Colorado Assembly Hearing February 9, 2017 Transcript Part I, Pro-Choice Bill 1086
February 9, 2014 Colorado Assembly: House Committee on Health, Insurance, and Environment Hearing on HB17-1086 Abortion Pill Reversal Information ActSponsors: Rep. J. Everett, Rep. D. Nordberg, Sen. V. Marble
Good afternoon. The House Health, Insurance, and Environment Committee will come to order. Conway, will you please call the roll.
Susan Beckman: Here. Janet Buckner: Here. Phil Covarrubias: Here. Daneya Esgar: Here. Steven Humphrey: Here. Dominique Jackson: Here. Chris Kennedy: Here. Lois Landgraf: Here. Susan Lontine: Here. Kim Ransom: Here. Madame Chair, Joann Ginal: Present. Good afternoon everyone. I thank you for coming today to this committee and testifying, to listen and I wanted to give a few housekeeping rules here. First of all there’s an overflow room for people who are standing in the back…There are three bills today that are very, kind of intertwined with each other so to speak, but please speak on the specific bill that we’re on, and if you’re going to speak on the other two bills then sign up for those as well. And at the request of the bill’s sponsors, we are going to alternate between a support and opposition, and you will be timed to a two-minute testimony, and some of you may come up individually and some of you may come up in groups, and that is up to the bill’s sponsor. So I believe that covers everything we need to cover for housekeeping. And our first bill today is House Bill 1086 presented by Representatives Everett and Nordberg. And which of you two would like to start first? Representative Nordberg.
Nordberg: Madame Chair, members of the committee, it is an honor to be here today to present House Bill 1086 with friend and colleague, Representative Everett. At its core, Bill 1086 is an informed consent measure. It would require physicians or qualified providers to present patients with informational material before chemical abortion is administered. Specifically, these materials would inform the patient that should they change their mind while undergoing the abortion process and wish to continue their pregnancy, there’s still the potential to do so, but time is of the essence. Information would also be provided on resources available, which might further assist to reverse the effects of chemical abortion, preserving the pregnancy should the patient desire to do so. In order to facilitate this information sharing for both the provider and patient, we’re asking CDPHE to place this content on their website. Today, we are fortunate to have several medical professionals, legal experts, and patients who can attest first hand, not only to full and scientific aspects of this process, but also the urgent need for informed consent, and greater disclosure about how this process works. I hope you engage them and take this wide-ranging process to heart. I think in doing so, you’ll recognize the urgent need for this bill. In closing, I want to emphasize – regardless of your stance on abortion, it is paramount that women have a right to know all of their options. No one should have to live with the burden of their choices for lack of information. This bill seeks to remedy just that, to give every woman a comprehensive list of her options, and to give her room to change her mind if she determines that that is the best choice for her. I thank you for your attention today, and respectfully ask for your consideration.
Chair: Thank you Representative Nordberg. Representative Everett, would you like to have some comments?
Everett: Thank you Madame Chair, members of the committee, and everybody else that showed up today for to testify and listen in. I think women should have information so they can have all the options and evaluate the risk. Having all the information is important. I want to tell you a story about my mom. Not many of you know that two years ago, on Martin Luther King day, Mom had a stroke, and I got a call from South Carolina from her specialist that said my mom was not responsive, and said there was a drug available that if she got the injection immediately that it had a slight chance of working and really help her healing process, it may have no effect, and it had a twenty percent chance of killing her. And this is my mom. So it’s a very emotional decision that was sort of thrust upon me. But that doctor was required to give me all the information so I could evaluate the risks and make that decision. I chose to have my mom get the injection, and she’s still alive today and doing very well. And I was happy to make that decision but the doctor, at that time, was required to give me all the information so I could evaluate the risks. Women should have that same information on any health decision, especially in this situation. I trust women. I trust doctors, and I think they should have all the information so they can evaluate the risks, and make a decision. That’s why I’m on this bill. I thank this committee for their consideration, and I look forward to testimony.
