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Medical Herbalism
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A side point but is this required? I've been prescribed quite a few drugs off-licence and never had a pharmacist say anything to me about it..
It certainly should happen. I suppose that maybe the pharmacist was in the dispensary on the phone to the doc, and didn't feel the need to mention it to you the patient. TBH, I think that if we were to explain to each and every patient every time we clarified and/or corrected something with a phone call to the doc, the patients would start to lose confidence in them! Not intended as a criticism, just an observation.0 -
A side point but is this required? I've been prescribed quite a few drugs off-licence and never had a pharmacist say anything to me about it..
If it's a consultant in the field they often don't say anything, as it's often common practice. In the neonatal ICU, more than half the drugs we use are off license. But the pharmacists say nothing, as we're all aware that licensing for extreme premature neonates doesn't happen that often.
Same with psych, gastro (hepatic conditions) and renal, and I'm sure many others.0 -
A few links that may be of interest
The Irish Institute of Medical Herbalists (IIMH)
http://www.iimh.org
I know I shouldn't make assumptions but if their article page is anything to go by I don't hold much hope for the Herbal Science course in CIT, which was developed by the IIMH http://www.cit.ie/courses/courselisting/herbalsciencehonourscr330/
and an old post on herbal remedies on Ben Goldacre's bad science site
http://www.badscience.net/2007/10/543/#more-543
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Ugh, the poster who said that I apparently "Rolled up here" and announced "Herbz Rock".....
The thread wants us to express our opinion on Herbal Medicine. I expressed mine. Your replies are unhelpful and off topic. Stop trying to put people down. And if you're going to quote me , get it right.0 -
Several posters asked about the relevance of the post. Sorry about that. I posted too quickly.locum-motion wrote: »Not sure of the relevance of your post to this particular thread, but anyway:
This thread started with a question on Medical Herbalism. Then it moved to questions such as “As this is a scientific discussion board, why don't you post up some of those studies, and tell us why they're strong enough evidence to incorporate herbs into clinical practice”; “can you post citations for studies of St. John's wort mentioned above? And also some of the citations for the nettle studies? What journals publish such studies?”; Can you post some citations?” After that it went onto another area.
Obviously for many in the conventional science/medicine world studies/data/citations give great credibility to a treatment and the absence of same means a treatment has no credibility.
The point of Lustral is that it proved studies/clinical trials etc can get it wrong and can get it wrong with disastrous results. And its not just Lustral/SSRIs, there’s also Thalidomide, Vioxx and many others that failed on a smaller scale.
That’s it, that’s the point. Lustral was widely used on teenagers even though it was never tested for teenagers but our conventional system allowed that to happen. Yet our system frowns on traditional/ancient beliefs because we cannot prove them. When it may be just that we cannot prove them yet. Who knows?
You’re wrong there. The drug was banned for teenagers in the UK. The MHRA statement said doctors were not to prescribe. Where a patient was already on the drug they could continue to prescribe while weaning them off but only in that circumstance. In Ireland, the negative findings are noted but doctors are allowed to prescribe. The latest information is that teenagers on these SSRIs are more likely be suicidal and more likely to harm themselves.locum-motion wrote: »Your paragraph beginning "Although SSRIs..." applies equally to the UK.
So now, you have a situation where two different jurisdictions come to two different conclusions using the same data. I fail to see the science in that.
The clear implication is that without data/studies efficacy is not proven. So without data/studies that conventional medicine approves, Medical Herbalism does not work.locum-motion wrote: »No one has said here that "scientific studies and quality data" is/are perfect. In fact, every opinion expressed on that subject has been about looking for and being aware of the flaws. That querying attitude is a part of science, usually referred to as "peer review". But, imperfect as it is, it is better than anecdotal evidence which invites conclusions based on logical fallacy.
Just because we can’t prove it does not mean it does not work. It just means we can’t prove it.
Humankind developed because smart people did not take things for granted and pursued theories and investigation that were contrary to popular belief - sometimes at great cost to themselves. Lets not lose that questionning attitude.
If Herbalism does not work, can someone explain why western corporations have invested millions in Asian countries trying to identify and patent the active ingredients? In Brussels alone there have been 285 patents for medicinal plants well known in Indian medical systems, principally ayurveda, unani and siddha. Why are multinational companies spending millions of dollars to patent treatments that they claimed were ineffective?0 -
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This has all opened up a bit of a can of worms, so let's look at the bigger picture here.
Kieran is probably a very nice guy. But he represents a difficult issue. You have a guy who, with the best will in the world I'm sure, is advocating an approach to healthcare based on anecdote. Now, that's fine when you're basing your claims around cabbage or something. But it creates a precedent. What's the difference between the active ingredient in a herb and the active ingredient in a drug? So, should we now tell drug companies that they don't have to rigorously test their drugs? Should all interventions be based on personal opinion, when even expert opinion has traditionally been the lowest form of evidence in medicine.
Kieran is inexperienced, and doesn't understand how healthcare works in the context of clinical practice. Fair enough. Maybe we should have been friendlier to him. But I guess you have to understand where people are coming from. On the forum, we have practicing healthcare professionals. I don't need to tell any of you the effort we put in and the sacrifices we often have to make in delivering decent evidence based care to our patients. It's 7pm here, and I'm just home. I was supposed to finish at midday (a half day I booked 3 weeks ago). The majority of people who work in health make sacrifices like that on a regular basis, for their patients. So what? Well, this is where context comes into it. A guy who really has very little experience of health comes in and tells us that there's good evidence for use of "herbs", which is his right to do. It's like saying there's good evidence for the use of "medicines", but that's another issue.
