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Rabu, 09 November 2011

Study: H1N1 Can Be Deadly Even for Healthy Kids

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Flu prevention is important for everyone, but here's another reason to make sure to get vaccinated: in a study of childhood flu deaths from the 2009 H1N1 pandemic, researchers found that otherwise healthy kids can succumb to the virus, particularly if they've already got an increasingly common bacterial infection.

The infection, methicillin-resistant Staphylococcus aureus (MRSA), sent previously healthy kids to the hospital and increased their risk of death from flu to eight times that of MRSA-free children, according to research published Monday in Pediatrics. MRSA, which is becoming increasingly resistant to antibiotics, can cause skin infections, invade surgical wounds and wreak havoc internally.

"There's more risk for MRSA to become invasive in the presence of flu or other viruses," said lead researcher Dr. Adrienne Randolph of the Division of Critical Care Medicine at Children's Hospital Boston in a statement. "These deaths in co-infected children are a warning sign."

MORE: CDC: 115 Kids Died of Flu Last Season, Most Weren't Vaccinated

The flu virus suppresses even robust immune systems, making the body more vulnerable to infection. And in children, who typically withstand exposure to massive quantities of bacteria, a dip in immunity may be the difference between a manageable bacterial colony and an invasive bacterial disease.

Randolph and her team examined the medical records of 838 children whose average age was 6; they were all admitted to intensive-care units with H1N1 flu virus during the 2009-2010 flu pandemic. Of the 75 children who died, most had at least one preexisting condition such as asthma or weakened immune systems that further compromised their ability to fight the flu. But researchers were particularly curious what contributed to the critical illnesses faced by the 251 children who were considered otherwise healthy.

They found that MRSA and its more common cousin, S. aureus, was to blame: it upped the risk of death for previously healthy kids who contracted H1N1, which is alarming because MRSA infections — though rare — are on the rise. A recent study found that more than 2% of all 2008 pediatric hospital admissions were due to MRSA — up from only .2% in 1999.

MORE: 1 in 10 Parents Skip or Delay Vaccines

"There's a nice message here about vaccines: that even otherwise healthy children are still at risk, and they are at risk of death,” Dr. Lisa Saiman, a professor of clinical pediatrics at Columbia University, told The New York Times. “These findings provide further support for the recent recommendations by the C.D.C. to immunize all eligible people."

Everyone older than 6 months should get vaccinated, recommends the Centers for Disease Control and Prevention (this year's seasonal vaccine also guards against 2009 H1N1, which hasn't mutated significantly since then). Roll up your sleeve — no excuses.

Meredith Melnick is a reporter at TIME. Find her on Twitter at @MeredithCM. You can also continue the discussion on TIME's Facebook page and on Twitter at @TIME.

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Pancreatic cancer 4th most deadly, treatments few

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FILE - In this Jan. 6, 2004 file photo, Apple CEO Steve Jobs displays the iPod mini at the Macworld Conference and Expo in San Francisco. Jobs, the Apple founder and former CEO who invented and masterfully marketed ever-sleeker gadgets that transformed everyday technology, from the personal computer to the iPod and iPhone, died Wednesday. He was 56. (AP Photo/Marcio Jose Sanchez, File)

FILE - In this April 24, 2009 file photo, Dr. Ralph Steinman of Rockefeller University speaks during a news conference in Albany, N.Y. Rockefeller University in New York says Ralph Steinman, co-winner of this year's Nobel Prize in medicine, has died. The university says Steinman was diagnosed with pancreatic cancer four years ago and died on Sept. 30, three days before the announcement. (AP Photo/Mike Groll, File)

FILE - In this Jan. 15, 2008, file photo, Apple CEO Steve Jobs holds up the new MacBook Air after giving the keynote address at the Apple MacWorld Conference in San Francisco. Apple on Wednesday, Oct. 5, 2011 said Jobs has died. He was 56. (AP Photo/Jeff Chiu, File)

Fred Velez, of San Francisco, holds an Apple iPhone displaying an early picture of Steve Jobs, as he and others gather outside an Apple store in San Francisco on Wednesday, Oct. 5, 2011. Jobs, the Apple founder and former CEO who invented and masterfully marketed ever-sleeker gadgets that transformed everyday technology, from the personal computer to the iPod and iPhone, died Wednesday. He was 56. Apple announced his death without giving a specific cause. He died peacefully, according to a statement from family members who said they were present. (AP Photo/Darryl Bush)eval("var currentItemd57851005a80479aaeeb90a12c70b9ff = 1;");eval("var nextd57851005a80479aaeeb90a12c70b9ff = 0;");eval("var previousd57851005a80479aaeeb90a12c70b9ff = 0;");

Pancreatic cancer is notoriously lethal — there are almost as many deaths from it each year as there are new cases. The deaths this week of Apple founder Steve Jobs and Nobelist Ralph Steinman bring unusual attention to this less-well-known type of cancer.

