The politics of science

Dr Galen

boardswalker wrote: »

Have you watched the video clip I referenced? Dr Beatrice Golomb makes the case very well.

Are you aware that this is being discussed around the world as an area of concern?

I have done as much as I can here. "You can bring a horse to water, but you can't make him drink".

Watch the video and then discuss the issues raised, please.

I have watched it and am well aware of the debate.

Glib comments and such aren't gonna be welcomed by me in fairness, especially when I'm trying to tease out the issues you have, in order to stimulate debate and find common ground.

I asked you to verify what I think your saying. Giving you the opportunity to clear things up for me, so that I can engage properly with you. I have no want at this stage to talk about what said video Dr lady says. It was a simple enough request mate and made in good faith.

Kurtosis

Oh my, you have been busy. I will reiterate the point I made earlier, that other posters have also made: to think pharma companies are completely altruistic in their activities is highly naive, first and foremost they are a business. A regulatory framework (which is not perfect) exists look out for consumers' health interests.

boardswalker wrote: »

Dr. Eric Topol, chief of cardiovascular medicine at the Cleveland Clinic, was Merck's first and most persistent critic. In 2001, he conducted a statistical analysis of all the available data about Vioxx. His study was published in the Journal of the American Medical Association.

What did his study — which came out after the VIGOR study — find?

"That study, which looked at all the data available for both the medicines of these COX-2 inhibitors and all other medicines, including aspirin, that were available, showed a very substantial worrying risk of heart attacks and strokes — across the board — from the VIGOR trial and about Vioxx," says Topol.

Topol examined data from a 1998 Merck clinical trial called Study "090", which was never published. Among 978 patients studied, serious cardiovascular events, including heart attack and stroke — were found about six times more often in patients taking Vioxx than in patients taking another arthritis drug or a placebo.

Thank you for the copy and paste job. As the author of the 60 minutes article goes on to say, "Merck says that study was too small and not statistically significant enough to be able to draw any conclusions. But Topol maintains that, combined with the VIGOR trial, it showed that by the year 2000, there was solid evidence that Vioxx was not safe. Merck says Topol's methodology was flawed and disputed his findings." So pooled data after VIGOR showed the CV risks, not before.

Should Merck have acted sooner to either restrict the use of or withdraw Vioxx? It seems so. Although I'm more familiar with our own current licensing system here as opposed to the FDA's workings circa 2000, the same principles apply. No drug is without its risks, there are no magic bullets in medicine. The medicines licensing authority is presented with a balancing act where they must weigh up the benefits and the risks of each treatment in deciding whether to license it or not. This is not a clear cut task and there are a multitude of factors to be considered in deciding if the risk-benefit ratio is favourable.

This brings up a whole other debate on pre-marketing data and post-marketing monitoring. The clinical trials carried out before a drug is licensed are never going to be sufficient, due to the controlled setting, limited time frame, population size and lack of real world complicating factors. This is why further trials can be conducted after it comes to market as well epidemiological studies and case reports from healthcare professionals. Again this is a necessary evil in the process of drug discovery and marketing that it is impossible to know everything about a drug before it is brought out.

boardswalker wrote: »

I think you are ignoring the point that key evidence was available but not published.

Available but not published? So the FDA and Merck were the only ones who knew about it?

boardswalker wrote: »

There does appear to be gaps in your knowledge of this particular case.

Here's a good summary of the information that came to light in one of the first Vioxx trials. This information has been in the public domain for several years now. In 2007 Merck agreed to pay $4.85 billion to settle thousands of cases brought by people who suffered heart attacks and strokes after taking its Vioxx painkiller

"The facts presented during the Vioxx trial showed that Merck distributed and promoted Vioxx without properly disclosing the dangers of the drug. The following summarizes some of the key facts of the case.

As far as I am concerned, and as I would suspect, many pharmaceutical companies would do similar. The critical matter is that there is a competent authority who have the final say on whether a drug should be on the market or not, the decision does not rest with doctors and other healthcare professionals in practice.

You may not be aware that there are a number of regulations governing clinical trials that detail the obligations of pharmaceutical companies in disclosing even suspected adverse reaction that occur during the trial. It is also a requirement that any employee of a pharmaceutical company (be they a receptionist, a medical rep or a chief executive) who gets information on an adverse reaction relating to one of their product, must report this to the IMB. As I said, I do not know if this was the case with the FDA in the early 2000's.

boardswalker

I posted the link to the talk on the Politics of Medicine because I am aware that this discussion is taking place elsewhere but such a discussion is never referenced in this forum.

The standard view here is that Pharmaceuticals have proven methods of action based on hard earned gains in science. “The standard on this forum is that if any poster says a therapy (any therapy, conventional or otherwise) works, then that poster has to back up that claim, citing published scientific studies”. – Locum-Motion.

To get approval to market a drug, the manufacturer carries out scientific studies to obtain evidence that the drug is safe and effective. The regulatory authority reviews the scientific evidence and makes a decision whether to approve the drug or not.

However, there is growing concern, among both the scientific and the wider community, that the evidence presented may be biased and incomplete and that conclusions drawn are not always consistent with the evidence from the studies. There is further evidence that conflicts of interest are not disclosed, that many of the supposedly independent peer-reviewed papers are in fact written by employees of the Pharmaceutical companies and held out to be good scientific research, without disclosing the provenance of the research.
I would like to see an open discussion of this.

I have been attacked for raising this issue. My right to ask the question is challenged. However, in responding to my posts the responders often inadvertently make my case for me.

