After undergoing procedures to open blocked arteries many people commit to healthy lifestyles: exercise, a balanced diet and -- many times - vitamin supplements. But not all vitamins are heart healthy and results of a new study suggest that one combination -- folate plus vitamins B6 and B1 -- might do more harm than good. This new study actually flies in the face of previous research, which suggested that folate supplements might actually benefit some heart patients after surgery.
This study of over 600 patients who had blocked arteries propped open with tiny, flexible mesh tubes, a procedure called stenting, found that those who took a high dose folate supplements for six months after the procedure were more likely to have stent failure than those who took a placebo. Making the matter worse, the patients that took the vitamin supplements actually had an increase in complications. Helmut Lange, MD, of Kardiologische Praxis, in Bremen, Germany said that patients who took the vitamin supplement mix had clear evidence of new narrowing in the stented arteries: the arterial opening had shrunk compared to stented patients who didn't take the folate. Outright stent failure, which is called restenosis, occurred in 35% of the patients put on the vitamin supplements, while the stent failure rate in patients who didn't take the supplements was 27. Super dosing of Folate may provide a clue to explain the unexpected results. Folate, promotes cell growth. So high doses might trigger an overgrowth of cells that line arteries. As the cells grew and formed new tissue the newly thickened arterial lining could then press against the stent causing it to narrow.
US isssues Guidelines to Pharma Companies
US. officials issued final guidelines warning drug makers that some sales and marketing practices, including gifts or payments to doctors, may run afoul of anti-kickback laws. Federal law prohibits payments to generate business under government health care programs such as Medicare and Medicaid. The guidelines point to various practices that risk violating the law.
The voluntary guidance was "designed to help companies prevent health care fraud and abuse by promoting a high level of ethical and lawful corporate conduct," Janet Rehnquist, inspector general for the Department of Health and Human Services, said in a statement. Two "suspect" practices identified were payments from a company to physicians or pharmacists to switch patients to the manufacturer's drug, and payments to doctors to listen to a pitch from a drug company sales representative. The guidance also warns against excessive payments for physician consulting and research services, and offering inappropriate entertainment, recreation, travel, meals or gifts to prescribers. Wining and dining doctors and offering other perks has been commonplace in the competitive drug industry, prompting criticism that doctors were prescribing medicines based on rewards rather than scientific merit. The guidelines, which finalize a proposal made in October, also stress that sales and price data provided to the government must be complete and accurate.
Drug for Sars by antisense therapy
Early trials at the US National Institutes of Health suggest that the antiviral therapy, developed by AVI BioPharma in Oregon, is highly effective at killing the coronavirus that is thought to cause Sars. If the full results, which are expected soon, confirm the findings, the drug could be given to patients within "months rather than years". The drug, which has been designed using the coronavirus's genetic sequence, is particularly promising because similar chemicals are already effective against viruses in the same family as Sars. More than 250 patients have also been treated with similar drugs in trials over the past three years, without side effects."
The drug uses a new technique known as antisense therapy, which is designed to attack RNA viruses such as hepatitis, West Nile virus, Norwalk virus and coronaviruses, the group to which Sars is thought to belong. These viruses consist of single strands of RNA, the messenger chemical normally used by genes to produce proteins. Antisense drugs are small segments of RNA designed in mirror image of the RNA virus they seek to attack. They bind to crucial sections of the virus, preventing it from replicating in human cells. Genetic tests have already shown that the Sars drug will not interfere with any critical RNA processes in human cells, but that it targets crucial sections of the coronavirus.
New network (GIN) for Guideline Development
WHO/EDM and WHO/EURO have become founding members of the new Guidelines International Network (GIN). This is a major new international collaboration involving organisations from around the world. GIN seeks to improve the quality of health care by promoting systematic development of clinical practice guidelines and their application into practice. GIN's aims include facilitatation of information sharing, education and knowledge transfer, and collaborative working, improve and harmonise methodologies for systematic guideline development in existing and new guideline programmes. It also helps in building links between organisations to improve coordination with other health care quality initiatives. The website is just open at (www.guidelines-international.net) but it is still under construction and only contains very basic information at present
Fast Track Approval to New Controversial Cancer drug
The approval of Gefitinib (Iressa) in the US, just days after the approval in Australia, may help AstraZeneca to recover from a drop in sales of Prilosec following the launch of a generic competitor. However, there remains controversy surrounding Iressa's side effects. AstraZeneca's Iressa received FDA accelerated approval for the treatment of advanced non-small-cell lung cancer (NSCLC). The product is the only FDA-approved option for third line patients and is a last chance therapy for the terminally ill. Iressa is a once-a-day pill which belongs to a new family of drugs known as epidermal growth factor receptor (EGFR) inhibitors, which target cancer cells to block signals that stimulate growth.
Lung cancer is the biggest cancer killer in the world and NSCLC is the most common form, accounting for 80% of cases. Iressa was approved in Japan in July 2002. In May 2003, Japanese authorities confirmed the drug had been linked to a total of 246 deaths since its launch. These related to Iressa's most serious side effect, interstitial lung disease (ILD), a serious pneumonia-like illness. Iressa's label includes a warning that the overall incidence of ILD is about 1%.
A consumer group, Public Citizen, approached the FDA to request that the drug not be approved but the FDA believes that the benefits outweigh the risks. Iressa is expected to become available in the US during May 2003 and cost in the region of $1,900 per month. The drug will benefit from being first to market, but it will face competition from other EGFR-targeted products, such as ImClone Systems' Erbitux and OSI Pharmaceuticals' Tarceva.
