~ CONTINUED ~

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, its 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 well 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 guideline?

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 son's 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?

Its Accutane. So, now lets say birth defects Ed Lammer, who I mentioned yesterday with my question to Dr. Woodcock indicates, and Ill 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 Roches 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 (thats 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. Its 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. Its called the Sloan survey. That's poppycock. We already have registries for four or five other drugs. So, if its 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, lets 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 Ive had the bill. How about the stuff coming across the border? You've had Purdue Pharma who said, "We wont 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 were 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.

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 nations 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 2002 Act Today Foundation.
1Michael and Caroline Bencz; Testimony: Energy and Commerce Committee's Subcommittee on Oversight and Investigation, "Issues Relating To The Safety of Accutane," December 11, 2002, Washington DC.
© Copyright 2004. All rights reserved.

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