HealthWeb

2006-08-19T19:51:00.000-04:00

Implantable Cardioverter-Defibrillator for Congestive Heart Failure

Background

Sudden cardiac death (SCD) can occur in patients with CHF despite optimal medical therapy.

Patients with NYHA Class IV heart failure who are not candidates for cardiac transplantation are often excluded from studies such as SCD HeFT due to their high mortality from progressive pump failure.

There have been many more trials looking at primary prevention of SCD in ischemic than in nonischemic cardiomyopathy.

The national coverage determination (NCD) by the Center for Medicare and Medicaid Services for reimbursement of ICD therapy impacts patient selection in the US.

Briefly, and relevant to the article at hand, Medicare covers ICDs for pts with ischemic and non-ischemic dilated cardiomyopathy (if non-ischemic, >9 mos), NYHA Class II or III heart failure, and measured LVEF <>

Pts must not have cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm
Pt must not have had a CABG or PTCA within the past 3 months
Pt cannot have had an MI within 40 days prior to ICD insertion
Pts may not have clinical symptoms or findings that would make them a candidate for coronary revascularization
Pts may not have any disease, other than cardiac disease (e.g., cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year.

Ischemic cardiomyopathy trials

Pts who have had an acute MI are at increased risk for SCD, usually due to a tachyarrhythmia.

MADIT I – Multicenter Automatic Defibrillator Implantation Trial

1st trial to demonstrate that ICDs can be used for primary prevention of SCD in high risk, asymptomatic pts

196 pts with prior MI, NSVT on monitoring, LVEF <>

At 27 month follow-up, findings were significant reductions in the incidence of overall mortality, cardiac mortality, and arrhythmic deaths in pts treated with ICDs. Subset analysis showed benefit only in high-risk pts with more severe heart disease (EF <> 0.12 sec). Benefit increased progressively with more risk factors.
ICD was compared to amiodarone without a control of no antiarrhythmic.

Based upon the results of MADIT I, the FDA approved the prophylactic use of the ICD in pts with the following:

Sustained VT induced by EPS and not prevented with IV procainamide
Ischemic heart disease
Prior MI
NSVT
Reduced LVEF (<>

MADIT II Trial

1232 pts with MI more than 30 days prior to enrollment (and more than 3 months if bypass surgery was performed) and LVEF <>

Pts were randomly assigned to a prophylactic ICD or conventional medical therapy.

The study was prematurely terminated at an average f/u of 20 months because the ICD reduced all-cause mortality (14.2 vs 19.8 % for conventional therapy, HR 0.65 (0.51-0.93). This survival benefit was entirely due to a reduction in sudden death and was present in all subgroups analyzed.

An unexpected finding was a higher rate of hospitalization for HF in the ICD group (20 vs 15%), possibly due to longer life spans in the ICD group due to prevention of SCD.

Another possible explanation for the increased hospitalization for HF is the development of myocardial injury and decreased LVEF after multiple ICD shocks.

CABG Patch Trial

This trial evaluated the efficacy of an epicardial ICD implanted at the time of CABG for reducing mortality in pts undergoing surgical revascularization for severe CHD who had LVEF <36%.>

900 pts, no history of sustained VT or syncope. Average f/u of 32 months. 101 deaths in the ICD group (71 cardiac) and 95 in the control group (72 cardiac). HR of 1.07 was not statistically significant.

Prophylactic therapy with ICD did reduce arrhythmic death by 45%, but 71% of the deaths in the trial were nonarrhythmic, so this reduction in arrhythmic death did not impact upon total mortality.

ICD therapy potentially did not reduce mortality because coronary revascularization itself has a beneficial effect in preventing sudden death.

This trial is the main reason why current guidelines recommend against ICD implantation for pts who have recently undergone coronary revascularization.

MUSTT trial

704 pts with a prior MI (<1>

2 year and 5 year rates for the primary end point were significantly lower for EPS guided therapy compared to no therapy, largely attributable to ICD therapy.

DINAMIT trial

Evaluated the role of prophylactic ICD implantation compared to no ICD in 674 pts with an MI within the preceding 6 to 40 days (unlike MADIT and MUSTT, which enrolled pts at least 3 weeks post MI).

LVEF <> 80 beats/min).

Exclusion criteria included sustained VT >48 hrs post-MI, NYHA class IV HF, or CABG or three vessel PCI post-MI.

No difference in annual all-cause mortality between ICD and control.

Arrhythmic deaths were more frequent in the control arm, nonarrhythmic deaths were more freqent in the ICD arm.

Potential reasons for less of an effect in this trial than in MADIT and MUSTT include that some SCDs in the early postinfarction period are due to recurrent ischemia, which is not completely treated by ICD discharge or ICD implantation may be riskier in pt immediately post MI.

This trial is the main reason that current guidelines recommend that ICD implantation should be deferred until at least 40 days post MI.

Nonischemic cardiomyopathy trials
Ventricular arrhythmias are common in HF pts with a nonischemic cardiomyopathy.

CAT and AMIOVIRT
Neither trial showed survival benefit of prophylactic ICD insertion compared to placebo or amiodarone.

CAT or Cardiomyopathy Trial, randomly assigned 104 pts with recent onset (<>

AMIOVIRT trial compared an ICD, sometimes with amiodarone, to amiodarone alone in 103 pts with moderate to severe nonischemic dilated cardiomyopathy with class I to III heart failure, LVEF <>

There was no significant difference in overall survival between the amiodarone and ICD groups at one year or three years.

Both trials were very small, AMIOVIRT did not have a placebo group and both had unexpectedly low mortality rates.

