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01/12/2017

Fetal tissue research furor continues

At the end of 2016, the Select Investigative Panel of the House Energy and Commerce Committee published its report—all 485 pages—of its investigation into procurement of tissue from aborted fetuses for research.  The investigation had been prompted by the 2015 undercover videos from David Daleiden and his “Center for Medical Progress,” which was adduced to support charges that Planned Parenthood clinics, in particular, had violated existing federal law in the performance of abortions and transactions to provide tissue from aborted fetuses to firms supplying medical research.

The Committee’s majority, of course, was Republican.  The Democrat minority on the Committee published a rebuttal.  The Executive Summary of that can be found here, and one link to the full minority report is here.

The majority report, as publicized, takes Planned Parenthood and several entities to task, and the minority rebuttal not only defends those groups but decries the majority’s tactics in the hearings.  I don’t intend to comment on those here.

Rather, I want to make limited remarks about the scientific contentions between the majority and its critics.  The journals Nature and Science have pushed back on several fronts.  In particular, the editors of Nature called the report “fantasy politics” that revised “the long history of the role of fetal-tissue research in vaccine and therapy development.”  The editors, writing, I suppose, under space constraints and the assumption that their audience knew that history as they know it, did not recount details.  The majority report does go into considerable detail, on pages 376 and following.  As I read the report, the majority admitted that fetal cells have been used in vaccine research and production, but their argument was that such cells need not be.  (Another Nature writer helpfully points out that the cells in question are cell lines, particularly two called WI-38 and MRC-5, used most notably in the development of vaccines against Rubella.)  The majority claims that the science of vaccine research has moved beyond the need for new fetal tissues.

Science took this point on directly, listing several vaccines that are still produced in WI-38 or MRC-5, rebutting statements in the majority report that fetal cells had “never” been used to produce a polio vaccine, and that “none” of the currently-licensed vaccines in the US are produced using fetal cells.

On the face of it, Science appears correct, but here’s a more extended excerpt from the majority report (pages 379-380, references eliminated from post for brevity but present in the original):

“The fetal-derived cell lines WI-38 and MRC-5 were adopted by the pharmaceutical industry as tools for the production of vaccines shortly after they were developed in the 1960s.And for a small minority of vaccines, these tools are still used today. However, these historic fetal-derived cell lines are still in use today for primarily economic, not scientific reasons. Obtaining FDA approval for a new vaccine is very labor intensive and costly. Consequently, once FDA approval has been secured for a particular method of producing a vaccine, Pharmaceutical companies tend to rely on this method, to avoid incurring new costs associated with “validating” the safety and efficacy of new procedures. Three major Pharmaceutical players (Merck, GlaxoSmithKline and Sanofi) adopted the fetal cell lines MRC-5 and WI-38 in the 1970s, shortly after they were developed. These companies were successful in gaining FDA approval for vaccines produced in these cell lines, and have continued using them ever since. However, viable alternatives exist and are used by other pharmaceutical companies for production of very similar vaccines (see Exhibit 9.3). [Blogger note:  I have not reviewed  “Exhibit 9.3.”]…

“Of the nearly 75 vaccine formulations currently approved by the Food and Drug Administration for use in the United States, only 11 (directed against Zoster, Varicella, Rabies, Rubella, Hepatitis A, Polio and Adenovirus) are produced using historic, fetal-derived cell lines, and none are produced using freshly isolated fetal tissue. Importantly, alternative vaccine formulations that do not rely on fetal-derived cell lines are available or all but five of these diseases (Adenovirus, Hepatitis A, Rubella, Varicella and Zoster), and there is no scientific reason these vaccines could not be produced using animal cell lines. For example, although vaccines against Hepatitis A are produced using the historic fetal-derived cell line MRC-5, modern vaccines against the related Hepatitis B virus are produced using genetically engineered yeast cells. In fact, the vast majority of modern vaccines are manufactured using bacteria, yeast or animal cells—and all of them could be manufactured in this manner. Human fetal tissue is outdated technology that is not necessary for modern vaccine production or research. For example, current vaccine research for HIV/AIDS, Cancer, Malaria and Ebola does not rely on human fetal tissue (see Exhibit 9.3.).”

Now, I am not an expert in vaccine production.  I will say that the majority report did seem thoughtful on this point.  Review it and the rebuttals for yourself.

The scientists otherwise complain that the Committee majority—clearly and admittedly opponents of abortion—wrongly discount the scientific merit of fetal tissue research, and the need for fetal cells, not replacements or surrogates, in that research.  The majority, they say, was too breezy about the possibility of using alternate cells or laboratory models.  Fetal tissue is more useful in certain research into HIV/AIDS, other infectious diseases, and especially to try to understand fetal development.    And fetal cell transfer is being studied again as a potential treatment for Parkinson’s disease.

But, as I have argued in the past, the empiric arguments from potential utility miss the ethical point.  Maybe cells procured a certain way will “work better” than alternatives, but have they been ethically procured?  And if not, we should limit the kinds of experiments we’re doing to what can be done within ethical boundaries.  If you don’t think unborn children warrant projection of life, or as human research subjects, except on the variable decision of someone else, then the expediency needs of the researcher win out.  If you do, there are limits.

And you should.

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