Bending the Rules of Clinical Trials - NYTimes.com

Louise (not her real name), a scientist and avid runner in her 50s, first noticed the strange pangs under her right ribcage a few weeks before we met. Her CAT scan revealed a liver so riddled with islands of tumor that the radiologist called them "too numerous to count." None of the standard surgical, radiologic or chemotherapy treatments would help, and her doctor told her that she had two, maybe three, months to live.

Louise came to us for a second opinion. I swallowed hard before going into her exam room to summarize my findings. It was, and still is, not easy for me to tell patients they are dying.

But her reaction surprised me. Instead of a grim silence or even tears, she simply smiled. "I want to become a grandmother," she said, looking over at her pregnant daughter-in-law, who was just beginning to show. Louise knew she was going to die from the cancer; she wanted only to live long enough to see her grandchild born.

For the rest of the afternoon, Louise's plea played over and over in my mind. I wanted to offer something — anything — that might increase her chance of survival by a few months. No standard therapy would work, so I wondered if a clinical trial, a study of a new drug or treatment, might hold some promise.

I also knew that every research trial maintained strict criteria for enrollment and that Louise was hardly the ideal candidate and might not qualify. While there were trials that accepted patients with diminished liver function, her organ was on the precipice of all-out failure. If she took part in a trial and her liver failed, she could muddy the data, perhaps even alter the trial's outcome. The investigators would assume that liver failure was a side effect of the experimental drug, a complication potentially so significant it could prevent future use of the drug. But the reality was that her liver failure would have probably had nothing or very little to do with the drug; it would have been the result of not having had enough normal liver to begin with.

Nonetheless, an experimental drug seemed to me to be my patient's only hope. I called up a medical oncology colleague and was ready to consider violating the entry rules of a clinical trial. "She just wants to see that child born," I said to my colleague. "I wonder if we could finagle things so she could be in a trial?"

It turns out that I am not the only doctor who has considered bending the admissions criteria of a clinical trial for a patient.

There is an essential conflict for doctors involved in clinical research. As collaborators in research, they want to obtain information that is valid and able to be generalized for all future patients; but as doctors working within a patient-doctor relationship, they need to focus only on improving the condition of the patient before them. A patient in a chemotherapy clinical trial, for example, might complain of severe nausea after receiving a dose of an experimental drug. While the doctor as researcher might place a high priority on limiting the types of antinausea medications because of fears they could interact with and affect the experimental drug's effects, that same doctor as patient advocate might choose to ignore the list of "approved" antinausea medications to use one that has previously worked.

Until recently, bioethicists who have studied the tension between these two competing commitments for doctors involved in clinical trials have primarily written about how patients might be particularly vulnerable. Some bioethicists have expressed concern that doctors might tolerate or promote research that could compromise a patient's well-being; others have worried that doctors might not fully inform patients of the potential risks involved.

Now, a recently published survey reveals that it may not be the patients who are most vulnerable, but the trials themselves.

In the current issue of the bioethics journal IRB: Ethics & Human Research, investigators from four different institutions surveyed over 700 clinicians involved in clinical trials and found that 90 percent believed that ignoring certain entry criteria was acceptable if a patient could, in their estimation, benefit from the trial. In addition, over 60 percent of those surveyed also believed that researchers should deviate from study rules if doing so might improve a patient's care.

While bioethicists and researchers have long suspected that doctors and other clinicians might be committing an occasional protocol infraction, few if any studies have looked at the extent to which such violations occur and how they might compromise research results.

"What struck me," said Charles W. Lidz, research professor of psychiatry at the University of Massachusetts Medical School in Worcester and lead author of the study, "was the number of clinicians who described circumstances where they would do things that violated protocol in order to help their patient."

Such violations could include altering medical records in order to get a patient into an H.I.V. treatment trial, downplaying a substance abuse history in order to help a patient enroll in a trial on depression, or artificially improving an otherwise poor kidney function test by having a patient drink a gallon of water the night before the study's blood draw.

