Unhealthy Medicine-Wash Post_Drug Profits Infect Medical Studies

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Sun, 8 Jan 2006 17:43:58 -0500

[sSRI-Research] Unhealthy Medicine-Wash Post_Drug Profits

Infect Medical Studies--LA Times

 

 

 

 

Unhealthy Medicine-Wash Post_Drug Profits Infect Medical Studies--LA Times

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

www.ahrp.org

 

FYI

Two critical commentaries by academic physicians who analyze the

malaise of American medicine are both timely and insightful.

 

 

Dr. Steven Woolf, professor of family medicine, epidemiology and

community health at Virginia Commonwealth University, writing in The

Washington Post, reminds us that the focus of medicine should be on

quality health care delivery. However, he notes, the imbalance in

expenditure for research (an investment n hoped for, not necessarily

delivered, " breakthroughs " ) far outpaces expenditure to ensure that

the American public actually benefits from effective treatments.

 

" We spend far more money on inventing new treatments than on research

into how to deliver them. Last year, Congress gave $29 billion to the

National Institutes of Health, most of it to devise better treatments.

The smaller federal agency responsible for solving problems with the

delivery of health care, the Agency for Healthcare Research and

Quality (AHRQ) , received only $320 million. Starkly put, for every

dollar Congress allocates to develop breakthrough treatments, it

allocates one penny to ensure that Americans actually receive them. "

 

What's more, the cost of health care is so high--thanks to the

billions spent mostly on marketing new, not necessarily improved

treatments-that average Americans are locked out: " According to a

widely cited study in the New England Journal of Medicine [NEJM],

Americans receive only 55 percent of recommended health care services.

And according to the Commonwealth Fund -- a nonprofit whose mission is

to promote a high-performing health care system -- nearly one-third of

the adult population, or 61 million people, cannot obtain care because

they are uninsured or underinsured. Even the insured struggle with

out-of-pocket medical expenses, a leading cause of personal bankruptcy. "

 

Dr. JOHN ABRAMSON, a clinical instructor at Harvard Medical School,

author of " Overdosed America " (HarperCollins, 2004), asks a stark

question exposing the most influential scientific journals to deserved

criticism for being complicit servants of industry, serving as

important cogs in industry's marketing campaigns that are largely

aimed at deluding the American public.

 

Citing " the unwarranted success of Vioxx " Dr. Abramson notes that

" greater safety was the only reason for doctors to have prescribed

Vioxx, given that it provided no better relief of arthritis symptoms

or pain and cost up to 10 times more than the older anti-inflammatory

drug, naproxen (sold without a prescription as Aleve). But Merck's own

study clearly showed that Vioxx was more dangerous than naproxen

overall and caused significantly more heart attacks, blood clots and

strokes - whether or not the patient had a previous history of

cardiovascular disease. "

 

" SO WHY, " he asks, " DID American doctors prescribe $7 billion worth of

Vioxx after Merck and the Food and Drug Administration knew all this? "

 

With this question, Dr. Abramson delivers a thunderbolt punch not only

to the corrupt practices of the pharmaceutical industry-the primary

beneficiaries of America's skewed health care system-but also to the

complicit prestigious scientific journals. By turning a blind eye and

publishing manipulated research reports by paid-for scientists who

often didn't see the data; publishing deceptive advertisements; and

accepting income for reprints of valuable tainted reports that are

then widely disseminated to physicians and the media, the journals

have been complicit in tainting the scientific literature and medical

practice that relies on that literature.

