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What's Wrong With Accutane?
Congressman Struggles To Protect Public From Powerful Acne Drug.
By Jamie Kosar
James Bencz was a thirty-one year old certified firefighter, a rescue diver, an athlete, and a business owner. On March 4, 2002 he was found at the bottom of a lake with a 44-pound barbell strapped around his body. Police know from the suicide note he left behind that the young man had killed himself.
Matthew Turney, was a sixteen year old who enjoyed playing baseball, swimming, lifting weights and playing the trombone in his high school band. On March 14, 2001 he was found dead in his parents bedroom with a self-inflicted gunshot wound.
Bart Stupak Jr., known as "BJ", was a seventeen year old who was popular in school, a football player, student body treasurer and president-elect of his high school class. On May 14, 2000 after a prom night party he took his father’s gun and shot himself in the head.
What did all these individuals have in common? They were all taking Accutane, a drug used to treat severe nodular cystic acne. The families of these young men came together on a cold December day in Washington to testify before a congressional committee investigating the safety of the drug. The possible causal role of Accutane with respect to "psychiatric injuries", particularly those resulting in suicide, were of particular concern. Approximately two hundred suicides have been linked to the powerful acne medication since 1982. However, some argue this figure may represent only a fraction of the real amount.
One committee member wondered "…if we’re not witnessing suicide but another thing going on here. Like a spontaneous action to commit self-destructive behavior". In other words, the behavior of these young men prior to their deaths seemed to suggest that they had no plans for death. That perhaps, an urge to commit suicide came on so fast and so strong that it left little warning not only to outsiders, but also to the victims themselves. The actions of these three young men in the days and weeks prior to their deaths seem to support such a possibility. For instance, the week he died, Bencz had plans to leave with several friends for a ski vacation to Austria. The day Turney died, he had asked a girl to an upcoming dance and she had agreed to go with him. He was even seen laughing and joking with his friends on the bus ride home. The week Stupak died, he had ordered his class ring and made an appointment to have his senior class pictures taken. Furthermore, not a single one of the young men had a prior history of mental illness.
However, the Swiss manufacturers of Accutane, Hoffman LaRoche, (known as Roche in the United States), claim there is no direct scientific evidence that supports a link between Accutane and suicide. Yet, the company has listed depression as a possible side effect of the drug since 1985.
Nevertheless, Roche claims that Accutane is intended to treat severe nodular cystic acne. But, in all three cases, the families say their children did not have this potentially disfiguring type of acne. In fact, the thirty-one year old Bencz was using the drug to get rid of pimples on his back and shoulders caused by his wetsuit. In light of these and other adverse reports surrounding the drug, why are physicians writing Accutane prescriptions for anything less than the most severe types of acne? Congressman Bart Stupak (D-Mich), father of BJ, has urged the Food and Drug Administration (FDA) for stricter controls on the drug. Stupak and other members of the committee found that approximately fifty percent of all Accutane prescriptions in the United States have been, and still are, written for teens with only "mild" to "moderate" acne. An internal FDA e-mail message dated August 31, 2001, cautioned that, "3% of Accutane prescribers…prescribe nearly 20% of Accutane scripts" and that this metric is, "unacceptable for ethical as well as scientific validity reasons."
Growing public concerns over the safety of the drug have spurred the FDA and Roche to take swifter action to manage the risks associated with Accutane. The FDA issued a Medication Guide to explain in plain language, the benefits and risks of the drug. Patients can also be offered an Informed Consent paper to sign. Signing it means the patient acknowledges they are fully aware of all the possible side effects cited by the manufacturer. The problem, however, is it's voluntary for physicians to offer this to their patients and not mandatory. Perhaps, not so coincidentally, the very same week the congressional hearings took place, the FDA issued a press release stating they were "strenthening controls designed to protect patients by restricting imports on certain prescription drugs". Accutane was included among the ten drugs on the list.
The FDA has also worked with Roche to implement a program called "SMART" (System to Manage Accutane Related Teratogenicity). Accutane’s role as a "teratogen" (causing birth defects) is undisputed. The birth defects caused as a result of women becoming pregnant while on Accutane are horrific. Children are born missing limbs, ears, vital internal organs and, in many cases, they suffer severe mental retardation (the FDA estimates 2,000 pregnancy exposures per year to Accutane, while Roche claims there have been 2,300 pregnancy exposures, in total, over the last twenty years to the drug). Under the SMART program, women must receive counseling about "pregnancy avoidance" and birth defects, agree to use two forms of contraception or abstain from having sex while on Accutane and must agree to monthly pregnancy tests. However, Lynn Martinez, Program Manager at the Department of Health Teratology and Birth Defects (DHTBD), stated that calls are still coming into the DHTBD offices from pregnant women exposed to Accutane even after the SMART program had been implemented.