He then tells us that the evidence is out there "On the internet" and that it's our responsibility to find it. Now, those of us who actually work in health know that's a crazy way to play the evidence game, and it gets a little exasperating after a while. Imagine at the end of a long shift in the hospital or practice, and the med student who works 9-4 comes over to you and gives you a few tips on how you could improve your practice, and then tells you to google the evidence underpinning his advice. I'm known as the local soft touch where I work, and I'd still lose it with him under those circumstances.
Then to top it off, you get the usual accusations about "power trips" etc.
But it's a simple issue at it's core. To change systems, you need to earn the respect of those around you. I'm sure Kieran couldn't care less about what we think of him. But he will have to impress the people who's practice he wants to change. So this might be a useful experience for him.
This forum is generally a welcoming place (I think!). But at the end of the day it's a scientific discussion board. You would be laughed out of UCD or Trinity's science department if you walked in and started telling them about "herbs", and insisted they check out the evidence on the internet. So, the ridicule of kieran is more to do with the forum being populated by people with a scientific bent, rather than being something intrinsic to the forum.
The reception would have been a LOT different if he'd posted something about a herb, linked us to a study, and then told us why the study was of good quality. the forum would be a lot richer for alternative practitioners who want to engage in scientific discussion. I've been a moderator here for almost 2 years, and in that time (to the best of my memory) we've never had a single piece of evidence posted and discussed by any of the many exponents of alternative medicine that we've had on here. I would welcome it. But I won't hold my breath.
In response to boardswalker, I'd much rather you started another thread about your issue, but we can address it here if you insist. You're getting regulatory bodies mixed up with researchers and doctors. I don't work in mental health, so maybe sam34 can shed some light on the particular issue at hand.
But regulatory bodies make assessments based on risk Vs benefit. In the UK, the regulatory bodies are much more powerful, as they pay for most medications. There are different rules about what I'm allowed prescribe here in oz, and what I was allowed prescribe in the UK, and under what circumstances I can prescribe them. That means the local health board has made a decision (based on the evidence). If they ban a drug, they may have decided that they are not willing to take the risks. Another health authority may recognise the potential benefits of a drug, and allow their doctors to prescribe it of they think the individual patient may benefit.
That doesn't mean the evidence doesn't exist. On the contrary. Medics are using the available evidence to inform these decisions.0 -
tallaght01 wrote: »I don't need to tell any of you the effort we put in and the sacrifices we often have to make in delivering decent evidence based care to our patients.
I agree totally with your point about evidence based health care. The point is that the SSRIs were never tested on teenagers. There never was evidence that they helped teenagers.tallaght01 wrote: »So, should we now tell drug companies that they don't have to rigorously test their drugs?
I think we should tell them that they should rigorously test their drugs. I think the standards that are being applied to complementary medicine should be applied to drugs companies.tallaght01 wrote: »It's like saying there's good evidence for the use of "medicines", but that's another issue.
I will just quote Dr. Harlan Krumholz, professor of medicine, epidemiology, and public health at Yale: "Science and the public good in a capitalist society depend on the free flow of unbiased information, but it doesn’t always work that way. Events are revealing that many pharmaceutical companies, along with their consulting academic physicians, have engaged in practices that obscure or misrepresent information about their products. Does the public realize the depth of these practices, and their implications for patient care? "tallaght01 wrote: »But at the end of the day it's a scientific discussion board
And the issue is the quality of some of the scientific research.tallaght01 wrote: »I would welcome it. But I won't hold my breath.
And I won't hold my breath waiting for someone to explain why drugs companies are spending millions investigatiing herbs that they want us to believe don't work.tallaght01 wrote: »You're getting regulatory bodies mixed up with researchers and doctors.
You're talking process and I'm looking at results. I have serious doubts about the research process.tallaght01 wrote: »That means the local health board has made a decision (based on the evidence).
What bothers me is that the evidence you cherish must be interpreted and any two individuals can interpret them differently. On the one hand, I am being asked to put my faith in the process and rigour of science and on the other its quite a subjective area.tallaght01 wrote: »That doesn't mean the evidence doesn't exist. On the contrary. Medics are using the available evidence to inform these decisions.
Are they really? Where was the evidence for the SSRIs. Read this from the New York Times in Sept 2004:
"Top officials of the FDA acknowledged for the first time on Monday that antidepressants appeared to lead some children and teenagers to become suicidal. Dr. Robert Temple, director of the FDA's office of medical policy, said ...that analyses of 15 clinical trials, some of which were hidden for years from the public by the drug companies that sponsored them, showed a consistent link with suicidal behavior."
So much for evidence.0 -
I'm genuinely at a loss to what point you want me to answer.
Do i distrust drug companies? Yes. Greatly. Just like many (most?) doctors.
Can two different bodies look at the same piece of evidence and use it in two different ways? Yes. For example....a drug has a 1 in 1000 chance of giving you kidney failure. One psychiatrist and his patient might think that a reasonable risk for a debilitating mental illness, and it gets prescribed. Another patient might not want to take that chance, or their psychiatrist may not want to take the chance.
But their decisions are informed by data.
You won't find many people here claiming:
1) drug companies are particularly trustworthy
2) research is perfect
3) drugs don't sometimes have nasty side effects.
But that's not a reason to abandon the research process. It works well. Medicine as a discipline is highly successful. Drug companies don't do the bulk of medical research.
As for your point about drug companies and herbs. They invest a lot of money into a lot of compounds. many of these are plant based. This in no way follows that "herbs" are useful in any kind of generalisable way. That just makes no sense.
But, so we can stop debating very general vacuous points, why don't you post some papers that you're specifically referring to, describe the evidence and your concerns, and we can discuss it. You'll find medic types like nothing more than picking apart flawed evidence.0 -
tallaght01 wrote: »You'll find medic types like nothing more than picking apart flawed evidence.
or talking about good, robust evidence to support a treatment0 -
That's true, mystik. The most recent meta analysis of lustral in the adolescent population I could find showed a positive risk:benefit profile in 2006.
