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--- Prominent cardiologist criticizes drug ads
In article <57gft05gqormdfei6l9i73qrh80iavb27r@4ax.com>, reeder >On 1 Jan 2005 16:03:18 -0500, hrubin@odds.stat.purdue.edu (Herman >Rubin) wrote: >>In article >>reeder >>>On 30 Dec 2004 16:00:24 -0500, hrubin@odds.stat.purdue.edu (Herman >>>Rubin) wrote: >>>>Do you have any idea what statistical significance means? >>>>I doubt that Topol does. >>>I'm sure Dr. Topol must have taken Statistics 101 in college: >>Statistics is not a normal part of the pre-med program. >>Also, methods courses make it difficult to understand >>concepts, and Statistics 101 is almost always a methods >>course. Any attempt to teach it otherwise would cause >>students who do not have a fairly strong mathematics >>backgroumd to get the material in another department, >>often under the name "research methods". >->>But in his response, Topol looks at data from a previous study that >compared 390 patients taking Vioxx to 588 patients taking a placebo. >The study, called 090, showed that five, or 1.3%, of patients taking >Vioxx had heart attacks or strokes, compared to one, or 0.2%, in the >placebo group. Although those numbers are small, they were >statistically significant, according to Topol. The data he based his >analysis on has previously been buried in FDA briefing documents. <<- >I would submit that to most educated people, a product or process >which produces a 0.2% defect rate is a helluvalot preferable to one >which produces a 1.3% defect rate. From this standpoint, all products have "defects". The question is, are the good points better than the bad ones? The "statistical testing" is whether the decay rates are equal. We do not know that the defect rate is 1.3% for Vioxx and 0.2% for the other painkiller; it could not have been a placebo, or the difference in the rates of reducing pain would have been obvious. The relative accuracy of the estimate of a low rate depends on the number defective, regardless of sample size. -- This address is for information only. I do not claim that these views are those of the Statistics Department or of Purdue University. Herman Rubin, Department of Statistics, Purdue University hrubin@stat.purdue.edu Phone: (765)494-6054 FAX: (765)494-0558
Herman Rubin wrote: > In article <1104329982.419333.95410@f14g2000cwb.googlegroups.com>, > MrPepper11 > >Los Angeles Times > >December 29, 2004 > > >Cardiologist Criticizes Drug Ads Aimed at the Public > >By Ricardo Alonso-Zaldivar, Times Staff Writer > > >WASHINGTON - The government should reassess its policy of allowing > >prescription drugs to be advertised directly to consumers, a prominent > >cardiologist urged Tuesday in the Journal of the American Medical > >Association. > > That the AMA would state this does not surprise me at all; > they have been consistently unwilling to let patients make > their own decisions, and maintain that physicians should > make all medical decisions. > > This is exactly what I oppose. Physicians should give > medical information and advice, but in all cases where > possible, the patient should make the decision. There are many places a patient can get medical information and advice. Advertising is not one of them. The point being made is that DTCA is more harmful than helpful. DTCA is not education but rather promotion which exaggerates benefits and downplays risks. It does not mention none drug options, how prevalent the illness is, or how successful the advertised drug is compared to a test group that took a placebo. > > >The heart attack risks of arthritis painkillers Vioxx, Bextra and > >Celebrex have exposed a regulatory "house of cards" at the Food and > >Drug Administration, wrote Dr. Eric J. Topol, chairman of > >cardiovascular medicine at the Cleveland Clinic. > > >"Unbridled promotion exacerbated the public health problem," Topol > >concluded. "The combination of mass promotion of a medicine with an > >unknown and suspect safety profile cannot be tolerated in the future." > > This is totally unclear. ALL medications have risks and > benefits; what is needed is to provide the known information, > and let people make up their own minds. The known information, in the past and now, does not include trials which found negative information. The information > provided in the advertising is more complete and more honest > than what is typically given by physicians. It is de facto the same, coming primarily as it does from the same source. Physicians on the front line get their drugs and continuing medical information from pharma, either delivered by pharmaceutical reps bearing glossy advertising brochures, by pharma sponsored seminars, workshops, conferences and "educational" junkets, from medical schools also receiving monies from pharma; pharma sponsored research, books, tuition, office equipment etc, and specialists acting as "consultants" to pharma (conflict of interest and biased information--NIH's Dr. Sonderland LA Times most recent example). > Even without direct advertising, we have always had "mass > promotion". This is not surprising; if a pharmaceutical > company is putting a half billion dollars in the development > of a drug through FDA approval, it must make lots of sales > to recoup the investment, and also the investment in drugs > which do not make it. Pharma spends a lot more on marketing than they do on research. See relevant comment in Marcia Angell's book and in the following study: http://www.nybooks.com/articles/17244 http://www.familiesusa.org/site/DocServer/PPreport.pdf?docID=249 > > >FDA officials have not publicly addressed the issue of whether > >high-powered advertising campaigns for newly approved drugs are in the > >best interest of public health. > > >Other leading academic researchers have suggested that new drugs should > >be subject to a trial period before they can be touted directly to > >patients. > > They are. There is a long testing period. Not long enough apparently. HRT, Baycol, Vioxx, Celebrex, Rezulin... And no post-marketing surveillance that pharma can wiggle out of. > > Also, there are other ways of learning about new drugs, > besides direct advertising. I do not believe that Humalog, > the Lilly quickly absorbed insulin, was so advertised when > I asked my endocrinologist whether it might be good for me. > He agreed with the trial, and I am still using it. > > What I object to is any