The US Food and Drug Administration announced its approval of a new sweetener, neotame, for use as a general-purpose sweetener in a wide variety of food products, other than meat and poultry. Neotame is a non-nutritive, high intensity sweetener. Depending on its food application, neotame is approximately 7,000 to 13,000 times sweeter than sugar. It is a free-flowing, water soluble, white crystalline powder that is heat stable and can be used as a tabletop sweetener as well as in cooking applications. Examples of uses for which neotame has been approved include baked goods, non-alcoholic beverages (including soft drinks), chewing gum, confections and frostings, frozen desserts, gelatins and puddings, jams and jellies, processed fruits and fruit juices, toppings and syrups.
In determining the safety of neotame, FDA reviewed data from more than 113 animal and human studies. The safety studies were designed to identify possible toxic effects, such as cancer-causing, reproductive, and neurological effects. From its evaluation of the neotame database, the FDA was able to conclude that neotame is safe for human consumption. New food additives, including new sweeteners, must be approved by FDA as safe before they may be marketed in the United States.
Drug marketing ethics in US bursts into political arena
The issue of aggressive drug marketing has burst from the internal debates of medical societies into the political arena. The US, Democratic gubernatorial hopeful, Steve Grossman is pushing a plan to publicly name doctors who accept gifts worth $25 or more from drug companies. Under the plan, the companies would have to list, doctor by doctor, who got the latest medical device, who flew free to a conference in Bermuda. ''''The public has a right to know who''s spending the money and who''s receiving it,'''' Grossman said in an interview. ''''It is affecting decisions that are costing people a lot of money and possibly affecting care. In 2000, 83,000 industry representatives plied doctors with $7.2 billion '''' (Rs 33,000 crore).'''' worth of free drug samples But in the last few years, a growing number of doctors have begun to argue that drug marketing skews prescribing decisions and boosts drug costs, which are rising 17 percent a year. Cambridge Hospital has banned drug representatives from bringing food and other largesse to its resident doctors who write the majority of inpatient prescriptions.
Under the Vermont law recently signed by Governor Howard Dean - himself a doctor - companies could be fined $10,000 for each gift over $25 they fail to report. Legislators in Massachusetts, Maine, New York, and Wisconsin have introduced similar bills. And Grossman latched onto the issue as part of his plan to make lowering prescription drug costs his top priority if elected. The pressure has drug companies on the defensive. Starting next week, new industry guidelines will forbid the most blatantly non educational gifts, like golf balls with company logos, fancy meals, trips to Broadway shows and baseball games, and token ''''consulting'''' trips to Caribbean resorts. US State Senator Richard Moore, an Democrat, last year introduced a bill that would require doctors, rather than companies, to report gifts worth at least $50 when they apply to renew their licenses every two years. The bill is opposed by the Massachusetts Medical Society as too cumbersome - though the group said it supported the goal of curbing companies'' influence. According to IMS Health, an industry tracking group, drug firms in US spent $15.7 billion (Rs 73,800 crore) on promotion in 2000.
Drugs restoring eyesight in offing
To doctors'' amazement, experimental new medicines are rescuing people from the brink of blindness so they can read and drive and sometimes even perfect vision. These lucky few are the first beneficiaries of an entirely new category of drugs that many hope will revolutionize the care of common eye diseases. Several competing medicines are in development, all based on similar principles. They are designed to stop the two top causes of adult blindness -- the "wet" form of macular degeneration, which affects the elderly, and diabetic retinopathy, the biggest source of blindness in working-age people. Vision loss seems halted for most if they take the drugs soon after their symptoms begin. Some experience stunning reversals of what would have been inevitable blindness. Russell, 76, of Worcester, lost vision in her right eye four years ago.
In May, her left eye went bad, too, and she was declared legally blind. But after four injections of one of the drugs her left eye is 20-25. She drives and reads and is thinking about returning to work as a nurse. Around the country (US), about 70 patients with wet macular degeneration have been treated with the same drug as Russell, Genentech''s rhuFab. Experts caution that most of the results from the studies on this and similar drugs will not be known for at least a year or two. And for now, the treatments are available only to study volunteers. None of the drugs are intended for the more common but less aggressive "dry" kind of macular degeneration, nor will they work after eyesight has been gone for months. An estimated 200,000 new cases of wet macular degeneration are diagnosed in the United States annually.
About 4 million U.S. diabetics have some degree of retinopathy, and 24,000 go blind each year. Both diseases result from misguided growth of blood vessels in the eyes. Since the new drugs attack this underlying problem, doctors hope they will work for both diseases. Other drugs in testing include: --Anecortave acetate from Alcon, --Eyetech Pharmaceuticals'' EYE001, which is injected into the eyeball like rhuFab for macular degeneration. --Bausch & Lomb''s Retisert implant, which exudes a steroid into the eye for up to three years and is being used for diabetic retinopathy and macular degeneration. --Lilly''s LY333531, the only pill among the new drugs; used to prevent worsening eye disease in diabetics.
