Alicia Ault

BALTIMORE — With at least six drugs and several devices to choose from for heart failure, it's important to approach asymptomatic and symptomatic patients differently, Dr. Edward Kasper said at a cardiovascular conference sponsored by Johns Hopkins University.

Dr. Kasper bases his treatment decisions on the 2005 guidelines from the American College of Cardiology and the American Heart Association for the diagnosis and management of chronic heart failure in adults (J. Am. Coll. Cardiol. 2005;46:e1–82).

For asymptomatic patients, the evidence is strong that ACE inhibitors reduce mortality, said Dr. Kasper, chief of cardiology at Johns Hopkins Bayview Medical Center, Baltimore. The best data come from the Studies of Left Ventricular Dysfunction (SOLVD) trial (N. Engl. J. Med. 1992;327:685–91) and from a separate long-term follow-up of the patients that found that after 12 years, 50.9% of those taking enalapril had died, versus 56.4% of those taking placebo (Lancet 2003;361:1843–8).

The data are not as clear for angiotensin receptor blockers or β-blockers in asymptomatic patients. Post-MI, both β-blockers and ACE inhibitors reduce mortality, Dr. Kasper said.

For primary prevention in asymptomatic patients with ischemic cardiomyopathy and an ejection fraction of less than 30%, implantable cardioverter defibrillators (ICDs) are the best choice, as shown in the Multicenter Automatic Defibrillator Implantation Trial II (MADIT-II). Patients were randomly assigned to a defibrillator or conventional medical therapy. The death rate was substantially lower for the ICD group—14%, compared with 20% for medical therapy. The results do not apply to nonischemic myopathy, he said.

For symptomatic patients, the first line is diuretics and restricted salt intake. β-Blockers and ACE inhibitors are also employed. Dr. Kasper cautioned against using NSAIDs for gout, noting that the drugs can worsen the heart failure. Most antiarrhythmics are contraindicated for the same reasons, Dr. Kasper said.

The main data backing ACE inhibitors in symptomatic patients come from the treatment arm of the SOLVD trial, and Cooperative North Scandinavian Enalapril Survival Study (CONSENSUS I) (N. Engl. J. Med. 1987;316:1429–35). Mortality was substantially reduced in both. The exact ACE inhibitor is not important, Dr. Kasper said. But the choice of β-blocker is important, he said. A study in 2003 in 3,029 patients with New York Heart Association class II-IV heart failure and an ejection fraction of less than 35% were randomized to 25 mg of carvedilol twice daily or 50 mg of metoprolol tartrate (Lopressor) twice daily. With a mean follow-up of 58 months, the all-cause mortality was 34% in the carvedilol group, compared with 40% in the metoprolol group (Lancet 2003;362:7–13).

Dr. Kasper said he generally uses carvedilol in new patients and either carvedilol or metoprolol succinate (Toprol XL) in established patients. Both drugs have been approved for the treatment of chronic heart failure.

For ICDs, the guidelines suggest implantation for class II or III patients who have an ejection fraction of less than 30%; patients with ischemic cardiomyopathy should be at least 40 days post MI. The primary data supporting a reduction in mortality come from the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) (N. Engl. J. Med. 2005;352:225–37). Implant candidates should have a life expectancy of at least a year, Dr. Kasper said.

Pacemakers should be considered in class III or IV patients who have an ejection fraction of less than 35% and a history of hospitalization or medical therapy, he said. The Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) study showed that biventricular stimulation with or without an ICD reduced the risk of death and hospitalization (N. Engl. J. Med. 2004;350:2140–50).

BALTIMORE — With at least six drugs and several devices to choose from for heart failure, it's important to approach asymptomatic and symptomatic patients differently, Dr. Edward Kasper said at a cardiovascular conference sponsored by Johns Hopkins University.

Dr. Kasper bases his treatment decisions on the 2005 guidelines from the American College of Cardiology and the American Heart Association for the diagnosis and management of chronic heart failure in adults (J. Am. Coll. Cardiol. 2005;46:e1–82).

For asymptomatic patients, the evidence is strong that ACE inhibitors reduce mortality, said Dr. Kasper, chief of cardiology at Johns Hopkins Bayview Medical Center, Baltimore. The best data come from the Studies of Left Ventricular Dysfunction (SOLVD) trial (N. Engl. J. Med. 1992;327:685–91) and from a separate long-term follow-up of the patients that found that after 12 years, 50.9% of those taking enalapril had died, versus 56.4% of those taking placebo (Lancet 2003;361:1843–8).

The data are not as clear for angiotensin receptor blockers or β-blockers in asymptomatic patients. Post-MI, both β-blockers and ACE inhibitors reduce mortality, Dr. Kasper said.

For primary prevention in asymptomatic patients with ischemic cardiomyopathy and an ejection fraction of less than 30%, implantable cardioverter defibrillators (ICDs) are the best choice, as shown in the Multicenter Automatic Defibrillator Implantation Trial II (MADIT-II). Patients were randomly assigned to a defibrillator or conventional medical therapy. The death rate was substantially lower for the ICD group—14%, compared with 20% for medical therapy. The results do not apply to nonischemic myopathy, he said.

For symptomatic patients, the first line is diuretics and restricted salt intake. β-Blockers and ACE inhibitors are also employed. Dr. Kasper cautioned against using NSAIDs for gout, noting that the drugs can worsen the heart failure. Most antiarrhythmics are contraindicated for the same reasons, Dr. Kasper said.

The main data backing ACE inhibitors in symptomatic patients come from the treatment arm of the SOLVD trial, and Cooperative North Scandinavian Enalapril Survival Study (CONSENSUS I) (N. Engl. J. Med. 1987;316:1429–35). Mortality was substantially reduced in both. The exact ACE inhibitor is not important, Dr. Kasper said. But the choice of β-blocker is important, he said. A study in 2003 in 3,029 patients with New York Heart Association class II-IV heart failure and an ejection fraction of less than 35% were randomized to 25 mg of carvedilol twice daily or 50 mg of metoprolol tartrate (Lopressor) twice daily. With a mean follow-up of 58 months, the all-cause mortality was 34% in the carvedilol group, compared with 40% in the metoprolol group (Lancet 2003;362:7–13).

Dr. Kasper said he generally uses carvedilol in new patients and either carvedilol or metoprolol succinate (Toprol XL) in established patients. Both drugs have been approved for the treatment of chronic heart failure.

For ICDs, the guidelines suggest implantation for class II or III patients who have an ejection fraction of less than 30%; patients with ischemic cardiomyopathy should be at least 40 days post MI. The primary data supporting a reduction in mortality come from the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) (N. Engl. J. Med. 2005;352:225–37). Implant candidates should have a life expectancy of at least a year, Dr. Kasper said.

Pacemakers should be considered in class III or IV patients who have an ejection fraction of less than 35% and a history of hospitalization or medical therapy, he said. The Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) study showed that biventricular stimulation with or without an ICD reduced the risk of death and hospitalization (N. Engl. J. Med. 2004;350:2140–50).

BALTIMORE — With at least six drugs and several devices to choose from for heart failure, it's important to approach asymptomatic and symptomatic patients differently, Dr. Edward Kasper said at a cardiovascular conference sponsored by Johns Hopkins University.

Dr. Kasper bases his treatment decisions on the 2005 guidelines from the American College of Cardiology and the American Heart Association for the diagnosis and management of chronic heart failure in adults (J. Am. Coll. Cardiol. 2005;46:e1–82).

For asymptomatic patients, the evidence is strong that ACE inhibitors reduce mortality, said Dr. Kasper, chief of cardiology at Johns Hopkins Bayview Medical Center, Baltimore. The best data come from the Studies of Left Ventricular Dysfunction (SOLVD) trial (N. Engl. J. Med. 1992;327:685–91) and from a separate long-term follow-up of the patients that found that after 12 years, 50.9% of those taking enalapril had died, versus 56.4% of those taking placebo (Lancet 2003;361:1843–8).

The data are not as clear for angiotensin receptor blockers or β-blockers in asymptomatic patients. Post-MI, both β-blockers and ACE inhibitors reduce mortality, Dr. Kasper said.

For primary prevention in asymptomatic patients with ischemic cardiomyopathy and an ejection fraction of less than 30%, implantable cardioverter defibrillators (ICDs) are the best choice, as shown in the Multicenter Automatic Defibrillator Implantation Trial II (MADIT-II). Patients were randomly assigned to a defibrillator or conventional medical therapy. The death rate was substantially lower for the ICD group—14%, compared with 20% for medical therapy. The results do not apply to nonischemic myopathy, he said.

For symptomatic patients, the first line is diuretics and restricted salt intake. β-Blockers and ACE inhibitors are also employed. Dr. Kasper cautioned against using NSAIDs for gout, noting that the drugs can worsen the heart failure. Most antiarrhythmics are contraindicated for the same reasons, Dr. Kasper said.

The main data backing ACE inhibitors in symptomatic patients come from the treatment arm of the SOLVD trial, and Cooperative North Scandinavian Enalapril Survival Study (CONSENSUS I) (N. Engl. J. Med. 1987;316:1429–35). Mortality was substantially reduced in both. The exact ACE inhibitor is not important, Dr. Kasper said. But the choice of β-blocker is important, he said. A study in 2003 in 3,029 patients with New York Heart Association class II-IV heart failure and an ejection fraction of less than 35% were randomized to 25 mg of carvedilol twice daily or 50 mg of metoprolol tartrate (Lopressor) twice daily. With a mean follow-up of 58 months, the all-cause mortality was 34% in the carvedilol group, compared with 40% in the metoprolol group (Lancet 2003;362:7–13).

Dr. Kasper said he generally uses carvedilol in new patients and either carvedilol or metoprolol succinate (Toprol XL) in established patients. Both drugs have been approved for the treatment of chronic heart failure.

For ICDs, the guidelines suggest implantation for class II or III patients who have an ejection fraction of less than 30%; patients with ischemic cardiomyopathy should be at least 40 days post MI. The primary data supporting a reduction in mortality come from the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) (N. Engl. J. Med. 2005;352:225–37). Implant candidates should have a life expectancy of at least a year, Dr. Kasper said.

Pacemakers should be considered in class III or IV patients who have an ejection fraction of less than 35% and a history of hospitalization or medical therapy, he said. The Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) study showed that biventricular stimulation with or without an ICD reduced the risk of death and hospitalization (N. Engl. J. Med. 2004;350:2140–50).

GAITHERSBURG, MD. — A Food and Drug Administration advisory committee declared that modafinil is not safe for treating ADHD in children and adolescents by a 12–1 vote, although committee members unanimously agreed the drug was effective for that indication.

At a meeting of the FDA's Psychopharmacologic Drugs Advisory Committee, the panel members were mainly concerned about modafinil's potential to cause Stevens-Johnson syndrome (SJS). The severe rash, which is often due to a hypersensitivity reaction to a drug, can be fatal in up to 5% of cases, according to Dr. Michael E. Bigby of the dermatology department at Harvard Medical School, Boston, and consultant to the panel.

Among 933 children and adolescents exposed to the drug during trials, there were 12 cases that could have been definite erythema multiforme (EM) or SJS, early prodromal EM or SJS, or suggestive of prodromal EM or SJS—a rate of 1.29%, said Dr. Glenn B. Mannheim, a medical reviewer in the FDA's division of psychiatry products.

The panel's discussion focused on one case that seemed most likely to be SJS—indicating a 1 in 1,000 risk. But they were not certain that was the true risk.

Dr. Bigby and Dr. Mannheim said that more cases could occur once modafinil (Provigil) is more widely used—even though there have been no reports of SJS in the 36,000 children who were prescribed the drug off-label in 2002–2005.

Given the trial data and the assumption that modafinil could capture 10% of the market for children under age 19 (based on other stimulants' sales), there could be 500–3,250 cases of EM or SJS, and 25–488 deaths, said Dr. Mannheim.

The dichotomy between the postmarketing experience and the trial data prompted the FDA to seek its advisers' input, said Dr. Robert J. Temple, director of the FDA's office of medical policy.

The FDA usually follows the advice of its panels.

The FDA has received six reports of serious skin reactions in adults, said Dr. Mannheim.

“I'd like to see an opportunity for the company to come back with additional data. That will give us additional assurance that this case was a fluke,” said panel chair Dr. Wayne K. Goodman, chair of the department of psychiatry at the University of Florida, Gainesville.

The committee said modafinil's manufacturer, Cephalon Inc., should conduct a 3,000-patient, open-label study to further clarify the risk of SJS.

After the meeting, Dr. Thomas Laughren, director of the FDA's division of psychiatry products, told reporters that if a case turns up in such a study, “then they have a problem.”

It was not clear why children had higher rates of skin-related adverse events than adults, but Dr. Mannheim noted that lab tests indicated that they had a 7–16 times higher area under the curve ratio of modafinil sulfone, a metabolite. The levels could not be explained by higher milligram-per-kilogram dosing, he said.

In two of the three phase III studies, children were given a flexible dose with weekly titration (170 mg, 255 mg, 340 mg, or 425 mg). In the third study they were given a fixed dose, with those under 30 kg receiving 340 mg daily, and those over 30 kg receiving 425 mg daily. The primary outcome was the total score on the school ADHD rating scale. In all three trials, children taking modafinil had a more significant drop in scores than those taking placebo. The total score for modafinil recipients—just over 20—was close to the normative score for a 10-year-old male, according to a Cephalon statement.

Panelists did not dispute the drug's efficacy, although many said it would not be a first-line choice.

Lesley Russell, Cephalon's senior vice president of worldwide clinical research, said modafinil offers clinicians an alternative, especially when children don't respond to other marketed drugs.

But Dr. Temple said that even though it's plausible that modafinil might work in nonresponsive children, the company had not proved that.

“The mere fact that people given a second drug respond after failing to respond to the first tells you nothing at all,” he said.

According to a company statement, modafinil may be less addictive and less apt to be diverted because it does not offer a “high” to recreational users. Jeffrey L. Vaught, executive vice president of research and development at Cephalon, said the drug is not water soluble and is not stable at high heat, which makes it difficult to crush for injection or smoking. Studies have shown that modafinil does not activate reward centers in the brain, and that it does not cause release of dopamine in vitro or in vivo.

