Katie Couric interviewed Rosemary Mathis and Emily Tarsell. Rosemary is President of SaneVax.org - devoted to informed vaccine/medical consent for the safety of all patients. Our reader Bob Moffit created this unofficial transcript for us to share with you. Our Anne Dachel shared in her News Review that TIME Magazine was quick to attack Couric for her willingness to air this story:
There is no "HPV Vaccine Controversy." At least, not when it comes to the injection's safety. And yet, that was the title of the lead segment on Katie Couric's daytime talk show, "Katie," this afternoon. The nearly half-hour story, which the program called their "Big Conversation," centered around two mothers who believe the vaccine for human papillomavirus (HPV) harmed their daughters.
Among the guests were Emily Tarsell, a mother who claims the death of her daughter, Christina, was caused by the HPV vaccine Gardasil in 2008. Another mother and daughter pair, Rosemary and Lauren Mathis, believe Lauren developed a bizarre illness characterized by nausea and fatigue due to the vaccine. Rosemary Mathis is now the director of the anti-HPV organization, SaneVax, Inc.
Tarsell and Mathis are understandably distraught mothers. But Couric is a journalist. . . .
The two HPV vaccines currently available, Gardasil and Cervarix, are both proven safe through clinical trials, independent studies, and post licensure monitoring. The CDC and FDA also continue to track the vaccines' safety.
And yet Couric has framed the issue as if there were a debate to be had about whether the HPV vaccines are good for the public's health. . .
Here is the unofficial transcript.
"I had my two daughters vaccinated and so did millions of other parents .. but .. some say the risks may outweigh the benefits. There are claims it could be dangerous in a handful of cases .. even deadly .. but .. nearly 80 million Americans have HPV and there are 14 million new cases reported every year. We want to keep our kids safe .. but .. is the vaccine the way to go? That's what we're asking as today's "Big Question".
VOICE-OVER: Human Papilloma Virus is a sexually transmitted disease that's almost impossible to avoid. According to the CDC, nearly all sexually active men and women will contract HPV at some point in their lives. For most people, having HPV doesn't cause any health problems .. the virus has few outside signs or symptoms .. and .. 90% of HPV infections will go away within 2 years. But the virus can also lay dormant for years or even decades before mutating into genital warts or causing 1 of 6 types of cancer .. the most common of which is cervical cancer .. a disease that claims the lives of 4,000 women a year in the U.S. To combat the spread of HPV, the FDA approved two vaccines .. Gardasil and Cerverix. Only Gardasil has been approved for boys by the CDC .. but .. both vaccines are recommended at the age of 11, with the hope of immunizing children before they become sexually active. Gardasil is administered in a series of three shots, Cerverix in two. While the FDA and CDC say the vaccines are safe, the Vaccine Injury Compensation Program (VICP) reported there have been over 200 claims against HPV vaccines, including 11 families who believe it caused their child's death. In June, 2008, twenty-one year old Kristina Tarsel from Spark's, Maryland, was found dead in her bedroom .. only a few weeks after being inoculated with Gardasil. While the autopsy report listed Kristina's death as "undetermined" .. her mother Emily believes she knows what killed her daughter.
KATIE: So, please welcome Kristina's mother, Emily Tarsel. Thank you so much for being here. First of all, I am so sorry about your daughter's death, just 21 years old. Tell us a little bit about Kristina, Emily.
EMILY: She had a great curiosity about life, she was an athlete and an artist .. and .. a philosopher.
KATIE: Sounds like an outstanding person with obviously an incredibly bright future. Did you all decide together she would get the HPV vaccine?
EMILY: When she was 20, we went to see the GYN for the first visit. The doctor was telling us that Gardasil would be safe and effective .. would prevent cervical cancer.
KATIE: Let's talk about Kristina's experience .. I know that she had symptoms after each shot that was administered. What were these symptoms?
EMILY: Well, because we have a case pending, I cannot go into detail about what happened each time. Umm, she was previously healthy, had no existing conditions .. umm .. she did begin to develop some things .. you know .. "Oh, I have a rash .. wonder what that's all about. I feel dizzy". And she reported this within a few days of her 3rd shot .. and .. within 18 days of the Gardasil shot .. she was found dead in her bed.
KATIE: When was the last time you saw your daughter?
EMILY: She was going back to Bard .. to be trained for a job that she'd have there on campus during the summer .. so .. I hugged her .. and .. I can still feel that embrace .. and .. I let her go .. and .. that was the last time I saw her.
KATIE: You have, I know, filed a federal claim because Gardasil was approved by the FDA. Why did you decide you were going to do that?