US backs new trade rules on drugs
The United States said that it would back a revision of global trading rules that would allow poor countries to import patented drugs quickly and cheaply to deal with health crises like AIDS. "We''re putting forward a framework for solving this problem," one American trade official said, explaining the American position as the 144 members of the World Trade Organization began three days of meetings on the topic. The European Union also put forward a proposal as delegates took up the question of revising the 1994 accord on trade-related intellectual property covering patents and copyrights. The accord''s grace period for developing countries to be in compliance and begin enforcing foreign patents ends on Jan. 1, 2005, and many poor countries are grappling with how to meet their trade-treaty obligations and still get affordable medicines to combat epidemics. Few have a domestic industry that could make many modern drugs, even under license.
At Doha, the organization endorsed the right of countries that are facing public health emergencies to set aside drug patents and authorize manufacturers inside or outside their borders to make generic versions of the drugs they need. The talks are meant to set the specific rules for doing so. Major pharmaceutical companies fear that the process will open the door to an uncontrolled flow of unlicensed medicines that will undermine their markets. Activists (NGOs) complained that both the American and the European proposals will mandate border controls, unnecessarily burden poor countries and leave them open to legal challenges from drug companies. "The proposal is needlessly complicated and won''t be very workable," said Ellen ''t Hoen, of Doctors Without Borders. She and others accused the industrialized countries of reneging on their commitments at Doha.
New technologies to administer more medicines via skin
Human skin is like a tightly woven fabric, seemingly impervious but porous at the microscopic level. Through its millions of tiny openings, the body oozes sweat and absorbs some substances applied to the skin. For decades, this sponge-like quality has inspired the creation of cosmetic creams and pain-relieving sprays, and in recent years, the development of nicotine and hormone patches. But fewer than a dozen drugs can be delivered through the skin because it can effectively absorb only a handful of compounds under ordinary conditions. Now, researchers are developing techniques to move a wider range of drugs across the skin barrier. Some work by making the skin more permeable, either by widening its pores through ultrasound waves or by softly puncturing the skin with a grid of microscopic needles.
Other techniques use a mild electric current to propel the drug through the skin or tag drug molecules with compounds that help it slip in through pores. Drug delivery with these techniques offers several advantages over pills and injections. It can ensure the steady release of medication into the patient''s bloodstream over long periods, improving the efficacy of a dose. It can prevent the rapid breakdown that many drugs taken orally undergo when they pass through the digestive system. Transdermal drug delivery is also painless and convenient - a big advantage for patients who hate injections or forget to take their pills on time.
Unlike nicotine and oestradiol molecules, which can pass through the skin easily, the molecules of drugs like insulin are too large to pass. To deliver such compounds transdermally, Mitragotri and his colleagues are developing an ultrasound device that can enlarge pores by striking them with shock waves. A vibrating metal rod in the device sends sound energy rippling through a column of liquid to generate the shock waves. A patient could strap the battery-operated device around an arm and switch it on for a few seconds. The skin in the area becomes highly permeable for 12 hours or so. A patch placed on the arm in this period could deliver medication that the patient''s skin would ordinarily be unable to absorb. One system is being developed by Vyteris, a company in New Jersey. Designed to deliver lidocaine, an anesthetic, the system is a small wearable device containing a patch filled with the drug. The patch is connected to an electronic controller that can be programmed to deliver a desired level of current.
Vyteris says the system has gone through trials and could be on the market by the end of next year. A wearable device developed by Cygnus uses iontophoresis to monitor glucose level in diabetes patients. It actually performs the reverse of drug delivery, using a current to draw glucose through the skin. A sensor measures the glucose level, which shows up on an electronic display. GlucoWatch, as the device is called, can be worn around the wrist and provides a fresh reading every 20 minutes. Dr. Mark R. Prausnitz, a researcher at Georgia Tech, said the development of new drugs, especially proteins that cannot be administered orally, would help the transdermal market expand significantly. He said he hoped one product in that market would be what his group was developing at Georgia Tech: a microneedle patch for delivering vaccines, DNA drugs and other large, unwieldy molecules. Prausnitz and his colleagues have designed arrays of microneedles, a "microscopic bed of nails" that can painlessly pierce the skin. The needles serve as channels for a drug to diffuse into the patient''s bloodstream. "A complete microneedle device could be the size of a Band-Aid, cost well under a dollar, require no batteries and cause no pain," Prausnitz said.
