What researchers don't want you to know about their clinical trials

[Guest guest]

Great article by the L.A. Times - link provided at the end of Mike

' article posted by me

earlier

http://latimesblogs.latimes.com/booster_shots/2009/10/clinical-trials-adverse-side-effects.html

Booster

Shots

Oddities, musings and news from

the world of health

What researchers don't want you to know about their clinical trials

October 26, 2009 | 1:01 pm

Clinical

trials can tell us whether new drugs or medical procedures work

better for patients than the old ways of doing things. They can also tell

us whether a new treatment is dangerous. But medical researchers

routinely emphasize the upside of the intervention they studied while

glossing over its risks for patients, according to a new report.

“The reporting of harm is as important as the reporting of efficacy

in publications of clinical trials,” a group of French researchers wrote

in a study being

published in Tuesday’s edition of

Archives of Internal

Medicine. “However, harm is frequently insufficiently

reported.”

How insufficiently?

The researchers examined 133 studies published throughout 2006 in five of

the most influential medical journals – New England Journal of Medicine,

Lancet, Journal of the American Medical Assn., British Medical Journal

and ls of Internal Medicine. Of those studies, 83% assessed new

drugs, and 55% were funded in whole or in part by for-profit

companies.

A total of 15 studies, or 11%, made no mention of any

adverse events whatsoever, the researchers found. An additional six

studies mentioned adverse events but didn’t provide any numerical data

about them.

Even when articles did include hard numbers, they were often presented in

a distorted way. For instance, 36 studies didn’t distinguish between

minor and severe side effects. Seventeen studies reported only the most

common side effects, and an additional 16 included only the most severe.

Five of the studies restricted themselves to the side effects that were

linked to the drug or treatment being studied in a

statistically significant way. (Such side effects are rare, since

clinical trials aren't designed to detect them.)

The numbers can also be distorted by focusing on the number of study

participants who had an adverse reaction instead of giving the total

number of adverse reactions. Of the 90 studies that included numerical

data on side effects, 31 did this, according to the French

researchers.

Only 17 articles described adverse events that prompted volunteers to

withdraw from studies; 63 gave no data on such withdrawals, the

researchers found.

The

Consolidated

Standards of Reporting Trials (a.k.a. “CONSORT”) was amended in 2001

to emphasize the necessity of reporting “all important adverse events or

side effects.” But clearly, the French team concluded, “the reporting of

harm remains inadequate.”

Dr. Ioannidis of the University of Ioannina School of Medicine in

Greece, was one of the first researchers to study the way safety data are

conveyed in medical journals. In an editorial accompanying the French

study, he attributed some of the under-reporting to companies intent on

“silencing the evidence” that their products could be harmful to

patients.

Ioannidis singled out the cases of

Vioxx, a painkiller that was withdrawn from the market because it

doubled the risk of heart attack and stroke, and Neurontin, an epilepsy

drug that the Food and Drug Administration linked to an 80% increase in

suicidal thoughts and behavior.

“In these cases,” he wrote, “marketing needs prevail over scientific

accuracy and clinical prudence.”

-- Kaplan

Photo: If the side effects of Vioxx were more accurately reported

during clinical trials, some deaths may have been averted. Credit:

Hulshizer/Associated Press

Sheri Nakken, R.N., MA, Hahnemannian

Homeopath

Vaccination Information & Choice Network, Washington State, USA

Vaccines -

http://www.nccn.net/~wwithin/vaccine.htm or

http://www.wellwithin1.com/vaccine.htm

Vaccine Dangers, Childhood Disease Classes & Homeopathy

Online/email courses - next classes start October 28 & 29

http://www.wellwithin1.com/vaccineclass.htm or

http://www.wellwithin1.com/homeo.htm

[Guest guest]

Great article by the L.A. Times - link provided at the end of Mike

' article posted by me

earlier

http://latimesblogs.latimes.com/booster_shots/2009/10/clinical-trials-adverse-side-effects.html

Booster

Shots

Oddities, musings and news from

the world of health

What researchers don't want you to know about their clinical trials

October 26, 2009 | 1:01 pm

Clinical

trials can tell us whether new drugs or medical procedures work

better for patients than the old ways of doing things. They can also tell

us whether a new treatment is dangerous. But medical researchers

routinely emphasize the upside of the intervention they studied while

glossing over its risks for patients, according to a new report.

“The reporting of harm is as important as the reporting of efficacy

in publications of clinical trials,” a group of French researchers wrote

in a study being

published in Tuesday’s edition of

Archives of Internal

Medicine. “However, harm is frequently insufficiently

reported.”

How insufficiently?

The researchers examined 133 studies published throughout 2006 in five of

the most influential medical journals – New England Journal of Medicine,

Lancet, Journal of the American Medical Assn., British Medical Journal

and ls of Internal Medicine. Of those studies, 83% assessed new

drugs, and 55% were funded in whole or in part by for-profit

companies.

A total of 15 studies, or 11%, made no mention of any

adverse events whatsoever, the researchers found. An additional six

studies mentioned adverse events but didn’t provide any numerical data

about them.

Even when articles did include hard numbers, they were often presented in

a distorted way. For instance, 36 studies didn’t distinguish between

minor and severe side effects. Seventeen studies reported only the most

common side effects, and an additional 16 included only the most severe.

Five of the studies restricted themselves to the side effects that were

linked to the drug or treatment being studied in a

statistically significant way. (Such side effects are rare, since

clinical trials aren't designed to detect them.)

The numbers can also be distorted by focusing on the number of study

participants who had an adverse reaction instead of giving the total

number of adverse reactions. Of the 90 studies that included numerical

data on side effects, 31 did this, according to the French

researchers.

Only 17 articles described adverse events that prompted volunteers to

withdraw from studies; 63 gave no data on such withdrawals, the

researchers found.

The

Consolidated

Standards of Reporting Trials (a.k.a. “CONSORT”) was amended in 2001

to emphasize the necessity of reporting “all important adverse events or

side effects.” But clearly, the French team concluded, “the reporting of

harm remains inadequate.”

Dr. Ioannidis of the University of Ioannina School of Medicine in

Greece, was one of the first researchers to study the way safety data are

conveyed in medical journals. In an editorial accompanying the French

study, he attributed some of the under-reporting to companies intent on

“silencing the evidence” that their products could be harmful to

patients.

Ioannidis singled out the cases of

Vioxx, a painkiller that was withdrawn from the market because it

doubled the risk of heart attack and stroke, and Neurontin, an epilepsy

drug that the Food and Drug Administration linked to an 80% increase in

suicidal thoughts and behavior.

“In these cases,” he wrote, “marketing needs prevail over scientific

accuracy and clinical prudence.”

-- Kaplan

Photo: If the side effects of Vioxx were more accurately reported

during clinical trials, some deaths may have been averted. Credit:

Hulshizer/Associated Press

Sheri Nakken, R.N., MA, Hahnemannian

Homeopath

Vaccination Information & Choice Network, Washington State, USA

Vaccines -

http://www.nccn.net/~wwithin/vaccine.htm or

http://www.wellwithin1.com/vaccine.htm

Vaccine Dangers, Childhood Disease Classes & Homeopathy

Online/email courses - next classes start October 28 & 29

http://www.wellwithin1.com/vaccineclass.htm or

http://www.wellwithin1.com/homeo.htm