Dangerous, Chilling Effect of Republican Select Panel

Floor Speech

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Ms. SCHAKOWSKY. Mr. Speaker, last week, Republicans on the panel they call the Select Investigative Panel on Infant Lives, which we call the Select Panel to Attack Women's Health, voted to recommend criminal contempt against a small biotech company and its owner and also release publicly the name of a doctor who has been interviewed privately by that panel. These actions are a disgrace to the House.

Over the past year, the select panel Republicans have abused congressional authority to harass, intimidate, and bully doctors and researchers, with the ultimate goal of driving companies away from fetal tissue research and ending lifesaving research. They have done this largely out of the public view and, ironically, at the same time that Chair Blackburn and other leading Republicans profess support for researchers and for funding 21st century cures.

Tragically, their stealth campaign against lifesaving research is working. One tissue procurement company informed the panel that: ``Due in large part to the costs borne from having to respond to these congressional inquiries, our client is no longer doing business.'' The University of California at Los Angeles told us that ``recent national events have increased the challenge of obtaining the fetal tissues'' needed for ongoing research. The negative publicity about fetal tissue research also delayed publication of a study whose findings have the potential to impact ``development of therapies for HIV, cancer, multiple sclerosis, asthma, and organ transplant rejection.''

UCLA went on to explain that one lab ``has reduced their effort on studies that require fetal tissues, despite the importance of this research, due to concerns about personal safety.''

Rockefeller University similarly told the panel that there is now ``a paucity of sources from which to obtain human fetal tissue, creating roadblocks to the conduct of important biomedical research'' and that one laboratory is ``currently unavailable to perform research that it hopes will lead to cures for human disease.''

Other researchers have reported that promising studies and clinical trials for neurological conditions, such as MS and Alzheimer's disease, have been halted or delayed due to reduced availability of fetal tissue for research. Other leading institutions, including Harvard, the Yale School of Medicine, and the University of Minnesota, have confirmed the importance of fetal tissue as a tool for understanding and treating diseases and conditions that impact millions of Americans.

The Republican attacks on this research are particularly troubling as scientists race to understand how the Zika virus impacts fetal brain development. A leading association of research scientists has explained that ``the use of donated fetal tissue, including placental tissue, has provided the best understanding of how Zika viruses behave in the body.'' These insights ``are already guiding the development of drugs that may protect the unborn baby from the ravages of the Zika virus.'' The Republican select panel's dangerous witch hunt has put this lifesaving research at risk. It is also endangering individual lives.

Last Monday, Chair Blackburn publicly released the name of a healthcare provider who was privately interviewed by the panel. This doctor has already been the target of harassment and threats and repeatedly asked the panel to safeguard her identity. Just last week, her lawyer informed Chair Blackburn that her university had to increase security as a result of a prior leak of information by panel Republicans. Even knowing this, they released her name.

This has gone on long enough. We are elected officials. It is our opportunity and responsibility to make things better for the people we serve. That privilege and the power that accompanies it should not be abused. This select panel should be brought to an immediate end.

Mr. Speaker, I include in the Record letters from the University of California at Los Angeles, Rockefeller University, and from university counsel regarding the danger that panel Republicans have created for this doctor and her students.

University of California,

Los Angeles, CA, September 19, 2016.
Hon. Jan Schakowsky,
Ranking Member, Select Investigative Panel on Infant Lives, Energy and Commerce Committee, House of Representatives, Washington, DC.

Dear Representative Schakowsky: On behalf of the University of California, Los Angeles (``UCLA''), I have attached UCLA's response to your letter of July 28, 2016, requesting that UCLA provide the Select Investigative Panel on Infant Lives with information to better understand the importance of and risk to fetal tissue research.

UCLA conducts research using fetal tissue that is vital to an understanding of human biology and to efforts directed toward new treatments for a wide variety of adult and childhood diseases and medical conditions. Our research is conducted in full compliance with federal and state law and in accordance with our tripartite mission of education, research, and public service. The information provided below answers the five specific requests made in your letter.

Please note that UCLA has omitted identifying information from the enclosed documents based on concerns for the safety and security of individuals conducting research. Should you have any questions regarding this response, please contact me.
Sincerely,
UCLA Health/David Geffen School of Medicine.

