Another critique of ALLHAT

I have felt like a voice in the wilderness. The ALLHAT study had critical flaws which diminish the extrapolations one can use in practice. I am not alone – Hyper Hypertension Hype

But neither the Times nor the NHLBI told the whole story: Most of the cheaper-is-better rhetoric rests largely on the fact that there was a 40-percent increase in strokes in African Americans receiving ACE inhibitors instead of diuretics. And it turns out that the increase was a function of the study design: Heart specialists know that blacks are less likely to die of stroke on diuretics. Yet many blacks in the study received the ACE inhibitors first and were not allowed diuretics anyway, since the inhibitors were being tested against the other drugs. It is not a far stretch to say this study demonstrated the stroke benefit of diuretics by unfairly denying blacks optimal care. What would have happened if blacks had been treated appropriately in the first place?

Indeed, since combination therapy is crucial to superior outcomes, it’s curious the study should have obsessed about the drug-to-drug face-off. The hypertension study found that in the first year, about 17 percent of all patients each were randomly assigned to a medicine had switched to another drug for reasons including such side effects as increased cholesterol or risk of diabetes. In the first year, at least 25 percent of all patients were taking one or more other blood-pressure drugs in addition to the one assigned to them in the experiment. By the end of the study ? the fifth year ? 40 percent of all patients were taking a combination of drugs that included beta blockers (which were not even evaluated in the head-to-head part of the study).

This analysis resembles mine at the time of the study release. The author is a bit more strident than me –

Large-scale trials should focus on comparing approaches to treatment ? not just drugs. As the study shows: Unless they compare all patients in all circumstances, trials tell us little more than what we want to hear. The NHLIB study must receive further scrutiny before the politicians and pundits begin attempting to dictate Medicare prescription-drug policy. To do any less would be to allow medical research to become a political tool, and to place life-and-death decisions in the hands of the New York Times and elected officials, not doctors and patients.

One of my teaching mottos is ‘Context!’. In this case one must consider the context of the study. Clearly diuretics work as first line agents. Clearly ACE inhibitors are desirable for many reasons (renal disease, heart disease, even prevention of diabetes in some patients). They work very well in combination. But this study excluded that possibility. So we spent $40 million dollars and really asked the wrong question!

Krauthammer on malpractice

Yesterday evening my son pointed me to this article. Sick, Tired and Not Taking It Anymore: Surgeons are striking in West Virginia. Here’s how to cure what ails them

Surgeons in West Virginia have gone on strike to protest the exorbitant cost of malpractice insurance. Good for them. Don’t talk to me about the ethics of doctors going on strike. So long as they agree to treat emergency cases, they have as much right to strike as anybody else. The premise of a free market is that people can withhold their labor if they find the conditions under which they work intolerable.

Many doctors do. Many, especially those in the inherently risky specialties, such as surgery or obstetrics, have been forced out of business by malpractice premiums or hounded out by malpractice litigation. A totally irresponsible legal system, driven by a small cadre of lawyers who have hit the mother lode, has produced perhaps the most dysfunctional medical-liability system in the world. Juries hand out millions of dollars not just for lost earnings but also in capricious punitive damages in which the number of zeros attached to the penalty seems to be chosen at random.

Please read the entire piece. Krauthammer has nailed this subject!

Health care priorities

The Institutue of Medicine has released 20 health care priorities – areas on which we should focus greater efforts. Ensuring World-Class Health Care

The priority areas, which were not ranked, are:
Asthma, doing a better job of supporting and treating those with chronic conditions.

Care coordination for the approximately 60 million patients with multiple chronic conditions.

Children with special health and care needs, particularly those with chronic conditions who require more than the normal level of care.

Diabetes, which can lead to high blood pressure, heart disease, blindness and other complications.

End-of-life care for people with advanced organ failures, concentrating on reducing symptoms.

Evidence-based cancer screening, which can reduce death rates for many cancers, including colorectal and cervical.

Frailty associated with old age, focusing on preventing falls, treating bedsores and improving advanced care.

