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30 avril Revolving Door Between Federal Government and DuPont?You wonder why it's OK for DuPont to have a self-policed, multi-year phaseout of carcinogenic Teflon... and then you read articles like this one:
Associated PressDuPont names former secretary of energy to boardAssociated Press, 04.29.09, 03:22 PM EDTChemical manufacturing company DuPont Co. said Wednesday that Samuel W. Bodman, former U.S. secretary of energy, was elected to its board during the company's annual shareholders meeting. Bodman, 70, served as deputy treasury secretary and deputy commerce secretary under President George W. Bush before being appointed to serve as energy secretary during Bush's second term. Previous to that, Bodman was chairman and chief executive of specialty chemical and materials company Cabot Corp. ( CBT - news - people ) DuPont ( DD - news - people ) shares rose 64 cents, or 2.3 percent, to $28.15 in afternoon trading. Merck Published a WHOLE FAKE JOURNAL!I mean, damn! This one speaks for itself. No witty remarks from me required.
Merck published fake journal
Posted by Bob Grant
[Entry posted at 30th April 2009 04:27 PM GMT]
Merck paid an undisclosed sum to Elsevier to produce several volumes of a publication that had the look of a peer-reviewed medical journal, but contained only reprinted or summarized articles--most of which presented data favorable to Merck products--that appeared to act solely as marketing tools with no disclosure of company sponsorship.
"I've seen no shortage of creativity emanating from the marketing departments of drug companies," Peter Lurie, deputy director of the public health research group at the consumer advocacy nonprofit Public Citizen, said, after reviewing two issues of the publication obtained by The Scientist. "But even for someone as jaded as me, this is a new wrinkle." The Australasian Journal of Bone and Joint Medicine, which was published by Exerpta Medica, a division of scientific publishing juggernaut Elsevier, is not indexed in the MEDLINE database, and has no website (not even a defunct one). The Scientist obtained two issues of the journal: Volume 2, Issues 1 and 2, both dated 2003. The issues contained little in the way of advertisements apart from ads for Fosamax, a Merck drug for osteoporosis, and Vioxx. (Click here and here to view PDFs of the two issues.) The claim that Merck had created a journal out of whole cloth to serve as a marketing tool was first reported by The Australian about three weeks ago. It came to light in the context of a civil suit filed by Graeme Peterson, who suffered a heart attack in 2003 while on Vioxx, against Merck and its Australian subsidiary, Merck, Sharp & Dohme Australia (MSDA). In testimony provided at the trial last week, which was obtained by The Scientist, George Jelinek, an Australian physician and long-time member of the World Association of Medical Editors, reviewed four issues of the journal that were published from 2003-2004. An "average reader" (presumably a doctor) could easily mistake the publication for a "genuine" peer reviewed medical journal, he said in his testimony. "Only close inspection of the journals, along with knowledge of medical journals and publishing conventions, enabled me to determine that the Journal was not, in fact, a peer reviewed medical journal, but instead a marketing publication for MSD[A]." He also stated that four of the 21 articles featured in the first issue he reviewed referred to Fosamax. In the second issue, nine of the 29 articles related to Vioxx, and another 12 to Fosamax. All of these articles presented positive conclusions regarding the MSDA drugs. "I can understand why a pharmaceutical company would collect a number of research papers with results favourable to their products and make these available to doctors," Jelinek said at the trial. "This is straightforward marketing." Jelinek also pointed out several "review" articles that only cited one or two references. He described one of these articles as "simply a summary of an already published article," and noted that they were authored by "B&J Editorial." "It appears that 'B&J' (presumably Bone and Joint) refers to the Journal, and B&J editorial presumably to the publishers or owners as there is no editor of the journal," Jelinek said in his testimony. "This is a subtle attribution, and many readers may not realise that the paper was written by the owners or publishers of the journal, presuming that is who would write under the heading of 'editorial'." Lurie, in examining two of the issues for The Scientist, agreed that one particularly strange element of the Australasian Journal of Bone and Joint Medicine is that it contains "review" articles that cite just one or two references. "I've never seen anything quite like this," he said. "Reviews are usually swimming in references." For example, one article on osteoporosis labeled above the title as a "meta-analysis" cites two references -- one itself a meta-analysis. "To the jaundiced eye, [the journal] might be detected for what it is: marketing," he said. "Many doctors would fail to identify that and might be influenced by what they read." Lurie noted that the Australasian Journal of Bone and Joint Medicine is akin to other publishing strategies employed by drug companies; paying for supplements to existing journals or publishing compilations of original research articles that tend to lack scientific rigor (so-called "throwaways"). "It's kissing cousin to two other tricks that the [drug] companies pull." In response to several questions about the publication posed by The Scientist, an MSDA spokesperson wrote in an email: "MSDA understood that Elsevier envisaged the complimentary publication would draw on the vast resources of Elsevier, publishers of many leading peer-reviewed journals including Lancet, Bone, Joint Bone Spine and others, to deliver novel and timely full text articles and abstracts to physicians." Many of the articles appearing in the Australasian Journal of Bone and Joint Medicine were in fact reprints or summaries of studies that originally appeared in other Elsevier journals. A spokesperson for Elsevier, however, told The Scientist, "I wish there was greater disclosure that it was a sponsored journal." Disclosure of Merck's funding of the journal was not mentioned anywhere in the copies of issues obtained by The Scientist. Elsevier acknowledged that Merck had sponsored the publication, but did not disclose the amount the drug company paid. In a statement emailed to The Scientist, Elsevier said that the company "does not today consider a compilation of reprinted articles a 'Journal'." "Elsevier acknowledges the concern that the journals in question didn't have the appropriate disclosures," the statement continued. "It is worth noting that project in question was produced 6 years ago and disclosure protocols have evolved since 2003. Elsevier's current disclosure policies meet the rigor and requirements of the current publishing environment." The Elsevier spokesperson said the company wasn't aware of how many copies of the Australasian Journal of Bone and Joint Medicine were produced or how the publication was distributed in Australia, but noted that "the common practice for sponsored journals is that doctors receive them complimentary." The spokesperson added that Elsevier had no plans to look further into the matter. One of the members of Australasian Journal of Bone and Joint Medicine's "Honorary Editorial Board," Peter Brooks, a rheumatologist in Australia, said he didn't recall who asked him to serve on the board, but noted that he was on Merck's Asian Pacific and international advisory boards from the mid 1990s until about 2004, as well as the advisory boards of other pharmaceutical companies, including Pfizer and Amgen. "You get involved in a whole bunch of things at this level," Brooks said, adding that he had put his name on "a few advertorials" for pharmaceutical companies about 10 years ago. As for the Australasian Journal of Bone and Joint Medicine, he said, "If it would have been put to me that [the journal] was just sort of a throwaway, then I would have said 'no'" to serving on its editorial board. He said he was never paid for his role, adding that he "didn't ever get [manuscripts] to review or anything like that," while on the board, because the journal did not accept original manuscripts for review. "Having looked at one issue, it actually had some marketing studies," Brooks said. "It also had papers that were excerpted from other peer-reviewed journals. I don't think it's fair to say it was totally a marketing journal." Editor's note (April 30): This story has been updated from a previous version. 29 avril Stop Doping Yourself Up With TylenolIs the pain really that bad? I did 36 hours of labor with no pain meds. I think you can tolerate your headache.
On the flip side, still no warning labels on the flu shots that contain mercury. What's a neurotoxin compared with stomach bleeding?