1. Past benefits of fetal tissue research.

Since the 1930's, fetal tissue has been used in a broad range of research that has led to lifesaving discoveries. The Association of American Medical Colleges (AAMC), of which UCLA is a member, has previously noted that human fetal tissue research has been critical in establishing permanent cell lines for use in vaccine research for diseases such as polio, hepatitis A, measles, mumps, rubella, chickenpox, and rabies. These established cell lines are currently being used to develop an Ebola vaccine.

Fetal tissue proved to be necessary for the production of consumer vaccines against measles, rubella, rabies, chicken pox, shingles and hepatitis A. According to the journal Nature, at least 5.8 billion vaccine doses have been derived from fetal tissue lines.

2. Potential future benefits that might be gained through continued
fetal research

Biomedical research continues to benefit from the use of new fetal tissue. According to the U.S. Department of Health and Human Services, ``fetal tissue continues to be a critical resource for important efforts such as research on degenerative eye disease, human development disorders such as Down syndrome, and infectious diseases, among a host of other diseases.''

As noted in the journal Nature, ``In the past 25 years, fetal cell lines have been used in a roster of medical advances, including the production of a blockbuster arthritis drug and therapeutic proteins that fight cystic fibrosis and hemophilia.'' Yet, existing fetal material and cell lines ``.

. . are of limited use for scientists because they do not faithfully mimic native tissue and represent only a subset of cell types. . . . The lines can also accumulate mutations after replicating in vitro over time.'' New fetal material is critical if we are to continue to pursue vaccines for HIV and other diseases as well as create treatments and cures for devastating illnesses such as Parkinson's and Alzheimer's Disease, blinding eye disorders such a macular degeneration, diabetes, and schizophrenia.

Our response to question 4 below cites a diverse range of diseases being studied by UCLA laboratories whose research requires the use of fetal tissues. These research activities are critical for the development of new therapies for the treatment of these diseases.

3. Unique aspects of fetal tissue in research, in comparison with adult
cells or other cellular organisms that might be used for research purposes

As described in the following summary of research performed in UCLA laboratories (response to question 4), human fetal tissues are critical for current and future research activities for multiple reasons. First, human fetal tissues exhibit biological properties that are distinct from those of tissues derived from children or adults, and these properties, often related to an enhanced capacity for growth and regeneration, can be highly desirable for the development of novel therapies. It therefore is critical to understand the unique properties of fetal tissues, which can be accomplished only through a direct analysis. Some therapies under development would require the direct use of fetal cells, such as recent clinical trials using fetal neural cells to treat patients with spinal cord injury or Parkinson's Disease. Most therapies, however, will emerge from the study of fetal tissues rather than directly including the cells in the ultimate drug product.

Second, the direct study of human fetal tissues is essential for an understanding of human development. This understanding is necessary for the advancement of fundamental biology, for the pursuit of therapies for the treatment of developmental diseases, such as Down syndrome and the microcephaly associated with Zika virus infection, and for the pursuit of therapies for the treatment of many other diseases that have been linked to developmental defects, including several cancers.

Third, human fetal tissues are critical for the establishment of mouse models for the study of human diseases and for the testing of potential new drugs and other therapies. For example, rodents are highly valuable for biomedical research, but they are inadequate for many studies of human disease and for the advanced testing of new therapies (e.g. HIV does not infect rodent cells). To circumvent the limitations of rodents, human fetal tissues can be implanted into immunocompromised mice, thereby generating an invaluable model system for studies that require the use of a living animal, such as the testing of new drugs. Importantly, human fetal tissues are essential for the establishment of these models due to their unique properties in comparison to tissues from children and adults.

4. Summary of any research conducted since 2010 that UCLA has been involved in that used fetal tissue or relied upon other studies that
used fetal tissue

Research laboratories at UCLA studying a wide array of human diseases have used fetal tissues for their medical research projects since 2010. A survey of these researchers resulted in a consistent response that the use of fetal tissues has been, and will continue to be, essential for progress in their fields. While much remains to be learned about the specific properties of fetal tissues, it has been well-established that their properties are distinct from those of adult tissues. Fetal cells often differ from other cells because the fetal cells need to support the rapid growth and maturation of the tissue during fetal and neonatal development; in contrast, the functions of cells from children and adults are usually restricted to maintenance of the physiological functions of the tissue. An understanding of the unique properties of fetal cells and tissues is likely to be of great value for the development of new treatments for a number of devastating human diseases.

