From The Alpha and the Omega - Volume III
by Jim A. Cornwell, Copyright © July 20, 2002, all rights reserved
"Volume III - Environmental Changes and World Wide Diseases 2011-2022"
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Volume III - Environmental Changes and World Wide Diseases 2011-2022
World Wide Diseases
Acquired Immune Deficiency Syndrome (AIDS), Human Immunodeficiency Virus (HIV), Sexually Transmitted Diseases (STDs),
Mad Cow Disease, Severe Acute Respiratory Syndrome (SARS), West Nile Virus, Tuberculosis
The year 2011 through 2022
The year 2011.
- 1/18/2011 Two drugs offer hope in treating hepatitis C - U.S. expected to approve new treatments this summer by Lauran Neergaard, AP.
Washington - Two powerful drugs are nearing the market that promise to help cure many more people of liver-attacking hepatitis C. So we are entering a whole new era of therapy said Dr. John Ward, hepatitis chief at the U.S. CDC. Today's two-drug treatment for hepatitis C cures only about 40 percent of people with the most common variety of the virus, and causes some grueling side effects.
Now major studies show adding a new drug - either Vertex Pharmaceutical's telaprevir or Merck & Co.'s boceprevir - can boost those cure rates to as high as 75 percent. And it allows to cut treatment time in half, to six months, lessening the time with the side effects.
The wait is on the FDA to approve the drugs.
- 4/10/2011 Drug abusers find a new, deadly high - Opana linked to 9 overdoses by Jessie Halladay, The Courier-Journal.
Police across Kentucky are seeing a surge in the illegal use of the painkiller Opana, a more dangerous version of OxyContin, linked to nine recent overdoses in Louisville. Users are "looking for something new" since the popular painkiller OxyContin was reformulated to make it more difficult for abusers to snort or inject. Oxymorphone, sold under the brand name Opana, is a drug legally used to combat minor or severe chronic pain.
- 4/26/2011 FDA: Hepatitis drug promising - Cure time appears to be much faster by Matthew Perrone, AP.
Washington - Both drugs will be brought before the FDA who has questions about how the drug should be combined with older medications for maximum effect. After 15 years of research to find a better therapy for a virus that infects about 3.2 million people in the U.S. Both drugs work by blocking the enzyme protease, which allows the hepatitis to reproduce. The FDA panel will vote on this Wednesday.
As of May 6, 2011, I have stopped typing from news articles and began using the Electronic Edition of the Courier-Journal newspaper so from this point on the articles are from those pages and may be shortened in some cases for highlights and space considerations.
- 5/9/2011
Study suggests more kids have autism by Carla K. Johnson, Associated Press
CHICAGO — a study in South Korea suggests about one in 38 children has traits of autism, higher than a previous U.S. estimate of one in 100. By casting a wider net and looking more closely at mainstream children, the researchers expected to find a higher rate of autism characteristics. But they were surprised at how high the rate was. They don’t think South Korea has more children with autism than the United States, but instead that autism often goes undiagnosed. U.S. estimates are based on education and medical records, not the more time consuming survey conducted in South Korea.
According to the research published today in the American Journal of Psychiatry, two-thirds of the children with autism traits in the study were in the mainstream school population, hadn’t been diagnosed before and weren’t getting any special services. Many of those likely have mild social impairments. “It doesn’t mean all of a sudden there are more new children with (autism spectrum disorders),” said co-author Dr. Young-Shin Kim of the Yale Child Study Center “They have been there all along, but were not counted in previous prevalence studies.” It’s not clear whether the children need special services or not, other experts said.
The study attempted to screen all 55,000 schoolchildren, ages 7 to 12, in a district of Goyang City, near Seoul, and took five years to complete. The study was funded in part by the National Institute of Mental Health, Children’s Brain Research Foundation and the George Washington University Institute for Ethnographic Research.
- 5/12/2011
Canadian researchers find bedbugs with supergerm by Mike Stobbe, Associated Press
ATLANTA — Hate insects? Afraid of germs? Re-searchers are reporting an alarming combination: bedbugs carrying a staph “superbug.” Canadian scientists have detected drug-resistant staph bacteria in bedbugs from three hospital patients from a downtrodden Vancouver neighborhood.
Bedbugs have not been known to spread disease, and there’s no clear evidence that the insects found on the patients or their belongings had spread the MRSA germ they were carrying or a second, less dangerous drug-resistant bacteria. But bedbugs can cause itching that can lead to excessive scratching. That can cause breaks in the skin that make people more susceptible to these germs, noted Dr. Marc Romney, one of the study’s authors. The study is small and very preliminary “But it’s an intriguing finding” that needs further research, said Romney, medical microbiologist at St. Paul’s Hospital in Vancouver.
The hospital is the closest one to the Downtown Eastside neighborhood near the city’s waterfront. Romney said he and his colleagues did the research after seeing a simultaneous boom in bedbugs and MRSA cases from the neighborhood. Five bedbugs were crushed and analyzed. MRSA, or methicillin-resistant Staphylococcus aureus, was found on three bugs. MRSA is resistant to several types of common antibiotics and can be deadly if it gets through the skin and into the bloodstream.
Two bugs had VRE, or vancomycin-resistant Enterococcus faecium, a less dangerous antibiotic-resis-tant bacteria. Both germs are often seen in hospitals, and experts have been far more worried about health care workers spreading the bacteria than insects. It’s not clear whether the bacteria originated with the bedbugs or if the bugs picked it up from infected people, Romney added. The study was released Wednesday by Emerging Infectious Diseases, a publication of the U.S. Centers for Disease Control and Prevention.
- 5/14/2011
FDA clears new hepatitis C drug
The Food and Drug Administration on Friday approved a highly anticipated hepatitis C drug from Merck that is the first new treatment for the virus in 20 years. The first-of-its-kind pill, Victrelis, has been shown to cure more patients in less time than the drugs now used. About 3.2 million people in the U.S. have hepatitis C, a blood-borne disease linked to 12,000 deaths a year. The current two-drug treatment cures only about 40 percent of people and causes side effects like nausea, fatigue and vomiting.
The FDA said it approved the new drug based on two trials in which more than 65 percent of patients were cured when combining Victrelis with the two older drugs. Like HIV drugs, Victrelis will be prescribed as part of a drug cocktail. Some patients were also able to eliminate the virus in seven months on the drug, nearly half the time needed with the current treatments alone.
- 5/18/2011
Study links genetics, nicotine addiction by Los Angeles Times
LOS ANGELES —What makes nicotine so addictive?
The answer to that question could help researchers develop a drug that would help smokers give up cigarettes for good. A study published online this week in the Proceedings of the National Academy of Sciences provides some useful clues. Researchers zeroed in on a particular gene called OPRM1. This gene contains instructions for building a type of receptor that allows opioids — including drugs like heroin and morphine as well as opioids produced inside the body — to make their presence known in the brain, triggering release of the feel-good chemical dopamine.
Nicotine prompts the body to produce more of its own opioids, which in turn releases more dopamine.
At a particular location on the OPRM1 gene, many people inherit an A (short for adenine) from both parents. But some people inherit a G (short for guanine) from at least one parent. . That small difference can affect whether smokers become addicted to nicotine.
Researchers from the University of Pennsylvania and colleagues found that the opioid receptors in the brains of smokers with the A/A version of the gene were a lot more active after smoking.
- 5/19/2011
Cold sores are not going away - Sneaky virus infects 7 in 10 by Alexia Elejalde-Ruiz, Chicago Tribune
For such a ubiquitous plague, cold sores can be mighty shaming. In addition to the indignity of wearing a bulging, weepy blister on your lip, sufferers also must contend with the stigma of its source: HSV-1, a type of herpes simplex virus. But unlike HSV-2, the virus that usually causes genital herpes, cold sores are not usually sexually transmitted (though they can be). Most people get infected with HSV-1 as kids, from kissy adults.
“It is one of the most common viral infections, and yet you’re a pariah,” said Dr. Adam Friedman, director of dermatologic research at Albert Einstein College of Medicine at Yeshiva University in New York. “People look at you like you’re a leper.” About 70 percent of Amer-icans are infected with HSV-1, but just a third of those infected have cold-sore outbreaks, said Bryan Cullen, professor in the department of molecular genetics and microbiology at Duke University Medical Center. Genetics likely separates the lucky from the unlucky, he said.
Sneaky virus
The hardy virus, which stays in your body your whole life, survives by moving up the sensory nerves after initial infection and vacationing in nerve bundles, where immune cells can’t find and destroy it Triggers such as stress, fatigue, sun exposure, picking at your lip or having a cold or the flu can reactivate some infected cells, which travel back to the initial infection site to cause a new outbreak.
There is no cure. Cullen and fellow researchers hope to find a way to disrupt the processes that keep the virus latent, so that they can coax it out of hiding all at once and ambush it with medication. But they’re not close to clinical trials, Cullen said.
HSV-1 has been implicated in a number of diseases, including Alzheimer’s, though that link is disputed. Though there are rare cases of severe complications from HSV-1 — such as when the virus spreads to the brain in immune compromised people, causing death or neurological damage — for the most part “the worst part about (HSV-1) is probably the social stigma,” Friedman said.
Though the virus is most contagious during an outbreak, when the virus is “shedding,” it’s also possible to transmit when no outbreak is visible. According to a study published in 2008 in an oral medicine journal, at least 70 percent of people with HSV-1 shed asymptomatically at least once a month.
Friedman recommends keeping your mouth away from others when you feel a cold sore coming, during the outbreak and for a few days after it goes away. That includes oral sex, as HSV-1 can be transmitted from mouth to genitals (HSV-2 also can be transmitted from genitals to mouth).
Treatment
Taking prescription antivirals such as acyclovir (Zovirax) or valacyclovir (Valtrex) can reduce healing time or prevent a blister from forming at all, clinical trials have shown. It’s best to attack during the “prodrome” stage, when many people feel tingling or itching at the infection site, or have flulike symptoms, before a blister appears.
Friedman suggests applying ice at the first hint of a cold sore, holding it against the infected site for no more than 15 minutes, to reduce swelling. You might also soak a cotton ball in whole milk and hold it against the sore for 10 to 15 minutes daily, Friedman said Milk contains the protein monocaprin, which can halt HSV-1. Finally, cover a blister with a thick emollient such as petroleum jelly to speed healing and protect the wound from bacteria, Friedman said.
- 5/26/2011
Vitamins appear to cut risk of autism by Los Angeles Times
LOS ANGELES — Women who reported not taking prenatal vitamins immediately before and during pregnancy were twice as likely to have autistic children, University of California, Davis, researchers reported Wed-nesday. If the women also had a mutation in a high-risk gene, they were seven times as likely to have children with the developmental disorder, the researchers reported.
Epidemiologist Rebecca J. Schmidt and her colleagues studied about 700 California families with 2- to 5-year-old children with autism who participated in the Childhood Autism Risk from Genetics and the Environment study from January 2003 to December 2009.
They found that mothers who took vitamins before or in the first month of pregnancy were only half as likely to have autistic children as those who didn’t. But for mothers who began taking them in the second month of pregnancy, there was no effect, suggesting that by the time most women learn they are pregnant, taking vitamins will provide little or no benefit in terms of autism.
- 5/31/2011
Drug shortages worsen at hospitals - Scarcity spurs rush to find substitutes by Lauran Neergaard, Associated Press
WASHINGTON — A growing shortage of medications for a host of illnesses — from cancer to cardiac arrest — has hospitals scrambling for substitutes to avoid patient harm, and sometimes even delaying treatment. “It’s just a matter of time now before we call for a drug that we need to save a patient’s life and we find out there isn’t any,” said Dr. Eric Lavonas of the American College of Emergency Physicians. The problem of scarce supplies or even completely unavailable medications isn’t a new one but it’s getting markedly worse. The number listed in short supply has tripled over the past five years, to a record 211 medications last year.
The vast majority involve injectable medications used mostly in emergency rooms, intensive care units and cancer wards. Shortages can last for weeks or for many months, and there aren’t always good alternatives. At Miami Children’s Hospital, doctors had to postpone for a month the last round of chemotherapy for Caroline Pallidine, 14, because of a nationwide shortage of cytarabine, a drug considered key to curing a type of leukemia. “There’s always a fear, if she’s going so long without chemo, is there a chance this cancer’s going to come back?” said her mother, Marta Pallidine. There are lots of causes for shortages, from recalls of contaminated vials, to trouble importing raw ingredients, to spikes in demand, to factories that temporarily shut down for quality upgrades.
Some experts pointedly note that pricier, brand-name drugs seldom are in short supply. The Food and Drug Administration agrees that the overarching problem is that fewer and fewer manufacturers produce older, cheaper generic drugs, especially the harder-tomake injectable ones. So if one company has trouble — or decides to quit making a particular drug — there are few others able to ramp up their own production to fill the gap, says Valerie Jensen, who heads FDA’s shortage office.
Shortages are wide-ranging, including:
- Thiotepa, used with bone marrow transplants.
- A whole list of electrolytes, injectable nutrients crucial for certain premature infants and tubefeeding of the critically ill.
- A cystic fibrosis drug named acetylcysteine.
- Injections used in the ER for certain types of cardiac arrest.
- Certain versions of pills for attention deficit hyperactivity disorder.
The FDA has taken an unusual step, asking some foreign companies to temporarily ship to the U.S. their own versions of some scarce drugs not normally sold here. Pending legislation would require manufacturers to give the FDA advance notice of problems such as manufacturing delays that might trigger a shortage. The FDA cannot force a company to make a drug, but it was able to prevent 38 close calls from turning into shortages last year by speeding approval of manufacturing changes or urging competing companies to get ready to meet a shortfall.
- 6/1/2011
Search continues for source in fatal E. coli outbreak by David Rising and Maria Cheng, Associated Press
BERLIN — The foodborne bacterial outbreak that has hit Germany and other European nations is unlike anything Western experts have seen: 16 dead and more than 1,000 sick, including nearly 400 suffering severe and potentially fatal symptoms. But several days into the health threat, scientists remain unsure what produce — and what country — is responsible. Investigators across Europe were frantically trying to determine the scope of the contamination by an unusual strain of the common E. coli germ — and where in the long journey from farm to grocery store the contami-nation occurred.
German authorities pointed to a few cucumbers from Spain, but further tests showed that those vegetables, while contaminated, did not cause the outbreak. In Germany, where the vast majority of deaths and severe illnesses have been reported, officials said that investigations including interviews with patients have shown that people were likely infected by eating raw cucumbers, tomatoes or lettuce. They are warning consumers to avoid those vegetables, and Russia went so far as to ban imports of those vegetables from Spain or Germany. In its most severe form, the infection can attack the kidneys, sometimes causing seizures, strokes and comas. It’s “extraordinary” to see so many cases of the kidney complication from a food borne illness, said Dr. Robert Ta uxe, a food borne disease expert at the U.S. Centers for Disease Control and Preven-tion. He added that the strain of E. coli in the European outbreak has not been seen in the United States.
- 6/2/2011
E. coli deaths rising in Europe - Experts hunt clues to outbreak’s cause by David Rising and Maria Cheng, Associated Press
BERLIN — The number of people hit by a massive European outbreak of food-borne bacterial infec-tions is one-third higher than previously thought. Also, a stunningly high number of patients suffer from a potentially deadly complication that can shut down their kidneys, officials said Wednesday. The death toll rose to 17, with German authorities reporting that an 84-year-old woman with the complication had died Sunday. Medical authorities appeared no closer to learning the source of the infection or the mystery at the heart of the outbreak. Officials don’t know why the unusual strain of the E. coli bacteria appears to be causing so many cases of hemolytic uremic syndrome, which attacks the kidneys and can cause seizures, strokes and comas.
