The AW Amazon Store
Buy Books by AWers!

 

Welcome to the AbsoluteWrite Water Cooler! Please read The Newbie Guide To Absolute Write

Page 1 of 5 12345 LastLast
Results 1 to 25 of 121

Thread: Narcolepsy, FDA ban, TNH, etc.

  1. #1
    Your Genial Uncle Absolute Sage James D. Macdonald's Avatar
    Join Date
    Feb 2005
    Location
    New Hampshire
    Posts
    25,366

    Narcolepsy, FDA ban, TNH, etc.

    -
    Last edited by JennaGlatzer; 01-04-2006 at 04:30 PM. Reason: don't know why this post got moved. Grr.

  2. #2
    Your Genial Uncle Absolute Sage James D. Macdonald's Avatar
    Join Date
    Feb 2005
    Location
    New Hampshire
    Posts
    25,366
    Guys, I'm going to hijack this thread for a moment to make a personal plea. Consider it a small "Alert the Media Day" exercise.

    First, read this:

    http://www.ascribe.org/cgi-bin/behol...=2005&public=1

    One of my editors, who has grown to be a close personal friend over the years, is facing the end of her working life within the month, thanks to the FDA.

    You can read about it here:

    http://nielsenhayden.com/makinglight...es/007140.html

    Please, take a moment to write to your Senators and your Representative, asking about the FDA's action. Write to your local media. Write to the FDA. It's good practice.

    This is important to me; this individual edited half-a-dozen of my books over the past dozen years, and the series isn't finished yet. I'm sure there are many more people, perhaps some you know, or some who live in your community, in the same fix.

    Thank you.

  3. #3
    Resident Curmudgeon Requiescat In Pace ResearchGuy's Avatar
    Join Date
    Mar 2005
    Location
    Sacramento area, CA
    Posts
    5,011
    Quote Originally Posted by James D. Macdonald
    ...Please, take a moment to write to your Senators and your Representative, asking about the FDA's action....
    Hmmm ...

    Seattle Post-Intelligencer (Seattle, WA); 10/25/2005
    The Food and Drug Administration has withdrawn approval for a drug used to treat attention deficit hyperactivity disorder because it has been associated with liver problems, including death, agency officials said Monday.

    The move means drug makers will no longer produce generic versions of pemoline, which was developed by Abbott Laboratories and sold under the name Cylert.

    Abbott discontinued the drug earlier this year, but generic versions have remained available.

    FDA is not recalling the drug, instead allowing pharmacies to sell their remaining stock as doctors still using it switch patients to other treatments.
    The stuff already lost its FDA approval.

    What, exactly, is the message to be sent to legislators? Please require the FDA to reinstate approval for generic versions of a drug associated with liver problems and death because it is the drug of choice for off-label use in one condition?

    I am not making light of this, Jim, but pointing out that there is a lot more to the story and that the deed was done already. Remaining stocks were allowed to be sold off, so the impact was slightly delayed. But it is a done deal. At this point, it would be a matter NOT of seeking to stop FDA from withdrawing approval but rather of asking FDA to reapprove a drug that it has already acted against on account of public health concerns. If that is what is to be sought, it will take some pretty persuasive AND informed correspondence to counteract, for instance:

    "FDA has concluded that the risk of liver failure with this drug outweighs the potential benefits," the agency statement says, noting that alternative treatments for ADD have come on the market since pemoline was introduced. [AP Online; 10/25/2005]
    MAYBE it could be argued that FDA should reapprove the drug SOLELY for use against narcolepsy (thus reducing the scope of the public health impact), but this faces two difficulties. First, the market for that use might be so small as to keep any generic drug manuacturer from making it. Second, the drug could still be used for off-label uses, which would now include what used to be THE label-indicated uses. Hence: the public health concern returns.

    Quoting from an FDA statement:

    Although the absolute number of reported cases of liver failure with pemoline is not large, the reporting rate for liver failure with pemoline is 10 to 25 times greater than the background rate of liver failure in the general population. [FDA ALERT [10/2005]: Liver Injury Risk and Market Withdrawal]
    It is probably not going to be persuasive to legislators to argue for the return to the market of a drug banned on account of unacceptable risks, especially with no positive incentive to legislators and much risk. (Opponents could attack incumbents who seek reintroduction into the market of a drug deemed too risky by the FDA, implying that they are in the pocket of the pharmaceutical industry [which many are, of course, but that wanders afield here] or indifferent to the risks to the public. Meanwhile, public interest groups were already incensed that the FDA did not order the immediate recall of existing stocks when the drug was banned.)

