[Bud]

Question: Of those of you that have sent letters, e-mail messages and called the various players in this lotronex withdrawal, have you gotten replys or returned calls from anyone other that customer service personnel and the other screeners? For example, I've yet to get a reply from the FDA and I have had a little luck with Glaxo, but their original replys were boilerplate. and, I haven't heard back from Oprah or Montel.If you have gotten past the barriers, can you let us know about it and how you did it?Thanks

[This message has been edited by Bud (edited 12-07-2000).]

 

[Throne King]

Not me,Bud.I have'nt heard a word.Nothing else in the news either. The pharmacy that I rushed to when I heard the story on NBC has not been notified,and this is day 4 or so.I suppose they are still filling prescriptions for it. It would be great,since they are supposed to be monitoring this board,if Glaxo would log in and give us some comments on the subject.~TK~------------------King of the Throne/Porcelain Prisoner

 

[JuliaNYC]

Hi Bud,I got no replies from anyone other than Glaxo Customer Service with a very "canned language" presentation by phone and Public Citizen, which sent me an e-mail referring me to their on line copy of the petition to withdraw (that was in response to my original August e-mail. I got nothing from them in response to my latest letters). I have written to the FDA a total of 5 times, beginning in August, and got no replies to any of those. I feel like I am dropping correspondence into a black hole. I never heard from ABC either.

 

[trbell]

would seem like all are fearful of saying anything?tom

 

[Guest]

Richard Here:I wrote the FDA. No reply. Being a reporter, I sent a story to the health editor of the New York Times. So far, no reply.I wrote to my Congressman. So far, no reply.And I spoke to a friend who is a wheel at the Journal of the American Medical Association. Still waiting on that.What say we form our own pressure group -- like that Wolfe character with the so-called "Citizens Committee." Call ourselves the "Lotronex Users Committee." More power in working together.Contact me.Richard Fireman<growingplace###compuserve.com>

 

[UnknownSoldier]

My email to Glaxo:I have been on Lotronex for the past several months. It> has worked wonders for me, and I have had no side effects. Since it is no> longer on the market, I wonder if you could recommend any alternative> medicines or therapies. I do not want the quality of my life to regress> to what it was before I started taking Lotronex. I am very upset about> the FDA's decision. Is there anyone to whom I should address> correspondence about these issues? Please respond as soon as> possible....Thanks, Jocelyn TaijeronResponseear Ms. Taijeron:Thank you for your email to Glaxo Wellcome. We appreciate the time you havetaken to inquire about our product, Lotronex* (alosetron hydrochloride).Please call your healthcare provider with any questions about your conditionand to discuss available management options. They know your medical historyand are in the best position to discuss your options.At the request of the U.S. Food and Drug Administration, Glaxo Wellcome hasdecided to voluntarily withdraw Lotronex from the market. Glaxo Wellcometook this step after in-depth discussions with the FDA about the safetyprofile of Lotronex. The FDA asked us to come to a meeting on November 28th prepared to discussthe withdrawal of Lotronex. The FDA may not agree that they asked us towithdraw Lotronex. At the meeting, Glaxo Wellcome suggested that Lotronexremain on the market while an independent scientific review of the clinicaldata was conducted. The FDA declined. In addition, we presented alternativeplans to the FDA that we believed would adequately and effectively addresspotential risks with Lotronex, such as label modifications, restricteddistribution, on-going patient education, and new clinical andepidemiological research. FDA disagreed as to the adequacy of theseprograms therefore we were left with no other option other than to complywith their request for withdrawal. We are deeply disappointed with theFDA's request.Thank you for emailing to share your experiences with us - we value yourinput. Given our recent discussions with the FDA, we do not anticipate thatthe FDA would allow the distribution and marketing of Lotronex in thefuture. However, if you would like to share your opinion directly with theFDA, you may contact: Janet Woodcock, MD Director, CDER, Food and Drug Administration HFD-001, WOC 2, Room 6027 1451 Rockville Pike Rockville, MD 20852 E-mail: WOODCOCKJ###CDER.FDA.GOV Phone: 301-594-5400 Fax: 301-594-6197Thank you for your email to Glaxo Wellcome. For your complete information,a copy of the Medication Guide and package insert for Lotronex isenclosed/attached. If we did not fully address your question or if you haveany further questions concerning our company or our products, you may callour Customer Response Center at 1-888-825-5249 during our normal businesshours, Monday through Friday, 8:00a.m. to 8:00 p.m. Eastern Standard Time.

 

[UnknownSoldier]

So it still seems canned, but at least a little more personal. Maybe if we keep working on Glaxo to market it with some of the restrictions, and on the FDA to approve it with the restrictions, say one email a week? Who's with me...

 

[tracey]

Spoke with Glaxo again this morning. The pharmacist I spoke with said that as far as he knew the FDA has not budged on it's demands to Glaxo and thus Glaxo will continue voluntary withdrawal. Interestingly, he told me that the pharmacies will have the drug in stock until January 31 and they are not legally liable for dispensing the drug if they still have it available. He told me to have my pharmacy call them to explain this to them. If I get them to concede, I am going to get a three month supply if possible and then extend it for as long as possible. Also, just quit my job this week as my symptoms are back in full force since stopping lotronex.