DEFINITE
458 pts enrolled, all received standard medical therapy, including an ACE and beta blocker in most instances.
Almost significant trend toward a reduction in the primary end point of all-cause mortality with an ICD (7.9 vs 14.1%, HR 0.65 (0.4-1.06). In the subset of NYHA Class III pts the difference was significant.

The trial was underpowered and may have shown a significant difference with more study subjects.

Cost-effectiveness of ICD implantation

Cost-effectiveness of ICD implantation for primary prevention of SCD is difficult to determine because there are several variables that enter the equation. The cost of device implantation, cost of generator change, projected life expectancy, and mortality rate, as well as efficacy of ICD therapy all matter. Quality of life adjustments are also factored in. A study entitled “ Cost-effectiveness of implantable cardioverter-defibrillators” Sanders et al., NEJM 20005; 353:1471, estimated cost-effectiveness of prophylactic ICD implantation. Use of an ICD was projected to add one to three quality adjusted life-years (QALYs), with a cost per quality-adjusted year of life saved from $34,900 in MADIT to $70,200 in SCD-HeFT. These costs all fall within the range of $50,000 to $100,000 per QALY gained that is considered to be acceptable in the US.

2005-02-07T20:59:00.000-05:00

ASBESTOSIS CAUSES CANCER

Exposure can cause malignant mesotheliomia and pulmonary fibrosis. It's wrong to espose people to the dangers of asbestosi s without telling them...

W.R. Grace Accused of Hiding Cancer Risk

From Forbes Magazine

02.07.2005, 06:19 PM

W.R. Grace and Co. and seven high-ranking employees knew a Montana mine was releasing cancer-causing asbestos into the air and tried to hide the danger to workers and townspeople, according to a federal indictment unsealed Monday. More than 1,200 people became ill, and some of them died, prosecutors said. The asbestos was naturally present in a vermiculite mine operated by Grace in the small town of Libby for nearly 30 years. The federal grand jury said that top Grace executives and managers kept secret numerous studies spelling out the risk the cancer-causing asbestos posed to its customers, employees and Libby residents.

...

Skramstad, 68, said he worked in the mine for 2 1/2 years and believes he not only contracted asbestosis there, but brought home asbestos fibers that also sickened his wife and two children. All of them now have asbestosis, Skramstad said. "They should have to pay," Skramstad said of the defendants. "They will never have to pay like we did, because it won't cost them their lives."

2005-02-01T23:13:00.000-05:00

PFIZER MAY HAVE HID CELEBREX DATA

Less than two months ago, Pfizer's drug Celebrex was found to increase the risk having a heart attack or stroke. At the time, Pfizer executives claimed that the results were new and unexpected...

From the Pfizer website:
These clinical trial results are new. The cardiovascular findings in one of the studies (APC) are unexpected and not consistent with the reported findings in the second study (PreSAP). Pfizer is taking immediate steps to fully understand the results and rapidly communicate new information to regulators, physicians and patients around the world,” said Hank McKinnell, Pfizer chairman and chief executive officer.

Now, it seems that Pfizer may have had evidence about this increased cardiovascular risk in 1999

Pfizer reveals study linking Celebrex to heart risks

By Diedtra Henderson,
Boston Globe Staff February 1, 2005

WASHINGTON -- Pfizer Inc. has revealed it completed a study four years ago that links its painkiller Celebrex to a ''statistically significant" increase in heart problems, bolstering demands for speedier dissemination of negative trial results.

The recent disclosure, on an industry-sponsored website, appears to contradict recent statements by the company. It is the second study known to connect Celebrex to cardiovascular troubles. Though medical experts disagree on how to interpret the newly revealed trial, they agree on this: The information should have been publicized much sooner.

''What's a bit disturbing is that this hasn't been published before," said Dr. Bruce Psaty, an epidemiologist and expert on cardiovascular health at the University of Washington in Seattle who has given congressional testimony critical of the drug industry. ''That's several years where it languished, unpublished. This just speaks to the need to have clinical trials registered and reported publicly in a prompt and complete way."

This issue is far from conclusive, but the data in 1999 should have either been given to the FDA or should have been published.

2005-01-29T18:32:00.000-05:00

HOW TO LOSE WEIGHT

Fidgiting is a good thing.....

Overweight? Maybe You Just Don't Fidget Enough, Researchers Say
Los Angeles Times (free subscription required)

Pacing and wriggling during the day can determine whether one is lean, study concludes. The difference between being obese or lean may be due to how much a person is apt to stand, pace, wriggle and shift about over the course of a day, a team of scientists reported in an intensive study of the consequences of fidgeting.
The researchers, who published their findings today in the journal Science, also suggested the amount of these mundane daily movements may be genetically ingrained — and that this would explain why some people could
get away with being slouches without gaining weight, whereas others, ostensibly no more lazy, became plump.

Although this means some people are more likely to become overweight in today's sedentary society, it does not mean they are fated to, said the study's principal investigator, Dr. James Levine, a consultant endocrinologist and professor of medicine at the Mayo Clinic in Rochester, Minn.The extra energy burned by the fidgety, lean group was about 350 calories a day — well within the reach of most people. The extra calorie burn amounts to at least 10 pounds a year.

2005-01-28T19:43:00.000-05:00

TOO MANY FLU VACCINES

Panic can be a bad thing...

Health Groups Now Worry About Flu Shot Surplus

CDC Takes Unusual Steps to Dispense Vaccine

Friday, January 28, 2005

The CDC announced that it would offer more than 3 million vaccine doses,
which are still in the federal emergency reserve, back to the manufacturer for marketing and resale to public and private providers. As enticement to
providers, any additional orders will be covered by a guaranteed return policy so that no physician will be stuck for a dollar loss with leftover
vaccine.

