Monthly Archives: May 2006

Smoke-free a fiery issue

  • 5/7/2006
  • Richmond, VA
  • John Reid Blackwell
  • TimesDispatch.com (www.timesdispatch.com)

New tobacco products heat up debate over merit of cigarette alternatives

Two new smoke-free tobacco products could be the wave of the future or a repeat of past missteps, some industry observers say.

Cigarette makers Philip Morris USA and R.J. Reynolds Tobacco Co. plan to test-market smokeless, spit-free tobacco brands targeted at cigarette smokers, fueling a debate among tobacco-control advocates over whether such products will help or hurt public health.

The move indicates that cigarette makers are looking for ways to cope with stricter laws against indoor smoking and possible federal government regulation of tobacco products. Manufacturers also may hope to spur demand among smokers for products that are potentially less risky than cigarettes, which cause cancer, heart disease and contribute to about 400,000 premature deaths in the United States each year, public-health agencies say.

“The marketplace is beginning to shift,” said Scott Ballin, a Washington consultant who works on tobacco- and health-policy issues. If Congress gives the Food and Drug Administration authority to regulate tobacco products, companies could be allowed to market alternatives as safer than cigarettes, provided they have proof.

“What is beginning to happen, in my view, is all these various companies are trying to position themselves to make sure they have a piece of the action,” Ballin said.

Studies have found that a large percentage of the more than 40 million U.S. smokers have tried to quit or would like to quit. Philip Morris says its research has found that some adult smokers are interested in smoke-free options. The company’s new product, Taboka, is designed to appeal to them.

Taboka, which will be test-marketed in Indianapolis, is a small pouch of tobacco that users place between the cheek and gum for a dose of flavor and nicotine similar to a cigarette’s. Unlike traditional moist snuff, it is designed so that users do not have to spit, and the pouches are discarded after use.

Taboka will be sold in containers of a dozen pouches for about the same price as a pack of Marlboros, the company’s most popular cigarette brand.

Taboka will join several products introduced in recent years and marketed as smoke-free alternatives to cigarettes. Those include Stonewall, sold by the Chester-based discount cigarette company Star Scientific Inc.

Some tobacco-control advocates have argued that smokeless tobacco can reduce the harm of nicotine addiction. Others fear that the new products will be a repeat of light and low-tar cigarettes, once widely perceived as safer than regular cigarettes.

As late as the 1980s, “the public-health community said, ‘If you can’t stop or won’t stop [smoking], at least switch to these low-tar and low-nicotine cigarettes,'” said Thomas Glynn, director of cancer science and trends for the American Cancer Society. “Now, 25 years later, we find it made no difference except to switch where the lung cancers were found from the upper part to the lower part of the lung,” because smokers tend to inhale light cigarettes more deeply.

“That is why you see so much caution” about new tobacco products, Glynn said.

Smokeless tobacco causes oral cancer, gum disease and may contribute to heart disease, all of which Philip Morris will acknowledge on the labels of Taboka packages. The U.S. surgeon general said in 1986 that smokeless tobacco is not a safe alternative to cigarettes.

About 7,500 people in United States died of oral cancer in 2005, and about 31,000 new cases are expected in 2006, according to the American Cancer Society. It is not clear how many of those are smokeless-tobacco users or smokers.

Other researchers argue that smokers who will not or cannot quit should switch to smokeless tobacco, which does not pose as much of a health risk as cigarettes. Brad Rodu, an oral pathologist and professor of medicine at the University of Louisville, is one proponent of smokeless as a “harm-reduction” strategy for smokers who cannot break their nicotine addiction.

He said numerous studies have found that users of smokeless tobacco run less risk of developing cancer than cigarette smokers.

Rodu and others point to Sweden, where a type of smokeless tobacco called snus is more widely used than cigarettes, and where lung cancer and oral cancer are less prevalent than in countries with higher smoking rates. Rodu said cigarettes cut about eight years off the life of the average smoker, while smokeless tobacco reduces life span by less than a month on average.

“I think this harm-reduction strategy is gaining momentum among public-health specialists,” Rodu said. “Cigarette smokers have a right to know about products that are safer.”

Still, Rodu said he would recommend that smokers quit all tobacco products, rather than switch from one to another.

Rodu’s conclusions are disputed by other researchers, who say the potential harm of increased smokeless-tobacco use far outweighs any potential benefits and that smokeless is a gateway product to smoking.

“I have seen no evidence to suggest that people can move successfully from smoking cigarettes to using smokeless,” said Glynn of the cancer society.

Ballin said Congress should take steps to regulate the tobacco industry and ensure that any new products pitched as potentially safer truly are safer. Tobacco companies, he said, “should not be able to make claims without having a third party take a look at it.”

May, 2006|Archive|

Indian approval for cancer drug: Biocon

  • 5/6/2006
  • New Delhi, India
  • staff
  • IBN Live (www.ibnlive.com)

Biotechnology major Biocon Ltd will seek Drug Controller General of India’s approval for its novel monoclonal antibody being developed for the treatment of head and neck cancer, Biomab EGFR.

“We will be submitting an application for approval to DCGI shortly and hope to be on target to launch ‘BIOMAb’ by this year end,” Biocon Chairman and Managing Director Kiran Mazumdar Shaw told PTI. Biocon’s Cuban partner, CIMAB has already got marketing approval for the molecule in China, Argentina, Colombia and Cuba, she said.

Confirming the marketing approval of its Cuban partner CIMAB, which originally identified the BlOMAb EGFR molecule, she said, “We have marketing rights for India and South Asia. We also have global manufacturing rights.”

On Biocon’s plans for the US market, she said the company, currently, does not have the rights to market the molecule in the United States. “We do not have rights for the US market but we hope to qualify as a supplier of the molecule there,” Shaw said.

When asked about the impact BlOMAb EGFR will have on revenues of Biocon in next two-three years, she said: “full impact on revenues from Biomab EGFR will be seen over the next few years.” The final product when launched would spearhead Biocon Biopharmaceuticals’ foray into proprietary products for cancer therapy in the country.

Clinical trials of the molecule were conducted at Manipal Hospital in Bangalore and KMC hospitals in Mangalore and Manipal.

May, 2006|Archive|