Jobs lived more than seven years after being diagnosed with a neuroendocrine tumor — a less common, slower-growing and more treatable type of pancreatic cancer than the kind that killed Steinman a week ago and actor Patrick Swayze two years ago.

The Apple chief kept details of his illness behind a firewall and declared he was cured after cancer surgery in 2004. However, five years later, gaunt and having lost a lot of weight, Jobs had a liver transplant. Experts said it was likely because his cancer had returned or spread.

A liver transplant sometimes can cure the type of cancer that Jobs had. But if it comes back, "it's usually in one to two years," said Dr. Michael Pishvaian of Georgetown University's Lombardi Comprehensive Cancer Center.

In January, Jobs announced his third and final leave of absence. He resigned in August and died on Wednesday.

Part of what makes pancreatic cancer so deadly is that the pancreas is as vital as the heart. You can live with just part of a liver or a colon, or only one kidney or lung. But the pancreas is a fish-shaped organ that makes digestive enzymes and insulin and other hormones that enable the body to make energy from food.

In the United States, pancreatic cancer is the fourth leading cause of cancer deaths. About 44,030 people will be diagnosed with it and about 37,660 people will die of it this year in the U.S., the American Cancer Society estimates.

Over the past 15 to 25 years, rates of pancreatic cancer have dropped slightly, possibly because of a decline in smoking, the cancer society says. However, cases have been rising since around 2002 and rose about 1 percent per year over the period 1998 to 2007, said the cancer society's deputy chief medical officer, Dr. Len Lichtenfeld.

Possible symptoms are fatigue, back pain, abdominal pain, unexplained weight loss, loss of appetite, jaundice and nausea, according to the Lustgarten Foundation, a private group that finances research on the disease.

This cancer often is not found until it is advanced or has spread, and overall survival is dismal: 20 percent after one year and only 4 percent after five years.

However, with a neuroendocrine tumor like the one Jobs had, "people can live a longer time; median survival is five to eight years," said Dr. Alan Venook, a pancreatic cancer specialist at the University of California, San Francisco.

The lifetime risk of developing pancreatic cancer is about 1 in 71, according to the cancer society. Men and blacks account for more cases than women and whites, possibly because of differences in smoking rates. Smokers have two to three times more risk of developing the disease. Use of smokeless tobacco also raises the risk.

Obese people, those who don't exercise much and diabetics also have more risk for pancreatic cancer. Alcohol use might play a role: Most studies haven't tied it to pancreatic cancer, but heavy drinking can lead to diabetes and liver and pancreas problems that pose a cancer risk, the cancer society says.

The best hope for a patient is that the tumor is operable. That was the case in February 2009, when U.S. Supreme Court Justice Ruth Bader Ginsburg had a small, early-stage pancreatic tumor removed at New York's Memorial Sloan-Kettering Cancer Center.

On the horizon are immune system treatments — research that Steinman, the Nobel recipient from Rockefeller University in New York, was studying in the lab and trying on his own pancreatic cancer.

The immune system has a hard time recognizing and fighting cancer because the enemy is not an invading germ but our own cells gone rogue. Treatments called therapeutic cancer vaccines are ways to modify cells to help the immune system recognize the risk.

One such vaccine by NewLink Genetics, a small biotech firm in Ames, Iowa, is in late-stage testing now for pancreatic cancer. The company website says the larger study was initiated after a mid-stage test suggested improvement in survival.

Dr. Roderich Schwarz, chief of surgical oncology at the University of Texas Southwestern Medical Center in Dallas, has enrolled a few patients in some immune therapy studies, which have not paid off in the past.

"Vaccines are coming along," and last year's approval of one for advanced prostate cancer suggests researchers may be learning to overcome some of the drawbacks of the past, he said.

"It's quite possible that vaccines will claim their territory in the treatment of these challenging tumors," Schwarz said. "It's still in the development stage rather than the proven stage."