Why is the SMART program failing? Part of the problem is that it’s a voluntary program. The FDA stated a 60% participation rate among prescribers, pharmacies and patients is one metric that if met, would indicate the program is succeeding. The idea would then be to move to 100% participation among these groups and that this "3-fold partnership, should enhance the program’s effectiveness, since failure at 3 levels is less likely…". But, that raises some important questions. Isn’t a 60% or even a 100% participation rate the wrong thing to measure in the first place? Isn’t the only important "metric", when all is said and done, a zero or close to zero number with regard to birth defects? Certainly, a 100% participation rate would be meaningless if the number of birth defects continued to remain relatively high. Not to mention, the SMART plan does absolutely nothing to address the psychiatric/brain injuries associated with Accutane.
Consequently, Stupak and other lawmakers point to Europe where mandatory registration of the drug have all but eliminated birth defects associated with Accutane in that part of the world. Also, a mandatory registry would be a critical step in addressing, managing, and containing the psychiatric injuries attributed to this powerful acne medication. One of the tragedies is that these types of injuries are largely preventable. In financial terms, according to the Institute of Medicine (IOM) "preventable adverse events cost the United States economy about $17 billion a year."
I met with Stupak in his Washington office on a soggy Thursday morning. Just before the interview was to commence he fielded a call from Australia where Accutane is marketed under the name RoAccutane. As our interview progressed it was apparent he was extremely knowlegable about the subject and very passionate in his convictions.
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Q: Were there any concerns in BJ’s life other than acne prior to his taking Accutane?
STUPAK: No, he struggled with a couple of classes in school. His grade point average was probably actually better than mine, at that point, [than] when I was in high school. I was too busy in high school playing sports and having a good time. Studies did not come serious until after I graduated from high school. We told him it’s harder to get into the schools you want. So, therefore you’ve got to get your grades up. But, if you take a look at all these Accutane cases that’s a common theme. A lot of these kids will be really good students and they just like lose interest and boom. Sleep all the time…in school. Not that BJ was sleeping in school. But, there’s a real pattern there where their grades just drop right off. And we really believe that it was the Accutane. We were on vacation [in Cancun] umm, I’m gonna say first week in January of 2000, the year he died, he was on his Accutane. And maybe it may have been his first month into it. And we were concerned about watching him in the sun, [making sure he used] sunblock and all that. We were concerned about his grades in some classes. He had to bring certain homework with him. He got his assignments beforehand. Did his homework. We went back and he wouldn’t complete assignments. It was like he couldn’t complete it. And you see that in kids, in a lot of these Accutane kids. So, he struggled in two classes.
Q: How far into his Accutane treatment was he?
STUPAK: Well, he died in May and he had maybe eleven more [pills] to go so probably five months, 40 milligrams.
Q: And the day it happened, I know it’s a sensitive issue, but if you can, take me through that day.
STUPAK: I had actually got up early that morning, before he even got up, to catch an airplane and flew to part of my district. I did some events. But, I promised him that I’d be home that night because it was his junior prom and he worked so hard the whole week. And that I would see him that night at the so-called "Grand March" and all this. So, I flew back home and sure enough, saw him, talked to him. Normal. Fine. He was going to have the party. Told him to keep everything under control. [he said] "Yeah", he would. "Your brother’s home and he’s gonna keep an eye on things." "Yup" [BJ replied]. Told him he looked good and we were proud of him. He thanked me for coming and I told him we would see him in the morning. We would all go to church and breakfast. And that was about it. We left then and he went off to the prom. They have the Grand March at the gym and then they have the dinner and all that at another location. He left for that and we went home. Got out the chips, the pop and made sure everything was all set for his party. We left our house maybe about eleven or midnight. I don’t know whatever it was. And we had a reservation at a motel just down the street and we stayed there. And that was it. I never saw him again. I saw him the next morning. Of course he was dead.
Q: Who discovered the body?
STUPAK: Ken and his buddies were actually like the chaperones of this party. BJ hung around with Ken’s friends and vica versa. And those guys did and they called us and 911.
Q: How did you link Accutane to BJ’s death?
STUPAK: Laurie actually did. You can call it mother’s intuition or whatever you want. The police asked me, of course, "Was he on any prescription drugs?" I said, "Yeah, Accutane." I actually went and got his Accutane [packet] and said, "Here’s what he was on." I don’t think they wrote it down. No big deal. Something told Laurie, if you will, her intuition or whatever, to check the Accutane. And actually she checked it and her thought was, "Okay BJ had alcohol that night and all that even though it was forbidden. Would that exacerbate [things], the Accutane and make him do something like this?" So, she went on the Internet. I don’t know what made her think of going on the Internet. But she did. Then she came across the MedWatch in late February when they were advising of depression, psychosis, suicide ideation and rarely in some cases, suicide. And this was supposed to be the warning that the FDA and Hoffman LaRoche was putting out to consumers. And we didn’t know anything about it. And that was 1998 and this was May of 2000. BJ’s packet had nothing on there at all. They never put the warnings on it. So, my question then was, "Why would they put this out after this drug had been on the market for some sixteen years or so?" So, that’s when the investigation really began. When Laurie suggested that Accutane had some link to BJ’s death. I remember telling her, "Laurie I don’t know how an acne medicine can affect the state of mind." I was skeptical at best. So, then we had to wait until we got all the blood tests back to make sure he wasn’t taking any illegal drugs, or see if he had too much alcohol, or what might have happened. He was clean on everything. The alcohol had showed he had some drinks but he wasn’t impaired, he wasn’t drunk or anything like that.