Pain drugs to carry more prominent U.S. warningsWed Apr 29, 2009 2:44am BST
By Susan Heavey WASHINGTON (Reuters) - Over-the-counter pain relievers such as Tylenol and Advil will carry bolder warnings about the risk of liver damage or stomach bleeding, the U.S. Food and Drug Administration said on Tuesday. Products containing acetaminophen, such as Johnson & Johnson's Tylenol, will carry a prominent package warning about the risk of severe liver damage if, for example, people took too much of the drug. Painkillers known as non-steroidal anti-inflammatory drugs, or NSAIDS, including Bayer AG's aspirin products, Wyeth's Advil and Johnson & Johnson's Motrin, will carry bold warnings about the risk of stomach bleeding, the FDA said. "We believe the new labeling requirements will add information concerning severe adverse effects of over-the-counter pain relievers and fever reducers that many consumers may not be aware of," said Matthew Holman, the FDA's deputy director for the Division of Nonprescription Regulation Development. The new rules, first proposed in late 2006, also apply to generic versions of the drugs and other nonprescription products that contain the painkilling ingredients, such as cold medications. NSAIDs are also known generically as aspirin, ibuprofen, naproxen and ketoprofennlude, according to the FDA. While the risks with these kinds of drugs have been known for years, FDA's Holman said it is important to better highlight them for consumers, who could unknowingly take multiple products containing acetaminophen. The new warnings will also point out the increased risk of liver damage with acetaminophen in consumers who drink three or more alcoholic drinks each day. They also call on consumers taking the widely used blood thinner warfarin to consult their doctors before taking acetaminophen products. Some companies have already revised their products' packaging to add some of the new warnings, Holman said, adding that all companies concerned must change their packaging by next April. In a statement, Johnson & Johnson's McNeil Consumer Healthcare unit, which makes Tylenol and Motrin as well as St. Joseph Aspirin, said it would make the labeling changes as requested. Wyeth spokesman Doug Petkus and Bayer spokeswoman Anne Coiley also said their companies would comply with FDA's order, adding that their products are safe and effective when taken as directed. The FDA's announcement comes ahead of a public FDA meeting in late June to discuss what other actions the agency could take to curb the risk of liver damage from products containing acetaminophen. The risk of liver damage or stomach bleeding with over-the-counter pain medications spurred the development of prescription pain drugs known as COX-2 inhibitors. But those drugs -- which included two now withdrawn drugs, Pfizer Inc's Bextra and Merck & Co Inc's Vioxx -- carried their own set of safety concerns, such as an increased risk of heart attacks and other cardiovascular problems. Only Pfizer's Celebrex remains on the U.S. market. (Reporting by Susan Heavey; Editing by Tim Dobbyn and Gerald E. McCormick)
News Flash: Docs on the Take from Big Pharma!Hahahahaha... The IOM, so timely...
Report calls for strict conflict of interest rulesTue Apr 28, 2009 11:34pm BST
CHICAGO (Reuters) - Doctors need to stop taking handouts from drug and medical device companies if they want to clean up the perception that industry has too much influence over the practice of medicine, the Institute of Medicine said Tuesday. The institute, one of the National Academies of Sciences that advises U.S. policymakers, said doctors need to voluntarily swear off lunches, drug samples and strictly disclose research funding to strengthen protections against financial conflicts of interest. "It is time to end a number of long-accepted practices that create unacceptable conflicts of interest, threaten the integrity of the medical profession, and erode public trust while providing no meaningful benefits to patients or society," said Dr. Bernard Lo, chair of the committee that wrote the report and professor of medicine at the University of California, San Francisco. "We also need more specific disclosure of the financial relationships that doctors and researchers have with medical industries," Lo said in a statement. Concern over research integrity in the United States has become more pronounced following accusations last year by Iowa Republican Sen. Charles Grassley that prominent Harvard University psychiatrist Dr. Joseph Biederman and others failed to fully disclose payments from drug companies. The report called for virtually anyone involved in the practice of medicine -- academic medical centers, journals, professional societies, researchers and doctors -- to set up or strengthen conflict of interest guidelines. Doctors who have any financial ties with industry should disclose them not only to their employers, but also to relevant medical organizations. The report also called for more uniformity in conflict of interest policies, and said current policies vary widely and many offer insufficient protections. The report also calls on professional societies, government agencies and groups that accredit medical schools to push for implementation of conflict-of-interest policies, and expose institutions that have not adopted the recommended policies. While the report calls for new legislation to beef up disclosure of financial conflicts, it also stresses the need for voluntary efforts by medical groups, industry and individual doctors. "If medical institutions do not act voluntarily to strengthen their conflict of interest policies and procedures, the pressure for external regulation is likely to increase," the committee wrote. (Editing by Maggie Fox) Big Pharma's Gonna Party Like It's 1976It's a good thing this new "swine" flu (quotation marks because this particular bug hasn't been isolated in pigs) came along--now vaccine makers can monetize the work they've been doing on the avian flu that never materialized in the US. (Did you know that there fewer than ten confirmed deaths from this new flu? Rush me a needle with a poorly tested vaccine, quick!)
Who's the big winner here? Check out these paragraphs from the NY Times' coverage:
The government also gave $1.3 billion, spread among several manufacturers, to develop ways of producing the vaccine in vats of animal cells rather than in eggs. Cell culture is less vulnerable to contamination and the process could save at least a few weeks. The results so far have been mixed. Solvay, which was awarded the biggest federal grant, nearly $300 million, decided it was economically too risky to build a flu vaccine plant in the United States. (Most of the grant money had not yet left federal coffers and will not be lost, Dr. Robinson said.) Sanofi-Aventis has also put cell culture production on the back burner, Dr. Robinson said. But Novartis is building a cell culture flu vaccine factory in Holly Springs, N.C., which might be ready for use in 2010 or 2011. The federal government is providing nearly $500 million in construction costs and guaranteed vaccine purchases. I'm glad we have no better way to spend our healthcare dollars...
***
Can biotech tackle swine flu?
Posted by Bob Grant
[Entry posted at 27th April 2009 05:32 PM GMT]
As reported cases of swine flu continue to accumulate (as of today, 40 had been reported in the US) and mainstream media outlets dust off their foreboding music tracks and positively scary taglines, a biotechnology company in Maryland says that its approach may speed development of a successful vaccine.
Researchers at Novavax have been developing vaccines for the H5N1 strain of avian flu, along with other strains of influenza, over the past few years using an approach built around virus-like particles (VLP)--viral membrane proteins in a matrix of lipids. Researchers from the company, with scientists from the Centers for Disease Control and Prevention (CDC), published a study last month in which they successfully protected mice against a reconstructed virus from the 1918 Spanish flu outbreak through intranasal immunization with H1N1 VLPs.
