Calpers Bets $1 Billion Bush Aide Can Exploit Health Adjustments
Calpers is the sole investor in Health Evolution Partners, a two-year-old private-equity firm in San Francisco run by David Brailer, a first-time money manager and former aide to President George W. Bush. Brailer, 50, coordinated Bushs planning for an electronic health-records network; Calpers is counting on him to earn its members 20 to 30 percent returns.
So far, Brailer has invested more than $120 million in 30 companies, and said he plans to spend $150 million to $200 million a year beginning in 2010. One company aims to save hospitals up to $1.6 million a year each, using a centralized center to read radiology images. Others make electronic chemotherapy pumps that save time and curb treatment errors, run pharmacy chains that blend alternative therapies with traditional drugs, or match consumers to insurance plans based on their medical history.
“What Brailer and Calpers are doing is unique and possibly revolutionary,” said Robert Galvin, chief medical officer of General Electric Co., which buys health care for 152,000 U.S. employees. “We hadnt seen capital going into opportunities to both provide new treatments and also promote efficiency and quality.”
Pain Points
Brailer said his investments focus on areas of the health- care system where waste and inefficiency are rampant. These systemic trouble spots, which Brailer calls “pain points,” cost the U.S. medical system about $700 billion a year, according to the New England Healthcare Institute, a nonprofit policy research organization in Cambridge, Massachusetts.
“We look for big pain points, really big, important pain for really big money,” Brailer said. “The broad cultural trend is for people to take more responsibility for their care.”
Five congressional panels have passed bills to extend health-care coverage to as many as 37 million uninsured Americans, through a mix of taxpayer subsidies and restrictions on insurers. Debate may begin as soon as next week on one measure being crafted by Senate leaders and aides to President Barack Obama.
Americans will have to navigate a more complex system even if Obamas health-care overhaul doesnt pass, Brailer said. Patients and doctors will need help controlling costs without sacrificing the quality of care, which offers an opportunity for companies with technologies that help doctors manage work better or let consumers comparison-shop, he said.
10-Year Trends
“There are 10-year trends that will change decision- making in health care, change drugs, change our entire conception of disease,” said Brailer, a physician who also has a Ph.D. in economics from the University of Pennsylvanias Wharton School. “Legislation wont affect secular trends, so the best way to put it is that were looking past it.”
Some of Obamas proposals build on Brailers work for Bush. Brailer worked as National Coordinator of Health Care Information Technology in the Bush administration from 2004 to 2006. He planned a national electronic medical-record network, which is now being built out with money from Obamas stimulus plan. The network will help control medical inflation and expand coverage, Obama has said.
Brailer, a registered Republican, said he chafed at some Bush administration policies, including its opposition to universal health insurance. He said some party members also privately criticized his work to create a national health- records network, using agreed-upon technical standards coordinated by the government, as interfering in free markets. Congressional Republicans cut his offices budget to zero for fiscal 2005, before the President used his executive authority to reallocate other money for the Department of Health and Human Services to keep the project going, Brailer said.
Brailers White House work was one reason the California pension system bet on someone who had never run a fund, said Calpers portfolio manager Mike Dutton, who helps oversee $42.3 billion in private-equity commitments.
“We wanted deep medical and policy expertise, working with our existing private equity but positioned a little different,” Dutton said. Brailer and his 12-person team at Health Evolution Partners are “more attuned to health-care operations, policy, trends, all the elements in the witches brew,” Dutton said.
Largest Investment
Calperss portfolio lost 23 percent of its value in the year ending June 30, the worst year since its founding in 1932. Its private equity bets dropped 31 percent in value, the system said July 21. It responded by raising the percentage of its $180.9 billion in assets it plans to put into private equity, taking advantage of a time when prices for the investments were low, Dutton said.
The systems investment in Brailer is among the largest it has ever given a first-time private-equity manager. The commitment is bigger than virtually any Calpers has made to firms other than veteran buyout groups such as the Carlyle Group, Blackstone Group LP and Texas Pacific Group Ltd.
“No matter how you look at it, $1 billion is a lot to allocate to someone with no track record,” said Susan Mangiero, a Trumbull, Connecticut-based pension consultant.
Panel Backs Vaccine as Cervical Cancer Alternative
The panel gave a limited endorsement to GlaxoSmithKlines vaccine, Cervarix, which the government licensed last week. Merck & Co. has had the vaccine Gardasil on the market since 2006.
