Larium - A comment

Old Sep 3rd 2002, 12:40 pm
  #31  
Javier GóMez-GarcíA
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Default Re: Lariam - A comment

"C. Josef" <[email protected]> escribió en el mensaje news:[email protected]
m
...
    > Before Lariam was licensed, not a single randomized, double-blinded field trial
    > performed on travellers was performed.

On travellers. But they had been performed on soldiers, peace corps volunteers and
air crews.

    > In fact all studies at that time had severe methodological shortcomings.

Yes, some of them were ruled out in later revisions, but others were not. This
happens quite frequently with lots of other drugs when trials are reviewed years
later. Just to point out there was no necessarily any *evil mind* in this, just messy
work. A large part of published science is messy work actually.

    > The first propper study that was performed was actually published in October 2001 -
    > with 29% neuropsychiatric side-effects for Lariam compared to only 14% in the
    > control group that took Malarone.

The Overbosch paper, I know. There is a clearcut difference in rates of
neuropsychiatric side-effects (not so in other types like gastrointestinal). I
insist, it is not my intention at all to defend Lariam, I don't even use it myself.
But I don't like either when sometimes certain facts may be presented as if there is
one drug proved a mankind's scourge (at least not while the drug is still approved
and litigations are not through) and another one presented as mankind's salvation,
like sometimes I've read of Malarone. Malarone is no panacea either. Strong
side-effects as well and just a single point mutation needed to elicit resistence,
which forecasts a short life.

All this just to say, the most important point not to miss is to avoid being bitten.
Of course this is more uncomfortable than just taking a pill and forgetting about
malaria altogether, but unfortunately that's the way it works, and that's the toll of
travelling.

Best,
--
------------------------------------------------------
Javier Gómez-García Editor www.kenyalogy.com
------------------------------------------------------
 
Old Sep 3rd 2002, 1:34 pm
  #32  
C. Josef
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Default Re: Lariam - A comment

Hi,

Javier Gómez-García wrote:

    >Yes, some of them were ruled out in later revisions, but others were
not.
    >This happens quite frequently with lots of other drugs when trials
are
    >reviewed years later. Just to point out there was no necessarily any
*evil
    >mind* in this, just messy work. A large part of published science is
messy
    >work actually.

Mmmmhhh, personally I have to admit I find it remarkable that the methodological
problems of the most widely quoted pro-Lariam study (Mefloquine compared with other
malaria chemoprophylactic regimens in tourists visiting east Africa) weren't noticed
by the authors in advance. And actually I have to say I also find it remarkable to
see these authors didn't just produce one or two methodologically problematic studies
in favour of Lariam, but something like five or six of them in a row. Now of course I
don't see any evil mind either, but nevertheless I find it very remarkable.

    >I insist, it is not my intention at all to defend Lariam, I don't
even use
    >it myself.

Personally I take doxycycline whenever travelling to malaria zones in Africa and I'm
neither in strong favour of Lariam nor Malarone, although both anecdotal reports from
friends as well as the the data from the studies on Malarone's safety published so
far sound more convincing to me compared to the Lariam studies. But I must admit
Malarone is definetly not free of side-effects and since it's a relatively new drug
we can't rule out very rare side-effects might be detected at some point. I
absolutely agree with you when you're saying it's problematic that Malarone is
perceived as a drug completly free of side-effects by some people.

    >But I don't like either when sometimes certain facts may be presented as if there is
    >one drug proved a mankind's scourge (at
least not
    >while the drug is still approved and litigations are not through) and another one
    >presented as mankind's salvation, like sometimes I've
read of
    >Malarone. Malarone is no panacea either. Strong side-effects as well
and
    >just a single point mutation needed to elicit resistence, which
forecasts a
    >short life.

We will see and it's hard to predict. I am fully aware of the case report about a
person who caught Malarone resistant malaria and the mutation that was found in the
parasites, but even though it raises concerns I have to say I don't see any reason to
be too alarmed at this point either.