Q: I have a brother and when we were younger we were very close. There were things that you obviously talk about with your brother that you don’t talk about with your parents. Have you talked to Ken and asked if BJ ever mentioned anything? Or did Ken ever notice anything with the benefit of 20/20 hindsight?
STUPAK: Yeah, nothing. Nothing. This kid lived life to the fullest. He loved life. That week he had ordered his senior class ring. He made an appointment to get his senior class pictures taken. You do it during the summer before your senior year. He ordered his varsity letter jacket. For college he had to take SAT tests, he applied to do that. He was playing baseball. He made plans with my brother to come watch his game up in my brother’s hometown up in Escanaba. Things like that. No indication. The last thing he said to his buddies was basically, "Alright, I’ll see you tonight to watch wrestling (pay-per-view). I’ll be a few minutes late because I'm going to the gym to shoot hoops with my Dad." Sunday night was "open gym" we called it in Menominee. So I’d go and shoot around and play horse or something like that. And we’d do that whenever I was around. So, that was the plan.
Q: Who was the last person to actually see him alive?
STUPAK: I won’t use the kid’s names. It’s too hard on the kids. It’s all in the police reports. I told the families I would not use their names. I want to keep that promise to them.
Q: Are there other common threads of odd behavior in Accutane patients? Maybe some things other parents observed?
STUPAK: Well, we still feel that there is a "high risk profile" out there. That’s a term that Hoffman LaRoche has used. I didn’t get a chance to bring it up much yesterday. If you noticed when the Turney’s questioned their dermatologist about it they said, "Matt did not fit the profile." There’s no doubt in my mind there’s a profile out there of kids that are going to be susceptible to the psychiatric injuries [of Accutane]. Some of the theories, and these are just observations people have made, there’s no scientific [confirmation]. They believe that the more outgoing, sensitive (meaning into their thoughts…music, things like this type of kids), athletic, low body fat [all make a higher risk profile]. The way it sort of goes is the Accutane will attach to the fat in the body. The body will absorb anything you give it and usually it will absorb it in the fat. These kids don’t have much fat. So, where’s all the fat in your body? It’s in your brain. The fat surrounds all the nerve endings in the brain and the neurological pathways that surround it so you don’t hurt them. For some reason, and that’s why you heard the "spontaneity" where you can’t predict what’s going to happen, your body gets too much in it. And there’s a spiking that goes on and it very much effects the brain. That’s one of the theories that a lot of people have put forth. In a lot of these cases many of these kids have high cholesterol. Some doctors have said to us that it’s usually a warning that your body cannot tolerate the drug. That it’s rejecting the drug. So, things like that. Those are some of the things we look at.
Q: Has anyone ever done a PET (Positron Emission Tomography) scan or brain type of scans where they can see the blood flow?
STUPAK: There’s actually been a doctor whose tried to do that. Unfortunately, he’s been frustrated in that effort. Yeah, there is a PET scan theory.
Q: Do you think Accutane adversely affects the brain?
STUPAK: They said it in 1998 that it does affect the adult human brain. A lot of these babies are still born and they have no brain. Anyway, the point I was trying to get to Roche yesterday and I hope it came through, was in these adverse events, where they had the kid that died from "death by adolescents", [cites a coroner’s report where nobody was curious enough to investigate further what "death by adolescents" meant]. And once you check that out, Roche is quick to say you have these confounding factors: drugs, alcohol, broken families, broken marriages, rejected by girlfriends. Typical teenage stuff. But, they never stop to go check out those factors. It’s just too easy, too convenient to brush this thing off as teenage suicide because that population has a high incidence of suicide (the third leading cause of death among youngsters). So, it’s easy to explain it away that way. And they really don’t want to know the truth. There’s no doubt there’s a lot that could be done. It’s interesting that a few cases the FDA…I put up that one chart, which led to the so-called change in labeling which they didn’t do for a couple of years. The report of February 1998 where we had the 31 cases of 19 attempted suicides and 12 suicides. And the FDA actually went back, that’s one of the blow up charts I had, so they said there was no preceding history of mental illness or disease in the majority of these. There was one there that it looks like about 10 out of 12 there’s no history [of mental illness]. In their time [period] they went back and looked at 51 cases and again these confounding factors are excluded. And in that one there are 51 cases they looked at, and of that, there went back and they found maybe 11 or 12 that could have had some psychiatric problems. So, you still have 40, or 78% with no confounding factors and no history of problems. So that right there gives you some indication of what’s going on here. But, scientifically, how you do it is going to be very difficult.