The situation in the area mirrors the national dilemma. At least a couple
of thousand doses of flu vaccine are on hand in public health departments, and numerous agencies are soliciting residents to get vaccinated. Private clinics that were canceled hastily last fall are being rescheduled. The District and Maryland have completely dropped the guidelines that prioritized who should get a shot based on medical conditions or age; Virginia is maintaining them, but loosely.

Two weeks ago, GW Medical Faculty Associates stationed physicians and
nurses at the Foggy Bottom Metro station, armed with 2,000 shots to give free to passersby. Business was initially steady, but then interest started dropping off. The workers stayed until midafternoon -- even extending their street clinic an extra hour -- and couldn't give away all the doses.

2005-01-24T16:45:00.000-05:00

PHARMACEUTICAL INDUSTRIES ARE GOOD

Hopefully, Merck's efforts will lead to a vaccine...

Potential HIV/AIDS

Health - AP
By JEFFREY GOLD, AP
Business Writer

NEWARK, N.J. - A potential HIV (news - web sites)/AIDS (news - web sites) vaccine developed by Merck & Co. that uses synthetic genes to prepare cells to fight the deadly virus is moving into the second stage of testing.

An approved vaccine would be about a decade away if the trial and a third study are successful, said officials with the international coalition that is collaborating on the work. "It is the most promising candidate that we've seen so far," said Sarah B. Alexander, associate director of the coalition, known as the HIV Vaccine Trials Network, or HVTN.
Volunteers began enrolling last month for the Phase II study, which will eventually give the potential vaccine's three doses to 1,500 people in North and South America, the Caribbean and Australia, the network and Whitehouse Station-based drug maker announced Monday.

The study is using male and female volunteers aged 18 to 45 of diverse racial groups who are at high risk for contracting HIV. Participants will receive counseling about how to reduce their risk of HIV infection, Alexander said.
About a dozen companies and organizations worldwide are attempting to develop an AIDS vaccine. Of the 10 associated with HVTN, the Merck candidate is the first to reach Phase II testing, Alexander said.
Seattle-based HVTN is funded by the National Institute of Allergy and Infectious Diseases (news - web sites) of the National Institutes of Health (news - web sites), an agency of the U.S. Department of Health and Human Services (news - web sites), and comprises more than 25 research institutions worldwide.

2005-01-02T02:14:00.000-05:00

ELI LILLY HIDES EVIDENCE ABOUT PROZAC

Looks like another pharmaceutical company has been less than honest with the American people...

From the Financial Times

Eli Lilly in storm over Prozac evidence
By Clive Cookson in London
Published: December 30 2004 19:38

Eli Lilly, the US drug company, suppressed evidence that Prozac, its best-selling antidepressant, could cause behavioural disturbances, according to allegations published on Thursday in the British Medical Journal.

The US Food and Drug Administration says it would review confidential Lilly documents handed over by the BMJ, which received them this month from an anonymous source. The reports and memos appear to suggest Lilly officials knew in the 1980s that Prozac had troubling side-effects and sought to minimise their likely adverse effect on prescribing.

...

One document, a clinical trial review dated November 1988, stated that 38
per cent of patients treated with Prozac but only 19 per cent of those given a placebo “reported new activation”.

To find out more, click here

Also, check out how the NY Post, which is owned by the same company as FOX covers this story.

2004-12-26T15:38:00.000-05:00

PFIZER EXECUTIVE BLASTS BIG PHARMA

Peter Rost, who is vice president of marketing at Pfizer, looks like he wants to clear his conscience (free subscription required)....

Big Pharma's Dirty Little Secret

By Peter Rost

Los Angeles Times
The American healthcare system is the best in the world. Or so we are often told. But is it really true? It is certainly the best system for drug companies, which can charge the highest prices in the world to some U.S. consumers. The Congressional Budget Office has estimated that average prices for patented drugs in 25 other top industrialized nations were 35% to 55% lower than in the United States.

And it is a pretty good system for hospitals, insurance companies and others that deliver healthcare services. Americans spend about twice as much per person for healthcare as do Canadians, Japanese or Europeans,according to the World Health Organization.

But it's not a good system for American citizens. The U.S. has shorter life expectancies and higher infant and child mortality rates than Canada, Japan and all of Western Europe except Portugal, according to the WHO
...
People today have to choose between drugs and food. The journal Diabetes Care recently reported on a study of older adults with diabetes. One in three said they went without food to pay for drugs.
...
In the next five years, branded drugs with annual sales of $72.9 billion are expected to lose patent protection. So we in the drug industry are fighting re-importation because we're worried about the bottom line. But when we have to choose between that and the lives of those who can't afford drugs, we have to choose life.
I joined this industry to save lives, not to take them. And that's the reason I've chosen to speak out.

Read the rest of the article. Mr. Rost is a brave man. He is certainly risking his career to tell the truth. Pharmaceutical companies are good companies. Without them, physicians would not have the necessary tools to help patients. But they need to be better corporate citizens especially since so many depend on their products.

2004-12-22T14:56:00.000-05:00

THE FDA - PART II

This is an article by Robert Reich, who was President Clinton's Labor Secretary, that delves into the recent failures at the FDA and what's being done to about them. It seems Congress is poised to act, but its actions may not be for the benefit of the American people...