The Advisory Committee on Immunization Practices did not state a preference for one vaccine over the other. But officials noted that while both protect against cervical cancer, the older Merck vaccine also protects against genital warts.
The committee advises a federal public health agency, the Centers for Disease Control and Prevention. The CDC still has to adopt the new recommendation for it to become official advice for U.S. physicians.
Both shots are a three-dose series that target two types of human papillomavirus, believed to be responsible for about 70 percent of cervical cancer cases. HPV is spread through sex.
The vaccine is considered most effective when given to girls at around age 11 or 12, before they become sexually active.
The Merck series costs about $390 and Glaxos costs about $385.
Committee members discussed whether it was appropriate or not to give a subtle nod to one vaccine over the other. To some, the fact that Gardasil also targets two other types of HPV that cause genital warts was an important consideration. Genital warts are not a serious condition, but there are a half million such infections a year, many of them in teens and young adults.
“It has an enormous impact on relationships and self esteem,” said Dr. James Turner, executive director of student health at the University of Virginia. Turner is not a voting member of the committee; he is a liaison to the committee on behalf of the American College Health Association.
Some cost-effectiveness studies have suggested the Glaxo vaccine series should be priced about $100 less than it is, since it doesnt protect against genital warts, said Harrell Chesson, a CDC economist.
But because its slightly less expensive than the Merck vaccine, some patients and doctors may still choose it instead, some experts said.
More women getting the Glaxo vaccine reported pain, redness and swelling at the injection site. Committee members said that could be due to the fact that the vaccine uses a new kind of adjuvant - a chemical compound used to boost the immune system and stretch the vaccines active ingredient, board members said.
CDC officials advised avoiding a statement on preference of one over the other. “We wanted to facilitate a market for both vaccines,” said Dr. Lauri Markowitz, a CDC HPV expert.
Neither vaccine is recommended for pregnant women - a precaution, because the effect of the vaccine on pregnant women and developing fetuses has not been thoroughly studied.
Last week, the Food and Drug Administration approved a new use for Gardasil, to prevent genital warts in boys.
The committee considered whether to recommend routine vaccination of boys against HPV, partly as a strategy to prevent the spread of HPV to girls. Fewer that 40 percent of the girls and young women recommended to get Gardasil have gotten a first shot, and fewer than 20 percent have had the whole three-dose series.
Some physicians who work with adolescents passionately endorsed such a step. But the committee decided not to do that, after hearing experts say such a strategy was not very cost effective, and female HPV vaccination rates are expected to rise without such a step.
But while doctors are not expected to prod families to get their boys vaccinated against HPV, the committee voted that for families who want it for their boys ages 9 to 18, it will be covered by a federal program that pays for vaccinations for children who are uninsured or on Medicaid or meet other criteria.
Glaxo, Human Genome Say Lupus Drug Worked 16 Weeks Into Study
The 865-patient study, known as Bliss-52, found Benlysta was more effective at easing pain, hair loss and skin rash than a placebo, London-based Glaxo and Rockville, Maryland-based Human Genome said in July, when they announced the initial results of the trial.
A full presentation of the data today showed that the improvement was statistically significant and sustained for both the higher dose and lower dose of the drug from week 24 and week 28, respectively, for the duration of the 52-week test. The rate of improvement was “generally consistent” across different groups of patients, according to the data presented today at the Scientific Meeting of the American College of Rheumatology in Philadelphia.
“The main thing were looking for is if the improvement versus placebo was sustained during the year,” Matrix Corporate Capital analyst Navid Malik said in an interview before the announcement. “How fast does this drug kick in?”
The initial findings triggered Human Genome Sciences shares to more than triple on July 20 to their greatest increase since the stock began trading in 1993. The positive overview of the data surprised analysts, who cited disappointing earlier clinical trials and a history of failures for treatments of lupus, which causes the immune system to attack healthy cells.
Peak Sales
Benlysta, known chemically as belimumab, may become the first new drug in 50 years for the autoimmune disease and bring in annual peak sales of $3.5 billion by 2015, according to Panmure Gordon analyst Savvas Neophytou.
Patients in the study received one of two doses of the drug or a placebo. At the lower dose, 51.4 percent of patients showed improved symptoms compared with 43.6 percent who took the placebo, Human Genome said in July. At a higher dose, 57.6 percent had improved symptoms, according to the company.
