Scientists have recorded the action involved in assembling telomerase, an enzyme used by cells to protect their genes during the potentially dangerous process of DNA replication. Using a sophisticated technique for tracking structural changes in individual molecules in real time, they have revealed how three of the protein and RNA components of the enzyme come together, altering their shapes along the way to ensure that the next piece will fit.

Research published in the February 25, 2007, issue of Nature.

Xiaowei Zhuang, Ph.D., HHMI investigator
Harvard University

For the full story, go to: http://www.hhmi.org//news/zhuang20070225.html

Regenerative Medicine: Pathways to Cure – Version 2.0

Garlic stinks for lowering cholesterol, a recent Stanford University study shows.

The study’s conclusions may disappoint the many Americans who take garlic and garlic supplements in hopes of controlling high cholesterol levels linked to heart disease.

They’re wasting their money, said Christopher Gardner, a nutrition scientist at the Stanford Prevention Research Center and a senior author of the study.

“It works in a test tube, on cells. In rats, it works,” Gardner said. “In humans, nothing. We are very disappointed with the results, but it was an excellently done study.”

A number of previous studies in people have shown that an active ingredient in garlic, allicin, can reduce cholesterol levels, but many were sponsored by supplement makers. Others were conducted using poor methodology, making their conclusions suspect, Gardner said.

A federal government-commissioned review of 1,800 studies on the health benefits of garlic found that while studies lasting less three months showed an improvement in cholesterol levels, longer studies did not. Still, garlic supplements remain popular, with U.S. sales now topping $150 million a year.

The Stanford researchers say their study is the first independently conducted, long-term study to examine whether both raw garlic and garlic supplements can reduce cholesterol in people with moderately high cholesterol. The $1.5 million study, sponsored by the National Institutes of Health, was published in Monday’s issue of the Archives of Internal Medicine.

An editorial accompanying the study noted that “the jury is still out” on whether garlic can improve overall heart health, even if it doesn’t lower cholesterol.

Too much LDL cholesterol, the “bad” cholesterol, can increase the risk of heart disease, and patients are encouraged to lower it through diet, exercise and medication. The 192 participants in the study had cholesterol levels high enough to merit trying diet or exercise to lower them, but not to require cholesterol-lowering prescription medication.

The researchers gave the subjects either raw garlic, Garlicin-powdered garlic, Kyolic-aged garlic or a placebo six days a week for six months. Raw garlic was added to condiments for the more than 30,000 sandwiches made for the study. The participants ate the equivalent of a clove of garlic each day, a bit more than a standard garlic supplement pill.

Alan Kornfield was surprised to find out he had been given placebos during the study, and dismayed by the study’s overall results.

“I’m really, really disappointed, because we love garlic,” said the 47-year-old San Mateo man who, with his wife, often adds garlic to whatever they’re eating and is now using the drug Lipitor to control his cholesterol. “I was hoping to do anything to avoid prescription drugs.”

Researchers monitored everyone in the study to make sure they didn’t gain or lose weight, which can affect cholesterol levels, and Gardner said the subjects didn’t significantly change their exercise or diet habits. In monthly checks, researchers found that the participants’ levels of LDL cholesterol remained nearly constant throughout the study.

An Archives of Internal Medicine editorial accompanying the study said that while the results “convincingly” demonstrated that garlic does not significantly lower LDL cholesterol, they do not prove that garlic is useless in preventing heart disease.

That point was echoed by Daniel Fabricant, vice president of scientific affairs for the Natural Products Association, a trade group. Fabricant acknowledged that the study appeared to be well-designed, but was troubled that it was presented as the last word on the issue.

“We know there’s some biological effect,” he said.

Garlic’s potential for improving heart health was first recorded about 3,500 years ago in Egypt, and Western researchers have been studying its medicinal qualities for two centuries.

Garlic may have other disease-fighting properties that should be studied further ? it seems to lower blood pressure, for example ? but reducing cholesterol isn’t one of them, Gardner said.

Still, there were some study participants who simply didn’t believe the results, he said.

“They were such zealots,” Gardner said. “They were going to keep taking it.”