Competitive Technical Intelligence (CTI) in Pharma R&D
In today's highly competitive life science environment, effective CTI can and must be a strong, strategic tool in helping companies exploit new opportunities and gain first-mover advantage in addition to sensing and warding off threats before they become real problems. The most savvy R&D organisations are seeking to improve the contribution that CTI can make to reduced risk .Any successful R&D organisation must be competent in all three competitive intelligence domains, but while many companies have well-developed and sophisticated marketing and business intelligence capabilities the same cannot often be said of CTI.In many cases there is often confusion between CTI and business intelligence or marketing intelligence. As an integral part of any high-performance R&D process, everyone in the R&D organisation requires, and should expect, high-quality CTI information.
Project managers need to be able to direct the work of large, complex and expensive discovery and development teams in a manner that best counters or beats the competitor's work. Often the best intelligence comes from within, through sources such as scientific meetings, advisory boards, conferences and recruitment interviews. An effective CTI group is also essential to managing the inflow of primary intelligence information from their own colleagues - analysing and re-distributing it within the company. Although often taken from research, development or MBA stock, CTI professionals are developed purposefully. Primary sources often provide intelligence that is unavailable elsewhere and provide the first sign of competitive activity. Most R&D companies spend considerable sums of money sending their staff to conferences.
Advanced CTI groups will have their professionals working diligently behind the scenes of a large conference or scientific meeting to help make the most of the intelligence gathering opportunity. They will plan and co-ordinate intelligence needs before the event, orchestrate intelligence gathering during the event and deliver the analysis after the event .
Largest Drug recall in Australia
The Commonwealth medicines watchdog, the Therapeutic Goods Administration (TGA), has suspended the licence held by Pan Pharmaceuticals Limited of Sydney to manufacture medicines after TGA inspectors found a series of serious safety and quality breaches by the company. These included substitution of ingredients, manipulation of test results and substandard manufacturing processes. In addition the regulator has ordered an urgent recall of 219 products.
Pan Pharmaceuticals is Australia's largest contract manufacturer of complementary medicines such as herbal, vitamin, mineral and nutritional supplements. They also manufacture some over-the-counter (OTC) medicines including pain relievers (paracetamol & codeine) and cold and flu preparations (antihistamine & pseudoephedrine). The action by the TGA follows advice received from an expert advisory group convened to give an independent evaluation of the TGA findings
Brain Chemical May Thwart Ravages of Aging: Study
A shot of a brain chemical called GABA essentially turned back the clocks in the brains of older monkeys, whose brain function briefly operated at levels normally seen in monkeys less than half their age. The finding may one day help scientists reverse similar age-related deterioration in the brains of people, according to the report published in the journal Science. GABA, or gamma-aminobutyric acid, is a messenger chemical that is essential for optimizing how brain cells transmit messages to each other and acts to put a damper on unwanted brain signaling activity.
Although GABA's age-related decline has not been documented in humans, a host of studies in mammals, including other primates, suggests that a similar process is at work in people, In the current study, Leventhal's team evaluated how a brain region called the visual cortex in old and young monkeys responds to micro-shots of GABA. Monkeys between the ages of 26 and 32 -- considered very old for monkeys -- that got GABA directly delivered to their neurons responded to visual patterns, such as flashing vertical and horizontal lines, in much the same way as monkeys aged 7 to 9 years old did ."The challenge now is to go and look at a variety of GABA-increasing drugs and see how they influence other areas of the brain" and whether or not they improve brain functions known to decline as people age, such as hearing and memory, said Leventhal.
Stem cells can become normal sperm
Researchers are very close to creating sperm outside of the body for the first time, New Scientist has learned. The feat has already been achieved with eggs. It was accomplished with cells originally derived from mouse embryos, but most experts see no reason why the technique would not work with human embryonic stem cells too. These cells do not develop far in culture, but when Noce's team transplanted them into testicular tissue he found after three months that they had undergone meiosis and formed what appeared to be normal sperm.
The critical next step would be to fertilise the artificial eggs with normal sperm, or use the artificial sperm to fertilise normal eggs. If the animals are normal, the race will be on to create artificial human egg and sperm cells this way. It is likely to be much harder with human cells. Attempts to obtain human eggs simply by growing slices of ovarian tissue have failed, and the only mouse created from an egg obtained this way was sickly and died young. It will also be slow: it takes up to six months for a human egg to mature.
Electonic nose sniffs out lung cancer
An electronic nose can identify people with lung tumours simply by sniffing their breath. While some cancer experts are sceptical, the creators of the e-nose at the University of Rome hope it could lead to the development of a simple breath test for the early detection of the disease. A variety of conditions can lead to specific compounds turning up in the breath. For example, aliphatic acids show up in the breath of people with liver cirrhosis, while di- and trimethylamine are found in the breath of those with failing kidneys. Lung-cancer patients exhale a cocktail of alkanes and benzene derivatives, though no one is yet sure why.
Gas chromatography and mass spectrometry are normally used to analyse gas mixtures, but these techniques are too expensive and elaborate to provide a practical diagnostic test. Electronic noses are already used for quality control in the food industry. Now the researchers in Italy hope their e-nose could provide a diagnosis. Like an animal or human nose, the electronic version uses an array of sensors that are not designed to detect any one chemical. Instead they respond to the overall profile of compounds in a sample. The sensors are quartz crystal, each coated with a slightly different metalloporphyrin that binds to a different range of volatile organic chemicals.In the study sixty people at the Forlanini Hospital took part, 35 waiting for an operation to remove a large lung tumour and the rest controls. Each test took just over a minute and the nose successfully pinpointed every cancer patient.
Compiled from WWW by Dr. Venkat Appaji Padmanabhuni
E Mail : appajipv@hotmail.com