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SANJAY GUPTA MD
Cancer Drug Shortage; How Close to a Cure for AIDS?; After the Fire
Aired July 22, 2012 - 07:30 ET
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
DR. SANJAY GUPTA, HOST: Hello and thanks for joining us.
The International AIDS Conference kicks off this weekend, and believe it or not, people are actually talking about a cure for AIDS. We're going to dig deeper into that.
Plus, stopping the stares. Young burn victims taunted at school. You're going to meet a woman who says she has a way to help.
But, first, you know, it's hard for me to believe that doctors in this country ever have to deny patients care just because they can't get them the medicine they need. But they do. Drug shortages have hit cancer patients particularly hard. In fact, last year alone, doctors told more than a half a million cancer patients the treatments they needed simply weren't available.
That leaves doctors scrambling for alternatives and a lot of patients, of course, in limbo. Patients like Renee Mosher. I met her last year. She had an aggressive form of ovarian cancer and couldn't get Doxil, the chemotherapy medication that she desperately needed.
(BEGIN VIDEO CLIP)
RENEE MOSHER, CANCER PATIENT: You know, you feel like you're in a fight with one hand tied behind your back. We just at the time said let's go with what we have and see what happens. And the cancer pretty rapidly recurred.
(END VIDEO CLIP)
GUPTA: That was just this past November. And Renee, unfortunately, did pass away. She never was able to get another dose of Doxil.
Her cancer specialist, Dr. Wendel Naumann and Renee's two daughters, Michelle and Nicole, join me now.
I'm so sorry for your loss. You know, I talked a lot about your mom, Michelle, after that program because I thought a lot about that. Can you -- can you tell me a little -- was she able to get any other treatment after that?
MICHELLE PHILIPP, RENEE'S DAUGHTER: She did. She was on another form of chemotherapy. But it didn't work like they had expected it to. She had some complications from that chemotherapy and got sicker and sicker. And then she went into hospice care about a month ago.
GUPTA: What was -- what was it like, Nicole? I mean, did she talk about this? I mean, was she -- because at the time, she was measured and calm when I spoke to her, I remember. She couldn't get the medication she needed. Did she talk to you about that?
NICOLE PENNIGER, RENEE'S DAUGHTER: Yes, absolutely. You know, it's frustrating because you feel like -- you're in this time now in 2012 and you feel like you're in America. Why can't you get these drugs that you need to treat something so serious?
But she was very open it how serious everything was. And her wishes and how she wanted everything done.
GUPTA: I mean, there are certain things, Michelle, that she wanted to do. One was to attend your wedding. She was able to make that.
Tell me about, what was that like for you?
PHILIPP: Yes, it was great. We weren't sure until last minute if she would be able to come. She had to fly to get there. So, we bought her the ticket, hoping it would give her something to look forward to, Even if she wasn't going to be able to come. She did. That was just wonderful.
GUPTA: What was she like, Nicole, you know, just the last few months? Was she -- I know you said she was in hospice. What was her spirit like? What did she talk about?
PENNIGER: For Michelle's wedding in April, it was phenomenal. Just the change of scenery, being in the Bahamas was good for her.
But even when she first started off at hospice care, at her house it was great. That's exactly what she wanted. We couldn't have asked for anything better. Even when we moved to the hospice house, everything was great.
You know, she understood, and we did everything that she wanted.
GUPTA: I'm going to ask Dr. Naumann this question, as well. Nicole or Michelle -- let me ask you, Michelle, did she -- did she -- it's hard to ask this almost, but did she think that had she gotten the Doxil that she would have survived?
PHILIPP: I think she thought it would have at least put her into remission at the time, or maybe save her from taking some the chemo that was detrimental to her that didn't do anything for the cancer. But she had to battle the side effects. I think she definitely thought that she would have had a better chance. I don't know -- I know she didn't know if it would actually cure her or, not cure her, but put her in remission again.
But I think she thought it would at least save her from doing something else that was more detrimental. GUPTA: Dr. Naumann, you and I talked about this last time you joined, obviously, Renee on the set. What do you think? I mean, you're a -- this is your area of expertise. Would it have made a huge difference? You assume it would because that's a medication you wanted. Can you say it would have made a huge difference?
DR. WENDEL NAUMANN, RENEE'S ONCOLOGIST: Right, it could have. I mean, you know, Renee lived with this disease almost six years. She got to go on a boat trip with her family. She got to go to the wedding in the Bahamas.