Q: Have you uncovered any evidence that Hoffman LaRoche had prior knowledge of the dangers of Accutane but did nothing?
STUPAK: Sure, the 1982 report that they turned in twenty years later. It’s part of one of our exhibits. November and December of 1981, in preparation for their application and support of their application to market Accutane in the United States, they did a pharmacology test. They gave Accutane to mice. The mice, the gross movement in that, weren’t necessarily impaired. But, they noticed the mice had increased irritability, increased sensitivity to touch, hyperactivity and lost their grip. They concluded that it was noticeable, but not markedly so, and would not effect humans they claimed. That report, and Roche admitted it yesterday, should’ve been submitted with their application. They did not submit it. No matter what the report says, here’s a document specifically used in the support of their application in the testing you have to do, [and] they did not submit it to the FDA! Twenty years later we found out about it. It’s part of the record. Do I think there’s other reports? Yes I do. There’s no doubt in my mind. What happened after that? So, we believe there are more. But, that was a report that showed the effect on the central nervous system on mice. Therefore, you either follow it up with a higher primate order, [or] you at least disclose it to the FDA. They’re the ones who make the decision whether we need more testing in the area to prove or disprove this theory. We probably could have caught it before this thing was ever approved.
Q: In the hearing yesterday, the doctor for Roche said basically, "yeah, you’re right that probably should have been submitted." Are there going to be legal consequences to that?
STUPAK: Well, now that we have the admission on record from them it’ll be something to look at. Oh, I think there’s all kinds of consequences on this one. Look at the new drug formula. Remember I went at it and Woodcock [Dr. Janet Woodcock - director of FDA’s Drug Evaluation and Research] refused to mention it because it’s an application pending before the FDA? So, I went to Skin and Aging magazine? You can comment on Skin and Aging magazine. That’s a publication. Remember we went back and forth on that?
Q: Yes.
STUPAK: In their new formula…Roche’s patent has ended on this thing [Accutane]. So, they’re trying to extend their patent. One way you extend it is to come up with a new formulation. And all they did was cut back from a 40 milligram to a 20 milligram. But, a pill just as effective for efficacy. And in there, in that new formula they found 11 out of 300 [almost 4%] of the people tested had psychiatric problems.
Q: Prior to testing?
STUPAK: During testing. They had two groups. One got the current formula. The other group got the new formula. [In the current] one person, according to Roche, had problems, central nervous system problems. The new formula, half as powerful, half as powerful, had eleven psychiatric problems. Now, they won’t comment on it, but there’s no doubt in my mind, they would not approve it just because of questions surrounding the psychiatric. Now, should we not, and that’s one of the questions the committee should follow up on, should we not get that report and see the extent and nature of the psychiatric problems that were discovered in these eleven people? There’s another report that you could use that indicates psychiatric. They have the information. They’re not sharing it with the American people.
Q: The types of brain damage or psychiatric damage…have there been other types of injury such as anxiety disorder or panic attacks associated with Accutane?
STUPAK: Yes. It’s there. It’s all there. They’re changing their labeling you know. And it wasn’t clear yesterday and maybe we didn’t do a good job on this part. They’ve had to change their label. The new label talks about "aggressive, violent behavior". The "depression" that you see with this, if you want to use that word, is not your garden type depression that we all see. It’s not that kind at all. It comes on [snaps fingers] like that. And it’s a violent outburst. We didn’t get into it yesterday because I had so many areas I could go. They talked about SIB’s throughout the whole thing. "Self-inflicted bodily harm". These kids, there’s one kid who set himself on fire and jumped off a cliff. He lived. He can’t tell you today why he did it. An Accutane kid. He left a note that doesn’t make any sense whatsoever. There’s a service man that was taking Accutane. Came home. He was probably about twenty years old. He was in boot camp. He knew his parents would be gone. They would be home on Sunday. He came home and ransacked the house looking for a gun to shoot himself. Couldn’t find one, so instead, he took a big knife and started stabbing himself. And his buddies happened to come through the kitchen door and found him on the kitchen floor full of blood all over the place. And to this day he doesn’t know why he did it. If he could’ve found a gun that day he would’ve killed himself.
Q: That reminds me of one of the parents’ testimonies. When their son killed himself by strapping a barbell to himself and jumping into a lake.