The Drug Enforcement Administration has deemed modafinil a schedule IV drug; other stimulants used to treat ADHD, such as Ritalin, are schedule II.

GAITHERSBURG, MD. — A Food and Drug Administration advisory committee declared that modafinil is not safe for treating ADHD in children and adolescents by a 12–1 vote, although committee members unanimously agreed the drug was effective for that indication.

At a meeting of the FDA's Psychopharmacologic Drugs Advisory Committee, the panel members were mainly concerned about modafinil's potential to cause Stevens-Johnson syndrome (SJS). The severe rash, which is often due to a hypersensitivity reaction to a drug, can be fatal in up to 5% of cases, according to Dr. Michael E. Bigby of the dermatology department at Harvard Medical School, Boston, and consultant to the panel.

Among 933 children and adolescents exposed to the drug during trials, there were 12 cases that could have been definite erythema multiforme (EM) or SJS, early prodromal EM or SJS, or suggestive of prodromal EM or SJS—a rate of 1.29%, said Dr. Glenn B. Mannheim, a medical reviewer in the FDA's division of psychiatry products.

The panel's discussion focused on one case that seemed most likely to be SJS—indicating a 1 in 1,000 risk. But they were not certain that was the true risk.

Dr. Bigby and Dr. Mannheim said that more cases could occur once modafinil (Provigil) is more widely used—even though there have been no reports of SJS in the 36,000 children who were prescribed the drug off-label in 2002–2005.

Given the trial data and the assumption that modafinil could capture 10% of the market for children under age 19 (based on other stimulants' sales), there could be 500–3,250 cases of EM or SJS, and 25–488 deaths, said Dr. Mannheim.

The dichotomy between the postmarketing experience and the trial data prompted the FDA to seek its advisers' input, said Dr. Robert J. Temple, director of the FDA's office of medical policy.

The FDA usually follows the advice of its panels.

The FDA has received six reports of serious skin reactions in adults, said Dr. Mannheim.

“I'd like to see an opportunity for the company to come back with additional data. That will give us additional assurance that this case was a fluke,” said panel chair Dr. Wayne K. Goodman, chair of the department of psychiatry at the University of Florida, Gainesville.

The committee said modafinil's manufacturer, Cephalon Inc., should conduct a 3,000-patient, open-label study to further clarify the risk of SJS.

After the meeting, Dr. Thomas Laughren, director of the FDA's division of psychiatry products, told reporters that if a case turns up in such a study, “then they have a problem.”

It was not clear why children had higher rates of skin-related adverse events than adults, but Dr. Mannheim noted that lab tests indicated that they had a 7–16 times higher area under the curve ratio of modafinil sulfone, a metabolite. The levels could not be explained by higher milligram-per-kilogram dosing, he said.

In two of the three phase III studies, children were given a flexible dose with weekly titration (170 mg, 255 mg, 340 mg, or 425 mg). In the third study they were given a fixed dose, with those under 30 kg receiving 340 mg daily, and those over 30 kg receiving 425 mg daily. The primary outcome was the total score on the school ADHD rating scale. In all three trials, children taking modafinil had a more significant drop in scores than those taking placebo. The total score for modafinil recipients—just over 20—was close to the normative score for a 10-year-old male, according to a Cephalon statement.

Panelists did not dispute the drug's efficacy, although many said it would not be a first-line choice.

Lesley Russell, Cephalon's senior vice president of worldwide clinical research, said modafinil offers clinicians an alternative, especially when children don't respond to other marketed drugs.

But Dr. Temple said that even though it's plausible that modafinil might work in nonresponsive children, the company had not proved that.

“The mere fact that people given a second drug respond after failing to respond to the first tells you nothing at all,” he said.

According to a company statement, modafinil may be less addictive and less apt to be diverted because it does not offer a “high” to recreational users. Jeffrey L. Vaught, executive vice president of research and development at Cephalon, said the drug is not water soluble and is not stable at high heat, which makes it difficult to crush for injection or smoking. Studies have shown that modafinil does not activate reward centers in the brain, and that it does not cause release of dopamine in vitro or in vivo.

The Drug Enforcement Administration has deemed modafinil a schedule IV drug; other stimulants used to treat ADHD, such as Ritalin, are schedule II.

GAITHERSBURG, MD. — A Food and Drug Administration advisory committee declared that modafinil is not safe for treating ADHD in children and adolescents by a 12–1 vote, although committee members unanimously agreed the drug was effective for that indication.

At a meeting of the FDA's Psychopharmacologic Drugs Advisory Committee, the panel members were mainly concerned about modafinil's potential to cause Stevens-Johnson syndrome (SJS). The severe rash, which is often due to a hypersensitivity reaction to a drug, can be fatal in up to 5% of cases, according to Dr. Michael E. Bigby of the dermatology department at Harvard Medical School, Boston, and consultant to the panel.

Among 933 children and adolescents exposed to the drug during trials, there were 12 cases that could have been definite erythema multiforme (EM) or SJS, early prodromal EM or SJS, or suggestive of prodromal EM or SJS—a rate of 1.29%, said Dr. Glenn B. Mannheim, a medical reviewer in the FDA's division of psychiatry products.

The panel's discussion focused on one case that seemed most likely to be SJS—indicating a 1 in 1,000 risk. But they were not certain that was the true risk.

Dr. Bigby and Dr. Mannheim said that more cases could occur once modafinil (Provigil) is more widely used—even though there have been no reports of SJS in the 36,000 children who were prescribed the drug off-label in 2002–2005.

Given the trial data and the assumption that modafinil could capture 10% of the market for children under age 19 (based on other stimulants' sales), there could be 500–3,250 cases of EM or SJS, and 25–488 deaths, said Dr. Mannheim.

The dichotomy between the postmarketing experience and the trial data prompted the FDA to seek its advisers' input, said Dr. Robert J. Temple, director of the FDA's office of medical policy.

The FDA usually follows the advice of its panels.

The FDA has received six reports of serious skin reactions in adults, said Dr. Mannheim.

“I'd like to see an opportunity for the company to come back with additional data. That will give us additional assurance that this case was a fluke,” said panel chair Dr. Wayne K. Goodman, chair of the department of psychiatry at the University of Florida, Gainesville.

The committee said modafinil's manufacturer, Cephalon Inc., should conduct a 3,000-patient, open-label study to further clarify the risk of SJS.

After the meeting, Dr. Thomas Laughren, director of the FDA's division of psychiatry products, told reporters that if a case turns up in such a study, “then they have a problem.”

It was not clear why children had higher rates of skin-related adverse events than adults, but Dr. Mannheim noted that lab tests indicated that they had a 7–16 times higher area under the curve ratio of modafinil sulfone, a metabolite. The levels could not be explained by higher milligram-per-kilogram dosing, he said.

In two of the three phase III studies, children were given a flexible dose with weekly titration (170 mg, 255 mg, 340 mg, or 425 mg). In the third study they were given a fixed dose, with those under 30 kg receiving 340 mg daily, and those over 30 kg receiving 425 mg daily. The primary outcome was the total score on the school ADHD rating scale. In all three trials, children taking modafinil had a more significant drop in scores than those taking placebo. The total score for modafinil recipients—just over 20—was close to the normative score for a 10-year-old male, according to a Cephalon statement.

Panelists did not dispute the drug's efficacy, although many said it would not be a first-line choice.

Lesley Russell, Cephalon's senior vice president of worldwide clinical research, said modafinil offers clinicians an alternative, especially when children don't respond to other marketed drugs.

But Dr. Temple said that even though it's plausible that modafinil might work in nonresponsive children, the company had not proved that.

“The mere fact that people given a second drug respond after failing to respond to the first tells you nothing at all,” he said.

According to a company statement, modafinil may be less addictive and less apt to be diverted because it does not offer a “high” to recreational users. Jeffrey L. Vaught, executive vice president of research and development at Cephalon, said the drug is not water soluble and is not stable at high heat, which makes it difficult to crush for injection or smoking. Studies have shown that modafinil does not activate reward centers in the brain, and that it does not cause release of dopamine in vitro or in vivo.

The Drug Enforcement Administration has deemed modafinil a schedule IV drug; other stimulants used to treat ADHD, such as Ritalin, are schedule II.

Fake Botox Murder Charge

A California beautician was indicted for manslaughter for allegedly causing the death of a client following a fake Botox injection. Martha Mata Vasquez was accused of injecting cooking oil into the buttocks of the client, who died of an embolism in November. Ms. Vasquez faces up to 8 years in prison. This appears to be the first death linked to a counterfeit injection, although at least four people were paralyzed last year after receiving a raw animal toxin, said Caroline Van Hove, a spokeswoman for Botox manufacturer Allergan Inc. The company and the Food and Drug Administration closely monitor the injectable market in the hope of rooting out fake products and illegal use by unlicensed practitioners, Ms. Van Hove noted.

Connetics Insider Trading

The Securities and Exchange Commission has charged a Connetics Corp. executive with insider trading. According to the SEC, Connetics vice president Alexander Yaroshinsky sold 15,100 shares of Connetics stock shortly after an April 2005 conference call with the FDA. During that call, the agency said it would issue a nonapprovable letter for Connetics' acne treatment Velac (clindamycin/tretinoin) because of potential carcinogenicity issues. Shortly thereafter, Mr. Yaroshinsky also purchased 2,076 "put" contracts, which positioned him to benefit if Connetics' shares fell. When the company made the FDA's views public in June, Connetics' share price fell 27%, and Mr. Yaroshinsky made at least $680,000, according to an SEC statement. At the SEC's request, a judge issued an order freezing Mr. Yaroshinsky's assets.

Sunscreen Lawsuits

Two law firms have filed suit against seven sunscreen manufacturers, claiming the companies are making false claims about the products' ability to block harmful sun rays and prevent skin disease, including cancer. Named in the suit are Schering-Plough Corp. (Coppertone), Sun Pharmaceuticals Corp. and Playtex Products Inc. (Banana Boat), Tanning Research Laboratories Inc. (Hawaiian Tropic), Neutrogena Corp. and Johnson & Johnson (Neutrogena), and Chattem Inc. (BullFrog). The law firms, which are seeking class action status, say that claims that products protect against UVA rays are false because there is no standard for measuring UVA protection. Sun protective factor (SPF) standards apply only to UVB rays. The suits further allege that the products can't be said to be waterproof because they lose efficacy when immersed in water. "Parents, especially, have been defrauded into believing the false labeling and advertising claims of these products," said Mitchell Twersky, of New York law firm Abraham, Fruchter & Twersky LLP, in a statement. The suits, filed in California Superior Court in Los Angeles, seek "an injunction on the claims, compensation for consumers and other remedies, including a public education program concerning sun protection paid for by the industry," according to a statement by the other litigating firm, Lerach Coughlin Stoia Geller Rudman & Robbins LLP of Los Angeles. Schering-Plough is still evaluating the lawsuit, said company spokeswoman Denise Foy, who added that the company has disputed similar allegations in the past and that product labels are in compliance with FDA regulations.

Unwilling to Pay for Quality

Payers and the federal government are prodding providers toward meeting quality benchmarks as the first step to getting paid for delivering better care, but a new poll suggests that Americans might not be willing to personally pay extra for improved quality. A Wall Street Journal/Harris Interactive health care poll found that one-third of 2,123 adults surveyed said they were in favor of having insurers pay more for higher-quality care. This is an 11% drop from 2003, when a similar survey was conducted. In 2006, 54% of those surveyed said they weren't sure whether physicians and hospitals should be paid more by insurers to provide better care; that was a 14% increase in uncertainty from 2003. Just under half of those surveyed said there are fair and reliable ways to measure and compare quality of care. When asked whether they would be willing to pay more out of their own pocket, 57% said it would not be fair for patients to pay more to receive treatment from physicians or hospitals that had been shown to give better care. Similarly, 55% said they would not be willing to pay a higher premium to get access to higher-quality medical groups and hospitals. Around half agreed that the currently used quality-assessment mechanisms are fair, including how often physicians give preventive tests (55%) and how often they meet benchmarks in managing chronic conditions (61%). Forty-one percent said malpractice suits were a fair way to gauge the quality of care given by a physician.

Smoking Rates Drop

The number of cigarettes sold in the United States in 2005 dropped 4.2% from 2004, the largest 1-year percentage decrease in sales since 1999, figures compiled by the Treasury Department show. "We are pleased to see that the long decline of cigarette consumption is continuing," Cheryl Healton, Dr.P.H., president of the American Legacy Foundation, said in a statement. "We also know that for the first time in the United States, there are more former smokers than current smokers." The National Association of Attorneys General also applauded the numbers, noting that the drop continues "the unprecedented long-term decline in cigarette smoking that began with the settlement of lawsuits" brought by state attorneys general against the major tobacco companies.

Fake Botox Murder Charge

A California beautician was indicted for manslaughter for allegedly causing the death of a client following a fake Botox injection. Martha Mata Vasquez was accused of injecting cooking oil into the buttocks of the client, who died of an embolism in November. Ms. Vasquez faces up to 8 years in prison. This appears to be the first death linked to a counterfeit injection, although at least four people were paralyzed last year after receiving a raw animal toxin, said Caroline Van Hove, a spokeswoman for Botox manufacturer Allergan Inc. The company and the Food and Drug Administration closely monitor the injectable market in the hope of rooting out fake products and illegal use by unlicensed practitioners, Ms. Van Hove noted.

Connetics Insider Trading

The Securities and Exchange Commission has charged a Connetics Corp. executive with insider trading. According to the SEC, Connetics vice president Alexander Yaroshinsky sold 15,100 shares of Connetics stock shortly after an April 2005 conference call with the FDA. During that call, the agency said it would issue a nonapprovable letter for Connetics' acne treatment Velac (clindamycin/tretinoin) because of potential carcinogenicity issues. Shortly thereafter, Mr. Yaroshinsky also purchased 2,076 "put" contracts, which positioned him to benefit if Connetics' shares fell. When the company made the FDA's views public in June, Connetics' share price fell 27%, and Mr. Yaroshinsky made at least $680,000, according to an SEC statement. At the SEC's request, a judge issued an order freezing Mr. Yaroshinsky's assets.