attempt by the AMA or FDA or anyone > else to restrict information. The are attempting to restrict advertising, not information. However, I believe that the > full information be given, and if it is, that the manufacturer > be exempt from liability from all unknown and most unexpected > side effects, and the consumer must know the risks and accept > them for the stated side effects. Will we get them to sign a release for every pill they take? Will translators be used? How will we ensure all with varying levels of education and comprehension are being served? Will we use the models courts use for non-English speakers, or those with established cognitive 'challenges'? How can we be sure the patient wasn't emotionally overcome and willing to sign do and accept anything (as they often are even in the abscence of this scenario?) > > I would suggest instead that if their cabal keeps someone from > getting a drug because of the restriction of knowledge, Again you *assume* that advertising is analagous to education. It is not. Education is never, nor should it be, so one-sided and so focussed to a goal determined in a marketing department. they > as individuals, not as agents of the government or officers > of the MDA, be fully responsible for the denial of treatment. > The one who makes the decisions is the one who should bear the > responsibility, Patients can only make decisions based on the best available evidence. And if the best available evidence is not all the available evidence, and the patient is compromised in understanding, then the patient needs an unbiased and uncompromised physican *as well as* his or her own best efforts, to comprehend what his or her options are. and recourse should require showing fraud or > irresponsible concealment of information, or direct failure to > adequately provide the care offered. Your perspective here would entangle healthcare and all its players even further into the litigious system you decry. Zee > -- > This address is for information only. I do not claim that these views > are those of the Statistics Department or of Purdue University. > Herman Rubin, Department of Statistics, Purdue University > hrubin@stat.purdue.edu Phone: (765)494-6054 FAX: (765)494-0558
In article <1104344919.067860.289990@c13g2000cwb.googlegroups.com>, Zee >Herman Rubin wrote: >> In article <1104329982.419333.95410@f14g2000cwb.googlegroups.com>, >> MrPepper11 >> >Los Angeles Times >> >December 29, 2004 >> >Cardiologist Criticizes Drug Ads Aimed at the Public >> >By Ricardo Alonso-Zaldivar, Times Staff Writer >> >WASHINGTON - The government should reassess its policy of allowing >> >prescription drugs to be advertised directly to consumers, a >prominent >> >cardiologist urged Tuesday in the Journal of the American Medical >> >Association. >> That the AMA would state this does not surprise me at all; >> they have been consistently unwilling to let patients make >> their own decisions, and maintain that physicians should >> make all medical decisions. >> This is exactly what I oppose. Physicians should give >> medical information and advice, but in all cases where >> possible, the patient should make the decision. >There are many places a patient can get medical information and advice. >Advertising is not one of them. >The point being made is that DTCA is more harmful than helpful. >DTCA is not education but rather promotion which exaggerates benefits >and downplays risks. It does not mention none drug options, how >prevalent the illness is, or how successful the advertised drug is >compared to a test group that took a placebo. Usually, the latter can be found in the PDR material, and occasionally comparison with placebo. If the drug is not enough better than placebo, the FDA is unlikely to approve it as it stands. The information about the tests and their results should be readily available, and the advertising should say where it is. The manufacturers will supply this if required. As to comparing different drug options, finding this information is quite difficult now, and the physicians normally do not have any comparison; they may know the options. With advertising, the public is likely to know the options. When it comes to comparing the options, individual variations come in quite strongly; for a doctor to ignore these is bad medicine. >> >The heart attack risks of arthritis painkillers Vioxx, Bextra and >> >Celebrex have exposed a regulatory "house of cards" at the Food and >> >Drug Administration, wrote Dr. Eric J. Topol, chairman of >> >cardiovascular medicine at the Cleveland Clinic. >> >"Unbridled promotion exacerbated the public health problem," Topol >> >concluded. "The combination of mass promotion of a medicine with an >> >unknown and suspect safety profile cannot be tolerated in the >future." >> This is totally unclear. ALL medications have risks and >> benefits; what is needed is to provide the known information, >> and let people make up their own minds. >The known information, in the past and now, does not include trials >which found negative information. This will not change if advertising is prohibited. I doubt if the usage of Vioxx and Celebrex would be any less if there had been no advertising. These are Cox-2 inhibitors, and for those with stomach or other sensitivity to the usual NSAIDS, they were the drugs of choice before there was advertising. Advertising may have increased the number taking them, but those who changed to them would not have been considered doing anything worse than possibly spending more than necessary. >The information >> provided in the advertising is more complete and more honest >> than what is typically given by physicians. >It is de facto the same, coming primarily as it does from the same >source. The advertising is required to provide a fair amount of information about side effects; the physicians do so much less often. In fact, most physicians do not know as much as is included in the advertising. >Physicians on the front line get their drugs and continuing medical >information from pharma, either delivered by pharmaceutical reps >bearing glossy advertising brochures, by pharma sponsored seminars, >workshops, conferences and "educational" junkets, from medical schools >also receiving monies from pharma; pharma sponsored research, books, >tuition, office equipment etc, and specialists acting as "consultants" >to pharma (conflict of interest and biased