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31 décembre

Genetic Links to Disease Actually Fairly Weak

Yet another shocker ;-)

http://www.reuters.com/article/scienceNews/idUSTRE4BT4Z520081230

Many studies needed to tie genes to cancer: study

Tue Dec 30, 2008 4:17pm EST

By Michael Kahn

LONDON (Reuters) - Many genes linked to various cancers do not appear to raise the risk of getting cancer after all, according to an analysis of hundreds of studies published on Tuesday.

The findings highlight the need to exercise caution over the increasing number of studies associating common genetic variations with a range of diseases, said John Ioannidis of the University of Ioannina School of Medicine in Greece.

"The whole thing about genetic variations and links to diseases like cancer are very exciting, but the general public should be quite cautious about jumping to the conclusion that if they have a change in one gene or another they are doomed," Ioannidis, who led the study, said in a telephone interview.

"Genetic effects are very complex and very subtle and we need to know a lot more before we can make strong recommendations based on genetic profiles."

Ioannidis said his team had looked only at common genetic changes or polymorphisms, not at rare mutations, which in genes such as BRCA1 and BRCA2 significantly raise breast cancer risk. The rare form of these variants, for example, accounts for an estimated 5 to 10 percent of breast cancers.

Since early 2007, variations at more than 100 places on the genome have been linked to diabetes, heart disease and certain cancers.

The problem, researchers say, is that many of these genes typically interact in a complicated manner and their ultimate effects are influenced by the environment -- diet, exercise, smoking and other behavior -- in often poorly understood ways.

Ioannidis and his colleague Paolo Vineis of Imperial College London analyzed hundreds of published studies linking genetic changes to different cancers. They found that, out of 240 associations between a specific mutation and a cancer, only two genes involved in DNA repair and tied to lung cancer -- XRCC1 and ERCC2 -- turned out to be strong candidates for such a link.

"Most of the associations had weak or modest credibility," he said. That included PARP1 for breast cancer and CCND1 for head and neck tumors.

The problem is that on their own, the earlier studies fail to provide a complete picture and run the risk of drawing conclusions from too limited an amount of data, Ioannidis said.

This does not mean studies linking genes to cancer and the risk of other diseases have completely missed the mark, but rather that it takes a mountain of evidence to reach strong conclusions when it comes to the human genome, he added.

"Our study shows that it really takes a lot of research effort and many, many studies to be able to pinpoint a couple of associations," Ioannidis said.

(Reporting by Michael Kahn; editing by Maggie Fox and Tim Pearce)


No More Free Pens from Big Pharma

I guess they'll just have to stick with straight-up bribes.

http://www.nytimes.com/2008/12/31/business/31drug.html?_r=2&ref=business

No Mug? Drug Makers Cut Out Goodies for Doctors


By NATASHA SINGER
Published: December 30, 2008
To Lehman Brothers, Linens ’n Things and the blank VHS tape, add another American institution that expired in 2008: drug company trinkets.

Starting Jan. 1, the pharmaceutical industry has agreed to a voluntary moratorium on the kind of branded goodies — Viagra pens, Zoloft soap dispensers, Lipitor mugs — that were meant to foster good will and, some would say, encourage doctors to prescribe more of the drugs.

No longer will Merck furnish doctors with purplish adhesive bandages advertising Gardasil, a vaccine against the human papillomavirus. Banished, too, are black T-shirts from Allergan adorned with rhinestones that spell out B-O-T-O-X. So are pens advertising the Sepracor sleep drug Lunesta, in whose barrel floats the brand’s mascot, a somnolent moth.

Some skeptics deride the voluntary ban as a superficial measure that does nothing to curb the far larger amounts drug companies spend each year on various other efforts to influence physicians. But proponents welcome it as a step toward ending the barrage of drug brands and logos that surround, and may subliminally influence, doctors and patients.

“It’s not just the pens — it’s the paper on the exam table, the tongue depressor, the stethoscope tags, medical calipers that might be used to interpret an EKG, penlights,” said Dr. Robert Goodman, a physician in internal medicine at Montefiore Medical Center in the Bronx.

In 1999, Dr. Goodman started No Free Lunch, a nonprofit group that encourages doctors to reject drug company giveaways. “Practically anything you can put a name on is branded in a doctor’s office, short of branding, like a Nascar driver, on the doctor’s white coat,” Dr. Goodman said.

The new voluntary industry guidelines try to counter the impression that gifts to doctors are intended to unduly influence medicine. The code, drawn up by Pharmaceutical Research and Manufacturers of America, an industry group in Washington, bars drug companies from giving doctors branded pens, staplers, flash drives, paperweights, calculators and the like.

The guidelines also reiterate the group’s 2002 code, which prohibited more expensive goods and services like tickets to professional sports games and junkets to resorts. And it asks companies that finance medical courses, conferences or scholarships to leave the selection of study material and scholarship recipients to outside program coordinators.

Diane Bieri, the executive vice president of Pharmaceutical Research and Manufacturers of America, said the updated guidelines were not an admission that gifts could influence doctors’ prescribing habits. Instead, she said, they were meant to emphasize the educational nature of the relationship between industry and doctors.

“We have never said and would never say that a pharmaceutical pen or notebook has influenced any prescription,” Ms. Bieri said.

But some critics said the code did not go far enough to address the influence of drug marketing on the practice of medicine. The guidelines, for example, still permit drug makers to underwrite free lunches for doctors and their staffs or to sponsor dinners for doctors at restaurants, as long as the meals are accompanied by educational presentations.

“Pens or no pens, their influence is not going to be diminished,” said Dr. Larry M. Greenbaum, a rheumatologist in Greenwood, Ind. He has made a point of collecting ballpoint pens advertising formerly heavily promoted medications, like the painkiller Vioxx, that were later withdrawn after reports of dangerous side effects.

Last year, besides giving away nearly $16 billion in free drug samples to doctors, pharmaceutical companies spent more than $6 billion on “detailing” — an industry term for the sales activities of drug representatives including office visits to doctors, meal-time presentations and branded pens and other handouts, according to IMS Health, a health care information company.

The industry code also permits drug makers to pay doctors as consultants “based on fair market value” — which critics say means that companies can continue to pay individual doctors tens of thousands of dollars or more a year.

“We have arrived at a point in the history of medicine in America where doctors have deep, deep financial ties with the drug makers and marketers,” said Allan Coukell, the director of policy for the Prescription Project, a nonprofit group in Boston working to promote evidence-based medicine. “Financial entanglements at all the levels have the potential to influence prescribing in a way that is not good.”

About 40 drug makers, including Eli Lilly & Company, Johnson & Johnson and Pfizer, have signed on to the code. Representatives of several pharmaceutical makers said their companies intended to comply with the guidelines, but they declined to discuss past marketing programs involving branded gifts.

The restrictions come as a blow to the makers and distributors of promotional products, an industry with an annual turnover of about $19 billion, according to Promotional Products Association International, a trade group. Such companies, accustomed to orders of up to a million pens a drug, stand to lose around $1 billion a year in sales as a result of the drug industry’s voluntary ban, the group said.

The sudden scarcity of free goodies, though, could enhance the cachet of collections that some doctors have assembled over the years as a mocking countermeasure to drug marketing. Dr. Nathan Anderson, a resident in internal medicine at a hospital in Texas, has posted photographs of the various items he has received on his blog, drugreptoys.blogspot.com.

Dr. Jeffrey F. Caren, a cardiologist at Cedars-Sinai Medical Center in Los Angeles, has collected more than 1,200 pens and mounted them on a pillar in his office.