Sunscreen Lawsuits

Two law firms have filed suit against seven sunscreen manufacturers, claiming the companies are making false claims about the products' ability to block harmful sun rays and prevent skin disease, including cancer. Named in the suit are Schering-Plough Corp. (Coppertone), Sun Pharmaceuticals Corp. and Playtex Products Inc. (Banana Boat), Tanning Research Laboratories Inc. (Hawaiian Tropic), Neutrogena Corp. and Johnson & Johnson (Neutrogena), and Chattem Inc. (BullFrog). The law firms, which are seeking class action status, say that claims that products protect against UVA rays are false because there is no standard for measuring UVA protection. Sun protective factor (SPF) standards apply only to UVB rays. The suits further allege that the products can't be said to be waterproof because they lose efficacy when immersed in water. "Parents, especially, have been defrauded into believing the false labeling and advertising claims of these products," said Mitchell Twersky, of New York law firm Abraham, Fruchter & Twersky LLP, in a statement. The suits, filed in California Superior Court in Los Angeles, seek "an injunction on the claims, compensation for consumers and other remedies, including a public education program concerning sun protection paid for by the industry," according to a statement by the other litigating firm, Lerach Coughlin Stoia Geller Rudman & Robbins LLP of Los Angeles. Schering-Plough is still evaluating the lawsuit, said company spokeswoman Denise Foy, who added that the company has disputed similar allegations in the past and that product labels are in compliance with FDA regulations.

Unwilling to Pay for Quality

Payers and the federal government are prodding providers toward meeting quality benchmarks as the first step to getting paid for delivering better care, but a new poll suggests that Americans might not be willing to personally pay extra for improved quality. A Wall Street Journal/Harris Interactive health care poll found that one-third of 2,123 adults surveyed said they were in favor of having insurers pay more for higher-quality care. This is an 11% drop from 2003, when a similar survey was conducted. In 2006, 54% of those surveyed said they weren't sure whether physicians and hospitals should be paid more by insurers to provide better care; that was a 14% increase in uncertainty from 2003. Just under half of those surveyed said there are fair and reliable ways to measure and compare quality of care. When asked whether they would be willing to pay more out of their own pocket, 57% said it would not be fair for patients to pay more to receive treatment from physicians or hospitals that had been shown to give better care. Similarly, 55% said they would not be willing to pay a higher premium to get access to higher-quality medical groups and hospitals. Around half agreed that the currently used quality-assessment mechanisms are fair, including how often physicians give preventive tests (55%) and how often they meet benchmarks in managing chronic conditions (61%). Forty-one percent said malpractice suits were a fair way to gauge the quality of care given by a physician.

Smoking Rates Drop

The number of cigarettes sold in the United States in 2005 dropped 4.2% from 2004, the largest 1-year percentage decrease in sales since 1999, figures compiled by the Treasury Department show. "We are pleased to see that the long decline of cigarette consumption is continuing," Cheryl Healton, Dr.P.H., president of the American Legacy Foundation, said in a statement. "We also know that for the first time in the United States, there are more former smokers than current smokers." The National Association of Attorneys General also applauded the numbers, noting that the drop continues "the unprecedented long-term decline in cigarette smoking that began with the settlement of lawsuits" brought by state attorneys general against the major tobacco companies.

Fake Botox Murder Charge

A California beautician was indicted for manslaughter for allegedly causing the death of a client following a fake Botox injection. Martha Mata Vasquez was accused of injecting cooking oil into the buttocks of the client, who died of an embolism in November. Ms. Vasquez faces up to 8 years in prison. This appears to be the first death linked to a counterfeit injection, although at least four people were paralyzed last year after receiving a raw animal toxin, said Caroline Van Hove, a spokeswoman for Botox manufacturer Allergan Inc. The company and the Food and Drug Administration closely monitor the injectable market in the hope of rooting out fake products and illegal use by unlicensed practitioners, Ms. Van Hove noted.

Connetics Insider Trading

The Securities and Exchange Commission has charged a Connetics Corp. executive with insider trading. According to the SEC, Connetics vice president Alexander Yaroshinsky sold 15,100 shares of Connetics stock shortly after an April 2005 conference call with the FDA. During that call, the agency said it would issue a nonapprovable letter for Connetics' acne treatment Velac (clindamycin/tretinoin) because of potential carcinogenicity issues. Shortly thereafter, Mr. Yaroshinsky also purchased 2,076 "put" contracts, which positioned him to benefit if Connetics' shares fell. When the company made the FDA's views public in June, Connetics' share price fell 27%, and Mr. Yaroshinsky made at least $680,000, according to an SEC statement. At the SEC's request, a judge issued an order freezing Mr. Yaroshinsky's assets.

Sunscreen Lawsuits

Two law firms have filed suit against seven sunscreen manufacturers, claiming the companies are making false claims about the products' ability to block harmful sun rays and prevent skin disease, including cancer. Named in the suit are Schering-Plough Corp. (Coppertone), Sun Pharmaceuticals Corp. and Playtex Products Inc. (Banana Boat), Tanning Research Laboratories Inc. (Hawaiian Tropic), Neutrogena Corp. and Johnson & Johnson (Neutrogena), and Chattem Inc. (BullFrog). The law firms, which are seeking class action status, say that claims that products protect against UVA rays are false because there is no standard for measuring UVA protection. Sun protective factor (SPF) standards apply only to UVB rays. The suits further allege that the products can't be said to be waterproof because they lose efficacy when immersed in water. "Parents, especially, have been defrauded into believing the false labeling and advertising claims of these products," said Mitchell Twersky, of New York law firm Abraham, Fruchter & Twersky LLP, in a statement. The suits, filed in California Superior Court in Los Angeles, seek "an injunction on the claims, compensation for consumers and other remedies, including a public education program concerning sun protection paid for by the industry," according to a statement by the other litigating firm, Lerach Coughlin Stoia Geller Rudman & Robbins LLP of Los Angeles. Schering-Plough is still evaluating the lawsuit, said company spokeswoman Denise Foy, who added that the company has disputed similar allegations in the past and that product labels are in compliance with FDA regulations.

Unwilling to Pay for Quality

Payers and the federal government are prodding providers toward meeting quality benchmarks as the first step to getting paid for delivering better care, but a new poll suggests that Americans might not be willing to personally pay extra for improved quality. A Wall Street Journal/Harris Interactive health care poll found that one-third of 2,123 adults surveyed said they were in favor of having insurers pay more for higher-quality care. This is an 11% drop from 2003, when a similar survey was conducted. In 2006, 54% of those surveyed said they weren't sure whether physicians and hospitals should be paid more by insurers to provide better care; that was a 14% increase in uncertainty from 2003. Just under half of those surveyed said there are fair and reliable ways to measure and compare quality of care. When asked whether they would be willing to pay more out of their own pocket, 57% said it would not be fair for patients to pay more to receive treatment from physicians or hospitals that had been shown to give better care. Similarly, 55% said they would not be willing to pay a higher premium to get access to higher-quality medical groups and hospitals. Around half agreed that the currently used quality-assessment mechanisms are fair, including how often physicians give preventive tests (55%) and how often they meet benchmarks in managing chronic conditions (61%). Forty-one percent said malpractice suits were a fair way to gauge the quality of care given by a physician.

Smoking Rates Drop

The number of cigarettes sold in the United States in 2005 dropped 4.2% from 2004, the largest 1-year percentage decrease in sales since 1999, figures compiled by the Treasury Department show. "We are pleased to see that the long decline of cigarette consumption is continuing," Cheryl Healton, Dr.P.H., president of the American Legacy Foundation, said in a statement. "We also know that for the first time in the United States, there are more former smokers than current smokers." The National Association of Attorneys General also applauded the numbers, noting that the drop continues "the unprecedented long-term decline in cigarette smoking that began with the settlement of lawsuits" brought by state attorneys general against the major tobacco companies.

New Orleans' two medical schools, Tulane University and Louisiana State University Health Sciences Center, seem poised for a post-Katrina recovery that may put them on better footing than before the floods wiped out much of their infrastructure and dispersed their faculty, residents, and student bodies.

Tulane and LSU officials are optimistic, but success is far from guaranteed.

"The next 6–12 months will be absolutely critical," said Barbara Beckman, Ph.D., dean of admissions at Tulane.

For now, officials at both schools say that the downsizing the schools have undergone may have a silver lining: It may better prepare the institutions to serve a smaller city with fewer doctors, patients, and hospital beds yet potentially more uncompensated care.

In late February, the U.S. General Accountability Office estimated that only 456 beds were open at three hospitals in the city, down from 2,269 before the storm. Outside the city, about 1,528 beds out of a total 1,814 had reopened.

Since the hurricane, 132 medical faculty members at Tulane and 270 at LSU have lost their jobs. The LSU faculty were furloughed, but most are not expected to return, Dr. Larry Hollier, chancellor of the Health Sciences Center, said in an interview.

Because it is primarily supported by the state, LSU has more of an uphill battle than does Tulane, which has benefited from its hospital being owned by HCA Inc., said Dr. Beckman.

Physically, 21 of 22 LSU buildings were seriously damaged by the hurricane and subsequent flooding. All of LSU's teaching facilities were under at least 5 feet of water at some point, according to Dr. Hollier.

In the months after the storm, the university was losing $13 million a month. By the end of 2005, it was facing a $50 million deficit even after $63 million in cutbacks.

In February, LSU received $50 million in federal hurricane relief money. "I never had any doubt that we would keep it going," said Dr. Hollier.

After the storm, LSU moved its residents to hospitals outside the city and across the state, in particular to Baton Rouge. Some are now back at work in New Orleans. At Touro Infirmary, which is down to 250 beds (from 345), LSU has 50 residents—a substantial increase from the 8 before the storm.

But just because LSU found positions for its residents doesn't mean the school was going to be paid for their salaries and upkeep. Under the federal graduate medical education program, schools are required to have affiliation agreements, and LSU does not have any with those new facilities. The school sought a waiver from the Centers for Medicare and Medicaid Services to receive payment for those new slots.

In April, CMS announced its intention to grant the waiver to LSU and all the schools affected by Katrina in an interim final rule. The waiver, which would let schools receive payments retroactive to the storm for residents at any institution, will become final later in the year.

Tulane sought the same waiver, said Dr. Ronald Amedee, dean of graduate medical education. Before the storm, the school had 46 fully accredited programs and 521 residents and fellows in the city. With the evacuation and closures, 217 were transferred to Texas Medical Center, 200 to other sites in Louisiana, and 110 to facilities across the United States. Before the storm, Tulane had agreements with 13 institutions; residents are now at 91 different hospitals, said Dr. Amedee.

LSU had 802 residents at 12 teaching hospitals around the state before the storm. Most were moved to other hospitals in Louisiana, and 100 have been granted permanent transfers.

On a bright note, the chaos in New Orleans has not dissuaded future physicians from seeking residencies at city institutions. Tulane's 70 residency slots were easily filled; 20 are from the medical school's 2006 graduating class.

"This is one of the most successful matches we've had in decades," said Dr. Amedee. "We really hit it big."

He said the school attracted top-tier candidates. But they were different from those in years past—many have done charity work in developing countries or with organizations like Habitat for Humanity.

"This is a group of people that came here and did not see water marks on buildings and debris piled up in the street as a negative—they saw it as a positive," Dr. Amedee said.

Tulane moved all 155 of its first- and second-year students to Baylor College of Medicine in Houston, where they are taking classes from the 150–200 faculty still on the Tulane payroll. The third and fourth years are taking electives in Louisiana, Texas, and elsewhere. Tulane aims to reopen its medical school in July.

Most LSU students were relocated to the school's main campus in Baton Rouge, but the schools of public health and graduate studies returned to New Orleans in January. Dr. Hollier said that he expected the medical and nursing students to start attending classes in the city in July, and that medical school applications are on par with previous years.

At Tulane, about 8,000 students have applied for 155 positions.

"I've got an overfilled class," noted Dr. Beckman, who said Tulane always has a large number of applicants, but "what's different this year is the enthusiasm level."

New Orleans' two medical schools, Tulane University and Louisiana State University Health Sciences Center, seem poised for a post-Katrina recovery that may put them on better footing than before the floods wiped out much of their infrastructure and dispersed their faculty, residents, and student bodies.

Tulane and LSU officials are optimistic, but success is far from guaranteed.

"The next 6–12 months will be absolutely critical," said Barbara Beckman, Ph.D., dean of admissions at Tulane.

For now, officials at both schools say that the downsizing the schools have undergone may have a silver lining: It may better prepare the institutions to serve a smaller city with fewer doctors, patients, and hospital beds yet potentially more uncompensated care.

In late February, the U.S. General Accountability Office estimated that only 456 beds were open at three hospitals in the city, down from 2,269 before the storm. Outside the city, about 1,528 beds out of a total 1,814 had reopened.

Since the hurricane, 132 medical faculty members at Tulane and 270 at LSU have lost their jobs. The LSU faculty were furloughed, but most are not expected to return, Dr. Larry Hollier, chancellor of the Health Sciences Center, said in an interview.

Because it is primarily supported by the state, LSU has more of an uphill battle than does Tulane, which has benefited from its hospital being owned by HCA Inc., said Dr. Beckman.

Physically, 21 of 22 LSU buildings were seriously damaged by the hurricane and subsequent flooding. All of LSU's teaching facilities were under at least 5 feet of water at some point, according to Dr. Hollier.

In the months after the storm, the university was losing $13 million a month. By the end of 2005, it was facing a $50 million deficit even after $63 million in cutbacks.

In February, LSU received $50 million in federal hurricane relief money. "I never had any doubt that we would keep it going," said Dr. Hollier.

After the storm, LSU moved its residents to hospitals outside the city and across the state, in particular to Baton Rouge. Some are now back at work in New Orleans. At Touro Infirmary, which is down to 250 beds (from 345), LSU has 50 residents—a substantial increase from the 8 before the storm.

But just because LSU found positions for its residents doesn't mean the school was going to be paid for their salaries and upkeep. Under the federal graduate medical education program, schools are required to have affiliation agreements, and LSU does not have any with those new facilities. The school sought a waiver from the Centers for Medicare and Medicaid Services to receive payment for those new slots.