These are important things. And this drug is the best drug available in that setting. We can't get it, it's frustrating. Not only does it interrupt treatment for patients, but you know, we have other drugs that are being investigated for approval in this country. And a big research protocol got put on hold for almost a year and a half because of the shortage.
GUPTA: I want you all to stick around. I'm going to bring in Dr. Sandy Kweder. She's deputy of the FDA Center for Drug Evaluation and Research Office of new drugs.
Thanks for joining us, Doctor. You've been listening in on this conversation. I have a feeling it's probably the first time you've heard a conversation like this.
Renee Mosher, you know, she was here last November. She couldn't get the medication she needed, Doxil. She passed away.
Her oncologist thinks it's in part because of not getting that medication. And people say this problem is getting worse. The shortages won't be resolved for some time to come.
First of all, is that true?
DR. SANDY KWEDER, FDA CENTER FOR DRUG EVALUATION & RESEARCH: I think -- made a couple of statements there. I think that there is no quick fix for this shortage problem. There's absolutely no quick fix.
And you're right, Dr. Gupta, I have heard this story many, many times as a practicing physician myself. I've experienced it. I have friends who have experienced it. Not just in the sphere of oncology but in other areas of medicine, as well, particularly in the anesthesia and pain medicine community. This is a crisis.
GUPTA: You know, one of the things that people ask immediately is why and why is this happening now. There was a recent report from the House of Representatives that largely blamed the FDA for the situation saying it shut down companies for what really were minor technical violations. And that was what led to these drugs being unavailable for people like Renee.
Did you foresee or did the FDA do you think foresee this possibility?
KWEDER: Well, let me just say very clearly that the report is incorrect. We are not in this situation because FDA is shutting down companies. FDA is part of the solution.
The FDA's enforcement to ensure high-quality drugs that -- to consumers in the United States which we expect as patients and consumers. The rules for that have not changed. Our inspection procedures have not changed.
What has changed is that there is an aging manufacturing infrastructure. And there are serious quality problems that have required companies to close down in order to fix the problems.
GUPTA: Is the idea -- is the possibility that this will cause a shortage, has that ever taken into account when -- because if just say, look, the company has all these problems, the only real answer is they're going to have to shut down. To say, look, the consequences of these lifesaving or life-longing (ph) medications are no longer going to be available, does the FDA that into effect? Because this former FDA deputy commissioner, Scott Gottlieb, told us that FDA inspectors in the field say it's not their job to worry about production.
KWEDER: Well, it's our job to worry about it. And -- and we're -- our drug shortages team. And before and when we issue warning letters today, we ask companies very specifically to -- to communicate with us, to talk to us about what their plans are in order to address the problem so that we can assess what the potential for a shortage is. And sometimes we can intervene and actually prevent the shortage.
GUPTA: Yes. You are always -- we always hear about the cases where it didn't work as opposed to where it did work.
KWEDER: Right. That's a good point.
Dr. Sandy Kweder, it's something we'd like to stay on top of. So, I really appreciate your candor in joining us today.
KWEDER: Thank you very much, and we are on it.
GUPTA: Yes, well, thank you.
And, Dr Neumann, Nicole and Michelle, thank you very much again.
GUPTA: Again, just telling the story makes such a huge difference. Really appreciate it.
Coming up, we're going to go to the International AIDS Conference where there's now talk of a cure.
Stay with us.
GUPTA: The world's biggest meeting on AIDS is about to unfold in Washington, D.C. The International AIDS Conference brings together top doctors, top researchers, plus government leaders and also people living with HIV. Here's something maybe you didn't know: this meeting hasn't been held in the United States since 1990. It couldn't be because people with HIV were forbidden from entering the country. Go figure. That ban was lifted in 2009.
At this year's meeting, there's a lot going on like research on how to prevent new infections. But for the first time in a long time -- and I've attended a lot of these meetings -- we're also hearing talk about a cure. Some experts believe we are getting closer. But with AIDS, even the word "cure" is complicated.
GUPTA (voice-over): He's known as the Berlin patient. In 2007, Timothy Brown was living in Germany and battling both leukemia and HIV. When a bone marrow transplant not only cured his cancer but, incredibly, seemed to cure his HIV, as well.
TIMOTHY BROWN, BELIEVED TO BE CURED OF HIV: My blood's been tested by many, many agencies. I've had two colonoscopies and they -- to test to see if they could find HIV in my colon. They haven't been able to find any.
