Cash Interests Taint Drug Advice_NATURE / Death a Risk of Antipsychotics

[Guest guest]

SSRI-Research@

Sun, 23 Oct 2005 17:58:25 -0400

[sSRI-Research] Cash Interests Taint Drug Advice_NATURE /

Death a Risk of Antipsychotics_AP

 

 

 

 

Cash Interests Taint Drug Advice_NATURE / Death a Risk of

Antipsychotics_AP

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

www.ahrp.org

 

FYI

An investigation by the journal, NATURE (the largest of its kind)

reveals that not only do conflicts of interest taint the conduct and

outcome of clinical trials, the authors who formulate clinical

practice guidelines have financial ties to the " relevant drug

companies. " The investigation found that one third of guideline

authors declared financial ties to " relevant drug companies, with

around 70% of panels being affected. "

 

The authors, Rosie Taylor and Jim Giles note, " These links with

pharmaceutical companies are more worrying than the financial conflicts

 

known to plague clinical trials and reviews, say public-health

experts, because the guidelines have such a direct effect on the drugs

that doctors prescribe. “

 

Practice guidelines are " specifically written to influence the

practice of doctors "

 

" In its survey, Nature studied more than 200 guidelines from around

the world that were

deposited with the US National Guideline Clearinghouse in 2004. Only

90 contained

details about individual authors’ conflicts of interest. Of those,

just 31 were free of industry

influence. "

 

Is it any wonder that drugs such as Baycol, Vioxx, Rezulin, Neurontin,

etc, etc become mega profit makers?

 

An example of one of the most audacious marketing schemes ever devised

to increase sales of psychotropic drugs--in particular the second

generation antidepressants and antipsychotics, drugs which (according

to an editorial in the Journal of the American Medical Association,

JAMA) " have raised challenging questions about their adverse effects

and toxic effects. Skeptics of the effectiveness of antipsychotic

drugs in schizophrenia suggested that sedation rather than a direct

drug action was causing patients to report fewer symptoms. "

 

The marketing scheme--which was recommended by the President's New

Freedom Commission on Mental Health-- is TMAP (Texas Medication

Algorithm Project).

 

TMAP is the psychiatric durg industry's roadmap to riches.

 

TMAP prescribing guidelines have elevated ineffective, highly toxic

drugs whose severe adverse effects require manufacturers to include

Black Box warning labels into mega blockbuster status. For example,

the second generation antipsychotics (e.g., Zyprexa, Risperdal,

Seroquel, Zeodon) have failed to demonstrate that they are any more

effective than the old neuroleptics--which have not proven to be

beneficial with long term use. The new 'aypical' antipsychotics are

linked to severe chronic illness: they have been shown to cause

premature death, diabetes (type II) , hypertension, stroke, obesity,

cardiovascular disease, akathisia--a state of unbearable physical and

psychological restlessness, and and long-term neurological

dysfunction. But because they are recommneded as first line treatment

by TMAP guidelines, these dangerous, toxic drugs bring in $10 billion

in US sales.

 

Similarly, the SSRI and SNRI antidepressants that are recommended by

TMAP (e.g., Prozac, Paxil, Zoloft, Celexa, Depakote, Wellbutron,

Zyban, Remeron, Serzone, Effexor, Buspar, Adderall, ) are widely

misprescribed--and they too have severe adverse effects----including

liver damage, mania, aggression, violence and an increased risk of

suicide and suicidal acts.

 

With each passing month, data analysis of the clinical trials in which

the drugs recommended by TMAP were tested, revalt the drugs are not

only therapeutically ineffective, but they trigger irreversible harm

for patients. The Associated Press reports (below) that a meta

analysis of the controlled studies involving elderly patients who were

prescribed an atypical antipsychotic, was published in JAMA:

 

" Among more than 5,000 elderly dementia patients, those taking any of

the drugs faced a 54 percent increased risk of dying within 12 weeks

of starting the medication, compared with patients taking dummy pills.