But when boardswalker posts his/her papers we can have a look at them, as my journal access at home sometimes gives me a dodgy search function, so there might be something more recent.0 -
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Back to basics. When talking about herbs - the original poster was asked several times about his evidence. And now you are asking me for evidence. You obviously think this evidence is all important.
The point is that the evidence is not always reliable. And you have admitted that.
Another poster said "Unfortunately many practitioners of herbal medicine (and I am aware that herbal medicine is not the same thing as either homoeopathy or any other of the so-called alternative therapies) take a less than rigourously scientific approach to their work."
That sentence could equally well be applied to conventional medicine.
Here's another quote from Dr. Harlan Krumholz, professor of medicine, epidemiology, and public health at Yale.
"However, when I worked as an expert in litigation related to Vioxx, an anti-inflammatory drug marketed by Merck, I was surprised to discover that many of the manuscripts on Vioxx were prepared and written by Merck or medical writing companies that Merck had commissioned. The company then often paid academics to become authors, placing their names at the head of scientific studies that were already planned, performed, interpreted, and drafted by the company. Some of these articles had well known authors, and their impact was substantial. The authors’ lack of involvement was not revealed, and, in some cases, the involvement of the company was not even mentioned."
What does this mean about the whole scientific process and for peer-review?
You ask for specific examples so you can pull apart flawed evidence.
I have given you Lustral and the SSRIs. Are you waiting for one thats easy to pull apart?
I also gave you quotes from an eminent academic that stated that drug companies and academics have suppressed evidence that did not suit. Surely this is a less than rigorous scientific approach.
You see, you want me to give you papers. I giving you information that shows that your papers can be and have been flawed with disastrous consequences for patients.
Lets get real about the value or reliability of scientific evidence. Knocking complementary medicine and putting conventional medicine on a pedastal on the basis of flawed evidence and a flawed scientic approach is foolish.0 -
So no actual evidence. Ah well. And the cycle continues :P
Tea, anyone?
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tallaght01 wrote: »So no actual evidence. Ah well. And the cycle continues :P
Tea, anyone?
we could be here a while... so lets make it an irish coffee.
i'll bring the whiskey if you bring the cream :pac:0 -
I can even arrange for herbal tea :P
I'll bite. I know I shouldn't. But the bizarreness of the argument intrigues me.
We have this guy, who gets wheeled out and basically says "Yea, drug companies are not reliable. They punt out bogey data, and they hide other data".
So that's fine. We're all on the same page as that guy, and I certainly interpret that as a call for the drug companies to open up all of their data for peer review.
So, that's what we're asking of the herbal lobby.
But, in a 24-esque twist, that same logic is being used to argue that the "evidence process" is flawed. I don't get this.
It's analogous to telling the police that some cops in donegal dicked around with some evidence before, so now the concept of evidence in a criminal trial is flawed, and now no-one should need to produce evidence for a jury to make up their mind.0 -
tallaght01 wrote: »I certainly interpret that as a call for the drug companies to open up all of their data for peer review..
Peer Review did not work. How much evidence do you need?
I know you don't want to see it - but peer review failed in many cases.tallaght01 wrote: »It's analogous to telling the police that some cops in donegal dicked around with some evidence before, so now the concept of evidence in a criminal trial is flawed, and now no-one should need to produce evidence for a jury to make up their mind.
I think the analogy would be better if you said a whole of cops rather than some. And as regards science and studies/peer review - who guards the guards?
You keep telling me that conventional medicine is better because of studies, peer review. But the evidence is that that studies and peer review failed in many cases - SSRIs, Vioxx etc.
And the reason you won't find it in studies is because the studies with the unfavourable results were suppressed. It won't appear in the journals.0 -
boardswalker wrote: »Peer Review did not work. How much evidence do you need?
I know you don't want to see it - but peer review failed in many cases
Have you heard of a better system? Peer review is flawed and for more reasons than you've listed but I've yet to see a better refereeing system proposed to be honest. No one with any scientific experience takes a peer reviewed paper as gospel truth, it's just passed *a* test, a tough one and one that weeds out the worst of the crap but not a perfect one.0 -
Having followed this thread and some similar threads, I can only conclude that the standards of proof applied to Pharmaceutical Drugs are much less stringent that what is applied to complementary treatments.
The key points that I have picked up are :-
(i) Herbs have been used for medicinal purpose in many cultures across the world for thousands of years.
(ii) For herbs to be accepted for use in modern clinical medicine their use must be backed up by academic papers documenting the rigorous scientific studies, subject to peer review, which proved that the herb is effective and safe for specific medicinal use. In other words they must pass the same stringent tests that modern medical treatments must pass.
“If you want those of us in the established order of things to take you and your practices seriously, then your (sic) going to have to provide evidence and back up said evidence, like we have to. None of us here can go round saying mad stuff, we can't even do things that we think we'd like to, unless we can show a rationale and some investigation.”
(iii) Not many people on this forum believe that
1) drug companies are particularly trustworthy
2) research is perfect
3) drugs don't sometimes have nasty side effects.
In fact, it has been accepted on this forum that Peer Review is flawed, and for more reasons than I’ve listed, but the counter-argument is that scientists have yet to see a better refereeing system proposed.
No-one has disputed that many medicines were licenced on the basis of incomplete data
I learned that Medical Practitioners are allowed to do off-licence prescribing. So-called "off label"or off-licence or unlicensed prescribing refers to the use of medicines outside of the indications for which they are licensed by national regulatory bodies. Off label prescribing is quite common in children, as most drugs are developed only on the basis of trials with adults.