information--NIH's Dr. >Sonderland LA Times most recent example). >> Even without direct advertising, we have always had "mass >> promotion". This is not surprising; if a pharmaceutical >> company is putting a half billion dollars in the development >> of a drug through FDA approval, it must make lots of sales >> to recoup the investment, and also the investment in drugs >> which do not make it. >Pharma spends a lot more on marketing than they do on research. See >relevant comment in Marcia Angell's book and in the following study: >http://www.nybooks.com/articles/17244 >http://www.familiesusa.org/site/DocServer/PPreport.pdf?docID=249 It is not so much research, as development. From the time research, theirs or others, has produced a promising chemical, until it is approved for the company to make available, is likely to cost a half billion or more. Also, the ones which do not end up being marketed, but which are tested, are likely to run to 100 million on the average. And if the FDA does not think they have done enough testing, back it goes. The cost of testing is not the drug, per se. It is the medical care of those being tested, whether given the drug or a placebo or an alternative. There is the question of dosage, and it may be necessary to test different dosages on thousands of people. The "worst case" scenario is not often, but all of this enters. It is for this reason that patents on drugs last at least until 10 years after the drug is approved for marketing; it may take more than 10 years from the discovery of the chemical and its possible usefulness for the approval to occur. >> >FDA officials have not publicly addressed the issue of whether >> >high-powered advertising campaigns for newly approved drugs are in >the >> >best interest of public health. >> >Other leading academic researchers have suggested that new drugs >should >> >be subject to a trial period before they can be touted directly to >> >patients. >> They are. There is a long testing period. >Not long enough apparently. HRT, Baycol, Vioxx, Celebrex, Rezulin... >And no post-marketing surveillance that pharma can wiggle out of. Do you ever want to get a useful drug? If a drug is suspected of increasing the cancer rate ten years down the line, it would be at least 10 years of substantial use before the drug can be used for any but experimental patients. The Rezulin problems were about one in 50,000, even without liver testing. For HRT, many studies of several years produced no indication of an increase in cardiovascular problems, until there was a long study with carefully randomized patients. This is very difficult to do, as for any long study, many will drop out. >> Also, there are other ways of learning about new drugs, >> besides direct advertising. I do not believe that Humalog, >> the Lilly quickly absorbed insulin, was so advertised when >> I asked my endocrinologist whether it might be good for me. >> He agreed with the trial, and I am still using it. >> What I object to is any attempt by the AMA or FDA or anyone >> else to restrict information. >The are attempting to restrict advertising, not information. At this time, it seems the AMA at least wants to restrict information. In fact, our miseducational system has done its best to see that laypeople have difficulty in finding and getting the information, as does the medical establishment until recently. Instead of advertising, we will have people looking in the literature and finding a posting of some kind, and there are many of those now, and disseminating it. These disseminations are not as subject to regulations as advertising. I have followed up on several of those, and find them to be lacking, including some on which medical decisions have been based by those whose knowledge of statistics is pure religion. >However, I believe that the >> full information be given, and if it is, that the manufacturer >> be exempt from liability from all unknown and most unexpected >> side effects, and the consumer must know the risks and accept >> them for the stated side effects. >Will we get them to sign a release for every pill they take? Will >translators be used? How will we ensure all with varying levels of >education and comprehension are being served? Will we use the models >courts use for non-English speakers, or those with established >cognitive 'challenges'? How can we be sure the patient wasn't >emotionally overcome and willing to sign do and accept anything (as >they often are even in the abscence of this scenario?) If you do not allow this, you will not be able to get any drugs. Have you seen the suit about children's Aleve? Considering that millions take it, do you not think that someone will react badly? We certainly can see that the medical information is translated. For those with cognitive "challenges", we have problems in any case. If a manufacturer states that one in 10,000 may get such a side effect from the drug, should there be any liability if that side effect occurs to that one? Take a look at any drug in the PDR, and see the information on side effects and indications of serious adverse reactions. Much of that is required to be in the advertising. >> I would suggest instead that if their cabal keeps someone from >> getting a drug because of the restriction of knowledge, >Again you *assume* that advertising is analagous to education. It is >not. Education is never, nor should it be, so one-sided and so focussed >to a goal determined in a marketing department. As I stated, the drug advertising I have seen in magazines and on television is quite fair. For prescription drugs, one would have to see a doctor in any case. >they >> as individuals, not as agents of the government or officers >> of the MDA, be fully responsible for the denial of treatment. >> The one who makes the decisions is the one who should bear the >> responsibility, >Patients can only make decisions based on the best available evidence. >And if the best available evidence is not all the available evidence, >and the patient is compromised in understanding, then the patient needs >an unbiased and uncompromised physican *as well as* his or her own best >efforts, to comprehend what his or her options are. It is often the case that a patient has more available evidence than most physicians. There was even one case when I asked a faculty member at a medical school about certain properties of a drug. He considered the