Consider comments such as

“Anyone who considers pharmaceutical companies to be completely altruistic is very naive. Hence why the current regulator framework exists and is necessary” - Penguin88. But Penguin88 does not address how the Regulator can ensure that it is working with sound evidence. We now know of problems where the evidence was not as good as it should have been, so that the regulators made their decisions based on incorrect information supplied to them.

“The regulatory system is not perfect, it can only work towards an ideal” – Penguin88. That’s my point.

“studies will occasionally be published by knackers. Unfortunately, that's the way of the world, and no amount of peer review solves that”. – Tallaght101. So peer review can’t do what it is supposed to do. Secondly, how do I tell who the knackers are, given the disturbing number of recalls particularly with block-buster drugs?

“The clinical trials carried out before a drug is licensed are never going to be sufficient, due to the controlled setting, limited time frame, population size and lack of real world complicating factors. This is why further trials can be conducted after it comes to market as well epidemiological studies and case reports from healthcare professionals.” Penguin88. So the “published scientific studies ” relied on at the regulatory stage may not be sufficient. Isn’t that what I am worried about. How many people have to die or be injured before we can determine that the drugs are not in fact safe.

You hide behind the Regulatory Process which is supposed to provide validity for the drugs. But you yourselves don’t seem to have full faith in the regulatory process. Can you not see why I find that concerning? Arguing, "you can trust us, we're scientists" doesn't work when we now know what some scientists have gotten up to and we're worried.

This is a serious issue and needs to be discussed thoroughly. I would have thought a forum like this would be a good place for such a discussion. I think the good scientists deserve that this discussion should take place.

boardswalker

boardswalker wrote: »

I posted the link to the talk on the Politics of Medicine because I am aware that this discussion is taking place elsewhere but such a discussion is never referenced in this forum.

The standard view here is that Pharmaceuticals have proven methods of action based on hard earned gains in science. “The standard on this forum is that if any poster says a therapy (any therapy, conventional or otherwise) works, then that poster has to back up that claim, citing published scientific studies”. – Locum-Motion.

To get approval to market a drug, the manufacturer carries out scientific studies to obtain evidence that the drug is safe and effective. The regulatory authority reviews the scientific evidence and makes a decision whether to approve the drug or not.

However, there is growing concern, among both the scientific and the wider community, that the evidence presented may be biased and incomplete and that conclusions drawn are not always consistent with the evidence from the studies. There is further evidence that conflicts of interest are not disclosed, that many of the supposedly independent peer-reviewed papers are in fact written by employees of the Pharmaceutical companies and held out to be good scientific research, without disclosing the provenance of the research.
I would like to see an open discussion of this.

I have been attacked for raising this issue. My right to ask the question is challenged. However, in responding to my posts the responders often inadvertently make my case for me.

Consider comments such as

“Anyone who considers pharmaceutical companies to be completely altruistic is very naive. Hence why the current regulator framework exists and is necessary” - Penguin88. But Penguin88 does not address how the Regulator can ensure that it is working with sound evidence. We now know of problems where the evidence was not as good as it should have been, so that the regulators made their decisions based on incorrect information supplied to them.

“The regulatory system is not perfect, it can only work towards an ideal” – Penguin88. That’s my point.

“studies will occasionally be published by knackers. Unfortunately, that's the way of the world, and no amount of peer review solves that”. – Tallaght101. So peer review can’t do what it is supposed to do. Secondly, how do I tell who the knackers are, given the disturbing number of recalls particularly with block-buster drugs?

“The clinical trials carried out before a drug is licensed are never going to be sufficient, due to the controlled setting, limited time frame, population size and lack of real world complicating factors. This is why further trials can be conducted after it comes to market as well epidemiological studies and case reports from healthcare professionals.” Penguin88. So the “published scientific studies ” relied on at the regulatory stage may not be sufficient. Isn’t that what I am worried about. How many people have to die or be injured before we can determine that the drugs are not in fact safe.

You hide behind the Regulatory Process which is supposed to provide validity for the drugs. But you yourselves don’t seem to have full faith in the regulatory process. Can you not see why I find that concerning? Arguing, "you can trust us, we're scientists" doesn't work when we now know what some scientists have gotten up to and we're worried.

This is a serious issue and needs to be discussed thoroughly. I would have thought a forum like this would be a good place for such a discussion. I think the good scientists deserve that this discussion should take place.

Let me see if I can follow your logic.

So because some scientists and scientific studies are suspect, All scientists and scientific studies are invalid?

And since you can show a horror story about a failure in regulation you don't have to bother addressing the actual science against and lack of science for a particular brand of quackery?

In that case I can totally ignore your points because people on the internet are liars, right?

Well if that strategy doesn't work I can always claim to be suppressed too...

locum-motion

boardswalker wrote: »

The standard view here is that Pharmaceuticals have proven methods of action based on hard earned gains in science. “The standard on this forum is that if any poster says a therapy (any therapy, conventional or otherwise) works, then that poster has to back up that claim, citing published scientific studies”. – Locum-Motion.

Purely in the interest of strict accuracy:
a. The first part of the above wasn't said by me, it was said by another poster. Now, I know it's outside the quotation marks, but nevertheless it might be read as being a quote from me.
b. You might also have considered including the later quote from me in which I qualified the above statement, where I said

A poster ... who posts something that is generally accepted by science is not going to be asked to back it up with the same rigour as someone who posts something that flies in the face of all experimental and theoretical possibility.

So, to recap, with examples. If a poster says -
a. "Aspirin is effective for Arthritis" - no back up needed. We all know it, it's not controversial, everybody agrees.
b. "Aspirin is effective for reducing blood pressure" - While Aspirin is generally accepted to have an effect on blood clotting, it's not used for blood pressure, so the poster has to back up their claim.
c. "A homeopathic preparation of <insert whatever you want> here is effective for <insert whatever you want>" - A poster saying this is not only likely to be challenged to back it up, but is quite likely to be ridiculed by other posters too.