Plant Steroid – Stigmasterol

Stigmasterol is an unsaturated plant sterol occurring in the plant fats or oils of soybean, calabar bean, wild yam, rapeseed, and in a number of medicinal herbs, including the Chinese herbs, Mai men dong and American Ginseng. Stigmasterol is chemically similar to animal 1) ___. Stigmasterol is used as a 2) ___ in the manufacture of synthetic progesterone, a valuable human hormone that plays an important physiological role in the regulatory and tissue rebuilding mechanisms related to estrogen effects. Stigmasterol also acts as an intermediate in the biosynthesis of androgens, estrogens, and corticoids. Research has indicated that 3) ___ may be useful in prevention of certain cancers, including ovarian, prostate, breast and colon cancers. Studies have also indicated that a diet high in phytoesterols may inhibit the absorption of cholesterol and lower serum cholesterol levels by competing for 4) ___ absorption. Plant sterols and stanols represent a group of 5) ___ that are an essential constituent of cell membranes in animals and plants. Cholesterol is actually a sterol of human cells, whereas phytosterols are produced by plants. The most common plant sterols are sitosterol, campesterol, and stigmasterol. Plant sterols, although structurally similar to cholesterol, are not 6) ___ by the human body and are very poorly absorbed. The specific plant sterols that are currently incorporated into foods, supplements and drugs are extracted from soybean oil and wild yams. Dr. Percy Julian did major research in plant steroids.

Target Health has worked on and is working on several combination drug-device (PMA Approved), drug/drug (NDA Approved) products.

Combination products (i.e., drug-device, drug-biologic, and device-biologic products) are increasingly incorporating cutting edge, novel technologies that hold great promise for advancing patient care. For example, innovative drug delivery devices have the potential to make treatments safer or more effective, or more convenient or acceptable to patients. Drug-eluting cardiovascular stents have the potential to reduce the need for surgery by preventing the restenosis that sometimes occurs following stent implantation. Drugs and biologics can be used in combination to potentially enhance the safety and/or effectiveness of either product used alone. Biologics are being incorporated into novel orthopedic implants to help facilitate the regeneration of bone required to permanently stabilize the implants. Since combination products involve components that would normally be regulated under different types of regulatory authorities, and frequently by different FDA Centers, they also raise challenging regulatory, policy, and review management issues. A number of criticisms have been raised regarding FDA’s regulation of combination products. These include concerns about the consistency, predictability, and transparency of the assignment process; issues related to the management of the review process when two (or more) FDA Centers have review responsibilities for a combination product; lack of clarity about the postmarket regulatory controls applicable to combination products; and lack of clarity regarding certain Agency policies, such as when applications to more than one Agency Center are needed. To address these concerns, FDA’s Office of Combination Products (OCP) was established on Dec. 24, 2002, as required by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). The law gives the Office broad responsibilities covering the regulatory life cycle of drug-device, drug-biologic, and device-biologic combination products. However, the primary regulatory responsibilities for, and oversight of, specific combination products will remain in one of three product centers — the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, or the Center for Devices and Radiological Health — to which they are assigned.

For more information about our expertise in Regulatory Affairs, please contact Dr. Jules T. Mitchel or Dr. Glen Park.

For more information about our expertise in Regulatory Affairs, please contact Dr. Jules T. Mitchel or Dr. Glen Park.

Botulism, a potentially fatal form of food poisoning, usually causes illness within 18-36 hours of exposure. Initial indication of illness in infants is decreased frequency or absence of stools. Other signs and symptoms noted are poor feeding, weak suck, lethargy, listlessness, weak cry, decreased body tone, and diminished overall movement. Difficulty with swallowing may be evident as secretions drooling from the mouth. This may be followed by decreased respiratory effort which may lead to respiratory arrest from airway occlusion from unswallowed secretions. The FDA is warning consumers not to use certain jars of Earth’s Best Organic 2 Apple Peach Barley Wholesome Breakfast baby food because of the risk of contamination with Clostridium botulinum, a bacterium which can cause botulism, a life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled. The affected product was sold in single individual jars and in variety packs (which contains 4 jars of the apple peach barley in the pack along with other varieties). The food is part of the firm’s “2nd Vegetables, Fruits and Blends” line intended for babies 6 months and older. The food was distributed through retail stores and sold through the Earth’s Best website. If consumers have any of the specified jars in their home, they should not use it and destroy it immediately. No illnesses have been reported to FDA or the manufacturer to date in connection with this problem. The affected baby food is as follows:

Baby Food UPC Code Lid Expiration Date
Earth’s Best Organic 2 Apple Peach Barley Wholesome Breakfast (4.5 ounce jars) 23923-20223 PFGJ14NP EXP 14 SEP 08 A
Earth’s Best Organic 2 Wholesome Breakfast Variety Pack (12 pack) 23923-20295 13 SEP 08
Earth’s Best Organic 2 Apple Peach Barley (4.5 ounce jars within 12 pack) 23923-20223 PF6J14 NP EXP 14 SEP 08 A

On display at the tech show at the Javits Center is the only computerized prosthetic leg called C-leg by a Canadian company, Otto Bock. There is a documentary about this leg, and it is truly awesome. The software is spectacular. It senses everything, as though the person’s brain is sending the usual messages to muscles in the leg, except it’s the computer sensing everything and sending the messages to the artificial leg.

new_c-leg.jpg

This week’s fun quiz. If you receive our weekly newsletter, then you already have the answer. To receive our newsletter via email, please email to julesmitchel at targethealth.com with “On Target” in the subject line.

Goat’s milk combined with synthesized 1) ___ proteins, has yielded an incredibly light fabric, called biosteel, that is both biodegradable and strong enough to stop 2) ___. The biodegradable fabric would need to be sealed from the environment if used in critical applications such as body armor or spacecraft, because 3) ___ could get in and digest it. Biosteel is created by transferring the spider gene for the protein, into goat mammary cells and collecting soluble protein from the milk. Genetically engineered goats are now producing the protein. The protein can be turned into a supermaterial, because of its natural role in the silk of a spider’s web. As the spider secretes the protein solution, the silk dries and pulls taut, transforming the proteins into a nearly crystalline and completely insoluble cable. Tests on natural silk show that it can be stronger and more elastic than high-tensile steel or the Kevlar® found in body 4) ___. Spider silk is five times stronger, by weight, than 5) ___ and more resilient than any polymer fiber. The technique used to make biosteel mimics the spider’s own method of production by using goat 6) ___ cells. It turns out that the way mammals produce milk proteins and spiders make silk proteins are broadly 7) ___. Both are produced in skin-like epithelial cells, then held in a space, or lumen, where shear stresses on the protein are minimized. This process termed “transgenics” is a proven and patented technology. This technology focuses on two segments of the 8 ) ___ device market: wound closure systems, including vascular wound repair devices, hemostatic dressings, patches and glues, and sutures; and other medical device products, such as ligament prosthetic devices. BioSteel® has the potential to become the next generation performance filament because it is tougher and lighter than the incumbent fiber, Kevlar®.

Opening in Business Development

With the release of Target Document® this week, the release of Target e*CRF® in March, and the release of Target Encoder in April, Target Health is looking for an energetic BD person with EDC experience in the pharmaceutical, CRO and Biotech sphere. Background in computer sciences a plus. Existing network of customers is a must. East coast based is desirable. This is an opportunity for the right person to grow a BD department and be part of an exciting growth company.

clip_image001.jpgPhlebotomy is the act of puncturing a vein to collect blood either for testing or transfusion. It is a skill employed by physicians and many professionals in allied health fields, including nurses, medical assistants, and clinical laboratory scientists. Health care is a rapidly expanding industry, and a new professional, the certified phlebotomist, helps to reduce the workload of doctors and nurses by focusing exclusively on blood collection, particularly in hospitals and blood drives.

Favorite product at the tech show [Javits Center] is “The Vein Viewer”, a new biotech firm by Phillips, Luminetx…! It’s awesome to watch your blood stream through your vein.

This technology is being used in health care as a small patch of material, laid over your arm, through which a nurse can find the right vein, from which blood can be taken, for various annual blood tests.

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