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SANJAY GUPTA MD
Meningitis Outbreak: Pharmacy Failure; Get Tested, Know Your Status
Aired October 13, 2012 - 16:30 ET
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
DR. SANJAY GUPTA, HOST: Hey there, and thanks for joining us. I'm back home after spending most of this past week chasing down answers in that meningitis outbreak.
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GUPTA: Over there, that is the NECC, the compounding facility. Back here, it's a recycling facility, essentially looks like a dump.
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GUPTA: You'll see what else I uncovered in just a moment. It's pretty remarkable stuff.
Also ahead, sugar, we talk about it all the time. Well, now it is the subject of a new short film called "The Real Bears" puts the polar bears of Coke literally under the knife. It's a cartoon, but it's pretty graphic stuff.
And hormone replacement therapy. I'll tell you this issue confuses women more than about just any other. I have an important answer based on a new announcement on the study.
But we begin with the meningitis outbreak, "Under the Microscope".
The plot thickens on the deadly and growing meningitis outbreak that's affecting now so much of the country. At the center of it all, contaminated steroid injections of 14,000 people in 23 states may have received. Now, they were made by NECC. That's a compounding pharmacy in Massachusetts that is licensed to distribute drugs in all 50 states.
Compound pharmacies were established so that the pharmacists could make custom specific doses for specific patients with individual needs. The FDA isn't in charged of regulating them for safety, because technically the pharmacies aren't making new drugs. They're just customizing drugs already on the market.
But I'll tell you what? In recent years, pharmacy compounding has grown into a much larger business. In fact, get this, it accounts for 37 million prescription drugs taken by patients in the United States every year. It's a big business, it has little oversight and it impacts all of us.
(BEGIN VIDEOTAPE) GUPTA: You work here?
UNIDENTIFIED MALE: I'm security for the facility.
(voice-over): All week, we have been trying to dig up anything to try to understand how a common steroid injection could have become so deadly.
UNIDENTIFIED MALE: Unfortunately, I have to ask you guys to leave the property.
GUPTA: No one here really wants to talk.
AUTOMATED VOICE: Your call has been forwarded to an automatic --
AUTOMATED VOICE: The number you dialed is not in service.
AUTOMATED VOICE: The call has been forwarded to an automatic voice message system.
GUPTA (on camera): All right.
UNIDENTIFIED MALE: Hello?
GUPTA: Hello, I'm trying to get ahold of Barry Cadden?
(voice-over): That one, wrong number.
(on camera): Is there somebody we can actually talk to? We've been living voice messages and --
(voice-over): I even went straight to the home of Barry Cadden. He's the owner of the facility. There was a car parked at the end of the driveway, no visitors allowed. I was told they would call me back, they didn't.
(on camera): We were trying to get information.
We were tipped off about a recycling facility that shares a space with the compounding facility. It's literally in the back yard. It amounted to a garbage dump.
We even saw this health vehicle bringing waste from a nursing home to be disposed of here.
And while there are no laws specifically prohibiting a compounding pharmacy being next to, well, this, the FDA tells us it's all part of the investigation.
But there was something else we noticed. Look closely at the name of this garbage facility connected to the NECC. Conigliaro, well, it turns out this is the maiden name of Barry Cadden's wife, Lisa. She's listed as a pharmacist at the NECC. (on camera): A little bit more digging and we found out that Barry Cadden, Gregory Conigliaro, who is Lisa's brother, are the owners of NECC, that recycling facility, and also this medical facility, called the Ameridose.
(voice-over): They wouldn't even let us on the parking lot here. Now if NECC is big, then Ameridose is the 800 pound guerilla. NECC has 21 employees and generated $8 million in revenue. Ameridose, 400 employees, generated $100 million in a year.
Ameridose does drug manufacturing, which is regulated by the FDA. But they also do add-mixing, that's a form of compounding. And that's regulated by the state pharmacy board.
(on camera): And here's something else, there's a woman named Sophia Pasedis. She's the vice president of compliance here at Ameridoes. But she was also appointed to the state pharmacy board back in 2008. We asked them about that, they say she has recused herself of all matters related to Ameridose and NECC.
(voice-over): Both companies have done business with the United States government. In fact, more than $800,000 worth of drug orders were placed with them by government agencies since 2007.
Together, both these companies produce hundreds of thousands of medication doses. And now, both have shut down their operations.
