The biggest frustration facing many doctors is the dearth of swine flu vaccine for their patients. But not Paula Soghomonian’s pediatrician at Pediatric Village in the District. She is not recommending the shots — or the nasal spray.

“The senior doctor there doesn’t believe in it and doesn’t want it for her patients,” Soghomonian said. “I think the feeling was it’s just too new.”

Soghomonian’s doctor is one of a small cadre of outliers who remain skeptical about the government’s unprecedented immunization campaign, citing doubts about the risks presented by the H1N1 virus or the safety of the vaccine, despite the fact that no worrisome reactions have been reported.

“My feeling is that this is all being over-hyped,” said Laurence J. Murphy, a pediatrician in Burke who also will not inoculate his patients. “Most people who get this virus do beautifully. I believe the vaccine hasn’t been tested enough. I just think the benefit of it at this point is not outweighed by the possible risk.”

Such contrarian voices, through the megaphone of cable news or in the quiet of exam rooms, have forced federal health officials to play defense as well as offense in their campaign to encourage immunization.

Public health leaders are at a loss to explain the skeptical minority, except to say that it mirrors the chronically low percentage of health-care workers who get the seasonal flu vaccine every year. Officials worry that these doubters could have a disproportionate influence in an already frustrating and confusing situation, and stress that the studies conducted so far and the intensive monitoring underway indicate that the vaccine is as safe as any flu vaccine.

“I am very disappointed, deeply puzzled and very disturbed by this,” said William Schaffner, president-elect of the National Foundation for Infectious Diseases. “The people for whom these doctors are not recommending this vaccine are clearly high-priority patients who could have very adverse outcomes if they get infected with the virus.”

Although no one has surveyed doctors’ views on the vaccine, polls show that people look to their physicians when deciding whether to get the shots or nasal spray. A nationally representative survey of 1,042 adults in September found that 68 percent said they trusted the advice of their doctor or their child’s pediatrician on this issue, far more than those who said they trusted top federal health officials and medical groups.

“People rely very heavily on their physician’s judgments about whether or not they should take a vaccine,” said Robert J. Blendon, a professor of health policy at the Harvard School of Public Health who conducted the survey. “They are at the top of the charts.”

As a result, the naysayers have left patients torn between a doctor’s long-respected advice, their own judgment and official recommendations.

“It’s like total confusion for me to try to figure out what to do,” Soghomonian said as she lined up with her 3-year-old daughter, Ally, on a recent morning at a District flu clinic.

“It’s really been very frustrating and very scary,” said Soghomonian, who eventually left after deciding to give her daughter only the seasonal flu vaccine. “I just want someone to tell me what to do, you know?”

Cheryl F. Edmonds, founder of the practice where Soghomonian takes her children, declined to be interviewed. But a member of her staff, who spoke on the condition of anonymity, characterized her concerns this way: “Her thing is there’s just not enough data.”

Murphy, the Burke pediatrician, said he has no reason to think the vaccine is unsafe — he, like many of the skeptics, said he generally supports vaccinations. But he wonders whether it was tested enough.

“They just didn’t have the time to do that properly. They mean well and they are not doing anything to mislead people in any direct way. The reality is no one knows. I’m not pretending to know. I don’t think they should pretend to know,” he said.

‘Jumping on the bandwagon’

Murphy is not alone. A smattering of obstetricians, family practice doctors, internists and other physicians nationwide who harbor doubts about safety of the vaccine or the danger the flu poses raise questions on blogs and during interviews, and counsel their patients not to get the immunization.

“What bothers me is pretty much every doctor in the country is jumping on the bandwagon and saying, ‘This vaccine is completely safe’ — even for the pregnant woman and the unborn baby,” said Bob Sears, of Orange County, Calif. “But they can’t give you a single study that backs up that statement.”

Officials repeatedly have stressed that while no vaccine is completely safe, there is no reason to believe the swine flu immunization would pose any unusual risks, and so far no problems have emerged.

“I can understand the hesitancy and reluctance to take a vaccine that appears to be new and different. All we can do is provide the facts,” said Thomas R. Frieden, director of the federal Centers for Disease Control and Prevention. “The facts are that this is the same manufacturing process, the same manufacturers, the same factories, the same safeguards as the seasonal flu vaccine that has been used for more than 100 million doses each year for many years and which has an excellent safety record.”

But Meryl Nass, an internist in Bar Harbor, Maine, still has doubts, especially given that most people who become infected get only mildly ill.

“In this situation, when there’s very little data, I don’t think people — and children in particular — should be asked to bear the burden of being experimental subjects,” said Nass, who has been blogging about her doubts. Nass also questions the assertion that the vaccine is safe for women in all stages of pregnancy.

