Archive for July, 2007
July 9th, 2007
For men, the risk of colon cancer increases with body weight in a nearly linear manner, a study shows. For women, the risk is more variable but still trends upward, particularly for those younger than age 67.
The findings highlight the importance of weight control for colon cancer prevention, Dr. Kenneth F. Adams, of the National Institutes of Health in Rockville, Maryland, and colleagues conclude in a report in the American Journal of Epidemiology.
They examined the association between body mass index (BMI) and colorectal cancer incidence in 307,708 men and 209,436 women enrolled in the NIH-AARP Diet and Health Study. BMI, a standard measure to determine obesity, is calculated using weight and height. A BMI of more than 25 is considered overweight, and more than 30 is obese.
The men and women were followed from 1995 to 2000. During that time, a total of 2,314 men and 1,029 women developed colorectal cancer. An association was observed between BMI and an increased risk of colon cancer, but not rectal cancer, for both men and women.
For example, men who were overweight with a BMI of 25 to less than 27.5 had a 22 percent increased risk of developing colon cancer, compared to men of normal weight. Overweight men with a BMI of 27.5 to less than 30 had a 44 percent increased risk of colon cancer.
In obese men with BMIs of 30 to 32.5, 32.5 to less than 35, 35 to less than 40, and 40 or more, the risk of colon cancer was 53 percent, 57 percent, 71 percent, and more than 2-fold higher, respectively, relative to normal weight men.
For women, being overweight with a BMI of 25 to less than 27.5 was associated with a 29 percent increased risk of colon cancer. Overweight women with a BMI of 27.5 to less than 30 had a 31 percent increased risk of developing colon cancer.
In obese women with BMIs of 30 to 32.5, 32.5 to less than 35, 35 to less than 40, and 40 or more, the risk of colon cancer was 28 percent, 13 percent, 46 percent and 49 percent higher, respectively, relative to normal weight women.
“Age did not significantly modify the BMI-colon cancer association for men,” Adams and colleagues report. “By contrast, colon cancer was associated with BMI in women aged 50 to 62 and 63 to 66 years, but not in those aged 67 to 71 years,” they note.
The association was not modified by hormone replacement therapy in women, or by physical activity in men or women — “indicating the importance of weight control as a prevention strategy for this very common malignancy.”
July 7th, 2007
Sometimes, you can’t stop your weight-loss secrets from leaking out.
Dieters have been flocking to drugstores to pick up Alli, the first over-the-counter weight-loss pill to be approved by the Food and Drug Administration, despite the scary warning: Stray too far from your low-fat diet and you just might poop your pants.
Still, it seems there’s no shortage of people willing to risk public humiliation to shed a few pounds. At one Los Angeles-area Walgreens, pharmacist Susie Uyu’s seen customer after customer march directly through the store toward the prominent Alli display. “I think they’re excited that it’s an over-the-counter product,” Uyu says. And even though pharmacist Miyuki Anderson, who works at a Bartell Drugs in Seattle, warns everyone who eyes the Alli display about the messy side effects, it doesn’t stop most of them from buying the diet pill.
The drugmaker states very clearly that it’s no miracle drug, and only promises to help people toward moderate weight loss. For example, if someone were to lose 10 pounds from dieting, they’d lose 15 by combining their diet with Alli.
The diet pill works by blocking 25 percent of fat from being digested. Alli users take one pill with every meal, and to avoid an “Alli oops,” they should eat less than 42 grams of fat a day, or about 15 grams per meal. But those fat grams can be sneaky. One grande Starbucks Caramel Frappuccino contains 15 grams of fat, and if an Alli user adds even a low-fat muffin to that meal, it could get icky.
“It’s so important to understand that you must adopt a low-fat, healthy lifestyle,” Jones says. “We call them treatment effects — that’s a signal for you that you’re not staying in the guidelines. What Alli will not do is make up for not living a healthy lifestyle.”
Some Alli enthusiasts have been conscientious enough to avoid any side effects. Carole McMahan, who’s trying to lose 10 pounds, started taking Alli the day the product hit drugstore shelves on June 15, and has been careful to follow the low-fat diet.
“No pun intended, but I’m very anal about it,” says McMahan, who’s 44 and lives in Greensboro, N.C. She appreciates the way Alli holds her accountable to her eating habits.
