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Thursday, January 29, 2009

A badge of honor: Kidney donation

Minnesota native Anthony Thein didn't hesitate back in 1967 when doctors asked him to donate a kidney to his ailing brother. "If you think it might help somebody survive, you say, 'Yes, of course,'" Thein says.

But kidney transplants from living donors were still uncommon in the late 1960s, and the operation carried risks for both parties. Doctors didn't know whether living with just one kidney could entail long-term medical repercussions.

"Yeah, we really did something crazy 42 years ago," Anthony says today.

Perhaps not. Researchers report in today's New England Journal of Medicine that people who donate a kidney have about the same probability of survival over several decades as people in the general population. And donors seem to have adequate kidney function and even less risk of severe kidney disease than occurs in the general public, nephrologist Hassan Ibrahim of the University of Minnesota and his colleagues report.

To arrive at these findings, the researchers pored over a database of kidney transplants performed at the University of Minnesota between 1963 and 2007 and tried to reach as many of the donors as possible. Using this data and death records from the Social Security Administration, the scientists were able to asses the mortality rate among 3,698 people who gave away a kidney within that time span.

The survival curves of these donors and the general public are close, even favoring the donors slightly. And the rate of end-stage renal disease, which necessitates dialysis and can put a person on a waiting list for a new kidney, was lower among the donors than in the general population.

The researchers also randomly selected 255 of the donors to undergo kidney function tests between 2003 and 2007. The team compared those results against tests done on a group of people who had both kidneys and who matched the donors in race, gender, body weight and age.

An analysis showed the donors had acceptable measures of basic kidney functions and even outperformed the control group on blood pressure measurements, says Ibrahim.

Self-reported information suggested the donors had a slightly better overall quality of life than people in the general population.

To be eligible to donate a kidney, a person must pass a physical examination and cannot have diabetes, high blood pressure or other serious ailments.

With that in mind, it's not surprising that kidney donors would have good mortality rates and better health-related quality of life than people in the general population, say physicians Jane Tan and Glenn Chertow of Stanford University School of Medicine, writing in the same NEJM issue. "Nevertheless," they note, "it is somewhat surprising and quite reassuring that rates of end-stage renal disease were also lower in kidney donors than in the general population."

These broader findings have been reflected in a personal way in Anthony Thein's life. Now 70 and semiretired, Thein says he hasn't encountered any problems from lacking a kidney, although he does sport a sizable scar across his midsection — a testament to being among the earliest donors. Donors' scars today are much smaller.

"Actually, I'm proud of my scar," he says. "It's sort of like a badge of honor."

Advice: Consider kidney donation.

Read the appeal of a woman with kidney disease for a kidney donor. Thanks to Nathan Seppa for his article yesterday in Science News, reprinted here.

Wednesday, January 28, 2009

Millions of people: Martin Delaney and AIDS Activism

In the early 1980s, several of his friends became infected with HIV, and died of AIDS. Though he himself was never HIV-positive, their deaths drew Martin Delaney into the AIDS movement.

When he heard about a cold remedy, ribavirin, that was being smuggled from Mexico because it had been found to strengthen the immune system, Martin made several runs to Tijuana to get some. Soon after, he decided he could be more effective by taking political action.

He launched Project Inform, which started "medically supervised guerilla trials" – community-based studies of the safety and efficacy of drugs that did not have federal approval. It sponsored town-hall-style informational meetings around the country, and set up a national AIDS-treatment hot line.

He "challenged the research and pharmaceutical community in the earliest years of the AIDS epidemic to consult with HIV-positive patients and their advocates" about treatment options, in the words of Project Inform's current executive director, Dana Van Gorder.

Martin died on Friday at age 63, of liver cancer. Just before he died, he received the Director's Special Recognition Award for "extraordinary contributions to framing the HIV research agenda" from the National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health.

NIH Director Antony Fauci, MD, said, "Millions of people are now receiving life-saving antiretroviral medications from a treatment pipeline that Marty Delaney played a key role in opening and expanding."

Advice: Like Martin, live a life of political action to help your sick friends.

Read a very different activist’s story.