Chris
 
Old Sep 4th 2002, 10:48 am
  #33  
Javier GóMez-GarcíA
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Posts: n/a
Default Re: Lariam - A comment

"C. Josef" <[email protected]> escribió en el mensaje news:[email protected]
com
...
    > Mmmmhhh, personally I have to admit I find it remarkable that the methodological
    > problems of the most widely quoted pro-Lariam study (Mefloquine compared with other
    > malaria chemoprophylactic regimens in tourists visiting east Africa) weren't
    > noticed by the authors in advance. And actually I have to say I also find it
    > remarkable to see these authors didn't just produce one or two methodologically
    > problematic studies in favour of Lariam, but something like five or six of them in
    > a row. Now of course I don't see any evil mind either, but nevertheless I find it
    > very remarkable.

Yes it is, but not more than many, if not most, science papers (at least biology,
can't talk so about physics or astronomy). Happens as well in the basic field, people
try to *sell* their results and interpretation of them can be made very liberally. So
no surprise this happens as well when actual sales are involved, and worth millions.
A slight degree of *result marketing* might be acceptable, but there is no defined
limit so as to what is *slight*, and sometimes it's definitely not.

    > But I must admit Malarone is definetly not free of side-effects and since it's a
    > relatively new drug we can't rule out very rare side-effects might be detected at
    > some point. I absolutely agree with you when you're saying it's problematic that
    > Malarone is perceived as a drug completly free of side-effects by some people.

Many people come to this ng seeking *paramedical* advice for issues like malaria
prophylaxis, and a word here favouring one drug over another can be very dangerously
powerful. I think all of us should be careful with this, because these personal
recommendations are often only the result of one single case (*my* experience), while
specialists have the big picture based on statistical figures and scientific
knowledge, even if they never travelled to Africa.

Best,
--
------------------------------------------------------
Javier Gómez-García Editor www.kenyalogy.com
------------------------------------------------------
 
Old Sep 4th 2002, 3:46 pm
  #34  
C. Josef
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Default Re: Lariam - A comment

"Javier G mez-Garc a" <[email protected]> wrote in message
news:<[email protected]>...

    > Yes it is, but not more than many, if not most, science papers (at least biology,
    > can't talk so about physics or astronomy).

Fact is the side-effects of Lariam have been known for many, many years. It's nothing
new at all and you can find many, many reports of neuropsychiatric side-effects in
paper that were published a long, long time ago. Still a number of professionals
denied such side-effects had anything to do with the drug despite of ever growing
evidence of neuropsychiatric reactions. One particularly good example for this is
Hans Lobel who formerly worked for the CDC. According to the Washington Post he still
said "The scientific data showed us there are no side effects that can be attributed
to mefloquine... . The long and the short of it is that scientific studies have not
shown any difference between mefloquine and a placebo" back at a time when studies
like the one by Barrett and colleagues was published in the BMJ and when a systematic
review of trials had critically discussed the quality of the published evidence
already. As I said, I don't see any evil mind whatsoever, but it seriously makes me
wonder what motivation a scientist like Hans Lobel had to say things like that at a
time when in my opinion it was more than obvious that Lariam can indeed cause
neuropsychiatric side-effects.

    > Many people come to this ng seeking *paramedical* advice for issues like malaria
    > prophylaxis, and a word here favouring one drug over another can be very
    > dangerously powerful.

I absolutely agree with you, but of course I would like to keep in mind all malaria
drugs with the exception of chloroquine/proguanile (available without a prescription
in some countries) require a prescription by a doctor. You can't just go to a
pharmacy and say: I would like some Lariam, Malarone, doxycycline or whatever.

Also I'm afraid the attitude of many doctors who ignored and even denied the
existance of malaria drug related side-effects - no matter if it was chloroquine,
mefloquine, atovaquone, doxycycline or whatever
- has a lot to do with the very unfortunate situation we have now.

    >I think all of us should be careful with this, because these personal
    >recommendations are often only the result of one single case (*my* experience),
    >while specialists have the big picture based on statistical figures and scientific
    >knowledge, even if they never travelled to Africa.

My opinion about the knowledge of medical professionals is a lot lower than yours
when it comes to malaria drug. In fact there are studies that show a high percentage
of doctors regularly ignore contraindications of malaria drugs, recommend drugs when
they're not really needed, etc. Therefore I'd always recommend to see a true
specialist - which means an expert for tropical diseases. Despite of the fact that
these are hard to find, even they don't necessarely agree when it comes to the right
choice for preventing malaria. Just compare the malaria prevention guidelines of
South Africa, Australia, the USA, Great Britain, France, Germany, Austria, Denmark
and Spain. The differences are often remarkable.