If Benlysta succeeds in its next trial, Bliss-76, the companies plan to apply for approval to sell it in the U.S., Europe and other countries in the first half of 2010.
The drug may fetch $15,000 to $20,000 a year per patient, based on the history of rheumatoid arthritis and multiple sclerosis treatments, Barry Labinger, Human Genomes chief commercial officer, said on July 20.
Human Genome is conducting Bliss-76, a 76-week trial of Benlysta. Both studies are being conducted under a “special protocol assessment” from the U.S. Food and Drug Administration, which allows a drugmaker to work with the agency to design a late-stage clinical trial with scientific goals that, if met, would be sufficient for marketing approval.
Results of the 76-week trial are expected on Nov. 2.
Merck, Glaxo Prepare For Hpv Vaccine Battle With U.s. Approvals
The Food and Drug Administration authorized sales of Gardasil to prevent genital warts in males ages 9 to 26 and Glaxos Cervarix to prevent cervical cancer in females ages 10 to 25, the companies said today in separate statements. Gardasil has been approved in the U.S. since 2006 and is part of routine vaccinations for school-age girls.
The shots target strains of human papillomavirus, or HPV, a common sexually transmitted virus that can cause cancer and serious infections. Concerns about Cervarixs safety contributed to a regulatory delay in 2007, helping give Merck a head start on the U.S. market. Outside advisers to the FDA on Sept. 9 backed Cervarix as well as Mercks proposal to expand Gardasils market.
“Nearly 17,000 new cases of genital HPV infection, of any type, occur each day in the United States, in both males and females,” said Anna Giuliano, a program leader in risk assessment, detection and intervention at the Moffitt Cancer Center in Tampa, Florida, in Mercks statement.
Broader use could revive Gardasils sales, which declined 5 percent last year to $1.4 billion amid questions about side effects and cost.
Approval in boys may add as much as $200 million to $300 million in annual sales for Merck, of Whitehouse Station, New Jersey, Leerink Swann & Co. analyst Seamus Fernandez said in a research report last month.
Challenge for Glaxo
London-based Glaxo faces a challenge in winning doctors and parents support for Cervarix because Gardasil also protects against genital warts. Cervarix is cleared in 100 countries, including approval today in Japan, and had sales of 125 million pounds ($232 million) last year, about one-sixth as much as Gardasil. The average estimate of three analysts surveyed by Bloomberg calls for sales worth 603 million pounds in 2013.
Demand for both vaccines will likely be affected by recommendations of the Centers for Disease Control and Preventions Advisory Committee on Immunization Practices next week. The 15-member panel that sets national guidelines plans to review Cervarix for girls and Gardasil for boys at an Oct. 21 meeting in Atlanta.
Twenty million Americans are infected with HPV, and most will be able to fight off the infection naturally. This year, an estimated 11,270 new cases of cervical cancer will be diagnosed in the U.S. and 4,070 women will die of the disease, according to the National Cancer Institute, a U.S. agency. About 1 percent of sexually active men in the U.S. will develop genital warts from HPV, according to the CDC.
Three Doses
Gardasil and Cervarix are given in three doses during a six-month period to trigger immune responses that help protect against the two HPV strains responsible for most U.S. cervical cancer cases. Gardasil also protects against two additional strains of HPV that cause 90 percent of genital warts.
It would cost more than $100,000 to vaccinate enough boys with Gardasil to get one year of additional life compared with less than $50,000 for girls, according to a study by Harvard University researchers presented in June. Mercks studies show it would cost $50,000 for boys and girls at a price of $400 per vaccine.
Paying for Shots
Merck will expand a patient rebate and dose replacement program to help cover the cost of the vaccine for 19- to 26- year-old men without health insurance and those with private insurance with partial or no coverage for the shots, according to the companys statement.
Glaxos studies showed a slight increase in miscarriages among young women who took Cervarix. Outside advisers to the FDA who backed the safety and effectiveness of Cervarix said Glaxos plan to register patients and monitor for pregnancies would mitigate any potential risks.
American depositary receipts of Glaxo, each representing two ordinary shares, fell 8 cents to $41.20 at 4:01 p.m. in New York Stock Exchange composite trading. Merck dropped 9 cents to $33.21.
Minn. Pigs May Have Tested Positive For Swine Flu
The samples were taken from pigs shown at the Minnesota State Fair between Aug. 26 and Sept. 1 as part of a university research project. Officials expect results next week to confirm whether the pigs were infected with swine flu virus, also known as H1N1.