While some doctors applaud the gift ban, others seem offended by the insinuation that a ballpoint pen could turn their heads. “It seems goofy to us; we like getting our pens,” Dr. Susan B. Hurson, an obstetrician and gynecologist in Washington, said in a telephone interview.

Dr. Hurson said she paid no attention to the logos on the pens she carries around in her doctor’s coat.

Prompted by a reporter’s question, she pulled out a handful of pens from her pocket and read off the drugs advertised: Clindesse, a cream for vaginal infection; Halo, a system for detecting breast cancer, and Evamist, an estrogen spray. “It’s hard for me to believe it influences what you prescribe.”

But Dr. Phillip Freeman, a psychiatrist in Boston, said that physicians who contended that the giveaways were benign might be suffering from denial.“The need to deny influence is damaging to the soul,” Dr. Freeman said. He suggested that doctors would feel less conflicted if they simply wore drug company patches on their white coats.

Pediatrics Under the Thumb of Big Pharma

Here's another one for the file of my friend who says that the mainstream medical journals aren't under the thumb of Big Pharma. I didn't write this piece--Deborah Kotz of US News did.

Another note: you don't have to have a pediatrician for your child. A family practitioner will (in general) take better care of your child by taking a more holistic approach, considering your whole family, rather than following in lockstep with the Big Pharma-controlled and CDC-politicized AAP.

http://www.usnews.com/blogs/on-medicine/2008/12/29/flexible-approach-to-vaccinations-comes-under-fire.html

Flexible Approach to Vaccinations Comes Under Fire

December 29, 2008 03:41 PM ET | Deborah Kotz | Permanent Link | Print

The American Academy of Pediatrics rolled out its new immunization schedule for kids in its latest issue of the journal Pediatrics , released today. The big change for this year is a new recommendation for an annual flu vaccine for all kids ages 6 months to 18 years—which follows the new guidelines of the Centers for Disease Control and Prevention.

Along with this policy statement and numerous research papers, the journal contains a "special article" that quite frankly shocked me for its one-sided treatment of a very important issue with regard to vaccinations. The article is an attack on doctors who take a flexible approach to vaccinations, working with parents who, say, don't want their 2-month-old to get vaccinated against eight different diseases at once, which is what's recommended on the AAP schedule.

It targets one particular pediatrician, Robert Sears, who described several alternative approaches to vaccination in a popular consumer book called The Vaccine Book: Making the Right Decision for Y our Child. Sears calls for spacing out some vaccinations by adding office visits and delaying some shots until a child is older. More controversially, he also has a plan for those who may want to skip some immunizations, such as the chickenpox vaccine. I spoke with Sears for this parents' guide to managing vaccinations.

Unfortunately, instead of allowing a pro-and-con debate about the benefits and drawbacks of pediatricians working with parents who wish to have some flexibility, the Pediatrics journal editors chose to feature just one side of this debate. The authors of the special article take a firm stand against allowing any deviation from the current vaccine schedule, arguing that in offering a middle ground, Sears is sending "antivaccine messages."

What's worse, the lead author, Paul Offit, who heads the vaccine education center at the Children's Hospital of Philadelphia, clearly has a conflict of interest. He's one of the patent holders of RotaTeq, a vaccine against rotavirus that's on the AAP's vaccine schedule. That means he stands to lose money if parents shun RotaTeq.

Offit, who didn't respond to a request to be interviewed late last week, lays out his valid concerns with Sears's book, and, as a widely respected expert in the vaccine field, his opinions deserve some attention. But he also fails to acknowledge any flaws in the government's system of monitoring adverse effects or the scarcity of good research studies that doctors could use to predict which patients may be vulnerable to adverse vaccine reactions. A host of government officials admitted there's a real need for more vaccine research, as I noted in a recent article that scrutinized vaccines.

This makes me wonder why Pediatrics chose to include this volatile paper as a stand-alone article rather than as part of a debate over what doctors should do to increase vaccination compliance. In an E-mail exchange, Sears told me he submitted a request to respond in the next issue of the journal but hasn't yet heard back from the editors. He also takes issue with Offit's slapping the "antivaccine" label on his book. Sears wrote:

The Vaccine Book is very pro-vaccine, and I believe that Dr. Offit has greatly misrepresented the book as anti-vaccine. He selectively quotes areas of the book that discuss some negative aspects of vaccines or some parental worries about shots, without revealing the pro-vaccine ideas I also share in such areas to give a BALANCED viewpoint from both sides. The vast majority of criticism I have received on the book has come from ANTI-vaccine activists who were hoping I'd come out against vaccines. That tells me I'm doing my job correctly.

You can read Sears's full rebuttal on his website.

Offit makes the argument that allowing flexibility will reduce the proportion of kids who get fully vaccinated, while Sears argues that parents will be driven away from vaccinations altogether by inflexible doctors. (For its part, the CDC recommends that doctors work with parents who wish to deviate from the schedule in an effort to get children as fully immunized as possible.)

So, which is better: a one-size-fits-all approach or a flexible one? That's a question I wish the journal editors had decided to address in a full-fledged debate.


Phthalates ... Um, Yeah, They're Bad for You

Sh*t, man, you mean endocrine disruptors aren't a good thing? Getting reproductive cancers from your shower curtain isn't a smart life choice? We shouldn't just trust Big Chemical on what's good for our health?

http://www.medpagetoday.com/PublicHealthPolicy/EnvironmentalHealth/12279

EPA Asked to Check Risks of Plastic Enhancers

By Kristina Fiore, Staff Writer, MedPage Today
Published: December 29, 2008

WASHINGTON, Dec. 29 -- Possible risks of phthalates -- plastic enhancers found in toys, cosmetics, and building materials -- should be investigated by the Environmental Protection Agency, concluded a report by the National Research Council.

Although few data are available on the health effects of phthalate exposure in humans, the chemical produced a variety of effects on the development of the reproductive system in male rats, including infertility, decreased sperm count, undescended testes, and hypospadias.

The effects that occurred in rats are typical of androgen disturbance, wrote Deborah Cory-Slechta, Ph.D., of the University of Rochester (N.Y.), a professor of environmental science and lead author of the report, and colleagues.

That risk should be evaluated along with other antiandrogenic chemicals that have similar health effects, said the NRC report.

"The cumulative risk assessment of phthalates should consider any chemical that leads to the disturbance of androgen action and is thus capable of inducing any of the effects on the development of the male reproductive system that are characteristic of phthalate exposure," the researchers said.

In light of several policy decisions in the U.S. and European Union, the EPA called on the NRC to review the health effects of phthalates, in order to evaluate the need for the EPA to conduct a full-scale cumulative risk assessment of the chemical.

Both the U.S. and EU have previously passed legislation restricting the concentrations of several phthalates in children's toys, and the E.U. has also banned several phthalates from cosmetics.

Because antiandrogens are known to produce similar effects either via reducing androgen concentrations or disrupting androgen-receptor signaling, these chemicals should all be evaluated comprehensively, the report said.

"In reproductive tissues that require androgen for normal development, it is unlikely that one can differentiate between a decreased concentration of androgen and antagonism of androgen-receptor signaling," the researchers said.

"Thus, any agent that can produce androgen insufficiency or block androgen-receptor signaling in the developing male fetus would have effects that are included in the array of malformations known to be caused by phthalates."

That risk should be evaluated along with other antiandrogenic chemicals that have similar health effects, wrote the researchers.

"The cumulative risk assessment of phthalates should consider any chemical that leads to the disturbance of androgen action and is thus capable of inducing any of the effects on the development of the male reproductive system that are characteristic of phthalate exposure," the researchers said.

Another chemical found in plastics, bisphenol A (BPA), was recently been the source of much discussion after the FDA was reprimanded for initially vouching for its safety. (See: FDA Spanked by Full Science Board on Bisphenol A Safety Stance)

In the NRC review, the researchers said that children may be more at risk for adverse effects because their urine concentrations of phthalate metabolites are generally higher than those found in adults.