Chair: Well, thank you Representative Everett and I’m, hope your mother has a speedy recovery. Representative Nordberg, do you want a support or opposition up first? I’m sorry –yes. I’m sorry. The committee has some questions and I’m – I’m just overwhelmed by the amount of people in here so I’m thinking they all want to testify so I forgot my own committee, so are there any questions for either bill sponsor from our committee from any of the – Representative Landgraf.
Landgraf: Thank you Madame chair, and Representative Everett I’m very sorry to hear about your mother and I’m glad she is recovering. Sounds like you made the right decision and it’s a good thing. So my question is this, would this bill, in any way hold a woman liable for a terminated pregnancy?
Everett: Madame Chair, Representative Landgraf, no. Nothing in the bill says that it will hold a woman liable for terminating a pregnancy, nowhere, anywhere in the bill. This just provides them with information so they can evaluate the risks and see where they want to proceed, whether they want to take the second pill or get that shot of progesterone to have the abortion pill reversal.
Landgraf: Thank you, Madame Chair. So would you, if you’re going to sum up your bill, would you say this actually gives women full information about an additional choice? We hear about choice so often, that they may have?
Everett: Thank you Madame Chair. Yes, I think women having all the information empowers them so they can make a good decision. And I trust women. I trust women if they’re given all the information, they’ll come to their, to a decision, and this doesn’t say that you should get the shot to the abortion pill reversal or not. It just says this information’s out there and you have that option, so they can make that choice.
Humphrey: Thank you Madame Chair and good morning – or afternoon to Representatives Nordberg and Everett. Thank you for bringing the bill. At present, do you believe that what Planned Parenthood is doing in terms of providing information or not providing information is endangering their clients?
Nordberg: Thank you Madame Chair, Representative Humphrey. We will have actually some patients who will be here today to discuss their experiences. I think that’s a great question to ask at that time.
Landgraf: Madame Chair. This is my last question for you guys. Do you know which of the states have passed similar legislation, and it’s my understanding that one of them is listening to this similar bill today?
Nordberg: Thank you Madame Chair, Representative Landgraf. Currently Arkansas and South Dakota have this measure on their books. Indiana and Louisiana are considering similar such legislation, and Arizona has something that is similar but not exactly comparable.
Beckman: Thank you Madame Chair. Representative Nordberg or Representative Everett, thank you for being here today. Just for clarification, so the website would be updated with the factual information needed for allowing the woman to know all her options, and then it would also be a requirement of the physician – hand that out to the patient because it will be easily printed off the website. Representative – is that correct? Is that how it works?
Nordberg: Thank you Madame Chair, Representative Beckman. Yes. More or less, we’re asking the Department of Public Health and Environment to facilitate that information on their website for both the convenience of the provider and the patient.
Beckman: Thank you.
Chair: Any other questions from our committee members? I don’t want to forget anybody. Seeing none, open up the witness testimony. Representative Nordberg, would you like support or opposition first?
Nordberg: Thank you Madame Chair. If we could have proponents please start first.
Chair: Okay, so Wendy Smith, would you please come up. You have two minutes and then after Wendy Smith will be Dr. Delgado, George Delgado. Oh, I’m sorry. You’re second here up after. First here – oh…That’s right. Next, and the person after Miss Smith is Karen Middleton. This is very – kind of juggling all those around here. So that will be the next person up. Thank you.
Wendy Smith: Good afternoon.
Chair: Oh, that’s okay. I’m sorry. Miss Smith, please proceed and tell us who you are and who you represent, and your testimony, please. Thank you.