“This particular strain we’re dealing with now seems to be unique,” said Dr. Hilde Kruse, program manager for food safety at WHO Europe: Germany’s national health agency said 1,534 people in the country had been infected by EHEC, a particularly deadly strain of the common bacteria found in the digestive systems of cows, humans and other mammals.
The Robert Koch Institute had reported 1,169 a day earlier. The outbreak has hit at least nine European countries, but virtually all of the sick people either live in Germany or recently traveled there. The U.S. is inspecting potential sources of contaminated produce in this country, but officials say there’s no cause for panic. The Robert Koch Institute said 470 people in Germany were suffering from hemolytic uremic syndrome, a number that independent experts were calling unprecedented in modern medical history. The syndrome normally occurs in 10 percent of EHEC infections, meaning the number seen in Germany could be expected in an outbreak three times the size being reported.
- 6/3/2011
‘Super-toxic’ E. coli kills 18 in Europe by Maria Cheng and Kirsten Grieshaber, Associated Press
LONDON — Scientists blamed Europe’s worst recorded food-poisoning outbreak Thursday on a “super-toxic” strain of E. coli bacteria that may be brand new. But while suspicion has fallen on raw tomatoes, cucumbers and lettuce as the source of the germ, researchers have been unable to pinpoint the food responsible for the frightening illness, which has killed at least 18 people, sickened more than 1,600 and spread to least 10 European countries.
An alarming number of victims — about 500 — have developed kidney complications that can be deadly. Chinese and German scientists analyzed the DNA of the E. coli bacteria and determined that the outbreak was caused by “an entirely new, super-toxic” strain that contains several antibiotic- resistant genes, according to a statement from the Shenzhen, China-based laboratory BGI. It said the strain appeared to be a combination of two types of E. coli.
“This is a unique strain that has never been isolated from patients before,” said Hilde Kruse, a food safety expert at the World Health Organization. This new strain has “various characteristics that make it more virulent and toxin-producing” than the many E. coli strains people naturally carry in their intestines. However, Dr. Robert Tauxe, a food-borne-disease expert at the U.S. Centers for Disease Control and Prevention, questioned whether the strain is truly new, saying it had previously caused a single case in Korea in the ’90s. He said genetic fingerprints may vary from specimen to specimen, but it isn’t necessarily enough to constitute a new strain.
“Though it appears to have been around awhile, it hasn’t called attention to itself as a major public health problem before,” Tauxe said.
The U.S. concerns
Whether it’s new or not, the nasty strain hitting Europe points out gaps in the U.S. food safety system that raise worries that similar outbreaks may happen here. It’s impossible to test for every illness-causing form of E. coli, even the kinds we already know about. Today, the food industry and health authorities focus mostly on a single strain that until now was considered the most dangerous. But some different strains collectively known as “the other E. colis” were sickening more and more people well before this extra-deadly European bug surfaced.
There’s no reason to stop eating fresh vegetables in the U.S., but officials are monitoring the situation carefully. nbsp; The Food and Drug Administration has stepped up testing of those foods imported from affected countries as a precaution, though very little is imported. And Agriculture Secretary Tom Vilsack said Thursday there’s no immediate threat from what’s happening in Europe. “We have to constantly look for ways to improve food safety, and that requires us to make sure that we’re testing for the right things,” he said.
European reactions
Meanwhile, Russia expanded a ban on vegetables from Germany and Spain to the entire EU to try to stop the outbreak spreading east, a move the EU called disproportionate and Italy’s farmers denounced as “absurd.” No deaths or infections has been reported in Russia.
Some scientists suspect the deadly E. coli might have been in manure used to fertilize vegetables. Kruse said it is not uncommon for bacteria to evolve and swap genes It is difficult to explain where the new strain came from, she said, but bacteria from humans and ani-mals easily trade genes.
- 6/4/2011
Vegetable scare hits Europe - ‘Cook it or don’t eat it,’ specialist says by Associated Press
BERLIN — Schools have pulled raw vegetables from menus, piles of cucumbers sit untouched on store shelves and farmers say that they’re losing millions. As scientists race to find the source of an E. coli outbreak linked to raw vegetables that has killed 18 in Europe and sickened nearly 2,000, consumers are swearing off lettuce, cucumbers and tomatoes. “Cook it or don’t eat it,” Hamburg, Germany, kidney specialist Rolf Stahl said at a news conference Friday. “That’s my personal recommendation.” Consumers from the northern city of Hamburg — the epicenter of the outbreak — to Bulgaria, Spain, France and Sweden were worried about which vegetables and fruit they could still eat and what they should avoid.
“We no longer offer cucumbers; people just won’t buy them anymore,” said vegetable vendor Mehmet Tanis at Berlin’s busy weekly market in the Kreuzberg district, adding his weekly profit is down $1,450 “They’re completely scared to get sick … though we always get … cucumbers from Jordan.”
Meanwhile, four people in the U.S. were apparently sickened by the outbreak in Europe, health officials said Friday. Three are hospitalized with serious complications, including kidney failure. All four were in northern Germany in May. Two other cases are being in-vestigated in U.S. service members in Germany, said the Centers for Disease Control and Prevention.
Most of those sickened say they ate vegetables beforehand. But being unable to pinpoint the source, German health authorities have issued a broad warning to avoid all tomatoes, cucumbers and lettuce. They initially suspected Spanish cucumbers after three samples tested positive for E. coli; later tests showed they were infected with a different bacteria strain than the outbreak’s. But the jitters have devastated Spain’s produce industry. In Almeria, a key agricultural region, the head of a farmer’s association said the market for exports to the rest of Europe is virtually dead.
- 6/5/2011
Drug cuts breast cancer risk - Side effects less in hormone blockers by Marilynn Marchione, Associated Press
CHICAGO — Millions of women at higher-than-usual risk of breast cancer have a new option for preventing the disease. Pfizer Inc.’s Aromasin cut the risk of developing breast cancer by more than half, without the side effects that have curbed enthusiasm for other prevention drugs, a major study found. It was the first test in healthy women of newer hormone-blocking pills called aromatase inhib-itors, sold as Arimidex, Femara and Aromasin, and in generic form. They’re used now to prevent re-currences in breast cancer patients who are past menopause, and doctors have long suspected they may help prevent initial cases, too.
Prevention drugs aren’t advised for women at average risk of breast cancer. Those at higher risk because of gene mutations or other reasons already have two choices for prevention — tamoxifen and raloxifene. But these drugs are unpopular because they carry small risks of uterine cancer, blood clots and other problems. “Here’s a third breast cancer prevention drug that may in fact be safer,” said Dr. Allen Lichter, chief executive of the American Society of Clinical Oncology.
The study was discussed Saturday at the society’s annual meeting in Chicago, along with another one that could change care for thousands of women each year with breast cancer that has spread to lymph nodes. It found that giving radiation to the armpit — not just the breast — after surgery significantly lowered the chances the cancer would return. The prevention study involved 4,560 women with at least one risk factor — being 60 or older, a prior breast abnormality or pre-invasive cancer, or a high score on a scale that takes into account family history and other things.
They received daily doses of either exemestane, sold as Aromasin, or dummy pills. After about three years, there were 11 cases of invasive breast cancer among those on the drug versus 32 among the others. That worked out to a 65 percent reduction in risk for those on the drug — enough that independent monitors decided all participants should be offered it.
Serious side effects, such as broken bones, high cholesterol and heart problems, were similar in both groups. Earlier studies of aromatase inhibitors found they can cause bone loss, vaginal dryness, problems having sex, joint pain and muscle aches, so it will take longer study to see if these occur, Lichter said.
The study’s leader, Dr. Paul Goss of Massachusetts General Hospital, figured that 26 women would need to take exemestane for five years to prevent a single case of breast cancer. Previous studies suggested 96 women would need to take it for five years for each breast cancer prevented.
Still, it could be a tough sell. These women have only about a 2 percent to 3 percent risk, individually, of being diagnosed with breast cancer in the next five years. A prevention pill that cuts that chance by 65 percent means they’ll have about a 1 percent risk, said Dr. Eric Winer, breast cancer chief at Dana-Farber Cancer Institute in Boston. “Many women are not willing to take a daily medicine” for such a small risk, he said.
Brand-name aromatase inhibitors cost $340 to $420 a month, although some are available as ge-nerics.
The second study involved breast cancer that has spread to the lymph nodes. Standard treatment is surgery followed by chemotherapy or hormone therapy and several weeks of radiation to the breast. Women with large tumors or many cancerous nodes also get radiation to the armpit and lower neck, but doctors don’t know if this helps women with smaller tumors or only one to three cancerous nodes. Dr. Timothy Whelan of McMaster University in Hamilton, Ontario, Canada, led a study of 1,832 such women. All received standard treatment with radiation to the breast, and half also had radiation to the armpit and lower neck. After about five years, 90 percent of those given wider radiation were cancer-free versus 84 percent of the others.
- 6/6/2011
German sprouts suspected in E. coli outbreak - Death toll climbs to 22 in Europe by Kirsten Grieshaber and Tomislav Skaro, Associated Press
HAMBURG, Germany — The terrifying E. coli outbreak in Europe appears to have been caused by vegetable sprouts grown on an organic farm in Germany, an agriculture official said Sunday as the toll climbed to at least 22 dead and more than 2,200 sickened. Preliminary tests found that bean sprouts and other sprout vari-eties from the farm in the Uelzen area, between the northern cities of Hamburg and Hannover, could be traced to infections in five German states, Lower Saxony Agriculture Minister Gert Lindemann said. “There were more and more indications in the last few hours that put the focus on this farm,” Lindemann said.
Many restaurants involved in what is now the deadliest known E. coli outbreak in modern history had received deliveries of the sprouts, which are often used in salads, Lindemann spokesman Gert Hahne said. Definitive test results should be available today, Lindemann said. As health officials tried to pinpoint the source of the unusually lethal outbreak, suspicion first fell on lettuce, cucumbers and tomatoes, perhaps from Spain.$nbsp; Spanish farmers complained that the accusations were having a devastating financial effect. “First it’s the ‘evil’ Spaniards, and then you hear, very surprised, that it is our neighbor,” said Dietrich Benni, who lives near the German farm. “It’s a bit scary all of this especially that it is coming from an organic place.” He added: “No more organic food for me for now.”
The farm was shut down Sunday and all its produce recalled, including fresh herbs, fruits, flowers and potatoes. Two of its employees were infected with E. coli, Lindemann said. He said 18 different sprout mixtures from the farm were under suspicion, including sprouts of mung beans, broccoli, peas, chickpeas, garlic lentils and radishes. As for how the sprouts became contaminated, Lindemann noted that they are grown with steam in barrels at 100 degrees Fahrenheit — an ideal environment for bacteria to multiply. He said it is possible that the water was contaminated with E. coli or that the sprout seeds — purchased in Germany and other countries — contained the germ. He said the farmers had not used any manure, which is commonly spread on organic farms and has been known to cause E. coli outbreaks.
Melanoma survival rises with new drugs - 2 studies yield promising results in skin cancer victims by Marilynn Marchione, Associated Press
CHICAGO — They’re not cures, but two new drugs produced unprecedented gains in survival in separate studies of people with melanoma, the deadliest form of skin cancer, doctors reported Sunday. In one study, an experimental drug showed so much benefit so quickly in people with advanced disease that those getting a comparison drug were allowed to switch after just a few months. The drug, vemurafenib, targets a gene mutation found in about half of all melanomas. The drug is being developed by Genentech, part of Swiss-based Roche, and Plexxikon Inc., part of the Daiichi Sankyo Group of Japan. The second study tested Bristol-Myers Squibb Co.’s Yervoy, a recently approved medicine for newly diagnosed melanoma patients, and found it nearly doubled the number who survived at least three years.
“Melanoma has just seen a renaissance of new agents,” and more are being tested, said Dr. Allen Lichter, chief executive of the American Society of Clinical Oncology. The new studies were pre-sented Sunday at the oncology group’s annual meeting in Chicago and published online by the New England Journal of Medicine.
“This is really an unprecedented time of celebration for our patients,” said Dr. Lynn Schuchter, of the University of Pennsylvania’s Abramson Cancer Center.
The new drugs are not by themselves cures, but “the future is going to be built upon the success” by testing combinations of these newer drugs, she said.
Melanoma is on the rise. There were 68,000 new cases and 8,700 deaths from it in the U.S. last year, the American Cancer Society estimates. Only two drugs had been approved to treat it, with limited effectiveness, until Yervoy, an immunesystem therapy, won approval in March.
The experimental drug, vemurafenib, is aimed at a specific gene mutation, making it the first so-called targeted therapy for melanoma. It got attention when a massive 70 percent of those with the mutation responded to it in early safety testing. The new study, led by Dr. Paul Chapman, of the Memorial Sloan-Kettering Cancer Center in New York, was the key test of its safety and effectiveness. It involved 675 patients worldwide with inoperable, advanced melanoma and the gene mutation. They got vemurafenib pills twice a day or infusions every three weeks of dacarbazine, a chemotherapy drug.
After six months, 84 percent of people on the drug were alive versus 64 percent of the others. Less than 10 percent on it suffered serious side effects: mostly rashes, joint pain, fatigue, diar-rhea and hair loss. About 18 percent of patients developed a less serious form of skin cancer. More than a third needed doses altered because of side effects. The study continues, and many remain on the drug.
“Within 72 hours, their symptoms improve; pain medicines can be reduced,” Schuchter said.
The study was sponsored by the drug’s makers, and many of the researchers consult or work for them. The firms are seeking approval to sell the drug and a companion test for the gene mutation in the U.S. and Europe. Yervoy, the other new drug, isn’t chemotherapy but a therapy to fuel the immune system to fight cancer. Dr. Jedd Wolchok, of Memorial Sloan-Kettering, led the first test of it in newly diagnosed melanoma patients: 502 got dacarbazine; half also got Yervoy. After a year, 47 percent of those on Yervoy were alive versus 36 percent of the others. At three years, survival was 21 percent with Yervoy, 12 percent for chemotherapy alone. Side effects included diarrhea, rash and fatigue. More than half on the new drug had major side effects versus one-quarter of those on chemotherapy alone. Bristol-Myers Squibb paid for the study. Treatment with Yervoy includes four infusions over three months, at $30,000 per infusion.
- 6/7/2011
No E. coli found in sprouts so far - Germany still awaits tests on 17 samples by Juergen Baetz and David Rising, Associated Press
HAMBURG, Germany — Backtracking for the second time in a week, officials Monday said preliminary tests have found no evidence that vegetable sprouts from an organic farm in northern Germany were to blame for the deadliest E. coli outbreak in modern history. A day earlier, the same state agency, Lower Saxony’s agriculture ministry, announced that the sprouts appeared to be the culprit in the outbreak that has killed 22 people and sickened more than 2,330 others across Europe, most of them in Germany, over the past month.
Last week, German officials pointed to tainted cucumbers from Spain as a possible cause, igniting vegetable bans and heated protests from Spanish farmers, who suffered heavy financial losses. Researchers later concluded the Spanish cucumbers were contaminated with a different strain of E. coli.
In outbreaks, it is not unusual for certain foods to be suspected at first, then ruled out.
In 2008 in the U.S., raw tomatoes were initially implicated in a nationwide salmonella outbreak. Consumers shunned tomatoes, costing the tomato industry millions. Weeks later, jalapeno peppers grown in Mexico were determined to be the cause.
The agriculture ministry said 23 samples from the organic sprouts farm tested negative for the highly aggressive, “super-toxic” strain of E. coli that is killing people, with tests on 17 more samples still under way. However, the negative results do not mean that previous sprout batches weren’t contaminated.
