| | Kurt,
Here are some excerpts from scientific journals which help provide some perspective here on 2 things:
(1) on this "wild & crazy" notion I have about US Health Care being at least one-third fascist
(2) on this "wild & crazy" notion I have that the government should get the hell out of health care altogether -- including the market for dietary supplements
Now Kurt, to your credit, you did not say that dietary supplements are dangerous. But I'd like to revisit the FDA's officially-primary role (to protect Americans from harm). Now, with this primary role in mind, you'd expect the FDA to proportion its budget toward the things causing the harm, right? But when you sum the harm done from drugs and supplements, more than 99% of the harm comes from the drugs -- yet the FDA doesn't spend more than 99% of its budget on "protecting Americans" by putting the money where it would most help. I'll have to do more research to validate this presumption, but it's my estimation that the FDA spends MUCH more than 1% of its budget battling the supplements.
Why is that, Kurt? Am I just a "conspiracy theorist"? Or do I have robust data which I'm drawing this stuff from? Let's look to "harm" for a moment. While many FDA-approved medicines save lives, here's a review article revealing the "scope" (hint: remember the number range: >750,000) of the yearly harm done by FDA-approved medicines ...
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A systems approach to preventing adverse drug events. Stud Health Technol Inform. 2003;92:95-102.
Anderson JG.
Department of Sociology and Anthropology, Purdue University, West Lafayette, IN, USA.
It is estimated that over three-quarters of a million people are injured or die in hospitals each year from adverse drug events. The majority of medical errors result from poorly designed health care systems rather than from negligence on the part of health care providers.
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Now Kurt, don't burn yourself out on this, but there are 2 ways that you could try to prove my intro (above) wrong:
(1) by finding an official document showing that the FDA spends <1% of its budget -- or even "only" 1%; or even "only" 2%! (over twice what it should be spending in order to protect Americans) -- chasing after dietary supplements and their currently-enjoyed "free market"
(2) by finding a peer-reviewed article somewhere stating that more than 7500 folks per year are injured or die from dietary supplement use
That's all you have to do.
:-)
And, do you think adverse drug events (ADEs) -- aka: adverse drug reactions (ADRs) -- are reported accurately, overreported, or underreported? Let's see ...
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Under-reporting of adverse drug reactions : a systematic review. Drug Saf. 2006;29(5):385-96.
Hazell L, Shakir SA.
Drug Safety Research Unit, Southampton, UK.
In total, 37 studies using a wide variety of surveillance methods were identified from 12 countries. These generated 43 numerical estimates of under-reporting. The median under-reporting rate across the 37 studies was 94% (interquartile range 82-98%).
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And, now that we know that they are underreported, do you think that that has anything to do with the pharmaceutical companies' "relationships" with those who "dispense" their products? Let's see what a review article says about that ...
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Factors that influence spontaneous reporting of adverse drug reactions: a model centralized in the medical professional. J Eval Clin Pract. 2004 Nov;10(4):483-9.
Herdeiro MT, Polonia J, Gestal-Otero JJ, Figueiras A.
Department of Preventive Medicine and Public Health, University of Santiago de Compostela, Spain.
RESULTS AND CONCLUSIONS: The results also indicate that, to improve the participation of health professionals in surveillance systems through spontaneous reporting, it might be necessary to design combined strategies that modify both intrinsic (knowledge, attitudes) and extrinsic (relationship between health professionals and their patients, the national health system and pharmaceutical companies) factors.
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And, with the above in mind, do you think that -- because 5 reasons were offered for reporting discrepancies -- that they're all probably equal and, therefore Big Pharma is, at most, 20% of the "problem"? In other words, do you think that the system which we have in America ISN'T a huge problem (or proportionally, THE LARGEST PROBLEM)? That the "supposedly-big" effects of 'Big Pharma' are just "imagined" by those on the "fringe"? That Big Pharma couldn't possible be operating in a monopoly, one where you can choose to screw folks over and still remain successful, because the government lets YOU decide what to provide as evidence to the public, while dis-allowing more-honest start-up companies entry into your market? Let's check that notion ...