From the Pharmaceutical Journal Vol 267
“Many psychiatrists see the use of drugs for indications outside those specified in their product license, or at doses which exceed the maximum recommended, as a necessary part of clinical practice. A recent study found that 65% of psychiatrists admitted to prescribing off-licence in the preceeding month. This practice, which has been prescribed as a necessary part of medicine, has implications for practice particularly regarding legal accountability and consent for treatment.”
Given the importance of studies/papers etc it is most surprising to see that Medical Practitioners are allowed off-license prescribing – essentially no, or insufficient evidence, exists to support the effectiveness of these drugs for the patient group and/or the presenting illness.
What this shows is that the tough standards are not applied consistently.
Elsewhere I discovered just how much large drugs companies distort data to hide unfavourable results.
I refer to an article in the New England Journal of Medicine titled “Lessons from Vioxx” (http://content.nejm.org/cgi/content/full/352/25/2576) . (In Nov 07, Merck offered € 4.85bn to settle all claims against them arising from use of their product Vioxx)
This article was written by someone who served on a US government committee investigating why unsafe drugs could remain popular for so long.
I could use many quotes from the article – how the drugs company distorts data, how it ignored FDA recommendations – but the one I think is most relevant to this thread is this – within Merck “Approved scientific studies were defined as those that provide "solid evidence as to why [doctors] should prescribe Merck products for their appropriate patients." By contrast, those studies that raised safety questions about drugs were considered background studies. Distributing the results of a background study was "a clear violation of Company Policy."
Most disturbingly, the writer concludes by saying “The testimony we heard indicated that Merck's marketing practices may be less aggressive and more ethical than those of many of its competitors. What is needed is a broad assessment of the ways in which all new drugs are promoted and prescribed in the United States.”
Meanwhile, going back to the unproven herbal treatments, it was reported earlier this year in the Guardian newspaper, that Indian officials, after trawling through the records of the global trademark offices, found 5,000 patents had been issued to multinational companies — at a cost of at least $150m (£104m) — for "medical plants and traditional systems". Yet the science and pharmaceutical industry lobbies strenuously to convince the public that these treatments do not work.
So, the bottom line is, double standards apply regarding the licensing and use of herbal or other complementary treatments and the licensing of treatments from conventional drug companies.0 -
boardswalker wrote: »Having followed this thread and some similar threads, I can only conclude that the standards of proof applied to Pharmaceutical Drugs are much less stringent that what is applied to complementary treatments.
Fair play to you for your extensive reading and your long post, however, I'm going to disagree with you on the above comment.
I think we're all in agreement that the current system isn't perfect, and the Vioxx example you've shown is just that, an example of the system falling down. Nevertheless, when the problems with Vioxx became apparent, it was swiftly withdrawn. Yes harm was done, but steps were taken to prevent further harm.
But yet you claim above that more stringent standards of proof are required of CAM (Complementary and Alternative Medicine). Not true. Medical and Pharmaceutical professionals just want CAM therapists to try to adhere to the same standards we have. Sure, the system isn't perfect, but it's the best one we've got. Just because it's imperfect doesn't mean that it's invalid and it does not give the CAM industry the right to just ignore it.
I'll leave you with this:
"A judgement about the quality of evidence can be informed by grading it along the lines of the list below:
1. Systematic review of multiple well-designed, randomised controlled trials (RCT)
2. At least one RCT
3. At least one well-designed intervention
4. At least one well designed observational study
5. Expert opinion, including users and carers*
As you see, the positive testimonials that usually constitute the only evidence offered by alternative practitioners (aka 'sucess stories') simply do not figure. Such accounts represent the poorest kind of evidence... There is no way to ascertain the veracity of testimonials and certainly no way of hearing from those for whom the treatment has failed."
The source for the above is Suckers - How Alternative Medicine Makes Fools of Us All, Rose Shapiro, Vintage Books, 2009. That book in turn quotes its source for the first part of the quote (as far as the *). It is National Service framework for Mental Health: Modern Standards and Service Models, UK Department of Health, 1999.
Thanks for reading.
L-M.0 -
Thanks for your reply.locum-motion wrote: »Nevertheless, when the problems with Vioxx became apparent, it was swiftly withdrawn. Yes harm was done, but steps were taken to prevent further harm."
Vioxx was introduced in 1999 and withdrawn in 2004. It was on the market doing damage for 5 years.
"After only 18 months on the U.S. market, clinical trial data on the adverse cardiac effects of rofecoxib began to appear in the medical literature.
In November 2000, the results of the VIGOR (Vioxx Gastrointestinal Outcomes Research)13 study were published, reporting a 0.4% incidence of heart attack in rofecoxib users (50 mg per day) versus 0.1% for naproxen users (1,000 mg per day), a rate 4 times higher for rofecoxib (absolute
risk difference = 0.3%, number needed to harm = 333).
The VIGOR study involved 8,076 patients who were at least 50 years of age (or at least 40 years of age and on long-term steroid therapy) and followed for an average of 9 months; concurrent aspirin use was not allowed in the VIGOR study."
http://www.amcp.org/data/jmcp/Editorial-551-554.pdf
I don't think the response was speedy at all.
During the monthly status conference with the federal judge in New Orleans coordinating most of the massive Vioxx litigation, Orran Greer of claims administrator BrownGreer PLC said 49,954 eligible claimants have now registered for a settlement.
Are you really satisfied with that?locum-motion wrote: »But yet you claim above that more stringent standards of proof are required of CAM (Complementary and Alternative Medicine). Not true. Medical and Pharmaceutical professionals just want CAM therapists to try to adhere to the same standards we have. Sure, the system isn't perfect, but it's the best one we've got. Just because it's imperfect doesn't mean that it's invalid and it does not give the CAM industry the right to just ignore it.
You have not dealt with off-license prescribing.
What standards apply to off-license prescribing. I would be happy for CAM therepists to have to comply with those!