In April, CMS announced its intention to grant the waiver to LSU and all the schools affected by Katrina in an interim final rule. The waiver, which would let schools receive payments retroactive to the storm for residents at any institution, will become final later in the year.

Tulane sought the same waiver, said Dr. Ronald Amedee, dean of graduate medical education. Before the storm, the school had 46 fully accredited programs and 521 residents and fellows in the city. With the evacuation and closures, 217 were transferred to Texas Medical Center, 200 to other sites in Louisiana, and 110 to facilities across the United States. Before the storm, Tulane had agreements with 13 institutions; residents are now at 91 different hospitals, said Dr. Amedee.

LSU had 802 residents at 12 teaching hospitals around the state before the storm. Most were moved to other hospitals in Louisiana, and 100 have been granted permanent transfers.

On a bright note, the chaos in New Orleans has not dissuaded future physicians from seeking residencies at city institutions. Tulane's 70 residency slots were easily filled; 20 are from the medical school's 2006 graduating class.

"This is one of the most successful matches we've had in decades," said Dr. Amedee. "We really hit it big."

He said the school attracted top-tier candidates. But they were different from those in years past—many have done charity work in developing countries or with organizations like Habitat for Humanity.

"This is a group of people that came here and did not see water marks on buildings and debris piled up in the street as a negative—they saw it as a positive," Dr. Amedee said.

Tulane moved all 155 of its first- and second-year students to Baylor College of Medicine in Houston, where they are taking classes from the 150–200 faculty still on the Tulane payroll. The third and fourth years are taking electives in Louisiana, Texas, and elsewhere. Tulane aims to reopen its medical school in July.

Most LSU students were relocated to the school's main campus in Baton Rouge, but the schools of public health and graduate studies returned to New Orleans in January. Dr. Hollier said that he expected the medical and nursing students to start attending classes in the city in July, and that medical school applications are on par with previous years.

At Tulane, about 8,000 students have applied for 155 positions.

"I've got an overfilled class," noted Dr. Beckman, who said Tulane always has a large number of applicants, but "what's different this year is the enthusiasm level."

New Orleans' two medical schools, Tulane University and Louisiana State University Health Sciences Center, seem poised for a post-Katrina recovery that may put them on better footing than before the floods wiped out much of their infrastructure and dispersed their faculty, residents, and student bodies.

Tulane and LSU officials are optimistic, but success is far from guaranteed.

"The next 6–12 months will be absolutely critical," said Barbara Beckman, Ph.D., dean of admissions at Tulane.

For now, officials at both schools say that the downsizing the schools have undergone may have a silver lining: It may better prepare the institutions to serve a smaller city with fewer doctors, patients, and hospital beds yet potentially more uncompensated care.

In late February, the U.S. General Accountability Office estimated that only 456 beds were open at three hospitals in the city, down from 2,269 before the storm. Outside the city, about 1,528 beds out of a total 1,814 had reopened.

Since the hurricane, 132 medical faculty members at Tulane and 270 at LSU have lost their jobs. The LSU faculty were furloughed, but most are not expected to return, Dr. Larry Hollier, chancellor of the Health Sciences Center, said in an interview.

Because it is primarily supported by the state, LSU has more of an uphill battle than does Tulane, which has benefited from its hospital being owned by HCA Inc., said Dr. Beckman.

Physically, 21 of 22 LSU buildings were seriously damaged by the hurricane and subsequent flooding. All of LSU's teaching facilities were under at least 5 feet of water at some point, according to Dr. Hollier.

In the months after the storm, the university was losing $13 million a month. By the end of 2005, it was facing a $50 million deficit even after $63 million in cutbacks.

In February, LSU received $50 million in federal hurricane relief money. "I never had any doubt that we would keep it going," said Dr. Hollier.

After the storm, LSU moved its residents to hospitals outside the city and across the state, in particular to Baton Rouge. Some are now back at work in New Orleans. At Touro Infirmary, which is down to 250 beds (from 345), LSU has 50 residents—a substantial increase from the 8 before the storm.

But just because LSU found positions for its residents doesn't mean the school was going to be paid for their salaries and upkeep. Under the federal graduate medical education program, schools are required to have affiliation agreements, and LSU does not have any with those new facilities. The school sought a waiver from the Centers for Medicare and Medicaid Services to receive payment for those new slots.

In April, CMS announced its intention to grant the waiver to LSU and all the schools affected by Katrina in an interim final rule. The waiver, which would let schools receive payments retroactive to the storm for residents at any institution, will become final later in the year.

Tulane sought the same waiver, said Dr. Ronald Amedee, dean of graduate medical education. Before the storm, the school had 46 fully accredited programs and 521 residents and fellows in the city. With the evacuation and closures, 217 were transferred to Texas Medical Center, 200 to other sites in Louisiana, and 110 to facilities across the United States. Before the storm, Tulane had agreements with 13 institutions; residents are now at 91 different hospitals, said Dr. Amedee.

LSU had 802 residents at 12 teaching hospitals around the state before the storm. Most were moved to other hospitals in Louisiana, and 100 have been granted permanent transfers.

On a bright note, the chaos in New Orleans has not dissuaded future physicians from seeking residencies at city institutions. Tulane's 70 residency slots were easily filled; 20 are from the medical school's 2006 graduating class.

"This is one of the most successful matches we've had in decades," said Dr. Amedee. "We really hit it big."

He said the school attracted top-tier candidates. But they were different from those in years past—many have done charity work in developing countries or with organizations like Habitat for Humanity.

"This is a group of people that came here and did not see water marks on buildings and debris piled up in the street as a negative—they saw it as a positive," Dr. Amedee said.

Tulane moved all 155 of its first- and second-year students to Baylor College of Medicine in Houston, where they are taking classes from the 150–200 faculty still on the Tulane payroll. The third and fourth years are taking electives in Louisiana, Texas, and elsewhere. Tulane aims to reopen its medical school in July.

Most LSU students were relocated to the school's main campus in Baton Rouge, but the schools of public health and graduate studies returned to New Orleans in January. Dr. Hollier said that he expected the medical and nursing students to start attending classes in the city in July, and that medical school applications are on par with previous years.

At Tulane, about 8,000 students have applied for 155 positions.

"I've got an overfilled class," noted Dr. Beckman, who said Tulane always has a large number of applicants, but "what's different this year is the enthusiasm level."

WASHINGTON — The direct and indirect costs of depression total $83 billion a year in the United States and a lack of access to care will cause that figure to keep rising, a new report by the Depression and Bipolar Support Alliance contends.

Though the estimate came from a 2003 study looking at the economic burden of depression from 1999–2000, it is considered the most recent figure (J. Clin. Psychiatry 2003; 64:1465–75).

The alliance, a nonprofit group, receives funding from the pharmaceutical industry and from individual donations and grants.

Its report, released at a Depression and Bipolar Support Alliance (DBSA) press briefing, is the first comprehensive study of how people with depression are faring in the mental health system, said DBSA President Lydia Lewis at the briefing.

The document draws mostly on previously published economic, epidemiologic, and clinical studies of depression and suicide, but brings that data together in one place. It also incorporates information culled from 100 interviews with insurers, patient advocates, employers, physicians, mental health providers, policymakers, drug manufacturers, and researchers.

The study concludes that there are many obstacles to care that lead to undiagnosed and untreated disease or delayed treatment, Ms. Lewis said. A little more than half—57%—of people with a major depressive disorder get any treatment, and only 22% receive at least minimally adequate treatment, defined as at least four outpatient visits with any type of physician in which an antidepressant or mood stabilizer was prescribed for a minimum of 30 days, or at least eight outpatient visits with a mental health specialist for psychotherapy lasting 30 minutes or more, according to the report (JAMA 2003;289:3095–105).

The system of care is tilted so far away from prevention and toward reaction that “it makes the L.A. County jail the largest single provider of mental health services in the U.S.,” said Ellen Frank, Ph.D., a professor of psychiatry and psychology at the University of Pittsburgh School of Medicine and chair of the DBSA's scientific advisory board.

The report stated that lack of access to care is dividing families. According to a Government Accountability Office report, parents in 19 states said they had surrendered custody of 12,700 children to the juvenile justice system so those children could receive mental health treatment.

Depression is also the main cause of suicide, which is the 11th leading cause of death overall, according to the Centers for Disease Control and Prevention, and the third leading cause of death in people aged 15–24.

As part of a five-point plan aimed at increasing access to care and improving diagnosis and treatment, the alliance is proposing an increase in reimbursement for primary care physicians. They are usually the first to see depressed patients but are not given incentives to spend the necessary time with them, the alliance said.

Similarly, the alliance is asking Congress to increase Medicare coverage of outpatient mental health services to 80%, the same rate as for other outpatient services. The report found that 2 million of the 35 million Americans over age 65 have depression.

The government and private sector employers should establish programs to forgive loans taken on by students who specialize in mental health fields, said the alliance. A debt forgiveness program might attract more students and ease a provider shortage, the group said. Currently, there are 40,000 psychiatrists but 19 million Americans who have depression.

Access to care also could be increased through wider availability of peer support programs, said the alliance. Essentially, peer support involves depressed people interacting with one another—through everything from group meetings to helping someone get to a therapist's appointment—said Dr. Jana Spalding, a former patient who is now the mental health peer specialist with the Broward County, Fla. sheriff's office.

Finally, the alliance urged private and academic researchers to more rapidly introduce new therapies, and to use imaging and other tools to learn how to increase response rates to current therapies.

WASHINGTON — The direct and indirect costs of depression total $83 billion a year in the United States and a lack of access to care will cause that figure to keep rising, a new report by the Depression and Bipolar Support Alliance contends.

Though the estimate came from a 2003 study looking at the economic burden of depression from 1999–2000, it is considered the most recent figure (J. Clin. Psychiatry 2003; 64:1465–75).

The alliance, a nonprofit group, receives funding from the pharmaceutical industry and from individual donations and grants.

Its report, released at a Depression and Bipolar Support Alliance (DBSA) press briefing, is the first comprehensive study of how people with depression are faring in the mental health system, said DBSA President Lydia Lewis at the briefing.

The document draws mostly on previously published economic, epidemiologic, and clinical studies of depression and suicide, but brings that data together in one place. It also incorporates information culled from 100 interviews with insurers, patient advocates, employers, physicians, mental health providers, policymakers, drug manufacturers, and researchers.

The study concludes that there are many obstacles to care that lead to undiagnosed and untreated disease or delayed treatment, Ms. Lewis said. A little more than half—57%—of people with a major depressive disorder get any treatment, and only 22% receive at least minimally adequate treatment, defined as at least four outpatient visits with any type of physician in which an antidepressant or mood stabilizer was prescribed for a minimum of 30 days, or at least eight outpatient visits with a mental health specialist for psychotherapy lasting 30 minutes or more, according to the report (JAMA 2003;289:3095–105).

The system of care is tilted so far away from prevention and toward reaction that “it makes the L.A. County jail the largest single provider of mental health services in the U.S.,” said Ellen Frank, Ph.D., a professor of psychiatry and psychology at the University of Pittsburgh School of Medicine and chair of the DBSA's scientific advisory board.

The report stated that lack of access to care is dividing families. According to a Government Accountability Office report, parents in 19 states said they had surrendered custody of 12,700 children to the juvenile justice system so those children could receive mental health treatment.

Depression is also the main cause of suicide, which is the 11th leading cause of death overall, according to the Centers for Disease Control and Prevention, and the third leading cause of death in people aged 15–24.

As part of a five-point plan aimed at increasing access to care and improving diagnosis and treatment, the alliance is proposing an increase in reimbursement for primary care physicians. They are usually the first to see depressed patients but are not given incentives to spend the necessary time with them, the alliance said.

Similarly, the alliance is asking Congress to increase Medicare coverage of outpatient mental health services to 80%, the same rate as for other outpatient services. The report found that 2 million of the 35 million Americans over age 65 have depression.

The government and private sector employers should establish programs to forgive loans taken on by students who specialize in mental health fields, said the alliance. A debt forgiveness program might attract more students and ease a provider shortage, the group said. Currently, there are 40,000 psychiatrists but 19 million Americans who have depression.

Access to care also could be increased through wider availability of peer support programs, said the alliance. Essentially, peer support involves depressed people interacting with one another—through everything from group meetings to helping someone get to a therapist's appointment—said Dr. Jana Spalding, a former patient who is now the mental health peer specialist with the Broward County, Fla. sheriff's office.

Finally, the alliance urged private and academic researchers to more rapidly introduce new therapies, and to use imaging and other tools to learn how to increase response rates to current therapies.

WASHINGTON — The direct and indirect costs of depression total $83 billion a year in the United States and a lack of access to care will cause that figure to keep rising, a new report by the Depression and Bipolar Support Alliance contends.

Though the estimate came from a 2003 study looking at the economic burden of depression from 1999–2000, it is considered the most recent figure (J. Clin. Psychiatry 2003; 64:1465–75).

The alliance, a nonprofit group, receives funding from the pharmaceutical industry and from individual donations and grants.

Its report, released at a Depression and Bipolar Support Alliance (DBSA) press briefing, is the first comprehensive study of how people with depression are faring in the mental health system, said DBSA President Lydia Lewis at the briefing.

The document draws mostly on previously published economic, epidemiologic, and clinical studies of depression and suicide, but brings that data together in one place. It also incorporates information culled from 100 interviews with insurers, patient advocates, employers, physicians, mental health providers, policymakers, drug manufacturers, and researchers.

The study concludes that there are many obstacles to care that lead to undiagnosed and untreated disease or delayed treatment, Ms. Lewis said. A little more than half—57%—of people with a major depressive disorder get any treatment, and only 22% receive at least minimally adequate treatment, defined as at least four outpatient visits with any type of physician in which an antidepressant or mood stabilizer was prescribed for a minimum of 30 days, or at least eight outpatient visits with a mental health specialist for psychotherapy lasting 30 minutes or more, according to the report (JAMA 2003;289:3095–105).

The system of care is tilted so far away from prevention and toward reaction that “it makes the L.A. County jail the largest single provider of mental health services in the U.S.,” said Ellen Frank, Ph.D., a professor of psychiatry and psychology at the University of Pittsburgh School of Medicine and chair of the DBSA's scientific advisory board.