A new strain of H1N1 is likely causing the current outbreak of swine flu in North America, which this weekend led both the World Health Organization and the CDC to declare a public health emergency. Gregory Poland, an immunologist and head of the Vaccine Research Group at the Mayo Clinic in Minnesota, said VLPs and other novel approaches to vaccine development, for combating influenza are exciting but untested. "The issue, from the perspective of influenza, is that none of these is approved," he said. In fact, the only FDA-approved VLP-based vaccines on the market are those developed to protect women from human papillomavirus. Novavax's typical timeframe, going from DNA sequence to a testable product based on VLPs, is 10 to 12 weeks, according to the company's vice president for strategy, Thomas Johnston. "The way we develop vaccines allows us to move pretty quickly once DNA sequences are known," Johnston told The Scientist, adding that Novavax--like scores of other biotechs and pharmaceutical companies--received the sequence data for the new H1N1 strain of swine flu late last week. "We have begun our process for developing a vaccine." Novavax's approach--which clones key viral genes, and uses insect cell cultures to produce the virus-like particles--is faster and safer than approaches that utilize live viruses, said Gale Smith, Novavax's vice president for vaccine development. Because the latest strain of H1N1 is transmittable from human to human, manufacturing a live virus vaccine represents significant safety risks, he added. But so might a relatively untested strategy. Novavax has two vaccine candidates in clinical trials: One, for H5N1, just completed Phase IIa trials, and a seasonal vaccine candidate is in Phase IIa trials now. According to Andrea Sant, an immunologist at the University of Rochester, traditional approaches, such as the commonly used subunit vaccines that consist of non-viable viral protein extracts, could be enough. "I think it's not impossible to make a conventional vaccine for next fall," at the typical start of the flu season, she said. Hildegund Ertl, an immunologist at the Wistar Institute in Philadelphia, cautioned that going the VLP route may be tricky because the approach is so new and relatively untested. "For a company that's in a pre-clinical stage for a new vaccine to think that their vaccine is going to help in this situation is very optimistic indeed," she told The Scientist. "I would stick to what we know about in case time is of the essence." Ertl and Sant agreed that how swine flu plays out in the human population--how the virus mutates, moves between hosts, etc--over the next couple weeks will determine which vaccine development strategy will be most effective. "A lot will depend on what happens over the next month," Sant said. Correction (April 28): The original version of this story mistakenly mentioned vaccines that use live virus cells. Viruses, of course, are not composed of cells. The Scientist regrets the error. * * *
Swine Flu Vaccine May Be Months Away, Experts Say
Published: April 28, 2009
Federal officials said it would take until January, or late November at the earliest, to make enough vaccine to protect all Americans from a possible epidemic of swine flu. And beyond the United States and a few other countries that also make vaccines, some experts said it could take years to produce enough swine flu vaccine to satisfy global demand. Although production is much faster than would have been possible even a few years ago, it still may not be in time to avert death and illness if the virus starts spreading widely and becomes more virulent, some experts said. In this country, the biggest problem is that despite years of effort, the country is still relying on half-century-old technology to make the flu vaccines. Federal authorities have spent years and more than a billion dollars trying to shift vaccine production to a faster, more reliable method — one that involves growing the vaccine viruses in vats of cells rather than in hen’s eggs, the old technology. And there are numerous small companies developing totally new approaches that might allow for the production of huge volumes of vaccines in a matter of weeks. But the cell-based production is not quite ready, and some of the newer techniques are not proven enough to satisfy many experts. “Those are all great technologies, but it isn’t going to happen in time,” said Dr. Greg Poland, head of the vaccine research program at the Mayo Clinic. Federal officials have not yet made a decision on whether the swine flu is enough of a threat to warrant vaccine production. But they are taking the initial steps. A potential problem is that producing swine flu vaccine might interfere with production of the seasonal flu vaccine for next winter. “We would have to most likely make a compromise,” Andrin Oswald, chief executive of the vaccine division at the drug maker Novartis, said in an interview. But Robin Robinson, who runs the emergency preparation research program for the federal Department of Health and Human Services, said most manufacturers would have finished producing the bulk of seasonal vaccine by June. If production of the swine flu vaccine were to start right after that, the first 50 million to 80 million doses would be available by September, Dr. Robinson said. A full 600 million doses, enough to provide the required two shots for each American, could be finished by January. If immune stimulants called adjuvants were added to the vaccine, that could reduce the dosage needed by each person, allowing enough doses to be ready by late November, he said. The vaccine industry is in a much stronger position to respond now than it was five years ago, when the United States had only two flu vaccine suppliers and was hit by a severe shortage. Now there are five suppliers to the domestic market. And the vaccine industry, once a backwater of the pharmaceutical industry, is attracting new investments, lured by government subsidies and higher prices for vaccines. Still, a study done with the World Health Organization and the International Federation of Pharmaceutical Manufacturers and Associations estimated that it would probably take four years of production to satisfy fully global demand for a vaccine to protect against the bird flu strain that has concerned health authorities for the last few years. Similar projections might apply to the swine flu vaccine, some experts say. “The bottom line is there won’t be enough vaccine quickly enough and the vaccine will largely go to the countries that already produce the vaccine,” because countries will restrict exports in a pandemic, said Dr. David Fedson, an independent expert on pandemic preparedness. The federal government is encouraging manufacturers to set up production in the United States, since all companies but one, Sanofi-Aventis, now import their flu vaccines. The government also gave $1.3 billion, spread among several manufacturers, to develop ways of producing the vaccine in vats of animal cells rather than in eggs. Cell culture is less vulnerable to contamination and the process could save at least a few weeks. The results so far have been mixed. Solvay, which was awarded the biggest federal grant, nearly $300 million, decided it was economically too risky to build a flu vaccine plant in the United States. (Most of the grant money had not yet left federal coffers and will not be lost, Dr. Robinson said.) Sanofi-Aventis has also put cell culture production on the back burner, Dr. Robinson said. But Novartis is building a cell culture flu vaccine factory in Holly Springs, N.C., which might be ready for use in 2010 or 2011. The federal government is providing nearly $500 million in construction costs and guaranteed vaccine purchases. 28 avril Swine Flu Highlights Need for Cleaner Livestock ConditionsJust like every politician who thinks that science is the answer to all of man's health problems, Obama has come out with a clownish statement about the swine flu and the need to increase spending on scientific research. Does it really take more scientific research to know that it's a bad idea to let animals eat and drink the waste of other animals?
President Barack Obama said Monday that he is closely monitoring the swine flu, and the global outbreak is cause for concern but not alarm. "We face more complex challenges than we have ever faced before,” Obama said. Merck Working on Another BS STD VaccineLast time I checked, the clap was eminently treatable with antibiotics (and preventable with smart sex practices like monogamy and/or condom use). I wonder how long it will take Big Pharma's best friend Rick Perry to make this mandatory for every pre-teen in Texas...
Monday, April 27, 2009, 10:01am CDT
Merck selects UTSA, Health Science Center to develop vaccineSan Antonio Business JournalTwo San Antonio research institutions have signed an exclusive license and research agreement with pharmaceutical giant Merck & Co. Inc. to work on a new vaccine for chlamydia. The University of Texas at San Antonio and the University of Texas Health Science Center at San Antonio will develop a treatment option that, one day, could target the sexually transmitted bacteria Chlamydia trachomatis. This sexually transmitted bacteria is responsible for nearly 2.3 million cases of infection in the United States. Long-term infection in women can lead to pelvic inflammatory disease, serious complications for newborns and infertility. The most common treatment today is antibiotics. Under the terms of the agreement, Merck will provide the funding for joint research at UTSA and the Health Science Center. South Texas Technology Management negotiated the exclusive license between Merck, UTSA and the Health Science Center. South Texas Technology Management is a regional technology transfer office for four South Texas UT System institutions. Health Science Center microbiology and immunology professor Guangming Zhong, UTSA professor of microbiology and immununology professor Bernard Arulanandam and UTSA research assistant professor Ashlesh Murthy are the three researchers involved in this collaboration. The team of researchers at the universities demonstrated that, in animal models of genital chlamydial infections, a vaccine composed of a select group of recombinant C trachomatis agents can fight the bacteria while preserving the female reproductive function. Building upon this research, scientists from Merck and the two University of Texas System schools will work toward developing an effective vaccine for use in human beings. “Chlamydia is the most common sexually transmitted disease caused by a bacterium, and the number of cases is on the rise,” Arunlanadam says. “While many researchers have tried to develop a chlamydia vaccine, none has been successful. We hope to change that.” The Merck license will be the first revenue-producing license for any technology produced at UTSA. Specific financial details are not being disclosed. Merck paid UTSA an upfront fee and reimbursed the University of Texas System for past patent expenses. Whitehouse Station, N.J.-based Merck (NYSE: MRK) is a global developer, manufacturer and distributor of vaccines Big Pharma Scores Big with Swine FluNow pediatricians will be prescribing Tamiflu and Relenza for every baby who comes into their offices with the sniffles for the next six months. Great. There is a reason these drugs were not approved for use in babies under one year of age... It's probably not a great idea to throw that caution out the window, due to panic over the swine flu that has sickened fewer than 75 Americans (and killed ZERO Americans). More sensible advice comes from Dr. Jay Gordon, a physician whose opinion I respect very much on a number of issues. Read his piece at the Huffington Post here: http://www.huffingtonpost.com/jay-gordon/tamiflurumsfeldh1n1-redux_b_191606.html FDA allows uncleared uses of flu drugs, tests
Mon Apr 27, 2009 10:05pm EDT
WASHINGTON (Reuters) - The U.S. Food and Drug Administration authorized emergency uses of the flu drugs Tamiflu and Relenza on Monday and a diagnostic test to help get a grip on a new strain of swine flu, the agency said on Monday. The U.S. government's declaration on Sunday that the swine flu is a public health emergency freed the FDA to take such action, the agency said in a statement. The FDA will now have the authority to allow public health and medical personnel to prescribe Relenza, GlaxoSmithKline's inhaled flu drug also known as zanamivir, and Roche AG's Tamiflu, a pill also known as oseltamivir, for unapproved uses. Tamiflu, approved for treating and preventing the flu in people over a year old, can now be used in children under 1 year. Doctors can also change the recommended dosage for children older than 1 year under the emergency use authorization. The FDA also gave more healthcare workers authority to distribute Tamiflu and Relenza, including some public health officials and volunteers. More than 40 people have been sickened by the new flu strain in the United States. The rRT-PCR Swine Flu Panel diagnostic test was authorized for testing samples from flu patients to determine if they have the new strain. A positive finding will presumptively conclude that the patient has the new, previously unseen strain of H1N1 swine flu. But a negative result will not be considered conclusive that a patient does not have the virus, the agency said. (Reporting by Jasmin Melvin, editing by Maggie Fox and Vicki Allen) 27 avril Don't Worry Too Much About Swine FluPeople who are old enough to remember the swine flu scare of 1976 are probably not panicking over this latest swine flu scare, but for those who aren't, a few thoughts...