Thanks to Dennis Hevesi for the source article in yesterday's issue of the New York Times.

Saturday, January 24, 2009

Remind your daughters: Mariana Bridi da Costa's misdiagnosed fatal infection

The 20-year-old Brazilian beauty queen Mariana Bridi da Costa died early this morning in the hospital. She had had a urinary tract infection (UTI), which was initially misdiagnosed, delaying the routine antibiotic treatment that probably would have saved her life.

The bacterial infection progressed rapidly, snowballing into more serious conditions. First, it spread to her blood ("septicemia"). The septicemia then caused an insufficient blood flow that triggered the quick deadening of tissue ("necrosis"), first in Mariana's hands and feet. But even the prompt amputation of her hands and feet could not save her life, as the septicemia (also called bacteremia or sepsis) apparently led to organ failure and her death.

As of now, it's not known whether she had acquired the UTI at home or in the hospital. Her boyfriend said she had felt ill in late December, perhaps from a UTI, and that her doctor had misdiagnosed the problem as a kidney stone, and prescribed medicine for that. This incorrect diagnosis evoked a wrong-drug error. The type of bacterial infection she had - Pseudomonas aeruginosa - is usually acquired in the hospital, not at home. A hospital-acquired infection, whose detection was delayed, may well have led to her death.

Mariana had been a finalist to represent Brazil in the Miss World contest.

Advice to mothers: Remind your daughters that they can prevent some UTIs by wiping themselves from front to back after using the toilet. Doctors can prevent some hospital-acquired UTIs by washing their hands before touching patients.

Read another Pseudomonas aeruginos story.

Thanks to Shari Roan for the source article in yesterday's Los Angeles Times.

Thursday, January 22, 2009

Without the routine cruelty: A path to health insurance for all

From Dr. Atul Gawande's essay in the New Yorker:
I once took care of a 19-year-old college student who had maxed out her insurance coverage. She had a treatable but metastatic cancer. But neither she nor her parents could afford the radiation therapy that she required. I made calls to find state programs, charities – anything that could help her – to no avail. She put off the treatment for almost a year because she didn't want to force her parents to take out a second mortgage on their home. But eventually they had to choose between their daughter and their life's savings.

For the past year, since universal health coverage in Massachusetts, I haven't had a single Massachusetts patient who has had to ask how much the necessary tests will cost; not one who has told me he needed to put off his cancer operation until he found a job that provided insurance coverage. And that's a remarkable change: a glimpse of American health care without the routine cruelty.

Dr. Gawande mentions this patient, and the Massachusetts model of health care for all, in the context of describing how governments have generally brought about universal coverage by expanding existing programs rather than starting completely afresh. He raises the possibility of achieving universal coverage by expanding Medicare, or the Veterans Health Administration's system, or Federal employees' insurance plan, etc.

The veterans' health system offers the best starting place, for it provides what is demonstrably the highest quality of care in our country. We should expand the VHA to offer universal care for four key reasons. First, its care for patients’ chronic illnesses is exceptional. Second, it offers care across the country, in a network of 170 hospitals. Third, it uses an integrated electronic medical record, so when patients move across the country, or have medical needs while on vacation, their medical records can easily remain accessible by nearby doctors. Fourth, it is primarily a provider network, rather than a virtual insurance network, which gives it more intrinsic capability to further improve the quality of care.

We should allow the VHA to recruit more physicians so we can offer uninsured people who live near VHA hospitals the option of getting their care through the VHA.

Read a very different story from Dr. Gawande.

Thanks to Dr. Atul Gawande for the source article in the Jan. 26 issue of the New Yorker.

Wednesday, January 21, 2009

The inauguration of Pres. Obama: A new era of responsibility - aleinu

In his inaugural speech, the President called on us to "begin again the work of remaking America." He later commented,

"What is required of us now is a new era of responsibility – a recognition, on the part of every American, that we have duties to ourselves, our nation, and the world, duties that we do not grudgingly accept but rather seize gladly, firm in the knowledge that there is nothing so satisfying to the spirit, so defining of our character, than giving our all to a difficult task."