Currently, the EPA evaluates chemicals that are similar in structure, rather than grouping them by health outcomes.

This approach "ignores the important fact that different chemical exposures may result in the same common adverse outcomes," according to the NRC report.

Focusing on outcomes "is more directly relevant to relating chemical exposures to human diseases and disorders," it said.

For example, the EPA could evaluate combined exposures to lead, methylmercury, and polychlorinated biphenyls (PCBs) because all of these contribute to cumulative risk of cognitive deficits consistent with IQ reduction in children, the researchers said, although the deficits are the results of different mechanisms.




Related Article(s):

One More Reason Aerobics Are Good for You

I like the elliptical machine, myself.

http://healthday.com/Article.asp?AID=622300

Vigorous Treadmill Workout Curbs Appetite Hormones
U.K. researchers say findings may lead to more effective ways to control weight

FRIDAY, Dec. 26 (HealthDay News) -- Aerobic exercise is better than non-aerobic activities at suppressing appetite, according to a U.K. study.

The research involved 11 male university students who participated in three types of sessions. In one, they ran for 60 minutes on a treadmill and then rested for seven hours. In another, they did 90 minutes of weight lifting and then rested for 6.5 hours. In the third session, they did no exercise.

The participants received two meals during each session and also reported their hunger levels at various points during each session. The researchers measured the students' levels of two major appetite hormones: ghrelin (which stimulates appetite) and peptide YY (which suppresses appetite).

During the treadmill session (aerobic exercise), ghrelin levels dropped and peptide YY levels increased, indicating that the hormones were suppressing appetite. During the weightlifting (non-aerobic) session, ghrelin levels decreased, but there was no significant change in peptide YY levels. The appetite hormone effects of both types of exercise lasted for a few hours.

Both types of exercise suppressed hunger, but aerobic exercise resulted in greater suppression of hunger. The findings were published online in the American Journal of Physiology -- Regulatory, Integrative and Comparative Physiology.

"The finding that hunger is suppressed during and immediately after vigorous treadmill running is consistent with previous studies indicating that strenuous aerobic exercise transiently suppresses appetite," senior author David J. Stensel, of Loughborough University, said in an American Physiological Society news release. "The findings suggest a similar, although slightly attenuated response, for weight-lifting exercise."

He said this line of research may lead to more effective ways to use exercise to help control weight.

More information

The U.S. National Institute of Diabetes and Digestive and Kidney Diseases has more about physical activity and weight control.



-- Robert Preidt

SOURCE: American Physiological Society, news release, Dec. 11, 2008

Last Updated: Dec. 26, 2008


New Research Suggests Avenues for Flu Antivirals

Maybe this will get some people off the flu pandemic bandwagon--new findings about ways the 1918 flu virus differed from typical flu viruses, as well as potential avenues of antiviral enhancements. See, it is possible to plan for potential flu pandemics without handing Big Pharma all your money to develop risky vaccines that may be unnecessary and harmful.

http://news.yahoo.com/s/afp/20081230/ts_afp/ushealthpandemicgenesvirus

US-Japanese study finds genes for 1918 'Spanish flu' pandemic


Mon Dec 29, 9:12 pm ET

WASHINGTON (AFP) – A US-Japanese research team announced it had isolated three genes that explain why the 1918 Spanish flu, believed to be the deadliest infectious disease in history, was so lethal.

The pandemic killed between 20 and 50 million people -- more than in all of World War I, which ended in November 1918 -- and spread around the world.

The genes allowed the virus to reproduce in lung tissue, according to research published in the Proceedings of the National Academy of Sciences.

"Conventional flu viruses replicate mainly in the upper respiratory tract: the mouth, nose and throat," said University of Wisconsin-Madison virologist Yoshihiro Kawaoka, who co-authored the study along with Masato Hatta, also of UW-Madison.

"The 1918 virus replicates in the upper respiratory tract, but also in the lungs," causing primary pneumonia among its victims," Kawaoka said.

"We wanted to know why the 1918 flu caused severe pneumonia," he added.

Autopsies of Spanish flu victims often revealed fluid-filled lungs severely damaged by massive hemorrhaging.

Virologists linked the virus' ability to invade the lungs with its high level of virulence, but the genes that conferred that ability were unknown, the researchers wrote.

The discovery of the three genes and how they help the virus infect the lungs is important because it could provide a way to quickly identify the potential virulence factors in new pandemic strains of influenza, Kawaoka said.

The genes could also lead to a new class of antiviral drugs, which is urgently needed as vaccines are unlikely to be produced fast enough at the outset of a pandemic to blunt its spread, he added.

The researchers generated Spanish flu viruses from genetic material extracted from preserved lung tissue of three of the pandemic's victims, thanks to Jeffrey Taubenberger's work at the Armed Forces Institute of Pathology.

Taubenberger was able to isolate the eight genes of the 1918 virus by the technique of inverse genetics.

Kawaoka's team blended genetic elements from the 1918 flu virus with those of current flu pathogens, generating viruses that carried different genetical combinations.

Tested on ferrets and mice, most of the combined viruses infected the upper respiratory tract of the laboratory animals but did not cause pneumonia.

One exception, however, included a complex of three genes that, acting in concert with another key gene, allowed the virus to efficiently colonize lung cells and make RNA polymerase, a protein necessary for the virus to reproduce.

The other key gene makes hemagglutinin, a protein found on the surface of the virus and that confers on viral particles the ability to attach to host cells.

The RNA polymerase is used to make copies of the virus once it has entered a host cell. The role of hemagglutinin is to help the virus gain access to cells, Kawaoka said.

Other co-authors of the study include Shinji Watanabe, Jin Hyun Kim and Masato Hatta, also of UW-Madison, and Kyoko Shinya of Kobe University, in Japan.

The work was funded by the Japanese Ministry of Education, Culture, Sports, Science and Technology and by grants-in-aid from the Ministry of Health, Labor and Welfare of Japan.


29 décembre

Novartis Buys CMV Vaccine

I'm counting the seconds until this one finds its way onto the CDC's schedule. Do we really need to inject babies with cytomegalovirus (a virus from the herpes family), or would it be a better idea to investigate improved hygiene and other methods of prevention?

http://www.newsobserver.com/business/story/1348489.html

AlphaVax sells vaccine to Novartis

From staff reports

Published: Mon, Dec. 29, 2008 09:42AM

Modified Mon, Dec. 29, 2008 09:43AM


AlphaVax, a Research Triangle Park company, has sold the rights to an experimental vaccine it is developing for $20 million to Swiss pharmaceutical giant Novartis.

The deal, announced this morning, also calls for Novartis to pay additional milestone fees and royalties, if the treatment succeeds in clinical trials.

The experimental vaccine could help prevent cytomegalovirus, a type of Herpes virus that can seriously harm patients with weakened immune systems, such as newborns or those with AIDS or cancer.

The virus affects 86,000 newborns in the U.S. and Europe each year, according to Novartis. The vaccine is expected to enter phase II clinical trials next year, Novartis said. If successful, it would be the first vaccine against CMV, the company said.

AlphaVax, founded in 1997, has attracted more than $125 million in grants, private equity and other funding.

Novartis is building a vaccine plant in Holly Springs that is expected to employ 350 people.


