2004N-0355 - Scientific Considerations Related to Developing Biotechnology Products
FDA Comment Number : EC1
Submitter : Ms. J LeClair Date & Time: 09/23/2004 04:09:09
Organization : Ms. J LeClair
Health Professional
Category :
Issue Areas/Comments
One in every two men in the U.S. will get cancer at some time in there lives, and one in every three women in the U.S. will get cancer at some time in there lives. Therefore it is time to direct resources to prevent these cancers. I have outlined ten cancer prevention vaccines that should be given the highest priority and fast tracked to prevent this epidemic. My request is to make these ten vaccines TOP priority at FDA and NCI and NIH for grant funding and FDA product approval.
Subject: Cancer prevention vaccines currently being developed.
Specifically, we are talking about the
1) Nicotine Vaccine, 2) Epstein Barr Vaccine, 3) Heliocobacter Pylori Vaccine, 4) HSV-2 Vaccine, 5) HPV-16 (and HPV-18) Vaccine also included in this section is the 6) Heat Shock E-7 Vaccine (Stressgen), 7) Chlamydia Trachomatis Vaccine 8) Hepatitis C Vaccine and the 9) Cytomegalovirus vaccine. 10) Although we do not discuss in this paper the Human Homologue of the Mouse Mammary Tumour Virus (HHMMTV) Vaccine in early stages of research at Tulane University, this vaccine could also be a candidate for fast tracking because of the causitive relationship between HPV 16, Epstien Barr and the HHMMTV viruses that act as cofactors with estrogen in the initiation and promotion of some types of breast cancer.
1.Cancer Prevention Vaccine #1: Nicotine vaccine
(Targets Tobacco and lung cancer)
The leading causes of death in 2000 was tobacco (435,000 deaths; 18.1% of total US deaths) based on data from CDC and reported in JAMA on March 10, 2004. These analyses show that smoking remains the leading cause of mortality. These findings, along with escalating health care costs and aging population, argue persuasively that the need to establish a more preventive orientation in the US health care and public health systems has become more urgent. One out of every three adults in the United States smoke cigarettes, millions have tried to stop the smoking addiction unsuccessfully.
Vaccines. The lead nicotine vaccine developers are Xenova from Great Britain and Nabi Pharmaceuticals from the United States. Both companies have applied technology to create a vaccine which will prevent the addictive substance in tobacco from crossing the blood brain barrier by creating antibodies to the nicotine. Both companies have been reported to be in Phase II of clinical trials. These two products have been called "buzz busters" that is, when the nicotine reaches the blood supply, the antibodies attach to the addictive substance, thus making the addictive substance to large to get through the blood brain barrier, the "buzz" is gone, and the addiction is broken. The nicotine vaccine needs to be tested in phase III of clinical trials, and if found to be safe and effective, than after accelerated phase III clinical trials, the nicotine vaccine needs to be made available to the American public, especially families who may choose to have teenagers vaccinated against nicotine, as a preventative vaccine. If effective, and the preliminary data would show that this may be the case, this vaccine will significantly reduce the number of deaths in the US to lung cancer. A successful nicotine vaccine would have a significant economic savings to the US federal budget in reducing medical costs for the care and treatment of lung cancer and other tobacco related cancers.
Due to space limits on this electronic comment form, Cancer Prevention Vaccines #2 threw #10 are being submitted in comments on next entry.