Doctors, Optometrists, and Psychologists on LASIK and Suicide

Think LASIK is "safe and effective"? You might change your mind after watching the videos below. Compare these videos to those that document strategies used by Big Pharama to deceive the public about risk Here.

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Optometrist David Hartzok on LASIK

Dr. David Hartzok works to save the vision of Lasik victims. Accordingly to Dr. Hartzok, some patients with highly experienced and reputable surgeons still have bad outcomes, thus suggesting that the lasers themselves are responsible for ruining these patient's vision.

FDA Enforcement Diminishing

SOURCE

A spokeswoman for the FDAs Center for Drug Evaluation and Research told the Center that since companies have better complied after receiving warning letters, the need for additional regulatory and enforcement actions has decreased. “We cannot measure the agency’s enforcement success — nor can we measure industry compliance — by counting warning letters and other actions individually,” she said. Congress passed the Food and Drug Administration Amendments Act of 2007 last fall, giving broader enforcement power to the agency. The impact of the law remains to be seen.

FDA Enforcement Actions Way Down

Enforcement actions by the Food and Drug Administration (FDA), which oversees food and pharmaceutical products, markedly declined under the Bush administration. The number of warning letters issued for various violations dropped by more than half, from 1,154 in 2000 to 535 in 2005, according to a June 2006 report by Representative Henry Waxman, a California Democrat, then ranking minority member of the House Committee on Government Reform. The “number of seizures of mislabeled, defective, and dangerous products” plunged by 44 percent, noted the widely cited report, which also found that officials at FDA headquarters had “routinely rejected the enforcement recommendations of career field staff.” Among the curtailed warning letters were those for violations of drug marketing practices to consumers. "From 2002 through 2005… it took the agency an average of 4 months to issue a regulatory letter, compared with an average of 2 weeks from 1997 through 2001," stated a December 2006 report by the Government Accountability Office (GAO). "FDA has issued about half as many regulatory letters per year since the 2002 policy change." The FDA has also fallen short in efforts to control “off label” drug use (using prescription drugs for nonprescriptive conditions), according to studies by the Center for Public Integrity and other watchdog groups. The GAO told Congress in July 2008 that the FDA took inordinate time issuing letters for offlabel abuses, limiting their effectiveness.

FDA's Medwatch Listing - LASIK

The FDA stated through news media prior to, and at the April 25th ('08) Ophthalmic Panel Meeting held in Gaithersburg (MD) that it has received only 140 complaints regarding adverse events from LASIK surgeries since LASIK's inception 10 years ago.

These are SOME of the adverse events posted at the FDA's website, listed by year:

2008 2007
2006 2005
1995 thru 2004

 

FDA Oversight

SOURCE

"Several Subcommittee investigations resulted in improvements to the public health. The Subcommittee has continued its investigation into the safety of the blood supply and has been instrumental in fostering important reforms at the American Red Cross, and the FDA. The Subcommittee's continuing commitment to improve the generic drug approval process has led to increased vigor in FDA regulation and enforcement. The Subcommittee continued its efforts to uncover and correct problems in food safety, particularly with regard to imported foods. Meanwhile, the Subcommittee's medical device investigations have highlighted both dangerous devices that were permitted to reach the market through lax approval processes, and potentially life-saving devices that have been delayed or kept off the market due to bureaucratic infighting or regulatory ineptitude. These efforts resulted in the release of a major report and in substantial reforms at the FDA." 103RD CONGRESS (1993-1994) ENERGY AND COMMERCE COMMITTEE

The Committee's oversight efforts since then have included:

Dingell, Stupak to Investigate FDA’s Medical Device Approval Process

FDA Medical Device Safety

FDA Drug Safety

FDA Food Safety

FDA's Conflicts of Interest

FDA's Compensation Practices

FDA Office of Regulatory Affairs Reorganization

FDA No-Bid Contracts

FDA Food Safety PDF Print E-mail

FDA Food Safety

SOURCE 

Letters (pdf)

October 2, 2008 Letter to FDA Commissioner von Eschenbach regarding Melamine Contamination in Chinese Milk Products