28 décembre

MMR + Varivax Caused Ben Zeller's Seizure Disorder

Here's a link to video coverage of the US Court of Federal Claims decision, as well as the story of Ben's vaccine injury first-hand, from Ben's mother:

Benjamin Joseph Zeller was born in Orlando, Florida on November 6, 2003. Because he was breech he was delivered by C-section, but everything else was perfectly normal; no complications during or after birth and we were out of the hospital in three days with a beautiful baby boy. Everything was terrific until he was 12 months old and Ben received his MMR and chickenpox vaccines. We were told by our physician that they were perfectly safe and the only side effect might be fever. Little did we know that Benjamin’s life would be permanently damaged.

Ten days after the vaccinations I was changing his diaper when he stopped breathing, turned blue and became lifeless. Luckily, my next door neighbor was an RN who performed CPR consistently. After three tries she got him breathing and then comforted me until the ambulance arrived. By the time we got to the hospital minutes later, little Ben was crying and alert, but started breaking out in a rash all over. The ER doctors said that my son suffered from a vaccination reaction and had probably suffered from a febrile seizure where, from a high temperature, babies lose consciousness and have seizure activity with shaking limbs. I had my doubts because his temperature that day was normal, and he didn’t shake or move at all. No, he was blue and lifeless, I said. I thought he had suffered sudden infant death syndrome. The doctors said not to worry; “this happens to healthy babies.”. They didn’t think any brain scans or an MRI were needed because he was crying, breathing and they could find no other problems, so I was told to give him Motrin every 6-8 hours for possible fever.

On Sunday Benjamin was rushed to the hospital because he was having seizures. Ever since his vaccinations he has suffered brain damage. They found central signal abnormality of the white matter of the brain, so that his newly developing brain cells could not communicate or develop properly because they could not send, receive, or remember the appropriate messages for proper growth. They finally concluded that he had delayed myelin deposition. Basically he was producing brain cells without a myelin sheath, the insulation that protects CNS cells. I was now told that Ben had a progressive degenerative neurological disorder or an unknown disease. It appeared that this disorder might cause him to possibly die because his entire neurological system could shut down over time. All the doctors knew to do was to prescribe more anti-seizure medications which were completely ineffective for my son. So they told me to up the dosages of the (useless) medications or to give him Ativan: good grief! The best that they could do was to recommend a strong tranquilizer for a 13-month-old. Ben had over 1,000 seizures in just four months, from 20-40 seizures every day. Still, the doctors gave us no hope, but I was determined to help Benjamin.

That’s when fate decided to drop in or better yet, drive by. In January of this year I was heading down Ocean Boulevard in Lauderdale-by-the-Sea, Benjamin was having a seizure, and this medical building caught my eye, the sign said something about brain recovery. When I pulled into the parking lot there was a guy outside wearing scrubs. I assumed he worked there and stopped the car. I said “My baby is having seizures, do you know anybody who could help him?” The guy in scrubs was Dale Wells, a hyperbaric technician for the Ocean Hyperbaric Neurologic Center. He told me to park the car and to come inside. He had something to show me. The first thing they did after they made sure that Ben was OK was to put on a video about CP and the brain injured child and then explained to me about HBOT and the treatment of children with seizure disorders. Everyone just wanted to help me and my beautiful baby boy. I don’t know who started crying first: Dale, Lisa B. (the nurse), or me. I think little Benjamin was the only one who wasn’t crying. I finally felt that there might be hope. In fact they offered to get us in to consult with Dr. Neubauer that very day. He told me that the cells in the brain don’t always die but just become wounded and inactive because of brain injury.

 First he ordered a SPECT brain scan which clearly showed all of the areas of the brain where there was no blood flow and I started hyperbaric oxygen treatments with Benjamin right away.  The experience was wonderful and simple. I sat in the chamber with Ben on my chest and watched TV for a one hour twice a day every day. I didn’t ever think something so simple could benefit my son because of his complex condition, but after the 6th treatment I noticed a significant difference in the intensity of Ben’s seizures. At about the 20th treatment little Benjamin started having less seizures every day. It seemed as if every week his seizures were going away. Now, after 68 treatments, he has not had a seizure for 12 days straight. We continue to receive HBOT treatments every day. Ben is now able to start with physical therapy and all the other treatments that he wasn’t able to have because of the seizure activity. 

HBOT is saving my son’s life. I want to compose a special THANK YOU to the entire staff at Ocean Hyperbaric Neurologic Center for their caring support and professionalism: “I truly believe everyone of you are chosen by angels. Dr. Neubauer and Dr. D. (George Daviglus,M.D.), I especially thank you for putting the time and effort to help little Ben. Dr. Neubauer, I will always admire all of the sacrifice you put into your patients’ care and the never-ending research that you have committed yourself to. Thanks for joining my son’s journey for a healthy life and making all the difference in the world to me and my family.”

Sincerely,

Little Benjamin J. Zeller,

Benjamin S. Zeller and Erin Zeller

26 décembre

Stryker Cranial Implants May Be Dirty

That's what "sterility issues" means, folks.
 
 

Stryker says it recalled facial implant kits

By MARLEY SEAMAN , 12.24.08, 02:09 PM EST
 

Medical device maker Stryker Corp. said Wednesday it recalled 322 custom-made cranial implant kits because of possible sterility issues, which the Food and Drug Administration advised could be lethal.

Stryker recalled all kits distributed between Nov. 5, 2007, and Oct. 23, 2008 because it can't be sure the kits were properly sterilized. Physicians received a recall letter Oct. 24, and on Thursday the FDA deemed the recall a Class 1, meaning there is a reasonable probability that use of the product will cause serious injury or death.

Physicians who used the implant kits were advised to follow up with patients for at least six months after surgery to check for infections. The letter also told patients how to identify and return any remaining implant kits.

The cranial implant kits are used to correct defects in the jaw and face, or cranium and face.

Stryker shares gained 16 cents to $40.05 in abbreviated trading Wednesday.

 

It's Not Just Monsanto Playing God Anymore

Is it really so much better for large corporations to insert genes from bacteria into the DNA of corn than it is for Joe Schmo to monkey around with DNA in his apartment? It's all part of a giant experiment on humanity (and the planet), taking place without our consent.
 
 
Amateurs are trying genetic engineering at home
 
By MARCUS WOHLSEN, Associated Press Writer Marcus Wohlsen, Associated Press Writer Thu Dec 25, 6:49 pm ET
 

SAN FRANCISCO – The Apple computer was invented in a garage. Same with the Google search engine. Now, tinkerers are working at home with the basic building blocks of life itself.

Using homemade lab equipment and the wealth of scientific knowledge available online, these hobbyists are trying to create new life forms through genetic engineering — a field long dominated by Ph.D.s toiling in university and corporate laboratories.

In her San Francisco dining room lab, for example, 31-year-old computer programmer Meredith L. Patterson is trying to develop genetically altered yogurt bacteria that will glow green to signal the presence of melamine, the chemical that turned Chinese-made baby formula and pet food deadly.

"People can really work on projects for the good of humanity while learning about something they want to learn about in the process," she said.

So far, no major gene-splicing discoveries have come out anybody's kitchen or garage.

But critics of the movement worry that these amateurs could one day unleash an environmental or medical disaster. Defenders say the future Bill Gates of biotech could be developing a cure for cancer in the garage.

Many of these amateurs may have studied biology in college but have no advanced degrees and are not earning a living in the biotechnology field. Some proudly call themselves "biohackers" — innovators who push technological boundaries and put the spread of knowledge before profits.

In Cambridge, Mass., a group called DIYbio is setting up a community lab where the public could use chemicals and lab equipment, including a used freezer, scored for free off Craigslist, that drops to 80 degrees below zero, the temperature needed to keep many kinds of bacteria alive.

Co-founder Mackenzie Cowell, a 24-year-old who majored in biology in college, said amateurs will probably pursue serious work such as new vaccines and super-efficient biofuels, but they might also try, for example, to use squid genes to create tattoos that glow.

