How Health Care in America Became Big Business–And Bad Medicine – OpEd NYT – Zoloft NYT Ad Fails to Disclose Suicide risk

How Health Care in America Became Big Business–And Bad Medicine – OpEd NYT
Zoloft NYT Ad Fails to Disclose Suicide risk

Mon, 25 Oct 2004

An Op-Ed in Sunday’ New York Times by Time magazine editors, Donald Barlett and James Steele, is a MUST READ assessment of what ails America’s health care system: Why there’s lots of Viagra and not enough flu vaccine.

"To understand what has gone wrong in health care, one need only look at the booming market for prescription drugs. Once upon a time, drugs were a needs-based product. You received a prescription when you were truly ill. Now many drugs are demand-driven, just like Froot Loops and Lucky Charms."

Although the US spends more per capita for health care, under the current, industy controlled health care system, Americans are getting a raw deal: Life expectancy for Americans ranks 29th in the world–sandwiched between Slovenia and Portugal. Ineffective, even hazardous drugs are diverting scarce resources from needed life-saving medicines. The pharmaceutical industry is undermining the health of Americans, as an impotent oversight agency stands idly by as drug manufacturers market hazardous drugs by making false claims about need, safety and efficacy. Drug companies make billions of dollars by selling drugs that cause heart attacks, stroke, liver damage, blood clots, degenerative muscle damage, or trigger suicidal behavior or induce cancer. And they have never been brought to justice – even when caught concealing life-threatening risks.

The following prescription drugs for reducing various symptoms have produced severe adverse effects that often are more serious than the condition for which they were prescribed. Yet, these drugs are blockbuster sellers, earning manufacturers billions of dollars:

Neurontin, Zoloft, Vioxx, Zyprexa, Risperdal, Paxil, Effexor, Prim-Pro, Oxycontin.

Sunday’s New York Times Magazine included a "special advertising supplement" that included an ad for the antidepressant, Zoloft. Despite FDA’s warning advisory (issued in March 2004), requiring antidepressant drug labels to warn about treatment induced suicidal behavior, the label reproduced in the Times advertisement failed to include the warning about an increased risk of suicide in patients taking antidepressants–as required by the FDA.

Pfizer’s reproduced "summary" of a 2003 Zoloft label in The Times is misleading inasmuch as it denies the role of its drug:

"The possibility of a suicide attempt is inherent in major depressive disorder and may persist until significant remission occurs."

The 2004 Zoloft label (which is read by physicians) includes four paragraphs under the heading "Clinical Worsening and Suicide Risk" including the following statement:

"Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers."

Pfizer failed to disclose the suicide risks in the Times ad – even after the FDA announced that a causal relationship has been established, and the suicide risks will have to be disclosed in a black box warning. The continued concealment of the hazards from the public, demonstrates corporate arrogance and the implicit expectation that the company will not be held accountable. The FDA’s failure to use its authority to prosecute companies that market drugs by concealing their hazards has resulted in preventable deaths and led the pharmaceutical companies to thumb their noses.

Barlett and Steele point out that the reason for the shortage of flu vaccine is that the profits to be had are measly in comparison to Viagra – the same can be said for the failure to produce much needed, new antibiotics, as antibiotic resistant infections are on the rise.

Under the current system, companies have little incentive to produce safe and effective needed drugs that improve people’s health, when it is more profitable to sell hazardous drugs. A cynic might suggest that pharmaceutical companies have done a cost / benefit analysis concluding that by concealing hazardous drug effects, they can reap additional profits from selling therapies to treat drug-induced (iatrogenic) chronic diseases, such as diabetes produced by such atypical antipsychostics as, Zyprexa (olanzapine) and Risperdal (risperidone).

Barlett and Steele call for a single health care agency, something on the order of the recommendation of the 9/11 commission in the area of national security. Such an agency – modeled after the Federal Reserve System – must be independent of industry influence or politics. A central agency would set health care policy and manage all aspects of health care to contain costs and reduce the 100,000 annual deaths due to adverse drug reactions. A central agency would maintain a centralized data base to monitor the safety and effectiveness of treatments and to track adverse drug reactions.

Although the authors don’t mention it, such an agency would be best suited to maintain a clinical trial registry, to replace the covered up harm and manipulation that has undermined the integrity of medical research. By replacing the culture of secrecy with transparency and openness, deceptive research practices – such as concealment of negative results–will be minimized simply by making the data accessible to independent scientists whose evaluation will either validate or refute the claimed findings. A centralized database will eliminate costly duplication of research that leads to blind alleys. Health care analysts will be able to monitor what works, what doesn’t, and ensure that needed, life-saving medicines are in supply. And a single payer agency would negotiate drug prices and eliminate the costly bureaucracy filling out insurance forms for thousands of plans.

Contact: Vera Hassner Sharav
212-595-8974

http://www.nytimes.com/2004/10/24/opinion/24barlettsteele.html?oref=login&pagewanted=print&position=

THE NEW YORK TIMES
October 24, 2004
OP-ED CONTRIBUTOR
The Health of Nations
By DONALD L. BARLETT and JAMES B. STEELE

For years the people in Washington have offered one plan after another that they said would provide health care for all Americans and rein in costs. Each plan has failed. Today more people than ever have inadequate coverage or no insurance at all. And still costs continue to spin out of control.

Notably absent from the rhetoric has been any mention of the existing system’s inherent flaw – the inability of market-based, for-profit medicine to deliver on the political promises.