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Potential for conflict of interest in the evaluation of suspected adverse drug reactions: use of cerivastatin and risk of rhabdomyolysis. JAMA. 2004 Dec 1;292(21):2622-31.
Psaty BM, Furberg CD, Ray WA, Weiss NS.
Cardiovascular Health Research Unit, Department of Medicine, University of Washington, Seattle, USA. psaty@u.washington.edu
CONTEXT: In recent years, US patients have increasingly been the first to receive new medications, some of which are subsequently discovered to have suspected adverse drug reactions (SADRs). ...
Although only a small percentage of cerivastatin users also took gemfibrozil, approximately half of the case reports of rhabdomyolysis occurred in users of this combination therapy, and a cerivastatin-gemfibrozil interaction was supported by the results of a 3-day pharmacokinetic study. In internal company documents, multiple case reports suggested a drug-drug interaction within approximately 100 days of the launch in 1998; however, the company did not add a contraindication about the concomitant use of cerivastatin and gemfibrozil to the package insert for more than 18 months.
Unpublished data available in July 1999 also suggested an increased risk of rhabdomyolysis associated with high doses of cerivastatin monotherapy. In late 1999 and early 2000, company scientists conducted high-quality analyses of the US Food and Drug Administration adverse event reporting system data. These analyses suggested that compared with atorvastatin calcium, cerivastatin monotherapy substantially increased the risk of rhabdomyolysis. To our knowledge, these findings were not disseminated or published. The company continued to conduct safety studies, some of them inadequately designed to assess the risk of rhabdomyolysis, until cerivastatin was removed from the market in August 2001.
CONCLUSIONS: Despite limitations of the available data, the asymmetry between the information available to the company and the information available to patients and physicians seems striking. A subjective element is present in the effort to infer whether or not the occurrence of untoward outcomes in users of a particular drug was actually the consequence of the use of that drug, and, under the current system, a pharmaceutical company's appraisal of SADRs may be influenced by economic considerations. Such an appraisal would best be made by an independent group.
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What about ephedra, Ed? -- you might say to me. Wasn't that stuff real dangerous (dangerous enough to be pulled from the market by the FDA?)? Wasn't that a big success for the FDA and the American people's welfare? Surely it couldn't be that our own government was acting illogically (or underhandedly) at the time! Well, let's see if that's true ...
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Safety of ephedra: lessons learned. Toxicol Lett. 2004 Apr 15;150(1):97-110.
Soni MG, Carabin IG, Griffiths JC, Burdock GA.
Burdock Group, 780 US Highway 1, Suite 300, Vero Beach, FL 32962, USA. msoni@burdockgroup.com
The consumer introduces a constellation of variables as well, including, but not limited to, acute and chronic diseases, inborn errors in metabolism, simultaneous use of prescription and over-the-counter drugs, dietary supplements, alcohol, illicit substances and certain foods (e.g. chocolate, caffeinated drinks), all or some of which may exert synergistic, additive or even antagonistic influences on the desired physiologic outcome.
The foregoing not withstanding, the majority of the published nonclinical and clinical studies, and history of use, support the safety of ephedra at the proposed use levels. However, the reports of adverse events submitted to FDA raise concern about the risk associated with ephedra without establishing a direct causal relationship. Given the foregoing, how best can a decision on safety be made? Should the question actually be "can ephedra be as toxic as reported?"
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Gee, what a great question, huh?: "can ephedra be as toxic as reported?" Wow, and it seems like such a simple question, if you just take a minute and think logically. With the millions upon millions upon millions of taxpayer dollars, did the FDA take that "minute" to think? No. But it did spend SEVERAL million US tax-payer dollars on ephedra (and likely several 10s of millions; if not 100 million or more). It's hard to say though. You see, there's this little thing called the Freedom of Information Act, and it's supposed to allow US citizens to request proportional budgeting from government agencies (so that we could see where our money is going).
Try getting one from the FDA, though. Just try it. And see what they say to you when you do. Go on. I mean, hell, it's not like you'll be AUDITED (the next year) by the IRS or anybody! You shouldn't have to worry about getting "raided" at gunpoint either. I mean, what are they going to do -- come in with guns drawn and confiscate your computer and all the saved information you had stored on CDs and such? No, that's only for really popular doctors who routinely give vitamin B shots to their patients -- like Jonathon Wright, MD -- and, heck, even HE got his stuff back (within only several years later!).
