Fraudulent autism vaccine study shows the flaws in medical journal system

Source: blogs.forbes.com Author: Robert Langreth The British Medical Journal’s conclusion that the original study that led to the autism vaccine scare was “an elaborate fraud” shows how flawed the current system for reviewing high-profile medical studies is. The study, by discredited British doctor Andrew Wakefield, was originally published in 1998 by the journal The Lancet, and was retracted last year. Now the BMJ has published an investigation by British journalist Brian Deer finding that the whole thing was a fraud. According to a BMJ editorial, “not one of the 12 cases reported in the 1998 Lancet paper was free of misrepresentation or undisclosed alteration…and that in no single case could the medical records be fully reconciled” with Lancet publication. The editorial concludes that there is “no doubt” that Wakefield was responsible. The study, with just 12 patients, was dubious from the beginning. Why did it take 12 astonishingly long years to find out the truth? Strict British libel laws may have had something to do with it. But the bigger problem is the limitations of the medical journal system. The Food and Drug Administration often examines much of the raw data when it analyzes whether to approve or restrict a drug. But medical journals rely more on the good faith of researchers and something called peer review, outside researchers who anonymously review papers. This is good at detecting conclusions that don’t match up with the data, flawed analysis, and and obviously faulty method. But it can leave them surprisingly vulnerable [...]

Thimerosol-Autism link was a legal theory in search of science

Source: blogs.forbes.com Author: Daniel Fisher What has been obvious to skeptics for years has finally become obvious to all: The supposed link between vaccines and autism is a sham perpetrated in the name of litigation. In a scathing series of articles and editorial in the British Medical Journal, researcher Andrew Wakefield, who wrote an influential Lancet article in 1998 suggesting vaccines cause autism, has been exposed as a fraud. What’s worse, he was paid by lawyers to perpetrate his fraud, more than $675,000 over two years. Wakefield’s theories and the shoddy research performed by a British lab helped fuel a similar wave of litigation in the U.S. With total disregard for the risk of needless injury and death they were helping to cause, trial lawyers and cheerleaders like Robert Kennedy peddled the story that the preservative thimerosol, containing minute traces of mercury, was the cause of an explosion in autism diagnoses. What they never said was this was a theory tailor-made for litigation. Science designed to serve the courtroom. The lawyers had a problem, you see. Congress, recognizing that vaccines will injure and kill a predictable number of people each year while saving many more, passed a law in 1986 taking away the right to sue vaccine manufacturers in standard courts. The cases were funneled to a special vaccine court where damages would be paid out according to a schedule. Lawyers didn’t like that, preferring the potentially much larger verdicts they could get from a jury. So they began looking [...]

Fox Chase researchers find estrogen may help precancerous cells spread in oral cavity

Source: www.fccc.edu Author: staff Head and neck cancer is the sixth most common type of cancer and is on the rise in some demographic groups, including young women without any known risk factors. Now, researchers at Fox Chase Cancer Center report that estrogen may increase the movement of precancerous cells in the mouth and thus promote the spread of the disease within the oral cavity. The new results, which are reported in the January issue of Cancer Prevention Research, may lead to novel chemoprevention strategies in the future. Margie Clapper, PhD, Co-leader of the Cancer Prevention and Control Program at Fox Chase Cancer Center, and colleagues reported earlier this year that estrogen metabolism changes after smoke exposure in the lungs and may contribute to lung cancer. To find out if this female hormone influences development of head and neck cancer, Ekaterina Shatalova, PhD, a postdoctoral fellow and first author on the paper, examined the impact of estrogen on precancerous and cancerous cells. They found that estrogen induces the expression of an enzyme called cytochrome P450 1B1 (CYP1B1), which is responsible for breaking down toxins and metabolizing estrogen. Interestingly, CYP1B1 induction occurred only in precancerous cells, which are neither totally normal or cancerous. Interestingly, estrogen did not induce CYP1B1 in cancer cells. With closer investigation, the team found that depleting the expression of CYP1B1 diminished the ability of precancerous cells to move and divide, as compared to similar cells with normal levels of CYP1B1. Estrogen also reduced cell death in the [...]