Chris
 
Old Sep 4th 2002, 5:56 pm
  #35  
Javier GóMez-GarcíA
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Posts: n/a
Default Re: Lariam - A comment

"C. Josef" <[email protected]> escribió en el mensaje news:[email protected]
com
...
    > Fact is the side-effects of Lariam have been known for many, many years. It's
    > nothing new at all and you can find many, many reports of neuropsychiatric
    > side-effects in paper that were published a long, long time ago. Still a number of
    > professionals denied such side-effects had anything to do with the drug despite of
    > ever growing evidence of neuropsychiatric reactions.

I know of many similar stories in the basic research field (i.e. people still
defending to death their largely refuted results), but this would bring us
way OT here.

    > I absolutely agree with you, but of course I would like to keep in mind all malaria
    > drugs with the exception of chloroquine/proguanile (available without a
    > prescription in some countries) require a prescription by a doctor. You can't just
    > go to a pharmacy and say: I would like some Lariam, Malarone, doxycycline or
    > whatever.

That's right Chris, but even there are some people trying to sell *2nd hand* through
this ng. Also, some people find a walkaround for a proper prescription: their
company's doctor, a friend physician,... Mind you, I was in Italy a couple of weeks
ago, I was under amoxicilin because of a throat infection and I ran out of it. When I
asked at a pharmacy I knew I needed a prescription, and the pharmacist told me so,
and of course I couldn't produce one. He doubted at first, but when he saw I was a
foreigner he finally did sell me the antibiotic.

    > My opinion about the knowledge of medical professionals is a lot lower than yours
    > when it comes to malaria drug. In fact there are studies that show a high
    > percentage of doctors regularly ignore contraindications of malaria drugs,
    > recommend drugs when they're not really needed, etc. Therefore I'd always recommend
    > to see a true specialist - which means an expert for tropical diseases. Despite of
    > the fact that these are hard to find, even they don't necessarely agree when it
    > comes to the right choice for preventing malaria. Just compare the malaria
    > prevention guidelines of South Africa, Australia, the USA, Great Britain, France,
    > Germany, Austria, Denmark and Spain. The differences are often remarkable.

Yes, always talking about infectious/tropical specialists, not *any* doctor. And
naturally there will always be differences in criteria, among different countries'
guidelines and among different specialists within these guidelines. This is quite
frequent in the biomedical field, but as long as recommendations are well supported
they are at least reasonable, unfortunately there is no math here, so there is no
single right choice, at least not until we have the prophylactic vaccine, if we do
ever have it.

Best,
--
------------------------------------------------------
Javier Gómez-García Editor www.kenyalogy.com
------------------------------------------------------
 
Old Sep 5th 2002, 5:54 am
  #36  
C. Josef
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Default Re: Lariam - A comment

"Javier G mez-Garc a" <[email protected]> wrote in message
news:<[email protected]>...

    > I know of many similar stories in the basic research field (i.e. people still
    > defending to death their largely refuted results), but this would bring us way
    > OT here.

Well, as long as this person who defended Lariam so strongly was a leading scientist
of the Centers for Disease Control, I don't think it's OT at all. Even today the CDCs
webpage just says: http://www.cdc.-
gov/travel/malariadrugs.htm


"Most travelers who take mefloquine have few, if any, side effects. The most commonly
reported minor side effects include nausea, dizziness, difficulty sleeping, and vivid
dreams. Mefloquine has very rarely been reported to cause serious side effects, such
as seizures, hallucinations, and severe anxiety. Minor side effects usually do not
require stopping the drug. Advise travelers who have serious side effects to see a
health care provider."

This information is plainly wrong, unless you have a definition of the terms
"serious" that is not identical with what is considered as "serious" by average
travellers. (The definition of "serious" by the Counsil for International
Organisations of Medical sciences is fatal, life threatening, leading to or
prolonging a stay in hospital, or resulting in severe disability. This is hardly the
same understanding of the term serious that average people have.)

But even if we use the above definition of "serious", the term "very rarely" means
such side-effects occur in less than <0.1%. Since the survey of travellers returning
from East Africa with this riduculous
1:10000 figure is methodologically doubtfull, I really have big problems with the
statements by the CDC, especially since they are written for laymen.