I've been giving my all to this difficult task, as have many readers. Now, in our healthcare and patient safety realm, there is both an encouraging early sign and a special sense of urgency.

Encouragingly, in the economic stimulus package, the version being considered by the U.S. House of Representatives includes $20 billion for health information technology. The President has called for making electronic medical records widely available to make our healthcare safer and less expensive.

Sen. Teddy Kennedy experienced a seizure during his lunch with Pres. Obama. Kennedy is terminally ill with brain cancer, and he has focused the rest of his life on achieving national health insurance. This underlines our sense of urgency: the time is now. As Rabbi Hillel said, "If not now, when?"

Indeed, many Jewish services end with the song Aleinu ("it is our duty," or literally, "it’s on us"). We can make that our personal closing benediction to the inauguration of our Community Organizer in Chief.

Advice: Host a house meeting on health care reform, and summarize the story for www.change.gov

Read another story from a speech by Barack Obama.

Monday, January 19, 2009

Miracle on the Hudson: Lessons for Hospitals

It seems miraculous that US Airways Flight 1549 from New York City landed without loss of life in the Hudson River. The Jewish Talmud says, "Expect miracles, but don't count on them." The airplane designers apparently relied on this in their design of key safety features which enabled a skilled airplane crew to land the plane safely. Seven of their life-saving practices reveal life-saving suggestions for hospitals.

1. Captain Chesley Sullenberger III remembered from his training that if a plane has to ditch, it should be done near a vessel. So he landed the plane near a boat that he saw on that stretch of the Hudson. Other boat captains saw the first boat captain head toward the plane, and they followed, rescuing the passengers promptly.

Lesson for hospitals: Train doctors and nurses on what to do in case of errors as rare as needing to ditch a plane in the water.

2.The plane's first officer, Jeffrey Skiles, was in control of the plane at take-off. But as soon as the plane ran into the flock of birds and both engines quit at about the same time, the more experienced Captain Sullenberger announced, "My aircraft," using the standard phrasing and protocol drilled into airline crews during training. "Your aircraft," Mr. Skiles responded. The airline industry explicitly trains pilots how to manage the change of command of the plane, and the appropriate terse ways to communicate that. This hand-off of authority was clear, immediate, and was automatically documented in the black box recorder. Trainers also teach crew members to routinely "say back" oral orders to ensure they have been correctly understood.

Lessons for hospitals:
Create ways to hand off responsibility for patients that are clear, immediate, efficient, reliable, and verified.

3. After Captain Sullenberger took command of the plane, he, First Officer Skiles, and the air traffic controller discussed returning to La Guardia Airport, but decided against it. The pilot didn't decide alone; the three people took time to have a brief discussion, even in the midst of their extremely urgent looming disaster. Airlines have long trained pilots to perform such "crew resource management" (often now called "crisis resource management" in healthcare).

Lesson for hospitals: Train your clinicians to quickly, promptly and routinely discuss critical options for treatment, while driving out subordinates' fear that a higher-ranking surgeon or doctor will punish them for speaking up.

4. A passenger in the exit row was able to correctly remove the emergency exit door because he had taken a minute at that time to "readthelaminatedsafetycardofinstructionsintheseatpocketinfrontofyou." The airline had taken the time to prepare instructions for this very rare event of a water landing and place them where they could be snatched and understood promptly.

Lesson for hospitals: Patients are your partners. Help them by placing a laminated card of instructions in patients' rooms on how and when to call a Rapid Response Team. (It's now a state law in Massachusetts, and perhaps other places, for hospitals to have Rapid Response Teams to reply promptly upon the unexpected sudden deterioration in a patient's condition.)

5. After Captain Sullenberger took command of the plane, he set his co-pilot to work at moving through a three-page checklist of procedures for restarting the plane's engines. Note that the detailed checklist had been developed well in advance precisely for this exceedingly rare event. It was in the cockpit, i.e., it was immediately accessible, and didn't require the co-pilot to have memorized the procedures.

In this case, the checklist wasn't helpful, since it was intended for planes in distress at much higher altitudes, which allows for more time to restart the engines.