While each of these violations was made in the best interest of individual patients, they also had the potential to compromise, and even negate, a trial's findings. "Not everyone had an account of how they would go around a protocol in order to help their patients, but a significant number did," Dr. Lidz said. "And they told their story proudly because it was a reflection of their commitment to patients."

Clinicians are motivated to "bend" protocol rules because they view the experimental therapy as promising. "There's a pervasive idea among clinicians and patients that a new drug or device is going to make things better," Dr. Lidz noted. But statistically, while many experimental treatments are as good as standard therapy, few actually end up being superior, and some are worse.

Nonetheless, Dr. Lidz maintains that participating in a clinical trial remains the right choice for most patients if their current treatment is not working. Patients in experimental protocols tend to receive more attention than those who are not enrolled, and clinical trials are central to determining if a new treatment really works. "If people don't join them," he remarked, "we are all in trouble. Patients just need to realize that they are doing this for a larger cause, not necessarily their own interest. And that larger cause is really important."

Despite the survey results, Dr. Lidz believes it is still possible to support the human connection and sense of obligation between doctors and their current patients while advancing the clinical research that may help future patients. Researchers devising clinical trials will need to make it clearer to doctors how important it is to follow the entry criteria and treatment protocol. And they will need to understand that a poorly designed clinical trial can force clinicians to choose between obligations to the research and their commitment to a patient.

"It's really easy to assume there are 'good guys' and 'bad guys' and that someone is not taking certain aspects of clinical research seriously," Dr. Lidz said. "But, in fact, there is something investigators are not adequately taking into account when designing trials. They need to recognize that the doctor-patient relationship is important to both the doctor and the patient and that one cannot design a protocol in such a way that ignores the feelings of the doctor and patient about how important it is to provide good care."

Louise, my patient with liver cancer, did end up receiving a new drug, but not as part of a clinical trial. Despite my suggestion that we try to squeeze her into a trial, my colleague found a way to give her the new drug off protocol. And whether it was because of that drug or, more likely, her extraordinary will, she survived to become a grandmother. She died just days after her grandson was born.

"In a certain sense," Dr. Lidz mused, "these survey results suggest that the doctor-patient relationship is in better shape than many people have suggested.

"If you are willing to go around the clinical trial design in order to provide better care for your patient, that suggests to me you are pretty committed to your patient. And in a sense, I think that is sort of reassuring."

http://www.nytimes.com/2009/10/29/health/29chen.html?hpw=&pagewanted=print

In Gay Culverhouse, N.F.L. Players With Head Injuries Find a Voice - NYTimes.com

As the president of the Tampa Bay Buccaneers and the daughter of their owner, Gay Culverhouse was the woman in the men's locker room. Twenty years later, she is trying to keep her former players out of the emergency room.

Sitting at a restaurant here Friday, she reconnected with a few Buccaneers retirees. There was Richard Wood, the fearsome linebacker known as Batman whose searing migraines and tendency to get lost while driving near his home leave him scared for his future. Across the table was Scot Brantley, an even harder hitter through the 1980s whose short-term memory is gone. Then there was Brandi Winans, former wife of Buccaneers lineman Jeff Winans, who slipped into such inexplicable depression, fogginess and fury several years ago that their marriage splintered.

Culverhouse looked at disability forms, listened to stories, offered counsel and expressed regret. She has done the same via telephone for another half-dozen former Buccaneers in their 40s or 50s who have increasing cognitive problems. Having followed story after story detailing how National Football League retirees are experiencing various forms of dementia at several times the national rate, and listening to the league and its doctors cast doubt that football played any role in their problems, she has emerged after 15 years to reconnect with players and sound an alarm.

She will testify before the House Judiciary Committee at its hearing on football brain injuries on Wednesday to, as she put it, "tell the truth about what's going on while I still have the chance."

Culverhouse has blood cancer and renal failure and has been told she has six months to live.

"I've got to see that someone stops this debacle before it gets any worse," said Culverhouse, 62, the daughter of the former owner Hugh Culverhouse who held various executive positions from 1985 to 1994. "I watched our team do anything it could to get players back on the field. We have to make that right."