 

May 8, 2008 Letter to 49 Multinational Food Processors about Contamination

Responses »

May 1, 2008 Letter to the presidents and CEOs of 10 private laboratories regarding to the role of the these labs in ensuring the safety of our Nation's food supply
April 30, 2008 Letter to Malt-O-Meal Company President and CEO Neugent in regard to the recall of its cereal due to the risk of potential Salmonella poisoning
April 30, 2008 Letter to FDA Commissioner von Eschenbach in regard to petitions before the FDA to utilize irradiation technology which could improve the safety of the food supply
April 30, 2008 Letter to FDA Commissioner von Eschenbach in regard to the recent outbreak of Salmonella associated with cantaloupe from Honduras
March 12, 2008 Letter to Humane Society President and CEO Pacelle requesting any further information the organization might contribute to the Committee's investigation of food safety issues
Feb. 27, 2008 Letter to HHS Secretary Leavitt in regard to the Agency's refusal to comply with a recently issued subpoena requesting documents
Feb. 21, 2008 Letter to Christopher Ranch in regard to the recent detection of a dangerous pesticide in imported Chinese ginger
Feb. 15, 2008 Letter to GAO Comptroller General Walker requesting information about the Agency's oversight study of the FDA
Feb. 14, 2008 Letter to Office of Management and Budget Director Nussle in regard to findings by the FDA's Science Board as reported in the January 29, 2008 hearing

March 18, 2008 response »

Feb. 11, 2008 Letter to New Era Canning Company in regard to a recent recall of the company's canned bean products due to the potential risk of botulism poisoning

February 26, 2008 response »

Feb. 7, 2008 Letter to FDA Commissioner von Eschenbach requesting further information regarding findings by the Science Board
Jan. 18, 2008 Letter to Soma Beverage Company, LLC President and CEO Lowe in regard to the recent recall of Metromint bottled water
Dec. 13, 2007 Letter to HHS Secretary Leavitt in regard to the recently signed Memorandum of Agreements between China and the United States
Dec. 21, 2007 Letter to Department of Agriculture Acting Secretary Conner in regard to additional questions for the record from the Nov. 13, 2007 Food Safety hearing

January 16, 2007 response »

Dec. 18, 2007 Letter to Government Accountability Office Comptroller General Walker in regard to the irradiation of food

January 9, 2008 response »

Oct. 30, 2007 Letter to FDA Commissioner von Eschenbach in regard to four cases of potential botulism poisoning from Castleberry's Food Company products

January 14, 2008 response »

Oct. 30, 2007 Letter to HHS Secretary Leavitt requesting records related to the decision not to adopt mandatory regulations on the handling of fresh produce
Oct. 4, 2007 Letter to GAO Comptroller General Walker in regard to an investigation into the efficiency of the agencies within the Committee's jurisdiction
Oct. 4, 2007 Letter to Navy General Counsel Jimenez requesting financial disclosure documents
Sept. 13, 2007 Letter to Giant Food, Inc. Chairman and CEO Alvarez in regard to meat that is packaged using in an atmosphere containing carbon monoxide

Oct. 11, 2007 response »

Sept. 13, 2007 Letter to Target Corporation Chairman and CEO Ulrich in regard to meat that is packaged using in an atmosphere containing carbon monoxide

Oct. 4, 2007 response »

Aug. 24, 2007 Letter to FDA Commissioner von Eschenbach in regard to reports of a plan to outsource FDA jobs to private companies

Oct. 31, 2007 response »
Sept. 4, 2007 response »

Aug. 13, 2007 Letter to Robert's American Gourmet Food, Inc. Chair Ehrlich in regard to a recent outbreak of Salmonella in the company's Veggie Booty Snack Food

Sept. 14, 2007 response »

July 31, 2007 Letter to The American Spice Trade Association Executive Director Deem in regard to concerns about the FDA contracting out surveillance and food sampling to private laboratories

Aug. 13, 2007 response »