We provide here a summary of seven representative research efforts at UCLA that rely on fetal tissues and for which the research is strongly dependent on continued availability of fetal tissue
CANCER: One project focuses on an effort to improve the treatment of a form of lymphocyte leukemia in young children.

Although the survival rate of these patients has improved dramatically, approximately 15% of pediatric patients with the most aggressive forms of the leukemia continue to die. A growing body of evidence suggests that these fatal leukemias may be unusually aggressive because they emerged from a unique type of B cell progenitor (B cells are white blood cells that secrete antibodies) generated only during fetal development. Research recently completed at UCLA has shown that the genetic regulation of fetal and adult B cell development is distinct. The aim of the ongoing research is to identify genes expressed only in fetal B-cell progenitors that contribute to the development of the aggressive forms of leukemia observed in young children.

IMMUNITY: Another UCLA research laboratory is immersed in an analysis of fetal T cells, another important type of white blood cell generated in the thymus. A primary goal of this laboratory is to develop improved strategies for rejuvenation of the immune system in cancer patients and in HIV patients whose immune systems have been compromised by chronic virus infection. Human fetal T cell progenitors have been found to be completely different from progenitors found in children and adults in their ability to rejuvenate the immune system.

This laboratory has been performing detailed comparisons of the molecular properties of the fetal and adult cells in an effort to understand how to speed up immune system rejuvenation and make the immune system healthier.

As exemplified above, one general reason several UCLA laboratories rely on fetal tissues for their research is that an examination of the properties of the fetal tissues is needed to understand how they differ from older tissues and from tissues derived from induced pluripotent stem cells (iPSCs). iPSC are cells with embryonic stem cell like properties that can be generated from a patient's own skin cells (by a method developed less than 10 years ago), and then matured into any of a wide variety of human tissues; these cells hold great promise for the treatment of many degenerative and chronic diseases. One goal of the researchers is to engineer adult cells and iPSC to possess the unique, beneficial properties of fetal cells. This goal can be achieved only if the molecular features of the fetal cells have been clearly defined.

LUNG DISEASES: A UCLA laboratory is pursuing new treatments for a form of lung disease in infants. A long-term goal is to treat this disease by generating iPSC from a patient and then converting the iPSC into therapeutic lung cells. The ultimate therapy would not require the use of fetal cells. However, successful development of the therapy depends on an understanding of the unique properties of fetal lung cells, which have been found by the UCLA laboratory to grow and divide far more robustly than comparable cells from children or adults. The laboratory has developed a disease model that is being used to understand the unusual growth properties of he fetal cells and how these properties can be harnessed for therapeutic benefit.

GENETIC AND MUSCLE DISORDERS: Another UCLA laboratory studies diseases of muscle, including muscular dystrophy, toward the goal of regenerating functional muscle in patients. Similar to the findings with fetal lung, this laboratory has found that the regenerative capacity of human fetal muscle cells greatly exceeds that of older muscle satellite cells. Recent studies of the underlying mechanisms have revealed possible molecular explanations for the differences between the fetal cells and older cells. This professor considers fetal muscle cells to be the ``gold standard'' for all efforts to develop therapies for degenerative muscle diseases, due to the powerful and unique regenerative properties of these cells. Quite simply, for an understanding of the important differences between fetal muscle cells and older muscle cells, which are critical for the development of novel therapies, there is no alternative to the ability to analyze the fetal tissues themselves. It is also noteworthy that several of these studies are moving rapidly toward clinical trials, which necessitates the focus on human cells rather than rodent models.

HIV: Another reason several researchers rely on the availability of fetal tissues is that the fetal tissues can be used to create mice implanted with a specific human tissue, thereby providing an animal model in which potential therapies for the treatment of diseases of that human tissue can be tested. Such mice can eliminate the need for the testing of therapies in non-human primates, and are often preferable to studies of non-human primates because they allow the direct study of human cells.

Some UCLA laboratories use mice containing a human immune system for their studies of potential HIV therapies. These mice, which can be generated successfully only with the use of human fetal cells, are extremely important for progress of the HIV field, as HIV does not infect rodent cells.