The N.F.L. and the players union have added programs to aid former players since their pension and disability plans came under public fire two years ago. One helps with joint-replacement surgeries, another with cardiovascular health screenings. The most prominent is the 88 Plan, which helps pay expenses for players with dementia. But for the hundreds of those whose cognitive decline falls short of dementia, the industry's disability plan has little to offer.

A recent New York Times analysis of the plan's 73 current members suggested that N.F.L. retirees ages 60 to 89 are experiencing moderate to severe dementia at several times the national rate. A recent telephone survey sponsored by the N.F.L. had similar results, corroborating findings from several independent studies, but the league and its doctors continue to discredit all evidence of such a link.

"Telling the players that football has nothing to do with it is literally adding insult to injury," Culverhouse said. "It's a joke. It's unconscionable."

Culverhouse read about the controversy, heard about how her former lineman Tom McHale had died at 45 with brain damage associated with boxers, and began calling her former players.

She had always been an N.F.L. misfit. An alumna of Columbia University with a master's degree in mental retardation and a doctorate in special education, she later became the Buccaneers' vice president for community relations and eventually president in 1991, always amid whispers that she was just the owner's daughter. But she relished a good fight; she caused a local uproar by threatening to sue the Palma Ceia Golf and Country Club because as a woman she was barred from using the team's corporate membership.

Every former player Culverhouse called had debilitating physical problems, she said. A stunning portion had cognitive ones, even in their mid-40s, and most of them lacked the short-term memory or concentration required to seek medical assistance or slog through the disability paperwork. One player told her, "I'm headed for the 88 Plan."

"The thing that I always admired about Gay is that she's a rebel with a cause," said Brantley, 51. "Football was a man's world. Still is. I've always said, if you want something done and done right, get a woman involved. No one else has shown any interest in us for a second. We might as well have the plague."

At a Lee Roy Selmon's restaurant in Tampa — Selmon is a former Buccaneers defensive lineman — Culverhouse spoke with her former players about others who might need her help, including a former Buccaneers fullback.

"I've got to get to" him, Culverhouse said.

"He's not good, no," replied Wood, 56. "It's tough to understand him because his speech is so slurred."

"I'll fly to Little Rock and fill out the paperwork for him and drive him to the doctors," Culverhouse said. "You get so far gone that you can't deal. It's easier to go home, pop a few pills for the pain and forget about it."

"Tell me about it," Brandi Winans said. After learning how cumulative brain trauma can contribute to serious emotional and substance-abuse problems 20 years after retirement, she said while breaking down, "I felt that I had deserted him." Brandi and Jeff Winans now reconnect on the phone twice a week. He lives in Northern California, and has said he is pursuing medical assistance for his cognitive issues.

All four at the table — the executive, the players and the spouse — insisted that they loved football and hoped it would continue. But they said that discussing the consequences of professional football in the 1970s and 1980s, when players routinely played through concussions with no idea of the risks, was important to comfort the retirees and, more important, to emphasize the seriousness of brain injuries to today's amateur athletes.

Dr. William Carson, the Buccaneers' team orthopedist from 1987 to 1997, said in a telephone interview that during his time and certainly before it, most players with "dings" — now understood as mild concussions — would be returned to games. And the players who never came out also played through those dings, and worse, risking cumulative damage only now understood.

Just the other day, Culverhouse called another one of her former players, Randy Grimes, who told her about his addiction to painkillers and his dwindling short-term memory. She helped explain his disability-plan options, how he was not alone. She did not tell him that she was dying, and that she would soon be in Washington sharing her experience with Congress.

Before they hung up, Culverhouse said that Grimes remarked: "I think I'm fighting this real good, Gay. Your father would be proud of me."

Culverhouse replied: "That's just amazing to me. Because what you did for Dad, playing so hard for us and not knowing the risks, that's what got you into this mess."

http://www.nytimes.com/2009/10/28/sports/football/28football.html?th=&emc=th&pagewanted=print

Do Women Need Such Big Flu Shots? - NYTimes.com

The emergence of the H1N1 swine flu has added urgency to what has become an annual ritual for millions of Americans: getting a flu shot. The good news is that scientists have developed a vaccine against the H1N1 virus. But it is taking much longer than expected to produce the hundreds of millions of doses the government had planned to distribute. And it is still too soon to know how effective the vaccine will be in preventing swine flu.