Lesson for hospitals: Sometimes you'll get lucky, and the patient will live despite your lack of a checklist. But you should, of course, have checklists for handling the most common errors. Expect laws soon to require the checklists.

6. The plane's force at impact would determine how many would live or die. It was critical to slow the plane. The pilots had to lower the flaps (movable devices on the wing) to slow the plane. But the flaps run on hydraulic power, driven by the now-useless bird-stuffed engines. The Airbus A320 has a "ram air turbine," essentially a little propeller, that drops down into the wind automatically in certain conditions, and produces electricity to provide the energy that allowed the crew to lower the flaps. With this automatic backup at work, the crew was able to slow the plane enough to make what felt like a hard landing, rather than a crash.

Lesson for hospitals: You may have generators that come into automatic use when the electricity fails. Perform a Failure Mode Effects Analysis to identify the failures that are most common and life-threatening, and ascertain where you need other automatic backups.

7. The Army Corps of Engineers is now searching the Hudson River for an engine, which may provide evidence on whether the plane really hit the birds. In effect, the government is helping to determine the cause of the accident.

Lesson for hospitals:
Outsiders may be willing to help you find the causes of accidents. Let them partner with you.

Read another story about a pilot.

Thanks to Matthew Wald and Al Baker for the source article in yesterday's NY Times.

Sunday, January 18, 2009

A state senator named Barack Obama: Disclosure of hospital infection rates

A night-shift nurse slipped into Jeanine Thomas' hospital room and whispered, "I don't know how you're taking this so well. If I were you, I'd be curled up in a ball crying."
The remark mystified Jeanine. She'd had ankle surgery, and yes, there had been complications. But she thought she was recovering. Was there something she didn't know?

In November 2000, Jeanine, then a 45-year-old antiques dealer, had slipped on ice and shattered her left ankle outside her suburban Chicago home. But days after surgery at her local hospital, the skin surrounding the incisions turned black, and her body swelled. Doctors wanted to amputate, but Jeanine, an avid tennis player, refused to let them.

Then, a friend told her about her mother's battle with MRSA, an antibiotic-resistant germ. Their symptoms matched. Jeanine confronted a doctor and learned the truth: She, too, had MRSA. Only now did the nurse's comment make sense.

Jeanine asked doctors how many people get MRSA. She was met by silence. "That's when I knew ― a light bulb went on in my head," she says. "They don't want anyone to know about this."

Jeanine epitomizes a revolt in health care. A growing number of consumer advocates ― many bound by ordeals with MRSA, or methicillin-resistant Staphylococcus aureus ― have vowed that if the U.S. hospital system will not heal itself, they will do it.
Five years ago, not a single state forced hospitals to reveal how many patients contracted infections while under their care. Now 25 states have some form of "report card" disclosure that can make hospitals more accountable.

After her ankle healed enough that she could walk, Jeanine cobbled together bits and pieces of information about a germ that few seemed to know about.

In 2003, she helped muster support for a bill requiring Illinois hospitals to disclose infection rates. A state senator named Barack Obama co-sponsored the legislation, which passed that year.

Thanks to Helen Haskell, and Seattle Times reporters Michael Berens and Ken Armstrong for the source story.

Saturday, January 17, 2009

Dear Mr. President-Elect: Patient Safety Legislation

President-Elect Barack Obama
The White House
1600 Pennsylvania Ave., NW
Washington, DC 20500-0001

Dear Mr. President-Elect,

The Consumer Health Quality Council is a unique grassroots organization. The Council consists of individual consumers who have experienced poor quality care, either directly or through loved ones, and who are motivated by their experiences to advocate for better quality care for all residents of Massachusetts.

The Council would like to advocate for certain provisions that we strongly hope to see in the new administration’s healthcare agenda. These provisions became state law in Massachusetts after we advocated for healthcare quality improvement legislation during the most recent session of the Massachusetts legislature. We chose the following areas of focus based on our experiences: reducing the rates of healthcare-associated infections and other serious preventable errors, promoting consumer empowerment, and improving patient and provider partnerships and communication. The following provisions are now law in Massachusetts:

1. Hospitals will no longer be reimbursed for care associated with serious preventable errors;
2. Hospitals are required to establish rapid response methods to allow for immediate assistance if a patient is deteriorating;
3. Hospitals must set up patient and family advisory councils; and
4. The Department of Public Health will publicly report hospital-specific rates of healthcare-associated infections and serious reportable events.

