Time to Regulate Big Tobacco

The House of Representatives is poised to vote next week on a pioneering bill that would give the Food and Drug Administration its first real power to regulate tobacco products, much as it now regulates food, drugs and medical devices. This is a critically important bill, the culmination of more than a decade of struggle to bring the renegade tobacco industry under regulatory control.
In the 1990s, the F.D.A. tried to regulate tobacco products under existing statutes, but the Supreme Court ruled that the agency had exceeded the authority granted by Congress. Now both houses are considering bills that would write the agency’s 1996 rules into law and add many other tools and powers as well. David Kessler, the former food and drug commissioner who led the regulatory battle more than a decade ago, called it “as strong a tobacco bill as we have seen in our lifetimes.”
The bill pending in the House would empower the F.D.A. to regulate both the content and marketing of tobacco products. The agency could not ban tobacco products outright or eliminate all nicotine from them, but it could reduce the levels of nicotine, eliminate other harmful ingredients and set product standards to protect the public’s health. It could also restrict advertising and promotion to the extent permitted by the First Amendment.
The Bush administration has opposed the bill on several grounds — none of them compelling. Its core objection is that the bill would heap new responsibilities on the F.D.A. at a time when the agency is struggling to enhance food safety and improve oversight of imported drugs, devices and foods. Of course, the reason the agency is struggling is that the administration, true to its animus against regulation, has failed to provide adequate resources during most of its tenure. The solution is to provide enough money and people to perform all vital tasks, not to duck a new one.
The administration further frets that user fees imposed on the tobacco industry won’t cover all costs of the regulatory effort, thus forcing the F.D.A. to cannibalize other programs to make up the difference. But the bill now clarifies that only the designated user fees and no other F.D.A. funds can be used to regulate tobacco.
The administration also contends — as do some anti-tobacco activists — that F.D.A. oversight could leave the public with the misperception that tobacco products are safe, or at least safer, with regulation. But the bill prohibits tobacco companies from implying that they have F.D.A. approval, and the agency has ample ways to remind the public that tobacco is harmful.
The bill has strong support from such organizations as The American Cancer Society, the American Heart Association, the American Lung Association and the Campaign for Tobacco-Free Kids. It is supported by Philip Morris, but opposed by most of the tobacco industry. It has strong bipartisan support in Congress.
The legislation needs to be passed this year by veto-proof margins in both houses, lest the reform impulse dissipate next year as a new administration and new Congress grapple with a host of complicated foreign, military and domestic issues.

Avastin - Wet Macular Degeneration: by Donald Arson

Avastin is the brand name for Bevaciumab a monoclonal antibody or an antibody that is an identical clone of a single parent cell. It was approved in 2004 by the FDA for use in the treatment of some cancers and is used as a first or second line treatment for patients.
As the first clinically available angiogenesis inhibitor the United States it inhibits new cancer cells by blocking the growth of blood vessels in pre-existing tumors. A solid, non-liquid, tumor needs to grow additional blood vessels to be able to reach a certain size.
With an angiostatic agent such as Avastin the growth of new blood vessels is slowed stopping the cancer from growing indefinitely. It is usually given every 14 days intravenously in the arm and can be used with other drugs in combination and with intravenous 5-fluorouracilâ€"based chemotherapy.
Developed by Genentech (NYSE: DNA), a leading biotechnology corporation, it is marketed in the United States under the Genentech name and outside the US under Roche.
When it was originally available in 2004 it was only FDA approved for the treatment of many forms of small cell lung cancer and metastatic colon cancer. A metastatic cancer, in this case colon cancer, is a cancer that spreads from one part or organ to another non-adjacent part or organ.
In 2008 the FDA opened up the doors and allowed for the treatment of breast cancer. There are also clinical trials under way to use Avastin for the treatment of non-metastatic colon cancer, metastatic renal cell carcinoma, metastatic breast cancer, metastatic glioblastoma multiform, metastatic hormone-refractory prostate cancer, metastatic or unresectable locally advanced pancreatic cancer, and metastatic ovarian cancer.
Avastin is also currently being used off-label, the practice of prescribing drugs for a purpose outside the scope of the drug's approved label, for the treatment of wet macular degeneration by some retinal specialists.
Wet macular degeneration or AMD is a condition that causes loss of vision from the growth of abnormal blood vessel choriocapillaries, through Bruch's membrane. This eventually leads to blood and protein leaking below the macula, an oval spot near the middle of the retina in the human eye. With AMD rapid, often irreversible vision loss can occur through the leaking, bleeding and scaring of the blood vessels if left untreated.
Dr. Philip J Rosenfeld, MD, PhD of the Bascom Palmer Eye Institute conducted a study that showed positive results for the treatment of AMD with Avastin. According to Dr. Rosenfeld’s study Avastin improved vision in as little as one week for patients treated for AMD.
For AMD treatment Avastin is used in very low amounts by retinal specialists. They usually have a pharmacists transfer the drug from the original vile to a pre-filled needles containing single doses. The specialists will then usually treat the patient in their own office.
As with any drug it is always best to talk to your doctor or pharmacist before starting any treatment