    At a minimum, some clarity in the message is needed.

    --Ken

    P.S. For more background: May 17, 2005 (last update) http://www.fda.gov/ohrms/dockets/doc...15/05p0115.htm, 2005P-0115: IMMEDIATELY REMOVE FROM THE MARKET PEMOLINE CYLER- ABBOTT LABORATORIES, AND ALL GENERIC VERSIONS, A STIMULANT DRUG FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER.
    Last edited by ResearchGuy; 01-04-2006 at 09:40 AM. Reason: Added p.s.
    [URL="http://www.umbachconsulting.com/KenCV.htm"][FONT=Franklin Gothic Medium][COLOR=royalblue]ResearchGuy[/COLOR][/FONT][/URL]
    [FONT=Franklin Gothic Medium][/FONT]
    [FONT=Franklin Gothic Medium][I][URL="http://www.umbachconsulting.com/pursuit.pdf"]The Pursuit of Publishing: An Unvarnished Guide for the Perplexed[/URL][/I]

    [/FONT][URL="http://www.amazon.com/Theres-Street-Colorful-Origins-Sparks/dp/1937123073/"][FONT=Franklin Gothic Medium][I]There's No Lake on Lake Street![/I] by James D. Umbach[/FONT][/URL]
    [SIGPIC][/SIGPIC]

  4. #4
    Fig of authority
    Join Date
    Feb 2005
    Location
    On a fig tree, presumably
    Posts
    5,162
    Ken, the makinglight site has some counterarguments about this drug's record of side effects.

  5. #5
    'Twas but a dream of thee El Jefe MacAllister's Avatar
    Join Date
    Feb 2005
    Location
    Out on a limb
    Posts
    21,459
    Wrote both my Senators.

    I'll start on the local media, tomorrow. This is terrible news.

  6. #6
    Shiny! SuperModerator Dawno's Avatar
    Join Date
    Feb 2005
    Location
    someplace around here, anyone seen my keys?
    Posts
    11,262
    If you don't know who your Congresscritter is you can go to this link http://www.house.gov/writerep/
    Senators:
    http://www.senate.gov/general/contac...nators_cfm.cfm

  7. #7
    SeanDSchaffer
    Guest

    Arrow Agreed, Mac

    Quote Originally Posted by MacAllister
    Wrote both my Senators.

    I'll start on the local media, tomorrow. This is terrible news.

    I'll be writing my Congressman as well. And the FDA, and a couple of local papers. Also, I've posted what Uncle Jim said, along with the links, at the Mudd Hole. I'm sure we have quite a few people over there who will want to say something as well.

    This just p!sses me off, frankly. I take a particular med that, without it, my other meds won't work at all. If I were to be forced off that med by the FDA, I would be in the hospital, psychotic, within a couple weeks regardless of the other meds I'm taking. I can only imagine what Teresa is going through. I hope everything works out for her and the other people who are affected by this.

  8. #8
    'Twas but a dream of thee El Jefe MacAllister's Avatar
    Join Date
    Feb 2005
    Location
    Out on a limb
    Posts
    21,459
    From the Making Light comment thread:
    Meredith suggested contacting Public Citizen. Here's the link to the contact page for their Health Research Group.

    Failing that, the e-mail address for that part of PC is hrg1@citizen.org
    Public Citizen is the Ralph Nader organization responsible for pushing this through, in the first place.

    It goes without saying, of course, that courteous and well-reasoned letters will do more good than the hot-tempered missive I'd like to fire off to them.

  9. #9
    The late, the great XThe NavigatorX mdin's Avatar
    Join Date
    Feb 2005
    Location
    Seattle, WA
    Posts
    2,375
    Was Ralph Nader responsible for getting the drug pulled in Canada and in England? Also, the drug company Abbott claims they were planning on discontinuing the drug anyway.

    I dislike Ralph Nader with a passion that can burn 1,000 ships, but I seriously think the anger here is misplaced. Just my opinion.

    My Art

  10. #10
    SeanDSchaffer
    Guest
    Quote Originally Posted by XThe NavigatorX
    Was Ralph Nader responsible for getting the drug pulled in Canada and in England? Also, the drug company Abbott claims they were planning on discontinuing the drug anyway.

    I dislike Ralph Nader with a passion that can burn 1,000 ships, but I seriously think the anger here is misplaced. Just my opinion.