Currently, these mice are being used to study gene therapy approaches for the treatment of HIV infection, with the studies leading rapidly toward clinical trials.

BRAIN/SPINAL CORE INJURY: Human fetal tissues are also of great value for studies of the unique structure of the human brain, which is dramatically different from that of the mouse brain. UCLA research has used human embryonic stem cell lines to generate brain organoids (collections of neuronal cells that self-assemble into structures that resemble small portions of the brain). A comparison to fetal brain tissue is essential for the researchers to evaluate the validity of their organoid method, which is currently being used to understand developmental diseases of the brain, as well as the impact of Zika virus on brain development. The laboratory hopes to use this model to screen for drugs that may protect the fetal brain from the growth impairment caused by Zika virus infection. This same laboratory is also studying strategies for the generation of spinal cord neurons in the laboratory, for use in determining the underlying causes of neurodegenerative diseases, such as spinal muscular atrophy and amyotrophic lateral sclerosis, and for screening for drugs that could slow disease progression and extend patient lifespan.

INFERTILITY: The final UCLA laboratory discussed in this report uses fetal tissues for studies aimed at the diagnosis and treatment of human infertility. State-of-the-art genomics methods are being used to develop reference maps of germ cells and of fertilized eggs at the earliest stages of embryonic development. One goal of these studies is to better understand the reasons for spontaneous miscarriages. These studies are strongly dependent on human fetal tissues because early embryonic development in mice differs substantially from that in humans. The reference maps being developed by this laboratory are also of great importance for the study of germ cell cancers.

5. Description of any recent changes experienced by UCLA in the availability of fetal tissue for research and the related impact of these changes, including whether or not there have been interruptions
and/or delays in research as a result.

Most UCLA researchers surveyed emphasized that recent national events have increased the challenge of obtaining the fetal tissues required for the research projects described above. One reputable company was forced to close due to legal expenses associated with challenges to its operations. This has delayed important studies and has forced laboratories to spend a considerable amount of time and resources searching for alternative suppliers. One laboratory has identified a reliable source of fetal tissues in Germany. Another laboratory has reduced their effort on studies that require fetal tissues, despite the importance of this research, due to concerns about personal safety. Of further note, recent publicity surrounding the procurement of fetal tissue delayed publication of a manuscript submitted by UCLA investigators to a renowned journal by more than seven months. The findings reported in that study have the potential to impact the development of therapies for HIV, cancer, multiple sclerosis, asthma, and organ transplant rejection.
____

The Rockefeller University,

New York, New York, September 21, 2016.
Hon. Jan Schakowsky,
Ranking Member, Select Investigative Panel, House of Representatives, Committee on Energy and Commerce, Washington, DC.
Dear Congresswoman Schakowsky: The Rockefeller University offers our response to your request for information regarding the importance and availability of fetal tissue as a critical resource in aspects of our scientific research. We set forth below your concerns and our responses.

Past benefits of fetal tissue research

Human fetal cells and tissues have had a decisive and major impact on our current understanding of the molecular and cellular origins of human organs and tissues. Human fetal tissues have allowed researchers to explore and understand the biology and uniqueness of human development. This knowledge has translated into the rational design of both treatment and prevention of numerous human diseases and has saved innumerable human lives.

Fetal tissue has contributed directly to the improvement of child and adult human health. In the 1960s, cell lines derived from fetal tissue were used to manufacture vaccines including those that counter measles, rubella, rabies, chicken pox, shingles and hepatitis A, cumulatively saving millions of lives. The rubella vaccine alone eliminates 5,000 miscarriages each year.

Fetal tissue has been used to uncover disease pathways that overlap with natural developmental processes and may guide development of therapeutic treatments for heart disease.

Fetal cell lines have been used in medical advances for the production of pharmaceuticals, including an arthritis drug and therapeutic proteins that fight cystic fibrosis and hemophilia. Every indication emphatically supports the notion that further understanding of degenerative diseases such as Alzheimer's, Huntington's, and a host of other devastating and as yet incurable conditions, depend specifically on access to fetal tissue.
Ongoing fetal tissue research is critical for continued advances in regenerative medicine, including organ/tissue regeneration of heart, liver, pancreas, lung, muscle, skin, and more, holding out hope for a wide variety of therapeutic discoveries.

