Strong criticism of Copaxone posted in Pub Med

[Guest guest]

this is 2nd hand, didn't go to Pub Med to find it, but it's from 2/13, so it's a recent addition. Thought someone here might be interested in reading it....

#1

Today, 04:02 AM

jackD

Distinguished Community Member

Join Date: Mar 2004

Location: land near Wash DC

Posts: 113

Strong criticism of Copaxone posted in Pub Med

: Prescrire Int. 2004 Feb;13(69):10-2. Glatiramer: new preparation. No place in multiple sclerosis.[No authors listed](1) Interferon beta-1a is the reference treatment for relapsing-remittingmultiple sclerosis. It reduces the frequency of exacerbations and was the firstinterferon beta shown to delay the onset of disability. (2) Glatiramer, apeptide with certain structural similarities to myelin components, was recentlyapproved for use in this indication. (3) Three randomised double-blind trialslasting a maximum of two years compared glatiramer with placebo. They showedthat glatiramer has no impact on the progression of disability. Glatiramerincreased slightly the interval between exacerbations: each patient avoidedabout one exacerbation after two years treatment. But the drug had no effect onthe number of patients who experienced exacerbation. Glatiramer has not beencompared with interferon beta in clinical trials. (4) The treatment withdrawalrates for adverse effects among patients treated with glatiramer and interferonbeta are about the same, although the two drugs have different adverse effectprofiles. Most patients using glatiramer have reactions at the injection site.Nearly half the patients given glatiramer have an immediate systemic reaction,and these can be serious. (5) Glatiramer therapy requires daily injections,unlike the more convenient interferon beta (which is given every three days).(6) Glatiramer is no cheaper than interferon beta. (7) In practice, the minorbenefits of glatiramer are offset by its adverse effects and less convenientadministration. There is currently no place for glatiramer in the treatment ofmultiple sclerosis.PMID: 15055208 [PubMed - in process]1: Cochrane Database Syst Rev. 2004;(1):CD004678. Therapy with glatiramer acetate for multiple sclerosis.Munari L, Lovati R, Boiko A.Azienda Ospedaliera Ospedale Niguarda Ca' Granda, P.zza Ospedale Maggiore, 3,Milan, ITALY, 20162.BACKGROUND: Some clinical data have shown that glatiramer acetate (Copaxone®), a synthetic amino acid polymer empirically found to suppress experimentalallergic encephalomyelitis (EAE), an animal model of MS, might help improve theoutcome of patients with multiple sclerosis (MS). OBJECTIVES: We performed aCochrane review of all randomised, placebo-controlled trials of glatirameracetate in MS, whatever the disease course. SEARCH STRATEGY: We searched theCochrane MS Group trials register (June 2003), the Cochrane Central Register ofControlled Trials (CENTRAL) (Issue 2, 2003), MEDLINE (PubMed) (January 1966 toJune 2003), EMBASE (January 1988 to June 2003) and hand searching of symposiareports (1990-2002) from the neurological Associations and MS Societies in bothEurope and America. SELECTION CRITERIA: All randomised controlled trials (RCTs)comparing glatiramer acetate and placebo in patients with definite MS, whateverthe administration schedule and disease course, were eligible for this review.DATA COLLECTION AND ANALYSIS: Both patients with relapsing-remitting (RR) andchronic progressive (CP) MS were analysed. Study protocols were comparableacross trials as to patient entry criteria and outcome definition. No majorflaws were found in methodological quality. However, efficacy of blinding shouldbe balanced against well-known side effects, including injection-site reactionsin glatiramer acetate-treated patients. MAIN RESULTS: A total of 646 patientscontributed to this review, as it is summarised in Table 01. Glatiramer acetatedid not show any significant effect on disease progression, measured as asustained worsening in the Expanded Disability Status Scale (EDSS). On the otherhand, a slight decrease in the mean EDSS score, driven by a major study, shouldbe considered in the light of the limited validity of this outcome measure. Nobenefit was shown in CP MS patients (progression at two years: RR=0.69, 95% CI[0.33 to 1.46]). The frequency of reported adverse events does not support anymajor toxicity associated with glatiramer acetate administration. The mostcommon systemic adverse event was a transient and self-limiting patternedreaction of flushing, chest tightness, sweating, palpitations, anxiety (relativerisk = 3.40 (95% CI [2.22 to 5.21], p <0.00001]). Local injection-site reactionswere observed in up to a half of patients treated with glatiramer acetate, thusmaking a blind assessment of outcomes questionable. REVIEWER'S CONCLUSIONS:Glatiramer acetate did not show any beneficial effect on the main outcomemeasures in MS, i.e. disease progression, and it does not substantially affectthe risk of clinical relapses. Therefore its routine use in clinical practice isnot currently supported. More investigations are needed. Further research shouldalso develop more reliable measures of patient disability over time and includequality of life among primary outcomes.PMID: 14974077 [PubMed - in process]http://brain.hastypastry.net/forums/showthread.php?t=7382