Unfortunately this is still the official position of the CDC and therefore I can only
say it's natural that rumours and gossip begin. I honestly can't remember a journey
to malaria zones Africa without having spoken to at least one traveller who had a
(perceived or real) bad reaction to Lariam and I assume this is rather typical. So
the situation is easy: People are given doubtfull information by medical
professionals and in real life they see things are quite different. I'm not surprised
one bit they don't trust their doctors anymore and look for advice in internet
discussion groups - which is of course a very unfortunate decision. But even though I
can only warn them not to base their decisions exclusively on gossipp in internet
groups, I can't blame them either as long as the information give by medical
professionals is as doubtfull as the official advice by the CDC.

    > That's right Chris, but even there are some people trying to sell *2nd hand*
    > through this ng.

I know and just like you I'm very, very worried about this. As I said I think the
only way to prevent this is more knowledge and more honesty on the side of the
professionals. While there are a large number of very good and sincere experts, the
overall advice given to travellers is poor to say the least and it urgently has to
be improved.

Chris
 
Old Sep 5th 2002, 11:42 am
  #37  
Javier GóMez-GarcíA
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Default Re: Lariam - A comment

"C. Josef" <[email protected]> escribió en el mensaje news:[email protected]
com
...
    > Well, as long as this person who defended Lariam so strongly was a leading
    > scientist of the Centers for Disease Control, I don't think it's OT at all.

I never said the Lobel story was OT. What I said is that there are lots of examples
of similar behaviours from very well-known and not so well-known scientists. This is
not (shamefully) a rare behaviour, but trying to prove this here would be OT, that
is, those other stories.

    > Unfortunately this is still the official position of the CDC and therefore I can
    > only say it's natural that rumours and gossip begin. I honestly can't remember a
    > journey to malaria zones Africa without having spoken to at least one traveller who
    > had a (perceived or real) bad reaction to Lariam and I assume this is rather
    > typical. So the situation is easy: People are given doubtfull information by
    > medical professionals and in real life they see things are quite different. I'm not
    > surprised one bit they don't trust their doctors anymore and look for advice in
    > internet discussion groups - which is of course a very unfortunate decision. But
    > even though I can only warn them not to base their decisions exclusively on gossipp
    > in internet groups, I can't blame them either as long as the information give by
    > medical professionals is as doubtfull as the official advice by the CDC.

Though I've heard of many sad stories of the pharmaceutical industry (and lived a
couple of them), I will just not easily assume that the CDC or any other healthcare
national or international organism is frivolously risking citizens' health at the
service of pharma multinationals or any other interest (I won't defend it isn't so
either, I just say I won't plainly take it for granted). I also don't want to
initiate or follow any crusade against (neither *for*) any drug or company. My only
intention is to remark that everyone should seek expert personalized advice from a
qualified professional, and afterwards take a responsible decision on an informed and
rational basis. Too much to ask for?

    > the overall advice given to travellers is poor to say the least and it urgently has
    > to be improved.

Totally agree.

--
------------------------------------------------------
Javier Gómez-García Editor www.kenyalogy.com
------------------------------------------------------
 
Old Sep 6th 2002, 5:49 am
  #38  
C. Josef
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Posts: n/a
Default Re: Lariam - A comment

"Javier G mez-Garc a" <[email protected]> wrote in message
news:<[email protected]>...

    > My only intention is to remark that everyone should seek expert personalized advice
    > from a qualified professional, and afterwards take a responsible decision on an
    > informed and rational basis. Too much to ask for?

Not at all! Sorry if my comments appeared as a criticism of what you said as they
were not meant like this. Basically I think I totally agree with most of what you're
saying. It was just an expression of my general frustration with the way the whole
Lariam controversy was dealt with by the CDC and other health authorities.

Chris
 
Old Sep 6th 2002, 8:14 am
  #39  
Javier GóMez-GarcíA
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Default Re: Lariam - A comment

"C. Josef" <[email protected]> escribió en el mensaje news:[email protected]
com
...
    > Not at all! Sorry if my comments appeared as a criticism of what you said as they
    > were not meant like this. Basically I think I totally agree with most of what
    > you're saying. It was just an expression of my general frustration with the way the
    > whole Lariam controversy was dealt with by the CDC and other health authorities.

Oh, never mind Chris! It was a very interesting conversation, and at least I hope
these discussions about Lariam keep other potential travellers aware.

Best,

--
------------------------------------------------------
Javier Gómez-García Editor www.kenyalogy.com
------------------------------------------------------
 

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