Wendy Smith: Okay. Thank you very much for allowing me to give testimony. My name is Wendy Smith, I’m obviously a woman. I’m a nurse practitioner. I’m here representing patients, family members. I’m also a mom who conceived when I was single and had – understand the difficult choices that women have to make. I’m here on behalf of my daughter, my granddaughter, three granddaughters. I’m here also on behalf of college students whom I mentor, as I’d like to discuss the – the drugs that are used in both the rescue and the abortion, medical abortion. Hormones and pregnancy primarily include estrogen and progesterone. Estrogen helps uterine growth and maintains uterine lining, activates and regulates production of other hormones through complex feedback mechanisms. Progesterone is produced primarily by the ovaries and then eventually by the placenta. It helps to maintain placenta functioning and a healthy uterine lining. The mif – the mifepristone – excuse me, I’m nervous, [mifepristone] competitively blocks to bind the progesterone receptor on the cells. It is taken in a single two hundred milligram tablet by mouth the first day, usually in the clinic, followed by misoprostol 24 to 48 hours after this. The woman is then seen 7 to 14 days after to confirm termination of pregnancy. Potential side effects of mifepristone is included in the drug information sheet. I would like to draw your attention to the fact that this drug has a FDA black box warning, which includes potential life-threatening bleeding, serious or life-threatening infection may occur. Besides these other potential side effects are listed in the drug information sheet and I will give you a copy. It includes things like vaginal bleeding, abdominal cramping, pelvic pain, headache, weakness, nausea, vomiting, and diarrhea. The significance of a black box warning is a sign when a drug has been – has been found to cause potential serious adverse erects- events that lead to either death or serious injury. It is to alert the prescriber to make sure that they are aware of the potential risks, and to hold them to responsible to discuss these risks with their patients. This drugs, these – this combination of drugs for the medical abortion also were approved under a program called REMS after post-marketing, and we had – we saw some adverse events that were quite serious, including loss of life. REMS stands for Risk -Nefprex Risk Evaluation and Mitigation Strategies. This requires patient education on potential side effects, and patient must sign a consent form saying they received this information. Misoprostol is given as part of this protocol. It works to induce –indr- to induce uter- uterine contractions. It’s usually taken 24 to 48 hours after the first pill, can be taken as two – 200 milligrams in the cheek.
Chair: Excuse me, Miss Smith. Can you wrap that up? We have two minute timing on the testimony. Thank you.
Wendy Smith: Okay. All right, I would just like to point out that the second pill, Misoprostol also has a Black Box warning about the risk of abortion, of course, birth defects, premature births, or uterine rupture, and that is after – usually after eight weeks the risk increases, eight weeks gestation. I’d like to draw your attention to the fact that the FDA approved extending the use of this medical abortion protocol to ten weeks. Progesterone has no Black Box warnings. It is given as an intermusculature injection over the first month and then tapered down. And I can give you more details on that, be glad to answer questions.
Chair: Thank you, very much Miss Smith, and I’m sorry, it is two minutes for each one, and I’m sorry to have cut you off like that. I want to give everybody fair warning out there. Are there any questions and comments from the committee members? Representative Landgraf.
Landgraf: Thank you Madame Chair. You use the term I’ve never heard, and that is a Black Box Warning. Can you go into a little bit of detail what that is?
Wendy Smith: Yes, I’d be glad to. A lot of – drugs are researched before they’re approved by the FDA. And sometimes, after post-marketing, we find there are serious adverse events and the public – that the public needs to be aware, that patients need to be educated on. So, the way the FDA approved this drug- this combination was very much outside of their traditional rigorous, scientific investigation. And so after the – it was approved and there was a post marketing period where they had serious debts. Then they applied this warning to all the drug information sheets and required the providers instruct patients – have the patients sign an informed consent about the Black Box Warning and other adverse events. So the Black Bar- Box is to alert providers and hopefully, the public that there are potentially life threatening or serious adverse events.
Landgraf: So I’m curious as to – I guess as to how you feel about patients, like the role of patient education and patient care, and whether you can separate patient care from patient information.
Wendy Smith: I think that’s an excellent question. A lot of my experience has been involved in clinical trials and involved in clinical trials and seeing patients everyday in the clinic. You cannot separate patient consent from care. A person has the right to know, to be informed, and to make an educated – that’s what informed consent is. They need all the information laid out before them so they can make a choice as to whether they want to take that risk or not. And I just would like to quote to you – the Institutes of Medicine have published a report crossing the quality chasm several years ago, and this quote is from their report. “Access to understandable health information is essential to empower patients to participate in their care. And patient-centered organizations take responsibility for providing access to that information.” The joint commission of accreditation of hospitals – I realize that most abortion clinics are not part of this, but it holds the same standards for any health care institution as far as providing high-quality, state-of-the-art, thorough informed consent. And they say patient care and patient education are inseparable. The goal is to integrate treatment and education so completely, that equipping the patient with knowledge and skills becomes as important as patient care.