 

 

" Three-quarters of the clinical studies published in the three most

respected medical journals (the New England Journal of Medicine, the

Journal of the American Medical Assn. and the Lancet) are now

commercially funded. As a result, our medical knowledge grows not in

the direction that best improves our health but toward corporate

profits, the way that plants grow toward sunlight. " Thus, " most of the

evidence in what doctors believe to be " evidence-based medicine " is

more infomercial than dispassionate science. "

 

Contact: Vera Hassner Sharav

212-595-8974

veracare

 

 

 

http://www.washingtonpost.com/wp-dyn/content/article/2006/01/06/AR2006010602269_\

pf.html

THE WASHINGTON POST

Unhealthy Medicine

All Breakthrough, No Follow-Through

By Steven H. Woolf

Sunday, January 8, 2006; B03

 

We tend to view medical advances -- the breakthroughs that produce

better medications, technology and procedures -- as the front line in

the war on disease. They capture the media's attention; we marvel over

the technological wizardry and the ingenuity of scientists; and to the

afflicted, each advance gives hope of a cure. The federal government

invests billions of dollars in this enterprise, and competition for

better products drives the highly lucrative pharmaceutical and medical

device industries.

 

But the promise of a cure requires an additional step: Patients must

receive the treatments promptly and properly. This step requires a

well-functioning system to deliver care, which our country lacks. We

spend far more money on inventing new treatments than on research into

how to deliver them. Last year, Congress gave $29 billion to the

National Institutes of Health, most of it to devise better treatments.

The smaller federal agency responsible for solving problems with the

delivery of health care, the Agency for Healthcare Research and

Quality (AHRQ) , received only $320 million. Starkly put, for every

dollar Congress allocates to develop breakthrough treatments, it

allocates one penny to ensure that Americans actually receive them.

 

This imbalance in investment may cost more lives than it saves. A

recent analysis by our research team at Virginia Commonwealth

University demonstrated that developing new treatments often does less

good than ensuring the delivery of older drugs to all those in need.

 

For example, we estimated that reminding physicians to offer

cholesterol treatments to patients seen in the doctor's office would

be seven times more effective in preventing heart attack deaths than

replacing older cholesterol-lowering drugs with more potent medicines,

such as those touted on TV. Even something as simple as more reliably

prescribing aspirin, which we have known for a decade can prevent

strokes, would prevent more strokes than prescribing the slightly more

potent new clot-busting medicines that drug companies have spent

billions of dollars to develop.

 

Physicians like me are admonished to close these gaps in the health

care delivery system, and there are helpful steps we can take in our

daily work. But to expect physicians to fix the problem without making

larger system changes is like telling pilots to stop flying into other

aircraft and not providing them with an effective air traffic control

system.

 

As an individual physician, I cannot restructure referral and

communication systems between local doctors' offices so that my

patients experience seamless handoffs when they go elsewhere for tests

or consultations. I cannot create electronic tools for my community to

remind me and my patients when tests and shots are due and to enable

doctors elsewhere to quickly retrieve and examine my patients' medical

histories.

 

I cannot abolish the insurance company policies that prevent my

patients from obtaining quality care when they should. I cannot create

consumer Web sites that would enable my patients to learn more about

their diagnoses, look up test results and exercise more control over

their health. I cannot curtail rising pharmacy bills that force my

patients to stop getting refills. Those changes can be implemented by

those who manage the systems, not by individual physicians.

 

For now, the statistics on the quality of care in America remain

disturbing: According to a widely cited study in the New England

Journal of Medicine, Americans receive only 55 percent of recommended

health care services. And according to the Commonwealth Fund -- a

nonprofit whose mission is to promote a high-performing health care

system -- nearly one-third of the adult population, or 61 million

people, cannot obtain care because they are uninsured or underinsured.

Even the insured struggle with out-of-pocket medical expenses, a

leading cause of personal bankruptcy.

 

The public complains of delays, rushed visits, impersonal attention

and medical errors. In a world that has embraced modern information

technology, most doctors' offices still use paper charts and regularly

misplace lab reports and telephone messages. Fragmentation in the

system is worsening, causing clumsy handoffs and miscommunication

between doctors. And every aspect of this crisis is worse for the

elderly, minorities and the poor.

 

I am not advocating that medical advances be abandoned in favor of

system solutions -- both are vital. But our leaders do need to find a

new equilibrium between investing in new treatments and investing in

delivering them. Politicians who neglect the unraveling of the health

care system are missing Americans' rising frustration and anger with

doctors, hospitals and insurance companies. A recent poll by the

Kaiser Family Foundation found that 56 percent of Americans are

worried that health care is worsening. In a 2004 survey conducted by

the Commonwealth Fund, 69 percent of Americans felt that improving the

quality of medical care should be a chief concern for Congress.