High blood pressure. One-third of victims aren’t aware of the disease, but left untreated it can lead to heart attack, stroke and kidney failure.

Immunization. “Every year diseases that can be prevented kill about 300 children and between 50,000 and 70,000 adults,” the committee said. Major killers: flu and pneumonia.

Ischemic heart disease, also known as coronary heart disease. Efforts should focus on prevention.

Major depression, which currently has a much lower treatment rate that other major diseases.

Medication management to prevent errors.

Noscomal infections. These are infections acquired in the hospital and kill an estimated 90,000 Americans annually.

Obesity, which is blamed for as many as 300,000 deaths annually in the United States.

Pain control in advanced cancer.

Pregnancy and childbirth, especially improving the quality of prenatal care.

Self-management and health literacy, using public and private organizations to increase the level of health education.

Severe and persistent mental illness; improving mental health care in the public sector, including state hospitals and community centers.

Stroke, the third highest cause of death in America.

Tobacco-dependence treatment for adults.

Not a bad list in my viewpoint but let me add this disclaimer – I once served on an IOM panel.

Spiraling health care costs

Recently I wrote about increasing health care costs, and the reasons behind those increases. Today the NY Times addresses the issue – Spending on Health Care Increased Sharply in 2001.

The major reason for the increase in health spending, Ms. Levit said, was an increase in the amount of medical goods and services purchased to care for an aging population.
“There was some increase in prices, but it was not as large as the increase in quantity,” Ms. Levit said. The increase in quantity took many forms: more days spent in hospitals, more outpatient services, more diagnostic tests, more prescriptions and greater use of new technology, which has the potential to extend life and improve its quality.

Patients seek more health care. An unintended consequence of extending life expectancy for somel diseases is increased health care costs! For example, using ACE inhibitors and beta blockers markedly improve survival for heart failure patients. During those additional years, the patients require more care – both for their heart disease and for other disease that patients their age develop. Thus, we will spend more money as we improve health care.

Democrats said the new data to supported their view that Medicare was more efficient than private insurance.

“Medicare increased payments to providers such as hospitals, home health agencies and nursing homes and still managed to keep overall spending growth to 7.8 percent in 2001,” said Representative Pete Stark, Democrat of California. “Meanwhile, private insurance premiums went up 10.5 percent. Given these results, I cannot understand why Republicans continue to devise plans for turning Medicare over to private health insurers and H.M.O.’s.”
But Republicans said that consumers had little incentive to shop for bargains in the health care market because they were insulated from most costs. Of every $100 spent on health care, consumers pay $14 from their own pockets, for co-payments and deductibles and items not covered by insurance.

Even though 41 million Americans are uninsured, the United States devotes more of its economy to health care than other industrial countries. In 2000, health accounted for 10.7 percent of the gross domestic product in Switzerland, 10.6 percent in Germany, 9.5 percent in France and 9.1 percent in Canada, according to the Organization for Economic Cooperation and Development.

The Democrats and the Republicans – so surprising that they view the same data differently! As Medicare decreases reimbursements (or fails to increase others), physicians, health care workers and hospitals shift costs to private insurers. One cannot look at Medicare alone and say that it is more efficient. It is efficient only at having physician limiting new Medicare patients (as I have written about often).

The Republicans do make an important point. Some health care costs come because the patient has no incentive to consider costs. That is a main argument for MSAs (medical savings accounts). For those who want the source article – Trends In U.S. Health Care Spending, 2001 Their abstract (the article requires subscription or you may buy it online) –

U.S. health care spending grew 8.7 percent to $5,035 per capita in 2001. Total public funding continued to accelerate, increasing 9.4 percent and exceeding private funding growth by 1.2 percentage points. This acceleration was due in part to increased Medicaid spending in the midst of a recession and payment increases for Medicare providers. Prompted by sluggish economic growth and by faster-paced health spending, health spending?s share of GDP spiked 0.8 percentage points in 2001 to 14.1 percent.