Toothless Tigers and "Tort Reform"

If you're worried about Celebrex and Vioxx, you ain't seen nothin' yet

December 22, 2004, The American Prospect

The White House says the Food and Drug administration is doing a "spectacular" job. Really? The FDA didn't respond to warning signs that block-buster painkillers like Celebrex and Vioxx increased the risk of heart attacks. Worse yet, its own drug-safety officer says the agency suppressed his research showing the apparent dangers of Vioxx. Belatedly, the FDA is now looking into the potential risks of Naproxin, an ingredient in many over-the-counter pain relievers. The FDA also failed to warn the public that antidepressants increase the risk of suicide among children who take them.

Meanwhile, new legislation is winding its way through Congress that would prevent people who are hurt by drugs approved by the FDA from winning large damage awards against companies that made them. FDA approval would shield drug makers from having to pay anything more than $250,000 even when it's proven that they negligently caused someone more than $250,000 of harm. Congressional sponsors understand this cap on damages will end lawsuits against drug companies because personal-injury lawyers won't want to take on the risks and costs of such cases. If this bill passes, companies like Pfizer and Merck, now facing a flood of lawsuits because of Celebrex and Vioxx, won't have to worry.

Big Pharma can muscle through legislation that protects itself from getting sued, but doctors can't pass similar legislation even though there is broad public support for limiting medical liability for physicians. Hmm, I wonder why?

2004-12-22T02:05:00.000-05:00

IS THE FDA PROTECTING AMERICANS?

Apparently, some of the scientists working for the FDA are concerned about the drugs they have approved...

Two-thirds of Food and Drug Administration scientists surveyed two years ago lacked confidence that the FDA adequately monitors the safety of prescription drugs, a report released Thursday shows.

31% of the scientists were only "somewhat confident" and 5% were "not at all confident" that final decisions on new drugs adequately assessed the drug's safety; 52% were mostly confident; and 13% were completely confident.

59% of them said the six months allotted to review some drugs wasn't
enough time

And 18% of the almost 400 respondents said they had been pressured to approve or recommend a drug despite reservations about its safety, effectiveness or quality.

2004-12-20T17:37:00.000-05:00

TROUBLE FOR CELEBREX

Celebrex is a member of a class of drugs called COX-2 inhibitors. Vioxx which was recently pulled from the market by Merck because it caused increase in heart attacks and strokes in some patients is also a member of this class drugs. These drugs were designed to provide pain relief for patients who could not take aspirin or ibuprofen. Aspirin, advil, and alleve are older generation drugs which can cause ulcers and bleeding in the stomach especially in the elderly. Initially, the COX-2 inhibitors were supposed to provide better pain relief without causing ulcers or gastric bleeding, but studies after the drugs were approved by the FDA questioned whether these drugs were an improvement over more traditional therapies. Here's what the former editor of the New England Journal had to say about the drugs

Both Celebrex and Vioxx, a similar medicine which Merck stopped selling in September after it was linked to heart attacks, are generally no more effective than over-the-counter medicines, said Dr. Marcia Angell, the former editor of The New England Journal of Medicine. "There was never much reason for these drugs in the first place," she said. "So one should accept virtually zero side effects from these drugs."

They certainly were more expensive than the other options. COX-2 inhibitors are expected to make up $8 billion dollars of Pfizer's total sales in 2004, which is about 8% of the company's worldwide sales. Analysts on Wall Street are expecting the $4 billion in 2005 to drop to $775 million by 2007.

Recently, a new trial has raised concerns that Celebrex may actually increase the chance of a heart attack

A clinical trial of the blockbuster arthritis drug Celebrex was shut down
yesterday after researchers found an increase in the risk of serious heart
disease and strokes in those taking the drug, the same side effects that caused
the related painkiller Vioxx to be taken off the market this fall.

Ernest Hawk, chief of gastrointestinal research for the NCI, said a team of
cardiovascular specialists had been brought in to help analyze the
cardiovascular risk of Celebrex for participants in the trial after Vioxx was
withdrawn in late September. Hawk said the experts, along with the safety
monitoring board of the trial, found that patients on 400 milligrams of Celebrex were 2.5 times as likely to have a heart attack or stroke as the group taking a placebo. For patients taking 800 milligrams a day, the risk of serious cardiovascular events was 3.4 times as great.

This recent finding has raised concerns especially amongst members of Congress that the FDA has not been doing its job in protecting the American consumer.

The announcement that Celebrex may pose serious risks similar to those of Vioxx quickly led to a new round of calls for reform at the FDA, which has come under heavy criticism for its oversight of prescription drug safety in recent months. Sen. Charles E. Grassley (R-Iowa), who has been especially critical, called for creation of an independent blue-ribbon review similar to the commission that studied the Sept. 11, 2001, attacks to recommend reforms.

2004-12-12T19:19:00.000-05:00

ARE ANTIDEPRESSANTS SAFE IN TEENAGERS ?

Doctors wrote about 11 million prescriptions for antidepressants for teenagers and young adults. It's a big business and pharmaceutical companies are determined to protect the money generated from prescribing these drugs to teenagers. More recently, however, these companies have come under closer scrutiny as researchers are finding that antidepressants known as Selective Serotonin Reuptake Inhibitors (SSRIs) may increase thoughts of suicide in certain young patients. In fact, earlier this year, the Food and Drug Administration ordered manufacturers to place a warning in bold print on antidepressants, alerting consumers that the drugs can cause suicidal tendencies in children and teenagers. The British have gone even further by banning all antidepressants except Prozac for use in children and asking physicians to pursue alternatives to drugs when dealing with depressed patients. The American medical community is divided with recent editorials in the New England Journal advocating a mixed strategy for depressed youth employing counseling with pharmocotherapy.