- Poor living conditions for livestock, including allowing poultry fecal matter to contaminate living quarters and water supplies for pigs, are what creates situations in which gene reassortment can occur between avian flu viruses and swine flu viruses. Treating animals well and providing good living conditions for all farm animals should be a primary concern for public health officials.
- The 1976 swine flu scare started when one soldier at Fort Dix died in early February 1976, and ended in December of the same year, when the CDC admitted that its national vaccination program was doing more harm than good. (Dozens of people died, and dozens more contracted Guillain-Barre Syndrome and were paralyzed.) During that time, the US government rapidly enacted laws providing funding for a swine flu vaccine and legal indemnity against swine flu vaccine injuries. Given that there were fewer than 10 confirmed swine flu cases in the US, and given the dozens of vaccine-related injuries and deaths, and given the cost of rapidly developing a vaccine, the big losers were the American public. Paying taxes to cover both Big Pharma's development of the vaccine and the payouts to individuals injured by the vaccine--because honestly, how good a job can you do in just a few months? it took somewhere in the neighborhood of 60 years to develop the vaccine against HiB, and that one isn't safe for everyone--the American people footed the bill as they shot themselves in the foot.
- Today, the vast majority of Americans have access to intravenous fluids at doctors' offices and at hospitals, as well as antiviral drugs such as Tamiflu and Relenza (which are reportedly effective against the confirmed cases of this new flu in the US). Is it really in our interest to hastily develop a vaccine of questionable safety and efficacy against an illness that appears to be responsive to current medical treatments?
Here are the typical alarmist reports from the media, lauding Big Pharma's willingness to step forward and accept money to develop a vaccine (for whose defects they will not be liable):
As flu hits, holes in W.H. health teamBy CARRIE BUDOFF BROWN | 4/26/09 6:37 PM EDT
The Obama administration declared a “public health emergency” Sunday to confront the swine flu — but is heading into its first medical outbreak without a secretary of Health and Human Services or appointees in any of the department’s 19 key posts.
President Barack Obama has not yet chosen a surgeon general or the head of the Centers for Disease Control and Prevention. His choice to run the Food and Drug Administration awaits confirmation. In an unusual Sunday briefing at the White House, acting CDC Director Richard Besser appeared on camera with Homeland Security Secretary Janet Napolitano and Obama homeland security adviser John Brennan to announce the emergency declaration in response to the swine flu outbreak. Napolitano is the former Arizona governor, and Brennan is a longtime CIA counterterrorism specialist once thought to be in line to run the agency. White House press secretary Robert Gibbs insisted the vacancies won’t hinder Obama’s response. “I want to be very clear here: There is a team in place. Part of it is standing behind me, and part of it working as we speak to identify exactly what [Besser] and others have talked about,” Gibbs said. “This notion that somehow that if there is not currently a secretary, that there is not the function that needs to take place to prepare for either this or any other situation is just simply not the case.” “I think it’s all hands on deck, and we’re doing fine,” Gibbs said. The Senate could vote to confirm HHS Secretary-designate Kathleen Sebelius as early as Tuesday. Obama’s first choice for the post, former Senate Democratic leader Tom Daschle, withdrew. As the swine flu outbreak intensified, Obama has received “multiple” briefings a day since Friday on the outbreak, and an interagency response team has been in constant communication, White House aides said.
Health officials have reported 20 cases across five states — Ohio, Texas, New York, California and Kansas — and expect the numbers to rise as doctors perform more tests to detect the illness. None of the U.S. cases have been fatal. The outbreak started in Mexico, where it has killed 80 and infected 1,300. Obama recently traveled to Mexico, and his host on a museum tour in Mexico City died the next day, showing flu-like symptoms, but Gibbs said, “the president’s health was never in any danger.” He said the flu has a 24- to 48-hour incubation period and that Obama left Mexico nine days ago and has not shown symptoms of the flu nor been seen by a doctor or received preventive treatment. Asked if the president’s decision to golf Sunday at Andrews Air Force Base was part of a White House strategy to reassure people, Gibbs chuckled and replied: “I’m not sure I’d draw a direct conclusion.” * * * http://uk.reuters.com/article/topNews/idUKTRE53P1IU20090426 Drug and vaccine makers on standby over swine fluSun Apr 26, 2009 4:53pm BST
By Ben Hirschler and Sam Cage LONDON/ZURICH (Reuters) - Drugmakers said on Sunday they could supply millions of doses of medicine and were ready to work on a vaccine against a new type of swine flu that has killed up to 81 people in Mexico and infected around a dozen in the United States. Roche Holding AG's Tamiflu, known generically as oseltamivir, and GlaxoSmithKline Plc's Relenza, or zanamivir, are both recommended drugs for seasonal flu and have been shown to work against viral samples of the new disease. Tamiflu is expected to be in greatest demand should swine flu develop into a pandemic, as experts fear it may, since it is given as a tablet. Relenza must be inhaled. Roche said it has a stockpile of 3 million packages of Tamiflu ready for use by the World Health Organisation (WHO), half held in the United States and half in Switzerland. "So far the WHO has not requested we deploy this stockpile. Of course, as soon as the WHO requires that we deploy it we will do so," said Roche spokeswoman Claudia Schmitt. Both Roche and Glaxo said they were in contact with the WHO, U.S. authorities and the government in Mexico. The two companies have received contracts in recent years from individual governments and corporations for stockpiles of their medicines, following earlier fears over bird flu. Those sales provided windfall profits, especially for Roche, and also benefited their respective partners. Tamiflu was originally invented by U.S. biotech company Gilead Sciences Inc , while Relenza was licensed to Glaxo by Australia's Biota Holdings Ltd. The longer-term battle against any pandemic, however, depends not on antiviral drugs but a successful vaccine. [Note the editorializing and recall that the CEO of Reuters is on the Board of Directors at vaccine manufacturer Merck.] Making a vaccine against a new strain of flu takes months and vaccine companies said they were on standby to start the development process as soon as possible. Leading flu vaccine manufacturers include Sanofi Pasteur, the vaccines division of Sanofi-Aventis SA, Glaxo, Novartis AG and Baxter International Inc. "Sanofi Pasteur, as the world leading producer of influenza vaccine, is standing ready to assess its capabilities to support public health efforts, should the WHO and other health authorities request support from influenza vaccine manufacturers," said spokesman Pascal Barollier. (Editing by Elaine Hardcastle) 26 avril Lariam and Iraq Soldier SuicidesJust going to give the first couple of paragraphs from this one; click over to Age of Autism and read the rest...
April 26, 2009Drugs, Death and the Manufacture of Doubt
I hope regular readers of this site will indulge a fairly extended incursion into a topic that, on the surface, is unrelated to autism but that connects at a deep level with our point and purpose. It concerns what I would call an analogous situation, and analogies sometimes have just as much power as direct argument and evidence. 24 avril Malaria Drugs in DevelopmentI'm particularly intrigued by the work Novartis is doing with artemisinin, a treatment that seems to be effective against malaria. I wonder how ethically the GSK and Sanaria vaccine trials will be--16,000 African children, and 104 "volunteers"... how different will it be from The Constant Gardener?