Let's see if there isn't even more documented wisdom regarding ephedra or its active compound, ephedrine ...
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The safety and efficacy of pharmaceutical and herbal caffeine and ephedrine use as a weight loss agent. Obes Rev. 2001 Aug;2(3):199-211.
Greenway FL.
Pennington Biomedical Research Center, 6400 Perkins Road, Baton Rouge, Louisiana 70808, USA. greenwfl@pbrc.edu
This review of the literature in Medline relative to the use of caffeine and ephedrine in the treatment of obesity concludes that caffeine and ephedrine are effective in causing weight loss. Caffeine and ephedrine give equivalent weight loss to Diethylpropion and superior weight loss compared to dexfenfluramine. Caffeine and ephedrine have a long history of safe, non-prescription use. The adverse events accompanying acute dosing are mild and transient. Adverse events with caffeine and ephedrine reach and remain at placebo levels after 4-12 weeks of continuous treatment, but data from randomized trials up to 6 months only are available. Obesity is chronic, requires chronic treatment, its incidence is increasing and it has few effective treatments. The benefits of caffeine and ephedrine in treating obesity appear to outweigh the small associated risks. Restriction of dietary herbal supplements containing caffeine and ephedrine, often with other ingredients, should be based on controlled clinical trials of these products.
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Hmm. Apparently, obesity (soon to be the #1 killer in this country) is more dangerous than this FDA-banned treatment. You know, Kurt, if you flip it around and turn it sideways -- it sounds like the logical thing to do; you know, in the public's interest (not Big Pharma's). We just have to remember to flip things around and turn them sideways, that's all. Then we'll be happy to have the government protect us from "the market."
:-)
But, even though several studies were reviewed, that's only ONE doctor's "interpretation" (of all of the relevant research)! -- you might say to me. Fine -- I'll say back to you. If it makes you feel any better, here are 3 more primary researchers reaching that same conclusion ...
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Pharmacological and clinical studies of ephedrine and other thermogenic agonists. Obes Res. 1995 Nov;3 Suppl 4:537S-540S.
Astrup A, Breum L, Toubro S.
Research Department of Human Nutrition, RVAU, Copenhagen, Denmark.
Mean weight loss was found to be 16.6 kg after 6 months when E+C was given as an adjuvant to an efficient hypoenergetic diet, which was 3.4 kg higher than in the placebo group. An additional 24 weeks treatment with E+C prevented relapse. In the first weeks of treatment E+C offset the hypotensive effect of energy restriction and weight loss, but the effect was transient, and after 8 weeks blood pressures were indistinguishable from those of the placebo group. E+C has no adverse effect on glucose and lipid metabolism, but has been shown to prevent the decline in HDL-cholesterol caused by weight loss. In a comparative trial the weight loss produced by E+C was similar to that of dexfenfluramine.
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Here's a multiple-choice question for you. If this stuff works well for obesity -- and it does work, at least as good as any FDA-approved prescription drug ever has in the last 30 years (I'm not counting the first half of the 1900s, when doctors prescribed DNP, which created hyperthermic death) -- and if obesity is becoming epidemic in the US (and it is) -- then what would be a good reason to ban the thing?
(A) it's so dangerous that it's an immediate public health hazard
(B) even though it's never been shown to be "dangerous" in the dozens of controlled studies when actual people took it and were monitored (for danger) -- it's still (somehow) in the public's interest to ban it
(C) in matters of the economy, more government control is better than less government control -- so if there are even merely 150 non-clinically-repeatable, not-able-to-show-as-"causal" "associations" (out of the several billions of servings sold here), then the government should step in and "protect us" from this proportionately-large danger; instead of focusing, say, over 99% of its resources and time on the FDA-approved drugs that are now killing well over 100,000 people per year
(D) the FDA and Big Pharma are in bed together -- merely protecting a monopoly on this huge, potential cash crop of American obesity
If you feel that the question is unfair, then just add an (E) answer -- of YOUR choice!
;-)
Ed
(Edited by Ed Thompson on 8/09, 8:59pm)
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