    I'm not really angry with Nader; so far as he's concerned in this I couldn't care less. My personal beef is with the FDA....and with whomever it was that decided further tests on the drug to see how well it worked with narcolepsy, were somehow unjustified. So far as I myself am concerned, that equates to just plain laziness.

    One other thing that seems to have gotten lost in all this was ResearchGuy's suggestion that people ask the FDA if there was a way they could approve the drug specifically and only for narcoleptics. I think that's a very logical and decent idea. That's actually what I'm planning on doing when I write to the FDA.

    In any case, this is a serious issue that I'm sure we all agree has to be dealt with. A lot of people will be losing their ability to function in the world around them. That thought scares me, whether Ralph Nader is responsible for it or not.

  11. #11
    'Twas but a dream of thee El Jefe MacAllister's Avatar
    Join Date
    Feb 2005
    Location
    Out on a limb
    Posts
    21,459
    Nav, this is what PNH said--I'm looking for additional links to clarify PC's role.
    Evidently Abbott, makers of brand-name Cylert, discontinued it in March—but Sandoz intended to keep making the generic version, until the FDA, pressured by Nader’s group, weighed in to discontinue it entirely—despite a last-minute appeal from the Narcolepsy Network.
    He cites this release, and this one.

  12. #12
    wishes you happiness JennaGlatzer's Avatar
    Join Date
    Feb 2005
    Posts
    9,695
    Quote Originally Posted by SeanDSchaffer
    I take a particular med that, without it, my other meds won't work at all. If I were to be forced off that med by the FDA, I would be in the hospital, psychotic, within a couple weeks regardless of the other meds I'm taking.
    Boy, is that hitting home for me right now. (I didn't take my med for two days because of sickness and a very screwy sleep schedule and I thought I was going to die last night... seriously.)

    Thing is, there are unknown risks of every medication, and for those of us who take them, we choose... is it worth the risk? If I knew I would die 5 years early because of the med I'm on, I'd still be on it. Quality of life is more important than quantity of life for me.
    I am no longer here. If you'd like to visit me, please find me at www.jennaglatzer.com or on Facebook. Thanks!

  13. #13
    SeanDSchaffer
    Guest
    Quote Originally Posted by JennaGlatzer
    Boy, is that hitting home for me right now. (I didn't take my med for two days because of sickness and a very screwy sleep schedule and I thought I was going to die last night... seriously.)

    Thing is, there are unknown risks of every medication, and for those of us who take them, we choose... is it worth the risk? If I knew I would die 5 years early because of the med I'm on, I'd still be on it. Quality of life is more important than quantity of life for me.

    You know how I found out about all my meds being in concert with the one, Jenna? I found out through experience, about a month ago.

    I have been very, very tired all day every day for the last several months. My Nurse-Practitioner suggested it could be the antipsychotic Seroquel, which at the time I took one dose of 300mg at night, every night. Without it, I couldn't sleep.

    He took me partially off the med, and the sleep problems did not go away. So he took me completely off the med. A week later, I realized I was not acting like my normal self, but rather as my Paranoid-Schizophrenic self. In other words, I was going quickly psychotic. I put myself back on the med and within a day, my Nurse-Practitioner expressed his agreement with my actions.

    I might point out at this point, that I was still taking three other meds, all for mental problems. None of them were working without the Seroquel, including another antipsychotic I take called Abilify.

    That's how I found out about the one med keeping the others in line.

    It's a subject I'm fairly open about, but for a lot of people, it's a terrifying thing to talk about. I feel horrible for Teresa, having to go through this junk, and I don't even know the lady. Anyone who has to go through that has my utmost sympathy, and my prayers are with them.

  14. #14
    wishes you happiness JennaGlatzer's Avatar
    Join Date
    Feb 2005
    Posts
    9,695
    Quote Originally Posted by SeanDSchaffer
    It's a subject I'm fairly open about, but for a lot of people, it's a terrifying thing to talk about.
    And God bless you for it... I wish everyone were as open about it. Helps a lot to realize that there are lots of us out there with these kinds of issues. I was so embarrassed of myself when I was first going through agoraphobia that I didn't even tell my friends. At some point I realized that mental illness wasn't something to be ashamed of, nor was it a fault or weakness of mine.

    Maybe we should open a new topic on this stuff. I know it has nothing to do with PA, or even PA overflow, but I'm glad we're talking about it. (Edit: Yup, I made it its own topic.)
    Last edited by JennaGlatzer; 01-04-2006 at 04:37 PM.
    I am no longer here. If you'd like to visit me, please find me at www.jennaglatzer.com or on Facebook. Thanks!