We are hopeful that quality improvement and cost containment and others will not only improve care for all residents of Massachusetts but will help to make healthcare reform a success. You can read the specific language for these provisions in the corresponding Sections 51H, 53E, and 53F of Chapter 305 of the Massachusetts General Laws here.

We urge you to emphasize the importance of access to high-quality healthcare for all Americans. Attached to this letter are several stories we have written on how medical errors have affected us, our families and caregivers, and our communities. These stories communicate the very real threat of errors happening in anyone regardless of income level, race, or educational level. We share these stories in the hope that they lead to changes in the healthcare system so that what happened to us will not happen to someone else.

Please let us know if we can provide any assistance. If you have any questions or would like any information from us, please contact Deborah Wachenheim, Health Quality Manager at Health Care For All (617-275-2902), or Ken Farbstein, President of the Consumer Health Quality Council (781-444-5525).

Thursday, January 15, 2009

About once a week: Hospital checklists

Today's Boston Globe ran a headline story about the use of checklists by hospitals:

In one instance, Dr. Gawande told the team before beginning surgery that his patient's adrenal tumor (over his kidney) was stuck to a major vein. As a result, the anesthesiologist brought more blood into the room to prepare for the possibility of major blood loss, one of the items on the checklist.

"The patient lost huge amounts of blood in under a minute," Dr. Gawande said. "He was saved by the fact that the anesthesiologist had the blood right there."

Dr. Gawande said that in his own operations at a Harvard teaching hospital in Boston, the checklist catches a potential problem about once a week.

Dr. Atul Gawande was the lead author of a paper published yesterday in the New England Journal of Medicine. The study of eight hospitals found that simple checklists used before, during and after surgery roughly halved the number of deaths of patients, and reduced the frequency of complications by more than a third.

Advice: Find out if your hospital uses surgical checklists.

Read a very different story by Dr. Gawande.

Thanks to Liz Kowalczyk for the source article.

Wednesday, January 14, 2009

She was visiting: Medical tourism to Israel

Caroline Ardeeser, a 78-year-old retired Florida resident, decided to forgo Medicare and hospitalization in the U.S. and pursued surgery in Israel. She was visiting Israel earlier this year, when her knees "gave out." Rather than return home, where she had stopped paying health insurance premiums, she chose to have the reconstructive surgery performed at the Sheba Hospital in Israel. The 90-minute surgery and a week's stay in the hospital cost her $16,000, which she had in savings.

She says that at her age, she cannot obtain private health insurance in the U.S. And even if she could, she estimates that with the co-pay, the surgery and the rehabilitation at home could have cost three times as much. She plans to have surgery on her other knee soon and is recuperating in a rented house in the West Bank city-settlement of Ariel. "I had a most positive experience here," she says.

Much of the medical tourism industry in Israel depends on brokers like Ira Nissel, who handled Caroline’s case. An immigrant from New York who came to Israel in the late 1970s, he is an entrepreneur who formed IMS Global four years ago to promote medical tourism to Israel.

A survey in 2008 by Deloitte Center for Health Solutions found that in 2007, 750,000 Americans traveled overseas for medical treatment. Spokespersons for the Israeli government said about 20,000 foreign tourists were served in Israel in 2007.

Advice to people lacking insurance: Consider the merits of getting care abroad – or of getting a U.S. president who favors universal health insurance.

Read a story about medical tourism.

Thanks to Netty Gross for the source article in the Oct. 13 issue of the Jerusalem Report.