“The CDC is telling women in all trimesters to go out and get vaccine. To my mind, this is reckless,” said Nass, who is advising her patients to consider receiving the vaccine only in their second or third trimesters.

‘Behind the curve’

Some doctors hear echoes of politics in the reactions to their concerns.

“You come out and offer some caution about the safety of the vaccine, and it becomes very political: Are you with us or are you against us?” said Kent Holtorf, whose Southern California practice specializes in treating chronic conditions. “It’s almost like Republicans and Democrats, and no one wants to toe the middle ground, because it could help the other side.”

Giuseppe Lancellotti, a pediatrician from Ephrata, Pa., argues that the vaccine has arrived too late to make a difference anyway.

“We’re just way behind the curve,” he said.

Government officials counter that it remains far from clear whether the second wave of infections currently sweeping the country has peaked. Even if it has, people will continue to become infected for months and another wave could hit later.

“The risk of not getting the vaccine is much greater than the risk from getting it,” said Anthony S. Fauci, who is leading the government’s ongoing testing of the vaccine at the National Institutes of Health.

Soghomonian was finally forced to make a snap decision when her husband took her 5-year-old son to get a seasonal flu shot and discovered the swine flu vaccine was available, too.

“I called him and said, ‘Just do both,’ ” she said. He did, but Soghomonian was still uneasy. “There was a moment of panic, like: What did I do?”

Nevertheless, Soghomonian was among the first few dozen people to line up last week at Wilson High School in the District to finally get her daughter vaccinated.

“It’s your pediatrician. Your children have been there since Day One. You feel like they know and you should listen to their advice. And here I’m going against it,” she said.

“Ultimately, you have to make your own decision.”

For five desperate minutes, emergency room doctors at UC Davis Medical Center frantically tried to revive Scott Hawkins.

In those five minutes, the 23-year-old California State University, Sacramento, student was hooked up to life support monitors, air pumped into his weakened lungs as he bled on a gurney.

Hospital officials said Hawkins was given the highest level of emergency care, with a phalanx of surgeons, specialists and nurses at the ready. His parents called the effort “heroic.”

Five minutes later, doctors pronounced him dead.

Few question the extent to which doctors tried to save the student’s life on Oct. 21, but the amount billed for his emergency care has provoked outrage – a further example, critics said, of what is wrong in a health care system that is roundly maligned for its escalating costs.

The charge for those five minutes: $29,186.50 – including a single-ticket item for $18,900.50, described on the itemized bill as “Trauma Rescue Service.”

What’s more, the Hawkins case may be a dramatic and brutal example of the wide disparities in the sticker price for medical care provided to those with insurance and those without it. With millions of Americans unemployed and increasingly uninsured, emergency rooms have become part of the focus of the high cost of medicine in this country.

“Part of the outrage is that those with the least are charged the most,” said Anthony Wright, executive director of Health Access California, a consumer advocacy group.

The bill sent to Hawkins’ family was an undiscounted “rack rate” that hospitals charge the uninsured – patients who do not have the benefit of having an insurance company negotiate deep discounts.

Hawkins was mistakenly classified by the hospital as medically indigent. Had the hospital realized that the student was insured, the bill would have been sent to his insurer, Kaiser Permanente, which would undoubtedly have paid thousands of dollars less.

A Kaiser spokeswoman said she could not discuss the Hawkins case because of privacy reasons.

However, an agreement is in place between Kaiser and UC Davis, including provisions for compensation for care.

“If you’re covered by an insurer, the contract is intensely negotiated between the insurer and the hospital,” said Maribeth Shannon, director of the California HealthCare Foundation’s market and policy monitor program.

Wright of Health Access said uninsured patients who use emergency rooms are often billed at “an inflated price – three or four times what insured people pay.”

UC Davis officials declined to discuss their billing practices, or how negotiations with insurance companies are conducted.

But Dr. Lynette Scherer, a general surgeon and chief of trauma at UC Davis Medical Center, said the public simply doesn’t understand how expensive it is to run a sophisticated emergency room and trauma center like the one at UC Davis.

“If he survived, we wouldn’t be even talking about the cost. We’d be saying: ‘That was money well spent,’ ” Scherer said.

“The unfortunate thing, obviously, was that the outcome in this case was horrible,” she said.

“I think people are just uneducated about the cost. … If people actually knew what they were getting – yes, the cost is high, but it’s your only opportunity to save a life,” she said.

Not only are emergency rooms available at all hours of the day, they are staffed by some of the most highly trained – and highly paid – personnel, including surgeons, trauma specialists, registered nurses and others trained specifically for emergency medicine.