Human tissue-based models for studying uniquely human viral diseases are important for understanding mechanisms of disease progression and developing preventive measures and therapies. Fetal tissue has been used to build increasingly complex models of human disease. A single human fetal liver yields material sufficient to produce dozens of humanized mice. Certain human viruses are severely host-range restricted, meaning they infect humans and no other animals.

Fetal tissues are essential for production of humanized mice that can be used in learning about such uniquely human conditions.

Potential future benefits that might be gained through continued fetal tissue research

Future benefits of fetal tissue research will include the enhancement of our basic knowledge of human development. It will inevitably impact clinical approaches and provide new means to address currently incurable diseases by providing new technological platforms. Scientists have used information gleaned from studies of motor neuron development to guide stem cells to become neurons and establish stem cell-derived models of Amyotrophic Lateral Sclerosis, a currently untreatable and fatal disease. These models have allowed researchers to develop new drugs that already are being used in clinical trials to treat ALS. Another of the most promising novel technical platforms in regenerative medicine is using cell-based therapy strategies to replace defective organs rather than attempting to repair the diseased tissue.

For some conditions, potential future benefits must be gained by human fetal tissue research. Certain humanized mice can be produced best with human fetal tissues. Such mice are unique in their ability to support long term infection, thus allowing evaluation of therapies aimed at finding cures.

It is increasingly important to study infection, disease mechanisms and antiviral interventions in human cells. Fetal tissue provides a rich source of stem cells for studies in cell culture and also engraftment into small animals that can then be used to model infection, disease progression and test therapies. These provide valuable preclinical models that increase the chances of success before progressing to human clinical trials.
Investigators continue to mine existing gene expression information from fetal tissue samples in order to understand gene function and growth-regulating pathways encountered in normal versus tumor samples. Much that applies to cancer can be learned from gene expression analysis in organ development.

Wide ranges of adult diseases and disorders have their origin during very early human development. Examples include types 1 and 2 diabetes, schizophrenia, and Huntington's disease. Knowledge of how the human fetus generates discrete organs will provide the blueprint for applying human embryonic stem cells for the generation of specific organs used for supportive and regenerative medicine.

Unique aspects of fetal tissue in research

Neither adult stem cells, nor reprogrammed somatic cells approach the versatility and quality of the natural stem cells derived from the fetus which remains the best resource for regenerative medicine. Model organisms, from the fruit fly to rodents, unfortunately cannot fully model human diseases.

We are aware of how many times promising solutions for diabetes, cancer, and neurodegenerative diseases have been shown to cure the mouse or rat but fail when tested in humans. The human neocortex, for example, contains cells and anatomy that are specifically human, and not found even in other primates. Fetal tissue provides a unique source of human cells that have the potential to be used directly or engrafted into immunodeficient animals. Human fetal tissue offers an important and unique resource for basic and medical research. There is no comparable substitute for fetal tissue for the accurate understanding of human development.

The adult immune system is ``educated'' to reject animal hosts, complicating the creation and production of animal models with humanized immune systems. In contrast to the adult, fetal immune cells have not yet been educated and therefore do not recognize the host as foreign. As a result, fetal tissues do not reject the host but rather are engrafted, leading to a chimera that is composed of mouse tissues and human immune cells. These mice are uniquely suited to finding cures through research.

Modern technologies have opened the door to studying the cellular interplay in complex human tissues during their development, normal, and disease states, as well as in aging.

From single-cell expression analysis of fetal tissue, a great deal about intracellular communication can be learned that will increase our understanding of how normal as well as malignant growth is governed, and how therapeutic interventions may take advantage of these molecular programs.

Recent changes experienced in the availability of fetal tissue for research

Currently, there is a paucity of sources from which to obtain human fetal tissue, creating roadblocks to the conduct of important biomedical research. Entities that previously provided the sources of human fetal tissue have either closed, due to external pressure, or currently offer more limited options than previously proffered.
Laboratories have experienced significant difficulties in securing fetal tissue for research. One lab reported: We used to receive fetal tissue once or more every week. Over the past year, the supply of fetal tissue has dwindled and become increasingly unavailable and unreliable--to the point where we can no longer depend on this important resource for our studies.