question reasonable, but did not find the information in the medical sources in his office. It took some "googling" by me to find it. >and recourse should require showing fraud or >> irresponsible concealment of information, or direct failure to >> adequately provide the care offered. >Your perspective here would entangle healthcare and all its players >even further into the litigious system you decry. No, it would not. If someone sues a manufacturer for events warned by the manufacturer, the one suing would have to pay all costs, including the costs of the manufacturer defending it. The same would be the case for suits against doctors for not achieving the best possible results. The present litigous system is due to expecting that all drugs are "safe and effective", and that if there are bad results in an operation, the doctor must have done something drastically wrong. We need to educate people to the fact that everything has risks and benefits, and as long as they, including the best estimate of the odds, are clearly stated, that there is no liability for poor results. Not only would we have to educate the public, but the physicians. They do not know how to think that way. We also are likely to need to provide computer programs for the evaluation; I am quite adept at both theory and computation, and I am likely to need that. -- This address is for information only. I do not claim that these views are those of the Statistics Department or of Purdue University. Herman Rubin, Department of Statistics, Purdue University hrubin@stat.purdue.edu Phone: (765)494-6054 FAX: (765)494-0558
Herman Rubin wrote: > In article <1104344919.067860.289990@c13g2000cwb.googlegroups.com>, > Zee > > >Herman Rubin wrote: > >> In article <1104329982.419333.95410@f14g2000cwb.googlegroups.com>, > >> MrPepper11 > >> >Los Angeles Times > >> >December 29, 2004 > > >> >Cardiologist Criticizes Drug Ads Aimed at the Public > >> >By Ricardo Alonso-Zaldivar, Times Staff Writer > > >> >WASHINGTON - The government should reassess its policy of allowing > >> >prescription drugs to be advertised directly to consumers, a > >prominent > >> >cardiologist urged Tuesday in the Journal of the American Medical > >> >Association. > > >> That the AMA would state this does not surprise me at all; > >> they have been consistently unwilling to let patients make > >> their own decisions, and maintain that physicians should > >> make all medical decisions. > > >> This is exactly what I oppose. Physicians should give > >> medical information and advice, but in all cases where > >> possible, the patient should make the decision. > > > >There are many places a patient can get medical information and advice. > >Advertising is not one of them. > > >The point being made is that DTCA is more harmful than helpful. > > >DTCA is not education but rather promotion which exaggerates benefits > >and downplays risks. It does not mention none drug options, how > >prevalent the illness is, or how successful the advertised drug is > >compared to a test group that took a placebo. > > Usually, the latter can be found in the PDR material, C'mon. I am not going to buy this and update it and lug it around. Most physicians (and pharmacists) do not read the PDR. Many physicans are surprised to learn, for example, that there are tear-out ADR forms in the back of this tome. A couple weeks ago I did a telephone interview with a local pharmacist, the owner of a couple pharmacies one located across from our university medical school. He was stunned to find, following my directions, particular information about a statin which every statin user who has suffered adverse effects knows. His volume was 2 years out-of-date. The situation is worse with large franchised (Costco) pharmacies. Do not startle them by asking for any actual medical info. and > occasionally comparison with placebo. If the drug is not > enough better than placebo, the FDA is unlikely to approve > it as it stands. I *have* seen something like that on the back of those glossy ads showing preturnaturally taut-skinned septugenarian surfers. Prob is, the people to whom these meds are being pitched cannot read print that is font size 4. And if they could, most of them would not understand it. The information about the tests and their > results should be readily available, Yes it should. Isn't. and the advertising > should say where it is. The manufacturers will supply this > if required. Really! Dr. Rubin. Really? Have you got shares in Conde Nast or something? > > As to comparing different drug options, finding this > information is quite difficult now, and the physicians > normally do not have any comparison; they may know the > options. With advertising, the public is likely to know > the options. Show me an one of those Viagra ads where it says something like: oh and check out our competition's drugs that do the same thing, possibly cheaper. Or, if you really are having probs, maybe better to talk to your wife about what's going on in your marriage, and/or, your doctor about what's going on with your health that could be causing this. Or: do not use this drug for a weekend frat party. And even if they did, this text is completely subverted by the sub-text of the pictures and the leaping grinning satisfied customers. When it comes to comparing the options, > individual variations come in quite strongly; for a > doctor to ignore these is bad medicine. Dr. Rubin no-one knew the options on say, Nexium (prilosec does job more cheaply and safely) or any number of drugs pushed this way. And by the way, you are not going to see a Conde Nast publication with a double-truck ad on...toenail fungus. > > >> >The heart attack risks of arthritis painkillers Vioxx, Bextra and > >> >Celebrex have exposed a regulatory "house of cards" at the Food and > >> >Drug Administration, wrote Dr. Eric J. Topol, chairman of > >> >cardiovascular medicine at the Cleveland Clinic. > > >> >"Unbridled promotion exacerbated the public health problem," Topol > >> >concluded. "The combination of mass promotion of a medicine with an > >> >unknown and suspect safety profile cannot be tolerated in the > >future." > > >> This is totally unclear. ALL medications have risks and > >> benefits; what is needed is to provide the known information, > >> and let people make up their own minds. > > > >The known information, in the past and now, does not include trials > >which found