The pigs did not show signs of sickness and officials said they likely contracted the virus from some of the nearly 1.8 million people who visited the fair.
The Department of Agricultures veterinary lab in Ames, Iowa, is conducting tests to confirm the results, Agriculture Secretary Tom Vilsack said in a statement.
In a conference call with reporters Friday, Minnesota Agriculture Commissioner Gene Hugoson said officials dont know what happened to the three pigs, but that they probably were sent to slaughter soon after they were shown at the fair, which ended on Labor Day.
“This is not an issue of food safety,” Hugoson said. “Pork products are and continue to be safe to eat.”
Authorities arent planning special measures if the tests confirm the Minnesota pigs had the virus. Hugoson said farmers will continue watching herds for flu symptoms, and slaughterhouse inspectors will continue rejecting pigs showing disease symptoms.
Agriculture officials had long expected the virus to reach domestic pigs this year and have guidelines to slow its spread, said Jeff Bender, director of the University of Minnesotas Center for Animal Health and Food Safety. Herd infections previously were reported in Canada, Australia, Argentina, Ireland, the United Kingdom and Norway. A hog vaccine for the virus is being developed but isnt yet available.
Jose Diez, a USDA veterinary official on Fridays call, said killing pigs to stop the spread of the virus has not been considered. He and other officials said swine usually recover quickly from influenza, and generally are sent to slaughter after theyre healthy and ready for market.
While the chance of a pig infecting a person is considered remote, the animals can act as mixing vessels if they happen to catch two different strains at the same time, allowing mutation of a new one. Officials said theres no evidence thats happened.
Still, the news was clearly unwelcome for the pork industry, which has worked to distance itself from the swine flu virus.
“At the end of the day this is not a big deal,” said Mike Wegner, a spokesman for the National Pork Board. “There is no reason for anyone to be concerned about the safety of pork, either eating or handling.”
Hugoson said its too early to gauge the impact of Fridays news on the industry, which already was struggling with decreasing exports fueled by virus fears.
“Im more concerned with the public fear,” he said. “How many thousands of people die a year from the flu? Most years nobody thinks about it, but now everyone is up in arms because of this H1N1 thing.”
Minnesota is the countrys No. 3 pork-producing state behind Iowa and North Carolina. Minnesota pork producers had 7.3 million hogs and pigs as of Sept. 1, according to USDA figures, while the national inventory was 66.6 million head. The pork industry contributes nearly $1.5 billion and more than 21,000 jobs to the states economy, according to the National Pork Producers Council.
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Associated Press writers Henry C. Jackson and Lauran Neergaard in Washington, and Michael J. Crumb in Des Moines, Iowa, contributed to this report.
Rockefeller Says Democrats Cant Tailor Health Care to Snowe
“We cant sort of hedge and say whats Olympia going to do,” Rockefeller, a West Virginia Democrat, said in an interview on Bloomberg Televisions “Political Capital with Al Hunt,” airing this weekend. “Weve got to decide what we want.”
Snowe, who this week voted for an $829 billion finance committee bill, is the only Republican to back an overhaul plan. Keeping the Maine lawmaker on board as the legislation moves through the Senate may help attract Democrats facing re- election battles and possibly other Republicans.
Senate Majority Leader Harry Reid is trying to craft a final measure that satisfies conflicting demands of his party, such as whether to include a government-run plan.
“If we calculate so finely and so exquisitely, were going to lose our leadership and our momentum,” said Rockefeller, 72. “And right now yes, we did get her vote. As she said yes for this one, it doesnt mean for the next round of votes.”
Rockefeller said Reids legislation would have to include a government plan, or public option, to compete with private companies, such as Indianapolis-based WellPoint Inc.
Counterweight to Malevolence
“There has to be a counterweight to the malevolence of the insurance industry,” Rockefeller said.
Snowe, who is being courted for her support on the health overhaul by the White House, has urged President Barack Obama to drop the public option and instead suggested a so-called trigger that would activate a public option only if private insurers fail to make coverage affordable.
While Rockefeller, a member of the finance committee, voted for the panels plan, he was critical of it because it failed to include the public option.
He and other Democrats say the public option is the best way to lower costs so more uninsured Americans can afford coverage. The finance committee measure instead offers $6 billion in seed money for nonprofit insurance cooperatives.
“There were 30 Democrats that signed a petition asking Harry for a public option,” he said.
