Wednesday, March 9, 2016

Planned Parenthood And Fetal Tissue Sale: Manufactured Controversy And The Real Ethical Debate

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Editor’s note: This post is part of a Health Affairs Blog Symposium on Health Law stemming from 4th Annual Health Law Year in P/Review conference hosted by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Holly Fernandez Lynch wrote an introductory post in January 2016 and you can access a full list of symposium pieces here or by clicking on the “The Health Law Year in P/Review” tag at the bottom of any symposium post. You can also watch the video of the presentation on which this post is based.

In 2013 the Center for Medical Progress appeared to have secured tax-exempt status for a fake company it set up called Biomax Procurement Services. The company’s “representatives” contacted the non-profit women’s health provider Planned Parenthood staffers and led them into conversations that were secretly recorded. The result, according to their website (as reported by CNN), was “a 30-month-long investigative journalism study by The Center for Medical Progress, documenting how Planned Parenthood sells the body parts of aborted babies.”

The videos were edited down and released slowly in a way designed to paint Planned Parenthood in the worst light. While some have called it a “hoax,” that’s not a word I would use in this case. When I think of great journalistic hoaxes I think of Orson Welles’s War of the Worlds (though more recent historical work suggests that the panic it caused may have been mythological). Instead what happened here, I want to suggest, is what I will call a “manufactured controversy.”

Manufacturing Controversy

Planned Parenthood received US $528 million of government money in 2014, much of it going to pay for services that include contraception and cancer screenings, which it provides largely to poor women. Abortions are only performed at about half of its 700 clinics, constituting approximately 3 percent of its services. Planned Parenthood says that at the time the videos were recorded its programs that provide fetal tissue to research facilities took place in only two states—California and Washington—at about only a half-dozen of its health centers. So right off the bat, when we talk about fetal tissue programs, we are talking about a very small part of what Planned Parenthood does.

Nevertheless, what, if anything, did Planned Parenthood do wrong in the videos shown by the Center for Medical Progress (and what a wonderful Orwellian name by the way!)? The videos show the Center’s David Daleiden using a fake identity (for which he has now been indicted) trying to lure Planned Parenthood staffers into talking about how money gets paid to abortion providers who take nominal reimbursements for moving body tissue from clinics to research facilities. Part of the video shows Deborah Nucatola, senior director of medical services at the Planned Parenthood Federation of America, telling undercover activists that tissues can be obtained for fees in the $30 to $100 range.

To watch the news reports you might have thought this woman was breaking the law. The most shocking thing about the controversy is that the activities were unquestionably legal. Here is the relevant statute (emphasis mine):

42 U.S. Code § 289g–2 – Prohibitions regarding human fetal tissue

(a) Purchase of tissue

It shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer any human fetal tissue for valuable consideration if the transfer affects interstate commerce.

(b) Solicitation or acceptance of tissue as directed donation for use in transplantation

It shall be unlawful for any person to solicit or knowingly acquire, receive, or accept a donation of human fetal tissue for the purpose of transplantation of such tissue into another person if the donation affects interstate commerce, the tissue will be or is obtained pursuant to an induced abortion, and—

(1) the donation will be or is made pursuant to a promise to the donating individual that the donated tissue will be transplanted into a recipient specified by such individual;

(2) the donated tissue will be transplanted into a relative of the donating individual; or

(3) the person who solicits or knowingly acquires, receives, or accepts the donation has provided valuable consideration for the costs associated with such abortion.

(c) Solicitation or acceptance of tissue from fetuses gestated for research purposes

It shall be unlawful for any person or entity involved or engaged in interstate commerce to–

(1) solicit or knowingly acquire, receive, or accept a donation of human fetal tissue knowing that a human pregnancy was deliberately initiated to provide such tissue; or

(2) knowingly acquire, receive, or accept tissue or cells obtained from a human embryo or fetus that was gestated in the uterus of a nonhuman animal.

(d) Criminal penalties for violations

(1) In general

Any person who violates subsection (a), (b), or (c) shall be fined in accordance with title 18, subject to paragraph (2), or imprisoned for not more than 10 years, or both.