“Contaminated food could have been completely processed and sold by now,” ministry spokeswoman Natascha Manski said. In that case, the number of people stricken might keep rising for at least another week, as the produce may have already been delivered to restaurants and grocery stores.
More than 630 victims are hospitalized with a serious complication that can lead to kidney failure.
- 6/8/2011
Germany draws fire on E. coli cases by Associated Press
LONDON — Outside health experts and German lawmakers roundly criticized Germany on Tuesday for a bungled investigation into the world’s deadliest E. coli outbreak, saying the infections should have been spotted much sooner. Many experts have been surprised, even shocked, at lapses in the German inquiry, and some say the culprit food may never be known. Weeks after the outbreak began on May 2, German officials are still looking for its cause. Spanish cucumbers were initially blamed, then ruled out after tests showed they had a different strain of E. coli. On Sunday, investigators cited German sprouts, only to backtrack a day later when initial tests were negative. The sprouts are still being tested.
“If we don’t know the likely culprit in a week’s time, we may never know the cause,” said Dr. Guenael Rodier, the director of communicable diseases at the World Health Organization. He said the contaminated vegetables have probably disappeared from the market. So far, the super-toxic strain of E. coli has killed 24 people, infected more than 2,400 and left hundreds hospitalized with a serious complication that can lead to kidney failure. New cases are being reported every day — 94 more in Germany on Tuesday. John Dalli, the European Union health chief, warned Germany against issuing any more premature conclusions about the source of contaminated food, saying it spreads panic and harms food producers.
- 6/9/2011
Hundreds of mutations may cause autism - Three studies report findings by Shari Roan, Los Angeles Times
LOS ANGELES —Autism is not caused by one or two gene defects but probably by hundreds of different mutations, many of which arise spontaneously, according to research that examined the genetic underpinnings of the disorder in more than 1,000 families.
The findings, reported in three studies published Wednesday in the journal Neuron, cast autism disorders as genetically very complex, involving many potential changes that may produce, in essence, different forms of autism. The affected genes, however, appear to be part of a large network involved in controlling the development of synapses, the critical junctions between nerve cells that allow them to communicate, according to one of the studies. The insights provide a wealth of targets to pursue in developing treatments, scientists said.
Understanding the genetic causes of autism spectrum disorders may promote more accurate diagnoses, and research on synapse formation and function could yield treatments that address the flow of signals between nerve cells. “For the first time we’re getting a sense of how many areas of the genome are likely to contribute to autism,” said Dr. Matthew W. State, associate professor of psychiatry and genetics at Yale University and the lead investigator of one of the reports. “We know there are multiple, different ways to get autism.” Autism spectrum disorders are a group of conditions, ranging from severe to mild, that are characterized by problems with social interactions.
Those with autism may exhibit repetitive behaviors and narrow, obsessive interests; some may have low IQs or problems with language development. About one in110 U.S. children has an autism spectrum disorder, according to the Centers for Disease Control and Prevention. An estimated 25 percent of cases are linked to inherited gene mutations. Some of these high-risk genes have already been identified. But researchers have been puzzled by the cause of the disorder in families with no history of autism.
India asthma sufferers cast hopes on fish by Omer Farooq, Associated Press
HYDERABAD, India — Thousands of people seeking relief from asthma gathered in southern India on Wednesday to swallow live sardines smeared with secret herbs that they believe will cure them. People travel every June from across India to Hyderabad for the treatment offered free by one family on a day chosen by as-trologers. The Goud family says it received the secret formula from a Hindu saint about 170 years ago but has refused doctors’ requests for the herbal mix, saying the saint warned it would lose its potency if commercialized.
After swallowing the live fish late Wednesday, the patients began a strict 45-day diet of 25 different foods, including lamb, rice, white sugar, dried mango, spinach and clarified butter. They must abstain from deep-fried food and repeat the treatment at least once within two years. Although the treatment has been criticized by doctors, thousands of people from across the country continue to flock to the annual event. “I have been coming here for the last two years and it has given me a lot of relife,” said Balbeer Singh, 45, a businessman who traveled from the northern city of Ludhiana. “There is definitely something good in this for our health, otherwise so many people would not have come,” said Santosh Ben, 35, a homemaker from the western city of Vadodra.
Cukes under scrutiny again in E. coli search
Berlin - Cucumbers were back on the radar of health authorities Wednesday as the possible cause of an E. coli outbreak in Europe that has killed at least 26 people and sickened more than 2,700 others. Two weeks ago, investigators blamed Spanish cucumbers for the deadly outbreak, then later ruled them out. Now, suspicions are on a cucumber of unknown origins that sickened a family in eastern Germany. The first food found to be contaminated with the strain, it was in compost, but there’s no solid evidence it’s the source.
- 6/10/2011
Dutch discover different, less deadly strain of E. coli
Amsterdam - Dutch authorities recalled red beet sprouts from three nations Thursday after samples were found to be contaminated with a strain of E. coli bacteria that’s apparently less dangerous than the one causing Europe’s deadly E. coli crisis. Meanwhile, German officials said three more people died of the illness Thursday, raising the toll to 29 in less than six weeks.
The Dutch Food Safety Authority said labs were still trying to identify the Dutch strain of E. coli, but said there have been no immediate reports of serious illness.
- 6/11/2011
European E. coli outbreak traced to German sprouts by Kirsten Grieshaber and David Rising, Associated Press
BERLIN — After a month of searching and testing thousands of vegetables, simple detective work trumped science in the hunt for the source of the world’s deadliest E. coli outbreak. The culprit: German grown sprouts. Health officials announced Friday that sprouts from a farm in northern Germany caused the outbreak that has killed 31 people, sickened nearly 3,100 and prompted much of Europe to shun vegetables. “It was like a crime thriller where you have to find the bad guy,” said Helmut Tschiersky-Schoeneburg, head of Germany’s consumer protection agency.
Health officials said that they tracked the bacteria’s path from hospital patients struggling with diarrhea and kidney failure to the restaurants where they’d dined to specific meals and ingredients they ate — and finally, back to a single farm.
There are more questions to answer, including what contaminated the sprouts in the first place: Was it tainted seeds or water, or nearby animals? That answer is still elusive. Still, it was little surprise that sprouts were the culprit. They have been blamed in least 30 food poisoning cases over the past 15 years in the U.S. and a large outbreak in Japan in 1996 that killed 11 people and sickened more than 9,000. While sprouts are full of protein and vitamins, their growing conditions and the fact that they are mostly eaten raw make them ideal transmitters of disease. Cultivated in water, they require heat and humidity — precisely the same conditions that E. coli requires to thrive. They have an abundant surface area for bacteria to cling to; washing will not help if the seeds themselves are contaminated.
“E. coli can stick tightly to the surface of seeds used to grow sprouts and they can lay dormant on the seeds for months,” said Stephen Smith, a microbiologist at Trinity College in Dublin. Once water is added to make them grow, the bacteria can reproduce up to 100,000 times. Interviews with thousands of patients — mostly women ages 20 to 50 with healthy lifestyles — led investigators to conclude initially that salads may be the problem. But the seemingly ubiquitous alfalfa, radish and other sprouts weren’t yet on anyone’s radar. The outbreak has sickened nearly 3,000 people in Germany, with 759 of them suffering from a serious complication that can cause kidney failure; 12 other European nations have 97 cases and the U.S. has three.
- 6/16/2011
Russia keeps food ban even as E. coli cases fall
Berlin - The EU protested Wednesday against Russia’s keeping a broad ban on European- grown vegetables despite the identification of sprouts as the source of a deadly E. coli outbreak. In-vestigators said last week they’d found that vegetable sprouts from a farm in northern Germany were the origin, and all signs show the crisis is declining. The Robert Koch Institute, Germany’s disease control center, said just nine more people were reported ill Wednesday, bringing the total since the start of the outbreak in May to 3,244; 37 people have died in Germany. More than 100 people have fallen ill in 13 other European nations, the U.S. and Canada, according to the World Health Organization.
- 6/23/2011
Report: E. coli outbreak was a blend of 2 deadly strains
London - A mix of two dangerous E. coli strains caused the recent deadly food poisoning outbreak in Germany, according to a new study of the bacteria’s DNA. Scientists said the E. coli outbreak strain combined one that makes toxin and one that sticks to the gut in a way that potentially speeds up the body’s absorption of the toxin They called it “unprecedented” in its lethality. Unlike previous outbreaks, the German E. coli strain caused three times as many cases of a severe complication that can lead to kidney failure. It was the deadliest E. coli outbreak in history, infecting 3,601 people and killing 39 across Europe More than 800 people developed kidney problems from the outbreak.
- 6/26/2011
Diabetes a global illness now - Doubling since 1980, 347 million cases seen by Maria Cheng, Associated Press
LONDON — The number of adults worldwide with diabetes has more than doubled in three decades, jumping to an estimated 347 million, a new study found. Much of that increase is due to aging populations — diabetes typically hits in middle age — and population growth, but part has been fueled by rising obesity rates.
With numbers climbing almost everywhere, experts said the disease is no longer limited to rich countries and is now a global problem. Countries in which the numbers rose fastest include the United States, Cape Verde, Samoa, Saudi Arabia and Papua New Guinea. “Diabetes may well become the defining issue of global health for the next decade,” said Majid Ezzati, chair of global environmental health at Imperial College London, one of the study’s authors.
He noted the figures don’t reflect the generations of overweight children and young adults who have yet to reach middle age. That could create a massive burden on health-care systems. “We are not at the peak of this wave yet,” he said. “And unlike high blood pressure and cholesterol, we still don’t have great treatments for diabetes.”
Still, in Britain and elsewhere in Western Europe, despite growing waistlines, there was only a slight rise in diabetes. Experts weren’t sure why and said there could be several reasons, including worse detection of the disease, genetic differences, or perhaps Europeans are better at getting heavy people to reduce their chances of developing diabetes. Women in Singapore, France, Italy and Switzerland remained relatively slim and had virtually no change in their diabetes rates. Numbers also stayed flat in sub-Saharan Africa, central Latin America and rich Asian countries.
Type 2 is the most common type of diabetes and is often tied to obesity. It develops when the body doesn’t produce enough insulin to break down glucose, inflating blood sugar levels. The disease can be managed with diet, exercise and medication but chronically high blood sugar levels causes nerve damage, which can result in kidney disease, blindness and amputation. For their estimate, Ezzati and colleagues examined more than 150 national health surveys and studies that tracked Type 2 diabetes in adults older than 25 in 199 countries and territories. They used modeling to estimate cases for another 92 countries.
- 6/28/2011
FDA issues salmonella warning on sprouts
Washington - The Food and Drug Administration has issued a rare warning, asking diners to avoid Evergreen Produce brand alfalfa sprouts or spicy sprouts because they may be linked to 20 cases of salmonella poisoning. The Idaho-based company declined an FDA request to voluntarily recall the sprouts, which the FDA says may be linked to illnesses in Idaho, Montana, New Jersey, North Dakota and Washington state. Nadine Scharf, who identified herself as the co-owner of the company, said Monday that the company has stopped producing the alfalfa and spicy sprouts. She said she doesn’t believe the agen-cy has enough evidence to link the illnesses to her products.
- 7/6/2011
Seeds from Egypt may link outbreaks of E. coli
London - One batch of fenugreek seeds imported from Egypt is the most likely common link between E. coli outbreaks in Germany and France, the European Food Safety Authority’s task force said Tuesday. The European Union will temporarily ban imports of “certain types” of seeds from Egypt and withdraw, sample and destroy seeds from one Egyptian exporter, the European Commission said in a statement. Fenugreek is a clover-like plant that is a common ingredient in curry. So far, the strain of E. coli has killed 51 people, including 49 deaths in Germany and one each in Sweden and the U.S.
- 7/21/2011
Map of DNA to fight disease - Black people could benefit by Eryn Brown, Los Angeles Times
LOS ANGELES — Two independent research teams have used a new method to develop the first detailed maps of the places where DNA is likely to be re-arranged in the genomes of black people, creating a tool that will help find genes that cause disease, scientists reported Wednesday. The new maps pinpoint thousands of “hotspots” on chromosomes where recombination— agene-swapping process that is crucial to creating genetic diversity but is sometimes linked to disease — is likely to occur.
The knowledge will help researchers uncover the genetic underpinnings of illness in all people but particularly in blacks, said Harvard Medical School geneticist David Reich, the senior author of a study published online by the journal Nature. To date, medical genetics studies have focused almost exclusively on people of European descent. “African Americans have a unique gene structure,” he said. “If they’re not studied, we won’t find the genes that cause disease.” Reich’s team, co-led by University of Oxford statistician Simon Myers, looked at DNA data collected from 29,589 unrelated black Americans who had participated in various genetic studies around the U.S. With so many subjects, Reich said, the map is the most accurate map available for any popu-lation. The team found about 2,500 hotspots that were active in people of West African descent but scarce among Europeans.
The second team, led by University of California, Los Angeles geneticists, looked at DNA from 2,864 black Americans and African Caribbean’s and also found significant differences from European DNA. The UCLA researchers published their results online in the journal Nature Genetics.
To construct the maps, both teams took advantage of a unique characteristic in blacks: their genes are a relatively recent blend of European and West African DNA. Reich likened the blending of genetic heritages to editing film.
Individuals produce eggs or sperm containing long sections of DNA from each of their parents. Much like reels of film, those sections are cut and spliced together. The splices are where recombination occurs. Because the mixture of African and European DNA in blacks Americans has taken place over just six generations, on average, each person’s reel of film has only broken up a handful of times . That leaves “a mosaic of large, unbroken chunks of genetic information” in black Americans’ genes, Reich said. The scientists compared those long chunks to known sequences of African and European DNA and figured out where the recombination hotspots were.
In populations where genetic mixing took place further in the past, such as South Asians, the DNA has been cut and spliced more times, Reich said. This results in smaller chunks of genetic information that are too short to compare to reference genomes. In such populations, scientists building recombination maps will have to rely on the same methods used in Europeans. These include comparing an individual’s DNA to that of his or her relatives to figure out where recombination has occurred.
- 7/28/2011
Tobacco regulation to get new test in appeals court
The free-speech rights of tobacco companies are improperly restricted by the Food and Drug Administration’s regulation of tobacco marketing, including the imposition of graphic warnings about the dangers of smoking, an industry attorney argued Wednesday.
Noel Francisco, a lawyer for R.J. Reynolds Co., told a three judge panel from the 6th U.S. Circuit Court of Appeals that the Family Smoking Prevention and Tobacco Control Act is too sweeping. It “restricts the adult population to what is fit for children,” said Francisco, who argued the case on behalf of multiple tobacco companies. U.S. Justice Department attorney Mark Stern said tobacco is “lethal and addictive” and the government has a right and duty to regulate how it is sold.
The appeals panel is weighing whether to overturn a January 2010 ruling by U.S. District Judge Joseph H. McKinley Jr. in Bowling Green, Ky. He rejected much of the first major challenge to the law brought by tobacco companies.
- 8/1/2011
Quick HIV field test promising - Might be used for variety of diseases by Christian Torres, The Washington Post
WASHINGTON — The first field trial for a “lab on a chip” accurately detected both HIV and syph-ilis among a Rwandan population, researchers reported Sunday.
Blood samples injected into the clear plastic, credit card-shaped device produced results within 20 minutes. This kind of test could offer a faster, cheaper and easier way to detect infectious diseases that afflict developing countries, according to the report published online by Nature Medicine.
