US President Bush nominated a physician and health care economist to head the Food and Drug Administration. Dr. Mark McClellan, a member of the president's Council of Economic Advisers. McClellan is best known for studies of the economic and policy factors that influence medical treatment conditions and helped draft Bush administration policy on prescription drug coverage for older people.The FDA job is very different, heading an agency that regulates the safety of drugs, medical devices, food and cosmetics, products that make up a quarter of the national economy. Indeed, the FDA isn't supposed to consider the costs of a treatment, just whether it works and is safe enough to be used. The agency has been leaderless since Bush took office, as the administration faced an impasse with Kennedy, who insisted the next commissioner have no close ties to any industry regulated by the FDA. McClellan appears to meet that test. (Ip-health )
Lack of appropriate meningitis vaccine catches world community
Médecins Sans Frontières (MSF) warns that thousands may die of willful neglect unless a vaccine is made available at an affordable price to the African countries most affected by meningitis.Meningitis is fatal in 50per cent of untreated cases, and even among patients who receive appropriate diagnosis and treatment, the disease kills 5-10per cent. 15-20per cent of the victims also suffer severe neurological damage such as deafness or mental retardation. Mass vaccinations are a ital part of a strategy to keep epidemics at bay.
MSF is calling for immediate action by WHO, governments and pharmaceutical companies to avert a potential disaster.A potentially fatal infection of the brain membrane, bacterial meningitis kills 25,000 people every year in the seasonal epidemics hitting countries in the so-called African meningitis belt stretching from Senegal to Ethiopia. For the first time in the recorded history of meningitis, a new strain, the W135, this year, infecting almost 13,000 people and killing 1,400. But the vaccines that are used in Africa do not cover the strain. A product that could be used exists in the Western markets, but there is no adequate supply, and it is priced beyond the means of African governments and people. .
What is needed now is an emergency action plan led by WHO and governments to oblige the industry to bring about a quick and affordable solution for African countries for the next epidemic season. (Ip-health)
Big drug makers' tactics
The hottest fight in USA now concerns the rules on the duration of drug patents. Under existing law, drug companies can extend patents for 30 months beyond their normal expiration dates by asserting that makers of cheap generic copies are violating some rule or other. The extension is automatic, however weak the assertion; what's more, the drug companies can make such assertions more than once for the same drug if it's protected by more than one patent.
The Senate has passed a bill to restrain this practice; it would allow only one automatic 30-month stay per drug and would require patent holders to convince a judge of the merits of their case in order to secure a second one.This is an eminently reasonable reform.
The Congressional Budget Office estimates that it would save consumers $60 billion over 10 years by making generics more widely available; it would do this without compromising drug companies' rights to defend their patents in court.
1.5 million patent applications filed in China
China agreed over one and a half million patent applications by the end of July this year. Over 80per cent of them originated inside the country. The number of professional and amateur inventors applying successfully for patents also increased. China has released eight laws designed to guarantee the legal protection of intellectual property.
These include Patent Law and Copyright Law. Protection has extended from information and technology fields to traditional knowledge and folk arts. China has also been adopting effective measures to protect the legal benefits of patentees, which greatly contributes to the improvement of market order.
US FDA reviews paracetamol and 450 deaths a year
In the United States paracetamol is associated with more than 1,00,000 calls a year to poison control centres, as well as 56,000 visits to emergency departments, 26,000 hospitalisations, and 450 deaths. The FDA appoints outside expert members to its advisory committees, and before meetings it provides them with background documents and lists of questions, in an effort to seek informed recommendations on important decisions about drug approval or regulation The FDA advisory committee simply recommended changes to labelling and better consumer education about paracetamol (marketed in the United States as Tylenol).
The FDA advisers did not seriously consider following the lead of the United Kingdom and some other countries, which have introduced measures to restrict the numbers of tablets per pack and replacing bottles full of loose pills with "blister packs." Such an option was not even suggested for consideration by FDA officers appearing before the advisory committee despite the fact that tentative evidence indicates that such reforms in the United Kingdom may have significantly reduced the number of drug related poisonings, liver transplantations, and deaths.
The reforms in the United Kingdom have also led to a substantial reduction in annual sales of tablets containing paracetamol and paracetamol compounds, from 123 billion to 84 billion. A confidential draft document reveals that the Office of Drug Safety also wanted the advisory panel to discuss whether the "maximum tablet strength should be decreased," whether "combination products be reformulated without acetaminophen," and whether there was "a need to standardize the various paediatric formulations. The advisory committee's chairman, Dr Lou Cantilena, said in an interview afterwards that the questions supplied by the FDA were too vague. The FDA refused a request by the BMJ for an interview. ( source -BMJ)
New impotence drug moves nearer to USFDA approval
The long- awaited competitor to Viagra - - christened Levitra- inches its way to final US FDA approval. Two early studies suggest it's longer lasting, has fewer side effects, and is safe for virtually everyone, including those with heart problems. Similar drugs approved in this class of medication carry warnings for men with heart disease. Levitra was developed by Bayer and GlaxoSmithKline and is scheduled for U.S. launch in 2003. Viagra, produced by Pfizer, revolutionized the treatment of male sexual dysfunction.