Cowell said such unfettered creativity could produce important discoveries.

"We should try to make science more sexy and more fun and more like a game," he said.

Patterson, the computer programmer, wants to insert the gene for fluorescence into yogurt bacteria, applying techniques developed in the 1970s.

She learned about genetic engineering by reading scientific papers and getting tips from online forums. She ordered jellyfish DNA for a green fluorescent protein from a biological supply company for less than $100. And she built her own lab equipment, including a gel electrophoresis chamber, or DNA analyzer, which she constructed for less than $25, versus more than $200 for a low-end off-the-shelf model.

Jim Thomas of ETC Group, a biotechnology watchdog organization, warned that synthetic organisms in the hands of amateurs could escape and cause outbreaks of incurable diseases or unpredictable environmental damage.

"Once you move to people working in their garage or other informal location, there's no safety process in place," he said.

Some also fear that terrorists might attempt do-it-yourself genetic engineering. But Patterson said: "A terrorist doesn't need to go to the DIYbio community. They can just enroll in their local community college."

25 décembre

Toys Not Made in China

Doesn't this tricycle look tempting? High-quality toys made humanely by people who don't tank-roll dissidents and kill Tibetans. The Maple Landmark toys are made in America.
24 décembre

DDT and PCBs Still Present in Marine Life off California Coast

http://latimesblogs.latimes.com/lanow/2008/12/ddt-pcb-comtami.html

Chemical pollution continues to haunt sea life

2:10 PM, December 23, 2008

More than a generation has passed since manufacturers routinely dumped DDT pesticide and the chemical PCB en masse onto the ocean floor off the Palos Verdes Peninsula via the Los Angeles County sewer system.

But new research by a Cal State Long Beach University lecturer and a masters student found these toxins continue to exact a toll on the local marine environment as evidenced in the high concentrations still present in marine mammals such as seals and sea lions.

The Environmental Protection Agency estimates that between the late 1940s and the early 1970s, about 110 tons of DDT and 11 tons of PCB were dumped off Palos Verdes' White's Point. The chemicals settled on the ocean floor, fanning out over about 25 square miles.

The study also (summarized here) analyzed the presence of toxins in blubber samples taken from 145 seals and sea lions that died at two facilities that treat sick and injured marine animals: the Fort MacArthur Marine Mammal Center and the Pacific Marine Mammal Center in Laguna Beach. The animals died between 1994 and 2006.

DDT, once a widely used an agricultural pesticide in the United States that is now banned, was found in slightly lower concentrations in sea lions than was found in studies on the marine mammals conducted in the early 1970s, according to the study published in the Marine Pollution Bulletin.

Adult male sea lions and seals had the highest concentration because they had the highest fat content. But the chemicals were also conspicuously present in pups, who absorbed them feeding on their mother's milk.

Mary Blasius, who conducted the bulk of the research, said the levels of contamination of the Los Angeles and Orange County coasts were 10 times higher for DDT and five times higher for PCB than in Northern California.

She noted that more research needed to be done on how the toxicity levels were affecting the marine mammals. But she said the study points up the dangers to humans, whose diets include some of the same animals consumed by the seals and sea lions.

"The animals that reside in the sediment are consuming these chemicals and then fish consume those organisms," Blasius said. "The higher you move up the food change, the more you ingest."

-- Andrew Blankstein


Poor Quality Control at Haemonetics

http://www.reuters.com/article/governmentFilingsNews/idUSN2353718420081223

UPDATE 1-U.S. FDA warns Haemonetics over quality control

Tue Dec 23, 2008 11:55am EST

(Adds details from FDA letter)

WASHINGTON, Dec 23 (Reuters) - Haemonetics Corp (HAE.N) has failed to correct a variety of manufacturing issues, including taking proper steps to ensure the quality of its blood collection products, the U.S. Food and Drug Administration warned in a letter released on Tuesday.

The company, which makes devices and other products to collect and process blood, must have an outside expert consultant audit its manufacturing and quality systems, the FDA also said in its letter dated Dec. 4.

After the letter's release, shares of Haemonetics were off 3 percent, or $1.70, at $54.07 in late morning trade on the New York Stock Exchange.

FDA officials uncovered the problems while inspecting the company's Niles, Illinois, plant in June and July. Haemonetic responded to the investigators' concerns in late July, but the FDA found many of its steps were inadequate.

Among the violations were Haemonetics' failure to set up quality control procedures for suppliers and contractors. It also did not properly set up systems to verify product standards, the letter said.

Representatives for the company did not immediately return a request for comment.

Haemonetics has 15 days to respond to the FDA's warning letter. The agency can take a variety of punitive actions, including levying fines or seeking an injunction, although most similar cases are resolved without further action.

The FDA posted the letter on its website here

(Reporting by Susan Heavey, editing by Dave Zimmerman)


Massachusetts Biotech Council Head Robert Coughlin Crooked

Government employees setting up private-sector jobs while still ostensibly working for the public? Say it ain't so!

http://www.boston.com/news/local/massachusetts/articles/2008/12/24/biotech_chief_fined_10000_over_ethics/

Biotech chief fined $10,000 over ethics


By Frank Phillips and Todd Wallack Globe Staff / December 24, 2008

The state Ethics Commission has imposed a $10,000 fine on a former top economic development aide to Governor Deval Patrick for secretly pursuing the presidency of the Massachusetts Biotechnology Council last year while using his state job to help develop tax breaks and other incentives that were crucial to the industry trade group.

The commission's investigation found that Robert K. Coughlin, a former state representative, began his quest for the $350,000-a-year Mass Biotech job just a few weeks after the new governor hired him to be undersecretary of business development.

He then spent the next five months secretly seeking the private-sector position without telling his superiors in Patrick's administration and without removing himself from policy decisions affecting his future employer, as required by state law, the Ethics Commission said.

Coughlin was a key Patrick administration official involved in developing the governor's $1 bil lion biotechnology industry stimulus, which included tax incentives and development grants for companies in Massachusetts.

The Ethics Commission, in finding Coughlin violated state ethics law, said his actions created an appearance that the Mass Biotechnology Council "could unduly enjoy his favor in the performance of his official duties."

The ethics investigation was sparked by a Globe story about Coughlin's job-seeking activities with the Mass Biotech Council that appeared shortly after he accepted the job in August 2007. Despite the fine, the Biotechnology Council said yesterday that it would take no action against Coughlin and planned to keep him in the high-profile post, in which he serves as the public face of the state's huge and influential biopharmaceutical industry.

The council, which has 550 members, including many large corporations, lobbies Beacon Hill on life science issues and the industry's economic needs. Coughlin's predecessor in the job, Thomas F. Finneran, the former House speaker, was forced to resign under a cloud after pleading guilty to federal obstruction charges almost two years ago.

In a statement, Mark Leuchtenberger, council chairman, said the council is "happy to have closure on this case."

"Bob Coughlin has done a great job leading the MBC, and we are confident we made the right choice in appointing him president. We look forward to having Bob lead the organization in 2009 and beyond," he said. Leuchtenberger led the search committee that chose Coughlin, a former Democratic state representative from Dedham.

David Giannotti, an ethics commission spokesman, said the Coughlin investigation is considered a confidential matter and declined to comment. The Globe obtained the Ethics Commission findings from a person whom Coughlin authorized to release the agreement.

In a statement, Coughlin expressed relief that the 15-month investigation that has clouded his tenure as head of the Biotechnology Council is over."I'm glad to have this matter resolved," he said "I have a great job and I love coming to work every day to lead an organization that represents not just jobs and growth opportunities, but most importantly improving the lives of patients."