“I started very cautiously, and I’ve just grown more and more comfortable with it,” McMahan says. “I just follow the diet. I knew I couldn’t go out and order hot fudge cake.”
But some Alli fans, like 25-year-old Rachelle Beaini, are just asking for it. Beaini, who lives in Henderson, Nev., and wants to lose 20 pounds, has lost 6 pounds in two weeks without a single side effect. Inspired by her success, last week she dared to eat a meal of chicken nuggets — while wearing white pants. (Still no unpleasant consequences, she swears.)
July 6th, 2007
Any magazine that dares to print the line, “When your clitoris gets frostbite, the terrorists win” is A-okay with us.
Women’s Health, sister publication to six-pack showcase Men’s Health, visibly outpaces sleepy competitors Self and Shape in the field of female-oriented fitness magazines. A hybrid of Vogue, Bust, Outside and the science journals at your nutritionist’s office, Women’s Health launched in late 2005 and may still be flying under the radar because it puts anonymous hotties on the cover and saves the celebrities—such as Tina Fey (30 Rock) and Jenna Fischer (The Office)—for the inside pages. This is no doubt an effort to save us from our own neuroses about skinny women of stage and screen, but it also gives the mag a welcome approachability.
But let’s talk about the sex. In addition to coverage of familiar and safe topics like nutrition, medicine, exercise and weight loss, Women’s Health dares to discuss female sexuality with a certain bright boldness that is neither too clinical nor too skanky. The frostbitten clitoris was the result of a feature testing out some oft-prescribed erotic experiments; another recent story about the world “down there” was illustrated with an oyster, a live beaver and a taco. Not that any of those are, you know, anatomically correct, but we love the moxie anyway. Check it out.
Source: http://www.eonline.com/coolstuff/detail/index.jsp
July 6th, 2007
Hedex Extra was meant to be the drug that pushed the envelope for millions of low-income Kenyan blue-collar workers shopping for a pain reliever.
It was heavily marketed as one of the country’s most potent painkillers, but now global pharmaceutical giant GlaxoSmithKline (GSK) is having a headache over the recall of this product.
Yesterday, it emerged that GSK is investigating a possible factory slip up that resulted in an error in its formulation—under the watch of the industry regulator, Kenya’s Pharmacy and Poisons Board.
But GSK said in a faxed statement that the product had been incorrectly stored in excessive temperatures above 30 degrees, causing the breakdown of the ingredient aspirin to form crystals of salicylic acid.
“Ingesting a dose of Hedex Extra damaged through incorrect storage may cause irritation to the mouth, throat and stomach.”
Hedex Extra was also meant to turbo-charge the growth of GlaxoSmithKline’s block-buster painkiller, Hedex, which was facing intense competition in the low end of the market, a category that was increasingly coming under competition from lower price name brand drugs, a host of generics and even fakes.
Just like GSK’s other pain relief brand, Panadol and Panadol Extra that targets more affluent consumers, Hedex Extra was launched as a product extension to Hedex, a companion and fighter brand against the likes of Beta Healthcare’s Mara Moja and Action in a bid to carve a bigger share of Kenya’s Sh2 billion analgesic drug market.
However, by the time Hedex Extra was brought to the market in January 2006, insiders knew that there were problems with the product’s formulation and there had been consumer complaints over the side effects of the drug.
It had been specially formulated for the Kenyan market with an extra pain relief strength than is usually marketed in Europe and other African markets.
Yesterday, it emerged in media reports that GSK had recalled Hedex Extra from the market. Business Daily’s interviews with retailers and pharmacists reveal that GSK started withdrawing the drug from the market in March and as late as last month.
Kenya’s Poisons and Pharmacy Board, which regulates the manufacture and marketing of drugs, confirmed that GSK started recalling the product in March. Until yesterday, GSK had not issued a public announcement over the product recall as industry standards requires in global medical marketing.
“In March, it was brought to our attention that there was a problem with Hedex Extra,” said Dr Wilfred Ochieng, Head of the Inspectorate division at the Pharmacy and Poisons Board, the governing body of the pharmaceutical industry.