Reid is “more likely” to include a version of the public option that requires the government to negotiate rates with providers, as private insurers do, than peg them to the less- expensive Medicare rates, Rockefeller said.
That proposal would be similar to an amendment offered by Senator Chuck Schumer, a New York Democrat, that was rejected by the finance panel.
Rockefeller also said he favors greater checks on insurance companies. He said he would introduce an amendment requiring insurers to spend 85 percent of their revenue on health care for consumers.
“This is in a couple of the House bills,” he said. “I think its a discipline which works very, very well.”
Rockefeller has expressed concern over a plan to impose a tax on insurance companies most-expensive policies because it would affect coal-miners and other working-class Americans. The finance committee bill is the only one of five overhaul versions passed by House and Senate panels to include the levy.
The 40 percent excise tax, which would begin in 2013, would be placed on insurers of employer-sponsored health plans with benefits exceeding $8,000 for individual coverage and $21,000 for families. Thresholds are increased by $1,850 and $5,000 for retirees 55 and older and for employees in union- heavy industries.
Antitrust Exemption
Complaints By Unhappy Lasik Patients Spurred Fda Warning, Study
The Food and Drug Administration said yesterday that recent inspections showed 17 undisclosed Lasik centers had inadequate systems for reporting adverse effects of the surgery. The agency also said it began a long-planned study with the National Eye Institute and the Department of Defense to examine how the laser procedures affect patients quality of life.
More than 12 million people in the U.S. have had Lasik to improve their vision since the procedure was approved in 1995. The American Society of Cataract and Refractive Surgery estimates up to 5 percent of patients arent happy with their results. Some dissatisfied consumers say those numbers are low and have set up Web sites to publicize their complaints.
“There has been a lot of pressure from unhappy patients to do something,” said Barbara Berney, a patient who had a failed Lasik surgery in 2001 and now cant drive at night or see in rooms with fluorescent light. She likens her vision to “looking through wrinkled wax paper.”
Berney is president of the Vision Surgery Rehab Network, which helps patients find other doctors to repair flawed procedures. She also is a patient representative to the FDA panel that will help conduct the quality-of-life study. That study was first announced after an agency hearing in April 2008 where many patients testified about negative Lasik experiences.
Delay Disappointing
“Im disappointed that it hadnt started sooner,” Berney said yesterday in a telephone interview.
Lasik surgeons slice a paper-thin flap from the top of the cornea covering the front of the eye and then reshape it, taking about 10 to 15 minutes per eye. Flattening the cornea fixes nearsightedness while making it steeper corrects farsightedness. Smoothing out irregularities repairs astigmatism, which causes blurry vision. Lasik stands for laser-assisted in situ keratomileusis.
Risks associated with Lasik treatment include partial loss of vision, double vision and dry eye syndrome, according to the FDA Web site.
Operators of Lasik surgery centers include TLC Vision Corp., based in Mississauga, Ontario, and LCA-Vision Inc. of Cincinnati. Advanced Medical Optics, a unit of Abbott Laboratories in Abbott Park, Illinois, and Alcon Inc., a unit of Swiss company Nestle SA, are among companies that make lasers used in the surgery.
FDA Inspections
Six TLC Vision centers were visited by FDA inspectors and four received warning letters, said James B. Tiffany, the companys president and chief operating officer.
James Salz, an ophthalmologist and clinical professor at the University of Southern California who owns a Los Angeles vision surgery center with other doctors, said Lasik is safe and effective for the vast majority of patients though it carries risks like any medical procedure.
The most frequent complication is infection while equipment-related problems are rare, he said.
“This is probably one of the most common elective procedures ever,” he said yesterday in a telephone interview. Until the economy declined last year, the industry was “doing over a million surgeries a year.”
Dissatisfied activists who have started Web sites are a small fraction of laser eye surgery patients, he said.
Pretty Successful
“Several hundred unhappy people out of millions means its a pretty successful procedure,” he said.
The FDA is continuing its inspections of Lasik operators, said Jeffrey Shuren, acting director of the agencys Center for Devices and Radiological Health.
Complaints By Unhappy Lasik Patients Spurred Fda Warning, Study
The Food and Drug Administration said yesterday that recent inspections showed 17 undisclosed Lasik centers had inadequate systems for reporting adverse effects of the surgery. The agency also said it began a long-planned study with the National Eye Institute and the Department of Defense to examine how the laser procedures affect patients quality of life.