negative information. > > This will not change if advertising is prohibited. > > I doubt if the usage of Vioxx and Celebrex would be any > less if there had been no advertising. These are Cox-2 > inhibitors, and for those with stomach or other sensitivity > to the usual NSAIDS, they were the drugs of choice before > there was advertising. Advertising may have increased the > number taking them, but those who changed to them would > not have been considered doing anything worse than possibly > spending more than necessary. > > >The information > >> provided in the advertising is more complete and more honest > >> than what is typically given by physicians. > > >It is de facto the same, coming primarily as it does from the same > >source. > > The advertising is required to provide a fair amount of > information about side effects; the physicians do so > much less often. In fact, most physicians do not know > as much as is included in the advertising. > > >Physicians on the front line get their drugs and continuing medical > >information from pharma, either delivered by pharmaceutical reps > >bearing glossy advertising brochures, by pharma sponsored seminars, > >workshops, conferences and "educational" junkets, from medical schools > >also receiving monies from pharma; pharma sponsored research, books, > >tuition, office equipment etc, and specialists acting as "consultants" > >to pharma (conflict of interest and biased information--NIH's Dr. > >Sonderland LA Times most recent example). > > >> Even without direct advertising, we have always had "mass > >> promotion". This is not surprising; if a pharmaceutical > >> company is putting a half billion dollars in the development > >> of a drug through FDA approval, it must make lots of sales > >> to recoup the investment, and also the investment in drugs > >> which do not make it. > > >Pharma spends a lot more on marketing than they do on research. See > >relevant comment in Marcia Angell's book and in the following study: > >http://www.nybooks.com/articles/17244 > >http://www.familiesusa.org/site/DocServer/PPreport.pdf?docID=249 > > It is not so much research, as development. From the time > research, theirs or others, has produced a promising chemical, > until it is approved for the company to make available, is > likely to cost a half billion or more. Also, the ones which > do not end up being marketed, but which are tested, are likely > to run to 100 million on the average. And if the FDA does not > think they have done enough testing, back it goes. > > The cost of testing is not the drug, per se. It is the medical > care of those being tested, whether given the drug or a placebo > or an alternative. There is the question of dosage, and it may > be necessary to test different dosages on thousands of people. > The "worst case" scenario is not often, but all of this enters. > It is for this reason that patents on drugs last at least until > 10 years after the drug is approved for marketing; it may take > more than 10 years from the discovery of the chemical and its > possible usefulness for the approval to occur. > > >> >FDA officials have not publicly addressed the issue of whether > >> >high-powered advertising campaigns for newly approved drugs are in > >the > >> >best interest of public health. > > >> >Other leading academic researchers have suggested that new drugs > >should > >> >be subject to a trial period before they can be touted directly to > >> >patients. > > >> They are. There is a long testing period. > > >Not long enough apparently. HRT, Baycol, Vioxx, Celebrex, Rezulin... > >And no post-marketing surveillance that pharma can wiggle out of. > > Do you ever want to get a useful drug? If a drug is > suspected of increasing the cancer rate ten years down > the line, it would be at least 10 years of substantial > use before the drug can be used for any but experimental > patients. > > The Rezulin problems were about one in 50,000, even > without liver testing. For HRT, many studies of > several years produced no indication of an increase > in cardiovascular problems, until there was a long > study with carefully randomized patients. This is > very difficult to do, as for any long study, many will > drop out. > > >> Also, there are other ways of learning about new drugs, > >> besides direct advertising. I do not believe that Humalog, > >> the Lilly quickly absorbed insulin, was so advertised when > >> I asked my endocrinologist whether it might be good for me. > >> He agreed with the trial, and I am still using it. > > >> What I object to is any attempt by the AMA or FDA or anyone > >> else to restrict information. > > >The are attempting to restrict advertising, not information. > > At this time, it seems the AMA at least wants to restrict > information. In fact, our miseducational system has done > its best to see that laypeople have difficulty in finding > and getting the information, as does the medical establishment > until recently. Instead of advertising, we will have people > looking in the literature and finding a posting of some kind, > and there are many of those now, and disseminating it. These > disseminations are not as subject to regulations as advertising. > I have followed up on several of those, and find them to be > lacking, including some on which medical decisions have been > based by those whose knowledge of statistics is pure religion. > > >However, I believe that the > >> full information be given, and if it is, that the manufacturer > >> be exempt from liability from all unknown and most unexpected > >> side effects, and the consumer must know the risks and accept > >> them for the stated side effects. > > >Will we get them to sign a release for every pill they take? Will > >translators be used? How will we ensure all with varying levels of > >education and comprehension are being served? Will we use the models > >courts use for non-English speakers, or those with established > >cognitive 'challenges'? How can we be sure the patient wasn't > >emotionally overcome and willing to sign do and accept anything (as > >they often are even in the abscence of this scenario?) > > If you do not allow this, you will not be able to get any > drugs. Have you seen the suit about children's Aleve? > Considering that millions take it, do you not think that > someone will react badly? > > We certainly can see that the medical information is > translated. For