(None of the above is strictly relevant to this current thread, and is basically a hangover from the previous homeopathy thread. However, since the genesis of this thread was the other, I'm addressing it here.)

BW,
Assuming all of your Vioxx information is correct (& I have no reason to believe it's not, I hasten to add), I think we can all agree that it is an example of the current system failing, and failing horribly. We also had this discussion on another thread some months ago, so I think there's an element of the argument going round in circles. But, one or two or ten or a hundred examples of the system failing don't mean that the entire system is wrong. (OK, 100 examples might!) I would like to think that each time the system fails, lessons are learned from how that happened, and steps are taken to try to prevent it happening again. Part of that change involves the campaigning of the likes of Beatrice Golumb, and yes, even yourself.

BUT (and yes, the big 'but' is deliberate), you introduced this whole Vioxx/Statins/Beatrice Golumb argument in response to another poster being asked to substantiate his claim that "It works...", the 'it' in this case being homeopathy. I can't help but wonder why you would do so. The only rationale I can think of for doing so is that you were saying "Science is flawed, so homeopathy is OK" (If that's not what you were trying to say, then please enlighten me as to what you were trying to say).

I apologise for once again quoting the Dara O'Briain sketch, but at the end of the day, his argument, though humourous, is true:
"just because science doesn't know everything, it doesn't mean that you can just fill in the gaps with whatever fairytale most appeals to you."

boardswalker

King Mob wrote: »

Let me see if I can follow your logic.

So because some scientists and scientific studies are suspect, All scientists and scientific studies are invalid?

And since you can show a horror story about a failure in regulation you don't have to bother addressing the actual science against and lack of science for a particular brand of quackery?

In that case I can totally ignore your points because people on the internet are liars, right?

Well if that strategy doesn't work I can always claim to be suppressed too...

My logic is simpler than that.
There have been a significant number of pharmaceutical recalls which lead me to believe that the approval system has flaws. Many scientists are concerned and there is a growing discussion about the risks and the problems. That discussion is not welcome here.

By the way, Vioxx (just one) killed between 38,000 and 55,000 in the US, depending on whose estimate you prefer to believe. Are you not concerned about that number of fatalities. That alone makes me question how reliable your studies and regulatory process is or can be.

boardswalker

boardswalker wrote: »

My logic is simpler than that.
There have been a significant number of pharmaceutical recalls which lead me to believe that the approval system has flaws. Many scientists are concerned and there is a growing discussion about the risks and the problems.

So therefore all medicine is harmful? All new medicines are harmful?
How simple would you like to make your hyperbole exactly?

And can you explain how these flaws and telling horror stories somehow negate the evidence against and the lack of evidence for homoeopathy?
Or did you just want an excuse to rant?

boardswalker wrote: »

That discussion is not welcome here.

"Help, help! I'm being repressed."

Seriously, pull the other one. The lone rebel voice thing is a tired old fallacy.
You're obviously using it to try and keep good honest scientist down...

boardswalker wrote: »

By the way, Vioxx (just one) killed between 38,000 and 55,000 in the US, depending on whose estimate you prefer to believe. Are you not concerned about that number of fatalities. That alone makes me question how reliable your studies and regulatory process is or can be.

Would you like to accuse me of eating babies too?

No where did I try to justify any of the actions to lead to those deaths.
But appeals to emotion are such convincing logical fallacies are they?

And again, if studies are unreliable as are peer review etc, how do you know that up to 55,000 people died due to this drug?
Did you examine each and every one?

Dr Galen

i hate doing this, but its serving a point here so its justified.

There have been a significant number of pharmaceutical recalls which lead me to believe that the approval system has flaws.

I don't think anyone here disagrees that the system has flaws. We seem to be in agreement on that one. Thats why medics etc have the peer review system, to catch those that get through. If you can think of any further ways to improve the regulatory system I know for fact that most of us would be all ears.

Many scientists are concerned and there is a growing discussion about the risks and the problems.

There has always been discussion about new drugs and therapies. Often coming from the ground up. To say that such discussion is a new thing, is false. Tragedies like Vioxx vring that discussion into the public eye, but it exists whether the media are reporting it or not. Again, I don't think you'll find any of us regulars here saying that such discussion isn't a good thing. Thats why we have journal clubs, practice development projects and such.

That discussion is not welcome here.

Bull

We make anyone, no matter who they are, back up what they claim here. Many of us would pull pharma reps to shreds when they sit in front of us tbh. I know one poster, (who funnily enough you've been arguing with) that won't even take a pen from a pharma rep, never mind use a product because the rep says they should.

Personally, all that I don't welcome is nonsense, hyperbole and post looking for the cheap headline. If you bothered to engage properly, you'd see that most of us are basically agreeing with your core points i.e the regulatory system sometimes fails.

By the way, Vioxx (just one) killed between 38,000 and 55,000 in the US, depending on whose estimate you prefer to believe. Are you not concerned about that number of fatalities. That alone makes me question how reliable your studies and regulatory process is or can be.

What would you have us do? Wring our hands and walk the halls wailing. Vioxx was a disaster, and lessons need to be learned. Its important to keep perspective though, what about the thousands of drugs that cause no harm and kill no one? I agree, systems need to be tightened but throwing out the baby with the bathwater isn;t the answer.