STUPAK: James Bencz. Yeah, that was the triathlete, the firefighter, the EMT guy. He actually called. Remember he’s thirty-one years old now, he’s not a young adolescent. Okay. He’s not gonna die from "death by adolescents" if you want to call it that. He actually called his doctor. They hadn’t heard the tape. The parents were told that he called almost frantic. And they went back and sure enough he had Accutane up on his computer. I mean, he realized what was going on but he still couldn’t pull himself back. He called the doctor for help. They told him, "Come back on Monday." Sunday he killed himself. We have one or two other cases where, like we’re sitting here talking, we’re the parents and the son would come in, "Hi, how are you doing!" Go through the door that opens into the garage and hung himself right there. The parents are sitting six feet away. You can’t stop yourself. You can’t say, "help me out". Hung himself. We had the kid up in the state of Washington who had his learners permit. So everyday his parents would let him drive the car out of the garage in the driveway. His parents were there. He didn’t come in. They figured that was odd and looked out and the car was there, still running. "Oh, he must be goofing around or something." They went out to go to work and there’s the kid hanging in the garage. BJ…his brother was there. Three of his best friends were there. This thing is so overpowering, you can’t ask for help.
Q: One of the Committee members made a remark to the effect that we may be witnessing a spontaneous urge to commit suicide as opposed to a well thought out and planned type of suicide. What are your thoughts on that?
STUPAK: The median time on the Accutane when these things occur is about 88 days. The "spontaneity", we mentioned it a number of times yesterday and I even asked the dermatologist person there, "Can you warn against spontaneity?" No. We see that. That’s why you have the new labeling change. The "aggressive violent behavior." It comes on that quick. You can’t look for a pattern: here’s step one of depression. Here’s step two. Here’s step three. Here’s step four. Now, here’s the point where they’re going to take their own life. It doesn’t come on that way. There is NO warning. Turney, Bencz, BJ. I’ve probably talked to forty or fifty of these families. It’s always the same thing. No way. No idea. No, nothing. And then boom something happens.
Q: Another family testified saying that even in hindsight they would have been unable to see anything. It was ten minutes their son walked in the door smiling saying, "Hi" and he seemed happy. Then ten minutes later he was dead.
STUPAK: Yup. That was the Turney family. And the reason why they know all this is because the grandmother lived right next door and the grandmother saw him get off the bus. Knew the coat he was wearing. That’s how they knew he hung up his coat. Grandmother said, "…then I saw him do this." Y’know? That’s how they pieced it all together. And you’re right they figure it’s about ten minutes. How do you protect your child? How do you protect anyone for that ten-minute breakdown period? You can’t. I have three doctors who’ve lost their sons on Accutane. I have a number of nurses who lost their sons and daughters on Accutane. They’re trained to see this stuff. If they don’t see it what chance do you or I have with our own children? We don’t have a chance.
Q: How many total reports of suicide are there to date associated with Accutane?
STUPAK: I’ll give you as of October 31, 2002: from the Fall of 1982 it’s 167 that the FDA knows of. I turned in another 37 last Friday. So, it could very well be at least 200. When I turn them in…they report them to my office. They get a letter from me saying you’ve got to report to the FDA [because] I’m not the regulatory agency. Some people will do that most of them will not. They’re so fed up with the FDA and everybody else on this Accutane. So as part of my responsibility then, if I get this, then I should turn it over to the FDA. So I do. I’ve turned in 90. Of those 90 now, at least 60 are new cases. So, if you throw in my 36, make this easy for me, you’re probably talking about another 24. And after your 167 you’re at about 200. And again, that represents 1% of the actual number.
Q: How do you arrive at your 1%?
STUPAK: Okay, how do you get it? All the statisticians, the epidemiologists that have looked at drugs over the years [extrapolate the numbers]. Remember this is a voluntary reporting system. So, it’s voluntary. The length of time the drugs been on the market, the severity of the injury compared to the medicine. This is for acne. You would never think someone’s going to commit suicide for taking a medicine for your skin. It’s not a psychotropic drug. You’re not on a life-threatening situation. You just don’t make the tie in. Plus is it a recognizable event within the community? No, it’s not. You’ve heard the dermatologist and everyone else say, "I don’t have these problems." That one dermatologist, "No, I’ve never had anybody have mental health problems with this drug." That’s the way you do it. It’s basically the length of time. When the FDA makes Roche put out another "Dear Doctor" then incidence goes up. For the first year that’s the way it is then it tails off. So, I’m sure after that hearing when C-Span starts running it we’ll get calls. So will the FDA. But the remoteness of…and again no medical or science proof as Roche tells all the doctors. So, they say, "Well, it can’t be." They simply dismiss it that way. But, as we showed yesterday in the one exhibit, there are nine different ways to look at causality. Eight of the nine have been proven on Accutane.
Q: The ways to look at causality is that something the FDA looks at as a guidline?