“This is a big step,” said Doris Rouse, a vice president at RTI International in North Carolina, who specializes in global health technologies and was not involved with the study. “What’s especially exciting about this device is that it’s rugged, easy to use and doesn’t require a lot of infrastructure or training.” Cheap HIV tests that provide results within 30 minutes have been available for years, but many rely on a decades-old method called lateral flow. A sample of blood or oral fluid is placed on a strip of paper, and like a pregnancy test, a colored band appears and can be interpreted to indicate infection.
Few lateral flow tests, however, have proved reliable across multiple settings and types of infection. Many people in developing countries instead rely on expensive and time-consuming laboratory analysis.
The lab on a chip trial shows 100 percent detection of HIV-positive cases, with only one false positive out of 70 samples, according to the report. When a dual test of HIV and syphilis was performed, the chip had similar accuracy for HIV; 94 percent of syphilis cases were detected, though there was a higher rate — four out of 67 total samples — for false positives.
Overall, the test proved successful in a difficult environment with little infrastructure, said Samuel Sia, one of the study’s authors and a biomedical engineer at Columbia University According to Sia the chip could also potentially detect hepatitis B and C, herpes, gonorrhea and chlamydia — infections that are often found in combination with HIV and have few reliable and cheap tests available. All infections could be detected on a single device, at the same time and with a small amount of blood — a fraction of a needle prick’s worth.
The chip — which the research team named mChip — is comparable in price to lateral flow tests. Sia estimated his device would cost $2 to $3; lateral flow tests can cost more than $4, and they lack the cost-efficiency of detecting multiple infections. Most lateral flow tests also require interpretation.
Funding is crucial for further development of the lab on a chip. A lack of interest from companies is likely keeping the test from reaching the ground within two or three years, Sia estimated, despite excitement from the global health community. “The challenge now,” he added, “is how to go from an academic study to distributing this test in the field.”
- 8/3/2011
Ground turkey tied to 1 death, 76 illnesses - Ky., Ind. among 26 states hit; no recall until origin known by Mary Clare Jalonick and Lindsey Tanner, Associated Press
WASHINGTON — One person has died from salmonella poisoning that appears to be linked to eating ground turkey, but the government is still investigating who produced the meat and has not initiated a recall, federal officials say. Seventy-six people in 26 states, including Kentucky and Indiana, have been made sick from the same strain of the disease. The federal Centers for Disease Control and Prevention did not say where the person who died became sick and released no details about the death, but California Department of Public Health spokesman Mike Sicilia said the death was one of two cases of the illness reported in Sacramento County.
The illnesses date to March, and the CDC said that cultures of ground turkey from four retail locations between March 7 and June 27 showed salmonella contamination, though those are not specifically linked to the illnesses. The agency said preliminary information showed that three of those samples have been linked to the same production establishment but did not name the retailers or the manufacturers.
The Agriculture Department oversees meat safety and would be the agency to announce a re-call. The department sent out an alert about the illnesses late last week telling consumers to properly cook their turkey, which can decrease the chances of salmonella poisoning. But the department has not given consumers any further warnings about the source of the tainted meat.
The Agriculture Department’s Food Safety and Inspection Service “has not linked these illnesses to a particular brand, product or establishment, and therefore has not issued a recall,” spokesman Brian Mabry said Tuesday.
Food safety advocate Bill Marler, an attorney who has represented victims of the nation’s biggest food-borne illness outbreaks, said he believes the three positive samples should prompt a recall. “Consumers have no idea what to do except not eat ground turkey,” he said. The illnesses are spread all over the country. The states with the highest number sickened were Michigan and Ohio, 10 ill-nesses each, while nine illnesses were reported in Texas. Illinois had seven, California six and Pennsylvania five. The remaining states have between one and three reported illnesses linked to the outbreak: Alabama, Arizona, Georgia, Iowa, Indiana, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, Nevada, New York, Oklahoma, Oregon, South Dakota, Tennessee and Wisconsin.
A chart on the CDC’s website shows cases have occurred every month since early March, with spikes in May and early June. The latest reported cases were in mid-July, although the CDC said some recent cases may not have been reported yet.
University of Pennsylvania bioethicist Art Caplan said the government’s handling of the outbreak raises ethical questions about why the public wasn’t warned sooner.
“You’ve got to protect the public health. That’s their first and primary value — not industry, not any other goal. They have to warn as quickly as they think there’s reasonable evidence for concern,” Caplan said.
He said that uncertainty about the outbreak’s source might explain the long silence, but added, “the moral duty is to really get the word out as soon as you have evidence of a problem.”
CDC spokeswoman Lola Russell said Tuesday it can take three to four weeks to confirm one case. Identifying an outbreak can take considerably longer than that when cases of foodborne illness occur sporadically, in several states, as has happened in the current outbreak, she said.
Russell said the CDC isn’t advising the public to avoid eating ground turkey, but does urge people to cook it properly.
Ground turkey is considered safe to eat when the internal temperature reaches 165 degrees. For turkey patties or burgers, internal temperatures on each side should be measured.
Other government advice:
- Refrigerate raw meat and poultry within two hours after purchase, one hour if temperatures in the house exceed 90 F.
- Refrigerate cooked meat and poultry within two hours after cooking.
- Wash hands with warm, soapy water for at least 20 seconds before and after handling raw meat and poultry.
The CDC estimates that 50 million Americans each year get sick from food poisoning, including about 3,000 who die. Salmonella causes most of these cases. The most common symptoms of salmonella are diarrhea, abdominal cramps and fever within eight hours to 72 hours of eating a contaminated product. It is life threatening to some with weakened immune systems.
Salmonella infections may last about a week and often don’t require treatment other than drinking plenty of water and other fluids. Sometimes antibiotics are used when the infection spreads from the intestines. The CDC says some salmonella bacteria have become drug-resistant because of antibiotics used to promote livestock growth.
- 8/4/2011
Cargill recalling ground turkey - 36 million pounds linked to outbreak by Mary Clare Jalonick, Associated Press
WASHINGTON — Meat giant Cargill is recalling 36 million pounds of ground turkey linked to a nationwide salmonella outbreak that has killed one person in California and sickened at least 76 others.
Illnesses in the outbreak date back to March and have been reported in 26 states coast to coast.
Cargill said Wednesday that it is recalling fresh and frozen ground turkey products produced at the company’s Springdale, Ark., plant from Feb. 20 through Aug. 2 because of possible contamination from the strain of salmonella linked to the illnesses.
Company officials said that all ground turkey production has been suspended at the plant until the company is able to determine the source of the outbreak.
“Given our concern for what has happened, and our desire to do what is right for our consumers and customers, we are voluntarily removing our ground turkey products from the marketplace,” said Steve Willardsen, president of the company’s turkey processing business.
The Minnesota-based company said it was initiating the recall after its own internal investigation, an Agriculture Department investigation and information about the illnesses released by the Centers of Disease Control and Prevention.
All of the packages recalled include the code “Est. P-963” on the label, said. The packages were labeled with different brands, including Cargill’s Honeysuckle White.
The CDC said cultures from four retail locations between March 7 and June 27 showed contamination with the same strain of salmonella. A chart on the CDC’s website shows cases have occurred every month since early March.
The states with the highest number sickened were Michigan and Ohio, 10 illnesses each. The remaining states have between one and three reported illnesses linked to the outbreak, according to the CDC: Alabama, Arizona, Georgia, Iowa, Indiana, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, Nevada, New York, Oklahoma, Oregon, South Dakota, Tennessee and Wisconsin.
- 8/11/2011
New approach holds hope for wiping out leukemia by Stephanie Nano, Associated Press
NEW YORK — Scientists are reporting the first clear success with a new approach for treating leukemia — turning patients’ blood cells into assassins that hunt and destroy their cancer cells.
They’ve only done it in three patients so far, but the results were striking: Two appear cancer- free up to a year after treatment, and the third is improved but still has some cancer. Scientists are preparing to try the same gene therapy technique for other kinds of cancer.
“It worked great. We were surprised it worked as well as it did,” said Dr. Carl June, a gene therapy expert at the University of Pennsylvania. “We’re just a year out now. We need to find out how long these remissions last.”
He led the study, published Wednesday by the New England Journal of Medicine and Science Translational Medicine.
It involved three men with very advanced cases of chronic lymphocytic leukemia. The only hope for a cure now is bone marrow or stem cell transplants, which don’t always work and carry a high risk of death.
Scientists have been working for years to find ways to boost the immune system’s ability to fight cancer. Earlier attempts at genetically modifying bloodstream soldiers called T-cells have had limited success; the modified cells didn’t reproduce well and quickly disappeared.
June and his colleagues made changes to the technique, using a novel carrier to deliver the new genes into the T-cells and a signaling mechanism telling the cells to kill and multiply. That resulted in armies of “serial killer” cells that targeted cancer cells, destroyed them, and went on to kill new cancer as it emerged.
For the experiment, blood was taken from each patient and T-cells removed. After they were altered in a lab, millions of the cells were returned to the patient in three infusions. “It was like the worse flu of their life,” June said. “But after that, it’s over. They’re well.”
- 8/14/2011
How to launch a WONDER DRUG - Potentia executives pursue new breakthroughs as Apellis by Patrick Howington, The Courier-Journal
Two years ago, in one of the biggest successes ever for Louisville’s young life-sciences industry, Potentia Pharmaceuticals sold a potentially groundbreaking vision drug to Alcon, the world’s largest eye-care company.
Now Potentia’s two main officers and their new company, Apellis Pharmaceuticals, are using the scientific concept behind that drug to develop a medication for two lung ailments — asthma and chronic obstructive pulmonary disease.&bsp; The drug is designed to block the flawed immune-system activity that causes the in-flammation that figures in those two diseases and many others, including Parkinson’s and Alzheimer’s diseases, said Cedric Francois, the company’s chief executive. Apellis, located in Crestwood, is in the early stages of developing its drug, with animal tests to begin soon.
But Francois said it has already raised $8 million — mostly from East Coast and foreign investors — to pay for ongoing research to gauge the drug’s potential. Apellis is expected to release details of its financing soon. Success in attracting money from major health care venture funds outside Louisville was also key for Potentia, which raised about $25 million to develop the macular degeneration drug it sold to Alcon.
That deal came six years after Potentia moved to Louisville from Boston, where it was established after some of its founders won business-plan competitions at Harvard University and the Massachusetts Institute of Technology.
Apellis hopes it won’t take that long to develop its lung drug to the point that a larger pharmaceutical company will buy rights to it. Francois said he hopes that will happen in one to three years.
“We kind of know how to do it now,” said Francois, a physician trained in Belgium and at the University of Louisville. The compound in the Potentia and Apellis drugs binds tightly to an immune-system protein to block the process that can cause chronic inflammation when the system fails to turn itself off properly after attacking a virus or bacteria. Scientists at the University of Pennsylvania discovered the drug, and Potentia acquired the rights to it in 2006.
After that, Francois and Pascal Deschatelets, a Harvardtrained chemist who is chief operating officer of Apellis, developed the compound into a drug that could be injected into eyes of patients with age-related macular degeneration, the leading cause of blindness.
Now they hope to create a form of the compound that can be inhaled into the lungs to treat severe asthma and COPD. Beyond that, they see the possibility of adapting the compound — which blocks a disease’s basic mechanism rather than treating its symptoms — for use against other conditions. “We believe that we have something very attractive that could be very, very important medically,” Francois said. “Hopefully (we can) create a conceptual shift where people target those diseases in different ways than they do today.”
Mike Yeadon, former chief scientific officer for respiratory research at drug giant Pfizer, said if Apellis’ approach works, it “will be the first to really get to grips with the disease.” Yeadon now has a consulting firm in England and has.
- 8/15/2011
Stores recall ground beef by Associated Press
DODGE CITY, Kan. — Kroger, Winn-Dixie and Publix Super Markets are recalling certain packages of ground beef due to possible E. coli contamination. The recalls involve meat from National Beef Packaging Co. of Dodge City sold mainly in Florida, Georgia, Alabama, Mississippi, Louisiana, South Carolina and Tennessee, but the meat could have been distributed nationwide. Kroger products include ground chuck, ground beef patties, and meatballs and meatloaf made in the stores. Packages have “sell by” dates of July 29-Aug. 12. Winn-Dixie products include ground chuck and patties with “sell-by” dates of July 31-Aug. 12. The Publix products include meatballs, meatloaf, ground chuck patties, stuffed peppers, seasoned Salisbury steak and others with “sell by” dates of July 25 through Aug. 12. The Agriculture Department said there have been no reports of illnesses.
- 8/16/2011
U of L gets funds to study macular degeneration
A retired anesthesiologist and graduate of the University of Louisville School of Medicine has given $4 million to U of L to fund research in macular degeneration. Dr. Geneva Matlock, of San Clemente, Calif., has given a total of more than $5 million to U of L in the past three years. Matlock was diagnosed with wet macular de-generation 10 years ago, but through treatment has retained her vision. But Matlock’s mother, who died at the age of 99, was blind for the last decade of her life.
“Dr. Matlock’s extraordinarily generous support of our research in macular degeneration speaks to the compassionate and selfless person she is, both as a physician and as a human being,” said Dr. Henry Kaplan, chairman of the Department of Ophthalmology & Visual Sciences at U of L, which will receive the money.
Kaplan’s department has several current research studies examining various aspects of macular degeneration, from causes to treatment with new medicines as well as stem cells.
- 8/17/2011
Tobacco companies sue FDA
Four of the five largest U.S. tobacco companies are suing the federal government over new graphic cigarette labels that include the sewn-up corpse of a smoker and a picture of diseased lungs.
R.J. Reynolds Tobacco, Lorillard Tobacco, Commonwealth Brands, Liggett Group and Santa Fe Natural Tobacco said they filed suit against the Food and Drug Administration late Tuesday. Commonwealth Brands, part of Imperial Tobacco, is based in Bowling Green, Ky.
The companies say the warning labels violate their free-speech rights by requiring them to carry a government sponsored, emotionally charged appeal to not use their legal products. They want the labels stopped.
- 8/18/2011
Brain-eating amoeba found in water kills 3
Atlanta - Two children and a young man have died this summer from a brain-eating amoeba that lives in water, health officials say.
This month, the rare infection killed a 16-year-old Florida girl, who fell ill after swimming, and a 9-year-old Virginia boy, who died a week after he went to a fishing day camp. The boy had been dunked the first day of camp, his mother told the Richmond Times-Dispatch.
Those cases are consistent with past cases, which are usually kids — often boys — who get exposed to the bug while swimming or doing water sports in warm ponds or lakes. The third case, in Louisiana, was more unusual. It was a young man whose death in June was traced to the tap water he used in a device called a neti pot. It’s a small teapot-shaped container used to rinse out the nose and sinuses with salt water to relieve allergies, colds and sinus trouble.
- 8/26/2011
Government detaining all Mexican papayas
The government is detaining all papaya imports from Mexico after testing showed high rates of salmonella contamination in the fruit.
Mexican papayas were linked to 100 cases of salmonella poisoning in 23 states earlier this summer. Subsequent Food and Drug Administration testing of papaya imports found a 16 percent sal-monella contamination rate in papayas from all over Mexico.
- 8/27/2011
Gene-targeting cancer drug OK’d
The Food and Drug Administration has approved a Pfizer drug for a subset of lung cancer patients with a particular genetic mutation.
The twice-a-day pill, called Xalkori, is part of a new wave of personalized medications that fight disease by targeting specific genes found in certain patients. Last week, the FDA approved another drug that uses similar gene targeting technology to treat two rare forms of lymph node cancer.
Xalkori is approved to treat a small subset of non-small cell lung cancer patients, less than 7 percent, who have an abnormal gene that stimulates cancer cells and causes tumor growth. It works by blocking proteins produced by the gene.
About 187,000, or 85 percent, of the 220,000 lung cancer cases diagnosed each year are nonsmall cell lung cancer.
