Merck Could Have Detected Vioxx Risks Earlier
November 23, 2009
Reuters
by Julie Steenhuysen
Heart risks from taking Merck & Co Inc’s painkiller Vioxx could have been detected more than three years before the company withdrew the drug from the market in September 2004, had the data been openly available, U.S. researchers said on Monday.
They said their analysis illustrates the need for quick, public disclosure of drug safety data.
“You could have known there were marked safety problems with Vioxx as early as 2000 and the signal only grew stronger,” said Dr. Harlan Krumholz of Yale University School of Medicine, who worked on the study published in the Archives of Internal Medicine.
Merck voluntarily withdrew Vioxx from the market in September 2004 after a clinical trial found the blockbuster drug increased the risk of heart attacks and strokes in long-term users of the medicine.
In November 2007, Merck signed a $4.85 billion deal to settle thousands of claims for heart attacks, strokes and deaths allegedly caused by the drug.
The study draws on company data from more than 30 clinical trials conducted by Merck between 1996 and 2004 comparing Vioxx, or rofecoxib, to a placebo or dummy pill.
Krumholz gained access to the data through his role as a paid witness for plaintiffs in lawsuits involving heart attacks or strokes that occurred after taking the drug.
“Most of the information we are using in this study was never published, or if it was published, they never included the key safety data,” he said.
Of the 30 studies, 18 were published before September 2004, when the drug was withdrawn, six were published after that, and six were never published.
“We’re suggesting this has to change,” Krumholz said.
The team pooled data from randomized clinical trials that compared Vioxx to a placebo.
They pooled the trials in the order the studies were done, and after each one, they analyzed the data to see if they could detect any signal that would suggest the drug was raising the risk of heart attacks and strokes.
They found a trend toward increased heart risks compared with placebo as early as December 2000, and a statistically significant signal by June 2001, nearly three and a half years before the company pulled the drug from the market.
Antibacterial Soaps Strip Away Essential Bacteria Too
November 22, 2009
Eureka Alert
On the skin’s surface, bacteria are abundant, diverse and constant, but inflammation is undesirable. Research at the University of California, San Diego School of Medicine now shows that the normal bacteria living on the skin surface trigger a pathway that prevents excessive inflammation after injury.
“These germs are actually good for us,” said Richard L. Gallo, MD, PhD, professor of medicine and pediatrics, chief of UCSD’s Division of Dermatology and the Dermatology section of the Veterans Affairs San Diego Healthcare System.
The study, to be published in the advance on-line edition of Nature Medicine on November 22, was done in mice and in human cell cultures, primarily performed by post-doctoral fellow Yu Ping Lai .
“The exciting implications of Dr. Lai’s work is that it provides a molecular basis to understand the ‘hygiene hypothesis’ and has uncovered elements of the wound repair response that were previously unknown. This may help us devise new therapeutic approaches for inflammatory skin diseases,” said Gallo.
The so-called “hygiene hypothesis,” first introduced in the late 1980s, suggests that a lack of early childhood exposure to infectious agents and microorganisms increases an individuals susceptibility to disease by changing how the immune system reacts to such “bacterial invaders.” The hypothesis was first developed to explain why allergies like hay fever and eczema were less common in children from large families, who were presumably exposed to more infectious agents than others. It is also used to explain the higher incidence of allergic diseases in industrialized countries.
The skin’s normal microflora – the microscopic and usually harmless bacteria that live on the skin – includes certain staphylococcal bacterial species that will induce an inflammatory response when they are introduced below the skin’s surface, but do not initiate inflammation when present on the epidermis, or outer layer of skin.
In this study, Lai, Gallo and colleagues reveal a previously unknown mechanism by which a product of staphylococci inhibits skin inflammation. Such inhibition is mediated by a molecule called staphylococcal lipoteichoic acid (LTA) which acts on keratinocytes – the primary cell types found on the epidermis.
The researchers also found that Toll-like receptor 3 (TLR3) activation is required for normal inflammation after skin injury.
Unhealthy Health Workers Hurting Patient Care
November 23, 2009
The Times
by David Rose
Health trusts must do more to help doctors and nurses exercise and give up smoking and heavy drinking, says the Government.