STUPAK: These spontaneous reports and remember they’re spontaneous reports, prompted us to ask whether other information supports a possible causal relationship. [first] Target organ of the observed event? Yes, the brain. [second] Other central nervous system events? Yes. [third] Positive challenge/dechallenge? That’s the basic tool you always use. You have a person on this drug that has attempted suicide, let’s say. They have those thoughts, then take them off. Wait a while. Put them back on. Those thoughts come back again? Yes, that’s challenge/dechallenge. [fourth] Are there published reports reflecting psychiatric associated with Accutane? Yes. Before the 1998 warning? Yes. [fifth] Are there clinical patterns in those reports similar? Those spontaneous reports? Yes. [sixth] Any retinoid socio-psychiatric disturbance? Yes, vitamin A. Vitamin A toxicity. We’ve known that for a long time. [seventh] Are retinoid receptors and binding proteins found in adult mammalian brains? Yes, hummingbirds and others. They’ve proven it already. It affects their brains. [eighth] Have any well conducted studies demonstrated functional role for retinoid receptors in the central nervous system? Yes, the neural pathways. [ninth] Has a mechanism of action been established to have come from observed events? No, in other words, we don’t have any scientific studies. But, eight out of the nine signals of causality supports it [the ninth and last point].
Q: What would it take to establish that causation? That’s what I’m perplexed by. STUPAK: Well, you, me, and the whole medical world. There is no way legally, ethically or morally can you take a group of kids who have severe nodular cystic acne [and do this type of test]. And first of all, they have to have severe nodular cystic acne and Doctor Graham [Dr. David Graham – Associate Director, Drug Safety, FDA] said ninety percent of the kids on this don’t have it.
Q: Is that what is meant by "off label"? ("off label" means doctors are prescribing Accutane for even mild to moderate cases of acne. "On label" is prescribing this drug only to people with severe nodular cystic acne).
STUPAK: Yes, "off label". Correct. And even those in support of Accutane said it was a very powerful drug and it should only be prescribed to people with "very severe". Okay? I don’t disagree. So, if you have forty here that have it and forty over here that have it, you can’t give one of them Accutane and the other one nothing. Ethically, morally, legally, medically. It’s illegal. So, you can’t really do a designed study. That’s the dilemma. Yeah, there are a number of tests you can do. And they’re working on them, which I can’t disclose.
Q: You can’t morally and ethically do it but Hoffman LaRoche continues to sell it. So could you recommend they do it? Even if they did do it, I don’t think they would turn anything over. Right?
STUPAK: Well, even if they did do it, when we went public on October 5, 2000 that was one of the recommendations. My wife and I went public and we thought Accutane caused our sons death. Six or seven other members of Congress joined me and we asked for independent studies. You have the National Institute of Health, CDC [Center for Disease Control] and there are some other independent agencies that can do this because we are very skeptical of the FDA and Hoffman LaRoche. As you can see from yesterday’s hearing, everybody’s skeptical in their ability to do something here on this drug.
Q: Can’t they do that last step in mice?
STUPAK: Well, they already did it. They turned in the record. And we have the record now twenty years later that shows that "yes" it did adversely effect the mice.
Q: So, then that last step has been met but not in humans?
STUPAK: Not in humans. We can go back here for mammals. Retinoid receptors have been found in adult mammal brain? Yes. And we know Vitamin A effects the brain. Put these two together and you have it! Well conducted studies demonstrate functional role for retinoid receptors in the central nervous system for mammals? Yes, they’ve done this. The only one we haven’t done yet is human beings. And you can’t.
Q: How many birth defects have there been since 1982 with Accutane?
STUPAK: Again, it’s hard to get to because you go back to this [pulls out another exhibit] 93 unwanted pregnancies, 42 abortions. So, we don’t know where this is. We know that probably 40% of the women, as came out yesterday, on Accutane, miscarry. Another 25% at least, have abortions. So those that are left [35%] are all affected. Why do they have abortions and miscarriages? It’s Accutane. So, now let’s say birth defects…Ed Lammer, who I mentioned yesterday with my question to Dr. Woodcock indicates, and I’ll use his words, "Thousands and thousands." Remember, what Graham said in 1990? He predicted between 10,000 and 15,000 abortions on this drug and thousands of birth defects on it. Of course, Roche said it’s 79. They’re full of it. Right here it’s 93! That’s only for one quarter! Last quarter of 1999. That’s Roche’s figures not FDA! 2,381 adverse events. Of those, 313 were serious. Serious has to be reported within 15 days. Here’s the breakdown: Psychiatric; one a day [89 reports]. Self-injurious behavior; 5 completed suicides, 5 attempted suicides, 5 reports of psychosis (that’s severe hallucinations things like this). 42 abortions! Of course you can’t count those because a fetus is not a patient [sarcastic]. That’s just one quarter. So, when they start saying 79, no [way] you just point to this and say, "you’ve got 93 right here". The numbers are already off! And you tell me that’s for 18 years? I’m giving you 90 days! And you got 93? Unwanted pregnancies: half of those pregnancies ended up in a birth defect. Remember? Half!