“It’s an extraordinary amount of resources at the ready for this patient who we haven’t met yet,” Scherer said.

Emergency crews at the hospital did everything they could to save the young man, Scherer said. He was not dead on arrival.

“When he arrived here, he met our criteria that he might still have a chance of surviving,” she said. “We never want to stop short with a patient with a chance of surviving.”

The federal Department of Health and Human Services estimates that the uninsured accounted for one in five emergency room visits in 2006.

Federal law prohibits hospitals from refusing emergency care to those who need it, regardless of their ability to pay.

“The expectation is that there should be an emergency department that’s open nearby, open 24 hours a day seven days a week,” said Elena Lopez-Gusman of the California chapter of the American College of Emergency Physicians.

“We want it all, we want it now,” she said. “And we don’t want to pay for it.”

A groundbreaking “fair pricing” law enacted three years ago limits how much hospitals can collect from low- and moderate-income consumers who are uninsured or underinsured.

Still, bills can pile up quickly.

“A person without insurance must be wealthy, or so poor as to be not worth pursuing by bill collectors,” said Patrick Johnson, chief executive officer of the California Association of Health Plans.

The House voted 220-215 late Saturday to pass health care legislation intended to bring relief to the 46 million Americans who lack health insurance, including nearly 7 million in California. The measure must be reconciled with the Senate’s version.

There is little debate that the uninsured pose burdens to the country’s health care system. The legislation being considered in the Senate and House would require nearly all Americans to carry health insurance, with the poor getting government subsidies to pay for coverage.

The uninsured are now at a disadvantage because they lack the bargaining power of insurance companies, Shannon said, but consumers should nevertheless attempt to negotiate their bills with doctors and hospitals. “Often hospitals are willing to negotiate the amount with families,” she said. “There’s always room for negotiation.”

Bethesda, MD - A randomized trial comparing two durations of cardiopulmonary resuscitation (CPR) by emergency medical service (EMS) personnel prior to attempting defibrillation was terminated prematurely when no survival difference turned up in a preliminary review of the data [1].

In addition, there was no outcomes difference seen in relation to a separate randomization that tested the effectiveness of a plastic device designed to optimize intrathoracic pressure during CPR, according to a press release from the National Heart, Lung, and Blood Institute (NHLBI).

The NHLBI is one of a number US and Canadian organizations sponsoring the trial, which is run by the 10-center Resuscitation Outcomes Consortium (ROC) and called the Prehospital Resuscitation Using an Impedance Valve and Early versus Delayed (ROC PRIMED) trial.

“After reviewing data on approximately 11 500 study participants, the study’s data and safety monitoring board (DSMB) recommended on October 23 that the NHLBI stop enrollment because sufficient data had been gathered and continuing recruitment was unlikely to change the overall outcomes of the study. The board had no concerns about the safety of any of the interventions tested,” according to the announcement.

The patients had been randomized to defibrillation performed after at least 30 seconds of CPR or after three minutes of CPR.

“The ROC PRIMED study answers a long-standing question in the EMS community over whether it is better to defibrillate earlier or later when trying to resuscitate a patient,” said Dr Ian Stiell (University of Ottawa, ON), principal investigator for the “early-vs-delayed” component of the trial. “Both techniques appear to be equally beneficial.”

In the trial’s other randomization, EMS personnel performed CPR using an “impedance threshold device” (ITD) or a nonworking sham version of it; again, survival was about the same in both groups.

The ITD, for which no manufacturer was listed, is described by the press release (based on words in the trial’s clinicaltrials.gov entry) as “a small, hard plastic device about the size of a fist that is attached to the face mask or breathing tube during CPR administered by EMS providers. The device is designed to improve circulation by enhancing changes in pressures within the chest during CPR.”

Source

1. National Institutes of Health. NHLBI stops enrollment in study on resuscitation methods for cardiac arrest [press release]. November 6, 2009. Available here.

Link:  http://public.nhlbi.nih.gov/newsroom/home/GetPressRelease.aspx?id=2670

NHLBI Stops Enrollment in Study on Resuscitation Methods for Cardiac Arrest

Different CPR Durations Found Equally Successful; CPR Device Does Not Add Benefit

When Dr. Matt Thompson, a pediatrician at the Kids Clinic in Spokane, Wash., found about a month ago that his six children had come down with H1N1, or swine flu, he did not give them the antiviral medication that might have made their sickness a bit shorter.

“They don’t have asthma; they’re not immune-compromised; they don’t work in a health care setting,” Dr. Thompson said. “I don’t tell that story to minimize concern about this virus, but here was a case where my kids weren’t that sick.”