  15. #15
    SeanDSchaffer
    Guest
    Quote Originally Posted by JennaGlatzer
    And God bless you for it... I wish everyone were as open about it. Helps a lot to realize that there are lots of us out there with these kinds of issues. I was so embarrassed of myself when I was first going through agoraphobia that I didn't even tell my friends. At some point I realized that mental illness wasn't something to be ashamed of, nor was it a fault or weakness of mine.

    That is a very hard thing to get through our thick skulls sometimes, isn't it? I cannot tell you how long it took me first to comprehend I even had an illness, and second to believe it was not my fault. What I can tell you is, that people are not so afraid, these days, of talking to a Mentally Ill individual as they would have been, say, thirty years ago. It's a refreshing change in attitude that I'm thankful for.

    What makes me so angry about the issue at hand, though, is that people are dismissing the benefits of the med that has been banned by the FDA, as 'supposed.' I mean, I have read the posts of at least two individuals on the Making Light forum that take that very med for Narcolepsy, and who point out point-blank that without that med their other meds don't work.

    But I guess people have to hear it from 'Qualified Individuals.' In other words, they want to hear it from experts, not patients who take the meds and experience the benefits of those meds every day. I know that sounds snide, but if people would listen to the experience of patients and their doctors instead of the rantings of a special interest group--and did you notice, as I did, that no one knew about this until they went to refill their prescription? Does anyone really think that was an accident?--those people would have so much more accurate information to work with that the rantings and ravings of the said special interest group would sound like the stupidity it really was.

    In such a case, this conversation would most likely not be taking place.


    Now, I've got the address for my congressman sitting in front of me. I don't yet have the FDA's address and was actually going to ask if they have an email address that I could send my questions to. Also, are there any other groups or agencies I should send my letter to?

    Finally, what exactly should the letter say? What is, for instance, the official name of the product involved and also the company that makes it? I want this to be informed, not just a bunch of ranting on my own part.

    Thanks.

  16. #16
    Resident Curmudgeon Requiescat In Pace ResearchGuy's Avatar
    Join Date
    Mar 2005
    Location
    Sacramento area, CA
    Posts
    5,011
    Folks can think what they wish about Public Citizen, but this, which is linked from the FDA docket site I noted in the P.S. to my previous post, was not easily dismissed by officials who have to enforce the food and drug laws.

    The FDA action was not exactly sudden, as this, from 1996, suggests. The black box warning turned out to be insufficient. Canada and the UK had banned the drug years ago in response to the same liver-toxicity issues.

    Of related interest: http://www.fda.gov/fdac/features/2001/301_liver.html:
    "Serious Liver Injury: Leading Reason for Drug Removals, Restrictions," by Michelle Meadows. Also: http://www.fda.gov/cder/livertox/monday.htm, "Drug-Induced Liver Injury: A National and Global Problem," 12-13 February 2001, Westfields Conference Center, Chantilly VA.

    None of that will help folks who need the drug despite its risks, but it may help to explain exactly why the decision was made.

    --Ken
    [URL="http://www.umbachconsulting.com/KenCV.htm"][FONT=Franklin Gothic Medium][COLOR=royalblue]ResearchGuy[/COLOR][/FONT][/URL]
    [FONT=Franklin Gothic Medium][/FONT]
    [FONT=Franklin Gothic Medium][I][URL="http://www.umbachconsulting.com/pursuit.pdf"]The Pursuit of Publishing: An Unvarnished Guide for the Perplexed[/URL][/I]

    [/FONT][URL="http://www.amazon.com/Theres-Street-Colorful-Origins-Sparks/dp/1937123073/"][FONT=Franklin Gothic Medium][I]There's No Lake on Lake Street![/I] by James D. Umbach[/FONT][/URL]
    [SIGPIC][/SIGPIC]

  17. #17
    Cultus Gopherus MacAllister Medievalist's Avatar
    Join Date
    Feb 2005
    Location
    An meodoheall monig dreama full
    Posts
    25,527
    The "serious liver injury" was in a very very few cases. Sure, it's better to not have any--but:

    1. Liver damage doesn't happen overnight; it takes a long time.

    2. Liver damage can be tested for, easily and cheaply. In Europe you can buy at home test kits.

    3. At their worse, cylert and pymoline are less dangerous to the liver than over indulgence in alchohol.

    4. The literature on both medications specifiy the need for regular testing.

    AW Admin: This account is rarely active
    About.Me
    AWers On Twitter
    Lisa L. Spangenberg
    My opinions are my own. | Who else would want them?