However, on Thursday, GSK said the drug had been recalled because of Acetyl Salicylic Acid was breaking down too fast releasing a by-product in unusually high concentrations than was medically allowed. This was making consumers who take it to experience severe irritation in the mouth and throats and even causing stomach upsets. This was after the company says that it received complaints from Mombasa.
A super strong pain killer, it contained a heady mix of paracetamol, aspirin and caffeine and was marketed as providing extra fast relief for not just head aches, but also migraines, back aches and tooth aches.
“The issue is currently being investigated by its manufacturers. Just four batches had a problem. We decided in liaison with GSK that it would be best to withdraw the product pending investigations,” said Dr Ochieng, “The recall of the product does not mean Hedex Extra is bad for consumers, it just means there is a slight defect, which can be resolved in time.”
A possible problem in its formulation could be to blame for the drug manufacturers latest headache with the product.
Dr Ochieng said factors leading up to the recall could be rooted in factory issues, confirming it was a stability issue, a phenomenon that makes Asprin start degenerating turning a normally harmless drug into a toxic one.
The Kenyan version of the drug — it is sold in varying strengths in different countries around the world — was specially formulated for the local market.
Industry players say it contained the largest admissible amounts of its various components allowed under the law.
“I believe it should have been offered in a single dose rather than in the usual double pack. It was really powerful,” said a pharmacist, who declined to be named.
The Kenyan version of Hedex Extra was the result of several years of research for the multi-national drug company. It was however more powerful than a similar product sold in other markets.
The drug was slated to be a front-runner for the British pharmaceutical firm in the highly competitive analgesics market, where generics are taking a bite out of GSK’s profits from its flagship Panadol.
The struggle to gain a share in Kenya’s Sh2 billion over-the-counter painkillers market has occupied both international and local manufacturers, who are competing against counterfeits and a growing generic presence.
In a country where 60 per cent of the population self-medicates, Hedex Extra was positioned to take on Mara Moja — produced by locally based competitor Beta Heathcare — and the growing generic segment on its strong formulation claim.
Kenya’s over the counter (OTC) market has attracted several major international pharmaceutical firms such as: GSK, AstraZeneca Group Plc, Novartis Consumer Health SA, Pfizer Consumer Healthcare Inc, Aventis SA, and Sanofi Winthrop Industries. There are also a number of local manufacturers such as Beta Healthcare and Dawa Pharmaceuticals.
Within the pain relief category, local firms now control over 80 per cent of sales. Companies like GSK manage to maintain their share through a mix of higher pricing models, guarantees on quality and aggressive marketing.
Hedex Extra rode the back of a localized marketing campaign Boda Boda (bicycle taxi) challenge after sponsorship of its successful soccer fiesta, Hedex Cup was cancelled.
GSK is the oldest company in OTC health care in Kenya, with annual sales said to total over US$400 million per year, according to research firm, Euromonitor. The company is aggressively fighting off the rising generic wave with market share figures reportedly falling from 52 per cent in 2005.
Last year, the British pharmaceutical firm staved off a potential recall of its famed Panadol brand, which was under scrutiny in other countries after one batch was withdrawn from the market.
The Pharmacy and Poisons Board have withdrawn two other products from the market in the last two years.
One, nimesulide, was a key component of children’s cold and flu medications and was withdrawn following an international ban of the product. The other was an infection depressant.
Globally, other big pharmaceutical firms have recalled back their painkillers after disastrous accidents. In the early 1980s, seven people in the Chicago area died after they took Extra-Strength Tylenol, an analgesic. Johnson & Johnson, its manufacturers, immediately pulled 31 million bottles of the painkiller, with an estimated retail value of more than US$100 million.
Source: http://www.bdafrica.com/index.php
July 5th, 2007
Gene therapy using nerve growth factors reversed erectile dysfunction in rats within four weeks, say University of Pittsburgh School of Medicine researchers.The Pittsburgh team found that the genes for the “glial cell line derived neurotrophic factor” (GDNF) and the GDNF family ligand, called neurturin, were both effective in treating erectile dysfunction in the rats. The genes were placed in a genetically engineered herpes simplex virus, which was then injected into the rats’ damaged cavernous nerve.
The finding suggests a potential new treatment for ED in men.