___

Online:

Cancer Institute: http://www.cancer.gov/cancertopics/types/pancreatic

Cancer Society: http://www.cancer.org/Cancer/PancreaticCancer/index

Survival rates: http://bit.ly/oAxKl5

Research and support: www.curePC.org and www.lustgarten.org

Vaccine study: http://www.linkp.com/products/hyperacute-pancreas.html

___

Marilynn Marchione can be followed at http://twitter.com/MMarchioneAP

Associated Press

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Pancreatic cancer declining, but among most deadly

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In January, Jobs announced his third and final leave of absence. He resigned in August and died on Wednesday.

This cancer often is not found until it is advanced or has spread, and overall survival is dismal: 20 percent after one year and only 4 percent after five years.

On the horizon are immune system treatments — research that Steinman, the Nobel recipient from Rockefeller University in New York, was studying in the lab and trying on his own pancreatic cancer.

"Vaccines are coming along," and last year's approval of one for advanced prostate cancer suggests researchers may be learning to overcome some of the drawbacks of the past, he said.

"It's quite possible that vaccines will claim their territory in the treatment of these challenging tumors," Schwarz said. "It's still in the development stage rather than the proven stage."

___

Online:

Cancer Institute: http://www.cancer.gov/cancertopics/types/pancreatic

Cancer Society: http://www.cancer.org/Cancer/PancreaticCancer/index

Survival rates: http://bit.ly/oAxKl5

Research and support: www.curePC.org and www.lustgarten.org

Vaccine study: http://www.linkp.com/products/hyperacute-pancreas.html

___

Marilynn Marchione can be followed at http://twitter.com/MMarchioneAP

Associated Press

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Why pancreatic cancer is so deadly

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Steve Jobs had a pancreatic neuroendocrine tumor. Apple Inc. announced his death Wednesday.About 95 percent of people with pancreatic cancer die from it, experts sayAs people age, the risk of developing pancreatic cancer goes upThe pancreas is an oblong organ that lies deep in the abdomenThere are two types of pancreatic cancer: exocrine tumors and endocrine tumors

(CNN) -- As the technology world mourns computing visionary and Apple, Inc. co-founder Steve Jobs, it's worth taking a closer look at the disease he publicly battled.

Jobs had a rare form of pancreatic cancer called a neuroendocrine tumor. Patrick Swayze, Joan Crawford, Margaret Mead and Luciano Pavarotti all died from a more common form of pancreatic cancer, called adenocarcinoma. Supreme Court Justice Ruth Bader Ginsburg underwent surgery for pancreatic cancer in February 2009 and, 18 days later, returned to the bench.

"Right now, pancreatic cancer is getting publicity, but it's a neglected disease," said Dr. Michaela Banck, medical oncologist at the Mayo Clinic, who treats patients with neuroendocrine tumors. "It doesn't draw the same attention as colon cancer and breast cancer. Activist groups raise small amounts of money, since it's a rare disease. It's a complicated disease. We don't have enough money to make progress as fast as we'd like to."

Who gets pancreatic cancer

Pancreatic cancer is the fourth-leading cause of death from cancer in the United States, after lung, colon and breast cancer. The lifetime risk of developing it is about 1 in 71. This year, about 44,030 people will be diagnosed with pancreatic cancer, and the disease will kill about 37,660 people, according to the American Cancer Society.

About 95 percent of people with pancreatic cancer die from it, experts say. It's so lethal because during the early stages, when the tumor would be most treatable, there are usually no symptoms. It tends to be discovered at advanced stages when abdominal pain or jaundice may result. Presently, there are no general screening tools.

Rates of pancreatic cancer have dropped slightly among men and women over the past 15 to 25 years.

As people age, the risk of developing pancreatic cancer goes up. Most patients are older than 45, and nearly 90% are older than 55. The average age at diagnosis is 72.

Men have a slightly higher likelihood of developing pancreatic cancer than women, which may partly result from increased tobacco use in men. In the past, when men more commonly smoked than women, the gender gap was wider.

There is also a noted association with race: African-Americans are more likely to develop pancreatic cancer than whites. Doctors don't know why, but speculate that higher rates of men smoking and having diabetes, and women being overweight, may contribute to that association.

What are the types of pancreatic cancer?

The pancreas is an oblong organ that lies deep in the abdomen, and is an integral part of both the digestive and endocrine system. It secretes hormones to regulate the body and also digestive enzymes to break down food.

There are two types of pancreatic cancer: exocrine tumors and endocrine tumors.