[Guest guest]

Larry:

If I may point out, the journal that you cite is one of the

lowest of the lows in the scientific community, i.e. trash. The

article is completely baseless and probably paid for by copaxone's

competitors. Of all the drugs that the medical community uses,

copaxone is perhaps the best. There is so much misinformation and

money involved, that one needs to be extra careful when reading

about MS.

With some luck, we will be able to do a head to head comparison

between copaxone and LDN.

Yash

--- In low dose naltrexone , " LarryGC " <larrygc@s...>

wrote:

> this is 2nd hand, didn't go to Pub Med to find it, but it's from

2/13, so it's a recent addition. Thought someone here might be

interested in reading it....

>

>

>

>

> #1 Today, 04:02 AM

> jackD

> Distinguished Community Member Join Date: Mar 2004

> Location: land near Wash DC

> Posts: 113

>

> Strong criticism of Copaxone posted in Pub Med

>

> -------------------------------------------------------------------

-------

>

> : Prescrire Int. 2004 Feb;13(69):10-2.

>

> Glatiramer: new preparation. No place in multiple sclerosis.

>

> [No authors listed]

>

> (1) Interferon beta-1a is the reference treatment for

relapsing-remitting

> multiple sclerosis. It reduces the frequency of

exacerbations and was the first

> interferon beta shown to delay the onset of disability. (2)

Glatiramer, a

> peptide with certain structural similarities to myelin

components, was recently

> approved for use in this indication. (3) Three randomised

double-blind trials

> lasting a maximum of two years compared glatiramer with

placebo. They showed

> that glatiramer has no impact on the progression of

disability. Glatiramer

> increased slightly the interval between exacerbations: each

patient avoided

> about one exacerbation after two years treatment. But the

drug had no effect on

> the number of patients who experienced exacerbation.

Glatiramer has not been

> compared with interferon beta in clinical trials. (4) The

treatment withdrawal

> rates for adverse effects among patients treated with

glatiramer and interferon

> beta are about the same, although the two drugs have

different adverse effect

> profiles. Most patients using glatiramer have reactions at

the injection site.

> Nearly half the patients given glatiramer have an immediate

systemic reaction,

> and these can be serious. (5) Glatiramer therapy requires

daily injections,

> unlike the more convenient interferon beta (which is given

every three days).

> (6) Glatiramer is no cheaper than interferon beta. (7) In

practice, the minor

> benefits of glatiramer are offset by its adverse effects and

less convenient

> administration. There is currently no place for glatiramer

in the treatment of

> multiple sclerosis.

>

> PMID: 15055208 [PubMed - in process]

>

>

> 1: Cochrane Database Syst Rev. 2004;(1):CD004678.

>

> Therapy with glatiramer acetate for multiple sclerosis.

>

> Munari L, Lovati R, Boiko A.

>

> Azienda Ospedaliera Ospedale Niguarda Ca' Granda, P.zza

Ospedale Maggiore, 3,

> Milan, ITALY, 20162.

>

> BACKGROUND: Some clinical data have shown that glatiramer

acetate (Copaxone

> ®), a synthetic amino acid polymer empirically found to

suppress experimental

> allergic encephalomyelitis (EAE), an animal model of MS,

might help improve the

> outcome of patients with multiple sclerosis (MS).