GUPTA: Brown's case is rare, the procedure is extremely dangerous and won't work in most patients because the bone marrow he received had a special genetic mutation, which made the stem cells in it naturally resistant to the virus. His doctor specifically looked for a donor with this special mutation, which is only carried by 1 percent of Caucasians. Even back then, five years ago, experts were wary of the word "cure" because HIV is known to hide within the body.
And sure enough, last month, research presented at an HIV conference said the virus had resurfaced in Brown. Experts disagree if the virus ever left, if he was re-infected or if the new traces are just from contamination in the testing lab.
DR. STEVEN DEEKS, PROFESSOR OF MEDICINE, UNIVERSITY OF CALIFORNIA-SAN FRANCISCO: So from a clinical perspective, he's cured.
GUPTA: Regardless, researchers believe the overall condition is proof of concept that the battle against the disease can advance beyond daily drug cocktails. And right now, a group of the world's top scientists are collaborating on a common goal: finding a real cure for AIDS.
One of those scientists is Dr. Francoise Barre-Sinoussi. She is one of two doctors who won a Nobel Prize in medicine for discovering HIV.
DR. FRANCOISE BARRE-SINOUSSI, PASTEUER INSTITUTE: If we work in the early years of HIV altogether, we can move forward very fast as well as for HIV cure.
GUPTA: Dr. Steven Deeks is also part of this group.
DEEKS: Most reasonable people say it's at best 50/50 that we're going to get a cure. So, we don't want to overhype this.
We're excited. We think it's possible. We think it's worth pursuing. But don't expect anything in the near future.
GUPTA: A few very preliminary studies are underway. At the conference, French researchers will report on 12 HIV-positive patients who were treated immediately after being exposed to the virus. And those results were promising.
BARRE-SINOUSSI: Now they're able to naturally control their infection without any treatment anymore.
GUPTA: Other researchers are studying a group of infected men and women whose level of virus is undetectable despite never having drug therapy. The hope is that someday what's in those patients might translate to a cure for others.
DR. DAVID MARGOLIS, PROFESSOR OF MEDICINE, UNIVERSITY OF NORTH CAROLINA-CHAPEL HILL: We might hope to be able to cure a few people within 10 or 15 years, in a sort of cancer treatment, tuberculosis treatment kind of model.
GUPTA: In this discussion, there are two ways to use the word "cure". One, where the virus is completely removed. And another, where the virus is still present but the patient can no longer infect others.
So far, Tim Brown is as close as they've gotten.
GUPTA: Now, one related story. This week, the FDA approved the first drug meant to prevent the AIDS infection. It's called Truvada. It's already been approved as a treatment for HIV. But studies show it can also stop new infections.
Of course, this isn't simple. This is a drug with side effects, mostly nausea, vomiting, and dizziness. But also serious ones, like liver and kidney problems in some people.
Also it's expensive. It costs about $14,000 a year. So, it's not for everyone. Again, it's called Truvada and it's meant for people at very high risk. For example, if your sex partner already has HIV.
It's also not fail safe, so it doesn't replace the need for safe sex.
And next, an incredible survivor who survived an explosion and fire, and now she's helping girls like her to feel comfortable in their own skin.
GUPTA: Lesia Cartelli has literally been to hell and back. When Lesia was just 9 years old, she was a few feet from a furnace in her grandparents' basement when it exploded in a ball of fire. The house was flattened, but somehow Lisa made it out alive.
Well, today, she runs a camp for little girls who have scars just like hers.
UNIDENTIFIED FEMALE: I'm Ruby Munoz (ph) and I was burned at three- years old.
UNIDENTIFIED FEMALE: I was in a car crash. I'm fine now.
UNIDENTIFIED FEMALE: I was in a house fire and I'm good now. Thank you.
UNIDENTIFIED FEMALE: I was burned with hot grease. I'm fine now, thank you.
UNIDENTIFIED FEMALE: I had a fire-burn accident on Halloween. I'm healing fast, so I can't complain.
GUPTA (voice-over): Take a close look at each one of these beautiful girls. Some of their scars are more apparent than others, but they have all gathered here to heal, together.
LESIA CARTELLI, FOUNDER AND CEO, ANGEL FACES: I see them arrive and they are wounded. They have a social armor on them. And, in each of those girls, I see me.
GUPTA: For Lesia Cartelli, this is personal. She was just nine- years old when she was badly burned in a natural gas explosion at her grandparents' home in Detroit.
CARTELLI: There was a gas leak that had been leaking for a few days. And my sister and I arrived at the home for dinner and I went down to the basement to play hide and seek.
GUPTA: Lesia was in the wrong place at the wrong time when the gas met the light on the furnace.