In all likelihood, we'd have a better H1N1 vaccine — and more of it — if in our preparations we had accounted for the biological differences between men and women.

Under the current guidelines, men and women are to get equal-sized doses of the H1N1 vaccine. Yet women's bodies generate a stronger antibody response than men's do, research shows, so less vaccine may be needed to immunize them. If we could give women a smaller dose, there would be more vaccine to go around. And we might also spare them the mild side effects that vaccines can cause, like pain at the injection site, inflammation and fever. All of these are more common in women than in men.

To be clear, it is essential that women get their flu shots, even if the current dose is more than they need. Pregnant women in particular should make sure they are protected, since those who get the swine flu are at least four times as likely as others with the virus to be hospitalized. (We don't know whether pregnant women are more susceptible to the H1N1 virus, but it's clear that once they are infected, they have a higher-than-average risk of complications.)

But ultimately we should do everything we can to vaccinate as many people as possible.

Many clinical studies have shown that men and women differ in their responses to several viral vaccines. A recent study demonstrated that women produce as many antibodies in response to a half dose of the seasonal flu vaccine as men make in response to a full dose. Other studies have revealed similar sex differences in response to vaccines for yellow fever virus, measles, mumps and rubella, hepatitis A and B viruses and herpes simplex virus.

Whether vaccines work differently in males than in females is not known. Clearly, more research on sex-dependent immune responses is needed.

In planning for the swine flu, however, public health authorities ignored the evidence that vaccines affect women more strongly than men. To determine the proper dose of H1N1 vaccine, the National Institutes of Health set up studies involving 600 children, from babies to teenagers — but neglected to investigate whether males and females should get the same dose.

Although our public health authorities remain confident they will eventually have enough vaccine for all Americans who want it, there almost certainly won't be enough for all the vulnerable populations in poorer countries. Only a handful of countries have plants to manufacture influenza vaccine, and the world's wealthiest countries have locked up most of what these plants can produce with signed purchasing contracts. We could make much more — and potentially save millions of lives — if we stopped giving women larger doses than they need.

http://www.nytimes.com/2009/10/28/opinion/28klein.html?th=&emc=th&pagewanted=print

Cancers Can Vanish Without Treatment, but How? - NYTimes.com

Call it the arrow of cancer. Like the arrow of time, it was supposed to point in one direction. Cancers grew and worsened.

But as a paper in The Journal of the American Medical Association noted last week, data from more than two decades of screening for breast and prostate cancer call that view into question. Besides finding tumors that would be lethal if left untreated, screening appears to be finding many small tumors that would not be a problem if they were left alone, undiscovered by screening. They were destined to stop growing on their own or shrink, or even, at least in the case of some breast cancers, disappear.

"The old view is that cancer is a linear process," said Dr. Barnett Kramer, associate director for disease prevention at the National Institutes of Health. "A cell acquired a mutation, and little by little it acquired more and more mutations. Mutations are not supposed to revert spontaneously."

So, Dr. Kramer said, the image was "an arrow that moved in one direction." But now, he added, it is becoming increasingly clear that cancers require more than mutations to progress. They need the cooperation of surrounding cells and even, he said, "the whole organism, the person," whose immune system or hormone levels, for example, can squelch or fuel a tumor.

Cancer, Dr. Kramer said, is a dynamic process.

It was a view that was hard for some cancer doctors and researchers to accept. But some of the skeptics have changed their minds and decided that, contrary as it seems to everything they had thought, cancers can disappear on their own.

"At the end of the day, I'm not sure how certain I am about this, but I do believe it," said Dr. Robert M. Kaplan, the chairman of the department of health services at the School of Public Health at the University of California, Los Angeles, adding, "The weight of the evidence suggests that there is reason to believe."

Disappearing tumors are well known in testicular cancer. Dr. Jonathan Epstein at Johns Hopkins says it does not happen often, but it happens.