More than 12 million people in the U.S. have had Lasik to improve their vision since the procedure was approved in 1995. The American Society of Cataract and Refractive Surgery estimates up to 5 percent of patients arent happy with their results. Some dissatisfied consumers say those numbers are low and have set up Web sites to publicize their complaints.
“There has been a lot of pressure from unhappy patients to do something,” said Barbara Berney, a patient who had a failed Lasik surgery in 2001 and now cant drive at night or see in rooms with fluorescent light. She likens her vision to “looking through wrinkled wax paper.”
Berney is president of the Vision Surgery Rehab Network, which helps patients find other doctors to repair flawed procedures. She also is a patient representative to the FDA panel that will help conduct the quality-of-life study. That study was first announced after an agency hearing in April 2008 where many patients testified about negative Lasik experiences.
Delay Disappointing
“Im disappointed that it hadnt started sooner,” Berney said yesterday in a telephone interview.
Lasik surgeons slice a paper-thin flap from the top of the cornea covering the front of the eye and then reshape it, taking about 10 to 15 minutes per eye. Flattening the cornea fixes nearsightedness while making it steeper corrects farsightedness. Smoothing out irregularities repairs astigmatism, which causes blurry vision. Lasik stands for laser-assisted in situ keratomileusis.
Risks associated with Lasik treatment include partial loss of vision, double vision and dry eye syndrome, according to the FDA Web site.
Operators of Lasik surgery centers include TLC Vision Corp., based in Mississauga, Ontario, and LCA-Vision Inc. of Cincinnati. Advanced Medical Optics, a unit of Abbott Laboratories in Abbott Park, Illinois, and Alcon Inc., a unit of Swiss company Nestle SA, are among companies that make lasers used in the surgery.
FDA Inspections
Six TLC Vision centers were visited by FDA inspectors and four received warning letters, said James B. Tiffany, the companys president and chief operating officer.
James Salz, an ophthalmologist and clinical professor at the University of Southern California who owns a Los Angeles vision surgery center with other doctors, said Lasik is safe and effective for the vast majority of patients though it carries risks like any medical procedure.
The most frequent complication is infection while equipment-related problems are rare, he said.
“This is probably one of the most common elective procedures ever,” he said yesterday in a telephone interview. Until the economy declined last year, the industry was “doing over a million surgeries a year.”
Dissatisfied activists who have started Web sites are a small fraction of laser eye surgery patients, he said.
Pretty Successful
“Several hundred unhappy people out of millions means its a pretty successful procedure,” he said.
The FDA is continuing its inspections of Lasik operators, said Jeffrey Shuren, acting director of the agencys Center for Devices and Radiological Health.
Giving Babies Tylenol May Blunt Vaccines Effects
It is the first major study to tie reduced immunity to the use of fever-lowering medicines. Although the effect was small and the vast majority of kids still got enough protection from vaccines, the results make “a compelling case” against routinely giving Tylenol right after vaccination, say doctors from the U.S. Centers for Disease Control and Prevention.
They wrote an editorial accompanying the study, published in Fridays issue of the British medical journal, Lancet.
The study only looked at preventive use of Tylenol - not whether it is OK to use after a fever develops.
Tylenol or its generic twin, acetaminophen, is widely recommended as a painkiller for babies. Many parents give it right before or after a shot to prevent fever and fussiness, and some doctors recommend this. The CDCs vaccine advisory panel says it is a reasonable thing to do for children at high risk of seizures, which can be triggered by fevers.
However, fever after a vaccine isnt necessarily bad - its a natural part of the bodys response. Curbing fever, especially the first time a baby gets a vaccine, also seems to curb the immune response and the amount of protective antibodies that are made, the new study found.
It was led by military and government scientists in the Czech Republic and was done at 10 medical centers in that Eastern European country. It involved 459 healthy infants, 9 to 16 weeks old, who were getting vaccines against polio, pneumonia, meningitis, whooping cough, tetanus, hepatitis and other childhood diseases.
Half were given three doses of Calpol, or paracetamol - a Tylenol-like brand sold in Europe - during the first day after vaccination. The others were given nothing besides the vaccines.
Babies given the painkiller were significantly less likely to develop a fever - 42 percent versus 66 percent of the others - and very few in either group developed a high one.
However, lower rates of protective antibody levels from several vaccines were seen in the group given the drug. Levels remained significantly lower in this group after booster vaccines, given when the babies were 12 to 15 months old.