July 31, 2007 Letter to Cheese Importers Association of America, Inc. President Lynch in regard to concerns about the FDA contracting out surveillance and food sampling to private laboratories
July 31, 2007 Letter to the National Fisheries Institute President Connelly in regard to concerns about the FDA contracting out surveillance and food sampling to private laboratories

Aug. 27, 2007 response »
Aug. 14, 2007 response »

July 31, 2007 Letter to Association of Food Industries, Inc. Chair Harloe in regard to concerns about the FDA contracting out surveillance and food sampling to private laboratories
July 31, 2007 Letter to Cocoa Merchants' Association of America, Inc. Director Day in regard to concerns about the FDA contracting out surveillance and food sampling to private laboratories

Aug. 28, 2007 response »

July 31, 2007 Letter to FDA Commissioner von Eschenbach in regard to the Agency's proposed reorganization

Sept. 6, 2007 response »

July 27, 2007 Letter to Bumble Bee Foods, LLC President and CEO Lischewski a recall of canned food products and dog food

Aug. 31, 2007 response »
Aug. 17, 2007 response »

July 27, 2007 Letter to FDA Commissioner von Eschenbach in regard to the use of carbon monoxide in treating meat which gives it the appearance of freshness after its date of expiration

Nov. 8, 2007 response »
Nov. 6, 2007 response »

Sept. 28, 2007 response »

July 22, 2008 Letter to FDA Commissioner von Eschenbach in regard to drugs sold in the U.S. by Ranbaxy, Inc. pdf file

August 28, 2008 response »

July 16, 2007 Letter to Safeway, Inc. Vice President McGinnis regarding the company's decision to cease sale of carbon monoxide treated meat
July 2, 2007 Letter to FDA Commissioner von Eschenbach in regard to FDA inspections of foreign manufacturing facilities in China and India
June 26, 2007 Letter to Tyson Foods, Inc. President and CEO Bond in regard to meat that is packaged using in an atmosphere containing carbon monoxide

Aug. 9, 2007 response »

June 26, 2007 Letter to Safeway, Inc. Chairman and CEO Burd in regard to meat that is packaged using in an atmosphere containing carbon monoxide

July 16, 2007 response »

June 26, 2007 Letter to Pactiv Corporation Chairman and CEO Wambold in regard to meat that is packaged using in an atmosphere containing carbon monoxide

July 24, 2007 response »

June 26, 2007 Letter to Hormel Foods Corporation and Cargill, Inc. in regard to the sale of meat that is packaged using an atmosphere containing carbon monoxide

Aug. 10, 2007 response »

June 21, 2007 Letter to Menu Foods Income Fund CEO Henderson in regard to additional questions for the record from the April 24, 2007 FDA Food Safety hearing

July 6, 2007 response »

 

June 21, 2007 Letter to GAO Acting Director Shames in regard to additional questions for the record from the April 24, 2007 FDA Food Safety hearing

July 6, 2007 response »

 

June 20, 2007 Letter to FDA Commissioner von Eschenbach in regard to the proposed closure of FDA laboratories

Aug. 29, 2007 response »

June 14, 2007 Letter to GAO Comptroller General Walker in regard to the contamination of pet-food containing the Chinese-imported "wheat-gluten"
June 6, 2007 Letter to Agriculture Under Secretary for Food Safety requesting more information regarding the safety of food imports from China

October 9, 2007 response »

June 5, 2007 Letter to FDA Commissioner von Eschenbach in regard to the increase of food imports from China and the safety of the imported products

July 9, 2007 response »

March 30, 2007 Letter to FDA Commissioner von Eschenbach in regard to the deaths of thousands of dogs and cats as a result of consuming contaminated pet food

Aug. 7, 2007 response »
June 7, 2007 response »

May 25, 2007 Letter to FDA Commissioner von Eschenbach requesting FDA documents pertaining to the investigation of the safety of food imported from China

Feb. 25, 2008 response »
Nov. 2, 2007 response »
Oct. 31, 2007 response
»
June 27, 2007 response »