“Because the herpes virus persists in the nerve cell for as long as it is alive and nerve cells typically do not reproduce, this represents the first-ever demonstration of a long-term treatment for ED that does not rely on the chronic administration of drugs that can have potentially harmful side effects,” study co-leader Joseph C. Glorioso, chairman of the department of biochemistry and molecular genetics, said in a prepared statement.
The study was to be presented over the weekend at the annual meeting of the American Society of Gene Therapy, in Seattle.
July 4th, 2007
I don’t know about you, but I hope all the Armani-clad zillion-dollar-a-year health-care CEOs are squirming in their $1,000 leather office chairs while Michael Moore’s “Sicko” hits theater screens this week. I haven’t seen Moore’s film about our much-flawed health-care system yet, but I, for one, believe it’s way overdue.
Like any industry, the health-care business is all about the Benjamins. In a moment, I will offer my simple prescription for taking America’s sicko health-care system off life support.
If I sound a little peeved at our lack of affordable, available health care, I am. In the spirit of full disclosure, I’ll share a couple personal examples of why I believe Moore needed to make this film.
Just recently, my monthly co-pay for the cholesterol-fighting drug Lipitor increased by 150 percent. I don’t care whose fault that is. One hundred fifty percent increases are criminal. Within seconds, I was on the phone to my primary care physician. He prescribed Simvastatin, the generic replacement i.e. Generic Viagra for the Pfizer pill. My co-pay returned to $10. I guess I shouldn’t be surprised at the meteoric rise in prescription costs. Moore’s film claims there are four health-care industry lobbyists for every member of Congress. Somebody has to feed their babies.
This next example is even better. Early last year, I had to pay $5,000 cash up front for a surgical procedure, since the surgeon I elected to use was out of my health-care network. In fact, he doesn’t even accept managed care plans. But, since he’s the top guy in his field, I felt the investment was worth it, knowing I was entitled to a partial reimbursement from my health-care provider afterward.
Weeks after the operation, I submitted a request for reimbursement, using the specified forms provided. I waited. And waited. And waited. Nothing.
Just so happens, I have a friend whose job is dealing with insurance payments for her doctor’s office. She offered to look into why I wasn’t receiving some money back. She knew how to navigate the system, which buttons to push. She knew who to ask for. Nearly a year after filing my original claim, a check for $1,400 showed up in my mailbox. Without my friend, I’d be just another American getting ripped off because of an insurance system that is convoluted and, in my opinion, deliberately burdensome.
Memo to those looking for a new career: Become a billing advocate for those of us hopelessly confused by today’s insurance procedures. You’ll make a fortune.
In all fairness to the “system,” we consumers need to take accountability by staying healthy. The fix? Eat well. Exercise. Doctors, how about taking down those clocks and posters in your office sponsored by the drug companies? They’re insulting to hard-working Americans. Can you replace your Viagra wall clock with one sponsored by the broccoli growers industry instead? Throw out your Ambien pens, and use pens from the American Heart Association.
source: http://www.nashuatelegraph.com
July 4th, 2007
The first generic versions of prescription Lamisil (terbinafine hydrochloride) tablets, used to treat nail fungus infection (onychomycosis). Such infections occur when fungi invade a fingernail or toenail or the skin underneath the nail.
Manufacturers include: Amneal Pharmaceuticals, Apotex Corp., Aurobindo Pharma USA Inc., Dr. Reddy’s Laboratories Ltd., Gedeon Richter USA Inc., Genpharm Inc., Glenmark Pharmaceuticals Inc., InvaGen Pharmaceuticals Inc., Mylan Pharmaceuticals Inc., Orgenus Pharma Inc., Roxane Laboratories Inc., TEVA Pharmaceuticals USA, Watson Laboratories Inc., Wockhardt USA Inc.
The remaining patent or exclusivity for Lamisil expired on June 30, 2007.
According to the online trade magazine, Drug Topics, Lamisil tablets are the 57th highest selling brand-name prescription drug by retail dollars in the United States.
In addition to terbinafine tablets, there is a generic version of over-the-counter Lamisil cream (terbinafine hydrochloride,1 percent) to treat athlete’s foot, a skin disease caused by a fungus that usually occurs between the toes. The cream is manufactured by Taro Pharmaceuticals U.S.A. Inc.