I'll leave you with some reading:
Book: What Doctors Don't Tell You:: The Truth about the Dangers of Modern Medicine (Mass Market Paperback)
by Lynne McTaggart (Author)
On the market since 1999 and not withdrawn yet.
Secondly,
Report of the Quality Interagency Coordination Task Force (QuIC) to the President, February 2000
Doing What Counts for Patient Safety:
Federal Actions to Reduce Medical Errors and Their Impact
http://www.quic.gov/report/
From the executive summary,
"It is clear that, although the United States provides some of the best health care in the world, the numbers of errors in health care are at unacceptably high levels. The Institute of Medicine’s report estimates that more than half of the adverse medical events occurring each year are due to preventable medical errors, causing the death of tens of thousands. The cost associated with these errors in lost income, disability, and health care costs is as much as $29 billion annually. The consequences of medical mistakes are often more severe than the consequences of mistakes in other industries—leading to death or disability rather than inconvenience on the part of consumers—underscoring the need for aggressive action in this area.
A wide body of research, including many studies funded by AHRQ, supports the IOM conclusions. The two seminal studies on medical error (Brennan, 1991; Thomas, 1999) have shown that adverse events occur to approximately 3–4 percent of patients. In another study (Leape, 1994), the average intensive care unit (ICU) patient experienced almost two errors per day. This translates to a level of proficiency of approximately 99 percent. One out of five of these errors were potentially serious or fatal. If performance levels of 99.9 percent—substantially better than those found in the ICU—applied to the airline and banking industries, it would equate to two dangerous landings per day at O'Hare International Airport and 32,000 checks deducted from the wrong account per hour (Leape, 1994).
Many of these adverse events are associated with the use of pharmaceuticals, and are potentially preventable. The IOM estimates the number of lives lost to preventable medication errors alone represents over 7,000 deaths annually—more than the number of Americans injured in the workplace each year. In addition, preventable medication errors are estimated to increase hospital costs by about $2 billion nationwide. A 1995 study estimated that problems related to the use of pharmaceutical drugs account for nearly 10 percent of all hospital admissions, and significantly contribute to increased morbidity and mortality in the United States (Bates, 1995). A 1991 study of hospitals in New York State indicated that drug complications represent 19 percent of all adverse events, and that 45 percent of these adverse events were caused by medical errors. In this study, 30 percent of the individuals with drug-related injuries died (Leape, 1991)."
What were you saying about the quality of evidence?
Thanks for reading.0 -
boardswalker wrote: »Many of these adverse events are associated with the use of pharmaceuticals
What were you saying about the quality of evidence?
Thanks for reading.
Would this be due more so to human error in the prescription of drugs and not the drugs themselves?
Medicine, dug research and prescription and the method of peer review are all far from perfect. No one disputes this and I’m quite sure healthcare professionals could list off many more problems in the delivery of healthcare to people but just because they are flawed does not remove the obligation of alternative medicine proponents to provide evidence supporting their claims of efficacy for their treatments.0 -
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boardswalker wrote: »Book: What Doctors Don't Tell You:: The Truth about the Dangers of Modern Medicine (Mass Market Paperback)
by Lynne McTaggart (Author)
On the market since 1999 and not withdrawn yet.
As a side point that woman has made claims about quantum mechanics that are basically bull**** and show a complete lack of understanding of quantum mechanics (in her "Living the Field" work). She is most certainly not someone who I'd trust for a scientifically informed view on anything. There are plenty of scientific criticisms of modern medicine without bringing people like her into it. Her book isn't withdrawn because there's always a market for anti-establishment work.0 -
I think I'll be a long time waiting for someone to explain to me how off-license prescribing is more proven than traditional herbal medicine. It doesn't look like anyone is prepared to take up that challenge.
I think you need to understand that the difference in treatment of herbal medicine and pharmaceuticals is not driven by patient safety, rather by profit issues.
Here's a comforting table to read.
http://www.consumerjusticegroup.com/drugrecall/drugrecalls.html
And how about this
The Federal Court of Australia has heard (in April 2009) that Merck & Co "prepared and gathered" doctors and academics to write the company's own research on Vioxx, which was then published in prestigious medical journals as independent studies.
The drug company also allegedly produced an entire journal -- called The Australasian Journal of Bone and Joint Medicine -- and passed it off as an independent peer review publication. These claims were put by lawyers acting for Graeme Peterson, who is suing Merck & Co and its Australian subsidiary Merck, Sharpe and Dohme for compensation.
Would you buy a used car off these guys?0 -
boardswalker wrote: »I think I'll be a long time waiting for someone to explain to me how off-license prescribing is more proven than traditional herbal medicine. It doesn't look like anyone is prepared to take up that challenge.
Ok, I'll give it a shot. First of all, the products themselves are licensed drugs, which means they're proven for safety and efficacy (your Vioxx example notwithstanding). So we know what's in them and that they're of acceptable quality. The person that signs off each batch of medicine is personally liable under criminal law should defective medicines cause any harm after release (how's that for an incentive to do your job properly?). The pharmacy that sources these drugs also have a legal and ethical obligation to ensure the medicines they supply are of acceptable quality, so by extension the prescriber can be satisfied that the product itself is fit for purpose. Can any CAM therapists say the same about their herbal medications?