The report stated that lack of access to care is dividing families. According to a Government Accountability Office report, parents in 19 states said they had surrendered custody of 12,700 children to the juvenile justice system so those children could receive mental health treatment.

Depression is also the main cause of suicide, which is the 11th leading cause of death overall, according to the Centers for Disease Control and Prevention, and the third leading cause of death in people aged 15–24.

As part of a five-point plan aimed at increasing access to care and improving diagnosis and treatment, the alliance is proposing an increase in reimbursement for primary care physicians. They are usually the first to see depressed patients but are not given incentives to spend the necessary time with them, the alliance said.

Similarly, the alliance is asking Congress to increase Medicare coverage of outpatient mental health services to 80%, the same rate as for other outpatient services. The report found that 2 million of the 35 million Americans over age 65 have depression.

The government and private sector employers should establish programs to forgive loans taken on by students who specialize in mental health fields, said the alliance. A debt forgiveness program might attract more students and ease a provider shortage, the group said. Currently, there are 40,000 psychiatrists but 19 million Americans who have depression.

Access to care also could be increased through wider availability of peer support programs, said the alliance. Essentially, peer support involves depressed people interacting with one another—through everything from group meetings to helping someone get to a therapist's appointment—said Dr. Jana Spalding, a former patient who is now the mental health peer specialist with the Broward County, Fla. sheriff's office.

Finally, the alliance urged private and academic researchers to more rapidly introduce new therapies, and to use imaging and other tools to learn how to increase response rates to current therapies.

Bill Seeks Consent for Off-Label Rx

A bill in the California assembly would require physicians to get informed consent from their patients before “prescribing, administering, or furnishing” a prescription for off-label use. A failure to adhere to the requirement would be considered a violation of the Medical Practice Act, which means physicians could be charged with a crime. The California Medical Association opposes the legislation and said the existing law is enough because physicians can be held liable for not disclosing risks. The bill would require physicians to specify that a medication is not approved by the Food and Drug Administration for the use that the doctor is recommending, and that the risks are unknown and there is not a consensus on the efficacy.

Obesity Linked to 2%–3% of Claims

Obesity accounts for 2%–3% of medical claims dollars, according to a retrospective study in the March issue of the Journal of Occupational and Environmental Medicine. Researchers at Gordian Health Solutions Inc. assessed claims from January 2000 to December 2004 from 61 employers. In 2004 inflation-adjusted dollars, total claims for the study period amounted to $4.55 billion. Obesity was responsible for 2.1% of total claims for male workers ($3.55/member per month) and 2.8% for female workers ($5.71/member per month). The true tally may be higher, said the researchers, noting that their analysis excluded prescription drug costs. Given that the data show a rise in obesity-related costs with increasing age, “childhood obesity may have significant lagged effects.”

IOM on Quality Improvement Groups

An Institute of Medicine committee has released a report on Medicare's Quality Improvement Organizations that describes these groups as spending too much time on reviewing beneficiary complaints and not enough on helping physicians and health care organizations to actually improve care. The panel said there are inherent conflicts when the QIO reviews complaints about organizations it needs to voluntarily participate in quality improvement efforts, and suggested that case reviews should be shifted to regional or national agencies. The 22-member IOM panel spent a year investigating the 41 organizations that are hired by Medicare to improve quality of care, address patient complaints, and review claims to ensure they meet quality benchmarks and reimbursement standards. Stephen M. Shortell, Ph.D., an IOM panel member, said the committee's main finding was that, while the quality of care has improved, “the pace of change is too slow, and gaps in quality persist.” QIOs should be providing more technical assistance to physicians and hospitals, said Dr. Shortell, who is a professor of health policy and management at the University of California, Berkeley. The IOM panel said that QIO boards—which it said are dominated by physicians—should include more consumers, representatives of other health fields, and health information technology experts, and have greater accountability to the public. The American Health Quality Association, a QIO trade group, said it supported most of the recommendations, but said that the organizations should continue to review complaints and appeals because it provided “invaluable opportunities to help providers improve care for all patients.” The AHQA also noted that 30 of 41 QIOs had signed a code of conduct that would make them more accountable.

Many Enrollees Happy With Part D

A new survey of Medicare beneficiaries who are receiving Part D drug benefits finds them to be largely satisfied. The survey—conducted 10 weeks into the new coverage—was paid for by America's Health Insurance Plans, and conducted by Ayres, McHenry & Associates Inc., a Republican polling firm. The poll surveyed 408 of the 5.2 million people over age 65 years who have self-enrolled in Part D, and 401 of the 6.5 million “dual eligibles,” who were automatically enrolled because they had Medicaid drug coverage. Of those who self-enrolled, 66% said it had been worth the time and effort to enroll, and four-fifths (84%) said they had no problem signing up. The majority—85%–90% of both groups—said they had no problem using the new benefit. “This is a dramatic departure from the conventional wisdom about this program,” said Whitfield Ayres, Ph.D., president of the polling firm. But Ron Pollack, executive director of the advocacy group Families USA, said it was not surprising that beneficiaries who went to the trouble to sign up were happy. Shockingly few have signed up, however, Mr. Pollack said. “America's seniors are clearly voting with their feet,” he said.

All Groups at Risk for Poor Care

Although disparities exist in health care among various ethnic and racial groups, those gaps are small compared with the health care everyone receives and what they should be receiving, according to a report from the Rand Corporation. “Differences exist. But they pale in comparison to the chasm between where we are today and where we should be,” said Dr. Steven M. Asch of the University of California, Los Angeles, the study's lead author. “These findings tell us that no one can afford to be complacent, and they underscore that the quality-of-care problem in this country is profound and systemic.” The study assessed preventive services and care for 30 acute and chronic conditions that constitute the leading causes of death and disability. Overall, participants received about 55% of recommended care, despite the fact that the recommendations for the conditions involved were widely known and accepted.

Bill Seeks Consent for Off-Label Rx

A bill in the California assembly would require physicians to get informed consent from their patients before “prescribing, administering, or furnishing” a prescription for off-label use. A failure to adhere to the requirement would be considered a violation of the Medical Practice Act, which means physicians could be charged with a crime. The California Medical Association opposes the legislation and said the existing law is enough because physicians can be held liable for not disclosing risks. The bill would require physicians to specify that a medication is not approved by the Food and Drug Administration for the use that the doctor is recommending, and that the risks are unknown and there is not a consensus on the efficacy.

Obesity Linked to 2%–3% of Claims

Obesity accounts for 2%–3% of medical claims dollars, according to a retrospective study in the March issue of the Journal of Occupational and Environmental Medicine. Researchers at Gordian Health Solutions Inc. assessed claims from January 2000 to December 2004 from 61 employers. In 2004 inflation-adjusted dollars, total claims for the study period amounted to $4.55 billion. Obesity was responsible for 2.1% of total claims for male workers ($3.55/member per month) and 2.8% for female workers ($5.71/member per month). The true tally may be higher, said the researchers, noting that their analysis excluded prescription drug costs. Given that the data show a rise in obesity-related costs with increasing age, “childhood obesity may have significant lagged effects.”

IOM on Quality Improvement Groups

An Institute of Medicine committee has released a report on Medicare's Quality Improvement Organizations that describes these groups as spending too much time on reviewing beneficiary complaints and not enough on helping physicians and health care organizations to actually improve care. The panel said there are inherent conflicts when the QIO reviews complaints about organizations it needs to voluntarily participate in quality improvement efforts, and suggested that case reviews should be shifted to regional or national agencies. The 22-member IOM panel spent a year investigating the 41 organizations that are hired by Medicare to improve quality of care, address patient complaints, and review claims to ensure they meet quality benchmarks and reimbursement standards. Stephen M. Shortell, Ph.D., an IOM panel member, said the committee's main finding was that, while the quality of care has improved, “the pace of change is too slow, and gaps in quality persist.” QIOs should be providing more technical assistance to physicians and hospitals, said Dr. Shortell, who is a professor of health policy and management at the University of California, Berkeley. The IOM panel said that QIO boards—which it said are dominated by physicians—should include more consumers, representatives of other health fields, and health information technology experts, and have greater accountability to the public. The American Health Quality Association, a QIO trade group, said it supported most of the recommendations, but said that the organizations should continue to review complaints and appeals because it provided “invaluable opportunities to help providers improve care for all patients.” The AHQA also noted that 30 of 41 QIOs had signed a code of conduct that would make them more accountable.

Many Enrollees Happy With Part D

A new survey of Medicare beneficiaries who are receiving Part D drug benefits finds them to be largely satisfied. The survey—conducted 10 weeks into the new coverage—was paid for by America's Health Insurance Plans, and conducted by Ayres, McHenry & Associates Inc., a Republican polling firm. The poll surveyed 408 of the 5.2 million people over age 65 years who have self-enrolled in Part D, and 401 of the 6.5 million “dual eligibles,” who were automatically enrolled because they had Medicaid drug coverage. Of those who self-enrolled, 66% said it had been worth the time and effort to enroll, and four-fifths (84%) said they had no problem signing up. The majority—85%–90% of both groups—said they had no problem using the new benefit. “This is a dramatic departure from the conventional wisdom about this program,” said Whitfield Ayres, Ph.D., president of the polling firm. But Ron Pollack, executive director of the advocacy group Families USA, said it was not surprising that beneficiaries who went to the trouble to sign up were happy. Shockingly few have signed up, however, Mr. Pollack said. “America's seniors are clearly voting with their feet,” he said.

All Groups at Risk for Poor Care

Although disparities exist in health care among various ethnic and racial groups, those gaps are small compared with the health care everyone receives and what they should be receiving, according to a report from the Rand Corporation. “Differences exist. But they pale in comparison to the chasm between where we are today and where we should be,” said Dr. Steven M. Asch of the University of California, Los Angeles, the study's lead author. “These findings tell us that no one can afford to be complacent, and they underscore that the quality-of-care problem in this country is profound and systemic.” The study assessed preventive services and care for 30 acute and chronic conditions that constitute the leading causes of death and disability. Overall, participants received about 55% of recommended care, despite the fact that the recommendations for the conditions involved were widely known and accepted.

Bill Seeks Consent for Off-Label Rx

A bill in the California assembly would require physicians to get informed consent from their patients before “prescribing, administering, or furnishing” a prescription for off-label use. A failure to adhere to the requirement would be considered a violation of the Medical Practice Act, which means physicians could be charged with a crime. The California Medical Association opposes the legislation and said the existing law is enough because physicians can be held liable for not disclosing risks. The bill would require physicians to specify that a medication is not approved by the Food and Drug Administration for the use that the doctor is recommending, and that the risks are unknown and there is not a consensus on the efficacy.

Obesity Linked to 2%–3% of Claims

Obesity accounts for 2%–3% of medical claims dollars, according to a retrospective study in the March issue of the Journal of Occupational and Environmental Medicine. Researchers at Gordian Health Solutions Inc. assessed claims from January 2000 to December 2004 from 61 employers. In 2004 inflation-adjusted dollars, total claims for the study period amounted to $4.55 billion. Obesity was responsible for 2.1% of total claims for male workers ($3.55/member per month) and 2.8% for female workers ($5.71/member per month). The true tally may be higher, said the researchers, noting that their analysis excluded prescription drug costs. Given that the data show a rise in obesity-related costs with increasing age, “childhood obesity may have significant lagged effects.”

IOM on Quality Improvement Groups

An Institute of Medicine committee has released a report on Medicare's Quality Improvement Organizations that describes these groups as spending too much time on reviewing beneficiary complaints and not enough on helping physicians and health care organizations to actually improve care. The panel said there are inherent conflicts when the QIO reviews complaints about organizations it needs to voluntarily participate in quality improvement efforts, and suggested that case reviews should be shifted to regional or national agencies. The 22-member IOM panel spent a year investigating the 41 organizations that are hired by Medicare to improve quality of care, address patient complaints, and review claims to ensure they meet quality benchmarks and reimbursement standards. Stephen M. Shortell, Ph.D., an IOM panel member, said the committee's main finding was that, while the quality of care has improved, “the pace of change is too slow, and gaps in quality persist.” QIOs should be providing more technical assistance to physicians and hospitals, said Dr. Shortell, who is a professor of health policy and management at the University of California, Berkeley. The IOM panel said that QIO boards—which it said are dominated by physicians—should include more consumers, representatives of other health fields, and health information technology experts, and have greater accountability to the public. The American Health Quality Association, a QIO trade group, said it supported most of the recommendations, but said that the organizations should continue to review complaints and appeals because it provided “invaluable opportunities to help providers improve care for all patients.” The AHQA also noted that 30 of 41 QIOs had signed a code of conduct that would make them more accountable.

Many Enrollees Happy With Part D

A new survey of Medicare beneficiaries who are receiving Part D drug benefits finds them to be largely satisfied. The survey—conducted 10 weeks into the new coverage—was paid for by America's Health Insurance Plans, and conducted by Ayres, McHenry & Associates Inc., a Republican polling firm. The poll surveyed 408 of the 5.2 million people over age 65 years who have self-enrolled in Part D, and 401 of the 6.5 million “dual eligibles,” who were automatically enrolled because they had Medicaid drug coverage. Of those who self-enrolled, 66% said it had been worth the time and effort to enroll, and four-fifths (84%) said they had no problem signing up. The majority—85%–90% of both groups—said they had no problem using the new benefit. “This is a dramatic departure from the conventional wisdom about this program,” said Whitfield Ayres, Ph.D., president of the polling firm. But Ron Pollack, executive director of the advocacy group Families USA, said it was not surprising that beneficiaries who went to the trouble to sign up were happy. Shockingly few have signed up, however, Mr. Pollack said. “America's seniors are clearly voting with their feet,” he said.

All Groups at Risk for Poor Care

Although disparities exist in health care among various ethnic and racial groups, those gaps are small compared with the health care everyone receives and what they should be receiving, according to a report from the Rand Corporation. “Differences exist. But they pale in comparison to the chasm between where we are today and where we should be,” said Dr. Steven M. Asch of the University of California, Los Angeles, the study's lead author. “These findings tell us that no one can afford to be complacent, and they underscore that the quality-of-care problem in this country is profound and systemic.” The study assessed preventive services and care for 30 acute and chronic conditions that constitute the leading causes of death and disability. Overall, participants received about 55% of recommended care, despite the fact that the recommendations for the conditions involved were widely known and accepted.

