was by far the cheapest, priced far below the $3,000 per month price tag of the brand name drug, Prograf, made by Astellas. But the Cleveland Clinic’s pharmacists — who did wide-ranging research to determine which drugs the hospital should or shouldn’t use — were growing uncomfortable with the number of recalls of Dr. Reddy’s drugs.
Over the next six months, the physician worked with his staff to make sure that none of their patients were taking the Dr. Reddy’s tacrolimus and that the hospital’s inpatient and outpatient pharmacies no longer carried it. But he couldn’t control what his patients took once they left the clinic’s grounds.
Soon enough, his worst fears were realized.
In October 2014, Cedric Brown, a 48-year-old patient who’d undergone a successful heart transplant 18 months earlier, was admitted to the hospital with symptoms of acute organ rejection. Despite Brown’s successful transplant and recovery, by the time he landed back in the hospital’s intensive care unit, he had gained 50 pounds and felt terrible.
Cleveland Clinic pharmacists developed a confidential blacklist of drugs it would no longer buy, dominated by generic drugs manufactured in India. The Dr. Reddy’s tacrolimus went on that blacklist.
The Cleveland Clinic’s doctors were not alone in their concerns about Dr. Reddy’s tacrolimus. In October 2013, a pharmacist at the Loma Linda University Medical Center in California reported to the FDA, through its online complaint database Medwatch, that “multiple patients” who used the Dr. Reddy’s tacrolimus had “unpredictable levels leading to inadequate immunosuppression and subsequent transplant failure.” The report from Loma Linda noted, “This has only been seen with the Dr. Reddy’s brand of Prograf.”
In a more recent article from APB News dated March 7, 2023, Dr. Reddy’s issued a recall of tacrolimus.
Dr Reddy's Laboratories is recalling over 4,000 bottles of a generic drug in the US due to a packaging error. The Hyderabad-based drug major is recalling 4,320 bottles of Tacrolimus Capsules which are used to prevent the body from rejecting a transplanted organ.
The affected lot is being recalled due to the “presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.
This is a Widespread Problem
Dr. Reddy’s is not the only drug manufacturer currently under scrutiny. Both Accord and Glenmark have also had issues following inspections of their plants in India. The FDA has issued recalls and restrictions on some or all of the drugs produced in those plants.
ProPublica has conducted a 14-month long investigation into the generic drug problem. A list of the articles published by ProPublica can be found at this link:
Pro Publica Releases Results of FDA Investigation
The Secret Gamble at the FDA That Exposed Americans to Risky Drugs — ProPublica
One Organization’s Efforts to Improve Drug Quality
For a little over a year, I’ve been volunteering with the Hypertrophic Cardiomyopathy Association (HCMA). The President and CEO of the HCMA, Lisa Salberg, has taken a special interest in generic drug quality as it pertains to anti-rejection drugs for heart transplant patients.
Recently, Lisa hosted a webinar on generic drug quality. It can be accessed via YouTube here: Generic Drug Quality Webinar
I urge you to watch this and learn about where your drugs are sourced.
In the early portion of this video, you will hear Lisa talk about Tacrolimus, a drug that is an essential anti-rejection drug to keep solid organ recipients from rejecting their precious gift of life.
My Personal Story
My first transplanted heart was perfect. In a rare but wonderful occurrence, the nerves grew back, and it functioned like I was born with it. I could run like a track star. Okay, maybe more like the comic relief at the track meet due to my lack of coordination, but I could run. I was never allowed to run as a child because of how bad my heart was, so running as an adult felt as miraculous as flying. I loved it.
I went back to work full time in less than a year after my transplant surgery. In early 2012, I was fired from that job because I got sick and missed too much time due to the immunosuppression drugs. I usually ended up in the hospital once per winter due to pneumonia or some other illness I contracted from sick coworkers with normal immune systems.
Later in 2012, I took a contract position at another company. They wanted my expertise but didn’t want to pay for my health insurance because I would drive up the cost of their group plan. Instead, I purchased a supplemental insurance policy so my meds would be covered.
That insurance policy denied name brand Prograf, and I was put on generic Tacrolimus through their mail order pharmacy. The generic brand was Dr. Reddy’s. During the summer of 2013, I started having trouble with shortness of breath. It was a hot and humid summer, and I was told it was probably my asthma and given an inhaler. In the fall, when it cooled down, my lungs burned when I ran. I told my cardiologist at U of M, and they did a pulmonary test. My lungs looked fine.
It was around this time that I became aware of the Cleveland Clinic’s ban on Dr. Reddy’s Tacrolimus and asked my transplant team about it. They agreed to switch me to a different generic manufacturer.
One year later, in October 2014, I nearly passed out at work and drove myself to the Emergency Room. Subsequent testing found vasculopathy (an insidious form of rejection) in my previously perfect heart. In June 2015, I arrived at the ER in grade 3 cardiac rejection. Thereafter, I went in and out of rejection for the next 3 years until I received my second heart transplant in October 2018, exactly four years after the initial diagnosis of vasculopathy.
I can’t say with certainty whether the generic drugs contributed to the loss of my first transplanted heart, but I’m sure it didn’t help. I wish I knew then what I know now about generic drug quality. I can’t go back in time to inform my younger self, so I’m sharing that information here with you in hopes it might help someone else.
How Can You Help Improve Generic Drug Quality?
Please, get to know where each one of your medications is manufactured. If you are interested in taking action to change the way in which generic medications are monitored, please follow the link below to generate a letter to your representatives.
By clicking "Contact Your Representatives" below, letters can be generated automatically and sent to your congressional members. All you need to do is fill out your information, so they know they are hearing from their constituents.
You can keep informed of updates by visiting the HCMA website:
Generic Drug Quality in the USA
Please share this information widely and urge others to also take action. You could save lives with this simple action.
Remember, you are your own best advocate. Be safe and be well.
I appreciate every single one of you. You’re why I’m here.
Wow. Had no idea about this issue. Thanks for sharing.