Exocrine tumors are the majority of pancreatic cancers, and the most common form is called adenocarcinoma, which begin in gland cells, usually in the ducts of the pancreas. Swayze died from this kind of pancreatic cancer. These tumors tend to be more aggressive than neuroendocrine tumors, the kind that Jobs had, but if caught early enough they can be treated effectively with surgery.

Pancreatic neuroendocrine tumors constitute only 1% of all pancreatic cancers. They can be benign or malignant, but the distinction is often unclear and sometimes apparent only when the cancer has spread beyond the pancreas.

The five-year survival rate for neuroendocrine tumors can range from 50% to 80%, compared with less than 5% for adenocarcinoma.

More advanced tumors have a higher risk of recurrence, and can spread to the liver, said Dr. Steven Libutti, pancreatic cancer expert and director of the Montefiore-Einstein Center for Cancer Care in the Bronx.

Treatment options

Pancreatic cancer is usually controllable only through removal by surgery, and only if found before it has spread, according to the National Cancer Institute. Palliative care can help a patient's quality of life if the disease has spread.

Two new drugs approved this year may help patients with pancreatic neuroendocrine tumors. They are believed to suppress the blood supply and metabolism of the tumor cells. That's good progress since, a year ago, the standard of care was chemotherapy, Banck said.

Everolimus, marketed by Novartis as Afinitor, received U.S. Food and Drug Administration approval to treat pancreatic neuroendocrine tumors and prevents transplant rejection. Potential side effects are serious, however: lung or breathing problems, infections and renal failure, which may lead to death.

Sunitinib malate, marketed by Pfizer as Sutent, is prescribed for the treatment of pancreatic neuroendocrine tumors, as well as, kidney cancer and GIST, a rare cancer of the bowel, esophagus or stomach. As with everolimus, there are risks to consider: it can cause liver problems and death.

Given that Jobs underwent surgery to remove his tumor in 2004 and died in 2011, his seven-year survival after treatment is consistent with the average survival for these kinds of tumors, Libutti said.

If pancreatic cancers are detected early, that may increase the odds of survival, but it also depends on how aggressive the particular tumors are in a patient. If surgery leaves behind microscopic aggressive tumor cells, they can cause a recurrence of cancer.

Jobs also underwent a liver transplant in Tennessee in 2009, which is "cutting edge stuff" for when neuroendocrine tumors spread, said Dr. Maged Rizk, director of the Chronic Abdominal Pain Center at the Cleveland Clinic who specializes in gastroenterology and hepatology.

Did Steve Jobs' money buy him a faster liver transplant?

But because it's so rare, there isn't a lot of evidence to support the transplant as a cure; the procedure could extend life, but immunosuppression drugs may allow any remaining cancer to grow faster, doctors say. And a European study found that the majority of patients who underwent liver transplant for this type of tumor had recurrence of the disease.

But many pancreatic cancers are detected in later stages because when the tumor is small, it often does not produce symptoms. As they grow, adenocarcinomas can obstruct the ducts from the liver and cause severe back pain. Neuroendocrine tumors sometimes produce insulin, so a patient's first symptoms could be low glucose levels. But most tumors do not produce hormones, Libutti said.

There are two rare genetic syndromes -- multiple endocrine neoplasia type 1 (MEN1) and Von Hippel-Lindau syndrome (VHL) -- that increase the risk of pancreatic neuroendocrine tumors. Other than that, though, it's unclear whether having a family member with pancreatic cancer increases an individual's risk.

Pancreatic cancer struck former President Jimmy Carter's family hard. He lost his father and all of his siblings, brother Billy and sisters Ruth Carter Stapleton and Gloria Carter Spann.

The future of treatment

Researchers are working on better understanding the way in which pancreatic tumors grow and spread, Libutti said.

"There are a number of agents that are being looked at in clinical trials that focus on pathways that may allow pancreatic cancer to evade normal processes," Libutti said.

One is an antibody that blocks a particular protein called PD-1 on the surface of pancreatic cancer, meaning chemotherapies would be more effective because there would be an enhanced immune response against the tumor. That work is being done by the National Cancer Institute.

Libutti's lab is working on targeted nanoparticle therapies for metastatic neuroendocrine tumors. The idea is that tiny particles are coated with material that hones in on tumor cells and delivers drugs to kill them without harming healthy tissue, reducing the toxicity to the body in general. This research is still in animal models.

"We're hopeful that in the not-too-distant future, we'll be ready to move into clinical trials," he said.