EMILY: If you have reason to believe your daughter's died from a product that caused her death, you want to hold people accountable.
KATIE: Well, we reached out to Merck, the manufacturer of Gardasil and in a statement .. the company defended the vaccine saying:
"Gardasil's safety was established in clinical trials involving more than 25,000 females and males .. they continued studying more than 500,000 people after more than a million doses had been administered."
"Parents should understand the extensive data supporting the safety profile of Gardasil and we encourage them to look to the CDC and FDA .. and .. the advice of their own physicians to make an "informed choice" about something as important as a vaccine to help prevent cervical cancer".
KATIE: Dr. Diane Harper is a professor at the University of Louisville and an international expert on HPV and HPV prevention. I know Dr. Harper, you are an integral part of the science of bringing the HPV vaccine into human trials. So, why initially, did you think this was such a positive development for cancer prevention?
DR. HARPER: I was very excited initially because I thought "yea, we have a vaccine". this could be very important .. especially in countries that don't have any screening with it. But, then I started looking at what isn't covered .. and .. I looked at the fact that Gardasil doesn't last long enough to prevent cervical cancer. HPV infections are something women get throughout their lifetime. The other thing that looking through the CDC data .. as well as other published data .. is that HPV is most often sexually transmitted. But, between the age of birth and 11 years of age .. 10 to 15% of these children are already infected with these virus types .. so, it isn't that you are completely negative until you are 11 years of age .. and then you're at risk .. so .. there's an underlying infection rate already there.
KATIE: So, that makes it not being from sexual activity, it's just because they have the virus?
Dr. HARPER: There's some kind of cutaneous transmission ... it's always skin to skin transmission and there's some kind of cutaneous transmission .. whether that's parental, whether that's babysitter, whether that's bath-tub .. we don't know.
KATIE: So, are you saying that you would now .. not recommend girls or boys get the HPV vaccines?
DR. HARPER: In the concept of cervical cancer prevention .. what I think is important for people to know .. Gardasil is an option .. but .. that's all it is. It's an option .. and .. if you feel comfortable that you want to take the vaccine to prevent yourself from getting an infection for a certain amount of time, that is your right to do. The benefit of taking Gardasil is that will happen. But, as we heard .. there are also some harms associated with it.
KATIE: In your expert opinion .. do the benefits outweigh the risks?
DR. HARPER: We have PAP screening now .. in our new recommendations .. that just came out a couple of months ago .. that use HPV testing and (cytology?)
KATIE: What is (cytology)?
DR. HARPER: I'm sorry .. PAP smears .. when you go in and get those cells scraped off your cervix, we put those two tests together we have nearly 100% ability to find pre-cancers which can be treated at a 100% cure rate .. and .. they can detect cancers. It is a much better PAP test than the one we had in the past, which could not detect cancers even if you get them. So, at this point, what I think is most important for people to understand .. PAP screening is key. PAP screening is key to all of this .. um .. if you get the vaccine, you still have to come in for PAP screening .. because of the other HPV types that could be causing changes on your cervix.
KATIE: And, with boys .. boys can get a number of cancers if they have the HPV virus .. correct?
DR. HARPER: The number of cancers boys can get are .. .anal cancer, head and neck cancer, penile cancer .. all three of those cancers occur in very low rates. NIH defines these as rare illnesses .. the only exception to that is men who have sex with other men. And, in that population .. the rate of anal cancer is just as high as the rate of cervical cancer before we had PAP testing. But, in boys, again, we have the efficiency is no more .. the trials lasted three years .. so .. the long duration of protection if your vaccinating somebody at 13 may not last long enough.
KATIE: I had no idea that it only lasted for five years. I thought it was a lifetime protection .. knowing that PAP smears were still necessary, but, I didn't realize the efficacy basically wares off after 5 years. So, when you hear about this Emily, when you hear Dr. Harper say these things, how does it make you feel?
EMILY: Well, it is the reason I am here because its an outrage .. that's why you have to know and you have to take responsibility for finding out.
KATIE: Well, Emily, thank you for coming and talking to us about this important topic .. about your daughter .. Kristina .. and I know it must be very painful for you to do that. We appreciate your being here and telling us your story and her story .. and .. Dr. Harper .. thanks to you as well.
KATIE: Up next .. a young woman who was so ill she was fighting for her life .. and .. her mother believes the HPV vaccine is to blame.