Goal of eliminating malaria in sight: experts
Fri Apr 24, 11:18 am ET
* Efforts bring goal of eradicating malaria within sight * Disease still infects 500 million a year, kills 1 million * Vaccine tests starting shortly By Jonathan Lynn GENEVA (Reuters) - Fresh efforts and funding to tackle malaria in recent years have brought the goal of eradicating the deadly disease within sight, health experts said on Friday. Wiping out malaria worldwide could take decades but many countries where it is endemic are on the brink of eliminating the disease, which infects up to 500 million people a year and kills nearly one million worldwide, they said. "The vision of achieving elimination in a number of countries is certainly in sight," said Rifat Atun, strategy director at the Global Fund to fight AIDS, Tuberculosis and Malaria, an international financing institution. Most malaria victims are children under the age of five and pregnant women. Roughly 90 percent of fatalities are in Africa, where malaria accounts for one in five childhood deaths. The goal of eradicating malaria, caused by a parasite transmitted in mosquito bites, could take until 2050 or 2060, said Richard Feachem, chairman of the Malaria Elimination Group. But it is now endemic in only about half the world's countries after being eliminated from others such as Canada and Finland since 1945, he told a news conference, launching two reports by the group for policymakers and health specialists. SQUEEZING MALARIA One report focuses on destroying malaria in countries such as Mexico, South Africa and China on the margins of the tropical areas where it is endemic. Feachem said the strategy was aggressive control in the heartland to reduce infection and death, elimination country by country from the margins, and research into drugs, vaccines and insecticides. He said countries could learn from tough rules imposed in Singapore. The tropical city state makes it illegal for construction companies to allow malaria-bearing mosquitoes to breed on building sites and makes individuals responsible for preventing stagnant water gathering in their homes. "In a country where the legislative and political environment permits it ... legislation can play an important role, requiring householders to do certain things," he said. The fight against malaria takes several forms -- spraying bednets and homes to deter mosquitoes, using drugs to treat infected people and finding a vaccine to prevent infection. Such treatments are brought to people in the world's poorest countries by international organizations and private groups such as the Bill and Melinda Gates Foundation, buying drugs from pharmaceutical companies at preferential prices. Some of these methods are controversial. The pesticide DDT has saved millions of lives from malaria, but concerns that its intensive use in agriculture could spread cancer led to its being banned in many countries for farming. New medical treatments such as a drug developed by Swiss pharmaceuticals company Novartis using artemisinin, a compound derived from a herb used in Chinese traditional medicine, are driving down deaths and infections, said Chris Hentschel of the Medicines for Malaria Venture. The treatment, administered to 57 million people last year, saved half a million lives last year. About 50 new drug projects are in the pipeline, Hentschel said. GlaxoSmithKline is about to start clinical trials of a vaccine in a test involving 16,000 children in seven African countries, which could reach the market within three years, the world's second-largest drugmaker said. (For more on the Malaria Elimination Group and its reports go to http://malariaeliminationgroup.org ) (For full Reuters Africa coverage and to have your say on the top issues, visit http://af.reuters.com/ ) (Additional reporting by Ben Hirschler in London; Editing by Stephanie Nebehay) * * * http://www.bizjournals.com/washington/stories/2009/04/20/daily76.html
Thursday, April 23, 2009, 5:22pm EDT
Sanaria to begin human trials of malaria vaccineWashington Business Journal - by Vandana Sinha Staff ReporterA Rockville company plans to begin the first human clinical trials of a malaria vaccine that uses a weakened version of the entire malaria parasite, instead of just pieces of it, to help shield victims from the disease. Sanaria Inc. is working with the Path Malaria Vaccine Initiative, a Bill and Melinda Gates Foundation-funded program at a global health nonprofit based in Seattle, to test an experimental vaccine for malaria on 104 healthy volunteers. The groups have already begun recruiting those volunteers after winning Food and Drug Administration approval for the trial and expect to inject the first patient in mid-May. This first phase of clinical trials will test the vaccine’s safety and effectiveness at two locations: the Naval Medical Research Center Clinical Trials Center in Bethesda and the Center for Vaccine Development at the University of Maryland School of Medicine in Baltimore. The malaria vaccine, Sanaria’s first product to go into humans and the only one in its pipeline, is expected to produce its first clinical data results in November after the trial ends in September. The company’s vaccine candidate contains a weakened form of the full live malaria parasite found in radiation-zapped mosquitoes to help patients gain immunity to the disease — a treatment method used similarly for smallpox, polio and measles. Most malaria vaccines being tested only contain genetically engineered proteins within small portions of the parasite, but Sanaria said it has created technology that allows physicians to deliver the full parasite into a patient’s system. “Development of Sanaria’s vaccine candidate is based in part on the findings from parallel studies conducted in the early 1970s by teams at the Center for Vaccine Development and the Naval Medical Research Center,” said Myron Levine, director of the University of Maryland School of Medicine’s Center for Vaccine Development. These are “findings that were never translated into a vaccine development effort because the task was considered to be impossible.” Sanaria officials said the trial will cost several million dollars, but would not disclose the exact figure. The roughly 50-person company, funded largely by the Gates foundation, opened a 23,500-square-foot manufacturing and lab facility on Medical Center Drive in the fall of 2007 to accommodate these tests. Yet Another Ted Kennedy Bill I Can Get Behind!I didn't realize that FDA inspectors do not currently have the power to seize contaminated drugs they find during manufacturing plant visits. Although such seizure could be construed as a lack of due process, I believe public safety should override this concern. Apparently, so does Chuck Grassley, who is co-sponsoring Senator Kennedy's bill.
Drug Plants May Get More Inspections Under Proposal (Update1)
By Catherine Larkin April 23 (Bloomberg) -- A revived safety proposal in the U.S. Senate would give regulators new funding and authority to inspect plants that make prescription drugs and medical devices. Legislation introduced today by Senators Charles Grassley, an Iowa Republican, and Edward Kennedy, a Massachusetts Democrat, would empower the Food and Drug Administration to collect inspection fees from companies and issue subpoenas or detain products when inspectors believe a product is adulterated or misbranded. The measure is similar to one introduced last year by the senators. Lawmakers faulted the FDA’s lack of inspections last year after contaminated heparin from China was tied to hundreds of deaths and allergic reactions. The Government Accountability Office, the watchdog arm of Congress, and some FDA scientists say the agency has approved products without proof they’re safe. “Our legislation is a practical solution to beefing up the FDA’s inspection work, both domestically and abroad, and holding the FDA accountable for its review of medical devices, where questions have been raised about the agency’s work,” Grassley said in an e-mailed statement today. Last year, the agency started to station employees overseas to help review the increasing number of ingredients and finished products imported to the U.S. Grassley serves as ranking member of the Senate Finance Committee and has often reviewed the FDA’s performance on various issues. Kennedy is chairman of the Senate Committee on Health, Education, Labor and Pensions, which is responsible for legislation concerning the FDA. To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net. Last Updated: April 23, 2009 16:30 EDT 22 avril Say What? HPV Vaccine for People Who Already Have HPVHow odd... Given that most HPV infections clear up on their own, without lasting consequences (such as cervical cancer), I wonder how Antigen Express determined how many cases of cancer were prevented by its HPV vaccine, among people who already had HPV.
Worcester Firm Unveils Cancer Vaccine StudyBy Matthew L. Brown Worcester Business Journal Staff Writer Yesterday A Worcester company has presented findings on a vaccine for certain types of cancer. Antigen Express Inc., a wholly-owned subsidiary of Worcester-based Generex Biotechnology Corp., presented the study, which includes pre-clinical findings on a vaccine for human papilloma virus-induced cancers, Monday at the ongoing annual meeting of the American Association for Cancer Research in Denver. Antigen has identified and modified a fragment of the HPV protein to enhance the production of cells that kill HPV target cells. The company said widespread use of existing HPV vaccines has been hindered by their expense. Gardasil, a vaccine marketed by drug maker Merck, protects against HPV. Antigen's vaccine prevents cancer even if HPV is present. No vaccine exists for patients with cervical or other cancers induced by HPV. Antigen is currently conducting trials of a similarly modified protein that may be able to kill breast, prostate and ovarian cancer cells. Generex develops drug delivery systems that allow drugs typically given by injection to be taken orally and absorbed by the inner lining of the mouth.