- 8/30/2011
Patients given organs infected with HIV
Taipei, Taiwan - One of Taiwan’s best regarded hospitals said HIV-infected organs were mistakenly transplanted into five patients after a hospital staffer misheard the donor’s test results by telephone.
The five are now being treated with anti-AIDS drugs, an official at National Taiwan University Hospital in Taipei said Monday. The official spoke on condition of anonymity because she is not authorized to deal with the media. The hospital said on its website over the weekend the mistake occurred because a transplant staffer believed he heard the English word “nonreactive” on the donor’s standard HIV test, while the word “reactive” was actually given.
- 8/31/2011
Lung cancer pill offers hope - Some treatment can be tailored by Linda A. Johnson, Associated Press
TRENTON, N.J. — Pfizer Inc.’s just-approved drug Xalkori, the first new medicine in more than six years for lung cancer, proves the value of precisely targeting rare diseases linked to gene variants, cancer specialists and Pfizer executives said Tuesday.
The drug was approved Friday in the U.S., along with a companion diagnostic test for just a small subset of lung cancer patients. It epitomizes drug makers’ new strategy of developing very expensive but effective medicines for relatively few patients to replace the blockbusters for the masses now getting competition from generic drugs. It’s also in the vanguard of long-awaited personalized medicine, in which doctors identify patients with gene changes or variations that fuel their disease, then try to match them with new medicines that target those specific genes. “This is a paradigm shift,” Dr. Paul A. Bunn Jr., a University of Colorado professor and cancer researcher involved in testing Xalkori, said during a conference call set up by Pfizer. “It used to be that everybody with cancer was treated the same,” with surgery and chemotherapy.
Xalkori, a pill with relatively minor side effects compared to those of chemotherapy, was approved for about 4 percent of patients with advanced non small cell lung cancer who have what’s called the ALK fusion gene. When ALK, short for anaplastic lymphoma kinase, and another gene on the same chromosome rearrange their positions and fuse, the ALK gene stays on constantly, fueling cancer cell growth. Xalkori blocks the kinase enzyme, a key in that process.
About 6,000 Americans a year develop this cancer, Pfizer said. Those patients, called ALK positive, can be identified with a $250 molecular diagnostic test developed by Pfizer’s partner, Abbott Molecular Oncology. The test was also approved Friday.
“You’re going to be sparing individuals side effects (and) the waste of resources, time and drug that really isn’t going to help them,” said Dr. Mark Kris, head of the thoracic oncology service at Memorial Sloan-Kettering Cancer Center in New York. In Pfizer-funded studies that led to Xalkori’s approval, tumors disappeared, shrank or stopped growing in just over half of patients for nearly two years on average. Research to determine overall survival continues.
By comparison, non small cell lung cancer, about 85 percent of cancer cases, is tough to treat and kills nearly 95 percent of patients within five years.Xalkori, known chemically as crizotinib, costs about $9,600 a month and is taken until it stops fighting tumors, at which point patients likely would be put on older chemo drugs.
- 9/2/2011
Virus targets, shrinks cancer cells by Ryan Flinn, Bloomberg News Service
SAN FRANCISCO — A genetically modified smallpox vaccine was able to target and shrink tumors in some cancer patients while leaving healthy cells unharmed, in the first study to show the potential of using a virus to fight human malignancies. Almost two-dozen patients with advanced cancers were injected with varying amounts of the virus, called JX-594, and six participants in the highest dose group had their tumors stabilize or shrink, according to the report released Thursday by the journal Nature. The trial demonstrated that a virus injected into the blood stream could infect and spread within tumors without harming other cells, said John Bell, one of the study’s authors and a cancer research scientist at Ottawa Hospital Research Institute. Results were from the first of three testing stages generally required for regulatory approval.
“It’s never been shown before that we could do this in humans,” Bell said in an interview. “We even see in some patients a modest therapeutic benefit. Researchers used the same strain of virus that’s used in the smallpox vaccine, called vaccinia virus, because of its natural ability to replicate itself in cancer cells, the report said. They then modified it to enhance its cancer-fighting properties.
While vaccinia virus is similar to smallpox, it doesn’t contain smallpox and can’t cause the disease, according to the U.S. Centers for Disease Control and Prevention.
The approach differs from so-called cancer vaccines, such as Merck & Co.’s Gardasil shot that targets a virus that causes cervical cancer, or Dendreon Corp.’s Provenge, which stimulates an immune response against prostate cancer cells. The therapy will be tested in a broader trial, said Bell.
- 9/5/2011
Boy in Indiana has swine flu - CDC says new strain is hybrid by The Indianapolis Star
INDIANAPOLIS — A new strain of swine flu has shown up in two young children in Pennsylvania and Indiana who had direct or indirect contact with pigs. There’s no sign the virus has spread beyond the two cases, the Centers for Disease Control and Prevention reported Friday. “We wanted to provide some information without being alarmist,” because people have contact with pigs at fairs this time of year, and doctors should watch for possible flu cases, said Lyn Finelli, the CDC’s flu surveillance chief. “We’re always concerned when we see transmission of animal viruses to humans.”
People rarely get flu from pigs — only 21 cases have been documented in the past five years — and it’s too soon to know how infectious this virus will be, Finelli said.
This particular virus has only been seen eight times in the past five years. The Indiana case was the ninth and the Pennsylvania case the 10th, according to the CDC’s Morbidity and Mortality Weekly Report issued Friday. In Indiana, the virus was picked up as part of routine flu surveillance, said Shawn Richards, respiratory epidemiologist for the state Department of Health. A boy younger than 5, who had chronic health problems, went to the hospital with flu symptoms on July 23. Richards declined to say where the case occurred.
When the boy’s flu test came back positive, the state’s virology lab requested the specimen because it’s unusual to see the disease at this time of year, Richards said. The lab found the flu strain to be nonhuman and sent it to the CDC. The boy had had no contact with pigs, but a caretaker did in the weeks before he fell ill. She was asymptomatic, Richards said. No other family members appear ill.
In the Pennsylvania case, a girl, also younger than 5, had contact with pigs at an agricultural fair last month. She, too, has recovered, and health officials are investigating reports of illness in other people who went to the fair. No additional cases have been confirmed.
The viruses in the two children were similar but not identical, and Richards said there was no indication of a connection between the two cases. Despite the rarity of such cases, there’s no reason for alarm, health officials say. “What it has told us is that our surveillance systems are working very well,” Richard said.
Studies showed that the virus includes a gene from the 2009 pandemic strain that might let it spread more easily than pig viruses normally do.
The new strain is a hybrid of viruses that have infected pigs over the past decade and a gene from the H1N1strain that caused the pandemic two years ago. It is the first combination virus to turn up in people since the pandemic, said Michael Shaw, a CDC lab chief. It’s classified as an H3N2 virus.
- 9/8/2011
Brain stents after strokes inflict damage
A device that doctors had hoped would be a major advance for many stroke patients appears to be doing more harm than good. The “Gateway-Wingspan” system,“ which was approved in 2005 in hopes of protecting thousands of stroke survivors from another, more devastating attack, turned out to cause more strokes and deaths than aggressively treating patients with drugs and advice, a federally funded study found. The New England Journal of Medicine published the results online Wednesday because of the immediate public health implications.
- 9/12/2011
Salmonella prompts 2nd turkey recall by M.L. Johnson, Associated Press
CHICAGO — Cargill Inc. announced a second recall of ground turkey products Sunday after a test showed salmonella in a sample from the same Arkansas plant tied to a recall last month. The second recall is much smaller than the one the company issued Aug. 3 for 36 million pounds of ground turkey. That recall followed a salmonella outbreak that federal health officials said had sickened 107 people in 31 states, killing one person. The second recall covers about 185,000 pounds of turkey, including trays of ground meat and patties, the U.S. Department of Agriculture said. The products were distributed nationwide under the Kroger, Fresh HEB and Cargill’s Honeysuckle White brands.
No illnesses have been tied to the second recall, which was initiated after a sample from the company’s plant in Springdale, Ark., tested positive for salmonella, the USDA said. Cargill halted production of ground turkey products at the plant Aug. 2 in anticipation of the recall announced the next day, spokesman Mike Martin said. Equipment was taken apart and steam-cleaned. Limited production resumed Aug. 10 after the USDA approved additional anti-bacterial safety measures, Martin said.
The sample that tested positive for salmonella was taken Aug. 24, the USDA said. It was the same strain of salmonella tied to the earlier illnesses, the agency said.
Ground turkey production at the Springdale plant has been suspended again while the Minnesota- based company looks at what other safety procedures might be needed, he said. Production of other products, such as whole turkeys, continues, he said. All ground turkey made at the Springdale plant has “P-963” or “963” on the package, in a USDA seal or perhaps on the cellophane, Martin said.
Consumers who bought products bearing that identification number can call 1-888-812-1646 for instructions on what to do, he said. The recall covers products made on Aug. 23 and 24. Cargill also is recalling ground turkey made on Aug. 30 and 31, the USDA said. Government officials say even contaminated ground turkey is safe to eat if cooked to 165 degrees.
- 9/22/2011
Doxil has proven an effective cancer weapon, but it’s in short supply — along with many other drugs - A LIFE AND DEATH WAIT by Laura Ungar, The Courier-Journal
Barry Norris was relieved and encouraged when a chemotherapy drug called Doxil shrunk a painful, disabling cancerous lesion on his foot to half its size.
But when he arrived at the James Graham Brown Cancer Center in late August for the third of six treat-ments, he was told there was no more Doxil available because of a nationwide shortage and sent home.
“It’s a kick in the head,” said the 54-year-old Louisvillian, who has a cancer called Kaposi’s sarcoma in several spots on his skin. “Am I going to have to spend the rest of my life with an open sore on the bottom of my foot when there’s something that can be done about it?” Across the country, thousands of Americans like Norris are being confronted with shortages of Doxil and dozens of other medications that are forcing them into less-effective treatments or no treatment at all.
“I’m really disappointed now that I can’t get it Now I’m going to have to try something else, and it might not be as effective. ... And there’s nothing I can do about it.”
Barbara Hagerman, 75-year-old ovarian cancer patient who was receiving Doxil treatment ber of drug shortages has nearly tripled over the past six years, rising from 61 in 2005 to a record 178 last year.
The FDA cites several reasons, including a lack of raw materials, manufacturing and quality problems, increased demand and some companies’ decisions to stop making older, less-profitable drugs. In the case of Doxil, which also treats ovarian cancer and multiple myeloma, drug makers give vague reasons regarding manufacturing that boil down to demand outstripping the ability to make the medication. Experts say most shortages involve medicines given by injection or intravenously in the hospital, and include not only cancer drugs but anesthetics, electro-lytes and other medications. “Doxil is the latest example of therapeutic chemo agents that have been in short supply. It feels very urgent when it’s a chemo drug,” said Dr. Beth Riley, a medical oncologist and hematologist at the Brown Cancer Center. “There are situations when there’s no alternative available. You compromise patient care in that situation.”
Barbara Hagerman, a 75-yearold Louisville woman with recurrent ovarian cancer, said she’s had four treatments with Doxil, which was successfully fighting her cancer, with few side effects. She was scheduled for four more treatments at Norton Cancer Institute when her doctor told her supplies had run out across the region and nation. “Now I’m going to have to try something else, and it might not be as effective. … And there’s nothing I can do about it,” said Hagerman, whose cancer was first diagnosed in 2009 and came back about six months ago.
Resuming treatment
Norris, who has lived with his disease since 2010, said he’s not sure if or when he will be able to resume his treatment with Doxil. In the meantime, his half-dollarsized lesion is so painful that he must use a wheelchair or crutches most of the time. “It feels like my foot is in boiling water sometimes,” said Norris. “I’m mad. It’s heartbreaking. It’s wrong.”
Norris said he believes profit considerations are at the root of the shortage. But officials at the companies that make and sell Doxil say the shortage has nothing to do with finances, and they are diligently working to increase the supply. There’s no generic equivalent for the drug, which is used by about 7,000 people at any one time and costs $3,234 for a cycle of treatment. The shortage “is due to manu-facturing issues at our third-party manufacturer,” said Monica Neufang, a spokeswoman for Pennsylvania-based Janssen Pharmaceuticals, which sells Doxil. “Our No. 1 priority is patients. … We deeply regret the circumstances that have caused this shortage.”
Jason Kurtz, spokesman for the Ohio-based third-party maker, Ben Venue Laboratories, would only say “we’re facing capacity constraints” with a drug that is complex to make. He wouldn’t specify what type of constraints, but said examples of such problems include unplanned downtime because of machinery breakdowns and capital- improvement projects that limit manufacturing capacity. Basically, Kurtz said,“The demand for the product is greater than the ability to produce it.”
Neufang said Janssen first notified doctors about supply problems in late June, and set up a first-come, first-served waiting list that now contains about 1,000 patients nationwide. Limited doses became available in early August and were allocated within two weeks, Neufang said, adding that she expects an intermittent supply over the coming months, with patients already on a course of therapy receiving first priority. Officials said they don’t know when the shortage will end.
In the meantime, Kurtz said his company is transitioning out of the contract manufacturing business to focus more on its Bedford Laboratories division, producing generic injectable drugs, but insisted that change doesn’t factor into the shortage. Neufang said her company is working with Ben Venue on the transition and has identified a potential alternative supplier.
As the companies sort out these issues, local doctors and pharmacists are left with one less tool in their fight against cancer. “We simply can’t get it any longer,” said Dr. Michael Kommor, an oncologist with the CBC Group Consulting in Blood Disorders & Cancer, part of Baptist Medical Associates. When a patient needs Doxil, “anyone in this practice is told you can’t treat that person because we don’t have the drug.”
Dr. David Doering, a gynecological oncologist at Norton Cancer Institute, said he has had to take patients off the drug in midtherapy. “This is the first time (a drug shortage) has really affected my practice.”
He said the Doxil shortage is particularly troubling since the medication is effective and generally causes less nausea and hair loss than other chemo drugs.
Also, he said, cancer sometimes grows resistant to the drugs used against it. So if Doxil is stopped and another drug started, the cancer may grow resistant to two drugs, giving doctors even fewer options.
“For some patients,” Doering said, “they can get to the point where there aren’t any more active drugs available for them.”
Patients’ options few
In the meantime, there’s little recourse for patients and doctors facing shortages.
Companies are not legally required to tell the FDA about problems that could lead to shortages, the agency says. Companies that are the sole source of certain drugs must tell the FDA six months in advance if they plan to stop making their product, but there’s no legal penalty if they don’t.
“FDA is urging drug makers to voluntarily notify us if they change production quantities of drugs as a matter of corporate responsibility and in the interest of public health,” FDA’s Ilisa Bernstein said in a statement to con-sumers.
When the agency does receive a warning of an impending shortage, officials said they work with other firms that make the drug — if any exist — and ask them to increase production. Or, officials said, they look for foreign versions of the product made by reputable firms and work to import it on a limited basis.
Last year, officials said FDA helped prevent 38 drug shortages because companies let them know about issues that could lead to supply problems.
Lawmakers and some medical leaders are pushing for more notification. Legislation introduced in Congress this summer and supported by the American Hospital Association would, among other things, require drug makers to notify the FDA at least six months in advance if they plan to discontinue a drug or if they expect an interruption or adjustment in the manufacturing process that could lead to a shortage.
Riley, the oncologist, said the requirement could lead to stockpiling and still wouldn’t make drugs any more available. But she said she’s glad the medical community and political leaders are trying to address the issue.
Still, she and others worry the shortages will continue to rise.