Chair: Representative Beckman.
Beckman: Thank you Madame Chair. Thank you. Miss Smith, so what sort of research exists on possible abortion complications, on this issue, and where does that research come from?
Wendy Smith: Yes. That is a good question. So historically, let’s look at this medical abortion procedure. So a lot of – the bulk of the research was done in France, and we don’t have – I don’t have access to all those trials but I will tell you that the FDA – DA had questions about them meeting the same standards as we have in the United States. The FDA also approved this drug, the combination, which is something they’ve never done in the pa – prior to that, approving the two drugs together. The manufacturer of – of the Misoprostol, which was approved with a brand name Cidotek (?) to protect the stomach from ant-inflammatory drugs, the pharmaceutical company back in 2000 sent a letter to the FDA saying they did not agree with approving it under this indication. There was no research to support the combination of the drug. Mis-mis-misprostol had been investigated independently as a single agent. The – the – Let me – I want to make sure I got the name of the org – the American College of Obstetrics and Gynecology – his name was Doctor Ralph Hale. At the time, wrote a letter saying that their organization supported approval of the FDA approval, however I would draw your attention to, and I can provide you the reference list that they gave, all the studies looked at this drug as a single agent, not in combination with the mif- mife-mifepristone. The problem is that once they approve the combination, that’s when they started seeing some problems with threat to life. I would also point out that the FDA is supposed to be a politically neutral organization. But a Freedom of Information Act in 2016 revealed that they did get political pressure from other organizations and I can get you a list of some of those organizations if you want. I don’t feel it appropriate to say them here cause I don’t want to bias the presentation, but I will tell you that present – then President Bill Clinton was putting pressure on the FDA (Food and Drug Administration) to approve this combination of drugs. And that was revealed in the Freedom of Information Act, and I can provide you with the file with that evidence. One other thing I would like to point out is that when the FDA was going to originally approve this combination of drugs, they were going to require that the providers have hospital privileges, hospitals within their community and -before they could prescribe that drug. Under pressure, that was removed from the original –
Chair: Miss Smith, I think we’re talking about the reversal of this drug and not the actual history of RU486 itself.
Wendy Smith: Correct, but I was asked about the Black Box and so there was concern with the data that was presented. And after it was approved, they found out about the adverse settings, so that it had not been researched together and that’s what generated the Black Box warning.
Chair: Thank you. I have a question for you, Miss Smith. Does progesterone have a Black Box warning?
Wendy Smith: No, Ma’am. It does not.
Chair: I have looked up on a website called ‘Hippocrates’ (garbled voices) and there is a Black Box warning for progesterone.
Wendy Smith: I – you know I appreciate your research, however if you look at that it was only a Black Box when progesterone was used in combination with estrogen. The reason for that Blacks Box was because of the women’s health initiative, the risk of stroke, heart attack and cardiac disease. I will tell you that in this rescue procedure, it’s looking at progesterone oil. So that when I say there’s not a Black Box, there is not a Black Box warning in progesterone in the oil form in the IM injection that is used for the rescue protocol.
Chair: Thank you, Miss Smith. The – it does say micronized progesterone, and what you’re talking about with the women’s health study and the NIH studies that showed that Provara, which was a combination of estrogen and progestin in what is known for women for hot flashes and it was the Provara part which was the methoxyprogersterone acetate portion which – but that causes cancer. But also in ‘Hippocrates’ the progesterone, micronized progesterone itself has a Black Box warning.
Wendy Smith: In the oil form in the IM injection, I am not aware that it does. But I will also tell you that when you talk about some of the si – the potential side effects, those combinations were used longer term and usually in women who were beyond menopause in studies that combined estrogen and progesterone, as far as progesterone oil by itself. If there are – I am not aware of a Black Box warning. I have the drug information sheets here I will provide for you. So.