As far as I know, none of us work for any regulatory bodies? So as I see it your having two arguments here. One is that the system has flaws, but then your trying to drag us all into that same boat. Just because a drug or treatment is approved does not mean every clinician in the country is going to use it. Clinical judegment and evidence based practice mean that simply doesn't happen. I see it every day.

boardswalker

locum-motion wrote: »

But, one or two or ten or a hundred examples of the system failing don't mean that the entire system is wrong. (OK, 100 examples might!)

What does somewhere from 38,000-55,000 deaths mean?

locum-motion wrote: »

I would like to think that each time the system fails, lessons are learned from how that happened, and steps are taken to try to prevent it happening again. Part of that change involves the campaigning of the likes of Beatrice Golumb, and yes, even yourself.

I would prefer to do something about it - like start a discussion, at least.

locum-motion wrote: »

BUT (and yes, the big 'but' is deliberate), you introduced this whole Vioxx/Statins/Beatrice Golumb argument in response to another poster being asked to substantiate his claim that "It works...", the 'it' in this case being homeopathy. I can't help but wonder why you would do so. The only rationale I can think of for doing so is that you were saying "Science is flawed, so homeopathy is OK" (If that's not what you were trying to say, then please enlighten me as to what you were trying to say).

No, the implication is that the scientific study method is totally reliable and because homeopathy or many other alternative treatments have not been tested using this method they are not reliable. I just want to highlight that the scientific study and regulatory method is not totally reliable. I would like to see a full discussion of the issues with the current methods.

Just because I have not tested doesn't mean it failed.

Homeopathy may not work but is it as much a killer as Vioxx was? Remember, Vioxx is not the only example of a product where the scientific method let us down. There are several examples of system failure out there.

The biggest danger with homeopathy is that it might not work. Given that you state it to have no active ingredients, what harm can it do?

Here's my anecdote.
An old man goes to his doctor and says that a faith healer sorted his problem. The doctor says, "that faith healer didn't do anything, that was just the placebo effect." The old man replied, "Well, doctor, if that placebo is so good, how come you don't use it."

locum-motion

boardswalker wrote: »

What does somewhere from 38,000-55,000 deaths mean?

Don't be disingenuous. You know what I meant.

boardswalker

boardswalker wrote: »

No, the implication is that the scientific study method is totally reliable and because homeopathy or many other alternative treatments have not been tested using this method they are not reliable. I just want to highlight that the scientific study and regulatory method is not totally reliable. I would like to see a full discussion of the issues with the current methods.

Just because I have not tested doesn't mean it failed.

It has been tested. Repeatedly.
It's never been shown to be more effective than a placebo.

The few studies that have shown more are invariably published without peer-review, have massive methodological flaws and rely on total crap science.

But it seems you are ignoring these studies before you've even looked at them.
Very open minded....

boardswalker wrote: »

Homeopathy may not work but is it as much a killer as Vioxx was? Remember, Vioxx is not the only example of a product where the scientific method let us down. There are several examples of system failure out there.

The biggest danger with homeopathy is that it might not work. Given that you state it to have no active ingredients, what harm can it do?

Very glad you asked.

http://whatstheharm.net/homeopathy.html

boardswalker wrote: »

Here's my anecdote.
An old man goes to his doctor and says that a faith healer sorted his problem. The doctor says, "that faith healer didn't do anything, that was just the placebo effect." The old man replied, "Well, doctor, if that placebo is so good, how come you don't use it."

So can you show a single faith healer who has ever actually sorted anyone's problem? Cause there's a million bucks in it for you.

Also I find it a bit rich that you're suggesting that doctors should use the placebo effect when it requires the doctors to lie to their patients for it work....

lonestargirl

boardswalker wrote: »

The biggest danger with homeopathy is that it might not work. Given that you state it to have no active ingredients, what harm can it do?

No, the biggest danger from homeopathy is that a patient will die from a curable diease because they don't receive the medication needed to cure that disease. Unfortunately I have seen this first hand with someone who now has terminal breast cancer as they opted for homeopathy upon their initial diagnosis.

As many other posters have said here, nobody believes that all pharmaceutical companies are angels or that the system is perfect but that does not translate into all pharmaceutical companies being devils and all conventional medication being dangerous.

locum-motion

boardswalker wrote: »

The biggest danger with homeopathy is that it might not work. Given that you state it to have no active ingredients, what harm can it do?

There have been examples, mentioned to you already, of people choosing homeopathy and dying where conventional medicine would have cured them and/or controlled their symptoms quite easily.
There was a case in Oz in the last year or two of a child who died of infected eczema. Eczema, ffs! The child's parents opted for homeopathy, while a simple steroid cream would have reduced the symptoms in a couple of days. (Admittedly, it wouldn't have cured the eczema, but eczema is one of those conditions where symptoms snowball and keeping symptoms at bay in turn reduces the chance of further attacks).
People don't die of eczema. It's eminently treatable with conventional medicine. Yet this child died.
Don't tell me that homeopathy does no harm!
Every time a patient opts to give their money to one of those quacks instead of a doctor, they're exposing themselves to a completely unregulated system. Although flawed, conventional medicine at least has a regulation system in place.

boardswalker

King Mob wrote: »

Very glad you asked.

http://whatstheharm.net/homeopathy.html

I'll see your whatstheharm.net and raise you http://www.scientificamerican.com/blog/post.cfm?id=deaths-from-avoidable-medical-error-2009-08-10

locum-motion

boardswalker wrote: »

... http://www.scientificamerican.com/blog/post.cfm?id=deaths-from-avoidable-medical-error-2009-08-10

Which is an example of the campaigning for change I was talking about earlier!

boardswalker

boardswalker wrote: »

I'll see your whatstheharm.net and raise you http://www.scientificamerican.com/blog/post.cfm?id=deaths-from-avoidable-medical-error-2009-08-10

You're joking right?

