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

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
veracare@ahrp.org

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@vcu.edu
Steven Woolf is a professor of family medicine, epidemiology and community health at Virginia Commonwealth University.   © 2006 The Washington Post Company

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