UNICEF discloses vaccine prices for 1st time (AP)

UNICEF is for the first time publicizing what drugmakers charge it for vaccines, as the world's biggest buyer of lifesaving immunizations aims to spark price competition in the face of rising costs.

On Friday, UNICEF posted on its website the actual prices that it has paid individual drugmakers for 16 vaccines purchased over the last decade. It's a move that a few Western pharmaceutical companies don't support. Novartis AG and Merck & Co., which only sells one of its many children's vaccines to UNICEF, both declined to have their prices published.

UNICEF said it will continue to disclose pricing of future vaccine deals, with the hope that the transparency will push drugmakers to cut prices and thus allow the organization to vaccinate more children and save more lives.

"Transparency will also help foster a competitive, diverse supplier base," said Shanelle Hall, director of UNICEF's supply division. She noted that it also will help UNICEF's partners and those governments that buy vaccines on their own to make more informed decisions in price negotiations with drugmakers.

UNICEF last year spent $757 million to provide 2.5 billion doses of vaccines to 99 countries, reaching an estimated 58 percent of the world's children.

Its price list shows significant disparity, with Western drugmakers often charging UNICEF double what companies in India and Indonesia do. Just as striking is the steady rise in prices in the last decade, with the cost of vaccines against measles, polio and tetanus roughly doubling between 2001 and 2010. Prices of a few vaccines have remained flat or declined as additional competitors entered the market.

There's also a huge spread in prices among various vaccines.

As might be expected, shots that have been around for some time and those vaccines made by multiple companies cost just pennies per dose, such as tetanus and tuberculosis shots and oral polio vaccine. But a combination shot for immunization against diptheria, tetanus, whooping cough, hepatitis B and haemophilus influenza can run UNICEF $3 or more per dose. The dual vaccine against 10 or more strains of pneumococcal disease, which causes ear infections and meningitis, costs $3.50 a shot. And some of the vaccines require more than one booster shot, adding to the cost.

The cost is partly justified by the complex manufacturing process used to make combination vaccines. And UNICEF still pays far less than the $71 and $114 per dose, respectively, that is charged in the U.S. for those two vaccines. But given that the organization's mission is to immunize entire populations of at-risk children, any savings means more can be vaccinated.

British drugmaker GlaxoSmithKline PLC said in a statement that it "always offers UNICEF our vaccines at our lowest price as they are targeted at the people who need them the most, but are least able to pay. We welcome UNICEF's move to publish retrospective prices for tenders and hope that this will help inform decisions for future vaccine procurement." Messages left with other Western vaccine makers seeking comment weren't immediately returned Saturday afternoon.

Daniel Berman, deputy director of the Doctors Without Borders Campaign for Essential Medicines, called the new price disclosures "a real step forward."

"By getting access to these prices, buyers will be able to take advantage of the increasing capacity of emerging countries to develop and produce quality vaccines at significantly lower costs," he said in a statement.

He added that GAVI, the Global Alliance for Vaccines and Immunization, "should flex its purchasing muscles to encourage manufacturers" to produce vaccines that don't require refrigeration and can be administered through patches or liquids, rather than needles.

GAVI, which is supported by contributions from developed nations and the Bill & Melinda Gates Foundation, is the primary funder of vaccines purchased by UNICEF. Helen Evans, interim CEO of the GAVI Alliance, said in a joint statement with UNICEF that GAVI "strongly believes in timely, transparent and accurate information on pricing."

Many of the largest global pharmaceutical companies � most recently Johnson & Johnson � have jumped into the vaccine business in recent years to diversify revenue as many of their blockbuster pills are facing generic competition. Vaccines are all but immune from generic competition in developed countries, and some newer shots, such as Pfizer Inc.'s Prevnar pneumococcal vaccine, now bring in billions of dollars in revenue each year.

Those big companies are looking to less-developed countries for future sales growth, and vaccines against crippling and deadly childhood diseases are cost-effective purchases for countries with small health budgets.

AIDS groups and advocates for affordable health care in developing countries have campaigned for years for big pharmaceutical companies to sell their patented medicines to those countries at drastically reduced prices, or to allow generic drug makers in countries such as India to do so. They've had some success, so UNICEF's new price plan is a logical strategy.

UNICEF's Hall said the organization hopes to expand the transparency initiative to other essential products that it buys for children. UNICEF supports child health and nutrition, good water and sanitation, and quality basic education for boys and girls across the globe.