Tuesday, January 13, 2009

We may as well milk it while we can: Zyprexa and prescription drug reform

Here's a victim’s name and face for the prescription drug reform issue. It's a story of cherry-picked studies, aggressive marketing to doctors by pharma salesmen bearing gifts, and an ultimately fatal side effect of Zyprexa:

His prom photo showed he was a handsome teenager with a messy mop of dark brown hair. He went to college to study political science. But within the next year or two John Eric Kauffman developed mental illness--a severe form of bipolar disorder. In 1992, in his late twenties, he suffered his most severe psychotic breakdown. Over the next 8 years, he didn't suffer any psychotic breakdowns, thanks to lithium and Stelazine. After that, a psychiatrist changed his medications, John stopped taking them, his condition worsened, and he was hospitalized. In the hospital he was given Zyprexa in a relatively high dose. He then remained on Zyprexa for 6 years, and gained 100 pounds, developing heart disease. John's weight gain probably contributed to her son's death in his forties from an irregular heart beat, according to a forensic pathologist. (NY Times, 1/5/07). More of John's story can be found here.

Drug maker Eli Lilly had done studies. But tens of thousands of lawsuits contend that Lilly did not fully disclose risks it discovered during studies conducted to get FDA approval for Zyprexa, risks that became more apparent in the years after the drug hit the market.

The preapproval studies lasted six weeks, not nearly time for diabetes to manifest itself, plaintiffs' attorney Joseph Saunders says, but there were red flags. Some 29% of participants gained significant amounts of weight. Rapid weight gain puts people at higher risk of developing diabetes.

Lilly paid $1.2 billion to settle 30,000 claims. And Lilly has more than private attorneys to worry about. Nine states have sued, claiming the company illegally promoted unapproved uses of Zyprexa and downplayed its side effects. The states want to be reimbursed hundreds of millions for Medicaid dollars they paid for Zyprexa.

In 2003, the FDA directed that not only Zyprexa, but all atypical antipsychotics carry a warning about increased risk of hyperglycemia and diabetes.

Lilly continued to market its drug as more effective but no more dangerous than its competitors. Only in Fall, 2007 did the company agree to change Zyprexa's label to state that its tendency to increase blood sugar levels, another diabetes risk factor, is higher than its competitors.

Asked Saunders: "Why did it take 10 years to warn people about something they knew from their clinical trials?"

In the meantime, Eli Lilly marketed Zyprexa aggressively to doctors. Here's a confessional story of one Zyprexa salesman, Shahram Ahari:

Salesmen wooed doctors with free samples, treated them to expensive dinners and paid them to give speeches at seminars.

"It practically sold itself," said Ahari, who sold Zyprexa in New York from 1998 to 2000.

The gravy train hit some bumps. Reps started hearing from doctors concerned about patients "blimping up." Competitors hammered them on it, derisively twisting Zyprexa's generic name, olanzapine, into "olanza-pig."

The Zyprexa sales reps eagerly awaited word from Lilly's brand team on how they should deal with the weight/diabetes issue. Ahari says this is what they came up with: Tell doctors to instruct patients to drink a glass of water before and after they eat, to suppress appetite.

"We'd have to do it with a straight face," Ahari said, "and after a while, it just became uncomfortable."

With doctors he knew well, he said his pitch was blunt: "Would you rather have a skinny, unwell patient or a fat, stable one?"

Doctors started reporting patients developing diabetes. "That was a big, scary thing," Ahari said. If the FDA required that Zyprexa carry a black box warning about diabetes, "it would have been death, market-wise."

He says sales reps were instructed to deflect the issues of weight gain and diabetes. "We were taught to downplay it and negate it, or to change the topic."

Lemons, the Lilly spokeswoman, says the company can't be certain what every sales manager told their sales reps, but "that has never been our corporate policy." She questioned Ahari's objectivity because she said he is now a paid witness for trial attorneys taking on pharmaceutical companies. Ahari says he was a paid witness in just one case, which was about preserving the confidentiality of physicians' prescribing patterns.

Like many critics, Ahari came to feel Zyprexa was effective, appropriate for many people. But he believed that the brass at Lilly downplayed the weight and diabetes problems because the clock on the patents was ticking. The thinking was, "we may as well milk it while we can." (St. Petersburg Times, 12/16/07)

Advice: Urge your government health watchdog agencies to require doctors to disclose their research funding, and require pharma companies to allow doctors to publish whatever results they see fit.

Thanks to Helen Haskell, NY Times reporter Alex Berenson, and St. Petersburg Times reporter Robert Farley.