A young man may have a lump in his testicle, but when doctors remove the organ all they find is a big scar. The tumor that was there is gone. Or, they see a large scar and a tiny tumor because more than 95 percent of the tumor had disappeared on its own by the time the testicle was removed.

Or a young man will show up with a big tumor near his kidney. Doctors realize that it started somewhere else, so they look for its origin. Then they discover a scar in the man's testicle, the only remnant of the original cancer because no tumor is left.

Testicular cancer is unusual; most others do not disappear. But there is growing evidence that cancers can go backward or stop, and researchers are being forced to reassess their notions of what cancer is and how it develops.

Of course, cancers do not routinely go away, and no one is suggesting that patients avoid treatment because of such occasional occurrences.

"Biologically, it is a rare phenomenon to have an advanced cancer go into remission," said Dr. Martin Gleave, a professor of urology at the University of British Columbia.

But knowing more about how tumors develop and sometimes reverse course might help doctors decide which tumors can be left alone and which need to be treated, something that is now not known in most cases.

Cancer cells and precancerous cells are so common that nearly everyone by middle age or old age is riddled with them, said Thea Tlsty, a professor of pathology at the University of California, San Francisco. That was discovered in autopsy studies of people who died of other causes, with no idea that they had cancer cells or precancerous cells. They did not have large tumors or symptoms of cancer. "The really interesting question," Dr. Tlsty said, "is not so much why do we get cancer as why don't we get cancer?"

The earlier a cell is in its path toward an aggressive cancer, researchers say, the more likely it is to reverse course. So, for example, cells that are early precursors of cervical cancer are likely to revert. One study found that 60 percent of precancerous cervical cells, found with Pap tests, revert to normal within a year; 90 percent revert within three years.

And the dynamic process of cancer development appears to be the reason that screening for breast cancer or prostate cancer finds huge numbers of early cancers without a corresponding decline in late stage cancers.

If every one of those early cancers were destined to turn into an advanced cancer, then the total number of cancers should be the same after screening is introduced, but the increase in early cancers should be balanced by a decrease in advanced cancers.

That has not happened with screening for breast and prostate cancer. So the hypothesis is that many early cancers go nowhere. And, with breast cancer, there is indirect evidence that some actually disappear.

It is harder to document disappearing prostate cancers; researchers say they doubt it happens. Instead, they say, it seems as if many cancers start to grow then stop or grow very slowly, as has been shown in studies like one now being done at Johns Hopkins. When men have small tumors with cells that do not look terribly deranged, doctors at Johns Hopkins offer them an option of "active surveillance." They can forgo having their prostates removed or destroyed and be followed with biopsies. If their cancer progresses, they can then have their prostates removed.

Almost no one agrees to such a plan. "Most men want it out," Dr. Epstein said. But, still, the researchers have found about 450 men in the past four or five years who chose active surveillance. By contrast, 1,000 a year have their prostates removed at Johns Hopkins. From following those men who chose not to be treated, the investigators discovered that only about 20 percent to 30 percent of those small tumors progressed. And many that did progress still did not look particularly dangerous, although once the cancers started to grow the men had their prostates removed.

In Canada, researchers are doing a similar study with small kidney cancers, among the few cancers that are reported to regress occasionally, even when far advanced.

That was documented in a study, led by Dr. Gleave that compared an experimental treatment with a placebo in people with kidney cancer that had spread throughout their bodies.

As many as 6 percent who received a placebo had tumors that shrank or remained stable. The same thing happened in those who received the therapy, leading the researchers to conclude that the treatment did not improve outcomes.

The big unknown is the natural history of many small kidney tumors, many of which are early kidney cancers. How often do small tumors progress? Do they ever disappear? Do they all need surgical excision? At what stage do most kidney cancers reach a point of no return?

These days, Dr. Gleave said, more patients are having ultrasound or CT scans for other reasons and learning that there is a small lump on one of their kidneys. In the United States, the accepted practice is to take those tumors out. But, he asks, "Is that always necessary?"

His university is participating in a countrywide study of people with small kidney tumors, asking what happens when those tumors are routinely examined, with scans, to see if they grow. About 80 percent do not change or actually regress over the next three years.