Powered By WizardRSS.com | Full Text RSS Feed | Amazon Plugin | Settlement Statement | WordPress Tutorials

UNAIDS to Vatican: Pope's HIV-condom view helpful (AP)

VATICAN CITY � The head of the U.N. AIDS agency told a Vatican conference on AIDS Saturday that Pope Benedict XVI's comments about the use of condoms in preventing HIV transmission had opened new prospects for dialogue with the U.N.

Dr. Michel Sidibe, executive director of UNAIDS, said it will help strengthen the fight for greater access to treatment for those afflicted. Sidibe said Benedict's views were important, even if differences remain between the U.N. and Catholic Church.

The U.N. says condoms should be an integral part of HIV prevention programs; the Vatican opposes condoms as part of its overall opposition to artificial contraception.

But Benedict said last year that a male prostitute who intends to use a condom might be taking a first step toward greater responsibility by looking out for the welfare of his partner, even if condoms aren't a moral solution.

"This is very important," Sidibe told the conference. "This has helped me to understand his position better and has opened up a new space for dialogue."

While Benedict's comments in the book "Light of the World" drew near-universal praise within the AIDS community, conservative Catholics insisted he wasn't altering church teaching and that the church's ban on condoms remained. After three attempts at clarification, the Vatican eventually issued a definitive ruling from the Congregation for the Doctrine of the Faith saying the pope in no way was changing church teaching.

Nevertheless, the impression left at least within the AIDS community was that he had made an opening � and Sidibe latched onto that in his comments Saturday.

Sidibe said previously the AIDS community and Catholic Church were "talking over" one another and often held opposing views about how to deal with the AIDS crisis. But he said Benedict's words had opened a new possibility for working together, particularly in agitating for greater access to anti-retroviral treatments for the world's poorest patients.

"Yes, there are areas where we disagree and we must continue to listen, to reflect and to talk together about them. But there are many more areas where we share common cause," Sidibe said.

Increasing access to treatment has become an even greater rallying call following the recently published results of a nine-nation study showing that HIV-positive patients who received early treatment were 96 percent less likely to spread the virus to their uninfected partners.

Sidibe called the research a "game-changer" in the fight against AIDS and Vatican officials said it gave new hope to couples where one partner is HIV-positive and want to have children.

While there had never been an official Vatican policy about condoms and HIV, some Vatican officials had previously insisted that condoms not only don't help fight HIV transmission but make it worse because they gave users a false sense of security. Some claimed the HIV virus could easily pass through the condom's latex barrier.

Benedict himself drew the wrath of UNAIDS and several European countries when, en route to Africa in 2009, he told reporters that the AIDS problem couldn't be resolved by distributing condoms. "On the contrary, it increases the problem," he said then.

The comments drew fierce criticism in Africa, where an estimated 22.4 million people are infected with HIV, two-thirds of the global total.

With his revised comments, the Vatican debate seems to have changed ever so slightly. The fact that Sidibe was even invited to speak at the Vatican was significant; usually only like-minded outsiders are invited to speak at Holy See conferences.

That said, the Vatican officials present made clear that condoms weren't the answer to fighting AIDS and that changing sexual behavior to emphasize marital fidelity was the best answer. Monsignor Zygmunt Zimowski, head of the Pontifical Council for Health Care Workers which hosted the meeting, didn't even refer to Benedict in his keynote speech.

Rather, he cited Pope John Paul II on three separate occasions, quoting him as speaking about the "crisis of values" that was behind the AIDS crisis.

Powered By WizardRSS.com | Full Text RSS Feed | Amazon Plugin | Settlement Statement | WordPress Tutorials

Is a repeat flu shot needed? This fall, maybe not (AP)

ATLANTA � Vaccine makers said this month they plan to make a record amount of flu vaccine for this fall and winter � enough for more than half the population. It's just not clear all those people will need it.

This year's flu shot will be a duplicate of last year's because the same flu strains are still circulating. So some experts say young, healthy people may have enough protection from last season's vaccine to skip getting it again this fall.

"For healthy people, it can't be said to be necessary," said Dr. Robert Couch, a flu vaccine expert at the Baylor College of Medicine.

Still, government health officials are urging nearly everyone to get this fall's flu shot. They say a vaccine's protection can fade significantly after several months � especially for those who are frail and elderly.