In a phase III clinical trial of 440 men with erectile dysfunction, after 12 weeks of Levitra, 71per cent of the men had improved erections. And a subset of men experiencing depression related to their impotence reported fewer symptoms of depression after taking Levitra. "Levitra contains a more efficient enzyme inhibitor, so only a very small amount of the drug is necessary. Several other companies are also working on drugs with PDE5 inhibitors."Levitra doesn't carry one disconcerting visual problem that many men report with Viagra: (source -Webmd )
Private library of unpublished FDA-related documents
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Drug stops herpes spread
A drug that treats genital herpes flare-ups may also prevent the spread of the disease. A study presented at the American Society for Microbiology meeting in San Diego finds that Valtrex, also known as valcyclovir, can reduce transmission of genital herpes by half.
The study involved 1,484 monogamous couples in which one partner was infected with herpes simplex virus type 2 and the other was not. The participants were given either Valtrex or a placebo every day for eight months. The couples were also offered advice on using a condom. By the end of the study, 2 percent of the people taking Valtrex passed the herpes virus on to their partners, compared to 4 percent of those taking a placebo. Valtrex also nearly eliminated herpes symptoms in the people taking it.
The Associated Press quotes experts who say these findings could have implications for reducing transmissionof other, more serious sexually transmitted diseases such as HIV. The study was funded by GlaxoSmithKline, which manufacturersValtrex.
Biotech cos. race to replace needles
Millions of diabetics aggravate their disease by skipping insulin injections. Each year, about 70 million get today's flu vaccine, In the San Francisco area, Inhale Therapeutics Systems Inc. And Aradigm Corp., are racing to get their versions of inhaled insulin approved by the government. If one or both companies succeed, analysts and biotech executives believe drug makers will try to convert other injectable drugs, including cancer therapies.
Such a breakthrough would not only make patients' lives easier, it could prove to be a big boon for the biotechnology industry itself because most biotechnology drugs on the market or near approval must be injected. These drugs involve bigger molecules than traditional medicines, so they require injections. Most of the market growth will come from the estimated four million diabetics who should inject insulin but don't because of aversions to needles Inhale's partner, Pfizer Inc., announced in July it would delay filing for FDA approval this year as planned.
The pharmaceutical company said it would conduct additional safety tests. Aradigm and its Danish partner, Novo Nordisk, launched a planned two-year human trial. They hope the results will persuade the FDA to approve their product. The companies insist their products are safe and will ultimately win approval, but they'll still have to convince the public. ( source -AP)
Vaccine prevents stroke in rats
Animal studies have shown that blood vessels undergo periodic cycles of inflammation. These cycles are more frequent and intense in stroke-prone animals. In rats with stroke risk factors, such as ht, diabetes, or advanced age, a single dose of a substance found in bacteria can provoke inflammation that leads to a blood clot or a blood vessel haemorrhage.
Researchers believe inflammation also contributes to stroke in humans. In the new study, human E-selectin and 2 other substances (used as controls) were tested in a total of 113 stroke-prone rats with genetically-induced HT. The results of the investigation were dramatic and during >1 year of study, the rats that received repeated E-selectin vaccine treatment had 16-times fewer ischaemic strokes than those given repeated treatment with a control substance.
Furthermore, none of the rats given repeated vaccine treatment had a haemorrhagic stroke, while the other groups had 2 to 3 haemorrhagic strokes on average during the study period. The researchers are now planning a Phase I trial to test the effects of human and bovine E-selectin vaccines in people at high risk for stroke. That trial will study whether the vaccines are safe
Birth control patch approved in Canada and Europe
Johnson & Johnson's Evra (norelgestromin+ethinyloestradiol transdermal system), the first birth control patch, which was introduced earlier this year in the US, has now been approved by Health Canada and the EC. It will be available by prescription in Canada early in 2003, from Janssen-Ortho; Janssen-Cilag companies in Europe anticipate launching the product during the second half of 2003. Ortho-McNeil Pharmaceutical markets the product in the US under the brand name, Ortho Evra, indicated for the prevention of pregnancy. (Source Espicom Business Intelligence)]
Millionaires Lining Up To Buy Personal Gene Maps
A service to map a person's entire genetic code is being offered by America's genome entrepreneur Craig Venter .The Sunday Times said that for £400,000 a person would get details of their entire genetic code within 1 week. "Armed with such information, the individual would be able to check for mutations linked with illnesses such as cancer and Alzheimer's.
The article noted that, at present, scientists know the genetic abnormalities associated with only a few dozen diseases, but it pointed out thousands more were expected to be discovered in the coming decades. Venter is said to have already signed up several millionaires, though he has declined to name them. "I have been approached by a number of people who want to have their individual genome decoded," he said. "Initially, we will be able to decode people's genes in less than a week but hope eventually to bring it down to less than a day."