 

Beyond dissatisfaction, the larger problem with our focus on medical

breakthroughs is that more Americans will die as a result. Solutions

that make the delivery of quality care more systematic are not as sexy

as robotic surgery, gene mapping and other medical advances, but they

are more apt to save lives. Failing to establish systems to ensure

that everyone receives recommended care is causing greater disease and

deaths at levels that can rarely be offset by medical advances.

 

Our inattention to quality of health care delivery is not only bad for

our health, but for the economy. The United States spends 15 percent

of its gross domestic product on health care, twice the average per

capita spending of all industrialized countries. As the costs of

treating disease spiral upward, higher costs are being shifted to

employees, who find their co-payments, insurance premiums and

deductibles climbing. At such a time, the business case for repairing

a dysfunctional delivery system could not be stronger.

 

Establishing organized systems of care would reduce disease

complications and related treatment costs, lower waste and

administrative costs created by inefficiency and produce a healthier,

more productive workforce.

 

Faced with this logic, why do our political leaders invest so little

in such solutions and continue to pour billions of dollars into the

development of new treatments? For some, it is because they share the

public's misconception that medical advances are more important than

repairing the delivery system. Others may not understand how bad the

health care system has become. Budget pressures keep some lawmakers

from doing more about quality. Spending two cents at AHRQ for every

NIH dollar would double the AHRQ budget to $600 million per year, but

that is a non-starter on Capitol Hill.

 

In the end, however, it all comes down to priorities. No organized

political constituency is devoted to lobbying Congress to improve the

quality of health, but perhaps it is time for the American people to

express themselves. After all, it is their health at stake.

 

Perhaps we have reached a point when progress in providing good care

-- when needed, with compassion and skill and without errors -- would

impress the public as a more meaningful " medical advance " than the

rollout of the latest device or pill. This year's congressional

elections offer an opportunity to place the importance of quality care

on the national political agenda. Other issues are important, but this

is a matter of life and death.

 

Author's email: swoolf

Steven Woolf is a professor of family medicine, epidemiology and

community health at Virginia Commonwealth University.

 

© 2006 The Washington Post Company

 

 

 

http://www.latimes.com/news/opinion/commentary/la-oe-abramson7jan07,0,1957242.st\

ory?coll==la-news-comment-opinions

The Los Angeles Times

Drug profits infect medical studies

By John Abramson

January 7, 2006

SEVERAL OF OUR most venerated scientific journals have recently been

besmirched by allegations of scientific misconduct. Shocking? We

should be just as shocked as Inspector Renault when he discovered

gambling at Rick's Cafe in Casablanca.

 

First, the New England Journal of Medicine made public its concerns

about crucial data having been withheld from its 2000 report on a

study sponsored by Merck exaggerating the safety of its blockbuster

drug Vioxx, now withdrawn. Then the lead author of a seminal article

published in the journal Science reporting the creation of viable stem

cells from cloned human embryos admitted he falsified results and

resigned his academic post in disgrace.

 

This week brings the news that a Johnson & Johnson subsidiary failed

to include the deaths of two patients in a clinical trial of its new

drug for heart failure, Natrecor, in an article published in the

Journal of Emergency Medicine.

 

Why shouldn't we be surprised? Because over the last 25 years,

clinical research has been largely privatized. Three-quarters of the

clinical studies published in the three most respected medical

journals (the New England Journal of Medicine, the Journal of the

American Medical Assn. and the Lancet) are now commercially funded. As

a result, our medical knowledge grows not in the direction that best

improves our health but toward corporate profits, the way that plants

grow toward sunlight.

 

This wasn't always so. Before 1980, most medical studies were publicly

funded, and most academic researchers scorned industry support. Now,

however, the vast majority of clinical trials are commercially funded,

and with the financial stakes so high, there is mounting evidence of

individual scientists and corporations manipulating their findings.

 

Even our most trusted journals are dependent on drug-company money.