Two weeks ago, five vaccine manufacturers announced plans to make between 166 million and 173 million doses for the coming season. That's at least 6 million more than the maximum ever produced.

It's quite a bet, considering the flu season that just ended was somewhat mild. But vaccine makers think it's a good one.

"We are confident in our 2011 projections for the U.S. market. They are based on ordering patterns as well as what's known about the epidemiology of the flu," said Liz Power, spokeswoman for Novartis Vaccines, one of the main manufacturers of flu shots for the United States.

Demand for vaccine has been growing in the U.S. More than 40 percent of the population was vaccinated against the flu in the last 10 months, the second year in a row vaccinations were at so high a level. Previously, only about a third of Americans were getting vaccinated, according to government figures.

The Centers for Disease Control and Prevention had something to do with that. Last year, the CDC began recommending an annual flu vaccination for everyone except babies younger than 6 months and those with egg allergies or other unusual conditions. That probably helped boost vaccination rates, along with the appearance in 2009 of swine flu, which was more dangerous than other strains to young people.

The CDC also is buying about 18 million of the 2011-2012 doses, primarily for government vaccine programs for children.

Other countries, even in Europe, do not promote flu shots as aggressively as the United States. Seasonal flu can be deadly, especially for the elderly and people with weak immune systems.

The biggest selling point for an annual shot, usually, is that flu strains are usually different each year. But this year, that argument goes out the window. The last time flu strains didn't change was during the winters of 2002-2004.

But there are other arguments for getting a flu shot. For one thing, the vaccine is only about 70 percent effective to begin with � and that's in a good year, when the vaccine is well-calibrated to circulating strains. That's not good enough to protect the U.S. population for one year, let alone two, CDC officials say.

But the main argument now is one of waning immunity. CDC officials believe that a year after someone gets the flu shot, antibody levels � an indicator of immunity � can fall by two-thirds or more. Some key studies indicate the resulting levels are not strong enough to be protective, said Nancy Cox, head of the CDC's chief of the CDC's flu division.

However, other studies are less clear. Some have suggested that a flu vaccination can provide sufficient protection for more than a year in adults, and perhaps two or three years in children.

Cox said some of those conflicting studies are outdated and flawed, and noted more recent U.S. studies that found large drops in children's immunity in just one year.

Other researchers sound less decided about which studies were right and which were wrong on this question.

"Nobody really, really knows," said Dr. John Treanor, a flu vaccine researcher at the University of Rochester School of Medicine.

But even if the question is unsettled, Treanor and other experts said the CDC's position is probably the wisest course.

"The bottom line is, with our current knowledge, we believe it is better to be re-vaccinated. And getting another shot is certainly not going to harm you," said Dr. Arnold Monto, an esteemed University of Michigan flu expert.

Powered By WizardRSS.com | Full Text RSS Feed | Amazon Plugin | Settlement Statement | WordPress Tutorials

NIH stops study of niacin to prevent heart attacks (AP)

WASHINGTON � A drug that boosts people's good cholesterol didn't go on to prevent heart attacks or strokes, leading U.S. officials to abruptly halt a major study Thursday.

The disappointing findings involve super-strength niacin, a type of B vitamin that many doctors already prescribe as potential heart protection. The failed study marks the latest setback in the quest to harness good cholesterol to fight the bad kind.

"This sends us a bit back to the drawing board," said Dr. Susan Shurin, cardiovascular chief at the National Institutes of Health.

The bad kind of cholesterol, called LDL, is the main source of artery clogs. Popular statin drugs, sold under such names as Zocor and Lipitor, plus generic forms, are mainstays in lowering LDL. Yet many statin users still have heart attacks, because LDL isn't the whole story.

HDL cholesterol, the good kind, helps fight artery build-up by carrying fats to the liver to be disposed of. That's one reason that people with too little HDL also are at risk of heart disease. So scientists are testing whether giving HDL-boosting drugs in addition to statins could offer heart patients extra protection.

The newest study tested Abbott Laboratories' Niaspan, an extended-release form of niacin that is a far higher dose than is found in dietary supplements. The drug has been sold for years, and previous studies have shown it does boost HDL levels. But no one knew if that translated into fewer heart attacks.