With early detection, he said, "our net has become so fine that we are pulling in small fish as well as big fish." Now, he said, "we have to identify which small fish we can let go."

http://www.nytimes.com/2009/10/27/health/27canc.html?_r=1&em=&pagewanted=print

Healthcare system wastes up to $800 billion a year | Reuters

The U.S. healthcare system is just as wasteful as President Barack Obama says it is, and proposed reforms could be paid for by fixing some of the most obvious inefficiencies, preventing mistakes and fighting fraud, according to a Thomson Reuters report released on Monday.

The U.S. healthcare system wastes between $505 billion and $850 billion every year, the report from Robert Kelley, vice president of healthcare analytics at Thomson Reuters, found.

"America's healthcare system is indeed hemorrhaging billions of dollars, and the opportunities to slow the fiscal bleeding are substantial," the report reads.

"The bad news is that an estimated $700 billion is wasted annually. That's one-third of the nation's healthcare bill," Kelley said in a statement.

"The good news is that by attacking waste we can reduce healthcare costs without adversely affecting the quality of care or access to care."

One example -- a paper-based system that discourages sharing of medical records accounts for 6 percent of annual overspending.

"It is waste when caregivers duplicate tests because results recorded in a patient's record with one provider are not available to another or when medical staff provides inappropriate treatment because relevant history of previous treatment cannot be accessed," the report reads.

Some other findings in the report from Thomson Reuters, the parent company of Reuters:

* Unnecessary care such as the overuse of antibiotics and lab tests to protect against malpractice exposure makes up 37 percent of healthcare waste or $200 to $300 a year.

* Fraud makes up 22 percent of healthcare waste, or up to $200 billion a year in fraudulent Medicare claims, kickbacks for referrals for unnecessary services and other scams.

* Administrative inefficiency and redundant paperwork account for 18 percent of healthcare waste.

* Medical mistakes account for $50 billion to $100 billion in unnecessary spending each year, or 11 percent of the total.

* Preventable conditions such as uncontrolled diabetes cost $30 billion to $50 billion a year.

"The average U.S. hospital spends one-quarter of its budget on billing and administration, nearly twice the average in Canada," reads the report, citing dozens of other research papers.

"American physicians spend nearly eight hours per week on paperwork and employ 1.66 clerical workers per doctor, far more than in Canada," it says, quoting a 2003 New England Journal of Medicine paper by Harvard University researcher Dr. Steffie Woolhandler.

Yet primary care doctors are lacking, forcing wasteful use of emergency rooms, for instance, the report reads.

All this could help explain why Americans spend more per capita and the highest percentage of GDP on healthcare than any other OECD country, yet has an unhealthier population with more diabetes, obesity and heart disease and higher rates of neonatal births than other developed nations.

http://www.reuters.com/article/newsOne/idUSTRE59P0L320091026?sp=true

Doctors question ethics of needles for children - National Post

With Canada on the brink of one of its largest-ever vaccination drives, a group of academics and doctors is urging health-care workers to make flu and other shots less painful for children, suggesting it is actually "unethical " for them to ignore the sting of injections.

Many doctors and parents believe a needle is nothing to fret about, with the hurt lasting only a moment and leaving no long-term effects, the researchers acknowledge in a series of medical-journal papers just published.

Using one of several possible pain-reduction techniques, however, could help avert needle phobias that affect as much as 10% of the population, last years and undermine vaccination campaigns, they argue.

Those methods -- from anesthetic cream applied to the skin to simply giving babies sugar water -- are seldom employed now, the panel says in the journal Clinical Therapeutics.

"The attitude is, 'It's only pain -- what's the big deal?' " said Anna Taddio, a pharmacy professor at the University of Toronto and lead author of the papers. "But it actually is when you start figuring out what all the costs of it are. It means someone is not going to donate blood ... and it means that person doesn't go to see the doctor, doesn't go to see the dentist because they don't want to be poked," she said. "They're probably sicker as a group of people."

The issue is becoming more pressing, given that Canadian children are receiving a constantly expanding range of vaccines --as many as 20 shots by age five -- while uptake on immunization is dropping, the journal articles argue.