  18. #18
    Your Genial Uncle Absolute Sage James D. Macdonald's Avatar
    Join Date
    Feb 2005
    Location
    New Hampshire
    Posts
    25,366
    Matt, reapproval and relabeling of pemoline is exactly what I'm asking for.

    Pemoline continued to be available in Canada under the Special Access Programme. England may have had something similar.


    The FDA address is:

    Andrew Von Eschenbach, M.D., Acting Commissioner
    U.S. Food and Drug Administration
    Food and Drug Administration
    5600 Fishers Lane
    Rockville, MD 20857

  19. #19
    Resident Curmudgeon Requiescat In Pace ResearchGuy's Avatar
    Join Date
    Mar 2005
    Location
    Sacramento area, CA
    Posts
    5,011
    Quote Originally Posted by Medievalist
    The "serious liver injury" was in a very very few cases. Sure, it's better to not have any--but:

    1. Liver damage doesn't happen overnight; it takes a long time.

    2. Liver damage can be tested for, easily and cheaply. In Europe you can buy at home test kits.

    3. At their worse, cylert and pymoline are less dangerous to the liver than over indulgence in alchohol.

    4. The literature on both medications specifiy the need for regular testing.
    Statistically, the damage was in a highly disproportionate number of cases, and at that included only reported cases and excluded those that had not yet developed sufficiently to be recognized.

    1. Liver damage can start quickly -- sometimes in hours (though probably not from that drug, not serious damage that fast anyway).
    2. We are not in Europe. More critically, the black box warnings FAILED.
    3. They are less dangerous than walking in front of a speeding bus, too. So what's your point? That is not the measure used in drug-safety evaluations.
    4. Which was not being done sufficiently (back to the black box warning having not achieved its purpose).

    In any event, the decision was made months ago, after years of working up to it and after FDA hearings and after at least two other countries had acted against the drug. The folks who need to be persuaded to put a liver-damaging drug back on the market are in the FDA, not hanging out on this board. If you have not called the FDA and talked with the responsible officials yet, perhaps that might be your next move. (Seriously. Call FDA and talk to the decision makers there. Congress will not touch this with a ten-foot pole. All risk, no benefit.)

    I see that Jim has cited a "special access program" for the drug in Canada. Maybe something like that is the solution here, if such an option exists. And if it does not exist, perhaps it should. THAT provides a focus for discussion with the FDA. But the folks who have to press for that are, I would think, physicians with patients for whom the drug is the only (or clearly the best) option.

    --Ken

    P.S. Pemoline, near as I can tell, was never approved for use against narcolepsy. That was strictly an off-label use. There are other (approved) treatments (on which I have no qualifications to express any opinion, and do not express any opinion). More information is available via http://www.ncbi.nlm.nih.gov/entrez/q...arch&DB=pubmed. Search on pemoline AND narcolepsy, for example. The challenge is a double one: to get the drug somehow approved again AND to have it NEWLY approved (on-label use) for use against narcolepsy.
    Last edited by ResearchGuy; 01-04-2006 at 10:44 PM. Reason: Added p.s.
    [URL="http://www.umbachconsulting.com/KenCV.htm"][FONT=Franklin Gothic Medium][COLOR=royalblue]ResearchGuy[/COLOR][/FONT][/URL]
    [FONT=Franklin Gothic Medium][/FONT]
    [FONT=Franklin Gothic Medium][I][URL="http://www.umbachconsulting.com/pursuit.pdf"]The Pursuit of Publishing: An Unvarnished Guide for the Perplexed[/URL][/I]

    [/FONT][URL="http://www.amazon.com/Theres-Street-Colorful-Origins-Sparks/dp/1937123073/"][FONT=Franklin Gothic Medium][I]There's No Lake on Lake Street![/I] by James D. Umbach[/FONT][/URL]
    [SIGPIC][/SIGPIC]

  20. #20
    SeanDSchaffer
    Guest
    Quote Originally Posted by ResearchGuy
    Snipped for content and length....

    But the folks who have to press for that are, I would think, physicians with patients for whom the drug is the only (or clearly the best) option.

    --Ken

    With the highest of respect to you, Ken, if the physicians in question are still prescribing the banned medication, as it would seem to be in Ms. Hayden's case, after it has been banned, does that not lead to the conclusion that the physicians were never told about this issue?