BPA Still in Food Packaging...which is why dry soups that you reconstitute yourself are safest, and glass bottles are best for beverages.
Few companies seeking substitutes to bisphenol A, study findsBy Journal Sentinel staff Posted: Apr. 21, 2009
Food and beverage companies are not doing enough to find substitutes to bisphenol A, a study released Monday by a consortium of environmental activists says.
BPA, a chemical that mimics estrogen, is used to line food and beverage cans, and is suspected of causing a host of illnesses, including cancer, diabetes, heart disease and obesity. Canada declared it a toxin last year and banned its use in baby bottles. The six major American baby bottle manufacturers have promised to stop making products with BPA, and Sunoco, one of five BPA makers in the United States, has limited its sale to exclude products for children younger than 3.
The report, compiled by Green Century Capital Management and As You Sow, surveyed major food companies and found that only Heinz was using an alternative in some of its products. Heinz and two other companies, Hain Celestial and Nestlé, say they are researching and testing alternatives to BPA in packaging, and all have plans to phase out use of the chemical.
Three companies - Del Monte, Hershey Co. and J.M. Smucker Co. - are not taking action beyond monitoring the industry, the report says. Just Say No to GMOsEarth Day: No GMO Challenge Launches Today Food Blogosphere Targets GMOs as Top Environmental Threat Consumers Asked to Buy Eco-Friendly Non-GMO Products
IMMEDIATE RELEASE – (Los Angeles, CA.) This Earth Day, co-sponsors Real Food Media and the Institute for Responsible Technology urge consumers to take the No GMO Challenge to protect themselves from one of history’s greatest man-made health and environmental threats – genetically modified organisms (GMOs). The No GMO Challenge begins with a spring-inspired cupboard cleanout and a 30-day commitment to eating as many non-GMO meals as possible. Organizers of the No GMO Challenge hope U.S. shoppers will flex their considerable spending power during the No GMO Challenge to buy only non-GMO products, starting Earth Day. People who have already signed up for the No GMO Challenge include moms, farmers, chefs, scientists, physicists, biologists, home cooks, retailers and food writers who regularly blog about healthier foods. Consumer polls show that 9 out of 10 Americans want GM foods labeled so they can avoid buying them. Nearly two-thirds of products on supermarket shelves contain unlabelled genetically modified ingredients. A controversial Food and Drug Administration exception made in the 1990s, permits GMOs to enter the food supply without adequate safety testing, say watchdog groups. To help get the word out about GM foods, organizers of the No GMO Challenge are asking people to pledge that for 30 days, they will avoid GMO food made from the 5 main GM crops: corn, soy, canola and cottonseed oil, and sugar from sugar beets. Ann Marie Michaels, the founder the Real Food Media Blog Network says, “We are asking consumers to try to avoid these foods and to blog about it, tweet about it, post about it on Facebook, and get the word out as much as possible. At the No GMO Challenge site http://realfoodmedia.com/no-gmo-challenge/, we’ll have videos and news articles you can link to or blog about or tweet, and you can also just write about your experiences going GM-free.” Bloggers can join a weekly blog carnival every Monday to share stories about GM food, and enter to win prizes every Thursday, from sponsors including US Wellness Meats, Zukay Live Foods and Tropical Traditions who will be giving away prizes like grass-fed meats, GMO-free salad dressings, and organic coconut oil. The rolling No GMO Challenge, similar to the Eat Local Challenge launches today and will continue until GMOs are driven out the food supply, organizers say. Consumers are asked to organize, educate and build awareness about the dangers of GMOs until that goal is realized. Jeffrey Smith, a leading expert on the health dangers of GMOs, says that Earth Day is the right time to draw attention to the environmental threat posed by GMOs. “GM crops concentrate corporate control of food, increase herbicide use without increasing average yields, endanger food security, are detrimental to sustainable and organic farming, and trap farmers in a cycle of debt and dependence. They shrink biodiversity, harm beneficial insects, damage soil bacteria, contaminate non-GM varieties, and persist in the environment. The presence of self-propagating genetic pollution might outlast the effects of global warming and nuclear waste.” Scientists warn that GM foods may set off allergies, increase cancer risks, damage food quality and produce lasting toxins in the environment. GMOs also increase the risk of antibiotic resistant strains of bacteria, due the use of antibiotic resistant genes in GM food. Non-GMO Trend Accelerating Worldwide concerns about GMOs have been accelerating. Recent government-funded studies in Austria and Italy linked GMOs to infertility, immune responses, and poorer health of new-borns. Other research links increased cancer risk to milk treated with genetically engineered bovine growth hormone has already forced most of the nation’s top dairies, plus Wal-Mart, Starbucks, Yoplait, and Dannon, to commit to stop using it in some or all their products. Last week, Germany became the sixth European Union nation to ban the planting of Europe’s only approved GM seed—a corn variety by US biotech giant Monsanto, which is engineered to produce its own toxic pesticide. German Agriculture Minister Ilse Aigner concluded that it ”represents a danger for the environment." Michaels, who is a rising star in the food blogosphere says, “The majority of Americans don’t trust GM foods and want them labeled. The sad thing is there’s so little information about it. Most of us are eating GMOs every day and we don’t even know it.” No GMO Challenge co-sponsor, the Institute for Responsible Technology (IRT), wants to remedy that by providing free Non-GMO Shopping Guides for participants. Full of informative charts, tips, and non-GMO brand selections, the Guide makes buying non-GMO easy. . IRT’s executive director Jeffrey Smith says, “We expect the No GMO Challenge to magnify the current trend away from high risk GM foods.” Blogger Sheri Ross Fogarty of MomsforSafeFood.org says, “The No GMO Challenge is particularly important for mothers, since children are most susceptible to the health risks of GM foods.” ### Real Food Media is a blog network that publishes stories about food and cooking, food politics, farming and producing food, health and nutrition, and green living. The Institute for Responsible Technology’s Campaign for Healthier Eating in America mobilizes citizens, organizations, businesses, and the media, to achieve the tipping point of consumer rejection of genetically modified foods.... * * * GMOs are, hands down, the greatest environmental threat to our planet.Did you know:
No GMO Challenge Website: http://realfoodmedia.com/no-gmo-challenge/
21 avril Recycling Myths and Realities...Q: If my recycling gets picked up in the same truck as trash, is it really being recycled? Q: How do I know if my city is really recycling my plastic, glass, aluminum, and paper? Q: Some places I’ve visited accept a long list of materials for recycling, but my city has very specific guidelines. Why are the rules so different from place to place? Q: My city only recycles plastics numbered 1 and 2. Is there a way I can recycle those numbered 3-7? Q: My grocery store accepts plastic bags for recycling. Can they really be recycled, or is the store greenwashing? Q: If I put the wrong number plastic in my bin, will it mess up the whole batch? Will it magically get recycled anyway? Q: Is a biodegradable product better than a conventional product if they both end up in a landfill? Q: Can you compost if you live in an apartment? Q: How can I start a recycling program in my city? Wyeth Cashes In On Problem It CreatedRead these posts, then read the article below. No wonder vaccines are growing at 32% compared with 8% for other drugs! Well, that, and the government mandates...
Posted on Sun, Apr. 19, 2009 A shot in the arm for vaccinesBy Miriam Hill Inquirer Staff Writer They are lethal bacteria. They slink into the human body cloaked in any of 91 versions of fuzzy sugar clouds that act as a coat of armor as they assault the immune system.