Medicare might not pay for implantation of the Charité artificial spinal disk if a proposed coverage decision becomes final in May.

According to the Centers for Medicare and Medicaid Services proposal, the evidence is not adequate to conclude that disk replacement with the Charité “is reasonable and necessary.”

CMS is accepting comments through April, and will make a final decision on May 6. The agency said it found little data in patients older than 65 years and, in addition, that the results of the pivotal Charité study “are unconvincing as a demonstration of net health benefit.”

Several specialty societies—including the North American Spine Society, the Scoliosis Research Society, and the Spine Arthroplasty Society—have commented, mostly saying that the jury is still out on older patients.

The Charité was approved by the Food and Drug Administration last November, but it has not been widely adopted and is rarely being paid for by insurers. So far, 176 procedures have been covered by insurers; Medicare has paid for a few cases as well, said Dr. Richard Toselli, worldwide vice president for research and development at DePuy Spine Inc. of Raynham, Mass., which makes Charité. The disk is indicated for 18- to 60-year-old patients with degenerative disk disease at one level, either L4/L5 or L5/S1. It has not been studied in patients older than age 60.

CMS began its coverage review at the request of Dr. Richard Deyo, an internist and professor of medicine and health services at the University of Washington, Seattle. In an interview, Dr. Deyo said he was concerned about the safety of the Charité in an older population partly because osteopenia and osteoporosis are contraindications.

Dr. Deyo also said the Charité had shown in trials only that it was not inferior to a type of fusion—Bagby and Kuslich (BAK) cages with iliac crest bone graft—a procedure he called “largely discredited.”

The disk is not intended to be implanted in patients older than age 65, so Medicare's proposal did not come as a great surprise, said Dr. Toselli. DePuy Spine is hoping that Medicare will pay for Charité implantation in its disabled beneficiaries, he said.

A split coverage decision would not be unprecedented. A CMS spokesman said the agency has in the past covered procedures or therapies for subgroups of the Medicare population, or has imposed restrictions on the prescribing or use of a device or therapy. In its Charité proposal, however, CMS said the data did not seem to support using the disk in the disabled, either.

Medicare might not pay for implantation of the Charité artificial spinal disk if a proposed coverage decision becomes final in May.

According to the Centers for Medicare and Medicaid Services proposal, the evidence is not adequate to conclude that disk replacement with the Charité “is reasonable and necessary.”

CMS is accepting comments through April, and will make a final decision on May 6. The agency said it found little data in patients older than 65 years and, in addition, that the results of the pivotal Charité study “are unconvincing as a demonstration of net health benefit.”

Several specialty societies—including the North American Spine Society, the Scoliosis Research Society, and the Spine Arthroplasty Society—have commented, mostly saying that the jury is still out on older patients.

The Charité was approved by the Food and Drug Administration last November, but it has not been widely adopted and is rarely being paid for by insurers. So far, 176 procedures have been covered by insurers; Medicare has paid for a few cases as well, said Dr. Richard Toselli, worldwide vice president for research and development at DePuy Spine Inc. of Raynham, Mass., which makes Charité. The disk is indicated for 18- to 60-year-old patients with degenerative disk disease at one level, either L4/L5 or L5/S1. It has not been studied in patients older than age 60.

CMS began its coverage review at the request of Dr. Richard Deyo, an internist and professor of medicine and health services at the University of Washington, Seattle. In an interview, Dr. Deyo said he was concerned about the safety of the Charité in an older population partly because osteopenia and osteoporosis are contraindications.

Dr. Deyo also said the Charité had shown in trials only that it was not inferior to a type of fusion—Bagby and Kuslich (BAK) cages with iliac crest bone graft—a procedure he called “largely discredited.”

The disk is not intended to be implanted in patients older than age 65, so Medicare's proposal did not come as a great surprise, said Dr. Toselli. DePuy Spine is hoping that Medicare will pay for Charité implantation in its disabled beneficiaries, he said.

A split coverage decision would not be unprecedented. A CMS spokesman said the agency has in the past covered procedures or therapies for subgroups of the Medicare population, or has imposed restrictions on the prescribing or use of a device or therapy. In its Charité proposal, however, CMS said the data did not seem to support using the disk in the disabled, either.

Medicare might not pay for implantation of the Charité artificial spinal disk if a proposed coverage decision becomes final in May.

According to the Centers for Medicare and Medicaid Services proposal, the evidence is not adequate to conclude that disk replacement with the Charité “is reasonable and necessary.”

CMS is accepting comments through April, and will make a final decision on May 6. The agency said it found little data in patients older than 65 years and, in addition, that the results of the pivotal Charité study “are unconvincing as a demonstration of net health benefit.”

Several specialty societies—including the North American Spine Society, the Scoliosis Research Society, and the Spine Arthroplasty Society—have commented, mostly saying that the jury is still out on older patients.

The Charité was approved by the Food and Drug Administration last November, but it has not been widely adopted and is rarely being paid for by insurers. So far, 176 procedures have been covered by insurers; Medicare has paid for a few cases as well, said Dr. Richard Toselli, worldwide vice president for research and development at DePuy Spine Inc. of Raynham, Mass., which makes Charité. The disk is indicated for 18- to 60-year-old patients with degenerative disk disease at one level, either L4/L5 or L5/S1. It has not been studied in patients older than age 60.

CMS began its coverage review at the request of Dr. Richard Deyo, an internist and professor of medicine and health services at the University of Washington, Seattle. In an interview, Dr. Deyo said he was concerned about the safety of the Charité in an older population partly because osteopenia and osteoporosis are contraindications.

Dr. Deyo also said the Charité had shown in trials only that it was not inferior to a type of fusion—Bagby and Kuslich (BAK) cages with iliac crest bone graft—a procedure he called “largely discredited.”

The disk is not intended to be implanted in patients older than age 65, so Medicare's proposal did not come as a great surprise, said Dr. Toselli. DePuy Spine is hoping that Medicare will pay for Charité implantation in its disabled beneficiaries, he said.

A split coverage decision would not be unprecedented. A CMS spokesman said the agency has in the past covered procedures or therapies for subgroups of the Medicare population, or has imposed restrictions on the prescribing or use of a device or therapy. In its Charité proposal, however, CMS said the data did not seem to support using the disk in the disabled, either.

Bill Seeks Consent for Off-Label Rx

A new bill in the California assembly would require physicians and surgeons to get informed consent from their patients before “prescribing, administering, or furnishing” a prescription for off-label use. A failure to adhere to the requirement would be considered a violation of the Medical Practice Act, which means physicians could be charged with a crime. The California Medical Association opposes the legislation. In a statement, the CMA said existing law is enough because physicians can be held liable for not disclosing risks. Off-label use often saves lives, the statement said. A.B. 2856 was introduced by Assemblywoman Loni Hancock (D-Berkeley). It would require physicians to specify that a medication is not approved by the Food and Drug Administration for the use that the doctor is recommending, that the risks are unknown, and that there is not a consensus on the drug's efficacy. A patient could withdraw consent at any time.

Women's Heart Health

A group of female lawmakers has introduced a bill to require gender-specific data in new drug and device applications and to expand free screening for low-income women. The HEART (Heart Disease Education, Analysis and Research, and Treatment) for Women Act (S. 2278) was introduced by Sens. Debbie Stabenow (D-Mich.) and Lisa Murkowski (R-Alaska). Reps. Lois Capps (D-Calif.) and Barbara Cubin (R-Wyo.) introduced the House companion bill (H.R. 4747). Few people realize that heart disease is the No. 1 killer of women, said Rep. Capps in a statement. The bill seeks to fund an education awareness campaign for physicians and patients, and to bar Food and Drug Administration approval of a drug or device if it does not include gender, race, and ethnicity data. It also calls for an annual report on women and heart disease to be compiled by the Agency for Healthcare Research and Quality and for hospital-quality data to be reported by gender. Finally, the bill would expand the WISEWOMAN (Well-Integrated Screening and Evaluation for Women Across the Nation) heart disease and stroke screening program from 14 states to all 50. The bill is supported by the American Heart Association, the American Stroke Association, and the National Coalition for Women with Heart Disease.

Smoking Rates Drop

The number of cigarettes sold in the United States in 2005 dropped 4.2% from 2004, the largest 1-year percentage decrease in sales since 1999, according to figures compiled by the Treasury Department. “We are pleased to see that the long decline of cigarette consumption is continuing,” Cheryl Healton, Dr.P.H., president of the American Legacy Foundation, said in statement. “We also know that for the first time in the United States, there are more former smokers than current smokers.” The National Association of Attorneys General also applauded the numbers, noting that the drop continues “the unprecedented long-term decline in cigarette smoking that began with the settlement of lawsuits” brought by state attorneys general against the major tobacco companies.

Survey: Part D Enrollees Happy

A new survey of Medicare beneficiaries who are receiving Part D drug benefits finds them to be largely satisfied. The survey—conducted 10 weeks into the new coverage—was paid for by America's Health Insurance Plans, and conducted by Ayres, McHenry & Associates Inc., a Republican polling firm. The poll surveyed 408 of the 5.2 million people over age 65 years who have self-enrolled in Part D, and 401 of the 6.5 million “dual eligibles,” who were automatically enrolled because they had Medicaid drug coverage. Of those who self-enrolled, 66% said that it had been worth the time and effort to enroll, and four-fifths (84%) said that they had no problem signing up. The majority—85%–90% of both groups—said they had no problem using the new benefit. Ron Pollack, executive director of the advocacy group Families USA, said it was not surprising that beneficiaries who went to the trouble to sign up were happy. Shockingly few have signed up, however, said Mr. Pollack. According to the poll, among those who regularly take a prescription drug—90% of the self-enrolled and 83% of dual eligibles—79% said the plan covered the drugs they needed. Mr. Pollack said that was a step backward for the low-income group, who had 100% coverage under Medicaid. A little more than half (59%) of self-enrolled seniors said they are saving money. Forty-six percent of the self-enrolled and 35% of automatically enrolled seniors said Part D critics were bashing the plan to score political points; 14% in both groups said politicians were sincerely trying to fix the plan; about half were undecided.

Patient/Doctor Decision Making

Decisions about medical treatment should be made by physicians and patients, according to a survey of 1,029 adults for the National Consumers League. More than 90% of respondents agreed that, “[all] medications, both over-the-counter and prescription, offer benefits but also carry some risk of side effects. It should be up to physicians and patients to weigh benefits against the risks and to make decisions that are right for them,” according to the survey. The poll also found that the public strongly supports broader access to treatments—even those carrying additional risks—for chronic diseases such as multiple sclerosis, Parkinson's disease, and Alzheimer's disease. “Everything in life carries risks, but in the case of chronic, debilitating conditions, the greatest risk is a lack of new and improved treatment options,” said Linda Golodner, the league's president. “It obviously makes sense for these patients to have access to as many treatment options as possible and make decisions that are right for them, even if there are additional risks.”

Bill Seeks Consent for Off-Label Rx

A new bill in the California assembly would require physicians and surgeons to get informed consent from their patients before “prescribing, administering, or furnishing” a prescription for off-label use. A failure to adhere to the requirement would be considered a violation of the Medical Practice Act, which means physicians could be charged with a crime. The California Medical Association opposes the legislation. In a statement, the CMA said existing law is enough because physicians can be held liable for not disclosing risks. Off-label use often saves lives, the statement said. A.B. 2856 was introduced by Assemblywoman Loni Hancock (D-Berkeley). It would require physicians to specify that a medication is not approved by the Food and Drug Administration for the use that the doctor is recommending, that the risks are unknown, and that there is not a consensus on the drug's efficacy. A patient could withdraw consent at any time.

Women's Heart Health

A group of female lawmakers has introduced a bill to require gender-specific data in new drug and device applications and to expand free screening for low-income women. The HEART (Heart Disease Education, Analysis and Research, and Treatment) for Women Act (S. 2278) was introduced by Sens. Debbie Stabenow (D-Mich.) and Lisa Murkowski (R-Alaska). Reps. Lois Capps (D-Calif.) and Barbara Cubin (R-Wyo.) introduced the House companion bill (H.R. 4747). Few people realize that heart disease is the No. 1 killer of women, said Rep. Capps in a statement. The bill seeks to fund an education awareness campaign for physicians and patients, and to bar Food and Drug Administration approval of a drug or device if it does not include gender, race, and ethnicity data. It also calls for an annual report on women and heart disease to be compiled by the Agency for Healthcare Research and Quality and for hospital-quality data to be reported by gender. Finally, the bill would expand the WISEWOMAN (Well-Integrated Screening and Evaluation for Women Across the Nation) heart disease and stroke screening program from 14 states to all 50. The bill is supported by the American Heart Association, the American Stroke Association, and the National Coalition for Women with Heart Disease.

Smoking Rates Drop

The number of cigarettes sold in the United States in 2005 dropped 4.2% from 2004, the largest 1-year percentage decrease in sales since 1999, according to figures compiled by the Treasury Department. “We are pleased to see that the long decline of cigarette consumption is continuing,” Cheryl Healton, Dr.P.H., president of the American Legacy Foundation, said in statement. “We also know that for the first time in the United States, there are more former smokers than current smokers.” The National Association of Attorneys General also applauded the numbers, noting that the drop continues “the unprecedented long-term decline in cigarette smoking that began with the settlement of lawsuits” brought by state attorneys general against the major tobacco companies.

Survey: Part D Enrollees Happy

A new survey of Medicare beneficiaries who are receiving Part D drug benefits finds them to be largely satisfied. The survey—conducted 10 weeks into the new coverage—was paid for by America's Health Insurance Plans, and conducted by Ayres, McHenry & Associates Inc., a Republican polling firm. The poll surveyed 408 of the 5.2 million people over age 65 years who have self-enrolled in Part D, and 401 of the 6.5 million “dual eligibles,” who were automatically enrolled because they had Medicaid drug coverage. Of those who self-enrolled, 66% said that it had been worth the time and effort to enroll, and four-fifths (84%) said that they had no problem signing up. The majority—85%–90% of both groups—said they had no problem using the new benefit. Ron Pollack, executive director of the advocacy group Families USA, said it was not surprising that beneficiaries who went to the trouble to sign up were happy. Shockingly few have signed up, however, said Mr. Pollack. According to the poll, among those who regularly take a prescription drug—90% of the self-enrolled and 83% of dual eligibles—79% said the plan covered the drugs they needed. Mr. Pollack said that was a step backward for the low-income group, who had 100% coverage under Medicaid. A little more than half (59%) of self-enrolled seniors said they are saving money. Forty-six percent of the self-enrolled and 35% of automatically enrolled seniors said Part D critics were bashing the plan to score political points; 14% in both groups said politicians were sincerely trying to fix the plan; about half were undecided.