those with cognitive "challenges", we > have problems in any case. If a manufacturer states > that one in 10,000 may get such a side effect from the > drug, should there be any liability if that side effect > occurs to that one? Take a look at any drug in the PDR, > and see the information on side effects and indications > of serious adverse reactions. Much of that is required > to be in the advertising. > > >> I would suggest instead that if their cabal keeps someone from > >> getting a drug because of the restriction of knowledge, > > >Again you *assume* that advertising is analagous to education. It is > >not. Education is never, nor should it be, so one-sided and so focussed > >to a goal determined in a marketing department. > > As I stated, the drug advertising I have seen in magazines > and on television is quite fair. For prescription drugs, > one would have to see a doctor in any case. > > >they > >> as individuals, not as agents of the government or officers > >> of the MDA, be fully responsible for the denial of treatment. > >> The one who makes the decisions is the one who should bear the > >> responsibility, > > >Patients can only make decisions based on the best available evidence. > >And if the best available evidence is not all the available evidence, > >and the patient is compromised in understanding, then the patient needs > >an unbiased and uncompromised physican *as well as* his or her own best > >efforts, to comprehend what his or her options are. > > It is often the case that a patient has more available > evidence than most physicians. There was even one case > when I asked a faculty member at a medical school about > certain properties of a drug. He considered the question > reasonable, but did not find the information in the > medical sources in his office. It took some "googling" > by me to find it. > > >and recourse should require showing fraud or > >> irresponsible concealment of information, or direct failure to > >> adequately provide the care offered. > > >Your perspective here would entangle healthcare and all its players > >even further into the litigious system you decry. > > No, it would not. If someone sues a manufacturer for > events warned by the manufacturer, the one suing > would have to pay all costs, including the costs of > the manufacturer defending it. The same would be the > case for suits against doctors for not achieving the > best possible results. We in Canada by and large are not a litigious society. I do not even consider this sort of thing and think, basically, this is reason why things have gone so wrong in America. It is get away with what you can, until you are stopped. Sue someone, they pay, and procedd with business as usual. Wrong wrong wrong. > The present litigous system is due to expecting that > all drugs are "safe and effective", and that if there > are bad results in an operation, the doctor must have > done something drastically wrong. We need to educate > people to the fact that everything has risks and > benefits, and as long as they, including the best > estimate of the odds, are clearly stated, that there > is no liability for poor results. Well good luck because I think as I have said above. And the major thing that is going to change this in this situation is more and better controls, and regulatory bodies which implement this and perform their mandate. > > Not only would we have to educate the public, but the > physicians. They do not know how to think that way. > We also are likely to need to provide computer programs > for the evaluation; I am quite adept at both theory and > computation, and I am likely to need that. Yes. Medical education has to be freed from pharma, industry, business, control. Physicians need to become physicians again, not pill dispensers. For example, I cannot even see my endocrinologist because I refuse to take a cholesterol lowering med. He does not see that his function is to help me achieve a certain goal, but only to achieve it with the medications made by the pharma which funds his clinic, his research, and pays him a fee per patient enrolled. Zee > > -- > This address is for information only. I do not claim that these views > are those of the Statistics Department or of Purdue University. > Herman Rubin, Department of Statistics, Purdue University > hrubin@stat.purdue.edu Phone: (765)494-6054 FAX: (765)494-0558
How drug companies work. Very cynically. ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ http://www.forbes.com/lifestyle/health/feeds/hscout/2004/12/30/hscout523176.html Health "The discovery of research, reportedly 'missing' for the past 10 years, that connects Prozac to increased suicidal tendencies and violence is one more tragic example of a greater problem: Unless we mandate that all research be disclosed to the FDA during the drug approval process, regulators have no choice but to make their decisions based on the best-case scenarios that drug companies report to them," U.S. Rep. Maurice Hinchey (D-N.Y.), whose office is reviewing the documents, said in a statement. "These decisions affect the health and lives of millions of Americans. If Eli Lilly's research indicated dangerous side effects of their product and they withheld that information, they knowingly jeopardized the public's health. Their failure to disclose what they knew may have cost lives." ------snip--------- The documents in question reportedly disappeared during a product liability suit brought in 1994 by families of the victims of Joseph Wesbecker, who, in 1989, killed eight people and wounded another 12 with an AK-47 before turning the gun on himself at his workplace in Louisville, Ky. Wesbecker, who had suffered a long history of depression, had started using fluoxetine just one month before the shootings. ~~~~~~~~snip~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~Zee Herman Rubin wrote: > In article <1104344919.067860.289990@c13g2000cwb.googlegroups.com>, > Zee > > >Herman Rubin wrote: > >> In article <1104329982.419333.95410@f14g2000cwb.googlegroups.com>, > >> MrPepper11 > >> >Los Angeles Times > >> >December 29, 2004 > > >> >Cardiologist Criticizes Drug Ads Aimed at the Public > >> >By Ricardo Alonso-Zaldivar, Times Staff Writer > > >> >WASHINGTON - The government should reassess its policy of allowing > >> >prescription drugs to be advertised directly to consumers, a > >prominent > >> >cardiologist urged Tuesday