NHS organisations will be expected to improve access to intervention programmes such as counselling or gyms as part of a drive to reduce sickness absence, which costs £1.5 billion a year.
The first national audit of staff habits has found that high rates of obesity, smoking, absenteeism and poor mental health were having a direct impact on the quality of patient care.
The Health Secretary is expected to accept all the recommendations of the final review, drawn up by Steve Boorman, a leading occupational health expert, in a written ministerial statement.
The review found that the scale of sickness absence in the NHS was equivalent to more than 45,000 NHS employees being absent from the workforce each year.
However, the Department of Health has suggested that health workers should be encouraged to set an example for patients and the general public when it came to promoting healthy lifestyles.
The review found that hospitals whose staff were in poorer health were less productive and had higher rates of patient mortality and superbug infection. More than three quarters of 11,000 staff polled acknowledged that the state of their health affected patient care.
Dr Boorman, a former GP and the chief medical adviser to Royal Mail, told The Times earlier this year that health awareness among NHS staff was “very inconsistent”. He said that a clear correlation had emerged between the performance of hospitals and staff health.
His recommendations include cutting smoking rates in the NHS, which are the same as in the general population, and providing more time or opportunities for staff to exercise.
Health workers with musculoskeletal and mental health conditions are also to be promised access to early interventions such as physiotherapy or counselling.
The review will call on trusts to appoint health and wellbeing leaders at board level to bring down rates of obesity, drinking and smoking, and on the Department of Health to devise and implement national standards and provide resources to ensure that these standards are given priority.
Study: Chest Ultrasound as Effective and Safer than CT Scan
November 20, 2009
Eureka Alert
Chest ultrasound can serve as a viable alternative to chest CT in the evaluation of pediatric patients with complicated pneumonia and parapneumonic effusion (a build-up of fluid between the lung and chest wall), according to a study published in the December issue of the American Journal of Roentgenology.
Pneumonia in the pediatric population is common. Both the diagnosis and therapy of complicated pneumonia is guided by imaging — CT, to date, playing a central role in complicated cases.
In the study, performed at the Albert Einstein College of Medicine and Montefiore Medical Center in the Bronx, N.Y., both chest CT and chest ultrasound were performed on 19 children with complicated pneumonia accompanied by parapneumonic effusion. “Our results showed that chest CT did not provide additional clinically useful information that was not also seen on chest ultrasound,” said Terry L. Levin, M.D., lead author of the study.
“No consensus exists on the optimal technique for imaging complicated pneumonia in children. Although chest CT allows rapid image acquisition, the rising use of CT in the pediatric population raises the concern of an increasing ionizing radiation burden,” said Levin. “The benefits of chest ultrasound over chest CT include its portability, absence of need for patient sedation, and that ultrasound does not use ionizing radiation,” she said.
“As a result of our study, we suggest that the evaluation of children with complicated pneumonia include chest radiography and chest ultrasound. Chest CT may be reserved for patients in whom chest ultrasound is technically difficult or discrepant with the clinical findings,” said Levin.
Monsanto Abandoning Crop to Avoid Additional Research
November 16, 2009
Greenplanet
Monsanto has abandoned its ambitious plans for two types of a so-called “second generation GM crop” rather than accede to a request from European regulators for additional research and safety data.
Monsanto has informed the European Food Safety Authority (EFSA) that it no longer wishes to pursue its application for approval of GM maize LY038 and the stacked variety LY038 x MON810. Both of these varieties were designed to accelerate the growth rate of animals. Two letters were sent to EFSA from the Monsanto subsidiary company Renessen at the end of April this year confirming the withdrawal of its applications originally submitted in 2005 and 2006. The letters cite “decreased commercial value worldwide” and state that the high-lysene varieties “will no longer be a part of the Renessen business strategy in the near future.” There has been no announcement of these decisions on the Monsanto web site, and there are no mentions on EFSA or European Commission web sites either.
In other words, there is a conspiracy of silence involving both the applicants and the regulators.
The two letters sent to EFSA in April requested the return of all dossier material (varietal characterization, experimental protocols, and test results) which was submitted with the applications for cultivation, animal feed and human food. EFSA acceded to this request, making it impossible for any future independent researchers to analyse the Monsanto / Renessen data.
