Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
Tempest in a Teapot?
- Verna E. Radcliffe (14 September 2002)
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What about the Patients?
- Julia R. Alberino (14 September 2002)
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Re: What about the Patients?
- Christopher Anton (17 September 2002)
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Take responsibility for yourself
- Melissa D. Harbin (18 September 2002)
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The politics of drug regulation
- David M Reith (19 September 2002)
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Have the FDA served its function?
- Richard G Fiddian-Green (21 September 2002)
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Response from senior physician at GlaxoSmithKline
- James BD Palmer (18 October 2002)
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Verna E. Radcliffe, Author/Petition to FDA & GSK for the Return of Lotronex 1212 Mohawk Lane, St. Joseph, Michigan 49085
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It appears Moynihan and Stolley have jumped on the wrong Bandwagon. Following the Public Citizen Party Line of trying to convince the public of it's own ignorance! I can't help but wonder why the target of their misinformed diatribe is Lotronex? Viagra has killed many hundreds of people and is still on the market! Oh, but I forget...Moynihan and Stolley are men. Sincerely, Verna Eileen Radcliffe |
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Julia R. Alberino, Analyst New York, NY 10009
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Just once I would like to see something in your publication that considers the patients who benefitted from Lotronex, who outnumber those who were harmed by at least 1000:1. I invite Dr. Stolley to walk in my shoes for even one day and then tell me that I don't have the right to consult with my doctor, assess the risks and benefits and decide for myself that the risk is more than woth it for me. I live with constant pain, multiple episodes of diarrhea daily, weakness and fatigue stemming from the dehydration that results from the diarrhea. The 22 months I took Lotornex were the best in my life: no pain, no diarrhea, no dehydration, no weakness and fatigue. Did I know the risks? Of course I did; this isn't an over- the-counter drug; I got it after an informed discussion with my gastroenterologist, with whom I kept in regular contact during the entire time period. Did the benefits outweigh the risks? in my case, absolutely. Did I have any side effects? No. Do I have side effects from the FOUR drug regimen I take now? Oh, yes, and they don't work half as well as Lotronex. Let me make an informed decision. I don't need Public Citizen, Sr. Stolley, or even the FDA to protect me. That's what I pay my doctor for.Will I take Lotronex again? In a heartbeat. |
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Christopher Anton City Hospital, Birmingham, UK B18 7QH
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Dear Editor I’m glad that Ms Alberino (1) has a good relationship with her gastroenterologist and feels an equal partner in an informed debate over the risks and benefits of Lotronex treatment. Unfortunately, not every patient/doctor relationship is as ideal as this. Doctors are busy people, consultations are often rushed (especially in this country), and many do not have time to keep up with the current medical literature or opinion. Two cases in point: cisapride and cerivastatin. (2-4) Both these drugs had well-recognised problems. Both of them were subject to increasingly stringent regulatory action, from both the MCA and FDA, warning prescribers of the dangers. Yet both continued to be misused or prescribed inappropriately and people died. Regulators have to act in the real world, not in the ideal, and if the risk of serious injury or death with Lotronex is as high as stated it seems best to err on the side of caution, at least initially. (5) References 1. Alberino JR. What about the Patients? http://bmj.com/cgi/eletters/325/7364/592#25485 accessed on 16th September 2002. 2. Medicines Control Agency. Current problems in Pharmacovigilance. 2000; 26: 9-10. 3. Henney JE. Withdrawal of troglitazone and cisapride. JAMA 2000; 283: 2228. 4. Charatan F. Bayer decides to withdraw cholesterol lowering drug. BMJ 2001; 323: 359. 5. Moynihan R. Alosetron: a case study in regulatory capture, or a victory for patients' rights? BMJ 2002; 325: 592-5. |
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Melissa D. Harbin, Customer Relations Parkersburg, WV 26101
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"Unfortunately, not every patient/doctor relationship is as ideal as this. Doctors are busy people, consultations are often rushed (especially in this country), and many do not have time to keep up with the current medical literature or opinion." Yes doctors are busy, and yes appointments can be rushed. This is why a patient should take some responsibility about their own health care and medications. Whenever I am given a medication, I discuss any questions with my doctor and pharmicist. Then, I read all enclosed information sheets before I take the medication. This is common sense! Why should I expect a doctor, a government agency, or a "public protection" group to take responsibility for my health care? People should practice a little common sense. If someone was constipated on Lotronex, and didn't have a bowel movement in three days, I would think that would be the first