    Further, if the physicians are not told, how are they going to mention any of the pros or cons to the FDA?

    Finally, why are physicians the only people who can bring this concern to light? If you have a friend who is dying of a particular disease, and you have a good idea what the disease is, do you refuse to tell anyone what you think is going on because you don't have the letters 'M.D.' behind your name?

    And just as it doesn't take an M.D. to say "These things are happening to someone I know," so it doesn't take an M.D. to tell the FDA "I think you've made a mistake in banning this particular med, and here are my reasons."

  21. #21
    Resident Curmudgeon Requiescat In Pace ResearchGuy's Avatar
    Join Date
    Mar 2005
    Location
    Sacramento area, CA
    Posts
    5,011
    Quote Originally Posted by SeanDSchaffer
    ...And just as it doesn't take an M.D. to say "These things are happening to someone I know," so it doesn't take an M.D. to tell the FDA "I think you've made a mistake in banning this particular med, and here are my reasons."
    For good or ill, physicians will get more of a hearing at FDA than will laymen. They can also cite the literature, understand the technical terminology, and talk peer-to-peer.

    I am not saying laymen should not communicate their concerns -- only that they will not be able to have the impact that physicans with relevant clinical practices might.

    BTW, "these things are happening to people I know" = anecdote. Not going to carry much weight with scientists and regulators who have been studying the issue for years, especially where their job is to evaluate and reduce risk AND where they have had years to see that the black box warning was insufficient to assure appropriate liver testing of those using the drug.

    But again: call. Talk directly to folks in responsible positions with respect to that decision. You might want to start here: http://www.fda.gov/cder/comment.htm. Ask for names and phone numbers of the responsible individuals. If need be, contact the CDER Ombudsman, whose link is on that page. Or try: Main FDA number: 1-888-INFO-FDA (1-888-463-6332).


    --Ken
    Last edited by ResearchGuy; 01-04-2006 at 11:04 PM. Reason: Added contact info.
    [URL="http://www.umbachconsulting.com/KenCV.htm"][FONT=Franklin Gothic Medium][COLOR=royalblue]ResearchGuy[/COLOR][/FONT][/URL]
    [FONT=Franklin Gothic Medium][/FONT]
    [FONT=Franklin Gothic Medium][I][URL="http://www.umbachconsulting.com/pursuit.pdf"]The Pursuit of Publishing: An Unvarnished Guide for the Perplexed[/URL][/I]

    [/FONT][URL="http://www.amazon.com/Theres-Street-Colorful-Origins-Sparks/dp/1937123073/"][FONT=Franklin Gothic Medium][I]There's No Lake on Lake Street![/I] by James D. Umbach[/FONT][/URL]
    [SIGPIC][/SIGPIC]

  22. #22
    Resident Curmudgeon Requiescat In Pace ResearchGuy's Avatar
    Join Date
    Mar 2005
    Location
    Sacramento area, CA
    Posts
    5,011

    Feel free to ignore this post

    But if you don't ignore it, you are on your own:

    A Chat with the FDA

    Mr. Jones calls Dr. Smith, of the Center for Drug Evaluation and Research, Food and Drug Administration. (Both names are fictitious.) Let’s listen in . . .

    RING RING RING

    Smith: Hello, CDER, Dr. Smith speaking. [CDER is pronounced “cedar”]

    Jones: Oh, hello, Dr. Smith. My name is Sam Jones. I am calling to ask that pemoline be approved for treatment of narcolepsy.

    Smith: Pemoline? May I ask what is your interest in that drug?

    Jones: Yes, my friend Mabel [another fictitious name] has narcolepsy, you know, where she falls asleep all the time—

    Smith: I know that narcolepsy is, Mr. Jones, thank you.

    Jones: —oh, of course. Anyway, her doctor had her using pemoline and it has helped a lot where nothing else did.

    Smith: I see. You are not a physician, correct, Mr. Jones?

    Jones: No, just a friend of Mabel. I am a writer, a novelist actually.

    Smith: You understand, of course, that I cannot discuss any patient’s specific situation, cannot make recommendations for treatment, cannot evaluate a physician’s treatment plan.

    Jones: Oh, yes, I see that. But there are lots of people with narcolepsy, and now they cannot get pemoline. Abbot stopped making its brand name version and now the FDA outlawed the generic version and there is not any left in the drugstores so it is important that it be allowed again.

    Smith: I see. Well, Mr. Jones, a few months ago, after hearings into evidence of liver damage associated with pemoline despite a “black box” warning on the drug for years, the FDA withdrew approval for marketing of the drug in the U.S.