Researchers enrolled more than 3,400 statin users in the U.S. and Canada who had stable heart disease and well-controlled LDL, but were at risk because of low HDL levels and too much of a different bad fat, triglycerides. They were given either Niaspan or a dummy pill to add to their daily medicine.

As expected, the Niaspan users saw their HDL levels rise and their levels of risky triglycerides drop more than people who took a statin alone. But the combination treatment didn't reduce heart attacks, strokes or the need for artery-clearing procedures such as angioplasty, the NIH said.

That finding "is unexpected and a striking contrast to the results of previous trials," said Dr. Jeffrey Probstfield of the University of Washington, who helped lead the study.

But it led the NIH to stop the study 18 months ahead of schedule.

Adding to the decision was a small increase in strokes in the high-dose niacin users � 28 among those 1,718 people given Niaspan, compared with 12 among the 1,696 placebo users. The NIH said it wasn't clear if that small difference was merely a coincidence; previous studies have shown no stroke risk from niacin. In fact, some of the strokes occurred after the Niaspan users quit taking that drug.

What's the message for heart patients?

Statin users who have very low LDL levels, like those in this study, don't need an extra prescription for niacin, said Dr. Robert Eckel, a University of Colorado cardiologist and American Heart Association spokesman who wasn't involved with the study.

But it's not clear if niacin would have any effect on people at higher risk or those who don't have a diagnosis of heart disease yet but take niacin as a preventive, said study co-leader Dr. William Boden of the University at Buffalo.

"We can't generalize these findings ... to patients that we didn't study," he said.

Eckel said it's "really hard to envision exactly what's going to happen in physicians' offices" in coming weeks as they discuss niacin with patients. The NIH urged people not to stop high-dose niacin without consulting a doctor.

Nor do the findings end hope that raising HDL eventually will pan out, Eckel said. While two other drugs have failed as well, he is closely watching some much stronger HDL-boosters, including a Merck & Co. drug named anacetrapib, that are under development.

___

Online:

Background on niacin: http://tinyurl.com/3vgablq

Niaspan: http://www.niaspan.com/

Powered By WizardRSS.com | Full Text RSS Feed | Amazon Plugin | Settlement Statement | WordPress Tutorials

UN puts off destroying last smallpox viruses (AP)

GENEVA � Health ministers from around the world agreed Tuesday to put off setting a deadline to destroy the last known stockpiles of the smallpox virus for three more years, rejecting a U.S. plan that had called for a five-year delay.

After two days of heated debate, the 193-nation World Health Assembly agreed by consensus to a compromise that calls for another review in 2014.

The United States had proposed a five-year extension to destroying the U.S. and Russian stockpiles, arguing that more research is needed and the stockpiles could help prevent one of the world's deadliest diseases from being used as a biological weapon.

But other ministers at the decision-making assembly of the World Health Organization said they saw little reason to retain the stockpiles, and objected to the delay in destroying them.

Dr. Nils Daulaire, head of the U.S. Office of Global Health Affairs and the chief American delegate to the assembly, expressed some disappointment but said the compromise was satisfactory.

"Three years is a reasonable time period in terms of the next review," he told reporters. "Obviously during that time period, we expect there will be meaningful progress in the research on anti-virals and vaccines and diagnostics."

The assembly declared smallpox officially eradicated in 1980, and the U.N. health agency has been discussing whether to destroy the virus since 1986.

Then in 2007, the assembly asked WHO's director-general to oversee a major review of the situation so that the 2011 assembly could agree on when to destroy the last known stockpiles.

WHO officials said in a statement that the assembly "strongly reaffirmed the decision of previous assemblies that the remaining stock of smallpox (variola) virus should be destroyed when crucial research based on the virus has been completed."

But the assembly won't again have to grapple with a decision over exactly when to do that until three years from now.

The assembly, like the U.N. General Assembly, is a world forum whose decisions aren't legally binding but do carry moral weight. So even if the assembly finally sets a date for destroying the stockpiles, it can't force the United States and Russia to comply.

Powered By WizardRSS.com | Full Text RSS Feed | Amazon Plugin | Settlement Statement | WordPress Tutorials

Teen bond overcomes girl's heart transplant fear (AP)

WASHINGTON � Courtney Montgomery's heart was failing fast, but the 16-year-old furiously refused when her doctors, and her mother, urged a transplant.