Scientists who have followed these two applications are quite convinced that the “decisions to withdraw” have nothing to do with commercial considerations and everything to do with food safety. In other words, the varieties are too dangerous to be allowed onto the open market. Objections came from scientists at the Canterbury University’s Centre for Integrated Research in Biosafety (INBI), New Zealand, who warned that the new corn was not safe for humans when cooked. They also expressed concerns about unpredictable health effects, increased levels of toxins in high- lysene corn, and possible allergies and links to cancer.
Irresponsible Reporting – Journalists Exaggerating Claims of Pharmaceuticals
November 20, 2009
Eureka Alert
An editorial published online November 20 in the Journal of the National Cancer Institute discusses the exaggerated fears and hopes that often appear in news coverage of cancer research. The editorial provides guidance for both the media and journals to help alleviate the problem.
Lisa M. Schwartz, M.D., M.S., and Steven Woloshin, M.D., M.S., of Center for Medicine and the Media at the Dartmouth Institute for Health Policy and Clinical Practice in New Hampshire, and Barnett S. Kramer, M.D., editor-in-chief of the JNCI, use recent media coverage of two studies from the New England Journal of Medicine and the JNCI to demonstrate their point.
Coverage of trial results of the new anti-cancer drug olaparib, which appeared in the NEJM, exaggerated hope in many ways. One national news outlet claimed the drug “was the most important cancer breakthrough of the decade,” but failed to note that the study was uncontrolled (so there is no way to know if the drug accounted for the findings), and very preliminary (it is not known if the findings will ever translate into longer life).
The editorialists also point to coverage of a JNCI article on alcohol consumption and cancer risk among women, which may have caused unwarranted fear: “A drink a day raises women’s risk of cancer,” read one newspaper headline. Unfortunately, the coverage did not provide the magnitude of the risk. Comparing the highest level of drinking (≥15 drinks a week) to the lowest (one to two drinks per week), the investigators observed a 0.6% absolute increase in the risk of breast cancer diagnosis: from 2% to 2.6% for more than 7 years.
Journalists are not the only ones to blame, though, according to the editorialists. Medical journals sometimes leave important elements out of studies. In many cases, absolute risks and study limitations are omitted from the abstracts and journal press releases.
To help journalists and medical journals, the editorialists include tip sheets with guidance on questions to ask study authors, the interpretation of common statistics, and ways to highlight study limitations.
National Consumer League Targeting Popular Cranberry Juice
November 20, 2009
Food Navigator
by Caroline Scott-Thomas
The NCL alleges that the product contains more sugar than cranberry and is made from cranberry skins rather than whole cranberries, after it commissioned independent testing by Krueger Laboratories on November 4 – although Ocean Spray claims that cranberries form the main component.
Choice sweetened dried cranberries are sold to food manufacturers as a lower cost alternative to its regular version, for use in products such as muffins, trail mix, granola bars and cereals.
The group’s executive director Sally Greenberg said in a letter to the FDA: “NCL believes that the term ‘sweetened dried cranberry’ has become established by common usage as the name for a food product consisting mainly of cranberries infused with sugar and dried to a specific moisture content. Ocean Spray’s ‘Choice’ product, because of its minimal cranberry content and use of other ingredients to simulate the flavor and color of cranberries, should not be named ‘sweetened dried cranberries.’”
Ocean Spray says that its Choice cranberries are made by infusing a sucrose syrup into “sliced superior grade cranberries”, which is dried and then “lightly sprayed with oil.” The ingredient statement reads: cranberries, sugar, citric acid, elderberry juice concentrate, sunflower oil.
However, no one from Ocean Spray was available for comment prior to publication of this article.
When questioned about what prompted the NCL to look into the cranberry content of the Choice product, Greenberg told FoodNavigator-USA.com: “We had a confidential tip from somebody…The important thing is that we had the product tested and it turns out the allegation is true.”
NCL said it is concerned that the Choice product is “capitalizing on the healthy image of cranberries and cranberry juice” when it is “really little more than cranberry skin infused with sugar syrup.”
Bee Pollen as a Superfood
Novmber 24, 2009
NaturalNews
by Mike Adams
There are many superfoods that boost immune function, but few do it with as much potency as bee pollen. Through its unique combination of minerals, vitamins, amino acids and enzymes, bee pollen offers one of the most revitalizing natural superfoods in the world (especially when collected from local bees who are in tune with your local environment).