 

There were 118 deaths among the 3,353 drug users versus 40 in the

1,757-patient placebo group, or 3.5 percent compared with 2.3 percent.

The risks were similar for each of the drugs.

 

The drugs are approved for treating schizophrenia and bipolar disease,

not elderly dementia. But because schizophrenia-like symptoms are

common in elderly patients with Alzheimer's disease or other dementia,

doctors frequently prescribe the drugs to these patients, too. Such

" off-label " uses are legal. "

 

One wonders how much money does the Alzheimer's Association get from

the makers of these drugs?

How else can one explain the following statement by that

organization's medical director?

" " The trade-off is clearly going to be this small risk, and for some

patients, the risk is worth taking. "

 

See: Risk of Death With Atypical Antipsychotic Drug Treatment for Dementia

Meta-analysis of Randomized Placebo-Controlled Trials

Lon S. Schneider, MD, MS; Karen S. Dagerman, MS; Philip Insel, MS

Vol. 294 No. 15, October 19, 2005

 

See also editorial:

 

Contact: Vera Hassner Sharav

212-595-8974

veracare

 

NATURE

Vol 437/ 20 October 2005 / 1070

NEWS

Cash interests taint drug advice

Rosie Taylor and Jim Giles

 

Researchers and physicians who write the rules on prescribing drugs

have extensive

financial connections with the pharmaceutical industry, an

investigation by Nature has

revealed. Public-health experts say that the results of the survey,

which is the largest of its

kind, suggest that drug companies are distorting decisions about how

their products are

being prescribed.

 

In the investigation of the panels that write clinical guidelines †"

documents that govern

the diagnosis and treatment of patients †" Nature found that more

than one-third of

authors declared financial links to relevant drug companies, with

around 70% of panels being

affected. In one case, every member of the panel had been paid by the

company responsible for

the drug that was ultimately recommended.

 

These links with pharmaceutical companies are more worrying than the

financial conflicts

known to plague clinical trials and reviews, say public-health

experts, because the guidelines

have such a direct effect on the drugs that doctors prescribe. “The

guidelines are specifically

written to influence the practice of many physicians,†says Niteesh

Choudhry, a specialist

in health policy at Harvard Medical School. “The effects of

conflicts may be translated

many times over to patients.â€

 

“The numbers in the survey are distressing,†agrees Drummond

Rennie, deputy editor of

the Journal of the American Medical Association and an advocate of

proposals to free

guidelines from industry influence. “Drug company sponsors see

guideline-issuing

bodies as perfect places to exert influence. The practice stinks.â€

 

Misguided?

The guidelines have moved on to doctors’ radar screens over the past

decade or so, in line

with an increased emphasis on using ‘evidence- based’ methods to

treat patients. Many

major professional bodies around the world, such as the American

College of Physicians,

now publish several guideline documents every year. The advice is

based on the results of

clinical trials, and tells doctors which drugs to prescribe and when.

 

In its survey, Nature studied more than 200 guidelines from around the

world that were

deposited with the US National Guideline Clearinghouse in 2004. Only

90 contained

details about individual authors’ conflicts of interest. Of those,

just 31 were free of industry

influence.

 

CONFLICTS OF INTEREST

In 685 disclosures examined in Nature’s survey of authors of

prescription guidelines.*

 

35% of authors said they had a conflict of interest of some kind.

16 authors helped to write guidelines on illnesses relevant to

companies in which they owned stock.

49% of guidelines did not include any details of authors’ conflicts

of interest

 

For full survey results, see

www.nature.com/news/2005/051017/full/4371070a.html

 

Half of those that gave individual details had at least one author

with a conflicting advisory

position in the pharmaceutical industry. More than a third of the

panels included at least one

member who gave seminars on behalf of a relevant drug company. And one

in ten

contained a member who owned stock in a company with products being

considered.

The latter type of conflict is especially worrying, says Bruce Fye of

the Mayo Clinic in Rochester, Minnesota, who raised the issue of

guideline ethics during his presidency of the American College

 

of Cardiology in 2002†" 3. Prescription practices promoted by

guidelines can have a direct

effect on drug sales and thus stock price. “Stock options should be

viewed as unacceptable,†he says.