For drug giant Wyeth, the opportunity to prevent these bacteria, known as pneumococci, from causing meningitis in children already rings up $2.7 billion in yearly sales of its Prevnar vaccine. That figure could grow to $6 billion or $7 billion, according to some analysts' estimates, if the U.S. Food and Drug Administration approves a new version of the vaccine for use in children and, after that, in adults 50 and older. Wyeth isn't the only big pharmaceutical company betting its future on a vaccine. Drug companies once viewed vaccine profits as poor relatives to blockbuster pills such as Pfizer Inc.'s Lipitor and AstraZeneca P.L.C.'s Nexium. Many vaccines are so crucial to preventing disease that drug companies can't charge high margins on them. But the profit outlook for vaccines has shifted. Vaccines are more costly and challenging to manufacture than most other pharmaceuticals, and are almost invulnerable to generic competition. Overall drug sales grew only 8 percent in recent years, compared with 32 percent growth for vaccines, according to research firm Datamonitor. Pneumococcal vaccines are especially challenging to create, because there are 91 strains of the bacteria. An effective vaccine must learn to recognize bacteria that don't always look the same. So as Wyeth, whose U.S. pharmaceutical headquarters are in Collegeville, heads toward its year-end merger with Pfizer, of New York, investors' eyes are on Prevnar. Wyeth's current version of the vaccine protects against seven of the pneumococcal bacteria strains. Since Prevnar was introduced in 2000, rates of pneumococcal meningitis, an inflammation of the membranes around the brain caused by bacteria, have fallen 64 percent in children under age 2, according to a study published in January in the New England Journal of Medicine. The drop in serious childhood infections paid off for adults, too, whose rates of pneumococcal meningitis fell 30 percent, the study said. Even though adults did not get the vaccination, lower rates of childhood diseases meant fewer infections in adults, an effect known as "herd immunity." But the study also pointed to a troubling trend: Strains of pneumococcal bacteria not covered by Prevnar have grown more common, especially a type known as 19A, which is antibiotic-resistant and causes many of the infections in the United States. Late last month, Wyeth asked the FDA to approve Prevnar 13, which protects against six additional types of pneumococcal diseases, including 19A, for use in infants and toddlers. The FDA granted the application fast-track status, a speeded-up process aimed at getting drugs that are effective against serious illnesses to market faster. Next year, Wyeth plans to apply for approval for Prevnar 13 for adults. Every year, an estimated 915,000 people 65 and older get pneumonia, and 40 percent of them end up in hospitals, according to a 2004 paper in the journal Clinical Infectious Diseases. Pneumonia often kills older people, said Richard Stefanacci, a geriatrician at the University of the Sciences in Philadelphia. The Centers for Disease Control and Prevention recommends that children younger than 2 and adults older than 65 get vaccinated against pneumococcal diseases. The current version of Prevnar is used in children, but the pneumococcal vaccine for adults is Merck & Co. Inc.'s Pneumovax 23. Pneumovax protects against the most aggressive strains of the disease in adults, said Cynthia Whitney, chief of the CDC's respiratory-diseases branch. But the hope is that Prevnar 13 would protect against a wider spectrum of the disease because even milder versions can result in hospitalizations and long recoveries for the elderly. Prevnar operates differently from Pneumovax. Besides increasing antibodies to fight pneumococcal bacteria, as Pneumovax does, Prevnar helps the immune system continue to recognize the bacteria long after the initial vaccination. "The advantage of that is you not only produce better immune response but you produce a memory," said Peter Paradiso, vice president of scientific affairs at Wyeth Vaccines. In theory, that should give people who get Prevnar longer protection than Pneumovax provides. Some research suggests the benefits of Pneumovax decline significantly after five years. But the scientific community is still waiting for Wyeth to complete studies of Prevnar's efficacy in adults. The company is conducting several studies of Prevnar 13 in adults, including one in Europe that will test it on about 80,000 people. "There are a lot of theoretical benefits, but we just don't have a lot of data to show those effects," the CDC's Whitney said. 20 avril Veterans Get AIDS from Crappy Health CareThis, too, can be yours if you support a single-payer health care plan. The problem with having the government pay for health care is that the quality is ... well, you can see from the article how the quality is. I feel sorry for veterans who sacrificed for their country and have no other health care options.
3 patients HIV-positive after VA clinic mistakesDespite dirty equipment, agency says facilities aren’t linked to the illnessesupdated 5:23 p.m. CT, Fri., April 17, 2009
CHATTANOOGA, Tenn. - Three patients exposed to contaminated medical equipment at Veterans Affairs hospitals have tested positive for HIV, the agency said Friday. Initial tests show one patient each from VA medical facilities in Murfreesboro, Tenn.; Augusta, Ga.; and Miami has the virus that causes AIDS, according to a VA statement. The three cases included one positive HIV test reported earlier this month, but the VA didn’t identify the facility involved at the time. The patients are among more than 10,000 getting tested because they were treated with endoscopic equipment that wasn’t properly sterilized and exposed them to other people’s body fluids. Vietnam veteran Samuel Mendes, 60, said he was surprised to learn of an HIV case linked to the Miami facility, where he had a colonoscopy. He was told he wasn’t among those at risk. “I was hoping and expecting to not get anyone contaminated like that,” he said. “It’s probably a little worse than we thought.” The VA also said there have been six positive tests for the hepatitis B virus and 19 positive tests for hepatitis C at the three locations. There’s no way to prove patients were exposed to the viruses at its facilities, the agency said. “These are not necessarily linked to any endoscopy issues and the evaluation continues,” the statement said. The VA has said it does not yet know if veterans treated with the same kind of equipment at its other 150 hospitals may have been exposed to the same mistake before the department had a nationwide safety training campaign. An agency spokeswoman has said the mistake with the equipment was corrected nationwide by the time the campaign ended March 14. The problems discovered in December date back more than five years at the Murfreesboro and Miami hospitals. The VA’s disclosure Friday was the department’s first comment since April 3, when the VA reported the one positive HIV test. VA spokeswoman Katie Roberts has declined to provide any details on how widespread the problems might have been other than saying a review of the situation continues. She said in an e-mail Friday that “there is a very small risk of harm to patients from the procedures at each site.” She said the HIV results “still need to be verified” in additional tests. The VA statement shows the number of “potentially affected” patients totals 10,797, including 6,387 who had colonoscopies at Murfreesboro, 3,341 who had colonoscopies at Miami and 1,069 who were treated at the ear, nose and throat clinic at Augusta. More than 5,400 patients, about half of those at risk, have been notified of their follow-up test results, the VA said. The Friday statement said the VA is “continuing to notify individuals whose letters have been returned as undeliverable, and working with homeless coordinators to reach veterans with no known home address.” The statement also said the VA has assigned more than 100 employees at the three locations to “ensure that affected veterans receive prompt testing and appropriate counseling.” All three sites used endoscopic equipment made by Olympus American Inc., which has said in a statement it is helping the VA address problems with “inadvertently neglecting to appropriately reprocess a specific auxiliary water tube.” Charles Rollins, 62, who served three tours in Vietnam with the Navy from 1966 to 1969, said the news concerns him because he’s used the Augusta ear, nose and throat clinic several times. “That’s terrible,” he said by phone as he socialized at an American Legion post in Augusta. EcoSMART Pest Sprays Are a Safe OptionBuy them here. Of course, you could always wait THREE YEARS for the government to tell you that the other products are toxic...