Q: Two thousand pregnancy exposures to Accutane per year and 95% end up in abortion. I think that was Dr. Graham. So, the 5% that go full term…
STUPAK: Half will have birth defects.
Q: So half will be normal?
STUPAK: Yes, but not many. Remember the testimony again yesterday was that they look normal but they’re not. Their IQ is at 80 to 85. That’s one standard deviation from the rest of the American society. According to Lammer [Dr. Ed Lammer – leading expert on birth defects associated with Accutane] you have to wait at least one year. Then you suddenly see they have vocabulary problems. Mental retardation starts to manifest itself.
Q: A lot of people take Accutane and don’t have problems. I heard two testimonies in support of the drug. In one testimony the woman called it a "miracle drug". Knowing the odds are one in a thousand or one in a hundred thousand, would you, I think I already know the answer, would you recommend it saying, "but here’s what you have to look out for?"
STUPAK: You do it with the registry. And you certify the doctors who can get this drug. That’s the argument over the registry that you heard going on. And the question we didn’t ask and we have privately asked some of these people, "Knowing there’s a registry, knowing you have severe nodular cystic acne and this will clean you up, would you register? Would you fill out their form? Would you go to a doctor who is certified to treat this because of the adverse events either for pregnancies or psychiatric?" Every one of them says, "Yes." If you’re that severe you’re still going to do it.
Q: Well, yeah it’s not like something that’s embarrassing. It’s very common and a lot of people have it.
STUPAK: Yeah, it’s not like it’s forbidden. If I’m depressed and I’m so embarrassed by myself of course I’m going to do it! You do it in Thalidomide [used for cancer and leprosy]. You do it everywhere else. Ed Lammer says, "in Europe you can count on one hand all the birth defects they have" [with Accutane]. Why? They tightly control and register this drug. In Sweden you’ve got to go through the Ministry of Health to get a prescription for this. They just don’t hand it out like we do in this country!
Q: So, why don’t they do this "Restricted Distribution." Why don’t they do this "Registry" with Accutane?
STUPAK: These psychiatric injuries would then manifest themselves. You then, in a way, have a controlled group. You’ll know what the confounding factors are in this person’s life before you take him on Accutane. Does he come from a split home? Is he failing in school? Does he have low self-esteem to begin with? Those are some warning signs of someone who may have depression before he even starts. And all that would be there. The best thing about the registry and everyone said, is the data you collect. It’s accurate data. That’s why Roche is so scared of the registry. Not because of birth defects, but because of psychiatric effects.
Q: And it would all pile up? The evidence would all pile up?
STUPAK: Yes.
Q: They defended that by claiming there would be a privacy issue involved. Is there any merit to that?
STUPAK: Yeah, there’s some merit to it but look what these people say. Does anyone like to fill out a form? No. And you’re going to ask some personal questions about your birth control and things like that. But they do it already. It’s called the Sloan survey. That’s poppycock. We already have registries for four or five other drugs. So, if it’s not privacy issue for those other four or five drugs why is it a privacy issue here?
Q: When the Committee asked the medical director for the March of Dimes why all this hasn’t been implemented with Accutane she said, "It’s a very complex program to implement". At least, that was her guess as to why there is no registry with the drug in this country.
STUPAK: Right, but they still do it with Thalidomide. And they do it for a couple of other drugs. So could they do it here? Yes. March of Dimes, of course, is advocating doing it. March of Dimes, their people, sat on the advisory committee in 2000 when they recommended registry and certification of all doctors.
Q: Did you ever sue Hoffman LaRoche?
STUPAK: Nope.
Q: Why?
STUPAK: Just haven’t done it. My focus has been here. We felt it was our responsibility not only as parents, but I as a legislator, to put forth public knowledge about this powerful drug. Even those who liked the drug and who testified on behalf of the drug, said that it’s a very powerful drug. And we think people need to know about it. And then they can evaluate the risks for themselves. The risks and the benefits.
Q: What would you like the FDA to do that they’re not already doing?
STUPAK: Well, let’s get the registry and certification. You know October 6, 2000 the FDA actually wrote a letter to Roche saying they’re going to do it. And then they backed off.
Q: But why would they back off? That’s their job.
STUPAK: Political pressure from Roche and everybody else. Pressure from the American Academy of Dermatologists. Pressure from doctors. Things like that. Look, something as simple as Informed Consent they won’t even do.
Q: Wait I’m a little confused. They’re an independent body. That’s their job. That’s what they’re supposed to do.
STUPAK: They’re really not an independent body. They’re a revolving door for pharmaceutical companies.
Q: How do they benefit?