July 3rd, 2007
An old ulcer operation is getting new attention as a possible alternative obesity surgery: a quick snip of a nerve that helps control hunger.
It’s far from clear if cutting the vagus nerve really helps _ initial pilot studies in a few dozen patients have just begun. Skeptics abound, and even proponents say it wouldn’t lead to nearly as much weight loss as more traumatic operations that shrink the stomach and reroute intestines.
It’s part of a hunt for middle-ground options for people scared of today’s surgery, or those not quite fat enough to qualify for it.
“By no means do I think this is a panacea,” cautions Dr. Robert Lustig of the University of California, San Francisco, who is studying the method along with University of Rochester surgeons.
“But I think this will be a rational alternative for a cadre of patients that are sort of in the middle there. With as much obesity as we have in this country, that’s a big middle.”
More than 177,000 people underwent obesity surgery last year, according to the American Society for Metabolic and Bariatric Surgery. The most popular method is gastric bypass, stapling the stomach to create a tiny pouch. Options include placing an adjustable band around the stomach, or cutting off the stomach’s side and rerouting the intestines.
Surgery can produce life-altering weight loss, if recipients adhere to diet and exercise advice, but each method comes with varying degrees of pain and risk, including a rare chance of death. So doctors are searching for alternatives.
Enter the vagus nerve, which snakes from the brain to the abdomen, with fibers reaching into multiple organs with different effects. Among them: The nerve spurs gastric acid production, and in the 1970s, surgery to cut where it attaches to the front and back of the stomach brought ulcer sufferers great relief _ after they recovered from open-abdominal surgery. Once better acid-reducing medications came along, this arduous operation was abandoned.
Yet surgeons at the time noticed, and subsequent animal studies confirmed, that these vagotomies could trigger weight loss. In addition to a less acidic stomach’s slower digestion, the vagus helps control appetite-stimulating brain hormones and signals our bodies to store more fat, Lustig explains.
Since doctors today can snip the nerve far less invasively, through just five pencil-sized cuts in the abdomen, it was time to test in the obese.
Thirty patients had a vagus snip at UCSF or the University of Rochester. The study isn’t complete. But of the 11 who are a year past surgery, all but one are shedding pounds, losing an average of 18 percent of excess weight so far, Lustig and Rochester’s Dr. Thad Boss reported at last month’s bariatric society meeting.
They suffered no serious side effects, and went home hours later with little pain.
“Every patient who had the vagus nerve cut says they’re not hungry,” adds Lustig _ although the one who didn’t respond got hungry again six weeks after surgery, perhaps because the nerve healed.
That’s less than half the weight loss of standard surgeries, warns Dr. Neil Hutcher of Bon Secour St. Mary’s Hospital in Richmond, Va., and a past president of the bariatric society.
“I have my doubts that vagotomy alone is going to be a significant weapon,” says Hutcher, who often cuts the nerve during standard gastric bypasses for a different reason _ to help those patients avoid the side effect of heartburn-causing acid buildup.
But, when Greensboro, N.C., surgeons added a vagotomy to 25 patients getting bands on their stomachs, the nerve-snip seemed to make that usually more modest operation about as effective as a gastric bypass _ with 43 percent loss of excess weight at six months, and counting.
For a more rigorous study, Rochester’s Boss is about to recruit 60 more patients headed for band surgery, giving half a vagotomy as well.
The pilot studies were funded by a startup medical device company called EndoVx Inc. that hopes one day to further simplify vagotomies, cutting the nerve by beaming high-intensity ultrasound waves down the throat.
Other doctors are testing if implants that treat epilepsy by stimulating the vagus nerve also might trigger weight loss, with mixed results so far.
For now, Boss stresses that vagus nerve-snipping remains highly experimental. He and Lustig will track their 30 patients for 18 months to check if ultimate weight loss is enough to warrant further study, and who responds best.
The goal is to help people like Garth Michaels of Walnut Creek, Calif., who twice backed out of standard obesity surgery, fearful of side effects and a long recovery. Thirteen months after he volunteered for the vagotomy experiment, he has dropped 66 pounds, to 246.