 

[Guest]

If Glaxo didn't withdraw Lotronex from the market, can you imagine how much more it would cost us to buy it? Insurance companies probably wouldn't pay for it either.

I would love to still have it on the market, but the FDA's demands go beyond what a drug company should have to do. Does anyone know if any other medications have such rigid demands placed upon them by the FDA (and are still on the market)?

 

[UnknownSoldier]

I am also taking Accutane, for which you HAVE to be on birth-control pills (females) since it causes birth defects. HAVE to have blood test every month because it can damage your liver. And there is a study you have to sign up for to evaluate the effects (they pay you $10 but that don't help me much!). And my doc said they? FDA? not sure who wants to impose more severe restrictions--you must prove you are on 2 forms of birth control (primary--birth control pills) and backup (such as condom), and go through a patient-education video. I can certainly understand these restrictions, but I don't mind them since it is for my own health and safety, and I would go through similar requirements/procedures to get Lotronex.

 

[Guest]

I would go through hoops to get Lotronex as well. But, I think the price for it would go out of sight if Glaxo had to do everything the FDA wants it to do. I don't know about all health insurances, but my HMO has a list of drugs, which they call their formulary. If the drug isn't on there, you pay a lot more than you normally would. The drugs that aren't on their formulary tend to be the most expensive ones. Also, I have a feeling that they might not pay for it at all.

 

[tracey]

I certainly feel for all of us if our drug plans refused to pay should lotronex be reinstated. However, I would be willing to pay whatever it cost because then I WOULD HAVE A JOB AGAIN!!! I can't work without it. Certainly it costs less than what I was earning.

 

[AnneMarie]

I received the same response from Glaxo that Unknown Soldier received. I was encouraged that I at least got a response and that they urge us to contact the FDA. However, I was discouraged by their statement regarding the possibility of Lotronex coming back. Perhaps they just don't want to give false hope. I have written to my senators and to the FDA. Can't help thinking that if we really hit them hard, something might be done.Best of luck to everyone!

 

[Bud]

Update: Spoke to Glaxo again today and a manager became involved when I told the customer service rep what Tracey's post said about the stuff being on the shelf until 1/31/00. The manger said the the customer service rep that spoke to Tracey should not have said that and asked for the URL for the post.Additionally, I asked if Lotronex still has FDA approval (sounds like a stupid question, but it's not). She said she could not answer that question and that I would have to contact the FDA if I wanted the answer. I pushed, and I'm good at pushing, but she wouldn't give in. Anyhow, I've sent that question along with others to the normal FDA address.I was hoping more would post as I'm sure most have had similiar experiences with no replys. I had hoped for enough postings in this thread to be impressive as I intend to write some legislators about Woodcock's non-responsiveness to our correspondence and calls with this thread being my proof. Too bad it hasn't been that effective.Thanks to those who've posted.

 

[tracey]

I know the name of the rep that I talked to at Glaxo but boy, the last thing I want to do is get anyone in trouble for telling me something helpful. This guy was super sympathetic and I think he was really just trying to give me some hope. Maybe I misunderstood him.

 

[suzie_0226]

I have also received the same letter from Glaxo. I have called glaxo twice and e-mailed them. I have e-mailed several people at the FDA several times...no response. I e-mailed Public Citizen (it seems it is really their fault)...no response. It seems that the FDA does not want to admit any wrong doing in the release or removal of the drug. The guy at glaxo actually told me they plan to do nothing because they do not want to make the FDA mad because they have other drugs that need approval (nothing to do with IBS). Basically the FDA folded because of Ralph Nader's group and now neither the FDA or Glaxo will back down. It is our lives in the middle of some stupid politcal game. There must be something we can do. Has everyone been e-mailing public citizen. They are the ones who wanted it pulled and the FDA caved. If they really want to help people they would do something to bring it back. If they have enough power to have it pulled maybe they can bring it back. Oh...I also want to say that I pressed the guy from glaxo...if this is all true...their PR people should be trying to get on 20/20 or dateline and have the story told. He said they would not do anything like that since the media can make the story sound any way they want. They are not trying. They are afraid of the FDA and the other drugs they can make more money on. Sorry to go on but I am so angry and feel so helpless.