indication to immediately stop taking the medication and consult the prescribing physician. "Regulators have to act in the real world, not in the ideal, and if the risk of serious injury or death with Lotronex is as high as stated it seems best to err on the side of caution, at least initially. (5)" Lotronex is a high risk medication?! Says who? An uneducated group that knows nothing about IBS, that's who! There has only been one confirmed death associated with Lotronex, and this is out of 250,000 active prescriptions. I hardly call that high risk. However, as pointed out by Verna, there have been many, many deaths as a result of Viagra and Accutane. Yet, they are still on the market. No one has a problem publicly talking about their impotence, but it's a crime to mention your bowel habits and the dire need for new, innovative medications for such problems. I am so tired of ignorant people making false statements about a medication that is safe and effective. Every drug has its risks and it is unreasonable for "advocate groups" to protect every person from every drug. Even Tylenol kills. It must have been a slow news day when this article was printed! Melissa Harbin, MA
*I HAVE NO FINANCIAL TIES TO ANY PHARMACEUTICAL COMPANY, ANY GOVERNMENT AGENCY, OR ANY PUBLIC ADVOCATE GROUPS. |
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David M Reith, Senior Lecturer Dunedin School of Medicine, University of Otago, Dunedin, New Zealand, 9001
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Dear Editor I have been reading with interest the debate in your journal about influences upon the decision of the FDA to re-register alosetron (Lotronex). One of the arguments advanced in this debate has been that the funding of the FDA by pharmaceutical companies translates to influence upon policy. This argument, I believe, requires refuting. Do citizens influence government policy through payment of taxes or through the casting of votes? Duties, levies, taxes and rates are commonly used by governments to fund the administration of aspects of their activities, but this does not translate to influence upon policies. The payment of a fee for a visa to visit a country is unlikely to translate to political influence within that country. Likewise, the payment of a fee to process an application for registering a drug does not translate to influencing the decision to accept, or reject, that application. Cost recovery, through application fees, is commonly used by regulatory authorities to finance their activities. This situation has arisen because of the increasing complexity of the process of drug regulation, both pre- and post-marketing. Dossiers submitted by pharmaceutical companies are extensive and complex, and therefore require great care in interpretation. Post-marketing surveillance has burgeoned in the past decade as a result of the expectations of consumers and the regulatory authorities. This has resulted in an increased workload for the regulatory authorities in processing Periodic Safety Updates. Governments have not been willing to finance these activities from general revenue, hence the need to levy pharmaceutical companies in order to fund these activities. The resulting increase in funding of regulatory activities from levies to the pharmaceutical industry has resulted in a lessening of political influence upon regulatory authorities. Political influence, in democratic countries, is achieved through votes, lobbying, media ownership and donations to campaign funds. Patient interest groups can be mobilised to influence a decision through lobbying. Likewise, politicians can be entertained and political parties can be influenced, sometimes through personal contacts. By having greater autonomy, through independent funding, regulatory authorities are less vulnerable to such political pressures. Greater transparency and accountability, rather than removing the levies upon industry, would improve the process of drug regulation. Drug development data, and the minutes of meetings of regulatory authorities, should be open to public scrutiny. Shareholders should be able to make company executives accountable for bad decisions by having access to company records. Likewise, government officials, and their political masters, should also be accountable for bad decisions. P.S. I have received payment for contract work from both the pharmaceutical industry, including GlaxoSmithKline, and the Therapeutic Goods Administration (Australian). I have been funded to speak at conferences, and attend meetings, by various pharmaceutical companies, including GlaxoSmithKline. I particularly like the sticky labels the drug companies hand out that can be used to stick messages, and shopping lists, on the refridgerator. |
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Richard G Fiddian-Green, None None