Drug makers don't just buy advertising in their pages. According to

Richard Horton, editor of the Lancet, they also pay up to $1.75

million for reprints of articles favorable to their drugs, which sales

reps then hand out to doctors.

 

And many journal articles are biased in favor of their sponsors'

products. A 2003 report in the Journal of the American Medical Assn.

found that clinical studies funded by drug companies are three times

more likely to conclude that the sponsor's drug is the treatment of

choice, compared to studies of the same drug that were not

commercially funded. (This study of the effects of commercial bias, by

the way, was funded by Danish research institutions.) The disturbing

conclusion is that most of the evidence in what doctors believe to be

" evidence-based medicine " is more infomercial than dispassionate science.

 

It's vital to protect the integrity of our medical knowledge. But the

current peer review system alone can't do the job. The journals, and

the peer reviewers they rely on, are in the untenable position of

having to trust that corporate sponsors have accurately and completely

reported their findings. At present, journal editors and peer

reviewers typically are not allowed unrestricted access to the data

from commercially sponsored research. Amazingly, many drug

company-funded researchers who write the articles are also not allowed

access to all of the data the company has collected.

 

There is no better cautionary tale than the unwarranted success of

Vioxx. Greater safety was the only reason for doctors to have

prescribed Vioxx, given that it provided no better relief of arthritis

symptoms or pain and cost up to 10 times more than the older

anti-inflammatory drug, naproxen (sold without a prescription as

Aleve). But Merck's own study clearly showed that Vioxx was more

dangerous than naproxen overall and caused significantly more heart

attacks, blood clots and strokes - whether or not the patient had a

previous history of cardiovascular disease.

 

SO WHY DID American doctors prescribe $7 billion worth of Vioxx after

Merck and the Food and Drug Administration knew all this?

 

Because the New England Journal article that ostensibly reported the

results of Merck's study didn't even mention either the cardiovascular

or the overall dangers of Vioxx. Instead, it reported only selective

data on heart attacks and strokes, allowing Merck to claim that Vioxx

wasn't a risk to people without a history of these problems. The

Journal's editors are now accusing Merck of withholding critical data.

Shame on Merck. But shame on the Journal too for not insisting that

the article include a discussion of the most important complications.

Doctors were left with the impression that Vioxx was safer than

naproxen when exactly the opposite was true.

 

The Journal again misled its readers in 2001, when one of its

influential review articles dismissed the dangers of Vioxx as perhaps

reflecting " the play of chance. " This article was published seven

months after FDA reviewers' concerns and Merck's own research data,

which documented the dangers, had been posted on the FDA's website.

Worse, the Journal violated its own policy prohibiting scientists with

conflicts of interest from writing review articles. (Both authors had

financial ties to Merck.) That the Journal disclosed those ties

mitigates neither its ethical breach nor the consequences of its

repeated understatement of the risks of Vioxx.

 

This is hardly an academic argument. According to an article in the

Lancet, based on Merck's own data Vioxx probably caused between 88,000

and 144,000 cases of serious heart disease.

 

The stem cell and Natrecor debacles offer further evidence that the

problem is not just individual bad actors or occasional lapses of

scientific integrity by drug makers. It's that even the most

prestigious journals are unable to perform the quality control that

doctors take for granted.

 

Sadly, the evidence shows that it's time for the journals to change

their policies from trust to " trust, but verify. " They should

introduce a new standard requiring an independent audit of the

accuracy and completeness of research reports before they are sent out

for peer review. These scientific auditors should be statisticians and

medical experts who are completely free of conflicts of interest and

are given unfettered access to the data.

 

The journals will rightfully claim they cannot afford to pay for such

scientific oversight. But the lack of oversight is even more costly.

Americans waste billions each year on drugs of dubious value. Until we

find a way to fund quality controls on published research, the cost of

our medical care will continue to soar and our health will suffer.

 

JOHN ABRAMSON, a clinical instructor at Harvard Medical School, is

author of " Overdosed America " (HarperCollins, 2004). He is a

consultant to attorneys of patients who took Vioxx and are suing Merck.

 

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