I suppose you'd have to when you can't address my points.

So much for that discussion you wanted...

ORLY?

boardswalker wrote: »

I'll see your whatstheharm.net and raise you http://www.scientificamerican.com/blog/post.cfm?id=deaths-from-avoidable-medical-error-2009-08-10

I can only conclude that either you are a troll or are a misguided believer in homeopathy.

So, I'll ask a question in the attempt to discern which it is. If you were diagnosed with testicular cancer, would you go with the conventional treatments recommened by a doctor, or with a homeopathic remedy?

If you would go with conventional therapy, please let us know why.

Dr Galen

King Mob, in fairness he ain't addressng any points by anyone. its nothing more than pushing a line and an agenda tbh.

I've tried boardswalker.

boardswalker

King Mob wrote: »

You're joking right?

I suppose you'd have to when you can't address my points.

So much for that discussion you wanted...

What points? A person goes to a homeopath and dies. That proves all homeopaths are faulty? Your example of scientific rigour? Hyperbole, even?

boardswalker

boardswalker wrote: »

What points? A person goes to a homeopath and dies. That proves all homeopaths are faulty? Your example of scientific rigour? Hyperbole, even?

Oh the hypocrisy...

It shows that people can die from preventable and easily treatable illnesses (with treatments and medicines which are very safe) by buying into a treatment with Zero regulation, Zero accountability and Zero evidence for efficacy.

So on one hand you wail against real medicines "lack of regulation and ethics" but then on the other hand can't see the harm in something with no regulation (or proof that it even works)?

And the other points you totally ignored in your quest for "open discussion".

It has been tested. Repeatedly.
It's never been shown to be more effective than a placebo.

The few studies that have shown more are invariably published without peer-review, have massive methodological flaws and rely on total crap science.

But it seems you are ignoring these studies before you've even looked at them.
Very open minded....

So can you show a single faith healer who has ever actually sorted anyone's problem? Cause there's a million bucks in it for you.

And

Also I find it a bit rich that you're suggesting that doctors should use the placebo effect when it requires the doctors to lie to their patients for it work....

boardswalker

ORLY? wrote: »

I can only conclude that either you are a troll or are a misguided believer in homeopathy.

If you read the thread, you'll know that I have never used homeopathy.

I am an occasional, thankfully, user of conventional medicine. But I don't believe it's perfect. And I know that I should understand what they are doing and why. I'll get a second (conventional) opinion if i think it warrants it.

I agree with whoever said this is going around in circles.

Despite all the evidence to the contrary you want me to believe that conventional medicine and medical science is whiter than snow and alternative medicine is evil and dangerous. But you cannot counter the evidence that indicates conventional medicine can be quite dangerous. There are risks everywhere and when there's big money riding on a drug or treatment, you can be sure its even more risky.

Kurtosis

I know that there are a couple of different strands of a debate going on at the moment but I would just like to address this post.

boardswalker wrote: »

To get approval to market a drug, the manufacturer carries out scientific studies to obtain evidence that the drug is safe and effective. The regulatory authority reviews the scientific evidence and makes a decision whether to approve the drug or not.

However, there is growing concern, among both the scientific and the wider community, that the evidence presented may be biased and incomplete and that conclusions drawn are not always consistent with the evidence from the studies. There is further evidence that conflicts of interest are not disclosed, that many of the supposedly independent peer-reviewed papers are in fact written by employees of the Pharmaceutical companies and held out to be good scientific research, without disclosing the provenance of the research.
I would like to see an open discussion of this.

I think you are having an open discussion on this! While the interpretation of clinical trials results may have some bearing in the context of a scientific paper, for the purposes of licensing the medicines, the IMB do not merely read a few pages of summary of the findings of the trial, they are supplied with all the clinical documentation dealing with the trials and are presented with all the raw evidence. This allows their own conclusions to be drawn.

Consider comments such as

“Anyone who considers pharmaceutical companies to be completely altruistic is very naive. Hence why the current regulator framework exists and is necessary” - Penguin88. But Penguin88 does not address how the Regulator can ensure that it is working with sound evidence. We now know of problems where the evidence was not as good as it should have been, so that the regulators made their decisions based on incorrect information supplied to them.

As I have said previously, I am only familiar with the current regulatory framework in this country and have pointed out how they try to ensure the evidence is sound. As above, they receive they receive the actual data from clinical trials before licensing. There are also legal requirements that they be notified during the trial of (suspected) adverse events and the whole reporting mechanism for post-marketing adverse events that come to light.

“The clinical trials carried out before a drug is licensed are never going to be sufficient, due to the controlled setting, limited time frame, population size and lack of real world complicating factors. This is why further trials can be conducted after it comes to market as well epidemiological studies and case reports from healthcare professionals.” Penguin88. So the “published scientific studies ” relied on at the regulatory stage may not be sufficient. Isn’t that what I am worried about. How many people have to die or be injured before we can determine that the drugs are not in fact safe.

It's not that pre-marketing safety data "may not be sufficient", it is not sufficient. Are you familiar with the nature of pre-marketing clinical trials? It usually consists of
Pre-clinical trials - testing in animals/in vitro, to give a broad view of tolerability and safety and other pharmacological paramaters.
Phase I clinical trials - testing in a small group of healthy humans, which gives further information on safety as well as actions of the drug.
Phase II clinical trials - testing in a larger group of humans, often people who have simple, uncomplicated cases of the condition of interest and gives safety as well as efficacy information.
Phase III clinical trial - testing in larger groups, RCTs that compare the new treatment to placebo or the current leading treatment for the condition.