    Jones: Can’t that be changed?

    Smith: Not without new hearings, if not new trials, and new evidence and interest from a pharmaceutical manufacturer.

    Jones: But what is Mabel going to do?

    Smith: You said narcolepsy?

    Jones: Yes.

    Smith: Well, speaking only in general terms, you understand, and not in regard to any specific patient, I need to tell you that pemoline has never been approved in the U.S. for use in treating narcolepsy. If a doctor has prescribed it for that purpose—and that is permitted, by the way, as an “off label” use of an approved drug—it was not in accordance with the drug label approved by the FDA. It is highly improbable that the FDA would consider a new approval of a drug removed from the market as a liver hazard in order that it be used to treat something it was never approved for in the first place.

    Jones: But, my friend and others need it!

    Smith: I see. What other options has her doctor explored—no, strike that. I cannot get into that sort of question. In general: there are other options, including on-label use of approved drugs. A physician can explore those with his or her patients.

    Jones: I don’t know about that. All I know is that Mabel took pemoline and it worked.

    Smith: I see. In order for pemoline to be newly approved, it would have to start the approval process from the beginning for treatment of a specific condition or conditions. A drug company would have to sponsor trials—a very expensive proposition—if initial approval were granted by the FDA. But the drug is off-patent and was already being dropped for lack of sales when the FDA removed approval. Abbot had ceased its brand-name version before the FDA acted. Because of the recognized liver toxicity plus the small market now for the drug plus the high costs of a new set of trials, it is very, very unlikely that any pharmaceutical company will seek to bring pemoline back to the market.

    Jones: But Dr. Smith, only a few patients had liver trouble!

    Smith: That is beside the point, Mr. Jones. We have standards for evaluating drug safety. Pemoline failed the standards, even after the black box warning was applied. The risks were not acceptable. Doctors were not reliably requiring liver tests. Anyway, there are other options for treatment of the conditions that pemoline WAS approved for, namely Attention Deficit Hyperactivity Disorder. This was an FDA docket item last spring. Anyway, the number of cases cited probably was a fraction of the total. Abbot itself was explicit about that in its letter announcing that it was discontinuing Cylert, its brand-name version. Let me read off the URL to that letter on the Web for you . . . here it is . . . [reads slowly] http://www.fda.gov/cder/drug/shortages/Cylert_Disc.pdf . You should read that letter, Mr. Jones, because it also addresses a list of other known risks of that drug and precautions directed to prescribing physicians.

    Jones: Well, is there some way that a special arrangement could be made for people with narcolepsy to get pemoline?

    Smith: Not lawfully in the United States, Mr. Jones, once existing stocks of the drug have been used up. And let me remind you: treating narcolepsy was NEVER an on-label use of the drug in the U.S. Because it is an off-label use (or was, rather) AND the drug has formally lost approval on account of documented liver toxicity, let me say informally it might be very risky for any doctor to attempt to provide it through other means. The malpractice risks—speaking informally here, again—would be enormous.

    Jones: So what do you advise, Dr. Smith?

    Smith: Again, speaking in general terms, and not with reference to any specific patient: patients should discuss treatment alternatives with their own physicians.

    Jones: Ok, thank you.

    Smith: You are welcome, and I hope things go well for your friend, Mr. Jones. Have her talk with her doctor or consult with a specialist if that is appropriate for her.

    Jones: Ok. Goodbye.

    Click.
    [URL="http://www.umbachconsulting.com/KenCV.htm"][FONT=Franklin Gothic Medium][COLOR=royalblue]ResearchGuy[/COLOR][/FONT][/URL]
    [FONT=Franklin Gothic Medium][/FONT]
    [FONT=Franklin Gothic Medium][I][URL="http://www.umbachconsulting.com/pursuit.pdf"]The Pursuit of Publishing: An Unvarnished Guide for the Perplexed[/URL][/I]

    [/FONT][URL="http://www.amazon.com/Theres-Street-Colorful-Origins-Sparks/dp/1937123073/"][FONT=Franklin Gothic Medium][I]There's No Lake on Lake Street![/I] by James D. Umbach[/FONT][/URL]
    [SIGPIC][/SIGPIC]

  23. #23
    Your Genial Uncle Absolute Sage James D. Macdonald's Avatar
    Join Date
    Feb 2005
    Location
    New Hampshire
    Posts
    25,366
    The black box warning worked.