 

In one example uncovered by Nature, guidelines for the treatment of

anaemia in HIVpositive

patients were written by a working group selected by Paul Volberding,

a leading AIDS researcher and physician, and vice chairman of the

Department of Medicine at the University of California, San Francisco.

Volberding convened the group at the request of Ortho Biotech, a

pharmaceutical company

 

based in Bridgewater, New Jersey. Ortho Biotech funded the group’s

meetings, and all

six members, including Volberding, had been paid by the company for

lecturing or consultancy

jobs. The group’s latest guidelines, published last year

(P.Volberding et al.Clin. Infect.

Dis. 38, 1454†" 1463; 2004), recommend the use of epoetin alpha, a

drug marketed by Ortho Biotech.

 

Slippery stats

Physicians’ organizations say that one or two authors with a

conflict of interest could not

influence a panel containing tens of members. But assessing just how

many authors

have such conflicts is difficult. In the Nature survey, 35% of the 685

authors involved

declared conflicting industry links (see graphic). Experts say that

this is likely to be

an underestimate, however, because it relies on authors’ own

declarations.

For example, the Center for Science in the Public Interest (CSPI),

based in Washington

DC, examined the disclosure statements on some randomly chosen

blood-pressure

guidelines published last year. Only one author declared a conflict of

interest, but further

checks by the CSPI revealed that four other authors had failed to

disclose research funding

from relevant drug companies.

 

The problem could be even worse in guidelines that don’t contain

conflict-of-interest

declarations, warns Merrill Goozner, director of the CSPI’s

Integrity in Science project. “It is

usually the journals and supplements that rely heavily on industry

advertising that are

least likely to have good disclosure policies.â€

 

The organizations that produce guidelines argue that industry links do

not necessarily

lead to biased advice. Some employ review panels to check prospective

guidelines †"

although conflicts of interest are just as likely to occur in review

panels. And authors insist

that they are careful to avoid bias. “We realized this would be a

concern and so looked very

“It’s not true that people can remain completely objective.â€

 

carefully at our recommendation,†says Volberding of the HIV

guidelines. “The committee

really was independent in its deliberations.†Critics say that the

influence exerted by

industry money is unconscious but powerful.

 

Funding for conference travel and accommodation has been linked with

increased

requests for a sponsor’s drug, for example. And meetings with drug

reps both decrease

physicians’ ability to spot erroneous claims about medications and

increase their requests

for new drugs with no demonstrated advantage over generics (A. Wazana

J. Am. Med.

Assoc. 283, 373†" 380; 2000).

 

“It’s not true that people can remain completely objective,â€

says Peter Gøtzsche, director

of the Nordic Cochrane Centre in Copenhagen, Denmark, which runs

independent

reviews of drug efficacy. Gøtzsche and others want guidelines to be

prepared in ways that reduce the potential for bias. Some such schemes

already exist. In Britain, for example, guidelines are provided by a

government-funded body called the National Institute for Health and

Clinical Excellence (NICE).

 

Although some of the experts used by NICE have industry links, the

institute itself is independent of industry and consults with other

stakeholders, such as patients’ groups.

 

Expert witnesses

In the United States an alternative process is being used for

conditions where there is conflicting

evidence as to the best treatment. Experts in a particular condition

†" those most likely to have relevant industry links †" are used as

witnesses, but the panel members themselves are chosen for their

skills at examining medical data. “If you have a conflict of

interest you can’t be on the panel,†says Susan Rossi, deputy

director of the Office of Medical Applications of Research at the

National Institutes of Health, which runs the scheme.

 

But the bodies that produce guidelines maintain that there just

aren’t enough experts without conflicts of interest. Nathaniel Clark

of the American Diabetes Association estimates that three-quarters of

members eligible to write guidelines have industry links, and other

organizations report a similar number.