There is no doubt that antidepressants have helped millions of people overcome the ravages of depression. Depression is a real disease and many who have it need drugs for them to cope with daily living. That being said, it is now clear that pharmaceutical companies have hidden data that shows that SSRIs can be dangerous in certain people.

Documents uncovered by ABC news prove that the makers of the popular antidepressants Paxil withheld data regarding failed to disclose important information about the possibility of an increased risk of suicidal behavior in some children taking the drug, as well as serious withdrawal symptoms when some patients stop taking Paxil.

Drug Maker Withheld Paxil Study Data
According to these documents, internal studies by GlaxoSmithKline concluded that Paxil had little or no effect in treating depression in children and adolescents. And as far back as 1997, the company was aware of studies reporting suicide-related behaviors in young patients taking the drug.
In spite of this information, GlaxoSmithKline distributed a memo to its sales force in 2001 touting the drug's "remarkable efficacy and safety in the treatment of adolescent depression
...
Additionally, the internal documents reveal GlaxoSmithKline had scientific
evidence Paxil could cause mild to severe withdrawal symptoms in some patients when they abruptly stopped taking the drug. A document the company distributed to sales staff referred to "withdrawal symptoms" and said they included problems like dizziness, nausea, fatigue, insomnia and nightmares, but advised the sales representatives to use the less-alarming term "discontinuation symptoms."
The documents suggest GlaxoSmithKline's sales strategy was to downplay this information in order to maintain its share of the billion-dollar antidepressants market.
"This is about money," said Rep. Henry Waxman, D-Calif., who is
on a congressional committee investigating antidepressants manufacturers.
"This is not about science, because what they're doing is withholding the
scientific information, suppressing the studies that could have a negative
impact on their sales and their profits."
...

According to the 1997 review, one study found that 25 percent of patients
taking Paxil in one experienced discontinuation symptoms (vs. 5.9 percent
for patients taking a placebo). In a study of patients with major
depression, 42 percent of the patients taking Paxil experienced one
discontinuation symptom.

Despite these studies, these documents reveal that GlaxoSmithKline
instructed its sales force to downplay or minimize the negative effects of
discontinuing Paxil from doctors
A 1998 "business plan guide" for sales reps instructed them to "minimize concerns surrounding discontinuation symptoms." Sales reps were also told to explain to doctors that the "discontinuation incident rate is two in 1,000 patients." This rate is markedly different from the results of the studies in the safety review published nine months earlier.

It is time that the public was made aware about the politics of the pharmaceutical industry. At the very least, there should be better disclosure by these companies. In medical school, we are taught to practice evidence-based medicine. It is increasingly difficult for physicians to practice good medicine if they do not have all of the necessary data. If drug companies to fail to disclose all of the data, then patients will lose trust in the medical system. This blog will follow developments on this issue closely so patients can be accurately informed when making decisions about their own health.

2004-12-09T14:44:00.000-05:00

MEDICAL CARE IN WAR

This article in the New England Journal of Medicine describes the role of physicians in Iraq. The health care professionals who treat our brave soldiers certainly demand a great deal of respect. Without them, many more soldiers would die.

The 274th FST is led by a 42-year-old surgical oncologist who was my chief
resident when I was a surgical intern. He went to West Point, Johns Hopkins Medical School in Baltimore, Brigham and Women's Hospital in Boston for surgical residency, and then M.D. Anderson Cancer Center in Houston for a fellowship. He was known in training for three things: his unflappability, his intellect (he'd already published 17 papers on work toward a breast-cancer vaccine), and the five children he and his wife had during residency. He owed the Army 18 years of service when he finally finished his training, and neither I nor anyone I know ever heard him bemoan that commitment. In 1998, he was assigned to Walter Reed Army Medical Center in Washington, D.C., where he practiced surgical oncology. Then, in October 2001, after the September 11 attacks on the World Trade Center and the Pentagon, he and his team were sent with the first troops into Afghanistan. He returned after service there only to be sent to Iraq, in March 2003, with ground forces invading from Kuwait through the desert to Baghdad.

The 274th FST traveled 1100 miles with troops over the next four months,
setting up in Nasiriyah, Najaf, Karbala, and points along the way in the
southern desert, then in Mosul in the north, and finally in Baghdad. According to its logs, the unit cared for 132 U.S. and 74 Iraqi casualties during that time (22 of the Iraqis were combatants, 52 civilians). Some days were quiet. Others, overwhelming. On one day in Nasiriyah, the team received 10 critically wounded patients, among them 1 with right-lower-extremity shrapnel injuries; 1 with gunshot wounds to the stomach, jejunum, and liver; another with gunshot wounds to the liver, gallbladder, and transverse colon; 1 with shrapnel in the neck, chest, and back; 1 with a gunshot wound through the rectum; and 2 with extremity gunshot wounds. The next day, 14 more casualties arrived.
On the arrival of the wounded, teams carry out the standard Advanced Trauma Life Support protocols that civilian trauma teams follow. However, because of the high incidence of penetrating wounds — 80 percent of casualties seen by the 274th FST had gunshot wounds, shrapnel injuries, or blast injuries — lifesaving operative management is required far more frequently than in civilian trauma centers. Today, military surgical strategy aims for damage control, not definitive repair, unless it can be done quickly. Teams pack off liver injuries, staple off perforated bowel, wash out dirty wounds — whatever is necessary to stop bleeding and control contamination without allowing the patient to lose body temperature or become coagulopathic. Surgeons seek to limit surgery to two hours or less, and then ship the patient off to a Combat Support Hospital (CSH), the next level of care. Abdomens can be left open, laparotomy pads left in, bowel unanastomosed, the patient paralyzed, sedated, and ventilated. For this
approach to be successful, however, control of air space and major roadways and establishment of the next-level hospital (achieved early in Iraq but delayed in Afghanistan) are essential.