    Since the black box warning went on six years ago, there has been exactly one case of liver damage associated with pemoline.

  24. #24
    Resident Curmudgeon Requiescat In Pace ResearchGuy's Avatar
    Join Date
    Mar 2005
    Location
    Sacramento area, CA
    Posts
    5,011
    Quote Originally Posted by James D. Macdonald
    The black box warning worked.

    Since the black box warning went on six years ago, there has been exactly one case of liver damage associated with pemoline.
    It worked in a sense by helping to drive down sales, which is a large part of what led Abbot to drop Cylert. Much less use = reduction in cases. But compliance with the testing requirement was poor, according to studies cited by the FDA: http://www.fda.gov/ohrms/dockets/AC/...ewredacted.doc

    Pemoline was approved by FDA in 1975 for ADHD with recommendations in the Precautions section to monitor transaminase levels periodically due to a 1% to 2% incidence of drug-induced liver injury. Reports of acute liver failure (ALF) led to a series of black box warnings and Dear Healthcare Professional letters in 1996 and 1999, shifting the drug to second line therapy and recommending baseline and bi-weekly transaminase monitoring. Although compliance with these recommendations was assessed to be poor,[1] the use of pemoline dropped off substantially over the next five years,[2] and no additional drug-related cases of liver failure were subsequently reported to FDA.[3]

    [1] Willy ME, Manda B, Shatin D, Drinkard CR, Graham DJ. A study of compliance with FDA recommendations for pemoline (Cylert). J Am Acad Child Adolesc Psychiatry 2002, 41(7):785-790.

    [2] FDA/CDER/ODS/DSRCS Review of the Proposed Risk Management Communication Plan for Cylert (pemoline) dated January 16, 2004.

    [3] Racoosin JA. FDA/CDER/Division of Neuropharmacological Drug Products (HFD-120) memorandum to Patient Information Sub-Committee Members, dated February 6, 2004.
    In any event, as I said before, folks concerned about the matter should call. I do not wish in any way, shape, or form to suggest otherwise. CALL! (And write. And visit if in the neighborhood of FDA.)

    I trust that the imaginary script I posted will not reflect real conversations. I will be interested in hearing reports of how the real conversations do go.

    --Ken
    Last edited by ResearchGuy; 01-05-2006 at 02:54 AM.
    [URL="http://www.umbachconsulting.com/KenCV.htm"][FONT=Franklin Gothic Medium][COLOR=royalblue]ResearchGuy[/COLOR][/FONT][/URL]
    [FONT=Franklin Gothic Medium][/FONT]
    [FONT=Franklin Gothic Medium][I][URL="http://www.umbachconsulting.com/pursuit.pdf"]The Pursuit of Publishing: An Unvarnished Guide for the Perplexed[/URL][/I]

    [/FONT][URL="http://www.amazon.com/Theres-Street-Colorful-Origins-Sparks/dp/1937123073/"][FONT=Franklin Gothic Medium][I]There's No Lake on Lake Street![/I] by James D. Umbach[/FONT][/URL]
    [SIGPIC][/SIGPIC]

  25. #25
    Chemically enhanced
    Join Date
    Feb 2005
    Posts
    440
    Sorry about your friend, James.


    Just a couple items:

    • Writing the FDA won't hurt but a more direct route might be to submit a Citizen's Petition. Here's a link:
    http://www.fda.gov/ora/fed_state/Sma...ide/petit.html


    If, and when, pemoline is ever reapproved by the FDA (slim chance, sorry to say) it will not be by a generic company. With the history of pemoline's liver toxicity, the FDA will almost certainly require a full round of clinical trials to determine safety and efficacy. By definition, a generic company does not expend the resources on such trials; they don't have to, the branded companies take the risk and spend the dollars, in most cases.

    So, any attempt to reintroduce pemoline to the market will almost assuredly be made by a branded company (Abbott, Merck, etc). Given the documented risks associated with the product and small market potential I would again have to say the chances are very small.


    • Something else that might be considered is assigning a drug like pemoline "orphan drug" status. Orphan drugs are those developed to treat diseases affecting less than 200,000 citizens. This is definitely a long shot but here is the link if you want to read up on it.
    Sorry I'm not more encouraging but good luck anyway.
    "The only sensible ends of literature are, first, the pleasurable toil of writing; second, the gratification of one's family and friends; and lastly, the solid cash."

    --Nathaniel Hawthorne

Page 1 of 5 12345 LastLast

Bookmarks

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •  
Custom Search