Another line of research is focused on finding biomarkers of pancreatic cancer so that a simple blood or urine test could be developed. Unlike screenings for other conditions such as colon, breast and prostate cancers, there is no routine way to see whether a patient has a tumor in the pancreas.

The future of medicine to help people with pancreatic cancer will involve genetics, said Banck. This would involve matching a person's particular type of tumor using genomic information with treatment.

"What's going to make real difference in the future is the revolution of the genomic era," she said.

CNN's Madison Park and Jacque Wilson contributed to this report.

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For older women, year following hip fracture can be especially deadly

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Fractures appeared to be most dangerous in the youngest segment of study participants.Many hip fractures happen in postmenopausal women with osteoporosisStudy is first to suggest cause-and-effect relationship between hip fracture and deathSeventeen percent of the women who experienced a fracture died during the year

(Health.com) -- Women age 65 and older who fracture a hip are much more likely to die from any cause during the following year than they would be if they had avoided injury, a new study suggests.

The increased risk of death associated with hip fractures was especially dramatic among younger women. In the 65- to 69-year-old age group, the odds of death were five times higher for women in a post-fracture year than they were for non-injured women of the same age, the study found.

Many of the 300,000 hip fractures that occur each year in the United States happen in postmenopausal women with the bone-thinning disease osteoporosis, typically after a fall or other accident. Researchers have already established that these fractures increase the risk of death, but they haven't been able to rule out the possibility that women who fracture a hip are already at greater risk before their injury.

Health.com: How to fight osteoporosis

The new study, which carefully compared age-matched women with and without fractures, is the first to suggest a possible cause-and-effect relationship between hip fracture and death, says lead author Erin LeBlanc, M.D., a researcher at Kaiser Permanente Northwest, the large nonprofit health plan in Portland, Oregon, that funded the study.

"Before we might have assumed that sicker women are just more likely to get hip fractures," she says. "But now we know that there is something about the hip fracture itself, and not an underlying condition, that is bringing on this increased risk of death."

LeBlanc and her colleagues, whose findings appear in the Archives of Internal Medicine, tracked women in four states across the country between 1986 and 2005, as part of a larger study funded by the National Institutes of Health. From this pool of study participants, the researchers matched each of the 1,116 women who'd had hip fractures with four women of the same age who had not.

Health.com: Surprising facts about healthy bones

Overall, women who suffered a hip fracture had twice the odds of dying within one year of their injury than did their counterparts in the control group during the same year. Seventeen percent of the women who experienced a fracture died during the year, versus 8% in the control group. (In addition to matching the women by age, the researchers took into account body mass index, medical history, and several other risk factors for hip fracture.)

The top three causes of death -- heart disease, stroke, and sepsis -- were the same for both the fracture and control groups. But more than half of the deaths in the fracture group occurred within three months of the injury, and nearly three-quarters occurred within six months; this suggests that something about the surgery, hospital time, immobility, or rehabilitation required after a hip fracture makes women more vulnerable, says LeBlanc.

In an effort to separate out the effect of hip fractures from the underlying death risk associated with preexisting health problems, the researchers performed a more detailed analysis in women age 80 and up, a group that is generally sicker and more likely to die.

Hip fracture did not measurably increase the one-year odds of death in this age group as a whole, but it nearly tripled the odds among the subset of women who considered themselves to be in good or excellent health. The fact that hip fracture was linked to an increased risk of death only when illness was removed from the picture provides more evidence that fracture can be a cause of death, the researchers say.

Health.com: 10 ways to prevent falls at home

Fractures appeared to be most dangerous in the youngest segment of study participants: For women 65 to 69, hip fracture quintupled the odds of death within one year. This was also the only age group in which the odds of death remained higher in the fracture group after the one-year mark.

The findings in these relatively young women should be a wake-up call to physicians and patients alike, says Silvina Levis, M.D., director of the osteoporosis center at the University of Miami Miller School of Medicine.

"Many people assume that this increased mortality mostly applies to the very old," says Levis, who was not involved in the study. "But having seen this result, I think younger women are the ones who should be very much aware and should talk to their doctors about ways of assessing risk."

Women should have a bone-density test at age 65 (or younger if they have other osteoporosis risk factors), and those with low bone mass or osteoporosis may want to consider taking medications to reduce their risk of fractures, Levis says.