 

The latest figures underline the urgency of breaking the deadlock. In

2002, Choudhry and

colleagues found similar levels of conflicts of interest, but he says

that physicians have since

assumed that disclosing conflicts is all that is required to solve the

problem. With drugcompany

stock-holders still sitting on the panels that make prescription

decisions, Choudhry warns: “We need a better way to deal with

conflicts of interest.†â–

 

© 2005 Nature PublishingGroup

 

 

 

The Associated Press reports that a new study fount that antipsychotic

drugs--Zyprexa, Risperdal, Seroquel and Abilify-- " can raise their risk

of death " in patients with dementia.

 

 

The irony is, the so-called non-profit group that claims it advocates

for patients with dementia finds a " bright " side. AP reports:

 

" William Thies, scientific director of the Alzheimer's Association,

said: " The trade-off is clearly going to be this small risk, and for

some patients, the risk is worth taking. "

 

What authority does William Thies have to make that jundgement?

 

 

 

 

Contact: Vera Hassner Sharav

212-595-8974

veracare

 

SEATTLE POST-INTELLIGENCER

http://seattlepi.nwsource.com/health/1500AP_Dementia_Drug_Risks.html

 

Tuesday, October 18, 2005 · Last updated 4:32 p.m. PT

 

Dementia drugs can increase death risks

 

By LINDSEY TANNER

AP MEDICAL WRITER

 

CHICAGO -- Drugs often used to treat elderly patients with

dementia-related aggression and delusions can raise their risk of

death, according to a study that reinforces new warning labels

required on the medications.

 

The researchers pooled results of 15 previous studies on drugs known

as atypical anti-psychotics and sold under the brand names Zyprexa,

Risperdal, Seroquel and Abilify.

 

Among more than 5,000 elderly dementia patients, those taking any of

the drugs faced a 54 percent increased risk of dying within 12 weeks

of starting the medication, compared with patients taking dummy pills.

 

There were 118 deaths among the 3,353 drug users versus 40 in the

1,757-patient placebo group, or 3.5 percent compared with 2.3 percent.

The risks were similar for each of the drugs.

 

The drugs are approved for treating schizophrenia and bipolar disease,

not elderly dementia. But because schizophrenia-like symptoms are

common in elderly patients with Alzheimer's disease or other dementia,

doctors frequently prescribe the drugs to these patients, too. Such

" off-label " uses are legal.

 

The study gave no information on the causes of death, but the Food and

Drug Administration warned in April that the drugs have been linked to

deaths from heart failure and pneumonia in elderly dementia patients.

At the FDA's request, manufacturers recently revised their drug labels

to include strong warnings of the increased risk of death.

 

Dr. Lon Schneider, a University of Southern California psychiatrist

and the study's lead author, said the results should instill caution

" but not a great sense of fear. "

 

" These drugs are clinically needed and there are actually few

alternatives " for elderly dementia patients, Schneider said.

 

Withholding the drugs from patients who need them could also prove

dangerous, by increasing the chances they might harm themselves and

others, he said.

 

The study appears in Wednesday's Journal of the American Medical

Association.

 

Dr. Ronald Landbloom of Zyprexa maker Eli Lilly & Co. said the drugs

" can be very helpful with aggressive psychotic patients who are

beating up caregivers and nursing home staff, and hurting themselves, "

but doctors need to be aware of the risks.

 

William Thies, scientific director of the Alzheimer's Association,

said up to about half of all Alzheimer's patients develop problems the

drugs can treat.

 

" The trade-off is clearly going to be this small risk, " and for some

patients, the risk is worth taking, Thies said.

 

---

On the Net: JAMA: http://www.jama.ama-assn.org

 

FAIR USE NOTICE: This may contain copyrighted (© ) material the use

of which has not always been specifically authorized by the copyright

owner. Such material is made available for educational purposes, to

advance understanding of human rights, democracy, scientific, moral,

ethical, and social justice issues, etc. It is believed that this

constitutes a 'fair use' of any such copyrighted material as provided

for in Title 17 U.S.C. section 107 of the US Copyright Law. This

material is distributed without profit.