Tobacco manufacturers must report ingredients to FDA

Source: www2.journalnow.com Author: Richard Craver The Food and Drug Administration is giving tobacco manufacturers less than three months to provide proof that any product introduced since February 2007 is "substantially equivalent" to products already in the marketplace. If a manufacturer does not file a report by March 22, or cannot substantiate its evidence, the FDA said Wednesday that it could remove the product from store shelves. The announcement updated the guidance provided to manufacturers in June 2009 as part of enacting the Family Smoking Prevention and Tobacco Control Act. Manufacturers of any product introduced after March 22 must submit an application and obtain a marketing order from the FDA before placing the product on the market. The emphasis of the new rules puts R.J. Reynolds Tobacco Co. in the bull's-eye because it has been the most prolific developer of tobacco products in recent years, including Camel Snus and the Camel orbs, sticks and filmlike strips for the tongue. "No known existing tobacco product is safe, and a market order issued by the FDA for these products should never be interpreted as such," said Dr. Lawrence Deyton, the director of the FDA's Center for Tobacco Products. "These products will not be safer, but we are required by this law to not allow even more dangerous products to cause further harm to those Americans who use tobacco products." The FDA defined "substantially equivalent" as "being the same in terms of ingredients, design, composition, heating source and other characteristics to an existing, single-predicate [...]

Henry Schein Dental selected as exclusive distributor of VELscope Vx System in North America

Source: www.prnewswire.com Author: press release LED Dental announced today that Henry Schein Dental will be the exclusive distributor of its revolutionary new VELscope Vx Enhanced Oral Assessment system in North America. Henry Schein Dental is the U.S. Dental business of Henry Schein, Inc. (Nasdaq: HSIC), the largest provider of health care products and services to office-based practitioners. In 2006 LED Dental introduced the first generation VELscope system, which was the first to employ fluorescence visualization to help dental practitioners detect oral cancer and other forms of oral disease. The VELscope system was also the first to receive FDA and Health Canada clearance to help clinicians detect cancerous and precancerous lesions that might not be apparent to the naked eye, and to help surgeons determine the appropriate surgical margin when excision of abnormal tissue is indicated. Since then, over 6,000 VELscope systems around the world have been used to conduct over 10 million oral health exams, which is more than any other oral disease detection technology. The VELscope Vx system is the latest and most advanced generation of VELscope technology. While retaining all of the capabilities of prior generations, its cordless design provides significantly greater portability and convenience. Moreover, a price of less than half the level of prior generations makes it feasible for many practices to have one in two or more operatories. In addition, a reimbursement code has been approved for this procedure, and is honored by many insurance companies. "As the world leader in oral disease detection, it [...]

HPV: To test or not to test

Source: www.rdhmag.com Author: Nancy W. Burkhart, RDH, EdD The dental practitioner has a responsibility to examine and assess the oral tissue status of all patients. Usually, we are happy to report that the tissue is healthy and no further treatment is necessary. Ethically, our role in assessment is both an understood practice as well as a legal one each time we interact with our patients. Within your practice, what is the expected role in assessing and relaying advice/recommendations to our patients? Do we rely strictly on scientific evidence with evidence-based protocol? Do we trust the developers/promoters of dental products to provide information to us? Do we relay personal opinion from colleagues, or do we reject opinion-based information? Do we search the scientific literature for current information, or call our colleagues and company representatives and obtain a consensus of what the best options may be for dissemination of information? We have all been in these situations. With busy practices, it is very time consuming to sit down and evaluate all the literature. Anyone who has been faced with a medical decision for a loved one or ourselves may actually feel exhausted while trying to sort through all of the options, treatments, and advice – some of which may even be at odds within specific group specialties in the way treatment is rendered. It can be very daunting, draining us both mentally and physically. So how do we approach this dilemma? For some time, we have known about the detrimental [...]

New snuff low in carcinogens, Virginia company says

Source: www2.journalnow.com Author: Richard Craver A small tobacco manufacturer in Richmond, Va., said Tuesday that it has developed a moist-snuff product that has the lowest levels of carcinogens — in this case nitrosamines — in the marketplace. That includes "99 percent lower than the levels found in conventional American moist snuffs, such as Copenhagen or Skoal, and 90 percent less than the level found in current snus products," the company said. Star Scientific Inc. plans to apply soon to the Food and Drug Administration for permission to market the product, part of its Stonewall brand, as "modified risk" under the Family Smoking Prevention and Tobacco Control Act of 2009. That act gave the FDA the regulatory control over new tobacco products. Star applied last year to market its Ariva and Stonewell lozenges as modified risk. "Our company's belief and hope is that the FDA will give a robust look at the science of our application and other reduced-risk applications," said Sara Machir, the vice president of communications and investor relations for Star. The request is likely to stoke further debate between two sets of anti-smoking groups. One set says smokeless tobacco serves as gateway products for teenagers to cigarettes and discourages users from quitting. The other set says the products are a way to reduce the risk of tobacco use compared with cigarettes. Scott Ballin, the past chairman of the Coalition on Smoking or Health, said the debate "is more about competition, market share and profits than it is about [...]