Health.com: 11 foods for healthy bones

LeBlanc says it's important for all postmenopausal women to get enough bone-strengthening calcium and vitamin D in their diet, avoid smoking and excessive alcohol intake, and assess their homes for hazards that could cause slips and falls. "Thinning of the bones is silent," she says. "It doesn't hurt, and if you're not proactive you might not know you have it until you break something."

These steps are especially important for a woman who has already had a fracture, LeBlanc adds, since she is at high risk for a second one.

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AP IMPACT: Hospital drug shortages deadly, costly

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In this Aug. 29, 2011 photo, Erin Fox, manager of the Drug Information Service at the University of Utah Hospital in Salt Lake City, stands by a board listing drugs in short supply. At hospitals across the country, "scoring drugs" has taken on a new meaning. Hundreds admit buying medicines at exorbitant prices from "gray market" dealers taking advantage of, and possibly exacerbating, a record shortage of life-saving prescription medicines. (AP Photo/Jim Urquhart)

This Aug. 29, 2011 photo, shows a board listing drugs in short supply at the University of Utah Hospital, in Salt Lake City. At hospitals across the country, "scoring drugs" has taken on a new meaning. Hundreds admit buying medicines at exorbitant prices from "gray market" dealers taking advantage of, and possibly exacerbating, a record shortage of life-saving prescription medicines.(AP Photo/Jim Urquhart)

In this Aug. 29, 2011 photo, Kelsey Olsen, a pharmacy buyer at the University of Utah Hospital in Salt Lake City, holds a tray of Magnesium Sulfate, a drug in short supply. At hospitals across the country, "scoring drugs" has taken on a new meaning. Hundreds admit buying medicines at exorbitant prices from "gray market" dealers taking advantage of, and possibly exacerbating, a record shortage of life-saving prescription medicines. (AP Photo/Jim Urquhart)

Chart shows the annual number of new drug shortageseval("var currentItemd57851005a80479aaeeb90a12c70b9ff = 1;");eval("var nextd57851005a80479aaeeb90a12c70b9ff = 0;");eval("var previousd57851005a80479aaeeb90a12c70b9ff = 0;");

TRENTON, N.J. (AP) — A drug for dangerously high blood pressure, normally priced at $25.90 per dose, offered to hospitals for $1,200. Fifteen deaths in 15 months blamed on shortages of life-saving medications.

A growing crisis in the availability of drugs for chemotherapy, infections and other serious ailments is endangering patients and forcing hospitals to buy from secondary suppliers at huge markups because they can't get the medications any other way.

An Associated Press review of industry reports and interviews with nearly two dozen experts found the shortages — mainly of injected generic drugs that ordinarily are cheap — have delayed surgeries and cancer treatments, left patients in unnecessary pain and caused hospitals to give less effective treatments. That's resulted in complications and longer hospital stays.

Just over half of the 549 U.S. hospitals responding to a survey this summer by the Institute for Safe Medication Practices, a patient safety group, said they had purchased one or more prescription drugs from so-called "gray market vendors" — companies other than their normal wholesalers.

Most also said they've had to do so more often of late, and 7 percent reported side effects or other problems with those drugs.

Hospital pharmacists "are really looking at this as a crisis. They are scrambling to find drugs," said Joseph Hill of the American Society of Health-System Pharmacists.

At a hearing Friday before the health subcommittee of the House Energy and Commerce Committee, hospital officials and other experts testified that the worsening shortages are preventing them from giving many patients the best care and are driving up costs.

"Considering the nation's budget crisis and our skyrocketing health care bill, these markups are nothing more than profiteering at the expense of patients and providers who are struggling to afford vital medicines," said Mike Alkire, chief operating officer of Premier Healthcare Alliance, a group that helps U.S. hospitals and other health providers improve their patient care and finances.

The shortages could cost hospitals at least $415 million a year, he said, citing data from health care providers across the nation. So far, hospitals have been absorbing the extra costs, but they'll soon have to start passing them on to insurers and patients, according to the American Hospital Association.

The scarcity of mainstay cancer drugs is not only hurting patients but is halting or disrupting clinical studies of potential new treatments, said Dr. Robert S. DiPaola, director of the Cancer Institute of New Jersey.

"The drug shortages of today can have a ripple effect on the availability of new drugs and treatment combinations tomorrow," he told the committee.

On Monday, the Food and Drug Administration is holding a meeting with medical and consumer groups, researchers and industry representatives to discuss the shortages and strategies to fight them.

The FDA says the primary cause of the shortages is production shutdowns because of manufacturing problems, such as contamination and metal particles that get into medicine.