That’s a much more gradual loss than with regular surgery, but Michaels says having his hunger curbed help him finally learn to exercise. He spends a half-hour on an exercise bike most days. And he learned to avoid former diet saboteurs _ french fries, sweets _ that caused foul burping after his vagotomy, in favor of fruits and vegetables.
“I will lose more, there’s no doubt about it,” says Michaels, 56, whose goal is 175 pounds. “It has given me such hope.”
July 2nd, 2007
Can an antipsychotic drug from the 1950s be paired with a 1980s antibiotic to shrink 21st-century tumors? Might an anticlotting drug help a steroid relieve arthritis? How about a cholesterol treatment and a pain reliever teaming up to tame diabetes?
Alexis Borisy, the pharmaceutical industry’s master matchmaker, is betting they can. And if he is right, he may have found a cheap and quick way to develop a new cornucopia of medicines.
Borisy is the 35-year-old co-founder and chief executive of CombinatoRx, a biotechnology company dedicated to the proposition that two old generic drugs can together make a powerful new medicine, often for an entirely different disease.
It is too early to tell if Borisy will succeed and, indeed, one of his company’s drugs failed in a clinical trial last week.
But with drug makers big and small struggling to fill their product pipelines, other biotechnology companies are also betting that pairing old drugs can be a better business than inventing new ones from scratch - which can take years and cost hundreds of millions of dollars, with no guarantee of success.
For example, Pozen, based in Chapel Hill, North Carolina, is developing combination drugs in partnerships with the pharmaceutical giants GlaxoSmithKline and AstraZeneca.
Orexigen Therapeutics of San Diego, recently went public based on the prospects for two combination drugs it is developing to treat obesity. And privately held Celator Pharmaceuticals of Princeton, New Jersey, has raised more than $40 million from venture capitalists to combine old cancer drugs in a new way.
“We think if we prove this concept clinically we have an almost unlimited pipeline,” said Andrew Janoff, the chief executive of Celator.
Helping propel the trend is the growing supply of drugs that have lost patent protection, providing a lode of material to test for newfound potential.
Information technology also plays a key role for CombinatoRx (which is pronounced com-bin-a-TOR-ics, as in the mathematics field that deals with combinations). The company relies on the latest robotic drug-screening technology and software to test several thousand pairs of medicines a day.
At its laboratory here, researchers and robots systematically pair about 2,000 generic drugs with one another, with two million different combinations possible.
Each is tested on human cells. If a drug pair inhibits the cells’ production of inflammatory proteins, for example, that might be reason to explore whether the combination might work against arthritis.
Borisy describes it as a “dumb, brute-force, empirical approach” that assumes current knowledge of disease is too limited to predict in advance what combinations might work. The company does, though, give priority to testing pairs it believes have the best chance of working.
Eight of the company’s randomly arranged marriages, including drugs for cancer, arthritis and diabetes, have moved into clinical trials - an unusually high number for a company that is only seven years old.
Besides being quicker or cheaper to develop than single new drugs, combinations might also be more effective. Doctors routinely use two or more drugs to treat people with cancer, heart disease, HIV infection and other diseases.
But only more recently have pharmaceutical companies decided to do the combination themselves as a way to increase their profit.
Successful combination drugs already on the market include Advair from GlaxoSmithKline, which pairs two asthma drugs, and Vytorin, which combines cholesterol-lowering drugs from Merck and Schering-Plough that work in different ways.
July 2nd, 2007
All veterinary products like generic drugs must be registered with the Health Ministry by the end of the month. Health Minister Datuk Seri Dr Chua Soi Lek said on Saturday it was to ensure that these products were safe for the use by farmers and those in the rearing industry. He said Beta Agonis, for example - which was banned in animal feeds - was still being used by pig farmers in the country. He said the drug was also found to have side effects on human being. “It is time that we make it compulsory for manufacturers and importers to register their products to help us to monitor and control the use of the drugs,” he said. Dr Chua said currently veterinary products need not be registered with the ministry. Dr Chua said the regulation applied to products manufactured locally and imported ones.
He said through the process, they could ensure that the veterinary products were of quality, effective and safe for use by farmers.
Dr Chua said manufacturers and importers of such products could register on-line with the Drugs Control Division of the ministry.
Source:- http://thestar.com.my/news/story.asp
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