Secondly, off-license prescribing is certainly not ideal, but in many cases it's the only option available. Good clinical practice dictates that a prescriber should always preferentially use a licensed product within it's licensed indications. However, in certain instances it is necessary to step outside these boundaries to act in the best interests of the patient. A prescriber understands this and accepts responsibility should an adverse event occur as a result of this. Now, let's turn that around: Have you considered the potential legal and professional implications of a prescriber choosing not to treat a patient because the unlicensed use/dose of a drug was their only option? I'll save you the effort - there would be a lot of dead patients and a lot of physicians guilty of negligence and malpractice. I deal with and advise about off-license prescribing on a daily (and sometimes hourly) basis. Say someone comes back from surgery and has no oral access but they need their usual antiepileptic tablets. Well, we could try to give him a licensed injectable version but maybe his IV access is rubbish, or maybe all his lines are being used for other drugs (very likely if they're in critical care). The only option left might be to crush up his tablets, mix it with something and put it down his feeding tube. Now that's a completely unlicensed use, formulation and route of administration of that drug. But it's the best solution available. We also have very reliable resources, best practice guidelines and hugely experienced colleagues to help make these informed decisions. And again I ask, can any CAM therapists say the same about their use of herbal medications?boardswalker wrote: »And how about this
The Federal Court of Australia has heard (in April 2009) that Merck & Co "prepared and gathered" doctors and academics to write the company's own research on Vioxx, which was then published in prestigious medical journals as independent studies.
The drug company also allegedly produced an entire journal -- called The Australasian Journal of Bone and Joint Medicine -- and passed it off as an independent peer review publication. These claims were put by lawyers acting for Graeme Peterson, who is suing Merck & Co and its Australian subsidiary Merck, Sharpe and Dohme for compensation.
Would you buy a used car off these guys?
Maybe I'm mistaken, but from what I can see nobody here is defending Merck's behaviour during the Vioxx controversy. I agree completely, their actions were abhorrent. In fact you'll find lots of bogey practices throughout the pharmaceutical industry, ranging from the unethical to the downright illegal. Nobody involved in conventional medicine is under any illusion that the primary objective of these companies is to make money, and that their primary obligations are to their shareholders and not the end user of their products. But for the most part, the regulatory processes involved keep them in check. We agree that it's not perfect and is not without flaws, but I'm struggling to figure out what you think may be a better system, or what standards you think CAM therapies should adhere to?0 -
In case nobody has noticed, Donal MacMathuna (?) writes a column in the Irish Times Health Supplement every Tues were he examines the evidence for various alternative or herbal remedy. He's a pharmacist or pharmacologist lecturing in DCU.0
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Ok, I'll give it a shot. First of all, the products themselves are licensed drugs, which means they're proven for safety and efficacy (your Vioxx example notwithstanding)........so by extension the prescriber can be satisfied that the product itself is fit for purpose.
That is simply wrong.
From the MHRA website http://www.mhra.gov.uk/home/groups/pl-p/documents/drugsafetymessage/con019472.pdf
"The safety of SSRIs has been under continual review by the MHRA since the products were first marketed. Two areas of public concern and scientific debate have been the issues of withdrawal reactions on stopping SSRIs and whether there is an increased risk of suicidal behaviour associated with treatment with SSRIs.
Based on the work of the Group, CSM ( UK Committee on Safety Medicines) issued advice on the use of SSRIs in the paediatric population in June, September and December 2003. In summary, that advice was that the
balance of risks and benefits for the treatment of depressive illness in under-18s is judged to be unfavourable for paroxetine (Seroxat), venlafaxine (Efexor), sertraline (Lustral), citalopram (Cipramil), escitalopram (Cipralex) and mirtazapine (Zispin). It is not possible to assess the balance of risks and benefits for fluvoxamine (Faverin) due to the absence of paediatric clinical trial data. Only fluoxetine (Prozac) has been shown in
clinical trials to be effective in treating depressive illness in children and adolescents, although it is possible that, in common with the other SSRIs, it is associated with a small increased risk of self-harm and suicidal thoughts."
So here was a class of drugs that were licensed, which according to you were proven for safety and efficacy and by your logic the prescriber could be satisfied that the products were fit for purpose. But they were not safe for adolescents nor are they fit for the treatment of depression in adolescents.
A key statement in one of the MHRAs statements is this "Paediatric Safety and efficacy cannot be extrapolated from experience in adults." from MHRA's Current Problems in Pharmacovigilance Sept 2003.
Your argument is completely wrong and dangerous.
It is scary that someone who can state
does not understand that licensing a product for use with a certain population and with certain indications does not necessarily mean that that product is safe for use with a different population and for different indications.I deal with and advise about off-license prescribing on a daily (and sometimes hourly) basis.0 -
I really didn't want to get dragged back into this, as it just gives me a headache. But i'd agree with somedose, who has put it very succinctly.
All i would add is that boardswalker is getting mixed up between evidence processes and regulatory processes, and seems to be using them interchangeably.
Here in Oz a drug can be approved by the TGA. Now, many drugs that have a good evidence base are not "licensed" by the TGA. The reasons for this are many. But a common one is that the trials have been done in a different country. So, say, a hepatitis A vaccine tested in Thailand may not be licensed in Australia because it's been tested in another country.
But the physician has the right to prescribe an unlicensed drug. It just has to be paid for privately, and the doc has to take full responsibility if things go wrong.
Lack of licensing does NOT mean a drug is unsafe.
The MHRA probably stuck their necks out too far when telling UK docs they can't prescribe SSRIs in kids, as that's not really there role, to the best of my knowledge. I don't think they can tell a doc what they can or can nor prescribe privately.
I prescribe many drugs in the neonatal intensive care setting that are unlicensed, but that have trials done on them.
Caffeine is probably the most common unlicensed drug given in the NICU. Prevents some of the babies from stopping breathing, and reduces rates of cerebral palsy in very low weight babies. Pretty good rationale for using it, backed up by good quality data in the NEJM.
Boardwalker is obsessed about proving that licensing does not equate to safety. That is very true. Licensing equates to a willingnes by the drug company spend a hell of a lot of money getting a drug licensed, which may include running another huge trial in that country. If it's a drug that won't be used that often, and the Oz government want them to run a new RCT, then they won't do it.
There is no point continually harping on about this.