Other reasons include theft of prescription drugs from warehouses or during shipment, as well as the "gray market" vendors who buy scarce drugs from small regional wholesalers, pharmacies or other sources and then sell them to hospitals at many times the normal price. These sellers may not be licensed, authorized distributors.

In addition, many companies have stopped making generic injected drugs because the profit margins are slim. Producing them is far more expensive than stamping out pills, and it takes about three weeks to produce a batch. Making things worse, companies don't have to notify customers or the FDA that they've stopped making a medicine. That means neither FDA nor competitors can fill the gap in time.

Only a half-dozen companies make the vast majority of injected generics. Even if other companies wanted to begin making a drug in short supply, they're discouraged by the lengthy, expensive process of setting up new manufacturing lines and getting FDA approval.

Hospitals that buy scarce medicines from the "gray market" are taking a gamble.

The drugs may be stolen and hospitals can't always tell whether a medicine was properly refrigerated — as required for many injectable drugs — or whether it's past the expiration date, said Michael R. Cohen, a pharmacist and president of the institute. The active ingredient might have degraded and the drug might not work well or could even harm the patient, he said.

Cohen attributes at least 15 recent deaths to drug shortages, either because the right drug wasn't available or because of dosing errors or other problems in administering or preparing alternative medications. But many deaths and injuries go unreported, he said.

In the worst known case, Alabama's public health department this spring reported nine deaths and 10 patients harmed due to bacterial contamination of a hand-mixed batch of liquid nutrition given via feeding tubes because the sterile pre-mixed liquid wasn't available.

So far this year, 210 drugs have been added to the list of those in short supply, one less than the total for all of last year, according to the University of Utah Drug Information Service, which tracks the shortages. That's triple the roughly 70 a year from 2003 to 2006, when shortages began to climb steadily.

"The shortages aren't resolving. They're piling up on top of existing ones," said Erin Fox, a pharmacist who manages the service. She said at least 55 drugs from shortages before this year are still unavailable or scarce.

The average price markup on drugs sold by secondary distributors was 650 percent, according to an Aug. 16 report by the Premier Healthcare Alliance. The figure is based on an analysis of 636 unsolicited sales offers that were faxed and emailed to hospitals from secondary distributors in April and May.

Virtually every offer was for at least double the normal price, the survey found. The drugs with the highest markups were for critically ill patients needing anesthesia or other medicines for surgery or for emergency care, cancer, infectious diseases and pain management.

In an extreme case, one vendor was offering a generic beta blocker for dangerously high blood pressure, normally priced at $25.90 per dose, for $1,200.

The FDA says it must uphold quality standards but also works hard to prevent shortages.

"When FDA detects a contaminant, whether it be shards of glass or metal particles or an infectious agent, we have to take action to protect the public," said Dr. Peter Lurie, a senior adviser in the FDA commissioner's office.

When such problems force a company to shut down production, the FDA urges other manufacturers to boost their output and expedites any approvals needed, said Valerie Jensen, associate director of the agency's drug shortage program. When raw materials used to make drugs are in short supply, the FDA tries to find new sources.

The agency averted 38 shortages last year, Jensen added. Another 99 have been prevented so far this year, Howard K. Koh, assistant secretary for health in the Department of Health and Human Services, told the committee.

Legislation pending in the House and Senate would increase penalties for drug thefts from warehouses and tractor-trailers. Another proposal, which has bipartisan support, would require drug manufacturers anticipating a shortage to immediately notify the FDA.

The pitches hospitals get from secondary distributors generally say they have small batches of specific drugs that are hard or impossible to find. "Are you enjoying this crazy 'roller coaster ride' of pharmaceutical shortages? ... I utilize over 60 vendors to locate and procure needed pharmaceuticals to assist when you have shortage needs," one reads.

Several distributors who sent hospitals solicitations for scarce drugs didn't return calls from the AP. One representative said he wasn't authorized to discuss the issue.

Another company, Novis Pharmaceuticals, defended the higher prices, saying secondary distributors have to charge far more because they don't get the big rebates manufacturers give primary distributors. They also have high costs to locate and transport batches of scarce drugs, although the company, which mainly distributes blood plasma, would not disclose its profit margin.

It's illegal for companies to collude to create a medicine shortage and raise prices, and there's no evidence of that. There's no federal law against price-gouging on prescription drugs, according to the FDA, but it does urge pharmacists to report cases to its Office of Criminal Investigation. An agency spokeswoman said she could not discuss whether any cases are being investigated.