Tuesday, January 6, 2009

No need for a bag: Informed consent for treatment of rectal cancer

Denise Grady's story:
Six years ago, a relative of mine found out that she had rectal cancer, and would need surgery, radiation and chemotherapy. She lives in a small town, and consulted a local surgeon at a community hospital.

He was pleasant and kind, and clearly explained her condition and the operation he would perform. He was also painfully honest, and said that because the tumor was large, he doubted that he would be able to save the sphincter muscles that make bowel control possible. She would very likely need a colostomy, a procedure to divert wastes out through an opening cut in the abdomen, and would have to wear a colostomy bag for the rest of her life.

She thought it over, and decided that, instead, she wanted a doctor who operated on patients like her all the time. She found a surgeon who specialized in rectal cancer, and today she's in good health, with no need for a bag.

Practice makes perfect for surgeons too. Hospitals and surgeons that perform a higher number of a certain kind of procedure are better at it. It’s not just the surgeon's skill; outcomes are better if nurses, intensivists, respiratory therapists, and physical therapists are more experienced at treatment of a given condition.

This goes beyond "informed consent," which sometimes refers only to a perfunctory explanation and an unquestioning patient. Patients should insist on a "well-informed consent" based on their active weighing of pros and cons.

Advice: If surgery is really necessary, have it done at a high volume hospital by a surgeon who has performed many of the procedures you need.

Read a story about well-informed consent.

Thanks to Denise Grady for the source article in today's NY Times.

Sunday, January 4, 2009

No ice for his swelling: Medical travel insurance

Mary Billard's story:
My husband Barry and I took an hour’s cab ride through steep and winding hills, past the undeveloped, Eden-before-the-fall landscape near the beach town of Senggigi, Indonesia.

We were wandering down the main street, reading menus, when the lights went out. A few more steps and, suddenly, Barry disappeared from my side. I looked down into an open concrete drainage ditch about four feet deep, and there he was at the bottom, getting to his hands and knees.

It was so dark I used a cell phone light to see a bleeding wound on his forearm. Then he felt a pain in his ankle. Over the next eight hours, we learned his ankle was fractured.

We went to the nearest clinic. Barry called the number on the back of his American Express card, connecting him to the Global Assist Hotline to find out what kind of medical help they could provide and to explore our trip back to the United States.

In the subsequent hours, we were on the phone almost constantly as Barry lay in a bed in the bare-bones clinic – with no ice for his swelling. We reached doctors in New York, family and others, and American Express, which monitored the diagnosis and care provided. (After we got home, I got a phone bill for $903.)

A decision was made: Barry would have the local doctor put a cast on his broken ankle, and then we would travel back home to New York City. He would not have surgery in rural Indonesia.

How to get him home? As premium American Express card members, we are eligible to receive emergency medical transportation assistance. But a fractured ankle does not justify getting an air ambulance. (Even if we had a medical travel insurance policy, it wouldn't cover an air ambulance, because this injury didn't require hospitalization.)

It's possible that a travel insurance policy would cover a ticket to fly home promptly, depending on medical necessity.

Next trip, we are definitely buying a comprehensive trip insurance policy. And bringing a flashlight.

Mary's advice: Before embarking on an overseas vacation, travelers should check their medical policy to see what is covered.

Read a very different medical story of a tourist to Asia.

Thanks to Mary Billard for the source article in today's New York Times.

Saturday, January 3, 2009

Our hearts go out to them: Bias in pharma-funded research for psychoactive drugs

In the final months of Rebecca Riley's life in Hull, Massachusetts, a school nurse said the little girl was so weak she was like a "floppy doll." The preschool principal had to help Rebecca off the bus because the 4-year-old was shaking so badly.

Rebecca — who had been diagnosed with attention deficit hyperactivity and bipolar disorder, or what used to be called manic depression — died Dec. 13, 2006 of an overdose of prescribed drugs. Rebecca was found dead on the floor of her parents' bedroom wearing only a pink pull-up diaper and gold-stud earrings, on top of a pile of clothes, magazines and a stuffed brown bear.