But others researchers, already upset by Venter's commercial approach to the Human Genome Project, are skeptical. "We know very little about the link between differences in genes and ill health. Until we do, mapping individual genomes will be like the Russians sending tourists into space. It is fun for those who can afford it, but it is just a good gimmick," commented another scientist.
Commercial potential for emerging drug delivery technologies
The commercial opportunities for drug delivery companies exist within lifecycle management. Enabling more efficient or convenient drug delivery offers the opportunity for pharmaceutical products to gain market share in competitive markets or defend market share when faced with patent expiry. The commercial potential for emerging drug delivery technologies is influenced by a broad range of market conditions, ranging from price and reimbursement to relative competitive advantage towards existing technologies.
Frost & Sullivan has recently investigated the commercial potential for inhalation drug delivery in diabetes treatment for the European markets. Inhalation insulin is the first emerging technology for systemic drug delivery expected to reach European markets, and should it prove successful, it could provide a much needed success story for emerging inhalation drug delivery technologies. More information is available at http://www.smi-online.co.uk/conferences
EU Big pharma struggles to keep pace with the US
Between 1997 and 2001, the pharmaceutical industry in the US and EU has undergone significant changes, including several large M&A deals. According to Datamonitor research, for every $1 billion in sales growth between 1997 and 2001, GlaxoSmithKline (EU) invested $14 million in R&D, compared with Pfizer (USA), which invested $214 million in R&D. This operating style is typical of the EU companies, which have not grown R&D investment at the same rate as their US counterparts. However, each of the EU companies still managed to increase their sales over the last five years despite this lower R&D spend.
The companies that have undergone significant mergers during the past five years - GlaxoSmithKline, Aventis, AstraZeneca, Sanofi-Synthelabo, Pfizer and Pharmacia - saw a large decrease in their liquidity levels and their ability to invest in their operations during the same period. Pfizer's M&A activity and high R&D investment has helped it achieve the highest sales growth. Pharmacia's five-year sales growth rate at 9.9per cent was comparable to Pfizer's 12.2per cent.
During the last five years US companies have benefited from a lower cost of capital since the US has a free-pricing structure, as opposed to the EU where governments tightly regulate the amount that drug manufacturers can charge for their products. The US companies are more likely to invest in their operations because they know they can recoup the expense. In contrast, in the EU big pharma's drug prices are continually beaten down through a combination of regulation and a desire to ensure that the EU's single market is really single
The recent French government deal with Pharmacia over the price of Celebrex, may also discourage major pharmaceutical firms from focusing their investments in the EU. The deal is to sell Celebrex within the French state reimbursement system at a "European" price but with a formal agreement that the price will be reduced by 18per cent in July 2004.The deal has been promoted as very innovative, striking an acceptable balance between Pharmacia's need to get to market quickly and to start recovering R&D costs and the government's desire to provide quicker access to this valuable new product.
Since the US pharmaceutical companies do not suffer from the same kind of regulatory pressure, although litigation costs and employee compensation levels are far higher in the US than in the EU, they have further incentives to continually invest in their operations knowing that they will see a high rate of return.
Due to the major divide between US and EU pharmaceutical companies in terms of growth and investment levels, the level of investment that US companies are willing to make, combined with a conducive business environment in the US, will leave them stronger going forward than their EU counterparts (Source-Datamonitor).
Sterilizing Blood
The blood supply may get even safer in the future. Tests are underway to see whether a process that essentially "sterilizes" blood can prevent the transmission of viruses and bacteria during transfusions. Donated blood is repeatedly tested for the presence of agents such as HIV and hepatitis, but no test yet exists for some other diseases, such as West Nile virus. Now 520 transfusion recipients including adults undergoing heart surgery and children with inherited anemia are enrolled in a study to test whether "pathogen inactivation" can reduce the risk of contracting diseases from blood transfusions.
The procedure involved adding a chemical to the blood that breaks up the genetic material of any viruses or bacteria present, leaving them unable to infect a new person. Red blood cells and platelets contain none of the type of genetic material targeted, and so are not destroyed, The Associated Press reports. Although the Food and Drug Administration has called the procedure promising, it will still be years before the technique can be approved, the AP says. Researchers will need to be sure that sterilized blood functions normally and carries no additional risks of its own.
Sprout warning
Cook your sprouts. That's an important reminder from the Food and Drug Administration, which is once again warning of the dangers of eating raw or lightly cooked sprouts. Alfalfa and other sprouts have caused outbreaks of salmonella and E. coli infections, which cause serious illness and death in elderly people, young children and anyone with a weakened immune system
The FDA warning comes in the wake of an E. coli outbreak in California caused by alfalfa sprouts, The Associated Press reports. Federal health officials recommend that you cook all sprouts thoroughly, even homegrown ones; avoid ordering salads and sandwiches that contain sprouts; and see a doctor immediately if you experience food poisoning symptoms after eating sprouts.
Compiled from WWW by Dr. Venkat Appaji Padmanabhuni
email : appajipv@hotmail.com