Another lab despaired: In the past, our laboratory was able to obtain fetal tissues nearly every week. For the last several months, we have been unable to obtain any fetal tissue. Humanized mouse production has come to a standstill, and we are currently unable to perform research that we hope will lead to cures for human disease.

Thank you for your interest in our research and the challenges it faces. I hope you find the information provided here responsive to your questions.
____

McDermott Will & Emery,

September 20, 2016.
Re Proposed Disclosure of Code Name Dr. Administrator's Deposition Transcript.

Hon. Marsha Blackburn, Chairman,
Hon. Jan Schakowsky, Ranking Member, House Select Panel on Infant Lives, Washington, DC.
Dear Chairman Blackburn: I am writing today on behalf of my client, the University of New Mexico (``UNM'') with regard to the notice posted by the Select Panel on its website last night of a business meeting on September 21, 2016. The Select Panel has proposed the meeting to consider, among other items, a resolution to release of the deposition transcript of UNM's doctor, code name: Dr. Administrator, who you publicly named in your online notice.

UNM objects to a vote to release the transcript at this time. The Select Panel would violate its own rules if it released the deposition transcript without having afforded the witness or counsel to review the transcript as required by the governing deposition regulations. See 161 Cong. Rec. E21-01 para.18 (``If a witness's testimony is transcribed, the witness or the witness's counsel shall be afforded an opportunity to review a copy. No later than five days thereafter, the witness may submit suggested changes to the chair.'') In fact, UNM counsel addressed this very issue with the Select Panel majority staff by email as recently as September 12, 2016 and offered to review the transcript in the Select Panel's office and at staff's convenience. See email from UNM Counsel, at Attachment 1. Majority staff never responded to this offer.

UNM continues to have grave concerns about the Select Panel Majority's repeated, intentional public disclosure of the names of its doctors, first in the Interim Report from July 2016, and again in the notice published on the Select Panel's website on September 19, 2016. UNM has asked repeatedly for over six months for assurances that the Select Panel would not disclose the names of its doctors or staff, who UNM has shown are in grave danger of harassment or worse by extremists who oppose their profession. One UNM doctor gave sworn testimony detailing the harassment and threats that this doctor and others have already received, both at their homes and at work. She laid out for the members of the Panel in her deposition why her name and the names of other doctors and staff should not be disclosed. She described the real fear these doctors carry with them each day. At various points your staff provided assurances to UNM counsel that they would take measures to protect the privacy and safety of UNM staff. The most recent and totally unnecessary online publication of a UNM doctor's name directly contravenes all of these assurances.

From the very beginning of this inquiry, UNM has expressed its well-grounded concerns regarding the safety and well- being of its students, faculty and staff. The potential for harm to these individuals is real and demonstrable. This is evidenced by the deadly attack at a Planned Parenthood clinic in Colorado last year--an attack where the assailant killed, among others, a police officer--as well as the specific death threats recently received by individuals connected to the procurement of fetal tissue. One of those death threats prompted an investigation by the FBI, and the arrest of an individual who made that specific threat. Counsel to UNM expressed these specific concerns repeatedly in correspondence to the Select Panel on January 29, February 16, February 19, March 3, April 11, and May 19 of 2016, and in various email correspondence.
The repeated public disclosure of these names demonstrates a knowing and intentional disregard for the safety of UNM personnel by the Select Panel Majority, who has been on notice since January 2016 of the charged environment surrounding these professionals and the potential danger they face. Going forward, the members of the Select Panel who vote in favor of this resolution to release the deposition transcript will personally bear responsibility for any harm that comes to these individuals.

UNM requests that if the Select Panel adopts a resolution to release the transcript, whether prematurely in violation of its rules or after UNM has had a chance to review it, that the Select Panel redact the UNM doctor's name from the transcript. The fact that the Select Panel has previously published the doctor's name does not excuse it from an ongoing obligation to avoid endangering UNM staff. Secondly, UNM requests that the Select Panel postpones the disclosure of the transcript by a minimum of a week so that UNM can work with local law enforcement and campus security to put additional security measures in place to protect students and staff.
Sincerely,
Stephen M. Ryan.

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