Chair: Thank you.
Wendy Smith: You’re welcome.
Chair: Representative Landgraf.
Landgraf: Thank you Madame Chair. Thank you, Miss Smith for your testimony. Is there any reason in the world that you can think of to restrict asset– restrict access to understandable health information, any reason you shouldn’t tell a woman what’s going on?
Wendy Smith: Personally I think that would be negligence.
Chair: Representative Lontine.
Lontine: Thank you Madame Chair and Miss Smith. You testified about being a registered nurse. What exactly are your medical credentials?
Wendy Smith: I am an acute care nurse practitioner. I specialize in hematology and oncology. I-I’ve- I’ve been involved with clinical trials and I take care of women of all ages, including women who have pregnancy during cancer.
Lontine: Thank you. Were you aware then that the American Congress of Obstetricians and Gynecologists have a published paper that says that medication abortion reversal is not reported by anybody of scientific evidence?
Wendy Smith: I’m sorry. What was the question?
Lontine: That the American Congress of Obstetricians and Gynecologists have a paper out – it’s on their website, that medication abortion reversals that you’re suggesting – that this bill suggests, is not supported by anybody of scientific evidence?
Wendy Smith: You know I would be glad to answer that as well. There is also the American Association of pro-life OBGYN oncologists who have come out with a fact sheet in support of this. Over a thousand women have undergone the reversal procedure. There are 325 providers right now who are participating in this. I would also again go back to data. So the medical abortion procedure it self, and the only reason I bring this up is because of organizations, as you point out, have endorsed it.
Lontine: Miss Smith, would you answer the questions?
Wendy Smith: Yes, yes, I’m getting to it.
Lontine: Thank you.
Wendy Smith: So when you look at the data that approved it – some of the data – some of the research that has shown there’s no dangers with the medical abortion pres-combination protocol, were published in a peer review journal, Obstetrics and Gynecology. The question is that who is approving and what are their affiliations. So some of that research on the safety of the pill where the co-authors, one- one was paid by Danco Pharmaceuticals, the company that distributes the drug. Another was high up in Planned Parenthood. Another in the study, the doctor was on the board of NARAL …
(NARAL Pro-Choice Colorado – www.cohealthinitiative.org “Each year, NARAL Pro-Choice Colorado releases legislative scorecards, political reports, and ballot guides to inform their member and the pro-choice community about the representatives, bills, and ballot initiatives that impact reproductive health, rights, and justice in Colorado. Every bill in the 2016 Colorado General Assembly that didn’t reflect NARAL Pro-Choice Colorado values and shared belief in women making their own private, personal medical decisions was defeated.”)
(Danco Laboratories) www.wikipedia.org/Danco_Laboratories “Danco Laboratores is an LLC, which was incorporated in 1995. Danco has a license from the Population Council to distribute the drug mifepristone, under the brand name Mifeprex. Mifeprex is the only drug distributed by Danco. The offices of Danco are in New York City, and are under an unlisted phone number and a post office box for security purposes.”)
The House Committee on Health, Insurance, and Environment voted six to five, tabling BH17-1086, Abortion Pill Reversal Information Act indefinitely. The committee members’ concluding comments at the end of the day after hearing all three potentially pro-life bills:
Susan Beckman: “Thank you so much and I will echo many of your comments about the really great testimony tonight. I really appreciate how respectful everyone was. I’ve learned a lot about abortion laws in Colorado -We are divided as a nation about this issue. It’s a value issue, it’s a moral issue that’s very deep for some. We’re divided as a state, our platforms as parties are very polarized on this issue, and I think it was a really good civil conversation to have and I think we need to continue to have these conversations because the life of a child is very important and the child has a right to live.”
Phil Covarrubias: “This has been an interesting evening and my first one as a legislator on a subject like this. Real fast, I guess I’m confused how we are as a society. The very people that speak to love, tolerance, and inclusiveness seem to be the very ones who want to protect the rapists, murderers, and thieves but not the babies. And so I’m really conflicted with that. I understand, I heard the testimony on both sides, and I hear it. I get it. But abortion’s wrong. For the most part, it’s wrong to do. It’s not that hard to figure that out. And I hope we can all, at some point come together. And somebody had mentioned that education really is truly the way to lower the number of abortions. I couldn’t agree with that more. The more we educate our young people coming up, I think we can lessen that number and hopefully get to a point where – where we really are respecting the life of the unborn.”