KATIE: Today's big conversation is about the HPV vaccine. Like Emily Tarsel, Rosemany Mathis of North Wilkesboro, North Carolina .. says she also wanted to protect her daughter Lauren from cervical cancer .. and .. followed her doctor's recommendation to have her daughter vaccinated .. but .. she now believes that decision nearly killed her daughter.
FILM INTRODUCTION OF MOM ROSEMARY AND HER DAUGHTER LAUREN:
"When you are a mother you always try to do the right thing for your child. You try to get them their vaccines .. and .. do the things your doctor tells you to do.
LAUREN: Before 8th grade, the doctor convinced my mom to give me the Gardasil vaccine. He said it was supposed to prevent cervical cancer.
ROSEMARY: He highly encouraged me to get the vaccine .. even though we had no history of cervical cancer in our family.
LAUREN: So I wound up getting all three shots .. and .. after each shot I got sick. After the first two shots, I was sick for about a week each time. After the third shot I got sick without getting better.
ROSEMARY: She was nauseous and had severe headaches .. she couldn't get out of bed.
LAUREN: There was a lot of pain involved, it's kinda like my whole body was just shutting down in different places. I missed three years pretty much ... I didn't go to school and laying in bed is just like ......? The lowest point was just sitting at home, staring at the wall, thinking that it might not get any better .. that I might not make it to see tomorrow .. or .. if I did make it to tomorrow .. I'll still be sitting staring at a wall.
ROSEMARY: I actually slept with her during all this time .. because I was afraid .. I was truly frightened she was going to die in her sleep.
LAUREN: My mom would just say .. I'm sorry for putting you through this .. cause I know it's my fault. But, it was never her fault. I always had faith it would turn out well.
ROSEMARY: I kept taking my daughter to the doctor every week and I felt like they were ignoring me. We'd be going back and fourth .. back and fourth .. between doctors. I didn't know how to help her .. but .. I tried my best to reach out .. figure out how to help her ... on the internet with other mothers and trying to figure out how they were treating the symptoms of their daughters.
No parent should ever have to go to their child .. to tell them they might die .. or that they may have a very severe outcome from a vaccine. Parent's shouldn't have to do that.
KATIE: Welcome Rosemary and Lauren Mathis. What an ordeal you both have been through. Rosemary, I know that you were frustrated because you felt you were being ignored by the doctors when you had concerns about how Lauren was doing. And then you finally get to a doctor at Duke. What did that doctor tell you?
ROSEMARY: The doctor looked through her records which were probably a foot tall ... all these medical records .. and .. he analyzed everything .. ran tests .. and .. he told me that she had a vaccine injury.
KATIE: Now, when he said a vaccine injury, he wasn't specific about Gardasil .. but ..that's the conclusion you drew?
ROSEMARY: No he was not, but, Gardasil was the only vaccine she had at that time.
KATIE: Lauren, tell me what a typical day was like for you when you were going through this .. because I know .. I understand .. you were in a great deal of pain.
LAUREN: A typical day was mostly spent in bed. If I was able to get up and walk around, I was doing pretty good. Due to the nausea and headaches .. the pain really came from .. a lot was my gall bladder had stopped functioning .. so that caused a great deal of pain.
KATIE: What was it like for you to watch your daughter go through this?
ROSEMARY: It was hard. I felt like I had let my daughter down. I let my guard down by letting her get the vaccine .. that I didn't do research because I trusted my doctor .. and .. my advice to parents is to go out and research this vaccine.
KATIE: And, Dr. Harper, what do you think about what happened to Lauren. Is this highly unusual?
DR. HARPER: Well, its highly unusual in that, as Merck will tell you .. millions of young girls have had this and haven't had Lauren's reaction. The point is you have to look at the benefit versus the harm. What your benefit can be from this versus what any possible level of harm that you as a patient are willing to tolerate.
KATIE: Rosemary, I know you and Norma Erickson, a journalist .. co-founded a website called "Sane.vax" .. and ... Norma's here today. Norma, why was it important for you to set up the website?
NORMA; Katie, it was important because, like Rosemary said .. she didn't know ay of these side effects .. she didn't know there were .. perhaps .. substantial risks.
KATIE: And did you all take part in legal action in the aftermath of Lauren's experience Rosemary?
ROSEMARY: No we didn't. My goal was to help other mothers .. so we built the website to consolidate these stories .. but .. my main focus has been to help others understand what's happening.
KATIE: 'Well, Rosemary and Lauren, we really appreciated your time and sharing your story with us and also Norma .. thank you very much for being here. Dr. Harper, again, thank you.