May 10, 2007 Letter to U.S. Customs and Border Protection Commissioner Basham in regard to the importation of wheat gluten, soy gluten, rice gluten, rice protein and soy protein
March 6, 2007 Letter to ConAgra Foods, Inc. CEO Rodkin in regard to the outbreak of salmonella in peanut butter produced by the company

April 23, 2007 response »

Feb. 21, 2007 Letter to FDA Commissioner von Eschenbach requesting all information pertaining to outbreaks of salmonella in peanut butter and cantaloupes as well as botulism in baby food
Feb. 15, 2007 Letter to FDA Commissioner von Eschenbach regarding the Agency's efforts pertaining to E. Coli found in vegetables

April 20, 2007 response »

Jan. 29, 2007 Letter to FDA Commissioner von Eschenbach regarding the outbreaks of produce-related, food-borne illnesses

May 8, 2007 response »
April 18, 2007 response »

 

News Releases

"Dingell, Stupak Applaud FDA Steps on Food and Drug Safety, Pledge Continued Oversight" -- November 18, 2008

"Dingell, Stupak to Investigate Melamine Contamination in Chinese Milk Products" -- October 2, 2008

"Dingell, Stupak Applaud FDA’s Approval of Irradiation on Lettuce & Spinach; After Eight Years, FDA Finally Acts on Petition to Help Prevent Foodborne Illness" -- August 22, 2008

"Dingell, Stupak Continue Food Safety Investigation as FDA Struggles to Pinpoint Source of Salmonella Outbreak" -- July 2, 2008

"Dingell, Stupak ask Multinational Food Processors about Contamination" -- May 8, 2008

"Energy and Commerce Committee Subpoenas Hallmark/Westland Chief"
-- March 5, 2008

"How Much Will it Cost to Adequately Fund FDA’s Core Programs? Energy & Commerce Leaders Release Recommendations of Former Members and Advisors to FDA’s Science Advisory Board" -- February 26, 2007
read the letter to Committee Chairmen »
read the FDA's Science Board Report »

"Dingell Blasts Bush’s Health Care Cuts" -- February 4, 2008

"Key Lawmakers Seek Probe into Bottled Water, Drinking Water Issues" -- January 31, 2008

"Dingell, Stupak Comment on FDA Plan for Overseas Inspections" -- January 25, 2008

"FCC Chairman Martin Responds to Letter from Chairman Dingell on Commission Procedures" -- December 11, 2007

"Dingell Responds to Bush Administration Import Safety Proposal; Working Group Recommends Agency Expansions, Fails to Mention Funding" -- November 6, 2007

"Dingell, Stupak Assert that FDA Letter to Sanofi-Aventis Vindicates Whistleblowers; 'Warning Letter' Shows FDA Knew Ketek Safety Study Was Compromised" -- October 25, 2007

"Dingell, Stupak Praise Giant, Stop & Shop for Ceasing Sale of Meat Treated with Carbon Monoxide" -- October 16, 2007

"Dingell, Stupak Release Report on Safety of Food Imported from China; Announce Series of Hearings" -- October 5, 2007

"Dingell, Stupak Praise Tyson Foods for Ceasing Sale of Meat Treated with Carbon Monoxide" -- August 13, 2007

"Dingell, Stupak Praise Safeway, Inc. for Ceasing Sale of Meat Treated with Carbon Monoxide" -- July 25, 2007

"Dingell, Stupak Commend Increase of FDA Chinese Seafood Inspection, Demand Greater FDA Accountability in Protecting American Food Supply" -- June 29, 2007

"Dingell, Stupak Open Investigation into Safety of Meat Treated with Carbon Monoxide; Demand Answers from Safeway, Meat Packers" -- June 26, 2007

"Contamination of Chinese Wheat Gluten Widespread Dingell, Stupak Dispatch Investigators to West Coast Ports" -- April 30, 2007

Hearing Materials

July 31, 2008 The Recent Salmonella Outbreak: Lessons Learned and Consequences to Industry and Public Health
(Witness List & Testimony)