2004-12-04T16:02:00.000-05:00

STRESS AND YOUR HEALTH

Can stress actually make you sick?

Check out this online documentary to learn more. It explores the physiological role of stress as well as the effect of stress on your health. It even provides four easy steps you can use to lower your anxiety.

2004-12-02T18:19:00.000-05:00

IS ALL HEALTHCARE EQUAL?

The success of any healthcare system rests on its ability project an image of competence. Consumers of medicine demand that they receive the best healthcare possible. Yet, just as in any other profession, differences between practitioners do exist. It's an uncomfortable reality for physicians and patients alike. Atul Gawande has been at the forefront of educating the public about the realities of health care. As a surgeon in Boston, he has tried to demystify the patient-doctor relationship and provide a view of both the power and limits of medicine.

This article in the New Yorker looks at the differences that exist within the American healthcare system. It's provocative and thought provoking. Not all doctors are all equal. Nor are all hospitals....

What happens when patients find out how good their doctors really are?
by Atul Gawande

It used to be assumed that differences among hospitals or doctors in a particular specialty were generally insignificant. If you plotted a graph showing the results of all the centers treating cystic fibrosis or any other disease, for that matter people expected that the curve would look something like a shark fin, with most places clustered around the very best outcomes. But the evidence has begun to indicate otherwise. What you tend to find is a bell curve: a handful of teams with disturbingly poor outcomes for their patients, a handful with remarkably good results, and a great undistinguished
middle.
...
It is distressing for doctors to have to acknowledge the bell curve. It belies the promise that we make to patients who become seriously ill: that they can count on the medical system to give them their very best chance at life. It also contradicts the belief nearly all of us have that we are doing our job as well as it can be done. But evidence of the bell curve is starting to trickle out, to doctors and patients alike,
and we are only beginning to find out what happens when it does.
...
We are used to thinking that a doctor's ability depends mainly on science and skill. The lesson from Minneapolis is that these may be the easiest parts of care. Even doctors with great knowledge and technical skill can have mediocre results; more nebulous factors like aggressiveness and consistency and ingenuity can matter enormously.
...
Once we acknowledge that, no matter how much we improve our average, the bell curve isn't going away, we're left with all sorts of questions. Will being in the bottom half be used against doctors in lawsuits? Will we be expected to tell our patients how we score? Will our patients leave us? Will those at the bottom be paid less than those at the top? The answer to all these questions is likely yes.
...
The hardest question for anyone who takes responsibility for what he or she does is, What if I turn out to be average? If we took all the surgeons at my level of experience, compared our results, and found that I am one of the worst, the answer would be easy: I'd turn in my scalpel. But what if I were a C? Working as I do in a city that's mobbed with surgeons, how could I justify putting patients under the knife? I could tell myself, Someone's got to be average. If the bell curve is a fact, then so is the reality that most doctors are going to be average. There is no shame in being one of them, right?

Except, of course, there is. Somehow, what troubles people isn't so much being average as settling for it. Everyone knows that averageness is, for most of us, our fate. And in certain matters looks, money, tennis we would do well to accept this. But in your surgeon, your child's pediatrician, your police department, your local high school? When the stakes are our lives and the lives of our children, we expect averageness to be resisted. And so I push to make myself the best. If I'm not the best already, I believe wholeheartedly that I will be. And you expect that of me, too. Whatever the next round of numbers may say.

2004-03-15T23:13:00.000-05:00

Aggressive lipid lowering protects against cardiac death in acute coronary syndrome

March 9, 2004

By Martha Kerr

NEW ORLEANS (Reuters Health) - Aggressive lipid lowering is superior to the current recommended treatment guidelines in reducing risk of death and coronary events in patients with acute coronary syndromes (ACS), researchers announced Monday at the American College of Cardiology's Annual Scientific Session 2004.

The New England Journal of Medicine has released results of the Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 (PROVE IT-TIMI 22) early to coincide with the announcement.

Principal investigator Dr. Christopher P. Cannon of Brigham and Women's Hospital in Boston, and colleagues in PROVE-IT randomized 4,162 patients hospitalized with ACS to either 40-mg pravastatin (standard therapy) or 80-mg atorvastatin (intensive therapy) daily as soon as their condition was stable.

The primary endpoint was death, myocardial infarction, rehospitalization for angina, revascularization 30 days or more after randomization, or stroke. Patients were followed for a mean of 2 years.

Dr. Cannon announced that the median LDL cholesterol level achieved with pravastatin was 95 mg/dL (2.46 mmol/L), achieving the current recommended target of LDL cholesterol levels below 100 mg/dL for patients with atherosclerosis.

Using "the most potent statin therapy we have at the highest doses [we have data on]," atorvastatin lowered LDL levels to 62 mg/dL (1.60 mmol/L), Dr. Cannon reported.

Analysis showed that aggressive statin treatment reduced risk of the primary endpoints 26.3% in the pravastatin group and 22.4% in the atorvastatin group. This translated to a reduction in risk of death or adverse events of 16% in favor of intensive statin therapy, Dr. Cannon said.

Dr. Cannon stressed that the trial was not designed as a head-to-head comparison of pravastatin and atorvastatin. He told Reuters Health that the focus needs to be on cholesterol levels and achieving the lowest LDL level possible.

Editorialist Dr. Eric J. Topol of The Cleveland Clinic in Ohio notes in the Journal that the PROVE-IT findings were surprising on several fronts. First, the effects of intensive therapy were rapid and evident within 30 days. The effects were seen in all subgroups, including women and diabetics. Inflammatory markers were lower in the intensive therapy group compared with standard therapy patients.