According to the medical examiner, Rebecca died of a combination of Clonidine, a blood pressure medication Rebecca had been prescribed for ADHD; Depakote, an antiseizure and mood-stabilizing drug prescribed for the little girl's bipolar disorder; a cough suppressant; and an antihistamine. The amount of Clonidine alone in Rebecca's system was enough to be fatal, the medical examiner said.

The two brand-name prescription drugs are approved by the Food and Drug Administration for use in adults only, though doctors can legally prescribe them to youngsters, and do so frequently.

Rebecca's death has inflamed a long-running debate in psychiatry. Some psychiatrists believe bipolar disorder, which was traditionally diagnosed in adolescence or early adulthood, has become a trendy diagnosis in young children.

"As a clinician, I can tell you it's just very difficult to say whether someone is just throwing tantrums or has bipolar disorder," said Dr. Oscar B. Bukstein, a child psychiatrist and associate professor at the University of Pittsburgh.

Marcia Angell's comments are particularly insightful. They'll appear in the forthcoming NY Review of Books in the issue of Jan. 15, 2009:

Some of the biggest blockbusters are psychoactive drugs. The theory that psychiatric conditions stem from a biochemical imbalance is used as a justification for their widespread use, even though the theory has yet to be proved. Children are particularly vulnerable targets. What parents dare say "No" when a physician says their difficult child is sick and recommends drug treatment? We are now in the midst of an apparent epidemic of bipolar disease in children (which seems to be replacing attention-deficit hyperactivity disorder as the most publicized condition in childhood), with a 40-fold increase in the diagnosis between 1994 and 2003.

Take the case of Dr. B., widely reported in Boston recently, about a professor of psychiatry at Harvard Medical School and chief of pediatric psychopharmacology at a major Harvard teaching hospital. Thanks largely to him, children as young as two years old are now being diagnosed with bipolar disorder and treated with a cocktail of powerful drugs, many of which were not approved by the Food and Drug Administration (FDA) for that purpose and none of which were approved for children below ten years of age.

Legally, physicians may use drugs that have already been approved for a particular purpose for any other purpose they choose, but such use should be based on good published scientific evidence. That seems not to be the case here. The doctor's own studies of the drugs he advocates to treat childhood bipolar disorder were, as the New York Times summarized the opinions of its expert sources, "so small and loosely designed that they were largely inconclusive."

In June, Senator Grassley revealed that drug companies, including those that make drugs he advocates for childhood bipolar disorder, had paid Dr. B. $1.6 million in consulting and speaking fees between 2000 and 2007. Two of his colleagues received similar amounts. After the revelation, the president of the hospital and the chairman of its physician organization sent a letter to the hospital's physicians expressing not shock over the enormity of the conflicts of interest, but sympathy for the beneficiaries: "We know this is an incredibly painful time for these doctors and their families, and our hearts go out to them."

Rebecca's case has lots of blame to go around, and many factors were involved. At this time, we can be sure of few things. Three things seem clear:

1. The consulting and speaking fees seem like a lot of money – enough to influence the doctor's judgment.

2. In the gray zone of the proper selection and dosage of psychoactive drugs for children, where the FDA has not specifically approved their use, we need research to be as pure, as unbiased, as possible.

3. Drug companies now own the right to cherry-pick the findings and the studies they fund, and they do so.

My opinion is that we must make doctors fully free to publish the results of their studies, and let the chips fall where they may. If so, more negative results of the usefulness of psychoactive drugs will probably be published. Currently, the drug companies often suppress such findings, e.g., as was done in half of studies of anti-depressants, according to a January 2008 article in the New England Journal of Medicine. If all such studies are published, doctors will be more skeptical of the value of these drugs, and are likely to prescribe them less frequently. We have to ask ourselves whether insisting, through government regulation, that doctors have this freedom to decide what to publish, and whether requiring doctors to disclose their research funding sources and amounts, would have saved the lives of Rebecca and other children.

Advice: Try to tighten your state’s requirements for disclosure of drug research studies and free rights for doctors to publish all research they perform.

Thanks to Helen Haskell and to Marcia Angell. Thanks also to the Associated Press for their article on March 23, 2007.