Dr. Thompson is on the conservative side of the question of when to give patients Tamiflu, the most frequently prescribed antiflu medicine, saying he fears creating a resistant strain of the virus.

According to the Centers for Disease Control and Prevention, antivirals should be given in the most severe cases of the flu, or when a patient is in a high-risk group, which includes pregnant women and children under 2.

But that leaves a large gray area for mild or moderate cases or people who have simply been exposed to the virus and want to prevent its taking hold. For the moderately ill, the drug may shorten the duration of symptoms by about a day. But it is expensive, costing about $100 for a 10-pill adult course, and it can have side effects like stomach aches, nausea and, more rarely, confusion and nightmares.

In part because of evolving advice about when to give the drug, there has been some confusion among doctors about whether to prescribe the antivirals for less severe cases.

It comes down to a judgment call for doctors and parents, said Dr. Andrew T. Pavia, chief of the division of pediatric infectious diseases at the University of Utah and chairman of the pandemic influenza task force of the Infectious Diseases Society of America.

“There is no group for whom treatment is inappropriate if they are ill with influenza,” Dr. Pavia said. But, he cautioned, “in mild to moderate illness, treatment has to be begun within 48 hours to have substantial benefit.”

The guidance “leaves room for clinical judgment,” said Dr. Anne Moscona, a professor of pediatrics and microbiology at the Weill Cornell Medical Center. “And it leaves room to decide on a case-by-case basis, thank God, but humans want to be told exactly what to do. If the C.D.C. gave more specific guidance than that, they would be making it up.”

Among those who should definitely take an antiviral are flu patients with symptoms severe enough, or nearly severe enough, for hospitalization, who develop a lower respiratory infection, who have a chronic condition like AIDS or lung disease, or who are pregnant, over 65 or under 2 years old, said Dr. Anthony Fiore, an influenza expert with the disease control centers.

The centers now discourage prescribing Tamiflu to healthy people as a preventive measure except in limited situations — for instance, to people with an underlying condition who have had significant exposure to the virus. Even then, agency guidance says, doctors can wait and treat such people only if symptoms begin to appear. People who live in a household with a flu victim have only a 15 percent to 25 percent chance of becoming infected even without antivirals, Dr. Pavia said.

In Britain, there has been a full-fledged debate about the propriety of prescribing Tamiflu to children, particularly after Andrew Castle, a tennis-player-turned-television presenter, announced that his 16-year-old daughter had “almost died” after receiving the drug (she also had been experiencing flu-like symptoms).

At the time, some healthy children in Britain were given the drug as a guard against getting sick, which also happened in isolated instances in the United States. In one British study, more than half the healthy children who took Tamiflu reported adverse effects.

Some British researchers have warned that the side effects could cause dehydration or other complications, but health officials there have said that those studies were done on people with influenza that is not swine flu, and that for high-risk groups the dangers of H1N1 outweigh the side effects.

Dr. Fiore said that there had been few reports of side effects in the United States, and that only a few cases of drug-resistant H1N1 had been recorded.

Dr. Thompson says he warns parents of the potential downside to Tamiflu, even though the side effects can be difficult to distinguish from the symptoms of flu itself.

“We tell them,” he said, “ ‘It’s medicine; this isn’t without risk. They can have stomachaches; they can act a little goofy. Let us know if that happens.’ And nobody’s called me.”

For any industry, there has to be at least some good news any time Congress votes to expand the market by tens of millions of customers.

But the business world found plenty to complain about Sunday, as it assessed the House bill that would make sweeping changes in the health care system and extend insurance coverage to millions more Americans.

Insurers do not like the provision to create a new government-run insurance program. Drug makers oppose billions of dollars in rebates they would have to give to the government over 10 years. Makers of artificial hips, heart defibrillators and other medical devices are not particularly happy about the proposed 2.5 percent tax on their products.

And employers large and small oppose rules that, for many of them, would make health care coverage — long a job benefit — become a federally mandated obligation.

That is why, as attention now shifts to the Senate, where Democratic leaders are trying to merge two bills into one, virtually every business group with a stake in the outcome will be hoping to strike at least a slightly better deal than they found in the House version.

And they may indeed get a break from the Senate, where the need for Democrats to compromise to win 60 votes may ensure a more business-moderate outcome.

And yet, many analysts said on Sunday that even the House bill was not as bad for business as many in the health care industry might have feared when the overhaul effort began many months ago.

“All industries stand to gain from this legislation,” Steven D. Findlay, senior health policy analyst with Consumers Union in Washington, said in an interview. “They’re going to continue to fight their narrow issues and get the best that they can get. But all of them are aware they stand to gain significant new business and new revenue streams as more Americans get health coverage and money flows into the system for them.”