Safety and efficacy are judged by RCTs. They work. They're not perfect. You may have a massive trial with 70,000 people enrolled, and not pick up a 1 in a million fatal side effect. this is why you have active and passive side effect surveillance for several years after a drug is licensed.
THIS is how safety problems are picked up. Doctors and pharmacists scrutinise RCTs and eta-analyses. Then we scrutinise safety data after licensing.
That's as good as it gets. It's the best balance between safety and speedy approval that you'll get. it beats the socks off the anecdote that's advocated by the alternative medicine industry.0 -
boardswalker wrote: »Your argument is completely wrong and dangerous.
It is scary that someone who....can state does not understand that licensing a product for use with a certain population and with certain indications does not necessarily mean that that product is safe for use with a different population and for different indications.
I understand the difference perfectly well, thanks very much, it's a fairly important part of my job after all. But hey, I appreciate the professional pointer. Maybe I didn't explain my point too clearly. You've previously questioned what the standards are in relation to unlicensed medicines and how their use is more proven than use of herbal medicines. I, and other posters, have given you an overview of how clinicians and other professionals can make informed decisions in such scenarios. When a drug is used outside it's licensed indications, we know that it's still a quality product that has been produced under strictly regulated conditions. And we can use evidence-based studies, local guidelines, approved resource texts and expert opinion to guide us on its use. Now tell me, please, how the use of herbal medications can compare to this and how CAM therapists would comply with such practices?
You've pointed out a couple of scenarios where the current dogma of evidence-based medicine and licensing has failed, and you're absolutely right. No drug is without risk. We know the system isn't perfect, but it's as robust as can be reasonably expected. You've shot down the current system on the evidence of a handful of high-profile failures, but seem to ignore every single other case (i.e. the non-failures). Does this not suggest that the system works quite well?
And don't forget that a cornerstone of any true scienctific discipline is the willingness to change thinking or practice based on evidence and outcomes i.e. we learn from mistakes (and successes). Look at thalidomide for example. This was almost single-handedly responsible for the rigorous safety testing that's now mandatory for all medicinal products. It was a tragedy, but who would argue that by paradox it was probably the most important event in terms of medicines safety. You've pointed to a list of FDA drug recalls...well, what does that tell you? Post-marketing surveillance throws things up that could never be predicted from pre-licensing trials, and when it does it gets acted on.
What more do you expect? What's the alternative? And more importantly, what do you think is an acceptable standard of safety and effectiveness for CAM medications to be judged against?0 -
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This thread is suffering a relapse just now. I was busy and unable to post over the past few weeks. However there are a few arguments being made against my criticism of the dodgy evidence for conventional medicine, that I need to respond to.
I’m not that sure that I am getting mixed up at all. Rather I am asking how reliable the evidence put forward actually is. And there’s plenty of reason to think that it’s not as reliable as you would like me to believe.tallaght01 wrote: »All i would add is that boardswalker is getting mixed up between evidence processes and regulatory processes, and seems to be using them interchangeably. .
Evidence-based processes, which usually build upon explicit, statistically based criteria, are subject to the important qualification that someone had to have conducted a convincing study. Because monopoly rewards are often the driver for research funding, evidence standards tend to favor monopoly products over other approaches to improving health outcomes, such as a new use for a generic drug, a better diagnostic strategy, or use of traditional remedies.tallaght01 wrote: »Now, many drugs that have a good evidence base are not "licensed" by the TGA.…..But the physician has the right to prescribe an unlicensed drug. It just has to be paid for privately, and the doc has to take full responsibility if things go wrong.
The question arises as to what evidence the physician has to support the use of the “unlicensed” drug.And we can use evidence-based studies, local guidelines, approved resource texts and expert opinion to guide us on its use. .
As far as I can determine, the bulk of the research is done by drugs companies. And we have already agreed that we can “find lots of bogey practices throughout the pharmaceutical industry, ranging from the unethical to the downright illegal. Nobody involved in conventional medicine is under any illusion that the primary objective of these companies is to make money, and that their primary obligations are to their shareholders and not the end user of their products” So what evidence/data can physicians rely on? Can a busy physician, so busy that he can’t take off his planned Wednesday afternoon, really keep up with all the research and study needed to remain on top of developments?
"Obviously doctors are very busy people, and their day is packed with patients. The question is how do doctors get information about medicines and new research into treatments and disease, and one of the easiest ways is this kind of presentation [”dine and dash”]. We think this is a benefit to both physicians and patients.” Mary Ann Rhyne, GlaxoSmithKline spokesperson, 11/11/2002
And what about the conflict of interest issues?
On October 3 last, the NY Times reported that “One of the nation’s most influential psychiatrists earned more than $2.8 million in consulting arrangements with drug makers from 2000 to 2007, failed to report at least $1.2 million of that income to his university and violated federal research rules, according to documents provided to Congressional investigators.
The psychiatrist, Dr. Charles B. Nemeroff of Emory University, is the most prominent figure to date in a series of disclosures that is shaking the world of academic medicine and seems likely to force broad changes in the relationships between doctors and drug makers. “
Earlier in 2007, The same newpaper reported that “According to the most recent data available from the national organization in charge of accrediting the courses, drug-industry financing of continuing medical education has nearly quadrupled since 1998, from $302 million to $1.12 billion. Half of all continuing medical education courses in the United States are now paid for by drug companies, up from a third a decade ago. Because pharmaceutical companies now set much of the agenda for what doctors learn about drugs, crucial information about potential drug dangers is played down, to the detriment of patient care.”
Similar concerns have been expressed in Australia. A recent article in the BMJ told that “In the case of one popular Australian provider of medical education, HealthEd, leaked documents and emails from a range of sources show drug company sponsors having input into the selection of some speakers at seminars held in recent years, despite the fact that these have been aggressively sold to general practitioners in brochures claiming that ‘all content is independent of industry influence.’”