GUPTA: And the Massachusetts Department of Health didn't say there was any direct evidence of contamination when it comes to products for Ameridose, but one thing this outbreak exposes is the incredible lack of oversight of compound pharmacies, which can put the public at incredible risk, as we've seen here. We're going to continue to try to push the state health department and the FDA to try to get you some answers.
And as you know, there is barely three weeks left to the presidential election. The next debate is Tuesday night. I'll be watching. Probably you will as well. I want to see what Mitt Romney says about his health care plan. He says he wants to repeal Obamacare, but also keep some popular ideas. For example, this --
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MITT ROMNEY (R), PRESIDENTIAL CANDIDATE: And with regards to health care, you had remarkable details with regard to my preexisting condition plan. You obviously studied up on it. In fact, I do have a plan that deals with people with pre-existing conditions. That's part of my health care plan.
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GUPTA: Now listening to that, it sounds like he wants to guarantee everybody a right to purchase coverage, no matter what. But that's not exactly it. I mean, here's how he explained things on "The Tonight Show". That was this spring.
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ROMNEY: People with pre-existing conditions, as long as they were insured before, they're going to be able to continue to have insurance.
JAY LENO, TV HOST: Well, supposed they were never insured before.
ROMNEY: Well, if they're 45 years old and they show up and they say, "I want insurance because I've got heart disease," it's like, hey, guys, you can't play the game like that, get insurance when you're well, and if you get ill, then you're going to be covered.
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GUPTA: Well, unfortunately, Governor, you know, this is simply not true. I see these patients all the time. They couldn't afford insurance when they're well, and can't afford it when they're sick, and 26,000 people die every year prematurely every year, when they don't need to. Those are the facts.
Yes, strictly speaking, what you're saying is right. What the governor is describing is pretty much the same protections as we have now. The problem is that many people still can't get health insurance under any circumstance.
Take a look at this. If you lose your job, you can still get health insurance through COBRA. To give you an idea, for a family of four, that now costs on average more than $1,100 a month. The Commonwealth Fund, the respective non-partisan organization, estimates that if you carry this out, about 72 million Americans would be left uninsured if you carry out the Romney proposals.
Now, we wanted to talk to Governor Romney or someone from his campaign about this, invited them to come on the show and specifically address how they would tackle this challenge, please explain to us how this all work, because as far as we can tell, tens of thousands of people's lives depend on it.
For this week, at least, they said, sorry, we can't make it. We're going to keep trying.
Coming up, though, there are 1.5 million people living with HIV in the United States, one in five don't know they're infected. But would you test your partner, if you could? Even do it perhaps secretly. Well, there's a new test that might allow for just that.
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EARVIN "MAGIC" JOHNSON, NBA HALL OF FAMER: Because of -- the HIV that I have obtained, I will have to retire from the Lakers today.
(END VIDEO CLIP) GUPTA: Who doesn't remember that day? Twenty-one years ago, hard to believe, next month, when NBA legend Magic Johnson shocked the entire world with that announcement. Magic is alive and well today. He's reiterating a point that he has made time and time again, that he hasn't take any special drug, that only a man of his celebrity could afford to have lived this long. Instead, he credits early detection to saving his life.
It's in part why he signed on as a spokesman as well for OraSure Technologies. It's a manufacturer of OraQuick, which is the very first at home rapid HIV test. In fact, he appeared on "CNN NEWSROOM" on Tuesday to talk about this.
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JOHNSON: Look, doctors are already using this, so this is nothing like new. And the great thing about it, they have been using it for many, many years. And so now, it's just available to the public. And so, it's great, because when you think about the fear factor, and you think about easterly detection can save your life, that is why I'm here 21 years.
BROOKE BALDWIN, CNN ANCHOR: Wow.
JOHNSON: I found out early, jumped on it, took my meds, I make sure, I still work out and I make sure I was comfortable with my new status.
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GUPTA: And I'll tell you, as part of all this, Magic is also encouraging everyone who engages in, quote, "high risk behavior" to get tested.
But who exactly are the people that should get tested? Will it make a difference overall? And how good of an idea is all of this?
So, joining me Boston to talk about this, Dr. Rochelle Walensky. She's a nationally recognized infectious disease physician. Thanks. Thanks for joining us.