Patient/Doctor Decision Making

Decisions about medical treatment should be made by physicians and patients, according to a survey of 1,029 adults for the National Consumers League. More than 90% of respondents agreed that, “[all] medications, both over-the-counter and prescription, offer benefits but also carry some risk of side effects. It should be up to physicians and patients to weigh benefits against the risks and to make decisions that are right for them,” according to the survey. The poll also found that the public strongly supports broader access to treatments—even those carrying additional risks—for chronic diseases such as multiple sclerosis, Parkinson's disease, and Alzheimer's disease. “Everything in life carries risks, but in the case of chronic, debilitating conditions, the greatest risk is a lack of new and improved treatment options,” said Linda Golodner, the league's president. “It obviously makes sense for these patients to have access to as many treatment options as possible and make decisions that are right for them, even if there are additional risks.”

Bill Seeks Consent for Off-Label Rx

A new bill in the California assembly would require physicians and surgeons to get informed consent from their patients before “prescribing, administering, or furnishing” a prescription for off-label use. A failure to adhere to the requirement would be considered a violation of the Medical Practice Act, which means physicians could be charged with a crime. The California Medical Association opposes the legislation. In a statement, the CMA said existing law is enough because physicians can be held liable for not disclosing risks. Off-label use often saves lives, the statement said. A.B. 2856 was introduced by Assemblywoman Loni Hancock (D-Berkeley). It would require physicians to specify that a medication is not approved by the Food and Drug Administration for the use that the doctor is recommending, that the risks are unknown, and that there is not a consensus on the drug's efficacy. A patient could withdraw consent at any time.

Women's Heart Health

A group of female lawmakers has introduced a bill to require gender-specific data in new drug and device applications and to expand free screening for low-income women. The HEART (Heart Disease Education, Analysis and Research, and Treatment) for Women Act (S. 2278) was introduced by Sens. Debbie Stabenow (D-Mich.) and Lisa Murkowski (R-Alaska). Reps. Lois Capps (D-Calif.) and Barbara Cubin (R-Wyo.) introduced the House companion bill (H.R. 4747). Few people realize that heart disease is the No. 1 killer of women, said Rep. Capps in a statement. The bill seeks to fund an education awareness campaign for physicians and patients, and to bar Food and Drug Administration approval of a drug or device if it does not include gender, race, and ethnicity data. It also calls for an annual report on women and heart disease to be compiled by the Agency for Healthcare Research and Quality and for hospital-quality data to be reported by gender. Finally, the bill would expand the WISEWOMAN (Well-Integrated Screening and Evaluation for Women Across the Nation) heart disease and stroke screening program from 14 states to all 50. The bill is supported by the American Heart Association, the American Stroke Association, and the National Coalition for Women with Heart Disease.

Smoking Rates Drop

The number of cigarettes sold in the United States in 2005 dropped 4.2% from 2004, the largest 1-year percentage decrease in sales since 1999, according to figures compiled by the Treasury Department. “We are pleased to see that the long decline of cigarette consumption is continuing,” Cheryl Healton, Dr.P.H., president of the American Legacy Foundation, said in statement. “We also know that for the first time in the United States, there are more former smokers than current smokers.” The National Association of Attorneys General also applauded the numbers, noting that the drop continues “the unprecedented long-term decline in cigarette smoking that began with the settlement of lawsuits” brought by state attorneys general against the major tobacco companies.

Survey: Part D Enrollees Happy

A new survey of Medicare beneficiaries who are receiving Part D drug benefits finds them to be largely satisfied. The survey—conducted 10 weeks into the new coverage—was paid for by America's Health Insurance Plans, and conducted by Ayres, McHenry & Associates Inc., a Republican polling firm. The poll surveyed 408 of the 5.2 million people over age 65 years who have self-enrolled in Part D, and 401 of the 6.5 million “dual eligibles,” who were automatically enrolled because they had Medicaid drug coverage. Of those who self-enrolled, 66% said that it had been worth the time and effort to enroll, and four-fifths (84%) said that they had no problem signing up. The majority—85%–90% of both groups—said they had no problem using the new benefit. Ron Pollack, executive director of the advocacy group Families USA, said it was not surprising that beneficiaries who went to the trouble to sign up were happy. Shockingly few have signed up, however, said Mr. Pollack. According to the poll, among those who regularly take a prescription drug—90% of the self-enrolled and 83% of dual eligibles—79% said the plan covered the drugs they needed. Mr. Pollack said that was a step backward for the low-income group, who had 100% coverage under Medicaid. A little more than half (59%) of self-enrolled seniors said they are saving money. Forty-six percent of the self-enrolled and 35% of automatically enrolled seniors said Part D critics were bashing the plan to score political points; 14% in both groups said politicians were sincerely trying to fix the plan; about half were undecided.

Patient/Doctor Decision Making

Decisions about medical treatment should be made by physicians and patients, according to a survey of 1,029 adults for the National Consumers League. More than 90% of respondents agreed that, “[all] medications, both over-the-counter and prescription, offer benefits but also carry some risk of side effects. It should be up to physicians and patients to weigh benefits against the risks and to make decisions that are right for them,” according to the survey. The poll also found that the public strongly supports broader access to treatments—even those carrying additional risks—for chronic diseases such as multiple sclerosis, Parkinson's disease, and Alzheimer's disease. “Everything in life carries risks, but in the case of chronic, debilitating conditions, the greatest risk is a lack of new and improved treatment options,” said Linda Golodner, the league's president. “It obviously makes sense for these patients to have access to as many treatment options as possible and make decisions that are right for them, even if there are additional risks.”

BALTIMORE — Preoperative screening to identify potential cardiac complications is often unnecessary and may not help a surgeon to reduce risk during an elective procedure, said Dr. Richard Lange at a cardiovascular conference sponsored by Johns Hopkins University, Baltimore.

There are many reasons to focus on patients who are at highest risk for complications. Nuclear stress testing alone costs about $10 billion each year, said Dr. Lange, chief of clinical cardiology at Johns Hopkins. There are 27 million people who undergo noncardiac surgeries each year in the U.S., but only 8 million have coronary artery disease or risk factors, and 50,000 will have a perioperative MI, he said.

Patients undergoing low- or intermediate-risk procedures aren't likely to need stress testing, he said. Endoscopic, superficial, cataract, and breast procedures are considered low risk, with a less than 1% complication rate. Procedures with an intermediate risk (1%–5% complication rate) include carotid endarterectomy, as well as head and neck, intraperitoneal, intrathoracic, orthopedic, and prostate procedures.

The highest-risk procedures (more than 5% complication rate) include emergent major operations, especially in elderly patients, in the aorta or other major vessels, in peripheral vasculature, and in procedures with large fluid shifts or blood loss, said Dr. Lange.

Usually, older patients and those with rhythm disorders, abnormal ECGs, a low functional capacity, or uncontrolled hypertension are considered to be at risk for cardiac complications. But none of these is an independent risk factor, said Dr. Lange.

However, six predictors have been identified as independent risk factors: a high-risk surgical procedure; a history of ischemic heart disease; a history of heart failure; a history of transient ischemic attack or stroke; insulin therapy; and a preoperative serum creatinine level greater than 2 mg/dL (Circulation 1999;100:1043–9). According to this Revised Cardiac Risk Index, the focus for work-ups should be on patients who have more than three of these risk factors.

Not all tests provide valuable information, either. A 2003 metaanalysis of the predictive ability of noninvasive tests found varying sensitivity and specificity results (Heart 2003;89:1327–34). Perfusion imaging, for instance, had a high sensitivity, but very low specificity. Dobutamine stress echocardiography had an 85% sensitivity and 70% specificity. Tests should provide a high positive predictive value, and—more importantly—should give the clinician information beyond what can be determined by the clinical risk factors, said Dr. Lange. And tests should lead to a strategy that reduces the risk of perioperative MI.

If a diagnostic test seems warranted and indicates increased risk, it's not always advisable to perform coronary revascularization, said Dr. Lange. Several studies have shown that patients who had a percutaneous coronary intervention (PCI) or coronary bypass artery graft (CABG) to minimize risk actually ended up in worse condition. The Coronary Artery Revascularization Prophylaxis trial found that high-risk patients who received a PCI or CABG followed by vascular surgery did no better than those who were given medical therapy (N. Engl. J. Med. 2004;351:2795–804). And, said Dr. Lange, there was a 9% rate of death or myocardial infarction during the revascularization procedure.

Stenting before noncardiac surgery may put patients at even higher risk, he said, citing three trials showing increased major bleeding, cardiac events, and death if the follow-on procedure was done within a few weeks. Drug-eluting stents may put patients at higher risk because of delayed endothelialization and increased risk of subacute and late thrombosis. The evidence suggests that noncardiac surgery should be done a minimum of 3–6 months after drug-eluting stent placement, he said.

BALTIMORE — Preoperative screening to identify potential cardiac complications is often unnecessary and may not help a surgeon to reduce risk during an elective procedure, said Dr. Richard Lange at a cardiovascular conference sponsored by Johns Hopkins University, Baltimore.

There are many reasons to focus on patients who are at highest risk for complications. Nuclear stress testing alone costs about $10 billion each year, said Dr. Lange, chief of clinical cardiology at Johns Hopkins. There are 27 million people who undergo noncardiac surgeries each year in the U.S., but only 8 million have coronary artery disease or risk factors, and 50,000 will have a perioperative MI, he said.

Patients undergoing low- or intermediate-risk procedures aren't likely to need stress testing, he said. Endoscopic, superficial, cataract, and breast procedures are considered low risk, with a less than 1% complication rate. Procedures with an intermediate risk (1%–5% complication rate) include carotid endarterectomy, as well as head and neck, intraperitoneal, intrathoracic, orthopedic, and prostate procedures.

The highest-risk procedures (more than 5% complication rate) include emergent major operations, especially in elderly patients, in the aorta or other major vessels, in peripheral vasculature, and in procedures with large fluid shifts or blood loss, said Dr. Lange.

Usually, older patients and those with rhythm disorders, abnormal ECGs, a low functional capacity, or uncontrolled hypertension are considered to be at risk for cardiac complications. But none of these is an independent risk factor, said Dr. Lange.

However, six predictors have been identified as independent risk factors: a high-risk surgical procedure; a history of ischemic heart disease; a history of heart failure; a history of transient ischemic attack or stroke; insulin therapy; and a preoperative serum creatinine level greater than 2 mg/dL (Circulation 1999;100:1043–9). According to this Revised Cardiac Risk Index, the focus for work-ups should be on patients who have more than three of these risk factors.

Not all tests provide valuable information, either. A 2003 metaanalysis of the predictive ability of noninvasive tests found varying sensitivity and specificity results (Heart 2003;89:1327–34). Perfusion imaging, for instance, had a high sensitivity, but very low specificity. Dobutamine stress echocardiography had an 85% sensitivity and 70% specificity. Tests should provide a high positive predictive value, and—more importantly—should give the clinician information beyond what can be determined by the clinical risk factors, said Dr. Lange. And tests should lead to a strategy that reduces the risk of perioperative MI.

If a diagnostic test seems warranted and indicates increased risk, it's not always advisable to perform coronary revascularization, said Dr. Lange. Several studies have shown that patients who had a percutaneous coronary intervention (PCI) or coronary bypass artery graft (CABG) to minimize risk actually ended up in worse condition. The Coronary Artery Revascularization Prophylaxis trial found that high-risk patients who received a PCI or CABG followed by vascular surgery did no better than those who were given medical therapy (N. Engl. J. Med. 2004;351:2795–804). And, said Dr. Lange, there was a 9% rate of death or myocardial infarction during the revascularization procedure.

Stenting before noncardiac surgery may put patients at even higher risk, he said, citing three trials showing increased major bleeding, cardiac events, and death if the follow-on procedure was done within a few weeks. Drug-eluting stents may put patients at higher risk because of delayed endothelialization and increased risk of subacute and late thrombosis. The evidence suggests that noncardiac surgery should be done a minimum of 3–6 months after drug-eluting stent placement, he said.

BALTIMORE — Preoperative screening to identify potential cardiac complications is often unnecessary and may not help a surgeon to reduce risk during an elective procedure, said Dr. Richard Lange at a cardiovascular conference sponsored by Johns Hopkins University, Baltimore.

There are many reasons to focus on patients who are at highest risk for complications. Nuclear stress testing alone costs about $10 billion each year, said Dr. Lange, chief of clinical cardiology at Johns Hopkins. There are 27 million people who undergo noncardiac surgeries each year in the U.S., but only 8 million have coronary artery disease or risk factors, and 50,000 will have a perioperative MI, he said.

Patients undergoing low- or intermediate-risk procedures aren't likely to need stress testing, he said. Endoscopic, superficial, cataract, and breast procedures are considered low risk, with a less than 1% complication rate. Procedures with an intermediate risk (1%–5% complication rate) include carotid endarterectomy, as well as head and neck, intraperitoneal, intrathoracic, orthopedic, and prostate procedures.

The highest-risk procedures (more than 5% complication rate) include emergent major operations, especially in elderly patients, in the aorta or other major vessels, in peripheral vasculature, and in procedures with large fluid shifts or blood loss, said Dr. Lange.

Usually, older patients and those with rhythm disorders, abnormal ECGs, a low functional capacity, or uncontrolled hypertension are considered to be at risk for cardiac complications. But none of these is an independent risk factor, said Dr. Lange.

However, six predictors have been identified as independent risk factors: a high-risk surgical procedure; a history of ischemic heart disease; a history of heart failure; a history of transient ischemic attack or stroke; insulin therapy; and a preoperative serum creatinine level greater than 2 mg/dL (Circulation 1999;100:1043–9). According to this Revised Cardiac Risk Index, the focus for work-ups should be on patients who have more than three of these risk factors.