Not everyone is convinced of the need for widespread action, though. Pain in immunization is undoubtedly a serious issue for a "subset" of children who could benefit from pain-reduction methods, but they are likely the exception, said Dr. Peter Nieman, a Calgary pediatrician. "For the majority of kids I've seen, it's a trade-off," he said. "On the one hand, nobody in their right mind would say, 'I love needles,' but on the other hand, the pain you put up with is a small price to pay for the benefit you get."

Nevertheless, Prof. Taddio's group, including pharmacists, physicians and pain researchers, is developing a formal practice guideline around vaccine-pain reduction that it hopes the Canadian Pediatric Society will adopt for its members soon.

There is also a movement to have pain reported as one of the adverse side effects of vaccine injections, which might encourage pharmaceutical companies to produce vaccines that hurt less, Prof. Taddio said. Some formulations are already less painful than others, a function of the chemicals used and how they interact with human tissue.

As a physician and pharmacologist in the emergency department of a London, Ont., hospital, Dr. Michael Rieder says he sees the impact of pain-induced needle fear "all the time," with older children and even teenagers recoiling at the approach of a hypodermic, whether it is to draw blood or inject local anesthetic.

"One of the biggest problems in pediatric acute care is fear of needles," he said. "If you have to draw blood and the child is struggling and fighting because they're afraid of a needle, it's not such an easy thing to do."

The group's review of evidence cites studies that suggest 90% of toddlers and 50% of school-age children experience severe distress during vaccination, with some evidence that early bad experiences can condition bodies to be more sensitive to pain in future.

About one in 10 people is estimated to have full-blown needle phobia, and 25% of adults to have significant fears, prompting them to avoid dental visits, fail to donate blood and neglect insulin injections, the researchers say.

In one study of 12,000 people, only 12% agreed to undergo a free flu vaccine, and virtually all of them chose a nasal spray instead of a needle, many of them citing the pain of injection for their decision.

In fact, recent polls suggest that only a third of Canadians plan to get the H1N1 vaccine, and Prof. Taddio believes memories of childhood immunization pain are likely a reason why some will pass on the shot.

To reduce needle pain, apply topical anesthetic creams; comfort babies by having them breast-feed or suck on sugar water during the shot; and simply distract the child. Doctors and others should also give needles without aspirating, a process designed to ensure they are not injecting vaccine into a blood vessel, Prof. Taddio said. Aspiration prolongs the pain and is not necessary, she said.

http://www.nationalpost.com/news/canada/story.html?id=2145150

Articles:

 

Foreword

Clinical Therapeutics, Vol. 31 (2009), pp. S47-S47.

by Anna Taddio

 

Physical interventions and injection techniques for reducing injection pain during routine childhood immunizations: Systematic review of randomized controlled trials and quasi-randomized controlled trials

Clinical Therapeutics, Vol. 31 (2009), pp. S48-S76.

by Anna Taddio, A. Lane Ilersich, Moshe Ipp, Andrew Kikuta, Vibhuti Shah

 

Psychological interventions for reducing pain and distress during routine childhood immunizations: A systematic review

Clinical Therapeutics, Vol. 31 (2009), pp. S77-S103.

by Christine T. Chambers, Anna Taddio, Lindsay S. Uman, McMurtry

 

Effectiveness and tolerability of pharmacologic and combined interventions for reducing injection pain during routine childhood immunizations: Systematic review and meta-analyses

Clinical Therapeutics, Vol. 31 (2009), pp. S104-S151.

by Vibhuti Shah, Anna Taddio, Michael J. Rieder

 

Inadequate pain management during routine childhood immunizations: The nerve of it

Clinical Therapeutics, Vol. 31 (2009), pp. S152-S167.

by Anna Taddio, Christine T. Chambers, Scott A. Halperin, et al.

Choosing Who Survives in a Flu Epidemic - NYTimes.com

New York state health officials recently laid out this wrenching scenario for a small group of medical professionals from New York-Presbyterian Hospital:

A 32-year-old man with cystic fibrosis is rushed to the hospital with appendicitis in the midst of a worsening pandemic caused by the H1N1 flu virus, which has mutated into a more deadly form. The man is awaiting a lung transplant and brought with him the mechanical ventilator that helps him breathe.