The ethics probe paints a more detailed picture of Coughlin's job-search activities while he was a state official than had previously been made public, and it shows that he was more active, and active far earlier, than was previously disclosed.

Robert K. Coughlin spent months secretly seeking the job without telling his superiors in Patrick's administration.

HELPED DEVELOP TAX BREAKS

Shortly after accepting his state job in January, Coughlin had several conversations in February and March with officials at the Biotech Council in which he expressed interest in the presidency, the Ethics Commission said. By late March he had put his name on the list of potential candidates with its private Boston search firm, Levin & Co. On April 1, he submitted his resume.

But it was not until July 24, after meetings with the council's search committee, that Coughlin disclosed to Patrick that he was a candidate for the post.

The investigation concluded that Coughlin kept his activities secret from his immediate boss, Daniel O'Connell, Patrick's secretary of housing and economic development. It found that in early May 2007, Coughlin had a "brief conversation in passing" in which Coughlin told O'Connell that he was in the "wide net" of potential candidates for the Biotechnology Council presidency. It concluded that he did not tell O'Connell that he submitted his resume or had met with the search firm's owner or the search committee.

Patrick's spokesman, Joseph Landolfi, said the governor has cooperated fully with the investigation, but declined to comment on the case because it has not been publicly released by the Ethics Commission.

"If, however, the commission concludes that Mr. Coughlin committed any violations, we fully support the imposition of sanctions," Landolfi said.

Coughlin's lawyer, Thomas R. Kiley, last year described some of Coughlin's meetings as "meet and greet" sessions that did not require disclosure to his superiors in state government. Kiley said last year that Coughlin was not applying for the job when he spoke with the selection committee on June 11.

Despite the ethics investigation that has dogged Coughlin during his first year on the job and the $10,000 fine, some biotech executives praised his performance yesterday.

"I am glad this cloud is behind him and we can move on," said John Maraganore, chief executive of Alnylam Pharmaceuticals Inc., a prominent biotechnology firm in Cambridge.

Maraganore said he thinks Coughlin has brought a lot of passion to the job. "I think [Coughlin] is off to a phenomenal start," he said.Coughlin is given an undisclosed annual performance bonus. Finneran received more overall, $475,904 in 2006, including about $430,000 in salary. Even though he resigned less than two weeks into the year, Finneran received $246,850 in 2007, mostly for severance, accrued vacation, and other departure pay.

Abbott's Humira Ad Misleading

http://money.cnn.com/news/newsfeeds/articles/djf500/200812231812DOWJONESDJONLINE000461_FORTUNE5.htm

FDA Warns Abbott Over Ad For Psoriasis Drug Humira

December 23, 2008: 06:12 PM ET

WASHINGTON -(Dow Jones)- Federal regulators warned Abbott Laboratories (ABT) over an advertisement for the company's psoriasis drug Humira, saying it is misleading and makes claims not supported by scientific evidence.

The ad for Humira suggests the drug is approved for any patient with moderate to severe chronic plaque psoriasis, even though the product is only approved for a more limited patient population, the Food and Drug Administration said in a Dec. 16 letter to the Abbott Park, Ill., company.

The letter, posted on the FDA's Web site Tuesday, notes that the ad presents risks associated with the drug in "extremely" small type that fails to adequately convey the serious risks connected to the product. Humira's label carries a black-box warning, the FDA's strongest, that details risks of tuberculosis and other infections, some fatal.

Humira, approved in 2002, is used to treat adult patients with moderate to severe chronic psoriasis, a skin disease characterized by red patches and flaky and scaly skin, who don't generally respond to topical medications. The drug, which brought in sales of $3 billion last year, is also approved to treat Crohn's disease, a chronic infection of the intestines.

The FDA wants Abbott to cease use of the ad and to respond by Jan. 2 with details about whether it intends to comply with the request.

-By Jared A. Favole, Dow Jones Newswires; 202.862.9207; jared.favole@ dowjones.com

Why Does Anyone Buy Food from China?

Do we really need to read a new article each week telling us yet another Chinese food that is contaminated with poison? Maybe we should just be smart and eat food that comes from our own country. They rolled tanks over people who disagreed with them. They are not trustworthy. Let's not eat their food.

http://www.latimes.com/business/la-fi-melamine24-2008dec24,1,4527706.story

Toxic melamine is suspected in seafood from China


Industry experts and businesspeople in China say that the industrial chemical has been routinely added to fish and animal feed to artificially boost protein readings.
By Don Lee and Tiffany Hsu
11:11 PM PST, December 23, 2008
Reporting from Los Angeles and Shanghai -- Melamine in Chinese-produced milk powder has sickened hundreds of thousands of children and added to a growing list of made-in-China foods banned across the globe. Now, some scientists and consumer advocates are raising concerns that fish from China may also be contaminated with the industrial chemical.

China is the world's largest producer of farm-raised seafood, exporting billions of dollars worth of shrimp, catfish, tilapia, salmon and other fish. The U.S. imported about $2 billion of seafood products from China in 2007, almost double the volume of four years earlier, according to the U.S. Department of Agriculture.

But industry experts and businesspeople in China say that melamine has been routinely added to fish and animal feed to artificially boost protein readings. And new research suggests that, unlike in cows and pigs, the edible flesh in fish that have been fed melamine contains residues of the nitrogen-rich substance.

Melamine, commonly used in plastics and dishware, can lead to urinary problems such as kidney stones and even renal failure.

Last year, pet foods made with melamine-laced ingredients from China sickened or killed thousands of dogs and cats in the U.S. This year, infant formula tainted with the chemical has been linked to illness in 294,000 small children and six deaths in China, according to China's Ministry of Health.

In the U.S., fish from China can be found in the frozen food aisle in supermarkets and is served in posh restaurants.

"China's a big place, and it does a lot of processing, and cheaply too," said Brian Dedmon, purchasing manager for the Fish King distribution plant in Burbank.

Fish King, which supplies hundreds of Southern California restaurants and has a store in Glendale, says it buys processed snow crab meat, squid and other seafood from China to meet market demand and because the price is competitive. Dedmon says the company relies on government inspections, its importers and its own experience to ensure the fish it buys is safe.

"We're definitely concerned about melamine, but by the time the fish gets to us, health issues should've been taken care of by the government agencies and brokers that we go through," he said.

Not on the checklist

But even though some U.S. fish importers are voluntarily testing for melamine, the U.S. Food and Drug Administration, which is responsible for ensuring the safety of imported fish, currently doesn't require seafood products to be screened for melamine. Yet research from its own scientists has raised a warning flag.

Laboratory studies of melamine-fed catfish, trout, tilapia and salmon by the FDA's Animal Drugs Research Center found that fish tissues had melamine concentrations of up to 200 parts per million. That's 80 times the maximum "tolerable" amount set by the FDA for safe consumption.

Iddya Karunasagar, a United Nations fish-product safety expert in Rome, said the FDA's research suggested fish would have to ingest large amounts of melamine to pose a health threat to humans, something that he considered unlikely. But he said there were no data on melamine levels in Chinese-produced fish and animal feed.

Other scientists said testing of melamine in farm-raised fish from China should be made mandatory because of the dearth of information about melamine levels in Chinese feed and fish.

"That's the problem; no one has a clue how much concentration and for how long" fish from China have ingested melamine, said Jim Riviere, director of chemical toxicology research at North Carolina State University in Raleigh. "There's an issue of relative human safety," he said. "It would be prudent to screen for melamine."

An FDA representative in Washington wouldn't comment on why Chinese-produced seafood didn't have to be analyzed for melamine when imported to the U.S. Nor were FDA researchers made available to comment on their agency's findings, reported recently in the Journal of Agricultural and Food Chemistry.

