Day: May 11, 2007

FDA cannot find anything in China

FDA Finds Chinese Food Producers Shut Down –

American inspectors who arrived in China last week to investigate the two companies that exported tainted pet food ingredients found that the suspect facilities had been hastily closed down and cleaned up, federal officials said yesterday.

“There is nothing to be found. They are essentially shut down and not operating,” said Walter Batts, deputy director of the Food and Drug Administration’s office of international programs.

Well, we gave them plenty of warning, did we not!

Indian Parliament Discusses Climate Change

India stresses on Kyoto standards-India-The Times of India

The discussion on global warming in Parliament will end with the statement of environment minister A Raja, possibly on Monday. He is bound to restate the country’s position on climate change in the international arena — that countries must bear “a common but differentiated responsibility” for climate change, a phrase that is the central pin of the Kyoto Protocol.

De-jargonised, it means, while every country is adding to the problem, there are some that are more responsible than others, and should, therefore, bear the burden and costs of cleaning up more than the smaller culprits

More highlights…

The US, between 1950-2003, emitted 10 times more carbon dioxide than India did. Europe emitted 8.5 times more. Yet US and Australia, two of the biggest emitters of greenhouse gases, have refused to ratify the Kyoto Protocol (which asks developed countries to reduce their emissions) on the pretext that developing countries like India and China are not undertaking emission cuts.

Worse still, if one looks at per capita emissions from different countries, which is a more equitable way of calculating emissions if one was to go by the principle that each person has as much right to the atmosphere as another, then India ranks a mere 120 compared to US which ranks 6 and Australia 10 on the culprits’ list. This is taking the emission levels of 2003.

Well, they are right, and they are wrong too. The developed world has a lot to more to cut back on and should make the bulk of the cuts. But India and China also need to grow using current state of the art knowledge, not using the 1950s coal intensive, energy inefficient model of increasing supply without paying attention to demand. We have also come to realize that IPCC reports, due to their consensual nature, are conservative. So, they will tend to understate the effects of climate change and overstate the costs. It may not be as expensive in India and China as long as attention is being paid to hw the infrastructure is being developed.

FDA to add warnings on Anemia Drugs

Oncologists are being bribed to over-prescribe these drugs, which seem to cause more harm than good when over-prescribed. The FDA is going to add a “warning” label. Let’s see what it does.

FDA panel urges curbs on 2 anemia drugs – The Boston Globe

Best-selling anemia drugs from Amgen Inc. and Johnson & Johnson should have their use restricted because of dangerous side effects, a US advisory panel said. Amgen shares fell the most in five years.

The panel of expert advisers to the Food and Drug Administration voted 15-2 in favor of new prescribing restrictions and 17-0 for new clinical trials during a meeting yesterday in Silver Spring, Md.

Shares of Amgen fell $5.77, or 9.1 percent, to $57.33 in Nasdaq Stock Market composite trading. J&J shares fell $1.61, or 2.5 percent, to $62.50 on the New York Stock Exchange.

The drugs raised the risk of heart attacks, strokes, and death when used at high doses, studies released in the last six months showed. An FDA warning in March prompted the US health program for the elderly and disabled to stop paying for treatments in certain patients, and doctors cut back on use. The products accounted for $6.6 billion, or 47 percent, of Amgen revenue in 2006.

“Many of us are concerned on the committee and have a lot of questions,” said Gail Eckhardt, an oncologist at the University of Colorado in Aurora, and the advisory panel’s chairwoman.

The questions concerned the design of trials, why regulators have limited access to results from company studies, and why the drugs have been marketed for improving quality of life if there isn’t sufficient evidence for the claim, Eckhardt said.

The FDA usually follows the recommendations of its advisory panels, although it isn’t required to do so.