A recent hospital association survey showed that almost all hospitals reported experiencing one or more drug shortages in the past six months, with 44 percent reporting 21 or more shortages. The survey also showed that three out of four hospitals reported rationing or restricting drugs in short supply.
“These shortages are becoming ever more frequent,” Kommor said. “It’s extremely concerning. This is no doubt going to get worse.”
Doctors said the long-term consequences of drug shortages are still unknown.
“We won’t know the impact of changing therapy until down the road,” Riley said.
Norris said he doesn’t think his cancer will kill him, but fears his lesions will grow and keep him from ever getting around on his own and doing things as simple as walking his dogs. He likened that to “a very, very slow aging and death.” “It’s frustrating to give up little parts of your life along the way,” he said. “And it feels like nobody can do anything about it. … All you can do is remain hopeful.”
- 9/28/2011
Listeria outbreak deadliest in decades
Washington - Health officials say as many as 16 people have died from possible listeria illnesses traced to Colorado cantaloupes, the deadliest food outbreak in more than a decade. The Centers for Disease Control and Prevention said Tuesday that 72 illnesses and 13 deaths are linked to the tainted fruit.
- 9/30/2011
Killer cantaloupe, scary sprouts spur fears by Associated Press
MILWAUKEE — Avoid foreign produce. Wash and peel fruit. Keep it refrigerated. None of these common tips would have guaranteed your safety from the deadliest food outbreak in a decade, the one involving cantaloupes from Colorado.
Whether it’s sprouts or spinach, hamburger or turkey; whether the government conducted double, triple or quadruple inspections, the truth is that no food will ever be completely free of risk. And a few foods have become so risky that certain people such as children, pregnant women and the elderly may do best to avoid them altogether until growers and the government figure out how to make them safer, some food experts say.
An unappetizing fact: Although the current cantaloupe outbreak has been tied to just one farm in Colorado, it’s at least the 19th outbreak involving that melon since 1984. It’s also the first one caused by listeria, a germ that actually likes to be in the refrigerator and thrives in this fruit, which cannot be cooked.
It’s not just fruits and vegetables. Earlier this week, Tyson Fresh Meats issued a recall for 131,300 pounds of ground beef — some of which was distributed in Indiana and Northern and Western Kentucky — because a family in southwestern Ohio fell ill after eating meat from the company that was contaminated with E. coli, the U.S. Department of Agriculture reported.
The recall is for beef sold as Kroger brands, at other stores, and the federal government, a Tyson spokesman said. Tyson produced the meat at its Emporia, Kan., plant Aug. 23, the USDA said in a news release. A Kroger spokesman said it would have been taken off store shelves Sept. 12, based on production date.
- 10/6/2011
Drug raised health risks in offspring by Marilynn Marchione, Associated Press
A drug that millions of pregnant women took decades ago to prevent miscarriage and complications has put their daughters at higher risk for breast cancer and other health problems that are showing up now,a new federal study finds.
Many of these daughters, now older than 40, might not even know of their risk if their mothers never realized or told them they had used the drug, a synthetic estrogen called DES. The new study suggests that infertility is twice as common and that breast cancer risk is nearly doubled in these daughters.
Debbie Wingard is one of them. The 59-year-old San Diego woman adopted two boys after being unable to conceive and has had breast cancer twice — when she was 39 and 49.
“There’s no knowing what’s going to happen as we age. There’s always the fear there’s going to be an-other cancer or another outcome,” she said. “I don’t think I’ll ever get to the point where I feel it’s behind me.” The sons of DES users also could face health risks — testicular problems and cysts — but these are less well studied and don’t seem to be as common. Even less is known about the third generation — “DES grandchildren.” Some research suggests these girls start menstruating late and have irregular periods, possible signs of fertility issues down the road. In the United States alone, more than 2 million women and 2 million men are thought to have been exposed to DES while in the womb and might want to talk with their doctors about when they should be screened for health problems.
“We don’t want to cause a panic of everyone rushing out thinking they’re going to get cervical or breast cancer. They just need to have that conversation with their physician,” said Dr. Sharmila Makhija, women’s health chief at the University of Louisville. The average woman has about a 1 in 50 chance of developing breast cancer by age 55; for DES daughters it’s 1 in 25, the study found. Risks for other health problems vary.
DES, or diethylstilbestrol, was widely used in the United States, Europe and elsewhere from the 1940s through the 1960s to prevent miscarriage, premature birth, bleeding and other problems. Many companies made and sold it as pills, creams and other forms.
Studies later showed it didn’t work. The claim of added breast cancer risk is being tested by 53 women in a lawsuit against DES makers under way now in Boston. Jackie White, 48, who lives in Centerburg, Ohio, said she had a misshaped uterus and reproductive problems, and found a lump last year that turned out to be breast cancer. Tests showed 20 tumors in one breast, two pre-cancers in the other and spread to her lymph nodes. “I ate a low-fat diet. I exercise faithfully so I was not overweight. I had none of the normal risk factors,” she said.
- 10/8/2011
Cantaloupe illness blamed for 21 deaths
Federal health authorities say a nationwide outbreak of listeria in Colorado cantaloupes is now responsible for 21 deaths and the number may continue to grow.
The Centers for Disease Control and Prevention on Friday reported new deaths in Indiana and New York. CDC said 109 people have been sickened — including the 21 dead — in 23 states from California to the East Coast.
The death toll in the cantaloupe outbreak is now tied with a1998 outbreak of listeria in hot dogs and possibly deli meats made by Bil Mar Foods, a subsidiary of Sara Lee Corp. That outbreak was also linked to 21 deaths.
- 10/12/2011
Study links vitamin E to prostate cancer By Rob Stein, The Washington Post
WASHINGTON — Large daily doses of vitamin E, long touted as a virtual wonder drug that could protect against cancer, heart disease, dementia and other ailments, increase the risk for prostate cancer among middle-aged men, according to a federal study released Tuesday.
The analysis of data from more than 35,000 healthy men concluded that those who took vitamin E every day at the relatively large dose levels commonly sold in drug, grocery and health food stores were 17 percent more likely to develop prostate cancer.
“You really have to question now how taking vitamin E will help someone,” said Eric Klein, a Cleveland Clinic prostate cancer expert who led what had been hoped to be a cancer- prevention study. “Not only is it unlikely to help them, it apparently could hurt them.” The findings, published in the Journal of the American Medical Association, are the latest in a series of carefully designed experiments that have found that vitamins and other dietary supplements are useless or possibly dangerous. On Monday, the Archives of Internal Medicine published a paper that concluded that older women might have a higher overall mortality rate if they take mul-tivitamins, folic acid, iron, magnesium, copper or zinc.
“Just because it’s ‘only a vitamin’ or ‘it’s natural,’ we assume it must be safe. But over and over again, we see that’s not necessarily the case,” said Howard Parnes of the National Cancer Institute, which funded the prostate cancer study.
- 10/15/2011
Bags of salad recalled for listeria check
SALINAS, CALIF. - A California producer of bagged salad mix is voluntarily recalling 2,100 cases dis-tributed under store brands in Ohio, Pennsylvania and Iowa because of the potential that some packages may be contaminated with listeria.
The lettuce was sold under the store brand names Hy-Vee salads and Giant Eagle’s “Farmers Market.” The lettuce has a “best if sold by” date of Oct. 14.
Random tests indicated the presence of the listeria organism in some of the bagged let-tuce. No illnesses have been reported.
- 10/19/2011
Malaria vaccine shows promise by Shari Roan, Los Angeles Times
LOS ANGELES — A malaria vaccine under development has passed a critical milestone with researchers reporting Tuesday that the shots protect about half of all children from the disease.
The Phase 3 clinical trial was conducted among 6,000 sub-Saharan African children 5 to 17 months old who were given three doses. The vaccine is designed to prevent the malaria parasite from infecting, maturing and multiplying in the liver and re-entering the bloodstream.
A malaria vaccine has been a goal for more than 20 years. The disease kills more than 1 million people each year — mostly sub-Saharan African children younger than 5.
Phase 2 results on the vaccine were published in 2004, and the new data confirm the earlier findings on safety and efficacy, said a principal investigator of the study, Dr. Tsiri Agbenyega of Ghana’s University of Science and Technology, Kumasi.
After 12 months of follow-up, the study found a 56 percent reduction in the risk of developing malaria and a 47 percent reduction in severe malaria. The risk of side effects in the vaccinated children was similar to that for the control group.
“This translates to tens of thousands of malaria cases being abated,” Agbenyega said at a news conference from Seattle, where the Malaria Forum was being hosted by the Bill & Melinda Gates Foundation. “Obviously, one would want to have higher efficacy when it comes to severe disease, but we are still hoping we can improve the efficacy of the vaccine.”
Whether a vaccine with even 47 percent efficacy is good enough to get a vaccine to the marketplace is not yet clear, said Dr. Regina Rabinovich, director of the infectious diseases program at the Gates Foundation, which has provided key funding for the malaria vaccine initiative. For decades, however, many health experts believed it was impossible to immunize against a parasitic infection, said Andrew Witty, chief executive of Glaxo SmithKline, whose company has helped develop the vaccine.
“We get used to seeing vaccines with 98 percent, 99 percent efficacy against common diseases in the West,” he said. “Obviously, we will strive to improve the efficacy of the vaccine, but this is a good start.”. Half of the world’s population is exposed to malaria. “This is one of the greatest scourges we face,” Witty said.
- 10/20/2011
Packing machinery may be listeria source
Washingron - Pools of water on the floor and old, hard-to-clean equipment at a Colorado farm’s can-taloupe packing facility were probably to blame for the deadliest outbreak of foodborne illness in 25 years, the Food and Drug Administration said Wednesday.
Government investigators found listeria bacteria on equipment in the Jensen Farms packing facility and on fruit that had been held there. The FDA said Jensen Farms had purchased used equipment that was corroded, dirty and hard to clean. And the packing facility floors were built so they were hard to clean, so pools of water potentially harboring the bacteria formed near the equipment.
The machinery was purchased in July, the same month the outbreak started.
- 10/21/2011
Danish study finds no cellphone-cancer link by Maria Cheng, Associated Press
LONDON — Danish researchers can offer some reassurance if you’re concerned about your cellphone: Don’t worry. Your device is probably safe.
The biggest study ever to examine the possible connection between cellphones and cancer found no evidence of any link, suggesting that billions of people who are rarely more than a few inches from their phones have no special health concerns.
The Danish study of more than 350,000 people concluded there was no difference in cancer rates between people who had used a cellphone for about a decade and those who did not.
Last year, a separate large study found no clear connection between cellphones and cancer. But it showed a hint of a possible association between very heavy phone use and glioma, a rare but often deadly form of brain tumor. However, the numbers of heavy users was not sufficient to make the case. That study of more than 14,000 people in multiple countries, in addition to animal experiments, led the International Agency for Research on Cancer to classify electromagnetic energy from cellphones as “possibly carcinogenic,” adding it to a list that also includes things such as coffee and gasoline engine exhaust.
But that designation does not mean the phones necessarily pose a risk.
Two U.S. agencies — the Food and Drug Administration and the Federal Communications Commission — have found no evidence that cellphones are linked to cancer. In the latest research, published online Thursday in the journal BMJ, researchers found cellphone users did not have a higher cancer risk compared with those without cellphones.
Cancer rates in people who used cellphones for about10 years were similar to rates in people without a cellphone. Cellphone users were also no more likely to get a tumor in the part of the brain closest to where phones are usually held against the head.
- 10/25/2011
Coffee linked to reduced risk of common skin cancer by Eryn Brown, Los Angeles Times
LOS ANGELES — Drinking coffee may reduce the risk of a common form of skin cancer, scientists reported Monday.
It appears caffeine may play a role in fighting basal cell carcinoma, they said. The team, based at Brigham and Women’s Hospital and Harvard Medical School in Boston, presented its study at the American Association for Cancer Research International Conference on Frontiers in Cancer Prevention Research.
Examining data from the Nurses’ Health Study, which followed 72,921people between1984 and 2008, and the Health Professionals Follow-Up Study, which followed 39,976 people between 1986 and 2008, the scientists found 25,480 skin cancer cases.
Basal cell carcinomas represented 22,786 of the cases, squamous cell carcinomas 1,953 and melanomas 741.
Women who drank more than three cups of coffee had a 20 percent reduction in risk for basal cell carcinoma. Men who drank that much coffee had a 9 percent reduction in risk of the slowgrowing cancer. People who drank the most coffee had the lowest risk.
The team didn’t identify reduced risk for squamous cell carcinoma. The discovery could help prevent cancers in the future, said co-author Fengju Song, a postdoctoral fellow in dermatology. “Daily dietary factors with even small protective effects may have great public health impact,” Song said in a statement. “Our study indicates that coffee consumption may be an important option to help prevent basal cell carcinoma.”
Unlike melanomas, which grow rapidly and can be deadly, basal cell carcinomas rarely spread to other organs. They are the most common form of skin cancer in the U.S., with about a million new cases each year.
Researchers will have to do more work to identify the mechanism behind the reduced cancer risk, Song said.
- 10/26/2011
Boys should get HPV vaccine, too, panel says by Mike Stobbe, Associated Press
ATLANTA — The controversial HPV shot given to girls should also be given to boys, in part to help pre-vent the spread of the virus through sex, a government medical panel said Tuesday.
The expensive vaccine, which protects females against cervical cancer, hasn’t been popular, and doctors admit it will be a tough sell to parents of 11and 12-year-old males, too.
For males, the vaccine is licensed to prevent genital warts and anal cancer. Experts say another key benefit of routinely vaccinating boys could be preventing the spread of the human papilloma virus to others through sex — making up somewhat for the disappointing vaccination rate in girls. The Advisory Commit-tee on Immunization Practices made the recommendation Tuesday. Federal health officials usually adopt what the panel says and asks doctors and patients to follow the advice.
The vaccine has been available to boys for two years, but Tuesday’s vote was the first to strongly recommend routine vaccination. Officials said the disappointing rate in girls encouraged them to take a new look. Just 49 percent of adolescent girls have gotten at least the first of the recommended three HPV shots, which have been recommended for girls for five years. Only a third had gotten all three doses by last year. “Pretty terrible,” said Dr. Anne Schuchat, a U.S. Centers for Disease Control and Prevention administrator who oversees the agency’s immunization programs. She attributed the low rates for girls to confusion or misunderstanding by parents that they can wait until their daughter becomes sexually active. It works best if the shots are given before a girl begins having sex. The vaccine is approved for use in boys and girls ages 9 to 26, but it is usually given to 11- and 12-year olds.
The committee also recommended the vaccination for males 13 through 21 years who haven’t been vaccinated previously or who haven’t completed the three-dose series. Tuesday’s vote follows recent studies that indicate the vaccine prevents anal cancer in males. A study that focused on gay men found it to be 75 percent effective.
But although anal cancer has been increasing, it’s still fairly rare in males, with only about 7,000 cases in the U.S. each year that are tied to the strains of viruses targeted in the HPV vaccine. In contrast, about 15,000 vaccine-preventable cervical cancers occur annually.
Some feel it’s unlikely that most families will agree to get their sons vaccinated primarily to protect girls. An estimated 50 percent to 80 percent of men and women are infected with HPV in their lifetimes, although most clear the infection without developing symptoms or illness, according to the CDC. The threat of genital warts hasn’t been persuasive yet, either.
Some data suggest less than 1.5 percent of adolescent males have gotten the vaccine. Its use against anal cancer may not be much of a selling point, said Dr. Ranit Mishori, a family practice doctor in Washington, D.C., and an assistant professor at the Georgetown University School of Medicine.
Some parents may say “ ‘Why are you vaccinating my son against anal cancer? He’s not gay! He’s not ever going to be gay!’ I can see that will come up,” said Mishori, who supports the committee’s recommendation.