How fish lowers heart disease risk
In a study of African tribes, a tribe eating a fish-rich diet had lower levels of the hormone leptin than a tribe eating a primarily vegetarian diet.. Leptin is secreted by fat tissue. In humans, leptin is a satiety factor, which in normal-weight people tells their bodies when they have consumed enough food. High leptin levels have been associated with obesity and increased risk for cardiovascular disease. As people gain weight, the body may stop listening to the leptin message, so more leptin is produced, explains senior author Virend K. Somers, , professor of medicine at the Mayo Clinic, Rochester, Minn. However, among the African populations in this study, higher body fat was not clearly associated with increased leptin levels. "Regardless of body fat or body mass index (BMI), leptin levels were substantially lower among the fish-eaters than among vegetarians," says Somers.
"We speculate that a fish diet may change the relationship between leptin and body fat and somehow help make the body more sensitive to the leptin message." The researchers compared leptin levels in two closely related African tribal populations living in Tanzania. The two groups are essentially the same tribe but they''re separated geographically. One group lives close to a lake and the other lives inland. The inland-dwelling tribe primarily eats a diet high in fruits and vegetables, while the tribe living by the lake eats freshwater fish as a main component of their diet. . Leptin, insulin and glucose levels were measured after an overnight fast. For those on the fish diet, men had average leptin levels of 2.5 nanograms per milliliter (ng/mL), and women had an average of 5.0 ng/mL. Among the tribe eating primarily vegetabls, men had average leptin levels of 11.2 ng/mL, and women had average levels of 11.8 ng/mL. Fish consumption is very low in most American''s diets, and it is unlikely that most Americans would make it a mainstay of their daily diet, Somers says. He would not recommend such a change based exclusively on these results.
HRT and heart attacks
The risks of taking hormone replacement therapy may outweigh the benefits for women with heart disease. study published in the Journal of the American Medical Association found that HRT offers no protection against second heart attacks, and can increase a woman''s risk of developing blood clots. The study is a follow-up to an earlier one that first challenged the long-held assumption that hormone replacement could prevent heart disease, The Associated Press reports.
In the study, researchers continued tracking 2,763 postmenopausal women with heart disease for an additional three years. During that time there was no difference in the rate of cardiac events for women who took hormones compared to women who took placebos. But women taking hormones had twice the risk of blood clots compared to women getting a placebo, particularly during the first few years of HRT. The women on HRT also had about a 50 percent greater risk of gallbladder disease. The researchers say the findings suggest women with heart disease should not take hormones after menopause. The AP quotes other experts who point out that it''s not yet known if HRT helps prevent heart trouble in women who don''t already have heart disease; a large study looking into that very matter is underway and expected to conclude in 2005
Biotech companies grow more business from skin
With biotech companies racing to find medicines to cure cancer, defeat obesity and treat arthritis, a few companies are finding a lucrative niche in the business of making skin. It comes from animal bones and tendons and even human cadavers, and it is used to treat severe burns and chronic wounds such as bedsores. When reconstructive and plastic surgery is thrown in, it adds up to a billion-dollar-a-year business. And the prospects for future growth from Integra LifeSciences and LifeCell are more than skin deep. The allure for large pharmaceutical companies is the prospect that technology may be used to mending heart muscles. Whatever the prospects, artificial skin already is helping severe-burn patients survive and recover from their injuries. Integra''s lead product, Dermal Regeneration Template, has been used on nearly 10,000 people. Most of the patients had third-degree burns. The artificial skin is formed from layers of silicon, cow collagen - a protein found in tissue and bone - and shark cartilage. It works like scaffolding, supporting the patient''s own skin cells and enabling them to regenerate dermal tissue.
While the silicon mimics the epidermis, the body''s protective top layer of skin, it''s the shark cartilage that plays a critical role. Integra started selling skin in 1996. After three years of trying to penetrate a broad, segregated market, the company partnered with Ethicon, part of Johnson & Johnson, in an effort to capture more business. The Food and Drug Administration said in April the skin could be used in reconstructive surgery - treating scars from old burns. LifeCell, a smaller company that sells artificial skin for burns, already is using its technology to heal injured tendons. Ultimately, we may be able to take recombinant human proteins and other elements that make up the human-tissue matrix, put them in a bioreactor and have it come out as human tissue."
New back pain device
People undergoing certain types of back surgery may benefit from a newly approved device. The Food and Drug Administration has approved Medtronic''s Infuse bone graft device for people who need
spinal fusion surgery to treat disk degeneration, The Associated Press reports. The device carries a genetically engineered protein that spurs bone growth. It is designed to help avoid the need to remove extra bone from the hips of people who have a disk fusion operation. In a study, 143 people who were given the
Infuse device fared as well as 136 people who had traditional spine fusion surgery for a degenerated disk, the AP says. Use of the device was no riskier than traditional surgery. But it could potentially cause excessive bone growth, and is not recommended for pregnant women, since the protein''s effects on a fetus are unknown. The manufacturer is also being required to do further studies to be sure the protein doesn''t cause cancer growth have long term effects on the immune system, the AP says.
Compiled from WWW by Dr. Venkat Appaji Padmanabhunie-mail : appajipv@hotmail.com