MS Patient, Ph.D.: Calling Dr. Thomas Hale

Since the birth of my daughter, the question of when to restart disease-modifying therapy has been constantly circling in my head. In particular, since she has been exclusively breast-fed up until this point, in many instances I have wondered whether a drug would be safe for me to take. Would it pass through the milk and affect her?

I’ve been thinking about this topic from both a personal and professional perspective due to my current situation, as well as interesting discussions that come up when talking to researchers for the News Synthesis articles that I am writing about MS and parenthood here on the MSDF. My article “MS Family Planning 101: Should DMTs Be Discontinued Before and During Pregnancy?” appeared on July 22, and you’ll be able to read the next article—on DMTs and breast feeding—soon. But one researcher’s story couldn’t wait.

This story comes from Thomas Hale, Ph.D., of the Texas Tech University School of Medicine, where he is a professor of pediatrics, the associate dean of research, and the executive director of the InfantRisk Center. He is a clinical pharmacologist by training and co-author of the book Medications and Mother’s Milk, which is now in its 16th edition.

Hale established lactation risk categories similar to pregnancy risk categories given by the U.S. Food and Drug Administration (FDA). Lactation categories are rated from L1, the most compatible, to L5, drugs that are contraindicated. In his work with the InfantRisk Center, he is detecting the levels in plasma and milk of drugs taken by breast-feeding mothers.

The relationship is clear, he says: The higher the level of drug in the plasma, the higher it is in the milk. While there may be conjecture about which drugs could pass into the milk, the aim of his research is to provide evidence to support these hypotheses. He has already published a study determining the transfer of intramuscular interferon β-1a into breast milk (Hale et al., 2012) and is currently working on manuscripts looking at the transfer of natalizumab and methylprednisolone in breast milk.

People interested in knowing the levels of a drug in breast milk or whether a drug is safe to take during pregnancy or lactation can contact InfantRisk by calling the helpline (806-352-2519) or by asking questions on the Webforum. Hale says that he gets about 60 calls a day, 70% from women who are pregnant or lactating or their relatives, and 30% from healthcare professionals. His website alone receives 1 million visitors a year from all over the world. This provides their center with an ideal system for recruiting women to their studies, passing the major hurdle: finding enough patients who are breast-feeding and taking a specific drug.

The other big hurdle, of course, is getting enough funding to do these studies, something Hale still struggles with. He wasn’t able to give me specifics, but he told me that he has done some clinical trials for pharmaceutical companies, which leaves enough money to fund most of his other studies. However, he’s also very interested in working with other researchers. He mentioned multiple times during our conversation that if any MSDF members would like to work with him, he’d be happy to.

I first heard about the InfantRisk Center by searching online for “Copaxone use among breastfeeding moms with MS,” which led me to a section on their Webforum for “Mothers with Special Conditions: Multiple Sclerosis.” I was especially intrigued by some posts from 2011. A moderator commented that Hale was planning a study of Copaxone (glatiramer acetate) use among breast-feeding moms, but the results of this study were not mentioned.

Initially, I was pretty skeptical about whether the site was a legitimate source for pregnant and nursing moms or if Hale was actually doing the Copaxone study. No researcher I had spoken with about drug use in pregnant or lactating women had mentioned it to me. But, InfantRisk’s main website is run by Texas Tech University Health Sciences Center, and they claim to be “dedicated to providing up-to-date evidence-based information on the use of medications during pregnancy and breastfeeding.”

I didn’t just take the website’s word for it and I decided to call the helpline number. When I asked to speak with someone officially for the Forum, I was given Hale’s number, which I called, fully expecting to reach a secretary and maybe schedule an interview for later that week. To my surprise, Hale answered the phone and talked with me happily for over half an hour. He confirmed that he was not doing the Copaxone study, but the reason was that they were unable to distinguish the amino acids that make up the drug from normal components in breast milk.

While he isn’t the only person interested in which drugs pregnant or nursing mothers can take, he may be in the unique position to carry out these studies. Ruth A. Lawrence, M.D., at the University of Rochester Breastfeeding and Human Lactation Study Center, who has also co-authored a book on this topic, called Breastfeeding: A Guide for the Medical Profession, also has a phone number clinicians can call for consultation, and there are a few other help lines worldwide. But Hale’s seems to be the most popular.

This popularity gives him the advantage in doing these studies. But what I find most exciting is that he is committed to providing evidence-based information, and he makes it easy for mothers to access this information and apply it to their everyday lives. This combination of ease of recruitment and friendly interaction with the patient may be the key to advancing our knowledge of safe drugs to take while pregnant or breast-feeding. If you’re a researcher with an interest in these questions and the funding to carry out these studies, it may make sense to collaborate with Hale. Alternatively, you may wish to use his site as a model for providing value to patients in return for recruitment into a trial or experiment.

One final point: Going forward it would be great if pharmaceutical companies did lactation studies as well, rather than simply providing the current blanket statement on most prescribing information that their drug is not recommended for breast-feeding mothers. However, I don’t realistically think these companies will do so until agencies worldwide start regulating this area.  

While the groundwork is ready for the FDA to start requiring lactation recommendations on labels, it could be years down the line if it happens at all. A draft of a document called “Guidance for Industry: Clinical Lactation Studies—Study Design, Data Analysis, and Recommendations for Labeling” was written in 2005. The latest update on the FDA website is from 2011, which states, “… the Final Rule is in the writing and clearance process. … When the Final Rule publishes, there will be a draft Guidance for Industry and information for healthcare practitioners about these important changes.“  The progress on this seems to be moving at a snail’s pace, but clinician researchers (within or outside of industry) don’t have to wait to do these studies on their own. Why not help Hale in his efforts to provide evidence-based data to better guide clinicians and patients wishing to use drugs during pregnancy or lactation?

Read other MS Patient, Ph.D. blog posts.