 

[UnknownSoldier]

I really hate to be lazy, but it is so hard for some of us to write letters. Maybe some generous helpful soul would post a form letter we can copy (of course we will add our own experiences to make it more personal), or at least give us an outline or some tips, and maybe we should mention we are members of this BB, that may be more effective than just unaffiliated people writing in (if it's political anyway). I am working on a letter, but like I said I am not too good at that. Any tips? I really do want to do something....Lotronex REALLY IMPROVED my quality of lifeJocelynjocelyn_t99###yahoo.com

 

[Kimmie]

I got an e-mail reply from Jennifer Howard [jhoward###citizen.org. Here it is:You have written to us expressing your concerns that Lotronex has been removed from the market. We are enclosing (as attachments and with URL's for internet access) two items that will clarify our position on this drugur petition to the FDA on 8/31/00 http://www.citizen.org/hrg/PUBLICATIONS/1533.htm the supplement to the petition on 10/30/00: http://www.citizen.org/hrg/PUBLICATIONS/1544.htm As you will see in figures 1 and 2 in the 8/31/00 petition, in randomized, placebo-controlled experiments involving a total of more than 1000 patients with diarrhea-predominant IBS, there was not very much difference in the improvement (pain/discomfort scores) of patients getting Lotronex vs those getting a placebo. In the first experiment-3001, the improvement in the placebo group after three months was 86% as much as in the Lotronex group. In the other trial (3002), the improvement in the placebo group was 95% as much as in the Lotronex group after three months. We understand that many of you believe that this drug has made a huge difference for you but the data collected by the company suggest that this is rare since most of the benefit was also seen in the placebo group. These marginal benefits mean that any significant dangers must be taken very seriously.Concerning the dangers of ischemic colitis, most of the patients who got this life-threatening adverse effect had diarrhea-predominant IBS and were apparently using the drug as recommended. In fact, several patients in clinical trials before marketing began experienced ischemic colitis, all in the Lotronex group, none in the placebo group, strong evidence for a causal relationship between the drug and this serious adverse effect.Given the under-reporting of adverse events, the actual number of cases of ischemic colitis is probably ten times higher than the 60 or 70 cases including five deaths reported to the FDA thus far. Among the letters we have received, are a number of people reporting Lotronex-induced ischemic colitis including several who had to have emergency surgery to remove part of their colon. Most of these cases had not previously been reported to the FDA.Although we have read many complaints similar to yours on an IBS web site bulletin board, we have also noticed several different more recent postings which merit repetition. One is as follows: "When I first heard about the removal of Lotronex, I was just inconsolable--like many of you, my new nearly ibs-free life was about to end. However, after reading all the info I could get my hands on, including info provided in the posts on this BB, and talking to my doc, I have decided that I for one would take Lotronex again ONLY IF more research on these deaths and ischemic colitis is done, and I can feel safer taking the Lotronex. It is hard to give it up, but I had never before liked taking any kind of medicine and especially didn't like being dependent on medicine......." Another:"I have also been on Lotronex since May & have had wonderful results. I too am upset that Lotronex is no longer available, however Glaxo has pulled the drug for our own good!! Would we rather have an ailment that will not kill us(even though I know it feels that way sometimes), or a drug that could cause us worse problems & even death!! I for one would rather search for an alternative method than Lotronex. I know this message will upset many of you & I am sorry if it does, but I thought my feelings should be heard........" In the 29 years since Public Citizen's Health Research Group was started, we have successfully urged the FDA to remove many unsafe drugs from the market. In the case of Lotronex, we did not think the small benefit-beyond that of a placebo-justified the risk. The FDA agreed.

 

[benbch]

i also received jennifer's e-mail and found it a very poor response. i'm biased, of course, but as an english major i can't help analyzing her circular (as well as unfounded) arguments.her only factual response to our concerns -- the clinical study -- simply shows that they had a poor sampling. obviously boards like this one (as well as the ibsgroup survey) show that lotronex HAS helped thousands of people! even men! i find it personally offensive to be told otherwise.secondly, i take issue with her trying to prove a point through selective quoting from this board. so she found two conservative-leaning ibs sufferers among hundreds of complaints! so what? i hate to blame jennifer personally, but i must admit i harbor quite a bit of anger against public citizen's misguided crusade.benbch###brown.edu

 

[Munchkin]

I,too,have received that same reply from Nader's group. If you think about it, that man has really screwed up this country, and not just with our Lotronex!I wrote To Dr. Woodcock at the FDA, no reply yet.On a positive side, I emailed my state senator in Illinois, and he called me the next evening! He was very sympthetic to my circumstances and made a good suggestion. He told me to contact the office of the Speaker of the House, Dennis Hastert, of Illinois. He is considered the third most powerful politician in America. If this election that Nader ruined doesn't get cleared up in time, he would actually serve as President.Anyway, my senator told me that the FDA is funded by Congress. And that having Mr. Hastert made aware of our plight might be just the thing we need to have congress do some "regulating" on the FDA. They are totally dependant on Congress for their $$$.So my advise is to contact the office of the speaker of the house. Sorry I should have looked up the link before I wrote this.I have also emailed Oprah, no answer. I would like to try to contact her producer on the telephone, but I need to organize my thoughts on paper and take some time off work to try to get through to them.Let's not give up. Let's make everyone we can think of aware of our problem. I may be simplistic, but as I see the Lotronex issue, it is a dosing problem that can simply be rectified by the patient keeping in touch with the doc who prescribed it.