Next, the researchers looked at 10 other vaccine studies and found some supporting evidence that using Tylenol to prevent fevers at the time of vaccination may curb immune system response rates. The same may not be true of using the drug to treat fevers after they develop.
The research was sponsored by Belgium-based GlaxoSmithKline Biologicals, which makes all the vaccines used in the study. Some authors have financial ties to the company, including owning stock in it, and Glaxo had a role in reporting the results.
Even with the fever-lowering drugs, more than 90 percent of children in the Czech study achieved protection from the various vaccines after the booster dose, so the effect of lower levels of antibodies on any individual might be small, Dr. Robert Chen and two other CDC doctors wrote in an editorial.
Its not known if Tylenol or other painkillers might reduce vaccine response in adults, but they are less likely to develop a fever after vaccination or to be so bothered by it, said Dr. John Treanor, a vaccine specialist at the University of Rochester Medical Center in Rochester, N.Y., who had no role in the study.
Tylenol is the only member of the family of over-the-counter pain relievers that is not a nonsteroidal anti-inflammatory drug, or NSAID.
“Theres been speculation for a long time that the use of NSAIDs might have an effect” on antibody production after vaccination, but this is far from proved, Treanor said.
Given that so few children develop high fevers after vaccines, skipping the meds unless fever develops “may be the way to go,” he said.
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Swine Flu 6 Months Later: Relief, But Winter Looms
Now that the initial scare over the swine flu has subsided, health officials warn we are not out of danger yet.
“Weve got many, many months ahead of us where we dont know what will happen and we need to take the best steps we can to protect ourselves,” Dr. Tom Frieden, director of the Centers for Disease Control and Prevention, said last week. “Our biggest concern is that the virus could change, mutate to become more deadly.”
With winter approaching, another fear is a one-two punch in which a resurgent swine flu batters young people before the vaccine is widely available, while the ordinary flu strikes the elderly. Also, emergency doctors are worried about the strain on ERs and hospitals.
To date, swine flu has hospitalized hundreds of thousands of people around the world and killed at least 4,500, including at least 600 in the United States. At least 81 U.S. children have died, including many who had no underlying health problems
The CDC was the first to identify the new flu. It was on April 15 and 17 that the agency determined that nasal samples from two children in Southern California contained a swine flu virus that had never been seen before. It was found to contain bits of bird and human flu.
At first the cases represented more of a scientific puzzle than a public health threat. The two children recovered, but investigators were perplexed by how they got it, since the two kids had not been in contact with each other or with pigs.
But within a week, the situation became more dramatic, when testing linked the two children and a handful of subsequent U.S. cases to hundreds of illnesses in Mexico City. Mexican authorities closed schools, museums, libraries and theaters to stop the spread of the disease as initial reports suggested it was killing as many as one in 15 of those infected - a horrifying death rate more than three times higher than the terrible flu pandemic of 1918-19.
A series of bad and good news followed. First, the bad: It quickly became clear that the virus was spreading not only in Mexico and border regions of the United States, but around the world. As health officials had long surmised, international air travel provided a rapid path to world contagion.
Whats more, studies indicated the millions of seasonal flu shots administered the previous winter offered no protection against the unusual new virus.
But then came some good news:
-While the flu vaccine was no help, the antiviral medication Tamiflu reduced the severity of illness if taken right after symptoms appeared.
-People 55 and older, who suffer and die the most from seasonal flu each year, seemed mostly to be spared by the new virus. Scientists credited some immunity that they had perhaps picked up from exposure decades ago to a similar-enough virus or vaccine.
In the United States, some of the initial response plans for the new swine flu, an H1N1 strain, envisioned “people dropping dead in the streets,” recalled Dr. Beth Bell, a CDC epidemiologist who has been a leader in the agencys response.
The disease kept spreading, and eventually the World Health Organization declared it the first global flu pandemic in 40 years. But even before then, U.S. health officials had downgraded some of their prevention advice, such as the call for schools to shut down for two weeks if any students became infected.
“Overall, its a fairly typical flu virus,” Richard Webby, a prominent researcher at St. Jude Childrens Research Hospital in Memphis, says now.
But this story is not over yet. There are still important unanswered questions.
Most health experts believe swine flu hits children and pregnant women harder than seasonal flu, but its not clear how much harder because officials dont know exactly how many have caught the swine flu and had only mild symptoms.