in the Journal of the American Medical > >> >Association. > > >> That the AMA would state this does not surprise me at all; > >> they have been consistently unwilling to let patients make > >> their own decisions, and maintain that physicians should > >> make all medical decisions. > > >> This is exactly what I oppose. Physicians should give > >> medical information and advice, but in all cases where > >> possible, the patient should make the decision. > > > >There are many places a patient can get medical information and advice. > >Advertising is not one of them. > > >The point being made is that DTCA is more harmful than helpful. > > >DTCA is not education but rather promotion which exaggerates benefits > >and downplays risks. It does not mention none drug options, how > >prevalent the illness is, or how successful the advertised drug is > >compared to a test group that took a placebo. > > Usually, the latter can be found in the PDR material, and > occasionally comparison with placebo. If the drug is not > enough better than placebo, the FDA is unlikely to approve > it as it stands. The information about the tests and their > results should be readily available, and the advertising > should say where it is. The manufacturers will supply this > if required. > > As to comparing different drug options, finding this > information is quite difficult now, and the physicians > normally do not have any comparison; they may know the > options. With advertising, the public is likely to know > the options. When it comes to comparing the options, > individual variations come in quite strongly; for a > doctor to ignore these is bad medicine. > > >> >The heart attack risks of arthritis painkillers Vioxx, Bextra and > >> >Celebrex have exposed a regulatory "house of cards" at the Food and > >> >Drug Administration, wrote Dr. Eric J. Topol, chairman of > >> >cardiovascular medicine at the Cleveland Clinic. > > >> >"Unbridled promotion exacerbated the public health problem," Topol > >> >concluded. "The combination of mass promotion of a medicine with an > >> >unknown and suspect safety profile cannot be tolerated in the > >future." > > >> This is totally unclear. ALL medications have risks and > >> benefits; what is needed is to provide the known information, > >> and let people make up their own minds. > > > >The known information, in the past and now, does not include trials > >which found negative information. > > This will not change if advertising is prohibited. > > I doubt if the usage of Vioxx and Celebrex would be any > less if there had been no advertising. These are Cox-2 > inhibitors, and for those with stomach or other sensitivity > to the usual NSAIDS, they were the drugs of choice before > there was advertising. Advertising may have increased the > number taking them, but those who changed to them would > not have been considered doing anything worse than possibly > spending more than necessary. > > >The information > >> provided in the advertising is more complete and more honest > >> than what is typically given by physicians. > > >It is de facto the same, coming primarily as it does from the same > >source. > > The advertising is required to provide a fair amount of > information about side effects; the physicians do so > much less often. In fact, most physicians do not know > as much as is included in the advertising. > > >Physicians on the front line get their drugs and continuing medical > >information from pharma, either delivered by pharmaceutical reps > >bearing glossy advertising brochures, by pharma sponsored seminars, > >workshops, conferences and "educational" junkets, from medical schools > >also receiving monies from pharma; pharma sponsored research, books, > >tuition, office equipment etc, and specialists acting as "consultants" > >to pharma (conflict of interest and biased information--NIH's Dr. > >Sonderland LA Times most recent example). > > >> Even without direct advertising, we have always had "mass > >> promotion". This is not surprising; if a pharmaceutical > >> company is putting a half billion dollars in the development > >> of a drug through FDA approval, it must make lots of sales > >> to recoup the investment, and also the investment in drugs > >> which do not make it. > > >Pharma spends a lot more on marketing than they do on research. See > >relevant comment in Marcia Angell's book and in the following study: > >http://www.nybooks.com/articles/17244 > >http://www.familiesusa.org/site/DocServer/PPreport.pdf?docID=249 > > It is not so much research, as development. From the time > research, theirs or others, has produced a promising chemical, > until it is approved for the company to make available, is > likely to cost a half billion or more. Also, the ones which > do not end up being marketed, but which are tested, are likely > to run to 100 million on the average. And if the FDA does not > think they have done enough testing, back it goes. > > The cost of testing is not the drug, per se. It is the medical > care of those being tested, whether given the drug or a placebo > or an alternative. There is the question of dosage, and it may > be necessary to test different dosages on thousands of people. > The "worst case" scenario is not often, but all of this enters. > It is for this reason that patents on drugs last at least until > 10 years after the drug is approved for marketing; it may take > more than 10 years from the discovery of the chemical and its > possible usefulness for the approval to occur. > > >> >FDA officials have not publicly addressed the issue of whether > >> >high-powered advertising campaigns for newly approved drugs are in > >the > >> >best interest of public health. > > >> >Other leading academic researchers have suggested that new drugs > >should > >> >be subject to a trial period before they can be touted directly to > >> >patients. > > >> They are. There is a long testing period. > > >Not long enough apparently. HRT, Baycol, Vioxx, Celebrex, Rezulin... > >And no post-marketing surveillance that pharma can wiggle out of. > > Do you ever want to get a useful drug? If a drug is > suspected of increasing the cancer rate ten years down > the line, it would be at least 10 years of substantial > use before the drug can be used for any but experimental > patients. > > The Rezulin problems were about one in 50,000, even > without liver testing. For HRT, many studies of > several years produced no indication of an increase > in cardiovascular problems, until there was a long > study with carefully randomized patients. This is > very difficult to do, as for any long study, many will > drop out. > > >> Also, there are other ways of learning about new drugs, > >> besides direct advertising. I do not believe that Humalog, > >> the Lilly quickly absorbed insulin, was so advertised when > >> I asked my endocrinologist whether it might be good for me. > >> He agreed with the trial, and I am still using it. > > >> What I object to is any attempt by the AMA or FDA or anyone > >> else to restrict information. > > >The are attempting to restrict advertising, not information. > > At this time, it seems the AMA at least wants to restrict > information. In fact, our miseducational system has done > its best to see that laypeople have difficulty in finding > and getting the information, as does the medical establishment > until recently. Instead of advertising, we will have people > looking in the literature and finding a posting of some kind, > and there are many of those now, and disseminating it. These > disseminations are not as subject to regulations as advertising. > I have followed up on several of those, and find them to be > lacking, including some on which medical decisions have been > based by those whose knowledge of statistics is pure religion. > > >However, I believe that the > >> full information be given, and if it is, that the manufacturer > >> be exempt from liability from all unknown and most unexpected > >> side effects, and the consumer must know the risks and accept > >> them for the stated side effects. > > >Will we get them to sign a release for every pill they take? Will > >translators be used? How will we ensure all with varying levels of > >education and comprehension are being served? Will we use the models > >courts use for non-English speakers, or those with established > >cognitive 'challenges'? How can we be sure the patient wasn't > >emotionally overcome and willing to sign do and accept anything (as > >they often are even in the abscence of this scenario?) > > If you do not allow this, you will not be able to get any > drugs. Have you seen the suit about children's Aleve? > Considering that millions take it, do you not think that > someone will react badly? > > We certainly can see that the medical information is > translated. For those with cognitive "challenges", we > have problems in any case. If a manufacturer states > that one in 10,000 may get such a side effect from the > drug, should there be any liability if that side effect > occurs to that one? Take a look at any drug in the PDR, > and see the information on side effects and indications > of serious adverse reactions. Much of that is required > to be in the advertising. > > >> I would suggest instead that if their cabal keeps someone from > >> getting a drug because of the restriction of knowledge, > > >Again you *assume* that advertising is analagous to education. It is > >not. Education is never, nor should it be, so one-sided and so focussed > >to a goal determined in a marketing department. > > As I stated, the drug advertising I have seen in magazines > and on television is quite fair. For prescription drugs, > one would have to see a doctor in any case. > > >they > >> as individuals, not as agents of the government or officers > >> of the MDA, be fully responsible for the denial of treatment. > >> The one who makes the decisions is the one who should bear the > >> responsibility, > > >Patients can only make decisions based on the best available evidence. > >And if the best available evidence is not all the available evidence, > >and the patient is compromised in understanding, then the patient needs > >an unbiased and uncompromised physican *as well as* his or her own best > >efforts, to comprehend what his or her options are. > > It is often the case that a patient has more available > evidence than most physicians. There was even one case > when I asked a faculty member at a medical school about > certain properties of a drug. He considered the question > reasonable, but did not find the information in the > medical sources in his office. It took some "googling" > by me to find it. > > >and recourse should require showing fraud or > >> irresponsible concealment of information, or direct failure to > >> adequately provide the care offered. > > >Your perspective here would entangle healthcare and all its players > >even further into the litigious system you decry. > > No, it would not. If someone sues a manufacturer for > events warned by the manufacturer, the one suing > would have to pay all costs, including the costs of > the manufacturer defending it. The same would be the > case for suits against doctors for not achieving the > best possible results. > > The present litigous system is due to expecting that > all drugs are "safe and effective", and that if there > are bad results in an operation, the doctor must have > done something drastically wrong. We need to educate > people to the fact that everything has risks and > benefits, and as long as they, including the best > estimate of the odds, are clearly stated, that there > is no liability for poor results. > > Not only would we have to educate the public, but the > physicians. They do not know how to think that way. > We also are likely to need to provide computer programs > for the evaluation; I am quite adept at both theory and > computation, and I am likely to need that. > > -- > This address is for information only. I do not claim that these views > are those of the Statistics Department or of Purdue University. > Herman Rubin, Department of Statistics, Purdue University > hrubin@stat.purdue.edu Phone: (765)494-6054 FAX: (765)494-0558 Start « Previous 1 2 3 4 5 6 Next » Related Discussion: XanGo (1 posts) these girls use this service for free - they just want phonesex from real guys 61 (1 posts) Eating Fish Protects Against Stroke (1 posts) Prevention of type 2 diabetes mellitus through inhibition of the Renin-Angiotensin system. (1 posts) Top Discussions From Our Archives Energy. Resilience. Vitality. Want some? Do you do website promotion with no success? Diabetes Spotted at an Earlier Age Other Discussion Categories Diabetes Symptoms Health Care Policy Health Care Providers HMO
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