New York's governor has declared a state of emergency and hospitals are following the state's pandemic ventilator allocation plan — actual guidelines drafted in 2007 that are now being revisited. The plan aims to direct ventilators to those with the best chances of survival in a severe, 1918-like flu pandemic where tens of thousands develop life-threatening pneumonia.

Because the man's end-stage lung disease caused by his cystic fibrosis is among a list of medical conditions associated with high mortality, the guidelines would bar the man from using a ventilator in a hospital, even though he is, unlike many with his illness, stable, in good condition, and not close to death. If the hospital admits him, the guidelines call for the machine that keeps him alive to be given to someone else.

Would doctors and nurses follow such rules? Should they?

In recent years, officials in a host of states and localities, as well as the federal Veterans Health Administration, have been quietly addressing one of medicine's most troubling questions: Who should get a chance to survive when the number of severely ill people far exceeds the resources needed to treat them all?

The draft plans vary. In some states, patients with Do Not Resuscitate orders, the elderly, those requiring dialysis, or those with severe neurological impairment would be refused ventilators, or admission to hospitals. Utah divides epidemics into phases. Initially, hospitals would apply triage rules to residents of mental institutions, nursing homes, prisons and facilities for the "handicapped." If an epidemic worsened, the rules would apply to the general population.

Federal officials say the possibility that America's already crowded intensive care units would be overwhelmed in the coming weeks by flu patients is small but they remain vigilant.

More ...

http://www.nytimes.com/2009/10/25/weekinreview/25fink.html?hpw=&pagewanted=print

Forty Years' War - A Place Where Cancer Is the Norm

M. D. Anderson Cancer Center has a mission statement, and everyone who works there, from the president to the cleaning crews, can state it like a catechism: to "eliminate cancer in Texas, the nation and the world."

For the nearly 90,000 patients who will go to the center in Houston this year, that mission cannot be fulfilled soon enough. They and their families arrive at the world's largest freestanding cancer hospital from around the world, often leaving behind jobs and stashing children with relatives for months. Some rent apartments or stay in mobile home parks near the hospital.

They enter through a soaring lobby, with cheery aquariums and exuberant volunteer greeters eager to help in any way. They come looking for hope.

But there is no mistaking what this place is: the front line of the frustrating war on a still largely incurable disease.

Doctors are encouraged to try everything, and when insurers balk, they pick up the phone, repeatedly, hoping to persuade them to pay for what may be unconventional treatments.

The federal government gives more cancer research money to this hospital than to any other, and the hospital has an abundance of specialists in many forms of cancer, including rare ones. Medicare offers more generous reimbursement, and the hospital offers treatments that often go far beyond what can be offered at most other places.

"I tell young physicians who are starting out here that the big limitation is imagination," said Dr. Martin Raber, an oncologist — and a cancer patient himself — at Anderson. "If you are good at what you do and you have great ideas, we will help you find the resources you need to make them happen."

But like a modern version of the tuberculosis sanatorium in Thomas Mann's "Magic Mountain," Anderson is a world where the best that medicine has to offer is often far from enough. The odds are still grim, and while there are exhilarating recoveries, the exhausting, dispiriting road traveled by many patients comes into sharp relief.

They are patients like 35-year-old Mindy Lanoux of San Antonio, who has melanoma that has spread to her liver and lungs, her odds of surviving in the single digits. She has been to the hospital 16 times in nine months, spending a week there each time for treatments so debilitating she wanted to give up. But she keeps returning, smearing peppermint oil under her nose when she walks in the medical center's door to hide the odor.

"The smell gets to me," Ms. Lanoux said. "It smells like cleaning products and the sickness and the medicines. It takes your brave edge off."

Then she and her father go to her room and start putting her things away. "We don't talk," Ms. Lanoux said. "There is no polite conversation. It is like an army setting up to do battle."

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http://www.nytimes.com/2009/10/25/health/research/25anderson.html?hp=&pagewanted=all