I am sure our Australian Readers know this already.
But who did the trials? If the FDA cannot adequately supervise the trials process and post-marketing safety what makes you think that individual physicians can get better comfort?tallaght01 wrote: »I prescribe many drugs in the neonatal intensive care setting that are unlicensed, but that have trials done on them.tallaght01 wrote: »Lack of licensing does NOT mean a drug is unsafe. .
So what does licensing mean? Why should we bother?tallaght01 wrote: »Boardwalker is obsessed about proving that licensing does not equate to safety. That is very true.
Interesting. According to the MHRA “We enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks.”tallaght01 wrote: »The MHRA probably stuck their necks out too far when telling UK docs they can't prescribe SSRIs in kids, as that's not really there role, to the best of my knowledge. I don't think they can tell a doc what they can or can nor prescribe privately. .
Trial Results are sent to the MHRA for assessment. The assessment team is made up of experts from different relevant specialties, each of whom has undergone additional training in medicinesassessment.
Are you really telling me that individual physicians working long hours without specializing training or resources can do a better job than the MHRA assessment team or the FDA assessment team.
Sorry, I don’t think that’s credible.
Early concerns about vioxx and Avandia, among others, were ignored or suppressed.tallaght01 wrote: »THIS is how safety problems are picked up. Doctors and pharmacists scrutinise RCTs and eta-analyses. Then we scrutinise safety data after licensing. .
During the Vioxx litigation, lawyers showed a January 2001 letter from Stanford Medical School professor Dr. James Fries to former Merck CEO Ray Gilmartin complaining that Merck researcher Louis Sherwood had called him to try to get him to make another professor stop saying negative things about Vioxx in lectures. Sherwood warned that if the professor didn't stop bashing Vioxx, he would 'flame out' and 'there would be consequences for myself and Stanford,' Fries wrote." [The Houston Chronicle, 7/19/05] It took three years from the raising of the concerns before the drug was withdrawn.
More recently, in connection with the diabetes drug Avandia, warnings were being ignored. From the NY Times, “A leading diabetes doctor sent the Food and Drug Administration a letter seven years ago that warned of the heart risks of the drug Avandia. And in the next year, the F.D.A. reprimanded the drug’s maker for playing down safety concerns, according to documents from 2000 and 2001.” It took until 2007 before a Black Box warning was put on the drug.
The problem is that, when concerns are raised, they are not responded to quickly enough.
Today, CAM is becoming more popular in the United States.tallaght01 wrote: »(Licensing) beats the socks off the anecdote that's advocated by the alternative medicine industry.
A 1998 article by Dr. Eisenberg in the Journal of the American Medical Association reported that almost half of U.S. adults used some form of alternative medicine. In fact, more visits are made to alternative medicine providers than to all U.S. primary care physicians put together. Fifteen million adults who took prescription medications in 1997 were also taking herbal and vitamin supplements (a type of CAM). People paid an estimated $27 billion for alternative treatments that year, which is comparable to what was spent on U.S. physician services in 1997.
Can you show me a Thalidomide or a Vioxx equivalent in CAM? We can hide behind science and statistics but thousands of years of use tell their own story.
What does PI for a GP Cost? Why is the PI for conventional medicine practitioners so dear if it’s so much safer?
Just to be clear - they were not my words, rather the words of the MHRA's Report on Current Problems in Pharmacovigilance Sept 2003. But hey, I know my place.I understand the difference perfectly well, thanks very much, it's a fairly important part of my job after all. But hey, I appreciate the professional pointer.
I think I’ve answered that above.When a drug is used outside it's licensed indications, we know that it's still a quality product that has been produced under strictly regulated conditions. And we can use evidence-based studies, local guidelines, approved resource texts and expert opinion to guide us on its use.
Two things.Look at thalidomide for example……but who would argue that by paradox it was probably the most important event in terms of medicines safety. ……. Post-marketing surveillance throws things up that could never be predicted from pre-licensing trials, and when it does it gets acted on.
Firstly, the thalidomide argument might have merit if the current situation supported the theory that we had in fact learned something.
New drugs continue to be heavily marketed to physicians (and in some countries to directly to patients) before they have an established safety profile. Despite the lack of evidence, alleged safety benefits of medicines are used to boost such sales and have been a factor in a number of drug withdrawals since thalidomide.
Secondly, as Vioxx and Avandia show, when post-marketing surveillance throws things up that could never be predicted from pre-licensing trials, it takes a long time to get acted on.
I’ll finish with some interesting and relevant quotes.
From Dr. Mehmet Oz, Professor of Cardiac Surgery at Columbia University: “Half of what we will teach you in Medical School, will, by the time you are done practicing, be proved wrong” and secondly “What we do now is such a terrible shotgun approach. At least 20% of the medications we give are probably not the right medications for you or the right doses.”
Finally, "The vast majority of drugs, more than 90 per cent, only work in 30 or 50 per cent of the people, I wouldn’t say that most drugs don’t work. I would say that most drugs work in 30 to 50 per cent of people. Drugs out there on the market work, but they don’t work in everybody".
Dr. Allen Roses , GlaxoSmithKline Senior V.P., Genetics Research, 12/8/2003
And you guys are worried about medical herbalism?0 -
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Well, full marks for persistance with this one!
Look, this hasn't really moved on from numerous previous posts. We know the current system isn't perfect. There have been some high-profile examples of this. It has happened before and it will surely happen again. Now, what about all the other thousands of approved drugs that have been used safely and succesfully? What does that say to you about the current system? That it works in the vast majority of cases...or that it's all coincidence?
And you still have yet to provide us with an alternative method of approval for drugs, or indeed a method of approval you think is valid for CAM products.0
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