Of course, new revenue streams apply only to companies in the business of selling medical goods and services. To employers required to provide worker health benefits or else, in many cases, pay some sort of financial penalty, the House legislation offers little to cheer about.

Employer groups complained on Sunday that the House bill would impose insurance obligations while doing little to rein in the medical costs that help drive premiums higher year after year. In fact, those groups argue, the bill’s creation of a government-run insurance program, which may pay doctors and hospitals less than private insurers do, could end up shifting even more medical costs to the private insurance system that employers use.

“This won’t just hurt business, it will hurt millions of workers who have coverage through their employers,” said John J. Castellani, president the Business Roundtable, a group of chief executives of some of the nation’s biggest companies.

And the National Federation of Independent Business, representing many small businesses, said it was furious with the legislation. Susan Eckerly, senior vice president of the federation, attacked mandates, which she called punitive, and “atrocious new taxes.” The legislation, she said, was “a failed opportunity to help small-business owners with their No. 1 problem — skyrocketing health care costs.”

Another group, the Small Business Majority, praised the legislation but said the Senate needed to take more steps to lower costs.

Employers hope the final Senate legislation ends up looking more like the bill the Finance Committee passed, which does not require companies to insure their workers.

Meanwhile, the health insurance industry has been increasingly vocal about the emerging shape of the legislation, and it was sharply critical of the bill that passed on Saturday night.

“The current House legislation fails to bend the health cost curve and breaks the promise that those who like their current coverage can keep it,” Karen M. Ignagni, the chief executive of America’s Health Insurance Plans, the industry trade association, said.

The reference to a broken promise refers, in part, to people enrolled in privately offered Medicare Advantage insurance plans, which would lose federal subsidies under the House bill. Ms. Ignagni warned of cuts that would “force millions of seniors out of the program entirely.”

But the promise reference also refers to the bill’s provision of a new government-run insurance plan that would compete directly with the health plans offered by private insurers. The insurance industry has long opposed such a move and warns that it will eventually force many people with private insurance into the government-run program.

That “public option,” as it is known, was also in the Senate health committee bill approved in July. And the Senate majority leader, Harry Reid, Democrat of Nevada, has also signaled that he intends to include some kind of public plan in whatever Senate legislation is reached.

But some observers say the House legislation is much less of a threat than the industry had feared. While insurers were worried that the government plan would be able to piggyback on the Medicare program in being able to demand lower prices than the private insurers get from doctors and hospitals, the House legislation does not give the government plan the same bargaining power as Medicare.

“The ability of that program to gain incredible market share and have the clout to severely undermine the market is minimized,” Robert Laszewski, president of Health Policy and Strategy Associates, a consulting firm in Alexandria, Va., said in an interview.

Erik Gordon, a business professor and industry analyst at the University of Michigan, said insurers would find it difficult to price their new risks but might not be hurt too much by the competition — considering how many new customers they would have.

The drug industry expected harsh treatment from the House and got it. The bill would require drug makers to pay much more in rebates and discounts than in the $80 billion, 10-year deal that the industry struck in June with the White House and the chairman of the Senate Finance Committee, Max Baucus. The House bill tacked on $60 billion or so in rebates over 10 years, raising the total to around $140 billion.

But the White House and Mr. Baucus have said they will stay with their deal. It remains to be seen whether it survives the melding of Senate bills being directed by Mr. Reid.

“A good critic doesn’t write his review at the end of the first act of a play,” Ken Johnson, senior vice president of the pharmaceutical trade group the Pharmaceutical Research and Manufacturers of America, said in an interview. “We’re hoping the second act is a lot better.”

And while the House legislation allows direct government negotiation of Medicare drug prices — something specifically precluded in the Senate Finance bill — it does not allow Medicare to create a formulary, or list of limited drugs. Mr. Findlay, of Consumers Union, said that largely neutered Medicare’s price-negotiating power, although it would represent a first step down the price-setting path that the industry is certain to fear.

In a victory for the biotechnology drug industry, the House bill would give biotech drugs, which can cost tens of thousands of dollars a year, protection from generic competition for 12 years.

Doctors were left holding a mixed bag. The American Medical Association supported the House legislation. But the doctors’ group did not get its quid pro quo — the restoration of $210 billion in cuts to physicians’ Medicare fees over the next 10 years, which were already scheduled before the current effort. Attempts in the House and Senate to restore those cuts have been set aside at least temporarily because the issue has been seen as a political distraction from the main health care overhaul effort.