 
June 12, 2008 American Lives Still at Risk: When Will FDA’s Food Protection Plan Be Fully Funded and Implemented?
(Witness List & Testimony)



 
March 12, 2008 Regulatory Failure: Must America Live with Unsafe Food?
(Witness List & Testimony)



 
Feb. 26, 2008 Contaminated Food:  Private Sector Accountability
(Witness List & Testimony)


 

Jan. 29, 2008 Science and Mission at Risk: FDA’s Self-Assessment
(Witness List & Testimony)


 

Nov. 13, 2007 Diminished Capacity: Can the FDA Assure the Safety and Security of Our Nation’s Food Supply? – Part 4 – Deception in Labeling
(Witness List & Testimony)


 

Oct. 11, 2007 Diminished Capacity: Can the FDA Assure the Safety and Security of Our Nation’s Food Supply? – Part 3
(Witness List & Testimony)


 

July 17, 2007 Diminished Capacity: Can the FDA Assure the Safety and Security of Our Nation's Food Supply? - Part 2
(Witness List & Testimony)
April 24, 2007 Diminished Capacity: Can the FDA Assure the Safety and Security of the Nation's Food Supply?
(Witness List & Testimony)

May 24, 2007 ConAgra response »
May 11, 2007 ConAgra response »
May 3, 2007 Aero Environmental response »

 

Statements

July 31, 2008 Chairman Dingell at the Subcommittee on Oversight and Investigations hearing entitled, “The Recent Salmonella Outbreak: Lessons Learned and Consequences to Industry and Public Health”

 

July 31, 2008 Chairman Stupak at the Hearing entitled, "The Recent Salmonella Outbreak: Lessons Learned and Consequences to Industry and Public Health"
June 12, 2008 Chairman Dingell at the Subcommittee on Oversight and Investigations Hearing entitled, “American Lives Still at Risk: When Will FDA’s Food Protection Plan Be Fully Funded and Implemented?”

 

June 12, 2008 Chairman Stupak at the Hearing entitled “American Lives Still at Risk: When Will FDA’s Food Protection Plan Be Fully Funded and Implemented?”

 

March 12, 2008 Chairman Dingell at the Subcommittee on Oversight and Investigations hearing entitled, "Regulatory Failure: Must America Live with Unsafe Food?"

 

March 12, 2008 Chairman Stupak at the Hearing entitled "Regulatory Failure: Must America Live with Unsafe Food?"

 

Feb. 26, 2008 Chairman Stupak at the Hearing entitled, "Contaminated Food: Private Sector Accountability"
Feb. 26, 2008 Chairman Dingell at the Hearing entitled, "Contaminated Food: Private Sector Accountability"
Jan. 29, 2008 Chairman Stupak at the Hearing entitled, "Science and Mission at Risk: FDA’s Self-Assessment"
Jan. 29, 2008 Chairman Dingell at the Hearing entitled, "Science and Mission at Risk: FDA’s Self-Assessment"
Oct. 11, 2007 Chairman Stupak at the Hearing entitled "Diminished Capacity: Can the FDA Assure the Safety and Security of the Nation's Food Supply? - Part III"

 

Oct. 11, 2007 Chairman Dingell at the Hearing entitled "Diminished Capacity: Can the FDA Assure the Safety and Security of the Nation's Food Supply? - Part III"

 

July 17, 2007 Chairman Stupak at the Subcommittee on Oversight and Investigations hearing entitled "Diminished Capacity: Can the FDA Assure the Safety and Security of the Nation's Food Supply? - Part 2"

 

July 17, 2007 Chairman Dingell at the Subcommittee on Oversight and Investigations hearing entitled "Diminished Capacity: Can the FDA Assure the Safety and Security of the Nation's Food Supply? - Part 2"

 

April 24, 2007 Chairman Stupak at the hearing entitled "Diminished Capacity: Can the FDA Assure the Safety and Security of the Nation's Food Supply?"

 

April 24, 2007 Chairman Dingell at the hearing entitled "Diminished Capacity: Can the FDA Assure the Safety and Security of the Nation's Food Supply?"

 

 

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