There are two vaccines against HPV, but Tuesday’s vote applies only to Merck & Co.’s Gardasil, which costs $130 a dose. The other vaccine wasn’t tested for males.
- 11/2/2011
Painkiller fatalities tripled in 10 years -Deaths from overdoses reflect rise in narcotic prescriptions by Stephanie Nano by Associated Press
NEW YORK — The number of overdose deaths from powerful painkillers more than tripled over a decade, the government reported Tuesday — a trend the nation’s top health official called an epidemic, but one that can be stopped.
Prescription painkillers such as OxyContin, Vicodin and methadone led to the deaths of almost 15,000 people in 2008. That’s more than three times the 4,000 deaths in 1999.
Such painkillers “are meant to help people who have severe pain,” said Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention in Atlanta, which issued the report. “They are, however, highly addictive.”
The report shows nearly 5 percent of Americans ages 12 and older said they’ve abused painkillers in the past year — using them without a prescription or just for the high. In 2008-09 surveys, Oklahomans reported the highest rate of abuse; the lowest was in Nebraska and Iowa.
Prescription drug abuse also is a scourge in Kentucky. A Courier-Journal series this year showed how prescription drug deaths have more than doubled in Kentucky in the past decade to nearly 1,000 a year, even as funding to combat abuse has dwindled.
The series also detailed the part Florida plays in Kentucky’s epidemic. Local law enforcement and drug policy officials estimate that 60 percent of Kentucky’s illicit pills come from the Sunshine State, making it the chief supplier for Kentucky’s painkiller addiction. The overdose deaths reflect the spike in the number of narcotic painkillers prescribed every year — enough to give every American a one-month supply, Frieden said.
Prescriptions rose as doctors aimed to better treat pain and as new painkillers hit the market. Frieden and White House drug czar Gil Kerlikowske said states need to act to reverse the trend.
States oversee prescription practices and can rigorously monitor prescriptions and crack down on “pill mills” and “doctor shopping” by patients, Frieden said. Doctors should limit prescriptions — giving only a three-day supply for acute pain, for example — and look for alternative treatments, he said.
“For chronic pain, narcotics should be the last resort,” he added.
A federal drug plan announced this year calls for state programs to track prescriptions. All but two states — Missouri and New Hampshire — have approved them, said Kerli-kowske.
But a number of states don’t have them in place yet or doctors aren’t using them enough to check on their patients’ past prescriptions, he said.
“America’s prescription drug abuse epidemic is not a problem that’s going to be solved overnight, but at the same time, we’re not powerless,” he said. He urged parents to get rid of unneeded or expired painkillers so they aren’t misused. Overall, there were 36,450 fatal overdoses in 2008, including accidental cases and suicides involving illegal drugs like heroin and cocaine along with prescription medicines. About three-quarters of the deaths from prescriptions involved narcotic painkillers.
Other findings of the CDC report:
- New Mexico had the highest overdose death rate (27 per 100,000) and Nebraska had the lowest (5.5). The national rate was 11.9.
- Fatal overdoses were more likely in men, middleaged adults and whites and American Indians.
- Sales of prescription painkillers are highest in the Southeast and Northwest.
Frieden noted the wide differences between overdose death rates among states. For example, West Virginia’s rate is about 26 per 100,000, while neighboring Virginia’s rate is only 9.
“This highlights the importance of states getting policies right on preventing drug abuse,” he said.
“For chronic pain, narcotics should be the last resort.” Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention
- 11/6/2011
Blood-thinner gets expanded approval
WASHINGTON - Federal health officials have expanded approval of a blood thinning drug to millions of patients with a common heart problem that can cause strokes and blood clots. The Food and Drug Ad-ministration approved Xarelto for patients with atrial fibrillation, which causes the heart’s upper chambers to beat chaotically and ineffectively. About 2.2 million people in the U.S. have the condition, a leading cause of stroke. Xarelto offers a new alternative to warfarin, which can cause dangerous internal bleeding or strokes.
Xarelto was previously approved to prevent stroke in patients receiving hip and knee replacements. Bayer and Johnson & Johnson developed the once-a-day pill.
Sugary, fatty food seen as addictive as drugs by Robert Langreth, Bloomberg News
NEW YORK — Cupcakes may be addictive, just like cocaine. A growing body of medical research at leading universities and government labs suggests processed foods and sugary drinks aren’t just un-healthy. They can hijack the brain in ways resembling addictions to cocaine, nicotine and other drugs.
“The data is so overwhelming the field has to accept it,” said Nora Volkow, director of the National Institute on Drug Abuse (NIDA). “We are finding tremendous overlap between drugs in the brain and food in the brain.” The idea that food may be addictive was barely on scientists’ radar a decade ago. Now the field is heating up. Studies have found sugary drinks and fatty foods can produce addictive behavior in animals. Brain scans of obese people and compulsive eaters, meanwhile, reveal disturbances in brain reward circuits similar to those experienced by drug abusers.
Twenty-eight scientific studies and papers on food addiction have been published this year, according to a National Library of Medicine database. As the evidence expands, the science of addiction could become a game changer for the $1 trillion food and beverage industries. If fatty foods and snacks and drinks sweetened with sugar and high fructose corn syrup are proven to be addictive, the food industr may face the most drawnout consumer safety battle since the anti-smoking push took on the tobacco industry a generation ago.
Food company executives and lobbyists are quick to counter that nothing’s been proven. In fact, the idustry says it’s making big strides toward offering consumers a wide range of healthier snacking options. No one disputes that obesity is a fast-growing global problem. In the U.S., a third of adults and 17 percent of teens and children are obese, and those numbers are rising. Worldwide, from Latin America, to Europe to Pacific Island nations, obesity rates are also climbing. Of course, sugars and fats have always been in the human diet; our bodies are programmed to crave them. What has changed is modern processing that creates food with concentrated levels of sugars, unhealthy fats and refined flour, without redeeming levels of fiber or nutrients, obesity experts said. Consumption of large quantities of those processed foods may be changing the way the brain is wired. Those changes look a lot like addiction to some experts. Addiction “is a loaded term, but there are aspects of the modern diet that can elicit behavior that resembles addiction,” said David Ludwig, a Harvard researcher and director of the New Balance Foundation Obesity Prevention Center at Children’s Hospital Boston. Highly processed foods may cause rapid spikes and drops in blood sugar, increasing cravings, his research has found.
Not everyone is convinced. Swansea University psychologist David Benton recently published a 16-page rebuttal to sugar addiction studies. The paper, partly funded by the World Sugar Research Organization, which includes Coca-Cola, the world’s largest soft-drink maker, argues that food doesn’t produce the same kind of intense dopamine release seen with drugs and that blocking certain brain receptors doesn’t produce withdrawal symptoms in binge-eaters as it does in drug abusers. What’s still unknown is whether the science of food addiction has begun to change the thinking among food and beverage firms, which are, after all, primarily in the business of selling the Doritos, Twinkies and other fare people crave.
- 11/12/2011
Some fear value of HPV vaccine overshadowed by Darla Carter, The Courier-Journal
Parodied on “Saturday Night Live” and debated in political circles, the controversy over the cervical-cancer vaccine took another twist this year when experts recommended the shot for boys.
But local and national health experts hope the lifesaving potential of the HPV vaccine — which protects against the human papillomavirus and most cervical cancer — won’t be lost amid sound bites and pop-culture spin.
“It is a good vaccine,” said Dr. Hatim Omar, chief of adolescent medicine at the University of Kentucky. It’s rare to “have something that actually reduces significantly the chance of one or more types of cancer.”
Most women who get HPV do not develop cervical cancer, but the American Cancer Society estimates there will be 12,710 new cases of invasive cervical cancer this year and about 4,290 deaths. “This is a tremendous women’s health issue that it’s aimed at protecting,” said Dr. A. Bennett Jenson, a co-developer of the HPV vaccine who’s based at the University of Louisville’s James Graham Brown Cancer Center.
Yet, the federal Centers for Disease Control and Prevention has not been satisfied with the number of girls getting the vaccine. Data from a 2010 U.S. survey shows only 32 percent of girls ages 13 to 17 receiving a complete series of shots, according to the CDC. Forty-nine percent had received one dose. Although those rates are up, other adolescent vaccines are having stronger showings.
“The HPV results are very concerning,” said Dr. Anne Schuchat, director of the CDC’s National Center for Immunization and Respiratory Diseases, in a press statement. “Our progress is stagnating, and if we don’t make major changes, far too many girls in this generation will remain vulnerable to cervical cancer later in life. Now that we have the tools to prevent most cervical cancers, it is critical that we use them.”
Republican presidential candidate Michele Bachmann of Minnesota cast HPV vaccination in a negative light during a debate in September, when she criticized Texas Gov. Rick Perry for attempting to make the vaccination mandatory for girls in his state. She also called the shots dangerous, noting a conversation with a mother who allegedly claimed that HPV vaccination had led to mental retardation in her daughter, according to news reports.
Safety defended
The comments drew a quick rebuke from health experts, including the American Academy of Pediatrics, which issued a statement saying, “There is absolutely no scientific validity” to the candidate’s claims.
“This is actually one of the most studied vaccines on earth,” Omar said. “Its safety profile is terrific.”
But “if you see it on the news and you hear the quick blurb that it causes mental retardation, it gets you scared,” said Dr. Sharmila Makhija, chairman of the Department of Obstetrics, Gynecology and Women’s Health at the U of L School of Medicine, who discloses that she once had ties to vaccine makers Merck and Glax-oSmithKline. “I think it’s our job as physicians to help bring out the information of what the real side effects and benefits are.”
“Saturday Night Live” recently did a parody of the vaccine, featuring ABOUT HPV VACCINES
What: Gardasil and Cervarix are two U.S. vaccines used to protect women from cervical cancer. Gardasil also can protect against genital warts and some other cancers, and is FDA-approved for use in both genders.
How: Recipients are supposed to get three shots, usually administered over a six-month period.
When to consider: It’s ideal for the shots to be given before a person becomes sexually active. The typical age is 11 or 12, but they also can be given to younger children as well as teens and adults.
Drawbacks: Everyone may not get full protection, and some HPVrelated disease is caused by types the vaccines don’t cover.
Side effects: These can include headache, fever, nausea, pain, redness, itching, swelling and bruising.
Some people faint or become dizzy.
Also, some people experience anaphylaxis, an allergic reaction.
Other possible problems: As of mid-September, there had been 71 reports of death among those who received Gardasail, with 34 of those confirmed, according to the U.S.
Centers for Disease Control and Prevention, which noted that about 40 million doses of Gardasil have been distributed in this country.
There was no pattern or clustering to suggest the deaths were caused by the vaccine, and some clearly had other causes. As of September, there also had been 52 reports of adverse events following Cervarix vaccination, with 98 percent being considered non-serious, according to the CDC.
A commercial for a fictitious doll that could give the vaccine to girls. It showed girls playing with the doll, which was equipped with a needle in each hand that would unexpectedly spring out to vaccinate the kids.
Jenson, a pathologist and vaccinologist who’s helping to develop a tobacco-based vaccine for cervical cancer at the Brown Center, worries that even in parody, the national attention could contribute to uneasiness among parents who may already be concerned about letting their kids receive vaccines.
Vaccinating boys
Dr. Monique Howard, an assistant professor of pediatrics at U of L, said most of the questions she’s been fielding lately are about whether boys need the shots. Vaccination is a good idea, she said, to protect boys from genital warts. Howard also noted that HPV has been associated with such conditions as penile cancer and some head and neck cancers.
“Some of the moms have been doing a really great job” getting their sons vaccinated, she said.
There are two HPV vaccines available in the United States — Merck’s Gardasil vaccine and GlaxoSmithKline’s Cervarix vaccine. Both protect against HPV types 16 and 18 that cause at least 70 percent of cervical cancer cases. Gardasil also protects against genital warts from HPV types 6 and 11, as well as vulvar, vaginal and anal cancers in women.
Both vaccines are approved by the U.S. Food and Drug Administration for girls and young women, between 9 and 26 (Gardasil) or 9 and 25 (Cervarix). Gardasil also is FDA-approved for boys and men for protection against genital warts, as well as prevention of anal cancer and abnormal or precancerous lesions. The vaccines protect against HPV lesions in females too.
Lesions can lead to multiple exams, biopsies and procedures to prevent them from developing into cervical cancer, said Makhija. “There’s a lot of benefit, I feel, for a young woman to get this (vaccine) to prevent the traumatic experience of going through those procedures or that diagnosis.”
Reasons for not reaching more girls might include confusion among parents about when the vaccine should be administered, and lack of promotion of the shots by some health-care providers, the CDC says.
Omar said he thinks some health-care providers aren’t that knowledgeable about HPV, adding, “We have a long way to go to educate providers themselves on this subject.”
Parental concerns
Talking to parents can be tricky because of how some Americans feel about sex.
There’s a misunderstanding among some parents “that if you talk about anything related to sex, then I think they become afraid, and then they think their kids are gonna have sex or you’re encouraging them to have sex, and then they don’t want them to have the vaccine,” Howard said.
But “it’s better, I think, to take a proactive approach and say, ‘You know, look, we’re human beings. Human beings do these behaviors. I just need to keep you safe,’ ” said Howard, who specializes in adolescent health. “It’s not promoting sex or anything like that; it’s trying to prevent cancer.”
Vickie Spann, 40, of Louisville has allowed her daughter, Tiffany, to start getting the shots and doesn’t think it will encourage the 14-year-old to become sexually active.
“My daughter is very headstrong on waiting for marriage,” Spann said.
Another Louisville mother, Darlene Tandy, said she, like Spann, wants simply to reduce her daughter’s risk of cervical cancer, and she agreed to let her daughter get the vaccine series. Now, her 19-year-old son has started to receive the shots as well, she said.
Getting vaccinated can be expensive, sometimes costing around $150 per shot. But some insurance companies cover it, as does the publicly funded Vaccines for Children Program. For those who meet certain criteria, the shots are just $10 each at the Louisville Metro Department of Public Health and Wellness, said spokesman Dave Langdon.
Federal health officials say the vaccines are safe, and Jenson said he’s looking forward to his grandchildren being vaccinated, adding, “There’s more and more diseases that are being associated with human papillomavirus that this vaccine will take care of in the future,” including, potentially, some lung and skin cancers.
And while much of the vaccination focus of the past has been on women, an advisory committee to the CDC voted in October to recommend Gardasil for boys. The committee advised routine vaccination for boys 11 and 12 and said that vaccination could begin as early as 9.
Previously, the advisory committee had given a “permissive recommendation” for the vaccine’s use in boys, but this stronger recommendation will make it part of the regular pediatric vaccine schedule if the CDC agrees.
“A routine recommendation usually helps providers have the confidence to make a strong rec-ommendation to the families that they are caring for,” Schuchat said in a press briefing.
The committee is hoping not only to protect boys from things like genital warts, anal cancer, and head and neck cancers, but to reduce the spread of HPV from males to females.
The recommendation makes sense to Omar. “If we’re going to make a dent in HPV, we cannot do it just by vaccinating girls,” he said. “The girls are going to get it from boys.”
- 11/14/2011
Study: New drug reduces heart deaths - Blood thinner cuts risk of 2nd attack by Marilynn Marchione, Associated Press
ORLANDO, Fla. — People recovering from a heart attack or severe chest pain are much less likely to suffer another heart-related problem or to die from one if they take a new blood-thinning drug along with standard anticlotting medicines, a large study finds.
But this benefit had a cost: a greater risk of serious bleeding, usually in the digestive tract.
Still, some doctors said the drug, Xarelto, could become a new standard of care for up to a million Americans hospitalized each year for these conditions. A low dose of the drug substantially cut the risk of dying of any cause during the study.
