Pharma, WHO, CDC, and FDA have persuaded our legislators that it is better to “hurry up, do something” than it is to “first, do not harm”. This may be setting a very bad precedent. Giving preference to political expediency over proven safety and efficacy sets the bar at a new all time low.

Perhaps FY 2010 will be a better year for U.S. DOJ in combating the corruption engaged in by the pharmaceutical industry which depletes the U.S. healthcare budget and undermines public health. See the federal Fraud and Abuse Statute, Fraud Enforcement and Recovery Act of 2009, and False Claims Act Correction Act of 2009. See also: http://www.scribd.com/doc/17300758/07....

Perhaps FY 2010 will be a better year for U.S. DOJ in combating the corruption engaged in by the pharmaceutical industry which depletes the U.S. healthcare budget and undermines public health. See the federal Fraud and Abuse Statute, Fraud Enforcement and Recovery Act of 2009, and False Claims Act Correction Act of 2009. See also: http://www.scribd.com/doc/17300758/07...

I raised concerns regarding ghost-written clinical research publications to both state and federal regulators more than 6 years ago. Why the sudden interest now ? See NY Times article link: http://www.nytimes.com/2009/09/18/bus...

In his Forward to Dr Horowitz's book, Dr Martin states, "Seemingly, U.S. government agencies, principally the FDA, have been reluctant to impose additional testing requirements on vaccines once they are approved for use. In effect, government officials are given a single opportunity to decide on a new vaccine's safety. Even then, government regulators themselves may be denied certain critical information belonging to the vaccine industry. Specifically, FDA regulations are written so as not to compel industry to reveal testing information not directly pertaining to the lots submitted for clinical use. The FDA is reluctant to admit its lack of knowledge about vaccines to the medical/scientific community. Yet, practicing physicians are expected to unquestionably endorse the safety of vaccines under all circumstances and to all individuals." "Aside from these bureaucratic barriers to viral vaccine safety assurance, there are additional major concerns. Since vaccine development information is considered proprietary‹protected by nondisclosure policies‹ government officials and researchers must shield potential safety issues from public scrutiny. This censorship is rationalized by the all too persuasive argument that vaccines cannot be criticized lest the public become non-compliant in taking them. Finally, this silence is buttressed by the small number of people capable of critically evaluating vaccine manufacturing and safety testing procedures. In essence, health care professionals and the general public know little about the possible dangers of live viral vaccines." "This basic flaw in the regulatory process must be addressed‹the FDA must be responsive to the medical-scientific community's need for accurate information regarding the potential hazards of products released for use in society. In the event that public health and safety concerns arise, industry should wave its right to maintain proprietary intelligence. This would enable the FDA to disclose more information concerning the safety of FDA regulated products to the medicalscientific community. Such a proposal should be included in the all pending and future FDA reforms." "It is against this background of possible risks of past viral vaccine studies, uncertain biological recombinants, bureaucratic censorship, a rising tide of medical consumerism in the information age, and an urgent need for legislative FDA reform, that Dr. Horowitz's work contributes. At minimum, what you are about to read exposes many important facts which, unfortunately, few people realize and all would be better off knowing. At best, this important text raises far greater hope that by knowing their origin, cures for the many complex emerging viruses, including AIDS, may be forthcoming."

The “endangered and dead” victims referred to in Davidsons’ Petition for Writ of Certiorari before Judgment (U.S. Supreme Court Docket Case # 04-537, certiorari denied on January 10, 2005), Issue # 2, at page 17, paragraph 1, had to collectively shudder when Judge Zapata dismissed Davidsons’ federal causes of action (CV-03-00110-FRZ and CV-03-00580-FRZ). A foreseeable consequence of his abdication of federal jurisdiction, is that the harm (intentional endangerments and deaths) made possible under color of the Prescription Drug User Fee Act (“PDUFA”) will continue unabated and evade review.

See page 21, paragraph 38, of Document 1 From 07-Cv-01530 Filed TXSD where it states, "Leanne M. Zumwalt is believed to have had actual knowledge of Jay Grossman's claims profile relative to other asthma allergy specialists in the Vivra network. I-Health Technologies Inc (a provider of professional claims processing) actually promoted (on the Vivra Inc website) it's "over 1 billion member months of data and experience", and it's capability of identifying "upcoders" and "undercoders", resulting in "savings" of 3-7% on professional claims (sometimes more)." See also page 11 of Document 48-9 From 07-Cv-00471 Filed TXSD, where it states, "Vivra manages single specialty networks in 15 specialty areas. . . and 8 million covered specialty lives".