Previous surgeries hadn't helped and the North Carolina girl didn't believe this scarier operation would either. It would take another teen who's thriving with a new heart to change her mind.

"I was like, `No, I don't want this. If I'm going to die, I'm going to die,'" Courtney recalls. "Now I look back, I realize I wasn't thinking the way I should have been."

Teenagers can add complex psychology to organ transplantation: Even though they're minors, they need to be on board with a transplant because it's up to them to take care of their new organ. Depression, anger and normal adolescent pangs � that tug-of-war with parents, trying to fit in � can interfere. It's not just a question of having the transplant, but how motivated they are to stick with anti-rejection treatment for years to come.

"The decision-making process that we go through, in terms of our ability to weigh factors in a rational sense, probably doesn't mature until you're in your late 20s," says Dr. Robert Jaquiss, pediatric heart surgery chief at Duke University Medical Center, where Courtney eventually was transplanted. "It introduces an enormous level of complexity to caring for these kids."

Then there's the sense of isolation. Far fewer adolescents than older adults undergo an organ transplant, making it unlikely that a teen has ever seen how fast their peers can bounce back.

Between 700 and 800 adolescents, ages 11 to 17, have some type of organ transplant each year. That's nearly 40 percent of the roughly 2,000 annual pediatric transplants. Teens fare better than any other age � child or adult � the first year after surgery. But long-term, adolescents do a bit worse than younger children, and the reason isn't biological, Jaquiss says. It's that teens, and young adults as well, tend to start slipping on all the required follow-up care.

One study found up to 40 percent of adolescent liver recipients eventually miss medication doses or checkups. It can be normal development, as teens start sleeping late and simply forgetting morning doses, or sometimes it's rebelliousness. Then there are medication side effects that Jaquiss says can be especially troubling to this image-conscious age group: weight gain, acne and unwanted hair growth.

And at the Children's Hospital of Pittsburgh, separate research with heart recipients has found chronological age is unrelated to "medical maturity." Young patients who had a hard time accepting a transplant as normal and who avoided family discussion of problems, for example, were less likely to stick with care.

Courtney's mother, Michelle Mescall, said that when the medical center advised that her daughter needed to agree to go on the transplant waiting list, "I said, `Well she's a minor, what do you mean? I'm going to make this decision.' I was just floored that it was now her decision."

Legally, the hospital could have proceeded with mom's OK. But clinical social worker Shani Foy-Watson says if that happened, Courtney's resentment could have torpedoed her recovery, setting up just those kinds of problems with follow-up care.

Foy-Watson says it's not unusual for kids who've lived with serious illness for years to have a hard time imagining normalcy � at the same age when it's normal to seek more independence from their terrified parents.

Courtney, of Asheville, N.C., was diagnosed at age 8 with hypertrophic cardiomyopathy, a thickened and hard-to-pump heart that's the leading cause of sudden death in young athletes. Her mother tried to shield her from doctors' death warnings, but says Courtney became anxious and depressed early on.

She had a defibrillator implanted and later heart surgery that offered only temporary relief, fueling resentment of her mother's medical choices. Courtney eventually had to give up her beloved cheerleading, and last year required home-schooling.

As a few weeks passed with Courtney still resisting a transplant, the social worker tried a new tack: A 17-year-old football player had received a new heart at Duke a few months earlier because of the same condition, and already was back at school in Raleigh. Would he meet with Courtney?

It was a gamble. No one told Josh Winstead, now 18, the reason for the meeting, and they might not have hit it off. But they did, and Courtney immediately changed her mind.

"I guess me doing what I do, being a kid, helped out the most," says Winstead, who took Courtney to his prom a week before her surgery. "It was more just showing her how normal my life is."

You hear all the advice from friends and doctors, Courtney says, "but it doesn't hit home like when Josh would tell me, `I have the same scars you do and this is how it felt and this is how I feel now.'"

She got her new heart last month. She's recovering well and exercising in hopes of getting back to the cheerleading squad.

Her mother's helping Courtney learn to handle a whopping 33 pills a day, and is proud of how her daughter has rallied: "I'm just dealing with how to let go and let her fly, but also be the parent of a 16-year-old."

___

EDITOR'S NOTE � Lauran Neergaard covers health and medical issues for The Associated Press in Washington.

Powered By WizardRSS.com | Full Text RSS Feed | Amazon Plugin | Settlement Statement | WordPress Tutorials