(2) Penalties applicable to persons receiving consideration

With respect to the imposition of a fine under paragraph (1), if the person involved violates subsection (a) or (b)(3), a fine shall be imposed in an amount not less than twice the amount of the valuable consideration received.

(e) Definitions

For purposes of this section:

(1) The term “human fetal tissue” has the meaning given such term in section 289g–1 (g) of this title.

(2) The term “interstate commerce” has the meaning given such term in section 321 (b) of title 21.

(3) The term “valuable consideration” does not include reasonable payments associated with the transportation, implantation, processing, preservation, quality control, or storage of human fetal tissue.

That last clause is essential. The word “reasonable” is important since payments that are reasonable are not treated as “valuable consideration” and thus not violating the statute. I have seen no legal authority suggesting the $30-$100 range in the video falls outside the realm of “reasonable payments.” Nothing in the law specifies how much is reasonable; there is no charge master or compendium of fees.

But how much, if any, of that was apparent from the discussion in the media?

Political Football

Certainly this was not the discussion in the political realm. Instead the fetal tissue sale issue became one more cudgel to use against Planned Parenthood, and quickly the specifics of the issue got swamped by the larger abortion politics.

In the Republican debates it became a question of who could denounce Planned Parenthood for its sins with more gusto. I think the winner was Carly Fiorina. As CNN among others reported in the September 16, 2015 Republican Debate, Carly Fiorina said “As regards [to] Planned Parenthood, anyone who has watched this videotape, I dare Hillary Clinton, Barack Obama to watch these tapes.” She continued, “watch a fully formed fetus on the table, its heart beating, its legs kicking while someone says we have to keep it alive to harvest its brain.”

Sadly for Fiorina, there was no such image in the material related to Planned Parenthood released by the Center. To give her the benefit it is possible she was referring to a different video, though news sources suggested that video was itself of quite dubious truth value.

But truth is often the first casualty in this season’s primary debates, whichever side of the aisle one is on.

The Real Debate (We Already Had)

As a bioethicist, what was perhaps most upsetting to me was the way the kabuki political theater obscured the fact that there was a real set of ethical questions to be discussed.

These are questions about complicity. For those who think abortion is seriously wrong, in what ways does the use of tissue from abortion make the user or downstream beneficiary of research complicit in that sin?

This is an interesting question that bioethicists have wrestled with for a long time. But when it comes to law, it is one the law has explicitly resolved in a way that allows fetal tissue use.

As my friend Alta Charo noted in a piece for The Washington Post:

Fetal tissue research is legal in all but a handful of states, and it has been conducted in the United States, with federal support, for decades, except for a brief moratorium on the use of National Institutes of Health funds in the 1980s. It is regulated by federal law, and was funded by the Clinton, Bush 43, and Obama administrations, most recently to the tune of about $76 million per year.

In 1975, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research studied the question and released a report concluding the practice was ethical. We had a short moratorium that was ultimately ended by the 1992 NIH Revitalization Act that received broad bipartisan support, including that of Senator Mitch McConnell. And while the Dickey-Wicker Amendment prohibits the NIH from funding “research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero,” that is not the law as to fetal tissue research.

So it is hard to see the current round of discussion over Planned Parenthood to be much more than a naked attack on it as an institution that performs abortions, and not really about fetal tissue very much at all.

Fetal tissue is and will continue to be an important input in some of our most important research, as Meredith Waldman recently summarized in Nature:

In 2014, the NIH funded 164 projects using the tissue, at a cost of $76 million… Analysis of the NIH projects shows that the tissue is used most heavily for research on infectious diseases, especially HIV/AIDS; in the study of retinal function and disease; and in studies of normal and anomalous fetal development.

But nothwithstanding the good of fetal tissue, Planned Parenthood was forced to change its policy.

Oct 13, 2015, Planned Parenthood announced it will maintain programs at some of its clinics that make fetal tissue available for research, but will no longer accept any reimbursement to cover the costs of those programs. That is the biggest legacy of this controversy.



from Health Affairs Blog http://ift.tt/1SA3Lsm

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