Most importantly, Dr. Topol notes, the trial shows a clear superiority of intensive therapy over current guidelines. This should change the clinical management of these high-risk patients.

The findings "herald a shake-up in the field," Dr. Topol asserts. The implications are "profound" and he predicts there will be "a sea change in the prevention and management of atherosclerotic vascular disease."

N Engl J Med 2004:350.

© Copyright 2004 Reuters Limited. Click for Restrictions.

2004-03-07T15:53:00.000-05:00

Subclinical Thyroid Disease: Clinical Applications

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Volume 291(2) 14 January 2004 p 239–243
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Copyright 2004 by the American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use. American Medical Association, 515 N. State St, Chicago, IL 60610.

[Scientific Review and Clinical Applications: CLINICIAN'S CORNER]
Col, Nananda F. MD, MPP, MPH; Surks, Martin I. MD; Daniels, Gilbert H. MD

Abstract
Subclinical hypothyroidism and hyperthyroidism are diagnoses based on laboratory evaluation with few if any clinical signs or symptoms. Subclinical hypothyroidism is defined as an elevation in serum thyroid-stimulating hormone (TSH) above the upper limit of the reference range (0.45–4.5 mIU/L) with normal serum FT4 concentration; subclinical hyperthyroidism is defined as a decrease in serum TSH below the reference range with normal serum FT4 and T3 concentrations. Though these conditions represent the earliest stages of thyroid dysfunction, the benefits of detecting and treating subclinical thyroid disease are not well established. Most persons found to have subclinical thyroid disease will have TSH values between 0.1 and 0.45 mIU/L or between 4.5 and 10 mIU/L, for which the benefits of treatment are not clearly established; treatment may be beneficial in individuals with serum TSH lower than 0.1 mIU/L or higher than 10 mIU/L. This article illustrates approaches to managing patients with subclinical hypothyroidism and hyperthyroidism through 5 case scenarios that apply the principles of evidence-based medicine. Because of the substantial uncertainty concerning the consequences of untreated subclinical hypothyroidism and hyperthyroidism, as well as the benefit of initiating treatment, patient preferences are important in deciding on management of subclinical disease.

2004-03-07T13:42:00.000-05:00

Administration Announces Details of Global AIDS Plan

The Bush administration yesterday announced details of its five-year global strategy on HIV-AIDS, including approval for the first $350 million in grants to religious groups and humanitarian organizations to combat the disease and offer relief to AIDS orphans.

"Today the money hits the table," Health and Human Services Secretary Tommy G. Thompson told reporters at a State Department briefing.

The U.S. goal over five years is to provide treatment to 2 million HIV-infected people, prevent 7 million HIV infections and provide care to 10 million people affected by HIV-AIDS, including patients and orphans.

But the new strategy, which outlines priorities for the $15 billion effort, immediately sparked criticism from AIDS advocacy groups for failing to include countries with long-term strategic value to the United States, including China and Russia. They also said that the administration is not taking advantage of Global AIDS Fund programs already in place and that the plan provides too few specifics.

"The report has a little of everything but no real clarity on a way forward," said Joanne Carter, legislative director of RESULTS, a grass-roots advocacy group.

The U.S. strategy is the largest commitment undertaken by a nation on a health issue.

2004-03-07T01:17:00.000-05:00

Chest Pain Relief by Nitroglycerin Does Not Predict Active Coronary Artery Disease

Relief with nitroglycerin is thought by some to be characteristic of anginal chest pain. What is the prognostic value of this clinical observation? Researchers in Maryland prospectively studied 459 patients who received nitroglycerin (0.4 mg) after they presented with chest pain to an emergency department.

The results of this study suggest that, in a general population admitted for chest pain, relief of pain after nitroglycerin treatment does not predict active CAD and should not be used to guide diagnosis.

Active CAD was present in 141 patients (31%). Nitroglycerin relieved chest pain in 181 patients (39%): 35% of those with active CAD (sensitivity) and 41% of those without active CAD (specificity, 59%). Likelihood ratios indicated that neither relief nor lack of relief with nitroglycerin predicted active CAD.

Symptom relief was defined as >/=50% decrease in self-reported chest pain within 5 minutes of receiving nitroglycerin. Active CAD was defined as >/=70% stenosis on cardiac catheterization; any serum troponin T elevation; a positive exercise-test result; or physician diagnosis of CAD, confirmed by a cardiologist who was blinded to nitroglycerin-relief status.

These study findings are not surprising, given the fact that there are many causes of chest pain besides myocardial ischemia, even in those with CAD. In addition, nitroglycerin is known to be associated with a strong "placebo effect" in patients whose chest pain syndrome should not react to.

Henrikson CA et al. Chest pain relief by nitroglycerin does not predict active coronary artery disease. Ann Intern Med 2003 Dec 16; 139:979-86.

Gibbons RJ. Nitroglycerin: Should we still ask? Ann Intern Med 2003 Dec 16; 139:1036-7.

2004-03-07T00:08:00.000-05:00

U.S. Lawmakers Push for Drug Monitoring Systems

U.S. lawmakers on Thursday called for better government oversight of legal but potentially addictive prescription drugs, including painkillers, stimulants and sedatives.

Democrats and Republicans said more monitoring programs are needed to track sought-after drugs that are easily obtained through prescription forgery, corrupt physicians, and patients switching from one doctor to another collecting prescriptions.

There is no "program in existence today that is doing everything that needs to be done" to monitor abuse, Kentucky Republican Rep. Ed Whitfield said at a House of Representatives Energy and Commerce subcommittee.