There are a number of problems associated with such a process and cannot feasibly be eliminated. There are too few patients involved in them and they tend to be too median-aged, they are too brief to fully understand the very long term effects, they are too simple compared to a real life situation where patients may be taking other medications, may not be dosing correctly or taking their medication at all.

For this reason there is a whole branch of most regulatory authorities with responsibility for pharmacovigilance. This ongoing active monitoring of medicines that are on the market yields information that is impossible to achieve with pre-marketing data - the efficacy and safety under "real life" conditions, the long term outcomes in large patient groups, the occurrence of rare side effects and the actual frequency of adverse effects. This is in addition to Phase IV clinical trials which can be run in order to gain a lot of this information as well as retrospective studies (i.e. epidemiology).

The resources that have been putting into the various post-marketing monitoring systems around the globe and the constant development of these systems shows that this is not a quick fix for the faults of pre-marketing data, it is merely a necessary part of the process that is involved in bringing a drug to market.

boardswalker

Oh the hypocrisy...

King Mob wrote: »

It shows that people can die from preventable and easily treatable illnesses (with treatments and medicines which are very safe) by buying into a treatment with Zero regulation, Zero accountability and Zero evidence for efficacy.

I can, and have, shown that people can die from preventable and easily treatable illnesses (with treatments and medicines which they were told were very safe) by buying into a treatment with regulation, accountability and evidence for efficacy.

Before you can throw stones at homeopathy or any other alternative treatments get your own house in order first. That's my point.

Showing me a website about homeopathy failures around the world after what happened in various hospitals throughout Ireland in the past few years. Were you joking?

Dr Galen

boardswalker wrote: »

If y
Despite all the evidence to the contrary you want me to believe that conventional medicine and medical science is whiter than snow and alternative medicine is evil and dangerous.

can you show me specifically where this has been said?

ORLY?

boardswalker wrote: »

I am an occasional, thankfully, user of conventional medicine. But I don't believe it's perfect. And I know that I should understand what they are doing and why. I'll get a second (conventional) opinion if i think it warrants it.

Despite all the evidence to the contrary you want me to believe that conventional medicine and medical science is whiter than snow and alternative medicine is evil and dangerous.

But you cannot counter the evidence that indicates conventional medicine can be quite dangerous.

So, in the testicular cancer scenario, what makes you think conventional medicine is more likely to help you than to kill you and homeopathy more likely to result in you dying from testicular cancer than helping?

I don't want anyone to believe that medical science is whiter that snow. MMR debacle? I do want people to know that homeopathy is stupid (not necessarily evil) and dangerous.

I would never try to convince anyone that there aren't circumstances where conventional medicine can be dangerous. Quite the contrary, I've already said that ALL medicine has the potential to be dangerous.

Kurtosis

boardswalker wrote: »

Oh the hypocrisy...



I can, and have, shown that people can die from preventable and easily treatable illnesses (with treatments and medicines which they were told were very safe) by buying into a treatment with regulation, accountability and evidence for efficacy.

Before you can throw stones at homeopathy or any other alternative treatments get your own house in order first. That's my point.

Showing me a website about homeopathy failures around the world after what happened in various hospitals throughout Ireland in the past few years. Were you joking?

I think there's only one person joking here.

Conventional medicine has harmed many; conventional medicine has shown efficacy in the vast majority of medical conditions.

Homeopathy has harmed many; homeopathy has not shown efficacy in the vast majority of medical conditions.

It's pretty clear cut.

boardswalker

boardswalker wrote: »

Oh the hypocrisy...

I can, and have, shown that people can die from preventable and easily treatable illnesses (with treatments and medicines which they were told were very safe) by buying into a treatment with regulation, accountability and evidence for efficacy.

And there's the thing. The medicines you're talking about actually work, and are shown to work.
Yes there are risks involved, but this does not invalidate all medicine.
Why do you think it does?

boardswalker wrote: »

Before you can throw stones at homeopathy or any other alternative treatments get your own house in order first. That's my point.

So what you're saying is it's ok to sell and treat people with something for which there is no evidence for and then tell them that it's effective and they don't need other treatments?

Because most real doctors won't do that.

And you can show that every single scientific study ever done was wrong, but there still won't be any evidence that Homoeopathy is any better than a placebo.

boardswalker wrote: »

Showing me a website about homeopathy failures around the world after what happened in various hospitals throughout Ireland in the past few years. Were you joking?

Here's the thing. We both can show failures of each others system. Can you show any successes of homoeopathy?

bleg

boardswalker wrote: »

By the way, Vioxx (just one) killed between 38,000 and 55,000 in the US, depending on whose estimate you prefer to believe.

Could I get a source on this? One of your sources I read said that 38,000 people taking Vioxx died but it did not say that an adverse reaction to Vioxx was the cause. A fairly important distinction...



Just a comment on the thread as a whole:

The politics of science is a bit of a contradiction. As science is at it's basest level the search for the truth, what is correct and what is incorrect. There isn't much room or tolerance for the conjecture and spin that we hear day to day from our politicians.

The scientific method is a fairly robust mechanism for searching for the truth. Even if you abuse it you get found out pretty quickly.

The way science is funded and regulated however is subject to lobbying and should be continually improved and monitored so that the independence and quality of research can be maintained. Nobody who understands the scientific method can argue otherwise.

bleg

ORLY? wrote: »

So, in the testicular cancer scenario, what makes you think conventional medicine is more likely to help you than to kill you and homeopathy more likely to result in you dying from testicular cancer than helping?

I don't want anyone to believe that medical science is whiter that snow. MMR debacle? I do want people to know that homeopathy is stupid (not necessarily evil) and dangerous.