OBJECTIVES: We performed a

> Cochrane review of all randomised, placebo-controlled trials

of glatiramer

> acetate in MS, whatever the disease course. SEARCH STRATEGY:

We searched the

> Cochrane MS Group trials register (June 2003), the Cochrane

Central Register of

> Controlled Trials (CENTRAL) (Issue 2, 2003), MEDLINE

(PubMed) (January 1966 to

> June 2003), EMBASE (January 1988 to June 2003) and hand

searching of symposia

> reports (1990-2002) from the neurological Associations and

MS Societies in both

> Europe and America. SELECTION CRITERIA: All randomised

controlled trials (RCTs)

> comparing glatiramer acetate and placebo in patients with

definite MS, whatever

> the administration schedule and disease course, were

eligible for this review.

> DATA COLLECTION AND ANALYSIS: Both patients with relapsing-

remitting (RR) and

> chronic progressive (CP) MS were analysed. Study protocols

were comparable

> across trials as to patient entry criteria and outcome

definition. No major

> flaws were found in methodological quality. However,

efficacy of blinding should

> be balanced against well-known side effects, including

injection-site reactions

> in glatiramer acetate-treated patients. MAIN RESULTS: A

total of 646 patients

> contributed to this review, as it is summarised in Table 01.

Glatiramer acetate

> did not show any significant effect on disease progression,

measured as a

> sustained worsening in the Expanded Disability Status Scale

(EDSS). On the other

> hand, a slight decrease in the mean EDSS score, driven by a

major study, should

> be considered in the light of the limited validity of this

outcome measure. No

> benefit was shown in CP MS patients (progression at two

years: RR=0.69, 95% CI

> [0.33 to 1.46]). The frequency of reported adverse events

does not support any

> major toxicity associated with glatiramer acetate

administration. The most

> common systemic adverse event was a transient and self-

limiting patterned

> reaction of flushing, chest tightness, sweating,

palpitations, anxiety (relative

> risk = 3.40 (95% CI [2.22 to 5.21], p <0.00001]). Local

injection-site reactions

> were observed in up to a half of patients treated with

glatiramer acetate, thus

> making a blind assessment of outcomes questionable.

REVIEWER'S CONCLUSIONS:

> Glatiramer acetate did not show any beneficial effect on the

main outcome

> measures in MS, i.e. disease progression, and it does not

substantially affect

> the risk of clinical relapses. Therefore its routine use in

clinical practice is

> not currently supported. More investigations are needed.

Further research should

> also develop more reliable measures of patient disability

over time and include

> quality of life among primary outcomes.

>

> PMID: 14974077 [PubMed - in process]

>

> http://brain.hastypastry.net/forums/showthread.php?t=7382

[Guest guest]

As I said, I didn't know it's worth. Just saw it and thought I'd pass it along for comment. Of the 4 CRABs, C always seemed to be the best of the batch. I even considered trying it just to see what it's like, but I was talked out of it, so I gave up the consideration.

----- Original Message -----

From: yashagrawal

low dose naltrexone

Sent: Wednesday, April 07, 2004 20:38

Subject: [low dose naltrexone] Re: Strong criticism of Copaxone posted in Pub Med

Larry: If I may point out, the journal that you cite is one of the lowest of the lows in the scientific community, i.e. trash. The article is completely baseless and probably paid for by copaxone's competitors. Of all the drugs that the medical community uses, copaxone is perhaps the best. There is so much misinformation and money involved, that one needs to be extra careful when reading about MS.With some luck, we will be able to do a head to head comparison between copaxone and LDN.

[Guest guest]

I save almost everything, between us all we should basically have a encyclopedia at our disposal.

Reg.

-- Fw: Fwd: Strong criticism of Copaxone posted in Pub Med

Strong criticism of Copaxone posted in Pub Med

----------------------------------------------------------------------

----

: Prescrire Int. 2004 Feb;13(69):10-2.

Glatiramer: new preparation. No place in multiple sclerosis.

[No authors listed]

(1) Interferon beta-1a is the reference treatment for relapsing-

remitting

multiple sclerosis. It reduces the frequency of exacerbations

and was the first

interferon beta shown to delay the onset of disability. (2)

Glatiramer, a

peptide with certain structural similarities to myelin

components, was recently

approved for use in this indication. (3) Three randomised

double-blind trials

lasting a maximum of two years compared glatiramer with

placebo. They showed

that glatiramer has no impact on the progression of disability.