STUPAK: Well, because then after a few years they will leave their position in FDA and go take very lucrative jobs within drug companies. It’s well known. In fact, one of the big epidemiologists, Dr. Nelson, who was at the FDA and now works for Roche, now claims there’s nothing wrong with this drug. That’s not what he was claiming when he was part of the FDA. They are not. They are ineffective, they’re unwilling, or unable or incompetent. There’s no other way to put it on this one. The Internet…five or six years I’ve had the bill. How about the stuff coming across the border. You’ve had Purdue Pharma who said, "We won’t sell anymore to Mexico." Try to get that with Roche. There are a number of things they can do. Informed Consent. Require the doctors to do it. It’s voluntary. What’s their answer? "We can’t tell doctors how to practice medicine." No, that’s true. But you can restrict the distribution of a drug when there’s a public health issue and they won’t do it.
Q: Because Accutane now has come off patent there are other generics getting ready to enter the market…
STUPAK: Right, there are four. Thirteen more pending.
Q: Are you worried there will be a confusion between Accutane and Isotretinoin [the generic name for Accutane]? Meaning people might think, "Oh this is Isotretinoin, or whatever name each manufacturer decides to call their brand, and not Accutane." When they are basically the exact same thing?
STUPAK: Well, not only are you worried about that, but you’re also worried about a broader distribution on a drug that we have known has raised serious questions not only on pregnancies, which is well established but, also on the psychiatric injuries. So, now we’re going to make this drug more widely distributed? It’s in generic form. Easier to get and less expensive. And if you look at the marketing strategy that Roche has employed they’re actually now trying to target certain groups and races.
Q: Like who?
STUPAK: Like African-Americans and Hispanics. They’re actually targeting them with their direct to consumer advertising that we talked about yesterday.
Q: And lastly, what would you say to a parent or any person considering using Accutane who might be reading this?
STUPAK: Don’t do it. It’s not worth the consequences. What is the benefit you’re receiving? Clean skin. But, you may have a child who is forever scarred mentally, physically. We talked about the strokes yesterday. Young people dying of strokes. We talked about heart attacks. We talked about the lymphoma. We talked about acute pancreatitis. Even if you don’t die from pancreatitis it’s very painful. We talked about the hearing loss. There’s vision problems. There are eighteen different warnings with this drug. Read them. And if you still think it’s worth it, that’s your decision. It’s just not worth it.
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It’s not surprising why Stupak has been critical of the FDA regarding Accutane. Their actions thus far have demonstrated considerable restraint. This restraint seems unwarranted amid mounting public health concerns. It also appears to be out of sync with their own internal communications. For example, a 1998 FDA memo stated, "Given all the pieces of evidence available, it is difficult to avoid the conclusion that Accutane can adversely affect the adult human brain in clinically significant ways and that Accutane use is associated with severe psychiatric disease in some patients." In addition, an October 6, 2000 letter from FDA’s Dr. Janet Woodcock to Roche stated, "…Roche should initiate a program whereby there is complete registration from all [Accutane] patients." Also, an FDA e-mail from Kathryn O’Connor (FDA Medical Review Officer) dated August 16, 2001 and marked "Confidential" stated, "Roche and the AAD are so adamantly opposed to collecting the real number of exposed fetuses for a reason and I personally do not believe them when they say it is concern for patients’ privacy…"
To further illustrate his concerns about the dangers of Accutane, Stupak cites an additional two hundred deaths among young Accutane users, from causes other than suicide (ie. strokes), that have been recorded in the nation’s Adverse Event Reporting System (AERS) since 1982. He also points to a 1999 report that covered only ninety days in which a staggering 13% of all adverse events reported in that period were labeled "serious". Of those labeled "serious", 28% came from "psychiatric" alone. This works out to about one person each day falling victim to a serious psychiatric injury while using Accutane. Two disturbing things immediately become obvious after reviewing the data. First, these figures are reported on a voluntary basis so the actual statistics could be much higher. And secondly, of the events labeled "serious", only "unwanted pregnancy" exposures while on Accutane rivaled the psychiatric injuries ("unwanted pregnancies" represented 30% of all "serious" reported events in the ninety-day period versus 28% for "psychiatric"). In other words, other than simple labeling changes and a voluntary Informed Consent, nothing is currently being done to manage the risks associated with the psychiatric injuries. And these types of injuries may very well represent a much greater financial cost and social burden to our society than do unwanted pregnancy exposures to the drug.
The implications are clear. Accutane is a very powerful drug that has been linked to suicides, birth defects and severe psychiatric/brain injuries. Either the FDA takes a more aggressive stance in managing and controlling ALL the risks associated with Accutane, or every day in this country our friends and loved ones will suffer severe consequences. Many of those consequences, some have argued (ie. brain injuries, severe birth defects), may even be a fate far worse than death.
Copyright ã 2002 Act Today Foundation.
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