Pharmaceuticals again ranked as the most profitable sector in the United States, topping the annual Fortune 500 ranking of America''s top industries. The pharmaceutical industry topped all three of Fortune magazine''s measures of profitability for 2001, making this decade the third in which the industry has been at or near the top in all the magazine''s measures of profitability.
The occasion was seized by critics of the industry as reflecting corporate greed. Frank Clemente, director of Public Citizen''s Congress Watch, said: "During a year in which there was much talk of sacrifice in the national interest, drug companies increased their astounding profits by hiking prescription prices, advertising some medicines more than Nike shoes, and successfully lobbying for lucrative monopoly patent extensions. Overall profits of Fortune 500 companies declined by 53% in 2001, while the top 10 US drug makers increased profits by 32% from $28bn to $37bn, according to Public Citizen''s analysis of the Fortune 500 data.
The drugs industry says it needs extraordinary profits to fund risky research and development of new drugs and to absorb the high cost of drug failures in clinical trials. The industry''s output of new drugs has risen only modestly in the past two decades, despite a more than six fold increase, after adjustment for inflation, in spending on research and development to more than $30bn a year. In the past few years output has actually declined. Many industry supporters blame tougher scrutiny by the Food and Drug Administration. The time spent to develop a drug, not counting the months consumed by government review, has lengthened from about nine years in the 1980s to more than 11 years, according to the Tufts Center for the Study of Drug Development, and the cost has more than doubled, after adjustment for inflation, to $800m.But Public Citizen notes that the Tufts Center gets money from drug companies and maintains that the centre''s figures are inflated to justify high drug costs
The Flop of the COX-2 NSAIDs
The year 1999 witnessed the launch of the COX-2 selective inhibitors, Vioxx(rofecoxib) and, later, Celebrex (celecoxib). These drugs were launched in a blaze of publicity, hailing an end to safety problems with NSAIDs.To the dismay of MSD and Pharmacia, the innovator companies, these drugs failed to meet the expectations of doctors Last month, the two manufacturers launched their second-generation products.Arcoxia(etoricoxib), launched by MSD in the UK, and Bextra(valdecoxib), launched by Pharmacia in the U.S, are said to greatly improve the gastrointestinal safety of this class of drugs, as well as being longer lasting and more effective at pain and inflammation control. They have been launched as improvements over the first generation of the COX-2 selective inhibitors, at the same price .Pharmacia launched the COX-2 inhibitor Dynastat (parecoxib) to the hospital market last month.This injectable NSAID for post-operative pain will bring additional revenues for Pharmacia. . Drugs such as diclofenac have been on the market for over twenty years and as such doctors know what to expect.. They are also so economical compared with the COX-2 inhibitors that they are likely to remain the NSAID of choice for patients at a lesser risk.
Bayer to Develop Malaria Medicine
German chemical and drug maker Bayer AG has signed an agreement with a United Nations-backed initiative to develop a new malaria medicine that would be priced at an affordable level in developing countries. Clinical trials for the drug are scheduled to begin in 2003, with the launch of the tablets expected in 2005, Bayer said in a statement. The medicine - using an active ingredient called artemisone for which Bayer holds patent rights - is to be developed and supplied by the German firm. The World Health Organization and its Medicines for Malaria Venture, which is financed by the World Bank and private foundations, will be responsible for its monitored distribution in developing countries. "The price in this market sector is to be set at a level that would allow all segments of the population who suffer from malaria in the developing countries to receive treatment," Bayer said. While malaria was wiped out in Europe and North America during the early 20th century, 40 percent of the world''s population still lives in malarial environments in tropical and subtropical countries. More than 300 million people are infected every year and more than one million people die, according to the WHO.
Doctors warned to be wary of new drugs
Doctors should be wary of starting their patients on newly approved drugs, because of the high rate of adverse side effects that go undetected until late in the post-marketing surveillance period, a new study says More than 10% of new drugs approved by the US Food and Drug Administration (FDA) have serious side effects that are not discovered on initial testing and marketing, says the study. The investigators analysed 548 drugs approved by the FDA from 1975 to 1999. The list of drugs was obtained from an online database of drug approvals maintained by the Tufts University Center for the Study of Drug Development. Only drugs defined as new molecular entities not previously marketed in the United States were included in the study. Drugs sold over the counter, diagnostic agents, and biological products were excluded. The researchers used the Physicians'' Desk Reference, an annual guide to prescription drugs, as a measure of developments in changes to labeling of adverse reactions, and they used the Federal Register and the FDA''s website to compile a list of drugs withdrawn for safety reasons. They found that over 10% (56/548) acquired a new "black box warning" indicating a serious adverse reaction that may result in death or serious injury or were withdrawn from the market. Sixteen drugs (3%) were withdrawn and 45 (8.2%) required one or more new black box warnings.
Half of the withdrawals occurred during the first two years after the drug''s introduction, and half of the new black box warnings occurred during the first seven years. Thus in 50% of the drugs an adverse reaction went undetected until relatively late in the course of a drug''s appearance. One of the drugs, Terfenadine (marketed in the United States as Seldane), a popular non-sedating antihistamine, was on the market for 13 years before being withdrawn. Another, Cisapride (marketed in the United States as Propulsid), which was approved as an aid to prevent gastrointestinal reflux, was available for six years before withdrawal. Both were withdrawn because of their risk of causing arrhythmia. The study found that the probability of a new drug acquiring a black box warning or of being withdrawn from the market over 25 years was 20%. They blamed the high prevalence of adverse drug reactions on aggressive marketing techniques by drug makers, rapid approvals by the FDA, and faulty post- marketing surveillance systems. They advise that "clinicians should avoid using new drugs when older, similarly efficacious agents are available" and that "patients who must use new drugs should be informed of the drug''s limited experience and safety record" and be closely observed.
A new technique that could revolutionise gene therapy
Scrunching up DNA into ultra-tiny balls could be the key to making gene therapy safer and more efficient. The technique is now being tested on people with cystic fibrosis. So far, modified viruses have proved to be the most efficient way of delivering DNA to cells to make up for genetic faults. But viruses cannot be given to the same person time after time because the immune system starts attacking them. Viruses can also cause severe reactions. As a result, researchers increasingly favour other means of delivering genes, such as encasing DNA in fatty globules called liposomes that can pass through the membranes round cells. But simply getting a gene into a cell is not enough - for the desired protein to be produced, you need to get the gene into the cell''s nucleus. At around 100 nanometres in size, most liposomes are too large to pass through the tiny pores in the nuclear membrane except when the membrane breaks down during cell division. Even if cells are rapidly dividing, delivering genes via liposomes is not very efficient - and it is no good for slowly dividing cells such as those lining the lungs. But researchers at Case Western Reserve University and Copernicus Therapeutics, both in Cleveland, Ohio, have developed a way to pack DNA into particles 25 nanometres across, small enough to enter the nuclear pores. The nanoparticles consist of a single DNA molecule encased in positively charged peptides and are themselves delivered to cells via liposomes. In cells grown in culture, there was a 6000-fold increase in the expression of a gene packaged this way compared with unpackaged DNA in liposomes. Trials have now begun in 12 people with cystic fibrosis, who have a faulty gene that means thick mucus accumulates in their lungs. The researchers will first test the technique on nasal cells before trying to deliver genes to the lungs.
Compiled from WWW by Dr. Venkat Appaji Padmanabhunie-mail : appajipv@hotmail.com