CARTELLI: The explosion goes off and I hear the screams of my family, the horrific screams. And a sense of urgency, of survival kicks in. I saw a hole in the back of the house at the top of the stairs with really bright light and I started climbing over bricks and nails and furniture and everything to get out.
I got out of the house, still on fire, my back and my face and my hair.
This is where the rubber meets the road, girls.
GUPTA: Lesia founded the Angel Faces retreat, now in its ninth year, to teach these young women in just one week what took her two decades to come to grips with. UNIDENTIFIED FEMALE: I'm so proud of you girls.
GUPTA: They begin by sharing the good, the bad, and the downright ugly.
CARTELLI: I want to hear from you girls, just bring it on, all out, some of the names that you are called. Hideous? Burn face? Crusty crab? Burn bitch?
UNIDENTIFIED FEMALE: They called us burned toast.
GUPTA: Each girl participates in individual and group therapy. They make arts and crafts, play sports, even learn how to enhance their appearance with corrective cosmetics.
CARTELLI: You know, there is nothing wrong, we tell the girls, in taking what beauty you have and making it more beautiful. And you know what? Sometimes that's all it takes for them to sit up a little taller.
GUPTA: To feel comfortable in their own skin, Cartelli urges her girls to share their stories so they can better respond to the uninvited stares and questions from strangers.
CARTELLI: It is important that the girls know they are not burn survivors. It's important that they know they are not the burn girl. They're girls, first, and that's my message to the girls that I want them to take back.
GUPTA: You know, Lisa says that the most important thing for these girls is good eye contact and simple smile. Like all of us, she said, they just want to fit in and be acknowledged for who they are on the inside. Great story.
Coming up, how to outsmart a sensitive stomach. We are chasing life with a top Olympic swimmer.
Stay with us.
(BEGIN VIDEO CLIP)
ANNOUNCER: Three, two, one -- liftoff. Liftoff of the Soyuz TMA-05M, carrying Suni Williams, Yuri Malenchenko, and Aki Hoshide on today's journey to the International Space Station.
(END VIDEO CLIP)
GUPTA: And there she goes. NASA astronaut Sunita Williams blasting off last weekend from Kazakhstan. I just love watching those takeoffs. She's headed for the International Space Station.
Suni is an exercise junkie, and here on this show, we're dedicated to building a more fit nation. So, last week, right here on SGMD, we showed you my visit to the Johnson Space Center in Houston.
Now, Suni has challenged me to a race. She's going to do it from space. She's going to race in the Nautica Malibu Triathlon, which I'll be running right here on Earth, along with the Fit Nation Lucky 7.
Now, between now and race day, September 16th, we're going to be checking in with Suni to see how her training is going on. Good luck, Suni.
GUPTA: You know, "Chasing Life" today, I want to talk about bad reactions to certain foods, foods with gluten. The Olympic Games start next weekend and some of the big events start in the pool.
Well, Dana Vollmer won gold as part of the relay in the 2004 Olympics. Well, today, she's one of the top gold medal contenders to the United States and she's also sensitive to gluten. For years, it was holding her back and the thing is that she didn't even know it.
GUPTA (voice-over): Dana Vollmer will be racing for gold in 100 meter butterfly and two relays. It's a sweet comeback after a bitter disappointment four years ago when she failed to qualify for the Olympic trials.
DAN VOLLMER, OLYMPIC SWIMMER: It just seemed like in my career, I always had something.
GUPTA: At one point, there was a heart condition, an ACL injury, shoulder injuries and back pain. But there are also mysterious stomachaches.
VOLLMER: I had been to the emergency room three times at meets for stomachaches.
GUPTA: More frustrating, doctors couldn't figure out what was wrong.
It turns out Vollmer was allergic to eggs and gluten, a protein found in wheat, rye and barley.
To get better, she cut it all out of her diet. It's amazing how much better I feel now. Avoiding gluten is a challenge, but it is one opponent she knows how to beat.
VOLLMER: I definitely want to put up a great race and, obviously, a gold medal is definitely on my mind.
GUPTA: Now, if you need to eat a gluten-free diet, make sure to read those labels very carefully. Gluten protein is in a lot of foods that you might not even expect like soy sauce and also some salad dressings.
That's going to wrap things up for SGMD. But you can stay connected with me at CNN.com/Sanjay. Also, let's keep that conversation going on Twitter @SanjayGuptaCNN.
Time now though to get a check of your top stories in "THE CNN NEWSROOM."