Not all tests provide valuable information, either. A 2003 metaanalysis of the predictive ability of noninvasive tests found varying sensitivity and specificity results (Heart 2003;89:1327–34). Perfusion imaging, for instance, had a high sensitivity, but very low specificity. Dobutamine stress echocardiography had an 85% sensitivity and 70% specificity. Tests should provide a high positive predictive value, and—more importantly—should give the clinician information beyond what can be determined by the clinical risk factors, said Dr. Lange. And tests should lead to a strategy that reduces the risk of perioperative MI.

If a diagnostic test seems warranted and indicates increased risk, it's not always advisable to perform coronary revascularization, said Dr. Lange. Several studies have shown that patients who had a percutaneous coronary intervention (PCI) or coronary bypass artery graft (CABG) to minimize risk actually ended up in worse condition. The Coronary Artery Revascularization Prophylaxis trial found that high-risk patients who received a PCI or CABG followed by vascular surgery did no better than those who were given medical therapy (N. Engl. J. Med. 2004;351:2795–804). And, said Dr. Lange, there was a 9% rate of death or myocardial infarction during the revascularization procedure.

Stenting before noncardiac surgery may put patients at even higher risk, he said, citing three trials showing increased major bleeding, cardiac events, and death if the follow-on procedure was done within a few weeks. Drug-eluting stents may put patients at higher risk because of delayed endothelialization and increased risk of subacute and late thrombosis. The evidence suggests that noncardiac surgery should be done a minimum of 3–6 months after drug-eluting stent placement, he said.

PHILADELPHIA — Hypertension, often called a condition without its own symptoms, manifests through heart attacks and strokes.

But a new study by researchers at the Texas Children's Hospital claims that children with hypertension may actually have symptoms such as headache and chest and abdominal pain, but that these signs are overlooked, according to Dr. Daniel I. Feig, who is chief of the hospital's pediatric hypertension clinics. He presented the results at the annual meeting of the American Society of Nephrology.

Dr. Feig and his colleagues studied 409 consecutive children who were evaluated at the facility's pediatric hypertension clinics for new-onset high blood pressure.

An estimated 2%–3% of children under age 18 years, and 15%–30% of obese children, have elevated blood pressure. Most of these children go undiagnosed, or are not managed well, he said. But it's important to address the hypertension early, he said, noting that the majority of hypertensive children go on to have elevated blood pressure as adults.

In adults, the poor outcomes are measured through heart attacks, strokes, or kidney failure, but in children, those events are rare. Some studies have shown evidence of organ damage in hypertensive children, including left ventricular hypertrophy, proteinuria, and accelerated atherosclerosis.

Clinicians use a statistical definition to quantify hypertension in children. Dr. Feig said he and his colleagues diagnosed hypertension when a child had a blood pressure greater than the 95th percentile, stratified for age, gender, and height, on three consecutive visits, over a 2-week time frame. They relied on charts from the Fourth Report on the Diagnosis, Evaluation and Treatment of High Blood Pressure in Children and Adolescents (Pediatrics 2004;114:555–76).

The researchers aimed to diagnose hypertension earlier in children and quantify the potential adverse outcomes if left unmanaged. They asked 409 consecutive children (aged 7–18 years) to fill out a questionnaire requesting self-reporting of 15 symptoms likely related to high blood pressure. After excluding those children who did not meet the entry criteria, they evaluated the questionnaires of 343 children and compared them with 150 healthy controls.

Children were asked to put a check next to a symptom that bothered them more than once a week. Of those with elevated blood pressure, 64% complained of more than one symptom, compared with 26% of normal children, a significant difference; 51% had one to four symptoms, and 14% had more than four symptoms.

The three most common symptoms were headache, which affected 42% of the hypertensive children, difficulty falling asleep, which affected 27% of that group, and daytime tiredness, which affected 26%. The hypertensive children were five times more likely to have these symptoms than normal children (odds ratios of 5.49 and 5.96, respectively).

Children also complained of chest and abdominal pain, failing at school, and having trouble concentrating.

The hypertensive children received counseling on how to modify their diets and were told to start exercising (low-impact cardiovascular training for 30 minutes a day for the sedentary kids). Children with severe hypertension or those who had elevated pressure due to a renal, cardiac, or another underlying condition were started on antihypertensives immediately. For the others, if they did not improve after 2 or 3 months of lifestyle changes, pharmaceuticals were added.

The most commonly used drugs included ACE inhibitors and calcium channel blockers.

Investigators asked the children to repeat the survey 4–6 months after starting treatment. Treatment seemed to make a substantial difference in the most common symptoms, with only 6.2% complaining of headache, down from 42%. Only 1.5% of children reported trouble falling asleep, and only 10% complained of daytime fatigue.

There was also a fairly big reduction in chest and abdominal pain, but there was no change in the number of children reporting difficulty at school—possibly because there was not enough time to detect a subjective change in school performance, or, more ominously, said Dr. Feig, because it might be that “cognitive changes due to early hypertension are irreversible.”

Children who received treatment improved regardless of whether they altered their lifestyle or took medications, suggesting that the most important intervention was lowering blood pressure, he said.

Dr. Stephen Daniels, a professor of pediatrics and environmental health at the Cincinnati Children's Hospital Medical Center, said the study challenges the conventional wisdom that hypertension is silent, but he was not convinced the symptoms were related to high blood pressure, citing potential design flaws.

The study “has generated a hypothesis that needs to be tested more completely,” he said in an interview. Hypertension is underdiagnosed in children, partly because pediatricians aren't always focused on measuring blood pressure or on how to interpret the measurements, he added.

“It would be important to know if there are symptoms related to high blood pressure that we're missing on a regular basis,” he said.

Children with hypertension may have symptoms such as headache and chest and abdominal pain. DR. FEIG

PHILADELPHIA — Hypertension, often called a condition without its own symptoms, manifests through heart attacks and strokes.

But a new study by researchers at the Texas Children's Hospital claims that children with hypertension may actually have symptoms such as headache and chest and abdominal pain, but that these signs are overlooked, according to Dr. Daniel I. Feig, who is chief of the hospital's pediatric hypertension clinics. He presented the results at the annual meeting of the American Society of Nephrology.

Dr. Feig and his colleagues studied 409 consecutive children who were evaluated at the facility's pediatric hypertension clinics for new-onset high blood pressure.

An estimated 2%–3% of children under age 18 years, and 15%–30% of obese children, have elevated blood pressure. Most of these children go undiagnosed, or are not managed well, he said. But it's important to address the hypertension early, he said, noting that the majority of hypertensive children go on to have elevated blood pressure as adults.

In adults, the poor outcomes are measured through heart attacks, strokes, or kidney failure, but in children, those events are rare. Some studies have shown evidence of organ damage in hypertensive children, including left ventricular hypertrophy, proteinuria, and accelerated atherosclerosis.

Clinicians use a statistical definition to quantify hypertension in children. Dr. Feig said he and his colleagues diagnosed hypertension when a child had a blood pressure greater than the 95th percentile, stratified for age, gender, and height, on three consecutive visits, over a 2-week time frame. They relied on charts from the Fourth Report on the Diagnosis, Evaluation and Treatment of High Blood Pressure in Children and Adolescents (Pediatrics 2004;114:555–76).

The researchers aimed to diagnose hypertension earlier in children and quantify the potential adverse outcomes if left unmanaged. They asked 409 consecutive children (aged 7–18 years) to fill out a questionnaire requesting self-reporting of 15 symptoms likely related to high blood pressure. After excluding those children who did not meet the entry criteria, they evaluated the questionnaires of 343 children and compared them with 150 healthy controls.

Children were asked to put a check next to a symptom that bothered them more than once a week. Of those with elevated blood pressure, 64% complained of more than one symptom, compared with 26% of normal children, a significant difference; 51% had one to four symptoms, and 14% had more than four symptoms.

The three most common symptoms were headache, which affected 42% of the hypertensive children, difficulty falling asleep, which affected 27% of that group, and daytime tiredness, which affected 26%. The hypertensive children were five times more likely to have these symptoms than normal children (odds ratios of 5.49 and 5.96, respectively).

Children also complained of chest and abdominal pain, failing at school, and having trouble concentrating.

The hypertensive children received counseling on how to modify their diets and were told to start exercising (low-impact cardiovascular training for 30 minutes a day for the sedentary kids). Children with severe hypertension or those who had elevated pressure due to a renal, cardiac, or another underlying condition were started on antihypertensives immediately. For the others, if they did not improve after 2 or 3 months of lifestyle changes, pharmaceuticals were added.

The most commonly used drugs included ACE inhibitors and calcium channel blockers.

Investigators asked the children to repeat the survey 4–6 months after starting treatment. Treatment seemed to make a substantial difference in the most common symptoms, with only 6.2% complaining of headache, down from 42%. Only 1.5% of children reported trouble falling asleep, and only 10% complained of daytime fatigue.

There was also a fairly big reduction in chest and abdominal pain, but there was no change in the number of children reporting difficulty at school—possibly because there was not enough time to detect a subjective change in school performance, or, more ominously, said Dr. Feig, because it might be that “cognitive changes due to early hypertension are irreversible.”

Children who received treatment improved regardless of whether they altered their lifestyle or took medications, suggesting that the most important intervention was lowering blood pressure, he said.

Dr. Stephen Daniels, a professor of pediatrics and environmental health at the Cincinnati Children's Hospital Medical Center, said the study challenges the conventional wisdom that hypertension is silent, but he was not convinced the symptoms were related to high blood pressure, citing potential design flaws.

The study “has generated a hypothesis that needs to be tested more completely,” he said in an interview. Hypertension is underdiagnosed in children, partly because pediatricians aren't always focused on measuring blood pressure or on how to interpret the measurements, he added.

“It would be important to know if there are symptoms related to high blood pressure that we're missing on a regular basis,” he said.

Children with hypertension may have symptoms such as headache and chest and abdominal pain. DR. FEIG

PHILADELPHIA — Hypertension, often called a condition without its own symptoms, manifests through heart attacks and strokes.

But a new study by researchers at the Texas Children's Hospital claims that children with hypertension may actually have symptoms such as headache and chest and abdominal pain, but that these signs are overlooked, according to Dr. Daniel I. Feig, who is chief of the hospital's pediatric hypertension clinics. He presented the results at the annual meeting of the American Society of Nephrology.

Dr. Feig and his colleagues studied 409 consecutive children who were evaluated at the facility's pediatric hypertension clinics for new-onset high blood pressure.

An estimated 2%–3% of children under age 18 years, and 15%–30% of obese children, have elevated blood pressure. Most of these children go undiagnosed, or are not managed well, he said. But it's important to address the hypertension early, he said, noting that the majority of hypertensive children go on to have elevated blood pressure as adults.

In adults, the poor outcomes are measured through heart attacks, strokes, or kidney failure, but in children, those events are rare. Some studies have shown evidence of organ damage in hypertensive children, including left ventricular hypertrophy, proteinuria, and accelerated atherosclerosis.

Clinicians use a statistical definition to quantify hypertension in children. Dr. Feig said he and his colleagues diagnosed hypertension when a child had a blood pressure greater than the 95th percentile, stratified for age, gender, and height, on three consecutive visits, over a 2-week time frame. They relied on charts from the Fourth Report on the Diagnosis, Evaluation and Treatment of High Blood Pressure in Children and Adolescents (Pediatrics 2004;114:555–76).

The researchers aimed to diagnose hypertension earlier in children and quantify the potential adverse outcomes if left unmanaged. They asked 409 consecutive children (aged 7–18 years) to fill out a questionnaire requesting self-reporting of 15 symptoms likely related to high blood pressure. After excluding those children who did not meet the entry criteria, they evaluated the questionnaires of 343 children and compared them with 150 healthy controls.

Children were asked to put a check next to a symptom that bothered them more than once a week. Of those with elevated blood pressure, 64% complained of more than one symptom, compared with 26% of normal children, a significant difference; 51% had one to four symptoms, and 14% had more than four symptoms.

The three most common symptoms were headache, which affected 42% of the hypertensive children, difficulty falling asleep, which affected 27% of that group, and daytime tiredness, which affected 26%. The hypertensive children were five times more likely to have these symptoms than normal children (odds ratios of 5.49 and 5.96, respectively).

Children also complained of chest and abdominal pain, failing at school, and having trouble concentrating.

The hypertensive children received counseling on how to modify their diets and were told to start exercising (low-impact cardiovascular training for 30 minutes a day for the sedentary kids). Children with severe hypertension or those who had elevated pressure due to a renal, cardiac, or another underlying condition were started on antihypertensives immediately. For the others, if they did not improve after 2 or 3 months of lifestyle changes, pharmaceuticals were added.

The most commonly used drugs included ACE inhibitors and calcium channel blockers.

Investigators asked the children to repeat the survey 4–6 months after starting treatment. Treatment seemed to make a substantial difference in the most common symptoms, with only 6.2% complaining of headache, down from 42%. Only 1.5% of children reported trouble falling asleep, and only 10% complained of daytime fatigue.

There was also a fairly big reduction in chest and abdominal pain, but there was no change in the number of children reporting difficulty at school—possibly because there was not enough time to detect a subjective change in school performance, or, more ominously, said Dr. Feig, because it might be that “cognitive changes due to early hypertension are irreversible.”

Children who received treatment improved regardless of whether they altered their lifestyle or took medications, suggesting that the most important intervention was lowering blood pressure, he said.

Dr. Stephen Daniels, a professor of pediatrics and environmental health at the Cincinnati Children's Hospital Medical Center, said the study challenges the conventional wisdom that hypertension is silent, but he was not convinced the symptoms were related to high blood pressure, citing potential design flaws.

The study “has generated a hypothesis that needs to be tested more completely,” he said in an interview. Hypertension is underdiagnosed in children, partly because pediatricians aren't always focused on measuring blood pressure or on how to interpret the measurements, he added.

“It would be important to know if there are symptoms related to high blood pressure that we're missing on a regular basis,” he said.

Children with hypertension may have symptoms such as headache and chest and abdominal pain. DR. FEIG