EPA Will Test Pesticides' Effect on Endocrine System
Washington Post Staff Writer Wednesday, April 15, 2009; 2:16 PM
The Environmental Protection Agency announced today it will order pesticide manufacturers for the first time to test 67 chemicals contained in their products to determine if they disrupt the endocrine system, which regulates both animals' and humans' growth, metabolism and reproduction. Researchers have raised concerns that chemicals released into the environment are interfering with animals' hormone systems, citing problems such as male fish in the Potomac River that are growing eggs. The chemicals, known as endocrine disruptors, may interfere with the hormones that humans and animals produce or secrete. "Endocrine disruptors can cause lifelong health problems, especially for children," said EPA Administrator Lisa P. Jackson in a statement. "Gathering this information will help us work with communities and industry to protect Americans from harmful exposure." The testing will begin this summer and focus on whether these chemicals affect the body's estrogen, androgen and thyroid systems, EPA officials said. It will eventually encompass all pesticide chemicals. Pesticide industry officials said they had anticipated the move, which was prompted initially by the 1996 passage of the Food Quality Protection Act, and they planned to cooperate on the matter. "It's been a long time coming," said Jay Vroom, president and chief executive of CropLife America, a major trade association. "For pesticides, we think the likelihood is extremely low we'll have any concerns come to the surface." Just this month EPA rejected a petition from CropLife America that would have changed aspects of the agency's Endocrine Disruptor Screening Program in an effort to reduce the costs and time requirements associated with the new testing regime. But Vroom said EPA indicated in its April 3 letter that it would take several of the industry's concerns into account, including leaving open the possibility in the future of using computer modeling in some instances rather than relying exclusively on laboratory animal testing. "That's an encouraging sign," he said, adding it appeared the agency would be willing to lower the number of lab animals required for testing. Linda Birnbaum, who directs the National Institute of Environmental Health Sciences and the National Toxicology Program, said the program represents "a more organized way to look at" how human exposure to pesticide chemicals could affect everything from bone growth to brain development. "This is a good beginning," Birnbaum said, adding that scientists need to examine how different hormone disruptors might interact or accumulate in the human body. "It's very important to know, can certain chemicals, especially chemicals that are out there that people are exposed to, impact our hormone system." While researchers have observed the most visible effects of these chemicals in animals, Birnbaum said it was likely some humans, depending on their particularly sensitivity, could experience similar problems. "I think it's unrealistic that humans are going to be immune," she said, adding that the studies need to determine "what are doses, how much of these chemicals do you need for cause and effect?" Linda Phillips, who manages EPA's Endocrine Disruptor Screening Program, said it will take about two years to obtain data from the two-tiered screening program, and then it could take the agency another year to make a final determination about the chemicals' effect on hormone disruption. Vroom said pesticide manufacturers are "very confident our products will come through with flying colors. If we do learn something about our products that raises a cause for concern, our industry will be at the table, ready and willing to step forward and take action to mitigate risk." Obama's People Are Sure CO2 Is Toxic, But Not Rocket Fuel or BPASay what? Yeah. The stuff you breathe out is so dangerous it needs to be regulated and limited, but perchlorate coming from dry cleaners in nonresidential buildings? Hey, no worries! Endocrine disruptors like BPA and phthalates, which are linked to genital deformities and obesity? No problem!
April 17, 2009
RegulationEPA Says Greenhouse Gases Pose Threat To Public HealthEnvironmentalists applaud endangerment finding but affected industries voice concernGlenn HessThe Environmental Protection Agency concluded today that greenhouse gas emissions contribute to air pollution that may endanger human health or welfare. The proposed finding, which triggers a 60-day public comment period before the agency makes a final endangerment ruling, opens the door to possible regulation of carbon dioxide as a pollutant under the Clean Air Act. "This finding confirms that greenhouse gas pollution is a serious problem now and for future generations," said EPA Administrator Lisa P. Jackson. EPA's endangerment finding states that "in both magnitude and probability, climate change is an enormous problem. The greenhouse gases that are responsible for it endanger public health and welfare within the meaning of the Clean Act." The agency identified six gases that pose a potential threat--carbon dioxide, methane, nitrous oxide, hydrofluorocarbons, perfluorocarbons and sulfur hexafluoride. "The science clearly shows that concentrations of these gases are at unprecedented levels as a result of human emissions, and these high levels are very likely the cause of the increase in average temperatures and other changes in our climate," EPA said in a statement. Environmentalists applauded the decision, while chemical manufacturers and refiners expressed concern. "At long last, the EPA has officially recognized that carbon pollution is harmful to our health and to the climate," said David Doniger, policy director of the Climate Center at the Natural Resources Defense Council. "With this step, Administrator Lisa Jackson and the Obama Administration have gone a long way to restore respect for both science and law." Calvin M. Dooley, president and CEO of the American Chemistry Council, which represents over 130 of the nation’s largest chemical companies, says the Clean Air Act "is not well-suited" to address greenhouse gas emissions from stationary sources, such as chemical plants and petroleum refineries. "Given the national implications of carbon dioxide regulation by EPA and the interdependent nature of climate and energy issues, climate policy should be discussed and developed in Congress, in tandem with energy policy," Dooley said. Should the Obama Administration choose to regulate greenhouse gas emissions under the Clean Air Act, it would constitute "EPA's single largest and potentially most complex assertion of authority over the U.S. economy and Americans' lifestyles," said Charles T. Drevna, president of the National Petrochemical and Refiners Association. "Such regulation would have an enormous impact on every facet of the economy, businesses large and small, as well as on the general population. Before moving forward, the U.S. must ensure that other major global contributors are similarly committed to reducing their ambient greenhouse gas concentrations," Drevna added. * * * http://www.reuters.com/article/environmentNews/idUSTRE53I1OO20090419 Congress to pass energy bill this year: White HouseSun Apr 19, 2009 1:04pm EDT
By Ayesha Rascoe WASHINGTON (Reuters) - U.S. lawmakers will pass major energy legislation, possibly including measures to address climate change, by the end of this year, a top White House official said on Sunday. "I do know this, at the end of this first year of Congress there will be an energy bill on the president's desk," White House Chief of Staff Rahm Emanuel told ABC's "This Week with George Stephanopoulos." When asked whether the bill would include a controversial cap-and-trade system aimed at curbing emissions of carbon dioxide, Emanuel said "our goal is to get that done. We will see." Democrats in the House Energy and Commerce Committee will begin hearings this week on proposed legislation that would limit greenhouse gas emissions and require companies to acquire permits to release carbon into the atmosphere. Energy and Commerce Committee Chairman Henry Waxman has said he wants the bill, which includes measures to boost energy efficiency and develop clean energy technology, to pass the committee in late May and the House of Representatives later in 2009. Senate Majority Leader Harry Reid, also a Democrat, said he hoped the Senate by the middle of 2009 would pass cap-and-trade legislation, which allows firms emitting more carbon dioxide than the limit to buy credits from those that emit less. No major bill addressing the issue has been introduced in the chamber. Democrats control Congress. But the attempt to enact new climate change laws at a time when the U.S. economy is in a deep recession has raised concerns among Republicans and some Democrats, who worry that doing so would raise costs for consumers and industry. Emanuel said it was understandable that there would be some objections to a program of this magnitude, but he disagreed with the criticism that the cap-and-trade system was a broad base tax increase. "No, what I believe is we're going to alter how we deal with our energy policy," Emanuel said. Congress faces pressure to act on climate change following the Environmental Protection Agency's finding last week that carbon dioxide posed a danger to human health, possibly paving the way for federal regulation of greenhouse gas emissions. Emanuel reiterated that the White House supported a legislative solution for reducing climate warming emissions. (Reporting by Ayesha Rascoe; Editing by Paul Simao) * * * http://www.chicagotribune.com/news/local/chi-crestwood-water-sidebar-bd19apr19,0,4347554.story Partial ban of dry-cleaning chemical under review
The Obama administration is mulling whether to force dry cleaners to phase out the cancer-causing chemical that soaked into the soil behind a Crestwood business and is still used in tens of thousands of shops nationwide. Exposure to the chemical, also known as PCE or perc, has been linked to health problems among workers. It also has contaminated groundwater in thousands of sites around the nation, usually from improper disposal. * * * http://www.upi.com/Science_News/2009/04/17/Phthalates-found-in-obese-children/UPI-87861240021891/ Phthalates found in obese childrenNEW YORK, April 17 (UPI) -- A U.S. study suggests endocrine disruptors such as phthalates may play a role in childhood obesity, the Mount Sinai School of Medicine said.
Researchers found children in New York's East Harlem are three times more likely than other children in the United States to be overweight. The study determined neighborhood characteristics -- including availability of convenience foods -- likely play a strong role in the number of obese children. Eighty percent of the children in the study reported purchasing food items from convenience stores at least one time per week, the hospital said in a report released Thursday. High levels of phthalates and Bisphenol A found in the children's urine may play a role in obesity by disrupting hormones that regulate growth and development, researchers said. Higher levels of three endocrine disruptors -- 2,5 DCP, MBP and MEHHP -- were also found. The levels of DCP, formed in the body from the chemical DCB, were three to 10 times higher than those found in a national sample of children the same age, the report said. The chemical is common in mothballs, room deodorizers and toilet bowl deodorizer cakes.
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