I know you've written a little bit about this. And you spent your entire career for really pushing for routine HIV screening. Is this a big deal? A big game-changer in your mind?
DR. ROCHELLE WALENSKY, ASSOCIATE PROFESSOR OF MEDICINE, HARVARD MEDICAL SCHOOL: Thank you very much for having me. It's a pleasure to be here. Since 2006, the Centers for Disease Control and Prevention have recommended routine HIV screening and that people in the United States, all adults in the United States know their HIV status.
So in my mind, any mechanism by which we can have people get tested, either in health care settings or outside of them, people motivated to buy the test themselves, I think is a good idea.
GUPTA: And I think, should it really be everybody? What is it going to do for them?
But let me just show you quickly what we're talking about here. It's available online now in more than 30,000 stores. It costs about $30.
The test is pretty simple to use. You basically use a swab to your upper and lower gums, place it into a solution, and then about 20 minutes later you get a response like a pregnancy test, one line shows up for negative, two for positive. It sounds pretty simple.
But, Dr. Walensky, you know, when people get tested it can obviously be a very monumental moment, you know? And part of, you know, getting tested is having counseling around, having support systems around to deal with this new possibly new diagnosis. What about that if you're doing this at home?
WALENSKY: Right. So that's an excellent question. I will tell you that OraSure has provided a 24-hour a day contact line for support services for anybody who might take the test by themselves. I think many of the people who are going to purchase the test are people who want to take control and responsibility for their sexual health. And I think that there are many services available to patients when they conduct the test, either through the OraSure 24/7, through the Department of Public Health or through their own health care provider.
GUPTA: There was another headline out of all of this, which I'm sure you read. And the company says this was unintended, to be clear. They say the use of a new test could involve screening potential sexual partners, maybe without them even knowing. In fact, three quarters of the 4,000 men and women in the company's clinical trial said they would either, quote, "definitely or very likely" use it to screen sexual partners.
What do you think about that? Is that wrong? Is that unethical?
WALENSKY: I think that nobody should be tested for any disease without their informed consent or at least being informed in recognizing that this is a good thing for them. I would find it hard --
GUPTA: Even your sexual partner? Even the sexual partner?
WALENSKY: Even for a sexual partner.
I think it would be great if sexual partners, new sexual partners wanted to conduct the test together, and be there for each other, as they both receive the results together and develop the test together. I can't conceive that one might swab somebody's check with or someone's gum with this, and not know that it's actually happening. But indeed, it should not be conducted without a person's knowledge, for sure.
GUPTA: Who should be getting this test? And I know you sort of talked about this. But you know, a lot of people watching right now, they -- maybe married couples who have been married for some time. I mean, is this something that everybody should go out and do, do you think? WALENSKY: Yes, that's a great question. I think everybody should know their HIV status. If they want to go purchase a test to find out the status that they want to get an HIV test with their doctor, I think everyone in the country should know their HIV status.
One thing I want to say is who should not use this test. And I want to be clear about that --
WALENSKY: -- because people can be falsely reassured. The people who should not use this test are the ones that had an encounter the night before that they're worried might have infected them. So, to be very clear, this test does not measure the virus itself. It detects the body's immune production or antibody production to that virus, which takes sometime to mound. So, the test if conducted today tells us about someone's HIV status as of about four to six weeks ago.
GUPTA: Great explanation. Dr. Walensky, again, important topic, a lot of people paying attention, about $40 for this at home test, the first of its kind to really to come about. Thanks so much for joining us. Hope to have you back.
WALENSKY: Thank you very much.
GUPTA: And still ahead, you remember these ads? They were for the truth campaign, and they were about smoking. Well, now, the same guy who made those ads had his sights set on sugar.
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UNIDENTIFIED MALE (singing): Sugar, sugar, I want to make you happy like the sun you shine, you brighten up a gray day sugar, sugar, so good, so good. Sugar.
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GUPTA: That was the beginning of a clip from a new animated short film about the dangers of soda. Those polar bears incidentally, they may look familiar. They are a little bit more crudely drawn version of the famous Coca-Cola bears.
Now, in the film, the soda-loving family gets more and more overweight. Papa bear loses a leg ultimately to diabetes, even develops erectile dysfunction. The film also features an original song by Grammy Award winning artist Jason Mraz. It's a big production.