Vice Chair, Daneya Esgar: “I’ve sat on this committee for three years now, and I’ve heard most of these bills, similar bills for three years now. And the conversations are never easy, and the conversations are never fun. This is a tough conversation to have, and we have it, and the voters constantly tell us what they think as well every time we’ve taken this to the ballot. I have a hard time when I sit and look at all the people in this room who’ve spent their entire day and night with us wanting to know why do we bring this up and why do we continue to go over this when the voters have spoken, when it’s in our U.S. Constitution that it’s a woman’s right to choose. And I want to echo what Rep. Buckner said because I don’t think people hear this enough. Being Pro-Choice does not mean that you’re Pro-Abortion. And we really just – when we – when we talk about these issues I think we have to keep those type of things in mind, and I do appreciate the civil discourse we’ve had because too many times people, and especially the media-sometimes we hear about the horrible things we say about each other on this issue. And I think at the end of the day we all want the same thing. We want to protect women. We want to protect people. It’s just a matter of science at the end of the day. And I will continue to fight to make sure that a woman is able to have that right to decide for herself with her doctor and her family what is the best choice for her.”
Steven Humphrey: “I thought I might end up on a bi-partisan note and quote Dr. Purell here when he said, ‘Science long ago established a human life begins at conception and that human development is a continuous, seamless process. What has become a significant debate in this country is not when human life begins but rather when and under what circumstances that human life deserves legal protection. I feel that by respecting all human life this state will be a better, more humane place for all of us to live. By arbitrarily deciding to protect life only at 20 weeks gestation or only at birth, or only during infancy, we diminish our humanity.’”
Lois Landgraf: “Thank you Bill sponsors, and I need to congratulate you. You guys have hung in there…I also want to thank the gentleman in the back in the blue shirt because I thought he said it best. I’m pretty sure it was you who said, ‘Ultimately this decision, this situation lies in a much higher being. And that regardless of what side you come down on this issue it will ultimately be somebody else that judges right or wrong.’ I’m sorry. I really appreciated that. I thought it was an outstanding thing for everybody to hear. And so thank you…”
Susan Lontine: “You know tonight we’ve heard a variety of things. We heard a bill that wanted to interfere with the ability of a doctor to practice medicine according to their training…” (HB17-1086) “Pro-Choice does not mean Pro-Abortion. It means that each woman be allowed to make their own decisions. Whether that choice is to have an abortion or to have a baby, it should be her choice made with the help of her family and her doctor – not government…”
Kim Ransom: “First of all I want to thank everyone for having this conversation. I know it’s not an easy one. I know it’s a late night and I do want to thank everyone for their patience and your politeness to our witnesses and to Representative Humphrey and myself cause I do think we heard from at least one witness that this is an important conversation to have, and I do think it’s important to at least look at – look at our society and ask – and rights of everybody…I talked about science and biology, that is what my emphasis tried to be…We’re looking at rights, and we’re balancing right to privacy of moms versus the right to life of that little tiny being that has a heartbeat and brain waves. And I guess that balancing act is the hard part and what we all have to examine. There are conflicting rights…I just want to make sure everybody understands that there are, there is scientific background for what we’ve been saying tonight.”
Madame Chair, Joann Ginal: “I’d like to comment. And I want to thank Eva for bringing this bill forward, It has come forward in my time, I think this is the fourth time. But I want to thank every one of you out there, who came out in support or opposition because it means a lot and we did have a civil and a very respectful conversation, which needs to be every time we talk about this issue. But I have a hard time with this bill because as a scientist, I do believe in science. And I haven’t heard science tonight…”
Abortion Pill Reversal is available – It is your choice!
The State of Colorado won’t give you the information, but we will.
call: 1- 877.558.0333 or click on www.abortionpillreversal.com