“Mortality trumps everything,” so a drug that improves survival is a win, said Dr. Paul Armstrong of the University of Alberta in Edmonton, Alberta, Canada.
He had no role in the study, which was discussed Sunday at an American Heart Association conference in Florida and published online by the New England Journal of Medicine. The study was sponsored by the drug’s makers — Johnson & Johnson and Bayer Healthcare — and some researchers work or consult for the companies.
Xarelto is approved now at higher doses for preventing strokes in people with a common heart rhythm problem and for preventing blood clots after joint surgeries. It works in a different way than aspirin and older blood thinners do.
Dr. C. Michael Gibson of Harvard Medical School led a study testing it in 15,500 patients who were leaving the hospital after a heart attack or severe chest pain from clogged arteries.
All were prescribed aspirin and an older blood thinner. One third also received a low dose of Xarelto, and one-third got a higher dose. After about a year on average, nearly 11 percent of those on just the usual medicines had suffered a heart attack, heart-related death or a stroke versus less than 9 percent of those on either dose of Xarelto.
The lower dose proved better and safer. Fewer than 3 percent of those getting Xarelto died of any cause during the study, compared with 4.5 percent of those getting just the usual medicines. That translates to a 32 percent lower risk with Xarelto. Xarelto’s makers will seek approval to sell it by year’s end of the year.
- 11/30/2011
China prepares to enter global vaccine market by Gillian Wong, Associated Press
BEIJING — The world should get ready for a new “Made in China” product — vaccines. China’s vaccine makers are gearing up over the next few years to push exports in a move that should lower costs of lifesaving immunizations for the world’s poor and provide major new competition for the big Western pharmaceutical companies.
But it may take some time before some parts of the world are ready to embrace Chinese products when safety is as sensitive an issue as it is with vaccines — especially given the food, drug and other scandals the country has seen. Still, China’s entry into this market will be a “game changer,” said Nina Schwalbe, head of policy at the GAVI Alliance, which buys vaccines for 50 million children a year worldwide. “We are really enthusiastic about the potential entry of Chinese vaccine manufacturers,” she said.
China’s vaccine-making prowess captured world attention in 2009 when one of its companies developed the first effective vaccine against swine flu — in just 87 days — as the new virus swept the globe. In the past, new vaccine developments had usually been won by the U.S. and Europe. In March, the World Health Organization announced that China’s drug safety authority meets international standards for vaccine regulation. It opened the doors for Chinese vaccines to be submitted for WHO approval so they can be bought by U.N. agencies and the GAVI Alliance.
“China is a vaccine-producing power” with more than 30 companies that have an annual production capacity of nearly 1 billion doses — the largest in the world, the country’s State Food and Drug Administration said.
But more needs to be done to build confidence in Chinese vaccines overseas, said Helen Yang of Sino-vac, the NASDAQ-listed Chinese biotech firm that rapidly developed the H1N1 swine flu vaccine.
“We think the main obstacle is that we have the name of ‘Made in China’ still; that is an issue,” she said.
China’s recent food and drug safety record doesn’t inspires confidence. In 2007, Chinese cough syrup killed 93 people in Central America. One year later, contaminated blood thinner led to dozens of deaths in the U.S., and tainted milk powder poisoned hundreds of thousands of Chinese babies and killed six.
The government has imposed more regulations, stricter inspections and heavier punishments for violators. Perhaps because of that, regulators routinely crack down on counterfeit and substandard drug making. One expert said it takes more than a regulatory agency to keep drugmakers from cutting corners or producing fakes.
“In the U.S., we have supporting institutions such as the market economy, democracy, media monitoring, civil society, as well as a well-developed business ethics code, but these are all still pretty much absent in China,” said Yanzhong Huang, a China health expert at the Council on Foreign Relations. “For China, the challenge is much greater in building a strong, robust regulative capacity.”
- 12/01/2011
Possible AIDS vaccine raises hope - It works on mice; test on humans next by Malcolm Ritter, Associated Press
NEW YORK — A study in mice suggests hope for a new approach to prevent AIDS — one that doctors now want to test in people.
The treated mice appeared to have 100 percent protection against HIV, the virus that causes AIDS. That doesn’t mean the strategy will work in people. But several experts were impressed. “This is a very important paper (about) a very creative idea,” said the government’s AIDS chief, Dr. Anthony Fauci. He didn’t take part in the research.
The study involved injecting mice with a protective gene, an idea that’s been tested in animals for a decade.
In the nearly 30 years since HIV was identified, scientists haven’t been able to find a broadly effective vaccine. One boost came in 2009, when a large study in Thailand found that an experimental vaccine protected about a third of recipients against infection. That’s not good enough for general use, but researchers are trying to improve it.
Researchers reported the results with mice online Wednesday in the journal Nature. They hope to test the approach in people in a couple of years. Another team reported similar success in monkeys in 2009 and hopes to start human tests even sooner.
A traditional vaccine works by masquerading as a germ, training the body’s immune system to build specific defenses in case the real germ shows up. Those defenses are generally antibodies, which are proteins in the blood that have just the right shape to grab onto parts of an invading virus.
Once that happens, the virus can’t establish a lasting infection and is cleared from the body. Scientists have identified antibodies that neutralize a wide range of HIV strains, but they’ve had trouble getting people’s immune systems to create those antibodies with a vaccine.
The gene-injection goal is straightforward. Rather than trying to train a person’s immune system to devise effective antibodies, why not just give a person genes for those proteins? The genes can slip into cells in muscle or other tissue and make them pump out lots of the antibodies.
The mouse work is reported by David Baltimore and colleagues at the California Institute of Technology. Ordinary mice don’t get infected with HIV. So the study used mice that carried human immune system cells.
Baltimore’s team used a harmless virus to carry an antibody gene and injected it once into a leg muscle. The researchers found that the mice made high levels of the antibody for more than a year. The results suggest lifetime protection for a mouse, Baltimore said, although “we simply don’t know what will happen in people.”
Even when the mice were injected with very high doses of HIV, they didn’t show the loss of certain blood cells that results from HIV infection.
- 12/2/2011
Obama on AIDS: ‘We can beat this disease’ - U.S. pledges to help hard-hit countries by Julie Pace, Associated Press
WASHINGTON — President Barack Obama set an ambitious goal Thursday for significantly increasing access to life-saving AIDS drugs for people in the U.S. and around the world, as he announced a renewed American commitment to ending a pandemic that has killed 30 million people.
“We can beat this disease,” Obama declared during a World AIDS Day event in Washington. Former Presidents George W. Bush and Bill Clinton also participated via satellite.
Obama pledged U.S. support to help 6 million people in countries hardest hit by the virus get access to antiretroviral drugs by the end of 2013, increasing the original U.S. goal by 2 million. And he announced plans to boost spending on HIV treatment in the U.S. by $50 million.
“The rate of new infections may be going down elsewhere, but it’s not going down here in America,” he said. “There are communities in this country being devastated still by this disease. When new infections among young, black, gay men increase by nearly 50 percent in three years, we need to do more to show them that their lives matter.”
The U.S. will also aim to get antiretroviral drugs to 1.5 million HIVpositive pregnant women to prevent them from passing the virus to their children; distribute more than 1 billion condoms in the developing world in the next two years; and fund 4.7 million voluntary medical male circumcisions in Africa over the next two years. Research shows circumcisions reduce the risk of female-to-male HIV transmission by more than 60 percent.
The new global goals build on the work of the President’s Emergency Plan for AIDS Relief, which focuses on prevention, treatment and support programs in 15 countries hit hardest by the AIDS pandemic. Bush launched the $15 billion plan in 2003.
The relief program’s budget is not expected to increase. Instead officials said the expanded targets would be funded through savings achieved by making the program more efficient and cutting treatment costs.
- 12/8/2011
Cancer treatment advance - New drugs for breast cancer were able to slow advanced cases by Marilynn Marchione, Associated Press
SAN ANTONIO — Breast cancer experts are cheering what could be some of the biggest advances in more than a decade: two new medicines that significantly delay the time until women with very advanced cases get worse.
In a large international study, an experimental drug from Genentech called pertuzumab held cancer at bay for a median of 18 months when given with standard treatment, versus12 months for others given only the usual treatment. It also strongly appears to be improving survival, and follow-up is continuing to see if it does.
“You don’t see that very often. … It’s a spectacular result,” said one study leader, Dr. Sandra Swain, medical director of Washington Hospital Center’s cancer institute.
In a second study, another drug long used in organ transplants but not tried against breast cancer — everolimus, sold as Afinitor by Novartis AG — kept cancer in check for a median of 7 months in women whose disease was worsening despite treatment with hormone-blocking drugs. A comparison group that received only hormonal medicine had just a 3-month delay in disease progression.
Afinitor works in a novel way, seems “unusually effective” and sets a new standard of care, said Dr. Peter Ravdin, breast cancer chief at the UT Health Science Center in San Antonio. He has no role in the work or ties to drugmakers.
Most patients have tumors like those in this study — their growth is fueled by estro-gen. Results were released Wednesday at the San Antonio Breast Cancer Symposium and some were published online by the New England Journal of Medicine. They come a few weeks after federal approval was revoked for another Genentech drug, Avastin, that did not meaningfully help breast cancer patients. It still is sold for other tumor types.
The new drugs are some of the first major developments since Herceptin came out in1998. It has become standard treatment for a certain type of breast cancer.
“These are powerful advances … an important step forward,” said Dr. Paul Burstein, a breast expert at Dana-Farber Cancer Institute in Boston who had no role in the studies.
But the new drugs are likely to be expensive — up to $10,000 a month — and so far have not proved to be cures. Doctors hope they might be when given to women with early-stage cancers when cure is possible, rather than the advanced cases treated in these studies.
Even short of a cure, about 40,000 U.S. women each year have cancer that spreads beyond the breast, and treatment can make a big difference in their lives.
Rachel Midgett, a 39-year-old Houston woman who has breast cancer that spread to multiple parts of her liver, ran a half-marathon in Las Vegas on Sunday. She has had three scans since starting on Afinitor nine months ago, and “every time my liver lesions keep shrinking,” she said.
- 12/9/2011
Bone drug aids breast cancer survival - Death risk lowered for Zometa users by Marilynn Marchione, Associated Press
SAN ANTONIO — Doctors were mostly hoping to prevent complications and relapses when they gave young women a medicine to keep their bones strong during breast cancer treatment. Seven years later, they found it did more than that: The bone drug improved survival, as much as many chemotherapies do.
The study found a 37 percent lowerriskofdeath among women who received the bone drug, Zometa. In absolute terms, it meant that 4 to 5 more women out of every 100 were alive seven years later.
It’s especially impressive considering that the women took the drug, given as an infusion every six months, for only three years. “The benefit persists” long after treatment ends, said study leader Dr. Michael Gnant of Austria’s Medical University of Vienna. He presented the research this week at the San Antonio Breast Cancer Symposium.
Zometa should now be offered to all patients like those in this study — younger women forced into early menopause by hormone- blocking cancer treatments, some specialists said. “It’s a new standard of care,” said Dr. James Ingle, a Mayo Clinic breast specialist who had no role in the study.
Bone drugs called bisphosphonates — sold as Fosamax, Boniva and Actonel — have long been sold for treating osteoporosis. Those are daily pills. Zometa, made by the Swiss company Novartis AG, is given intravenously to treat cancer that has spread to the bone.
Hope that it could do more grew in 2008, when Gnant reported that it lowered the risk of a cancer recurrence in a study of 1,800 premenopausal women with early-stage breast cancer. All had surgery followed by hormone blockers, and half also received Zometa.
Now, with seven years of follow- up, researchers see that Zometa not only helped keep cancer from coming back, but also improved survival. There were 33 deaths among women given the bone drug and 49 among those not treated with it.
That magnitude of benefit is comparable to many chemotherapy treatments. Researchers think because Zometa strengthens bones, it’s tougher for cancer to spread there and the drug may also have direct effects against circulating cancer cells or microscopic tumors. Zometa’s side effects were mostly fever and bone and joint pain, and doctors saw no cases of jawbone decay, a serious problem long linked to bisphospho-nates. Zometa costs more than $1,000 in the U.S. and about half as much in Europe, though the price may drop when its U.S. patent expires in 2013. Novartis helped pay for the study and Gnant consults for the company.
- 12/10/2011
FDA panel backs new birth control patch
ADELPHI, MD. - A panel of federal health advisers says Johnson & Johnson’s Ortho Evra birth control patch remains a beneficial option for women seeking birth control, despite increasingly strong evidence that the drug carries a slightly higher risk of dangerous blood clots than older birth control pills.
The Food and Drug Administration’s panel of reproductive health experts voted 19-5 that the benefits of the weekly Ortho Evra patch outweigh its risks, including a potentially higher risk of dangerous blood clots that can cause heart attack, stroke and other life-threatening problems.
Panelists said it was important to keep the drug available for women who have difficulty taking a daily pill.
- 12/11/2011
Gene therapy used to treat hemophilia
ATLANTA - In what’s being called a landmark study, researchers used gene therapy to successfully treat six patients with severe hemophilia, a blood-clotting disorder.
The study, led by researchers at the University College London Cancer Institute and St. Jude Children’s Research Hospital in Memphis, Tenn., was preliminary. But a single infusion using the new treatment worked in some patients for more than a year, boosting their clotting ability.
Experts said the new method needs to be tested on many more patients to confirm whether it’s effective and prove there are no risks.
- 12/21/2011
U.S. asks labs to shield bird flu data - Some fear terrorists could use research by Lauran Neergaard, Associated Press
WASHINGTON — The U.S. government paid scientists to figure out how the deadly bird flu virus might mutate to become a bigger threat to people — and two labs succeeded in creating new strains that are easier to spread.
On Tuesday, federal officials took the unprecedented step of asking those scientists not to publicize all the details of how they did it.
The worry: That this research with lots of potential to help the public might also be hijacked by bioterrorists. The labs found that it appears easier than scientists had thought for the so-called H5N1 bird flu to evolve in a way that lets it spread easily between at least some mammals.
“It wasn’t an easy decision,” said Dr. Anthony Fauci, infectious diseases chief at the National Institutes of Health, which funded the original research.
The viruses are locked in highsecurity labs as researchers at the Erasmus University Medical Center in the Netherlands and the University of Wisconsin-Madison prepare to publish their findings in scientific journals.
But biosecurity advisers to the government recommended that the journals Science and Nature publish only the general discoveries, not the full blueprint for these man-made strains. Tuesday, the government announced that it agreed and made the request.
In statements, the two research teams say they’re making some changes, if reluctantly. The journals are mulling what to do, and the government didn’t say precisely what should be left out. But Science editor-in-chief Dr. Bruce Alberts said his journal pushed the government to set up a system so certain international researchers would be able to get the full genetic recipe for these lab-bred strains — especially those in bird flu-prone countries like China and Indonesia.
“This is a sort of watershed moment,” said Alberts, noting it’s thought to be the first time this kind of secrecy has been sought from legitimate public health research.
He doesn’t want to publish an abbreviated version of the findings unless he can direct scientists how to get the full, if confidential, details.
“It’s very important to get this information out to all the people around the world who are living with this virus and are working on it,” Alberts said.
H5N1 has caused outbreaks in wild birds and poultry in a number of countries. But it only occasionally infects people who have close contact with infected poultry, particularly in parts of Southeast Asia. It’s known to have sickened nearly 600 people over the past decade. It’s deadly, killing about 60 percent of the time.
The concern is that one day, bird flu might begin spreading easily between people and cause a pandemic. The NIH wanted to know what genetic changes it should monitor for, as a warning.
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