UP NEXT ..SHOULD BOYS BE VACCINATED
KATIE: And, we're talking about the HPV vaccine today. Dr. Malica Marshall is a pediatrician at Mass General Hospital in Boston .. Malica ..nice to see you .. welcome.
KATIE: So .. we've heard some really tragic .. heartbreaking stories today about girls and the HPV vaccine. What's your reaction to these stories?
MALICA: I think we have to be careful not to jump to the conclusion that just because something happens soon after something else .. that one thing actually caused the other. There have been independent doctors and scientists who have looked at all the data .. and .. there's been a lot of data over the past few years .. and .. they have come to the conclusion that the HPV vaccine doesn't seem to be any riskier than any of the other vaccines that we routinely use.
KATIE: So, what is your recommendation for girls and boys?
MALICA: The HPV vaccine has been approved for girls and women .. ages 9 through 26 .. but .. the CDC recommends that girls around the age of 11 to 13 get the series and that's because we want to get them before they become sexually active.
KATIE: And for boys as well .. starting at age 11?
MALICA: We think it's important for boys for two reasons .. it can prevent cancers in men as well .. like anal cancer, head and neck cancers. It can help prevent genital warts which can be a real nuisance and very difficult to treat. Also, by vaccinating boys .. you are helping prevent the further spread of HPV. So, you are protecting society at large.
KATIE: What are some of the common side effects you are seeing among your patient population?
MALICA: We haven't seen .. to my knowledge .. any significant or serious side effects. With any injection, you can get redness and pain at the injection site. Some girls have developed low grade fevers .. and .. there have been reports of fainting. Now as it turns-out .. teenagers and tweens often faint with injections and it doesn't look like they are fainting any more with the HPV than they do with other shots.
KATIE: Let me ask you about some of the issues that have been raised today. If 95%of HPV cases naturally clear-up on their own ... why would you need a vaccine to prevent it?
MALICA: My understanding is that it can persist in 10 to 20% of people who contract it. yes, most people clear it within a couple of years ... but .. there are people that continue to have it. We can't identify who is going to hold onto the virus and who is actually going to clear it. So, 20 to 30 years down the road .. a woman might be faced with cervical cancer and we know that 12,000 American women deal with cervical cancer every year. 4,000 die . and .. we still have women who are dying from cervical cancer .. in this country ... despite the PAP smear screening . We don't have a lot of treatments that can actually prevent cancer .. the HPV vaccine is one of the treatments we do have.
KATIE: We have another mother and daughter here with us today .. from Basking Ridge, New Jersey.
KATIE TO MOM: Your daughter's pediatrician recommended that she get the HPV vaccine .. why did you decide that was the right thing to do?
MOM: They gave me the information to tell me about the risks and what to expect .. the efficacy of the vaccine. I just wanted to do a little of my own research .. and .. after doing that, I actually waited until my daughter was 14 years old just because I thought, since it was a relatively new vaccine, let me just take my time and I was confident at that time there wasn't any sense of urgency. I wanted her to be a little bit older and also for her to feel comfortable with taking a vaccine .. such as ... Gardasil.
KATIE: Evoni (daughter's name?) .. what was it like for you? Did you feel comfortable with the whole notion of this?
EVONI: I felt pretty confident about me being fine afterwards. After the first round, I didn't display any side-effects .. so I was confident about the second ... the same with the third.
KATIE: Mira (mom's name?) .. after hearing these stories today, do you have any second thoughts about what you did?
MIRA: I did what I felt was best at the time .. based on the knowledge I had .. so I don't have any regrets.
KATIE: We've obviously heard two different sides about the HPV vaccine .. and .. I think for parents watching .. it's probably still rather confusing ..when you hear these heart-breaking stories these families have endured. So, the bottom line .. Dr Harper .. what would you say to parents listening to this conversation?
DR. HARPER: I have a couple of pieces of advice. One is to remember pediatricians are expert at giving vaccines, that's what they do, they're trained to give vaccines. The pediatricians do not do PAP smears. Be your own advocate, be comfortable in saying no .. it's not for you .. and .. you want to go with the PAP smear screening system. The next piece of advice is to know the best gift you can give your daughter when she turns 21 .. give her a free certificate for a PAP smear .. and .. encourage her to continue with the PAP smear screening for the rest of her life.
KATIE: And Malica .. what would be your advice as a pediatrician to parents watching?
MALICA: I would encourage parents to do exactly as this mom did .. she did her own research .. she spoke to her pediatrician .. she spoke to family and friends .. and saw they had daughters who went through it and didn't have any adverse effects .. and .. I hope they will actually make the decision to vaccinate.