Research undertaken by Riviere and others show that melamine in feed consumed by pigs and cows is excreted in the urine or otherwise flushed out, leaving virtually no trace of it in the muscle or meat of the animals. But fish appear to be different,toxicologists say.

Fang Shijun, who has monitored the melamine problem for several years, says he believes that the adulterated products are being supplied only by small operators, which abound in China.

Like those who added melamine to milk and diluted it with water to increase profit, feed businesses can sell more by substituting melamine for real protein sources, especially with the cost of corn and other raw materials having soared in the last couple of years.

"It is impossible to calculate how many of them have done that," said Fang, manager of feed research at Shanghai EFeedLink Information Technology, an agriculture consulting and research firm.

In the U.S., aqua-cultured seafood from China can be found in restaurants and in markets that sell frozen shrimp, catfish fillets and roasted eel, among other fish. U.S. importers such as Boston-based Stavis Seafoods, which sells products under the brand Foods From the Sea, are taking precautions and doing their own testing.

"It's our reputation behind it," company Chairman Richard Stavis said. Thus far, he said, the testing has not turned up melamine in the catfish and tilapia that Stavis buys from China.

U.S. importers have for some years been testing for a variety of antibiotics and substances, including the suspected carcinogen malachite green, which some Chinese fish farms use to control disease.

Since last year, the FDA has been restricting entry of shrimp, catfish, dace, eel and basa from China unless those shipments come with an independent lab report certifying the seafood is free of such additives. Melamine isn't included on that list of additives.

The Chinese government, facing increasing pressure from the public, has begun to crack down on melamine suppliers and has widened inspections to include feed. And many Chinese exporters of farmed fish say government inspectors are coming around more often and examining samples.

But shipments of filthy and contaminated fish from China continue to be detained at U.S. ports, exposing holes in a food-safety system that analysts say is undermined by a lack of resources, corruption and unscrupulous businesses that will sometimes mislabel or reroute goods through other countries.

Last month, 26 containers of shrimp, crawfish, tilapia and other fish from China were refused entry in Long Beach and other U.S. seaports. Inspectors cited a variety of reasons: salmonella, unsafe additives, unapproved drugs and labeling problems, according to FDA records on its website.

U.S. consumer advocates say the FDA has its own resource issues.

"They're so understaffed at the borders that despite whatever orders they have, we can't be sure that products aren't just coming through anyway," said Jean Halloran, food policy initiatives director for Consumers Union, the publisher of Consumer Reports. "We need much better testing," she said, including of melamine in fish.

FDA officials last month opened three offices in China, part of a strategy to deploy agency staff in countries where many U.S. foods now originate and where they can work with local inspectors and the industry.

"We cannot inspect our way to import safety; we have to roll our borders back and work with producers and have [their products] certified by people we trust," said Michael Leavitt, secretary of the U.S. Health and Human Services Department, under which the FDA operates, during a visit to China last month.

A food-source issue

Karunasagar, the U.N.'s fishery expert, said governments in China and elsewhere needed to tackle the problem at the source. "More than the fish, we should monitor melamine in the feed."

But that's easier said than done. In the U.S., commercial fish farms have to use feed from a handful of approved suppliers, but in China, there may be hundreds of thousands of sources for feed, said Steve Dickinson, an American attorney in China's coastal city of Qingdao who ran a salmon-farming business in Washington state.

Melamine has "infected the whole system in China," he said.

More than 15 feed suppliers in various parts of China were contacted for this story. Most of them declined to comment or said they didn't add melamine. But some of them said the practice of spiking feed with it had been going on for at least the last six years, with inspectors checking some types of feed products more tightly than others.

"It is not so regulated, for example, in the fish powder industry," said Zhuge Fulai, manager of Lianfeng Protein Feed Plant in Shandong province.

Fang, the feed research manager in Shanghai, said adulterating feed was particularly rampant in 2003 and 2004. He doubts that many feed suppliers today are adding melamine, given the awareness and the government's publicized crackdown, but neither he nor anyone else thinks the problem has been eradicated.

"We still need more government supervision," Fang said. "We need to have more random checks and to fully execute regulations and standards."

don.lee@latimes.com

tiffany.hsu@latimes.com

23 décembre

Ridiculous Jack***es F*** Up Their Babies by Forcing Early Delivery

As our Bradley coach told us, the baby will come when he's ready to come. Forcing the issue doesn't help, and doing it to fit someone's Christmas schedule is ****ing insane. Below is some evidence as to why, as if we needed any.

I've heard too many stories of "they had to induce me" or "the doctor had another baby to deliver, so they did a C-section" ... it makes me spitting mad. You hear mothers say that they'd do anything for their kids--anything but stay pregnant for another couple of weeks, it seems.

http://online.wsj.com/article/SB122999215427128537.html

  • DECEMBER 23, 2008

New Research Shows Why Every Week of Pregnancy Counts


This time of year, some hospitals see a small uptick in baby deliveries thanks to families eager to fit the blessed event in around holiday plans or in time to claim a tax deduction. Conventional wisdom has long held that inducing labor or having a Caesarean section a bit early posed little risk, since after 34 weeks gestation, all the baby has to do was grow.

But new research shows that those last weeks of pregnancy are more important than once thought for brain, lung and liver development. And there may be lasting consequences for babies born at 34 to 36 weeks, now called "late preterm."

A study in the American Journal of Obstetrics and Gynecology in October calculated that for each week a baby stayed in the womb between 32 and 39 weeks, there is a 23% decrease in problems such as respiratory distress, jaundice, seizures, temperature instability and brain hemorrhages.

A study of nearly 15,000 children in the Journal of Pediatrics in July found that those born between 32 and 36 weeks had lower reading and math scores in first grade than babies who went to full term. New research also suggests that late preterm infants are at higher risk for mild cognitive and behavioral problems and may have lower I.Q.s than those who go full term.

What's more, experts warn that a fetus's estimated age may be off by as much as two weeks either way, meaning that a baby thought to be 36 weeks along might be only 34.

The American College of Obstetricians and Gynecologists, the American Academy of Pediatrics and the March of Dimes are now urging obstetricians not to deliver babies before 39 weeks unless there is a medical reason to do so.

"It's very important for people to realize that every week counts," says Lucky E. Jain, a professor of pediatrics at Emory University School of Medicine.

It's unclear how many deliveries are performed early for nonmedical reasons. Preterm births (before 37 weeks) have risen 31% in the U.S. since 1981 -- to one in every eight births. The most serious problems are seen in the tiniest babies. But nearly 75% of preterm babies are born between 34 and 36 weeks, and much of the increase has come in C-sections, which now account for a third of all U.S. births. An additional one-fifth of all births are via induced labor, up 125% since 1989.

Many of those elective deliveries are done for medical reasons such as fetal distress or pre-eclampsia, a sudden spike in the mother's blood pressure. Those that aren't can be hard to distinguish. "Obstetricians know the rules and they are very creative about some of their indications -- like 'impending pre-eclampsia,'" says Alan Fleischman, medical director for the March of Dimes.

Why do doctors agree to deliver a baby early when there's no medical reason? Some cite pressure from parents. "'I'm tired of being pregnant. My fingers are swollen. My mother-in-law is coming' -- we hear that all the time," says Laura E. Riley, medical director of labor and delivery at Massachusetts General Hospital. "But there are 25 other patients waiting, and saying 'no' can take 45 minutes, so sometimes we cave."

There's also a perception that delivering early by c-section is safer for the baby, even though it means major surgery for the mom. "The idea is that somehow, if you're in complete control of the delivery, then only good things will happen. But that's categorically wrong. The baby and the uterus know best," says F. Sessions Cole, director of newborn medicine at St. Louis Children's Hospital.