I would never try to convince anyone that there aren't circumstances where conventional medicine can be dangerous. Quite the contrary, I've already said that ALL medicine has the potential to be dangerous.

All substances are poisons. Get enough of any one thing in the wrong place and you could cause a death air in the circulatory system and water in the lungs being prime examples!!

ORLY?

bleg wrote: »

All substances are poisons. Get enough of any one thing in the wrong place and you could cause a death air in the circulatory system and water in the lungs being prime examples!!

I think you may have misinterpreted me.

tallaght01

The problem is boardswalker doesn't understand the difference between "science" and "regulation" and "dishonesty".

This has been his fundamental problem ever since he started pushing his agenda on here in 1699, and it will always be thus.

I have suggested he masturbate more, in order to encourage the wisdom of the gods into his life, but this has failed.

I think a new approach is needed.

Dr Galen

tallaght01 wrote: »

The problem is boardswalker doesn't understand the difference between "science" and "regulation" and "dishonesty".

This has been his fundamental problem ever since he started pushing his agenda on here in 1699, and it will always be thus.

I have suggested he masturbate more, in order to encourage the wisdom of the gods into his life, but this has failed.

I think a new approach is needed.

Tallaght01

We both know that there is no need for that kinda remark. If we are one hand telling BW that this is a science forum and all that goes with it, people can't then be coming along and making quips about masturbating more etc.

Seriously no more of this shoite from anyone else

Cheers

DrG

ORLY?

ORLY? wrote: »

So, in the testicular cancer scenario, what makes you think conventional medicine is more likely to help you than to kill you and homeopathy more likely to result in you dying from testicular cancer than helping?

If I can get an answer out of him for the above I'll leave him to it.

bleg

ORLY? wrote: »

I think you may have misinterpreted me.

No no, just continuing on your point.



There is no such thing as an easy fix in preventing disease and staying healthy. It's tough work. Anybody who says different is talking lies.

boardswalker

From an article by Ben Goldacre in February of this year.

"Homeopathy doesn't work. But are the claims for other medicines any better?

Drug ads that don't back up their claims show how dumb doctors can be about evidence and how lax regulation has become"

That's what I'm saying.

And a comment from SomeDose on 30 June this year in a thread entitled "Lancet and MMR....".

"From time to time I see applications from consultants to use new drug therapies and, in some cases, the trials and studies they submit as "evidence" are complete tosh. "

Well said. Now, can you understand my concern?

boardswalker

penguin88 wrote: »

Conventional medicine has harmed many; conventional medicine has shown efficacy in the vast majority of medical conditions.

Homeopathy has harmed many; homeopathy has not shown efficacy in the vast majority of medical conditions.

This forum expects evidence to back up claims such as these.

Where is the evidence that the scale of harm from homeopathy is in the same range as the scale of harm from conventional medicine.
And I am including iatrogenic diseases under conventional medicine.

Dr Galen

There really is no point in discussing this with you. You fail to address anything we are saying to you that doesn't fit your narrow agenda.

I use the word agenda there loosely tbh, because I'm not actually sure what it is you want to discuss. It appears all you want to do is post up things you find on the internet and make big broad statements, that sound good as as media-esque soundbites but have no real substance to them. Then when people make the effort to respond to you, you just ignore them.

boardswalker

boardswalker wrote: »

This forum expects evidence to back up claims such as these.

Where is the evidence that the scale of harm from homeopathy is in the same range as the scale of harm from conventional medicine.
And I am including iatrogenic diseases under conventional medicine.

We've already shown the harm from homoeopathy.
Can you show any benefit?

How many diseases has homoeopathy cured?
How many viruses has it driven to extinction?

From an article by Ben Goldacre in February of this year.

"Homeopathy doesn't work. But are the claims for other medicines any better?

Drug ads that don't back up their claims show how dumb doctors can be about evidence and how lax regulation has become"

That's what I'm saying.

The article also says "Quacks see shortcomings in medicine as justification for their own dubious behaviour"
Sound familiar?

Also the majority of his article is relying on a study done by medical researchers. Which you claim are unreliable.
Why do you think this study is accurate and somehow immune to the things you think invalidate other studies?
I have a feeling that only reason you do think so is because you think it supports you world view....

And a comment from SomeDose on 30 June this year in a thread entitled "Lancet and MMR....".

"From time to time I see applications from consultants to use new drug therapies and, in some cases, the trials and studies they submit as "evidence" are complete tosh. "

Well said. Now, can you understand my concern?

So both Some Dose and Ben Goldacre are in the medical profession yet still can identify when the drug companies are trying to pull a fast one?
Huh... I thought they where incapable of doing that from what you where implying....

Oh and BTW, you're still ignoring most of my points. Think you'll get round to them at any point?
Or are you not interested in an "open discussion"?

locum-motion

boardswalker wrote: »

This forum expects evidence to back up claims such as these...

I draw your attention back to this post.

ORLY?

ORLY? wrote: »

So, in the testicular cancer scenario, what makes you think conventional medicine is more likely to help you than to kill you and homeopathy more likely to result in you dying from testicular cancer than helping?

Boardswalker, you still haven't had a go at answering my question, I'm really curious as to your answer.

Kurtosis

boardswalker wrote: »

This forum expects evidence to back up claims such as these.

I didn't think my statements were particularly outlandish.

Where is the evidence that the scale of harm from homeopathy is in the same range as the scale of harm from conventional medicine.

To answer your question, I don't know where such evidence is. This is because you are trying to put words into my mouth - I never claimed that the scale of harm of the two was equivalent.

The fact of the matter is both do harm, one shows benefit, one does not. As I said, it's pretty clear cut.

