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--- Prominent cardiologist criticizes drug ads
Personally, I find the mass-market advertising (print, tv and radio) of potent medications unfortunate and, as in the case of alcohol, wouldn't miss seeing it. I do find some of these slick commercials very 1984-ish. Perhaps it would change the focus of pharma and force patients to rely on and talk more to their doctors. I disagree with Topol's opinion in that there will always be safety issues with drugs and curtailing "unbridled promotion" will not lessen that reality. But at least we won't be bombarded with actors pretending to be real people pretending to find relief from real (powerful) drugs. L. "MrPepper11" @f14g2000cwb.googlegroups.com: > 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. > > 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." > > 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. > > Topol's sharply worded opinion article, to be published next month, was > posted on the medical journal's website as part of the growing debate. > > Critics have accused the FDA of being too cozy with the drug industry > and unwilling to pursue evidence of problems with medications that it > has already approved. > > Manufacturer Merck & Co. withdrew Vioxx from the market in late > September after a company-sponsored study confirmed research by Topol > and others that it increased chances of heart attacks and strokes. > Topol was among the chief critics of the drug. > > New warnings have been added to the Bextra label, and concerns have > been raised about possible problems with Celebrex, both produced by > Pfizer Inc. The company recently agreed to suspend Celebrex advertising > while experts sorted out preliminary study findings that indicated a > heart risk for patients taking a high dose over many months. > > All three drugs are of the same family of chemical compounds. > > Celebrex and Vioxx, taken by millions of patients worldwide, were > heavily advertised on television and in magazines and were considered > blockbuster successes for their manufacturers. But though Vioxx had > fewer side effects on the stomach than earlier generations of arthritis > medicines, none of the three drugs was proved to be markedly better at > reducing pain. > > "These drugs were mass-marketed from the moment they were commercially > available in the new world of direct-to-consumer advertising, with > unrealistic expectations about pain relief, marked gastrointestinal > protection and safety," wrote Topol. "One has to question the wisdom of > allowing direct-to-consumer advertising for lifestyle medications that > have no capability of preserving life or preventing major events such > as [heart attack] or stroke." > > Proposals for FDA reform include creating an independent office to > monitor the safety of drugs already on the market and granting the > agency new legal authority to require drug companies to conduct > follow-up studies that would identify potentially dangerous side > effects. > > New drugs are usually tested on several thousand people before being > approved, but problems may not emerge until hundreds of thousands of > patients have used a medicine. > > -------- > > Full text available at > http://jama.ama-assn.org/cgi/content/full/293.3.366v1 > > Arthritis Medicines and Cardiovascular Events-"House of Coxibs" > Eric J. Topol, MD > > JAMA. 2005;293:(DOI 10.1001/jama.293.3.366). >
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. >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 information provided in the advertising is more complete and more honest than what is typically given by physicians. 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. >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. 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. 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. I would suggest instead that if their cabal keeps someone from getting a drug because of the restriction of knowledge, 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, and recourse should require showing fraud or irresponsible concealment of information, or direct failure to adequately provide the care offered. -- 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
hrubin@odds.stat.purdue.edu (Herman Rubin) wrote: >>"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. True. People forget that every drug is essentially a poison, attempting to interfere with the body's normal functioning in some way. We hope the side effects are more than offset by the benefits, but that may not always be the case, either individually or globally.
Steve 4ax.com: > hrubin@odds.stat.purdue.edu (Herman Rubin) wrote: >>>"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. > > True. People forget that every drug is essentially a poison, > attempting to interfere with the body's normal functioning in some > way. We hope the side effects are more than offset by the benefits, > but that may not always be the case, either individually or globally. > > I think you're putting words into Mr. Rubin's mouth. He never used the word "poison". And what of drugs that attempt to interfere with the body's abnormal functioning? Are they "poison" too? L.
Steve wrote: > hrubin@odds.stat.purdue.edu (Herman Rubin) wrote: > >>"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. > > True. People forget that every drug is essentially a poison, > attempting to interfere with the body's normal functioning in some > way. We hope the side effects are more than offset by the benefits, > but that may not always be the case, either individually or globally. Quite so. And even in the case of so called abnormalities...what we are sure we know today may not be the case tomorrow. HRT was promoted on the basis that menopause is an illness. Must treat. Must introduce a substance (poison) that the body never could make even prior to menopause: estrogen from pregnant mares. Cholesterol is promoted as being dangerous in all but the lowest numbers. Yet our bodies produce it. Are we sure a continually changing danger level (determined by scientists in conflict of interest) is a pathology? Maybe we should exercise, reduce stress, stop smoking and drinking to excess, and follow prudent diet; consistently, throughout our lives, and not just temporarily for three months before we agree to take a poison designed and proven to lower cholesterol (but little else). Zee 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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