Glatiramer

increased slightly the interval between exacerbations: each

patient avoided

about one exacerbation after two years treatment. But the drug

had no effect on

the number of patients who experienced exacerbation. Glatiramer

has not been

compared with interferon beta in clinical trials. (4) The

treatment withdrawal

rates for adverse effects among patients treated with

glatiramer and interferon

beta are about the same, although the two drugs have different

adverse effect

profiles. Most patients using glatiramer have reactions at the

injection site.

Nearly half the patients given glatiramer have an immediate

systemic reaction,

and these can be serious. (5) Glatiramer therapy requires daily

injections,

unlike the more convenient interferon beta (which is given

every three days).

(6) Glatiramer is no cheaper than interferon beta. (7) In

practice, the minor

benefits of glatiramer are offset by its adverse effects and

less convenient

administration. There is currently no place for glatiramer in

the treatment of

multiple sclerosis.

PMID: 15055208 [PubMed - in process]

1: Cochrane Database Syst Rev. 2004;(1):CD004678.

Therapy with glatiramer acetate for multiple sclerosis.

Munari L, Lovati R, Boiko A.

Azienda Ospedaliera Ospedale Niguarda Ca' Granda, P.zza

Ospedale Maggiore, 3,

Milan, ITALY, 20162.

BACKGROUND: Some clinical data have shown that glatiramer

acetate (Copaxone

®), a synthetic amino acid polymer empirically found to

suppress experimental

allergic encephalomyelitis (EAE), an animal model of MS, might

help improve the

outcome of patients with multiple sclerosis (MS). OBJECTIVES:

We performed a

Cochrane review of all randomised, placebo-controlled trials of

glatiramer

acetate in MS, whatever the disease course. SEARCH STRATEGY: We

searched the

Cochrane MS Group trials register (June 2003), the Cochrane

Central Register of

Controlled Trials (CENTRAL) (Issue 2, 2003), MEDLINE (PubMed)

(January 1966 to

June 2003), EMBASE (January 1988 to June 2003) and hand

searching of symposia

reports (1990-2002) from the neurological Associations and MS

Societies in both

Europe and America. SELECTION CRITERIA: All randomised

controlled trials (RCTs)

comparing glatiramer acetate and placebo in patients with

definite MS, whatever

the administration schedule and disease course, were eligible

for this review.

DATA COLLECTION AND ANALYSIS: Both patients with relapsing-

remitting (RR) and

chronic progressive (CP) MS were analysed. Study protocols were

comparable

across trials as to patient entry criteria and outcome

definition. No major

flaws were found in methodological quality. However, efficacy

of blinding should

be balanced against well-known side effects, including

injection-site reactions

in glatiramer acetate-treated patients. MAIN RESULTS: A total

of 646 patients

contributed to this review, as it is summarised in Table 01.

Glatiramer acetate

did not show any significant effect on disease progression,

measured as a

sustained worsening in the Expanded Disability Status Scale

(EDSS). On the other

hand, a slight decrease in the mean EDSS score, driven by a

major study, should

be considered in the light of the limited validity of this

outcome measure. No

benefit was shown in CP MS patients (progression at two years:

RR=0.69, 95% CI

[0.33 to 1.46]). The frequency of reported adverse events does

not support any

major toxicity associated with glatiramer acetate

administration. The most

common systemic adverse event was a transient and self-limiting

patterned

reaction of flushing, chest tightness, sweating, palpitations,

anxiety (relative

risk = 3.40 (95% CI [2.22 to 5.21], p <0.00001]). Local

injection-site reactions

were observed in up to a half of patients treated with

glatiramer acetate, thus

making a blind assessment of outcomes questionable. REVIEWER'S

CONCLUSIONS:

Glatiramer acetate did not show any beneficial effect on the

main outcome

measures in MS, i.e. disease progression, and it does not

substantially affect

the risk of clinical relapses. Therefore its routine use in

clinical practice is

not currently supported. More investigations are needed.

Further research should

also develop more reliable measures of patient disability over

time and include

quality of life among primary outcomes.

PMID: 14974077 [PubMed - in process]

http://brain.hastypastry.net/forums/showthread.php?t=7382

--- End forwarded message ---