The top three wholesalers say they try to alleviate problems by working with drug manufacturers, updating hospitals on shortages and rationing scarce supplies by giving their regular hospital customers a portion of their normal order. McKesson Corp. and Cardinal Health Inc. say they halt sales to any smaller distributors found to be diverting drugs or otherwise breaking rules. AmerisourceBergen Corp. does background checks on customers.

The hospital association and other groups urge hospitals not to buy from unaccredited vendors, to insist on documentation of the drug's source if they must, and to report price gouging to state authorities. But only three states — Kentucky, Maine and Texas — have price-gouging laws that specifically cover medicines.

"Something has to be done here," said pharmacist Michael O'Neal, head of drug procurement for Vanderbilt University Medical Center in Nashville, which has had to purchase medicines from secondary suppliers about 70 times over the past two years.

"This is unethical," he said. "We're talking about people's lives."

___

Summary of state price-gouging laws: http://www.ncsl.org/default.aspx?tabid=14434

Institute for Safe Medication Practices consumer site: http://www.consumermedsafety.org/

Associated Press

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Italian Scientists On Trial Over Deadly Earthquake

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The trial of seven Italian scientists began this week. They are charged with manslaughter for failing to adequately warn the residents of L'Aquila, Italy, about the risk of an earthquake in 2009. Host Scott Simon speaks with Rick Aster, president of the Seismological Society of America, about the trial.

SCOTT SIMON, host: This is WEEKEND EDITION from NPR News. I'm Scott Simon. The trial of seven Italian scientists began this week. They're charged with manslaughter, for failing to adequately warn the residents of L'Aquila, Italy about the risk of an earthquake in 2009. Now the scientists were members of a provincial disaster risk committee. They met in March 2009 to discuss the earthquake risk posed by recent small tremors.

The scientific community tells me there is no danger, a committee spokesman said at the time, because there is an ongoing discharge of energy. The situation looks favorable. Six days later an earthquake killed more than 300 people in L'Aquila. Now the scientists who sat on that committee could face up to 12 years in prison.

Rick Aster is president of the Seismological Society of America. He and his colleagues around the world sent a petition with more than 5,000 signatures calling for the charges to be dropped. Dr. Aster joins us from the New Mexico Institute of Mining and Technology. Thanks for being with us.

RICK ASTER: My pleasure, Scott.

SIMON: What was your first reaction when you first heard about these charges?

ASTER: Well, the initial reaction of the seismological, and I think the broader scientific community, was that this was outrageous, given the fact that earthquakes are unpredictable at this stage in our state of knowledge. Indeed, they're the last great natural disaster for which there is no predictive capacity. And the statement that an ongoing discharge of energy was occurring, so the situation looked favorable was demonstratively scientifically incorrect. Small earthquakes do not function as a safety valve, in a sense, for large earthquakes.

SIMON: Can you see where families of people who've lost loved ones would feel from would feel a lot of frustration by being told the situation looks favorable and then just six days later, well, just six days later 300 people die.

ASTER: Indeed. That really was a tragic miscommunication on the part of Italy's Department of Civil Protection.

SIMON: Why then have you organized this petition and why do you feel that geologists shouldn't be held responsible (technical difficulty).

ASTER: Well, I guess again, Scott, one has to realize one's dealing with an inherently unpredictable phenomena. So the ability to inform people and keep the population ready has to be weighed against the cost of false alarms in this situation, which is very high.

SIMON: Mm-hmm.

ASTER: Because if in a situation like this, you told people to expect an earthquake then you'd be wrong 99 times out of 100. So you get into both the disruption to society and the crying wolf scenario, where you worry that if, you know, you issue false alarms much, much more frequently than you issue true alarms, that process is also useless, unfortunately.

SIMON: Do you have any concern as a scientist, Dr. Aster, that when even if scientists are right, as you suggest 99 percent of the time, that when a mistake like this is made it tends to undercut the credibility of everybody in the field?

ASTER: Well, I think people have to realize, and the community is very honest about it, that earthquake prediction is an extremely daunting scientific, technical and indeed, a political issue, so I don't think we're misrepresenting our ability to predict earthquakes; everyone would agree is essentially null.

SIMON: Rick Aster is the president of the Seismological Society of America. Thanks very much.

ASTER: Thank you, Scott.

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AP IMPACT: Hospital drug shortages deadly, costly

01.48 egaoart No comments

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