We’ve put together a collection of research for you here, describing the health benefits of bee pollen. NaturalNews reminds everyone to be mindful when consuming bee products due to the very high stresses already placed on honeybees in North America and Europe. Make sure your source practices organic bee farming and does not expose honeybees to high-fructose corn syrup or other chemicals that may be harmful to bee populations.
Bee pollen and your immune system
Bee pollen has been used throughout history as a superfood to restore energy and recuperative powers to the ailing individual. Bee pollen improves allergies in many individuals, and hence may have a regulating effect on the immune system by helping to dampen unnecessary autoimmune attacks which saves immune warriors for the real cancer battle. There is no toxicity to bee pollen. Other bee products with extraordinary healing properties include royal bee jelly and propolis, which is the antibiotic compound used by bees to disinfect their hives before occupation.
- Beating Cancer with Nutrition by Patrick Quillin, PhD,RD,CNS
While the effects are not so dramatic for everyone with arthritis, bee pollen is used by natural healthcare practitioners around the world to help alleviate arthritis symptoms. Energy Boost: Bee pollen is a popular supplement among many athletes, who report that it helps them train hard and recover quickly. Many athletes report that it helps increase stamina. Immune Support: Bee pollen is reported to help strengthen the immune system. People susceptible to reoccurring colds and respiratory tract infections may be helped.
- The Natural Physician’s Healing Therapies by Mark Stengler, N.D.
Bee pollen has more amino acids and vitamins than other amino-acid-containing products like beef, eggs, or cheese. Bee pollen is one of the few vegetable sources of vitamin B12 (Scheer 1992). A tablespoonful of bee pollen contains about 45 calories and is 15% lecithin (which is required for normal fat metabolism) by weight (Kamen 1991).
- PDR for Herbal Medicines, Fourth Edition by Thomson Healthcare, Inc.
Bee pollen’s natural phenylalanine content acts as an appetite suppressant. Bee pollen helps build the immune system and provides energy for the entire body. It contains 35% protein, 55% carbohydrate, 2% fatty acids and 3% minerals and vitamins. It is high in B-complex and vitamins A, C, D and E and contains lecithin. Where to buy it: Health food stores, in the refrigerated section. Bee pollen is actually many small granules similar to the size of a grain of wheat or quinoa and is usually sold in a plastic container.
- Get Balanced-the Natural Way to Better Health with Superfoods by Jan Lovejoy
Like other bee products, bee pollen has an antimicrobial effect. In addition, it is useful for combating fatigue, depression, cancer, and colon disorders. It is also helpful for people with allergies because it strengthens the immune system. It is best to obtain bee pollen from a local source, as this increases its antiallergenic properties. Fresh bee pollen should not cling together or form clumps, and it should be sold in a tightly sealed container. Some people (an estimated 0.05 percent of the population) may be allergic to bee pollen.
- Prescription for Nutritional Healing, 4th Edition: A Practical A-to-Z Reference to Drug-Free Remedies Using Vitamins, Minerals, Herbs & Food Supplements by Phyllis A. Balch, CNC
The human consumption of bee pollen dates back to antiquity; it was frequently used in the Olympic games in ancient Greece. Today bee pollen is gaining increasing popularity as effective protection against many of the common pollutants in the environment, including carbon monoxide, lead, and mercury. Bee pollen is used to treat allergies, since it desensitizes the individual. There have also been studies showing that bee pollen strengthens the resistance of the immune system to both cancer and radiation.
- Optimum Health – A Cardiologist’s Prescription for Optimum Health by Stephen T. Sinatra, M.D.
Bee Pollen Description: Bee pollen is the pollen produced by flowering plants, which clings to bees as they gather nectar. Bee pollen contains many vitamin and minerals, as well as flavonoids such as rutin and quercitin. It is thought that the minute amounts of pollens desensitize a person for the same pollen allergies.
- Prescription for Natural Cures: A Self-Care Guide for Treating Health Problems with Natural Remedies Including Diet and Nutrition, Nutritional Supplements, Bodywork, and More by James F. Balch, M.D. and Mark Stengler, N.D.