He explains that a complex series of events occurs in late pregnancy to prepare the baby to survive outside the womb: The fetus acquires fat needed to maintain body temperature; the liver matures enough to eliminate a toxin called bilirubin from the body; and the lungs get ready to exchange oxygen as soon as the umbilical cord is clamped. Disrupting any of those steps can result in brain damage and other problems. In addition, the squeezing of the uterus during labor stimulates the baby and the placenta to make steroid hormones that help this last phase of lung maturation -- and that's missed if the mother never goes into labor.

[Why Every Week of Pregnancy Counts] Gail Zuniga/WSJ

"We don't have a magic ball to predict which babies might have problems," says Dr. Cole. "But we can say that the more before 39 weeks a baby is delivered, the more likely that one or more complications will occur."

In cases where there are medical reasons to deliver a baby early, lung maturation can be determined with amniocentesis -- using a long needle to withdraw fluid from inside the uterus. But that can cause infection, bleeding or a leak or fetal distress, which could require an emergency c-section.

Trying to determine maturity by the size of the fetus can also be problematic. Babies of mothers with gestational diabetes are often very large for their age, but even less developed for their age than normal-size babies.

Growing beyond 42 weeks can also pose problems, since the placenta deteriorates and can't sustain the growing baby.

Making families aware of the risks of delivering early makes a big difference. In Utah, where 27% of elective deliveries in 1999 took place before the 39th week, a major awareness campaign has reduced that to less than 5%. At two St. Louis hospitals that send premature babies to Dr. Cole's neonatal intensive-care unit, obstetricians now ask couples who want to schedule a delivery before 39 weeks to sign a consent form acknowledging the risks. At that point, many wait for nature to take its course, says Dr. Cole.


Did Your Doctor Leave a Device Inside You?

These truly are reasons to stay out of the hospital. Unfortunately, MRSA and others are even bigger reasons.

http://online.wsj.com/article/SB122998909696028341.html

DECEMBER 23, 2008

For Patients, a List of Hospital Hazards


By LAURA LANDRO

You could call it the top 10 reasons to stay out of the hospital.

The Ecri Institute, which conducts patient-safety research and investigates medical-device incidents, last week issued its second annual report on the top 10 technology hazards that should be on every hospital's list of safety concerns for medical-device use.

In all, five of the hazards on the list are new, while a total of five from last year dropped off the list, including infusion-pump programming errors and the misconnection of blood-pressure monitors to IV lines.

But Dan Ault, senior project engineer and manager for Ecri's problem reporting network and author of the report, say that none of the items dropped from the list have stopped being "significant concerns."

The revisions are based on the prevalence and severity of the reports the group has received over the past year; recalls and actions it has reviewed; and other published reports.

[Combo]

New on the list are air embolisms from the contrast-media injectors used to inject dye into patients for X-ray imaging of blood vessels. Though there are safety features on the injectors to reduce the risk, they aren't foolproof, and errors can be fatal.

Also new on the list is retained surgical devices -- such as a sponge or clamp left in a patient -- and "unretrieved fragments," like a piece of a surgical tool that breaks off and either isn't noticed by the surgical team or is lodged in a part of the anatomy too risky to attempt retrieval.

Though burns during electrosurgery dropped off the list from 2007, burns from another source made the top 10: the fiber-optic lights used on endoscopes and headlamps to illuminate treatment sites.

Also new on the list: serious problems with anesthesia equipment just before it is to be used on a patient (or after it is too late), including misconnected breathing circuits and ventilator leaks.

Finally, misleading displays on medical devices -- such as infusion pumps with confusing displays -- can mislead clinicians into making serious errors, like misprogramming medication doses.

Mr. Alt says the report is intended to highlight all the things that can go wrong, so users can understand "where things can fall apart" and take steps to avoid problems.

And while some problems involve a faulty device, he says, "it's generally a misunderstanding on the part of user. No one reads the manual, or even has the manual after day one, and even if they are trained they get busy or move on to something else."

The bottom line: "If devices are used safely there are going to be fewer incidents, and each person in the chain during the process has a responsibility to prevent a problem," he says.

Write to Laura Landro at laura.landro@wsj.com

GSK Shifts Political Bribes from Donations to Lobbying

...and tries to pass it off as reform. Ha! Let's see--GSK gave $375 THOUSAND in political contributions in 2007, and $8.24 MILLION in lobbying, and they're pretending that the $375,000 is the bit that's going to make a difference in getting "special treatment"? Hahahahahahahahaha...

http://www.bizjournals.com/triangle/stories/2008/12/22/daily3.html?jst=b_ln_hl

Monday, December 22, 2008, 9:58am EST  |  Modified: Monday, December 22, 2008, 10:49am

GSK to end state-level political contributions

Triangle Business Journal


GlaxoSmithKline says it will stop giving corporate political contributions – though the company will keep intact a political action committee that has given away millions in recent election cycles.

The drug company says its new policy will be to stop corporate political contributions around the world. In the past, the company has made contributions to state-level candidates in the U.S. and Canada.

In calendar year 2007, according to a company report, it gave about 250,000 British pounds (about $375,000) to candidates for state-held offices in the U.S. About 51 percent of that money went to Republicans, while 47 percent went to Democrats.

"We continue to believe that it is important for GSK to be engaged in policy debates and the political process," CEO Andrew Witty said in a written statement. "However, we need to ensure that there is no implication whatsoever that corporate political contributions provide us with any special privilege. We do not believe they have, and in the few countries we have given contributions we have done so in full compliance of the law."

GSK is not ending all means of political contributions. The company says it will keep intact an employee-run political action committee in the U.S.

Since the 1990 election cycle, according to the Center for Responsive Politics, PACs associated with GSK and its predecessor companies have donated more than $6 million to federal candidates and political parties.

GSK's announcement Monday also will not affect the company's lobbying practices. According to GSK's most recent corporate responsibility report, the company spent $8.24 million on federal lobbying activities in the U.S. in 2007.

GlaxoSmithKline (NYSE: GSK) is based in London. Its U.S. headquarters are in North Carolina, where the company employs more than 5,000.


Auto-Immune Disorders Result from Stress on Anergic B-cells

I wonder what type of stress... interesting that the researchers didn't spend any time on that one...

http://news.yahoo.com/s/hsn/20081223/hl_hsn/scientistsdiscovertriggerforautoimmunediseases;_ylt=AsKz5FvyxqEgecqaLKCs1Iy3j7AB

Scientists Discover Trigger for Autoimmune Diseases


Mon Dec 22, 11:47 pm ET

MONDAY, Dec. 22 (HealthDay News) -- Healthy adults have potential autoimmune disease-causing cells, but these cells stay in an "off" state, a U.S. study shows.

Immune cells that attack the body cause autoimmune diseases such as lupus and rheumatoid arthritis (RA). Whether the switched-off cells in healthy adults are true precursors of the self-attacking immune cells and, if so, what prevents them from causing disease in certain people, isn't known, the researchers said.

J. Andrew Duty, of the Oklahoma Medical Research Foundation, and colleagues found that anergic (dormant) autoimmune disease-causing cells account for 2.5 percent of immune B-cells circulating in the blood of healthy adults.

These anergic cells don't appear to cause problems in healthy adults, but did produce self-reactive antibodies when exposed to a strong stimulus in lab experiments. This means these anergic cells may contain the precursors for the self-attacking B-cells in patients with autoimmune disease, the researchers said.

In previously healthy people, anergy may somehow break down and allow self-attacking B-cells to cause autoimmune disease.

The study was published in the Dec. 22 online issue of The Journal of Experimental Medicine.

More information

The U.S. National Women's Health Information Center has more about autoimmune diseases.