About 6.2 million Americans abused prescription drugs in 2002, and emergency-room visits related to abuse of narcotic pain relievers have increased 163 percent since 1995, according to the Substance Abuse and Mental Health Services Administration.

The Bush administration this week announced a new effort to combat prescription abuse through physician education and by targeting illegal Web pharmacies.

2004-03-06T16:03:00.000-05:00

Poll: Public Supports Health Care for All

The public's growing unease with the current health care system has built support for a new approach that would mean care for all Americans...

By almost a 2-1 margin in this poll, 62 percent to 32 percent, Americans said they preferred a universal system that would provide coverage to everyone under a government program, as opposed to the current employer-based system.

That support drops significantly, however, if universal coverage would mean a limited choice of doctors or longer waits for nonemergency treatment.

When people were asked the question slightly differently in a poll a year ago, they were less enthusiastic. Asked if they wanted a taxpayer-funded, health care system run by the government, fewer than half said yes. Robert Blendon, a specialist on health care public opinion at Harvard University, said the public's worries about health care have increased this year.

"Health care is really rising as a political issue," Blendon said. "When the economy gets bad and health care costs continue to rise, this becomes an
economic issue."

2004-03-06T15:11:00.000-05:00

NIH Stops Estrogen-Alone Arm of Woman's Health Initiative

The National Institutes of Health (NIH) has instructed participants in the estrogen-alone study of the Womens Health Initiative (WHI), a large multi-center trial, to stop taking their study pills and to begin the follow-up phase of the study.

Letters have been sent to all participants in the estrogen-alone study, 11,000 healthy postmenopausal women who have had a hysterectomy, informing them of a recent NIH review of the study data. The increased risk of stroke in the estrogen-alone study is similar to what was found in the WHI study of estrogen plus progestin when that trial was stopped in July 2002. In that study, women taking estrogen plus progestin had 8 more strokes per year for every 10,000 women than those taking the placebo.

After careful consideration of the data, NIH has concluded that with an average of nearly 7 years of follow-up completed, estrogen alone does not appear to affect (either increase or decrease) heart disease, a key question of the study. At the same time, estrogen alone appears to increase the risk of stroke and decrease the risk of hip fracture. It has not increased the risk of breast cancer during the time period of the study.

In an interview with Jacques Rossouw, MD, National Heart, Lung, and Blood Institute project officer of the Woman's Health Initiative, the clinical alert issued by the NIH, is "not intended to cause any change in clinical practice. The complete data will be published in a peer-reviewed journal in the next two months, [after which] the [U.S. Food and Drug Administration] FDA and the professional bodies will consider whether changes in practice guidelines are needed. In the meantime, the FDA guidance is that if hormones are used, they should be used at the lowest dose and for the shortest possible period. Measures to reduce stroke risk are no different for hormone users than nonusers, and of course include due attention to all the risk factors, especially high blood pressure."

2004-03-06T09:52:00.001-05:00

Cholesterol Lowering Statins Reduce Stroke Risk

Researchers writing in current issue of British journal The Lancet have found that statins, a groups of drugs that lower blood choleterol, can reduce the risk of stroke by almost 25% in patients at risk for stroke. The study included 3280 adults with cerebrovascular disease, and an additional 17 256 with other occlusive arterial disease or diabetes, which were randomly allocated 40 mg simvastatin daily or matching placebo.

The results demonstrate that statin therapy rapidly reduces the incidence not only of coronary events but also of ischaemic strokes, with no apparent effect on cerebral haemorrhage, even among individuals who do not have high cholesterol concentrations.

Professor Anthony Rudd, an expert in stroke medicine at St Thomas's Hospital, London, said: "These findings reinforce earlier research from the Heart Protection Study which was published two years ago....On the basis of that study, we are redrafting the national guidelines on the care of people who have had an ischaemic stroke... The guidelines, to be published in June, will say that people with cholesterol above 3.5 [135 mg/dL] should be put on a statin".

Overall, there was a highly significant 25% (95% CI 15-34) proportional reduction in the first event rate for stroke (444 [4·3%] simvastatin vs 585 [5·7%] placebo; p<0·0001), reflecting a definite 28% (19-37) reduction in presumed ischaemic strokes (p<0·0001) and no apparent difference in strokes attributed to haemorrhage (51 [0·5%] vs 53 [0·5%]; rate ratio 0·95 [0·65-1·40]; p=0·8). In addition, simvastatin reduced the numbers having transient cerebral ischaemic attacks alone (2·0% vs 2·4%; p=0·02) or requiring carotid endarterectomy or angioplasty (0·4% vs 0·8%; p=0·0003).

The reduction in stroke was not significant during the first year, but was already significant (p=0·0004) by the end of the second year. Among patients with pre-existing cerebrovascular disease there was no apparent reduction in the stroke rate, but there was a highly significant 20% (8-29) reduction in the rate of any major vascular event (406 [24·7%] vs 488 [29·8%]; p=0·001). The proportional reductions in stroke were about one-quarter in each of the other subcategories of participant studied, including: those with coronary disease or diabetes; those aged under or over 70 years at entry; and those presenting with different levels of blood pressure or lipids (even when the pretreatment LDL cholesterol was below 3·0 mmol/L [116 mg/dL]).

Original Article (subscription required)

Effects of cholesterol-lowering with simvastatin on stroke and other major vascular events in 20 536 people with cerebrovascular disease or other high-risk conditions Lancet 2004; 363: 757-67

Heart Protection Study Collaborative Group*

2004-03-06T09:34:00.000-05:00

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