Pharmaceuticals Writing Own Drug Labels Without Side Effect Information
November 24, 2009
NaturalNews
by E. Huff
Two doctors from the Dartmouth Institute for Health Policy and Clinical Practice recently reported that many prescription drug labels do not contain accurate information about all side effects and the true severity of listed side effects, and they fail to mention that certain medicines are not truly effective.
A long standing problem, drug companies are in charge of writing their own drug information which is then presented to the Food and Drug Administration (FDA) for final approval. Though tasked with negotiating accurate and sensible wording, the FDA often lets slide inadequate information that is both misleading and outright deceptive.
Lunesta, a prescription sleeping drug created by Sepracor Inc., is touted on its information label as being superior to placebo in alleviating insomnia and inducing restful sleep. Test results from the most comprehensive study performed on the drug revealed that the drug did not reduce insomnia and that there were no meaningful improvements in next-day functioning and alertness as drug advertisements claimed.
Even though the study’s findings were provided to the FDA for further review, the FDA allowed misleading information to be published on Lunesta’s information sheet anyway. In response to allegations that the company is misleading the public about Lunesta, Sepracor retorted that information above and beyond what is required by the FDA is always available to those who request it.
Rozerem, another insomnia drug produced by Takeda Pharmaceutical Co., omitted similar information from its drug information sheet. Though no empirical sleeping improvements occurred in test patients who received treatment with Rozerem, the company did not disclose this fact on the product label. Takeda continues to market the product untruthfully.
Other examples of drug label deception include Novartis’ Zometa bone cancer drug. The drug’s information label states that ingesting the 8-milligram dose poses a greater risk of kidney damage with no explanation about how great a risk. Truth be told, 33 percent of patients in a test study died when taking the 8-milligram dose of Zometa.
As disturbing as all of this is, it illustrates the grave failure of the FDA in performing its job. Drug companies seemingly run the show from start to finish, researching, manufacturing, and self-regulating their own products. The FDA time and time again has caved at the behest of corporate pressure.
The FDA must be held responsible for its utter failure to function as it should. In direct opposition to its own mission statement which summates its purpose as defender of public health, the FDA operates as a corporate lapdog to pharmaceutical interests. It is time that the people demand the dismantling of this corrupt organization and the formation of a new one.
Your Asthma Could be Caused by Acetaminophen
November 24, 2009
NaturalNews
by S. L. Baker
Acetaminophen, the pain reliever and fever reducer found in Tylenol and many other over-the-counter as well as prescription drugs (such as Lortab), is often hyped for its supposed safety — specifically because it doesn’t cause stomach upset as often as aspirin. However, in recent years, it has become clear that acetaminophen can cause liver damage and, when combined with alcohol, stomach bleeding. Now comes another warning: researchers have linked the drug’s use to an increase in asthma and wheezing in both children and adults.
According to the National Institute of Allergy and Infectious Diseases (NIAID), asthma affects 16 million adults and nearly 7 million children in the US. It is, in fact, the most common serious chronic disease of childhood. A respiratory disease of the lungs, it is marked by episodes of inflammation and narrowing of the lower airways in response to asthma triggers which include infectious agents, stress, cigarette smoke, air pollution, dust mites and pollen. A new study just published in the November issue of Chest, the peer-reviewed journal of the American College of Chest Physicians, suggests acetaminophen can also be an important asthma trigger.
Canadian researchers at the University of British Columbia in Vancouver, British Columbia, conducted a detailed analysis of 19 clinical studies which contained information linking asthma and/or wheezing to taking acetaminophen. In all, a huge number of research subjects — 425,140 — were included in these studies.
The results of the investigation showed the odds of having asthma were significantly raised among people who took the pain reliever. The analysis specifically showed a worrisome risk of asthma in children who had been given acetaminophen in the year prior to their asthma diagnosis or in the first year of life. And the findings raised another red flag concerning the use of acetaminophen by pregnant women. The study results showed an increase in the risk of asthma and wheezing in children if their mothers had taken the drug prenatally.
Writing in Chest, the researchers called for future studies to further confirm their analysis. They concluded: “The results of our review are consistent with an increase in the risk of asthma and wheezing in both children and adults exposed to acetaminophen.”