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The Thalidomide story scared everyone and placed great pressure upon the FDA to regulate drugs. Whilst that has undoubtedly done much good might it not now be doing harm? Might not FDA approval of drugs have instilled a false sense of security and discouraged doctors for thinking for themselves? Might not the FDA be in effect fostering cookbook medicine? Has not NICE angered doctors and their patients by witholding opportunities to give patients the opportunity of benefitting from the latest treatments? Are not doctors fed up with being treated like children? The medical profession is far better educated today about the merits of clinical studies than every before and in a far better position to make competent decisions for themselves. Thanks to the internet, the medical profession also has far greater access to the latest published material and expert opinions than ever before. In any event by their very nature the results from prospective randomised studies apply only to those circumstances in which the drug was tested with its inclusion and exclusion criteria. In reality not all patients and in the case of some drugs only a few patients meet these criteria. Furthermore few studies, such as the recent study on prostate cancer, have included mortality from all causes or have had a follow up long enough to known what the long term effects upon outcome, be that disability-adjusted, quality-adjusted, or simply unadjusted, might be. Surely the decsion to treat or not to treat is best left to the doctor and the patient as it once was. Is it not far better that doctors be kept up-to-date about pathogenetic mechanisms and natural history of diseases by giving them all the support they need to access the exponentially increasing volume of relevant information efficiently, encouraged to attend national and international meetings, and given access to the latest theoretical therapeutic options, clincial trials in progress, the results of Cochrane reviews and the results of the latest outcome studies. Giving them in addition the computing capability to track their patients efficiently and monitor outcomes and costs would be an additional benefit. I think we would be a lot better off if decsions were left up to doctors and their patients as they always were. The risk of litigation should be a big enough deterrent to irresponsible management. The benefits of deregulation would include quicker access to the latest therapeutic options and a fall in the price of drugs especially for those in lesser developed countries. |
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James BD Palmer, Sr VP, New Product Development GlaxoSmithKline
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Dear Sir, I was the senior physician at Glaxo Wellcome and GlaxoSmithKline personally involved in all the key meetings which resulted in the withdrawal of Lotronex and the subsequent approval for reintroduction, and as such I feel compelled to reply to both the article (1) and editorial (2) regarding Lotronex. Moynihan sees a complex web of intrigue where none existed, at least from the viewpoint of Glaxo Wellcome and GlaxoSmithKline. Here is what I believe are the key elements of the story from our position. We had a medical disagreement with the FDA over the etiology of the serious adverse events occurring in patients taking Lotronex. Together with our external experts, we believed that there were two discrete and distinct events. Firstly, ischemic colitis which in general was benign and self-limiting and secondly the complications of constipation which led to the serious sequelae described by the FDA. We believed for ischemic colitis the risk/benefit was acceptable and that the risk of serious constipation could be managed with appropriate physician and patient education. FDA did not accept this position and believed all the serious events were linked to a single pathology; i.e., ischemic colitis. In November 2000 we had several meetings with the FDA leading to a meeting on 28 November where we realized we could not come to agreement on certain key matters, including the etiology of serious adverse events in patients taking Lotronex and a risk management program to address the serious events of concern while providing for continued, adequate patient access. We decided at that time we had no viable option but to withdraw the drug voluntarily. Having withdrawn the drug it was not our intention to reintroduce it. However, thousands of patients contacted both us and the FDA to stress the benefits of the drug. It was these pleas that led GSK and the FDA to try to find common ground to reintroduce the drug. This culminated in April 2002 in an Advisory Committee where there was a full and transparent review of all available data. Over the last 18 months we have worked with the FDA to find a way forward for this drug which will balance safety concerns and practicality in prescribing with the clear desires of patients to have an effective treatment for IBS. Those who were at the Advisory Committee could not fail to have been moved by patient testimonies from those whose lives had been changed by Lotronex. The implication that we were somehow in collusion with the FDA is simply not true. This is a highly regulated industry and everyone in industry accepts and respects FDA’s authority. Finally in the article it refers to “GSK’s changing view of the dangers of Alosetron” – the implication being we as a Company had been inconsistent in our view, this is not the case – the facts being that from November 1999 to April 2002 the data did change and this was reflected in a change in interpretation. The BMJ articles have clouded the subject of the Lotronex reintroduction by misrepresenting the facts as they actually happened. I hope this helps clarify what actually happened – at least from our viewpoint, and also let’s not forget who is the ultimate beneficiary – the patients with IBS for whom Lotronex is an effective therapy. Yours faithfully, James B. D. Palmer, FRCP
1) Moynihan, Ray. Alosetron: a case study in regulatory capture, or a victory for patients’ rights? BMJ 2002; 325: 592-95. 2) Lievre, Michael. Alosetron for irritable bowel syndrome. BMJ 2002; 325: 555-6. |
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