If you are seriously trying to debate this, I would suggest you take the more sensible approach and perhaps consider homeopathic and conventional medicine in term of risk/benefit, weighting the advantages of each against the dangers associated with them.

If that was the only post you found enough of a problem with to address, then the other posters on thread must be doing pretty well.

SomeDose

Sigi wrote: »

I'm not sure where I had the study but I'll find it.I promise you however the whole concept of cholesterol being behind heart disease or any ill effects is complete and utter bull****.

Come on then, we're still waiting...:)

For what it's worth, there is a sizeable minority of the scientific community who would broadly agree with your sentiments. Unfortunately, I'm not sufficiently well-read on that particular topic to be in a position to critique their theories and supporting evidence. With that in mind, I'm happy to defer to the more widespread consensus and body of evidence that contradicts your position. It would be hypocritical of me to do otherwise, considering I advocate the appropriate use of statins as part of my professional role. But, since I try to adopt a scientific approach as much as possible, I'm happy to eat my words should good evidence to the contrary be found.

So, it would be interesting to hear why you take that standpoint, and why you believe the current evidence supporting the cholesterol hypothesis of heart disease is invalid.

SomeDose

King Mob wrote: »

....So both Some Dose and Ben Goldacre are in the medical profession yet still can identify when the drug companies are trying to pull a fast one?
Huh... I thought they where incapable of doing that from what you where implying....

Actually I'm a hospital pharmacist...but carry on!

Biologic

Sigi wrote: »

In response to the op I would like to point out the amount of cholesterol lowering medication on the market with no benefit whatsoever to the patient.The whole cholesterol myth is bullsh*t spread by the pharmaceutical companies themselves with simply the goal of profits and it has been shown that in people with high cholesterol those who go on statins for it have a higher mortality rate than those who don't.

Sigi wrote: »

I'm not sure where I had the study but I'll find it.I promise you however the whole concept of cholesterol being behind heart disease or any ill effects is complete and utter bull****.

Comments like these are quite frustrating. I'll see your elusive study and raise you one, two and three, none of which are sponsored by an evil PharmaCorp multinational.

locum-motion

Sigi wrote: »

In response to the op I would like to point out the amount of cholesterol lowering medication on the market with no benefit whatsoever to the patient.The whole cholesterol myth is bullsh*t spread by the pharmaceutical companies themselves with simply the goal of profits and it has been shown that in people with high cholesterol those who go on statins for it have a higher mortality rate than those who don't

Sigi wrote: »

I'm not sure where I had the study but I'll find it.I promise you however the whole concept of cholesterol being behind heart disease or any ill effects is complete and utter bull****.

locum-motion wrote: »

"I promise you" is not sufficient evidence to convince most of the posters on this forum that you're right and they're wrong. Post links to studies that back up your assertions, and be prepared to argue their merits.

Biologic wrote: »

Comments like these are quite frustrating. I'll see your elusive study and raise you one, two and three, none of which are sponsored by an evil PharmaCorp multinational.

I suspect, Biologic, that we may be waiting quite a while for Sigi to come back to us on this. A quick check on Sigi's other posts show several saying it's quite alright to cheat in the Leaving Cert, which s/he was sitting last month. Now, I'm not saying that an LC student is incapable of coming up with a convincing argument *, but I do think it's unlikely from this particular poster.

(*: unlike some others on this forum, I do know what the phrase "argument from authority" means!)

YFlyer

King Mob wrote: »

So then no you don't know what an argument from authority is.


And again, the only way you know, and can know, that these withdrawn drugs are harmful at all is because of scientific research.
But then you say scientific research is not reliable, so then how do you know that the drugs are harmful..

Unless of course you only believe certain scientific research....

The research in making the drug and the research in testing is not the same.

YFlyer

tallaght01 wrote: »

Jesus christ, you'd get a pain in the balls reading all that.

Most people who A) care for their patients b) understand science and c) have an open mind know that:

The number one aim of the drug companies is to make money. They have, and will in the future, cover up bad results, and people will come to harm from it.

This is a result of sheer criminal dishonesty, and science relies on a degree of integrity.

This does not make science flawed. It means studies will occasionally be published by knackers. Unfortunately, that's the way of the world, and no amount of peer review solves that.

The vast majority of studies are sound, in terms of being what they're supposed to be, and in being performed in good faith.

The above doesn't change the fact that homeopathy is bollocks.

Homeopathy is a placebo effect, and if it brings comfort to some, then let them believe what they like.

The real militant alternative medicine side are characterised by walls of texts and by rehashing the opinions of the minority (ALWAYS "an eminent scientist").

They will invariably try to move the goalposts by debating the failings of conventional medicine (of which there are many), rather than the abject failure of the homeopathy community to use the billions they earn to produce some evidence of effect.

Anyone who argues with them in any kind of rational way is wasting useful energy that would be far better utilised having an oul <mod snip>.

Just walk away, boys. Just walk away.

Edit: And you can be sure as hell that they never read any of the trials they link, let alone understand them.

Why is this homeopathy is bollocks line been splurted out the whole time?

locum-motion

YFlyer wrote: »

The research in making the drug and the research in testing is not the same.

Eh? What has that got to do with the current discussion? So there's different researchers involved at different points. So what? How is that relevant?

YFlyer

YFlyer wrote: »

The research in making the drug and the research in testing is not the same.

Ok, and?

YFlyer wrote: »

Why is this homeopathy is bollocks line been splurted out the whole time?

Because Homoeopathy is bollocks?

YFlyer

King Mob wrote: »

Ok, and?

Because Homoeopathy is bollocks?

boardswalker was not intended to discuss homoeopathy when he started the thread.