Two decades ago, when Washington embraced the for-profit model to curb escalating charges, health care spending represented 10.5 percent of gross domestic product. Now it is approaching 16 percent. We spend more per capita on health care than any other developed country. Yet on the important yardsticks, like life expectancy measured in healthy years, we don’t even rank among the top 20 nations. In fact, according to the World Health Organization, we come in an embarrassing 29th, sandwiched between Slovenia and Portugal.

The explanation for this abysmal record is one that politicians decline to discuss. The market functions wonderfully when we want to sell more cereals, cosmetics, cars, computers or any other consumer product. Unfortunately, it doesn’t work in health care, where the goal should hardly be selling more heart bypass operations. Instead, the goal should be to prevent disease and illness. But the money is in the treatment – not prevention – so the market and good health care are at odds. Just how much at odds is seen in the current shortage of flu vaccine, as men and women in their 80’s and 90’s line up for hours at a time, hoping to get the shot they have been told they need, but may not receive because not nearly enough has been manufactured.

The reason for the shortage is this: Preventing a flu epidemic that could kill thousands is not nearly as profitable as making pills for something like erectile dysfunction, a decidedly non-fatal condition. Viagra, for example, brings in more than $1 billion a year for its maker, Pfizer. The profits to be made from selling flu vaccine are measly in comparison. If selling flu vaccine were as lucrative as marketing Viagra, sports broadcasts and the nightly news would be flooded with commercials warning that “winter is almost here; ask your doctor about flu vaccine” – and it would be available to anyone who wanted it. Instead, while many of those at risk of the flu go without the vaccine, primetime programs are sponsored by the makers of Viagra (“Get back to mischief”), Cialis (“Will you be ready?”) and Levitra (“Stay in the game”).

To understand what has gone wrong in health care, one need only look at the booming market for prescription drugs. Once upon a time, drugs were a needs-based product. You received a prescription when you were truly ill. Now many drugs are demand-driven, just like Froot Loops and Lucky Charms. Instead of using the cartoon characters that sell cereals, the drug companies employ celebrities.

One of the earliest was Lauren Hutton, the supermodel whose enthusiastic endorsement of Wyeth’s hormone replacement therapy helped propel prescriptions for all such drugs from 58 million in 1995 to 90 million in 1999. Ms. Hutton made the rounds of the talk shows, telling her “personal” story. She said her doctor warned her that if she didn’t take estrogen, “I was up for colon cancer, eye loss, osteoporosis, shrinkage, lots of things.”

More recently, Merck recruited Dorothy Hamill, the Olympic gold medalist, to pitch Vioxx. “This is my favorite time to skate,” Ms. Hamill said in a commercial. “I guess it’s from all those years of 5 a.m. practices. But it’s also the time when the pain and stiffness of osteoarthritis can be at their worst.”

As has been the case with so many other drugs, estrogen therapy and Vioxx proved to be a triumph of marketing over science. Not only did the hormone replacement drugs fail to provide the promised protection, studies found they increased the risk for developing cancer and heart disease. Vioxx was withdrawn last month after evidence from clinical trials showed that it increased the risk of heart attacks and strokes.

Since 1997, when the Food and Drug Administration loosened restrictions on television commercials for prescription drugs, the marketing departments of pharmaceutical companies have exercised ever-greater influence on which drugs will be brought to market. That’s why we have three drugs to treat erectile dysfunction, a condition that once was called “impotence.” The name change was essential for the products to be sold by the likes of Bob Dole or Mike Ditka, the former Chicago Bears coach.

Aggressive marketing and pricing have made pharmaceutical companies America’s most profitable industry. On the whole, Americans pay higher prices for prescription drugs than anyone else in the world because the United States is the only industrialized nation that does not exert influence over prices.

What’s needed to control the costs and to provide basic health and hospitalization coverage for all Americans is an independent agency that would set national health care policy, collect medical fees, pay claims, reimburse doctors fairly and restrain runaway drug prices – a single-payer system that would eliminate the costly, inefficient bureaucracy generated by thousands of different plans. It’s not such a radical idea; a single-payer system already exists for Medicare.

Such an agency would need to be free of politics and could be modeled on the Federal Reserve System, whose members are appointed to terms that do not coincide with the terms of either the president or the Senate. It could be financed through two taxes, a gross-receipts business tax and a flat tax, similar to Medicare, but on all individual income.

Under a single-payer system, never again would you be asked, when calling to make a medical appointment, “What type of insurance do you have?” Never again would doctors need bloated office staffs to track what is and is not covered under thousands of insurance plans. Never again would you have to worry about being bankrupted by a medical emergency. Never again would American business be saddled with the responsibility for providing health insurance.

A unified, single-payer system could do more than pay the bills. It could gather information to more accurately identify the surgical procedures and drugs that work, and those that don’t. It could funnel research money to where it will do the most good rather than to those areas with the largest and most vocal constituency, thereby treating the victims of various diseases and conditions more equitably.

It could make possible a centralized computer network to reduce the 100,000 deaths each year from adverse drug reactions – a number of fatalities five times greater than those caused by street drugs like cocaine and heroin. Similarly, a nationwide network could track medical errors across the country to increase accountability and to identify hospitals or surgeons who make repeated mistakes. And it could guarantee supplies of needed medications. In short, over time such a system could transform the practice of medicine and give all Americans the first-class health care they deserve – without breaking the bank.

Donald L. Barlett and James B. Steele are editors at large at Time and the authors, most recently, of “Critical Condition: How Health Care in America Became Big Business-And Bad Medicine.”

Copyright 2004 The New York Times Company

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