Michael Jacobson is the executive director of the Center for Science in the Public Interest. That's the group that produces the film. He joins me now from Washington.
Good to see you again, Michael.
MICHAEL F. JACOBSON, CENTER FOR SCIENCE IN THE PUBLIC INTEREST: Good to see you, Sanjay. Thank you for having me.
GUPTA: Sure. Important topic. As you know, we do a lot of reporting on this.
And let me get right to it. We certainly know that sugar, sweet and beverages contribute to overweight and obesity, I think most people realize that. But we've also seem to have known that for a long time.
Why now, Michael, make this movie? People will say sugar consumption is, in fact, maybe already going down in this country, albeit slowly.
JACOBSON: Yes, sugar and soda consumption has been going down slowly. But the scientific community has been doing studies and reached really a consensus that soft drinks are the one food or beverage that's been demonstrated to cause weight gain and obesity. And if we're going to deal with this obesity epidemic, that is the place to start.
So, you know, on the one hand we just see -- just Coca-Cola, forget Pepsi and the other companies -- just Coca-Cola spends $2 billion a year on advertising and other forms of marketing for sugary drinks. We thought that that should be -- we should level the playing field a little by giving people some real information that soda may cause temporary happiness in the short term. But in the long term, all too often, soft drinks contribute to obesity, which is a cause of diabetes, and other illnesses.
GUPTA: And I want to talk about the specifics regarding sugar. You did pick on Coke, specifically in this campaign with the polar bears, we did reach out to Coca-Cola for response. You may have seen this sort of response from them, Michael, as well.
But they said, quote, "This is irresponsible and the usually grandstanding from the CSPI. It's not going to help anybody understand energy balance, which is key according to recognized experts who've studied this issue, a group that doesn't include CSPI. Enough said." Enough said is part of the quote, as well.
They suggested, by the way, Michael, before I let you respond. They suggest that we reach out to the American Beverage Association. They were unable to provide anyone to come on and talk about this or even provide a statement. They don't want to seemingly talk about this.
But what they seem to be saying, is that -- you know, is this vilifying sugar specifically, and can sugar be a part of a healthy diet, even in the form of a drink, Michael?
JACOBSON: Well, occasionally, sure, we don't want to wipe out soft drinks. But we would like to see soft drinks return to the dietary role they played in the '50s, which was occasionally, and small portions, special treat. Now, people are guzzling huge containers of soda cup every day of their lives practically.
GUPTA: Is there a right amount? I mean, just being specific -- because people say, what does it mean? What is the safe amount?
JACOBSON: Well, think of a can of Coke, a 12-ounce can, contains about 90 spoons of sugar. The American Heart Association recommends that women limit themselves to 60 spoons of sugar a day, and men to 90 a day. So one Coke, and you have shot your wad for sugar. And you're getting sugar from, you know, cookies and cakes and ice cream and countless other foods.
JACOBSON: But you know, having one or two sodas a week would be reasonable. Having a 32-ounce giant Coke at a fast food restaurant every day is a prescription for disease.
GUPTA: And you can't do that in New York anymore, something else we've talked about on the show.
You know, we talk about this all the time, Michael, hope to have you back. We invited the representatives from Coke to actually come on the program, as well as the beverage industry, but they both declined. But to be continued.
Michael Jacobson, thank you so much.
JACOBSON: Thank you so much, Sanjay.
GUPTA: Don't go anywhere just yet. Still ahead, chasing life. This one is for the women out there. You really want to hear this.
GUPTA: And we're "Chasing Life" this week. And this one is for the ladies.
There has been a lot of controversy surrounding hormone replacement therapy to help women deal with the symptoms of menopause. Previous studies found it led to increased cardiovascular risks, heart risks. But a new study finds that it might actually be a matter of timing.
Take a look at this. Women who started HRT as soon as seven months after menopause didn't carry the same risk as compared to women who delayed taking HRT, hormone replacement therapy. The women who took the hormones earlier could actually reduce their chances in the future of developing heart problems.
Now, as you point out, it's the first study to show this. And I should add that hormones should not be a way to stop heart disease or cancer. But this could be some promising news out there to help women chase life.
It's going to wrap things up for SGMD today. But stay connected with me at CNN.com/Sanjay. Also, let's keep the conversation going on Twitter @SanjayGuptaCNN.
Time now though to get a check of your top stories in "THE CNN NEWSROOM."