House GOP targets tobacco programs

Source: www.desmoinesregister.com Author: Tony Leys Iowans no longer would face gruesome photos of mouth cancer or TV portrayals of smarmy cigarette salesmen if House Republicans get their way. GOP leaders want to end to the "Just Eliminate Lies" program, which sponsors graphic anti-tobacco ads and organizes youth conferences to battle smoking. Linda Upmeyer, a Garner Republican set to become majority leader, said Just Eliminate Lies often spends money on superfluous activities, such as merchandise giveaways. "If we're going to do smoking cessation, I don't think Iowans want to buy backpacks and T-shirts," she said. House Republicans proposed junking the program this week as part of a large package of budget cuts. They also proposed ending a program called Quitline Iowa, which provides telephone counseling to people who want to quit smoking. Upmeyer said she'd heard that callers often did not get prompt responses from the contractor that runs Quitline. "These are ineffective programs," she said, and they should not be a priority in a tight budget year. Organizers denied the allegation. Cathy Callaway, who is chairwoman of the Iowa Tobacco Prevention and Control Commission, said she hadn't heard of major problems with Quitline Iowa. She also noted that the percentage of Iowa high-schoolers who smoke regularly dropped to 20 percent in 2008 from 31 percent in 2000, when Just Eliminate Lies started. She said she believes the program was targeted because of its controversial ads. A 2008 analysis of the program showed that teen smoking had declined, but it also [...]

Health and philanthropy—the tobacco connection

Source: www.thelancet.com Author: Simon Chapman On June 14, the world's two richest men, Mexico's Carlos Slim Helú and the USA's Bill Gates, jointly announced that they would each contribute US$50 million to the Latam health project to increase vaccinations and improve child nutrition and natal health in central America.1 Slim already contributes reputedly $2·5 billion annually to his Instituto Carlos Slim de la Salud, which runs a large variety of health programmes in Latin America.2 The latest announcement will naturally attract widespread acclaim as an outstanding example of philanthropy. But it also invites important questions about consistency and competing interests. Any assessment of Slim's net contribution to public health must balance the impact of his philanthropic contributions as well as the indirect health consequences that flow from his wealth generation with a less appreciated source of his wealth. Descriptions of Slim's vast fortune generally concentrate on his telecommunications empire.3 Relatively little is mentioned about his long-standing majority ownership of the Mexican tobacco company Cigatam,3 which has since 2007 been 80% owned by Philip Morris.4 Slim's website acknowledges that Cigatam “turned out to be the first and most important because of its cash flow, providing the Group with sufficient liquidity to capitalize on available opportunities and thereby increase its acquisitions of big companies”.5 Nor is it as widely publicised that he has a continuing role as a non-executive director6 of the world's largest tobacco company, Philip Morris International (PMI). The company's shareholders doubtless expect him—like all directors—to make a major contribution [...]

Quitting smoking makes economic sense

Source: www.latimes.com Author: Francesca Lunzer Kritz What does it cost to stop smoking? For just about anyone, less than it does to keep smoking. Many smokers burn through thousands of dollars each year buying cigarettes alone. Then there are peripheral costs like breath mints, extra trips to the dry cleaner and higher premiums for health insurance. Quitting costs money too, but it's a better long-term investment. Plus, much of what you'll need to get started — nicotine gum, patches and even counseling sessions — is often available free. "The cost of quitting isn't typically the reason smokers give for not giving up the habit," says Dr. Cheryl Healton, president of the American Legacy Foundation, a smoking cessation advocacy group based in Washington, D.C. "But finding out that it can be a very manageable cost is good news for smokers who make the decision to stop." Nationwide, the average cost of a pack of cigarettes (including the federal cigarette tax and state sales taxes) is about $5.51, according to the Campaign for Tobacco-Free Kids in Washington, D.C. For those who smoke a pack a day, that works out to about $155 a month, or just over $2,000 a year. Quitting, on the other hand, generally costs $25 to $150 a month, according to Dr. Michael Fiore, director of the University of Wisconsin Center for Tobacco Research and Intervention. One-on-one counseling may add to the tab, he said. Smokers may need to make several attempts before they kick the habit for good, [...]

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