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 Drug Safety PDF Print E-mail

FDA Drug Safety

SOURCE

Letters (Letters are in Adobe pdf format)

October 8, 2008 Letter to FDA Commissioner von Eschenbach regarding Actavis Totawa, LLC pdf file
Sept. 19, 2008 Letter to Secretary Rice regarding the expansion of Ranbaxy Probe to Include PEPFAR Program
Sept. 2, 2008 Letter to Schering-Plough and Merck on Vytorin-Cancer Link pdf file

Read the Report on the Simvastatin and
Ezetimibe in Aortic Stenosis (SEAS) Study »

August 21, 2008 Letter to companies Schering-Plough and Merck & Company regarding the safety of Vytorin and Conflicting Study Data

September 4, 2008 Response »

July 31, 2008 Letter to the head of Wyeth Pharmaceuticals regarding a clinical trial being conducted in Ghana to test whether moxidectin can inhibit the production of the parasite associated with river blindness
July 22, 2008 Letter to FDA Commissioner von Eschenbach in regard to drugs sold in the U.S. by Ranbaxy, Inc.

August 28, 2008 Response »

June 25, 2008 Letters to FDA Commissioner von Eschenbach in regard to adverse events linked to the the ProHeart 6 canine heartworm treatment

Letter requesting documents »
Letter requesting information »

April 30, 2008

Letter to FDA Commissioner von Eschenbach in regard to the recent outbreak of Salmonella associated with cantaloupe from Honduras pdf file

August 21, 2008, response »

 

April 11, 2008 Letter to Schering-Plough Corporation and Merck and Co., Inc. in regard to the Committee's continuing investigation of the ENHANCE trial

April 25, 2008 response »

 

March 31, 2008 Letter to Johnson & Johnson and Amgen Inc., requesting documents relating to the marketing strategies of a class of drugs known as Erythropoiesis-Stimulating Agents (ESAs)

read the Johnson & Johnson Letter »
read the Amgen Inc., Letter »

March 28, 2008 Letter to FDA Commissioner von Eschenbach requesting personnel files of those FDA employees involved in the failed effort to inspect Chinese facilities that supplied bulk heparin to Baxter Laboratories
March 19, 2008 Letter to FDA Commissioner von Eschenbach requesting documents relating to confusion over which Chinese facility supplied bulk heparin
March 12, 2008 Letter to Scientific Protein Laboratories, LLC CEO Strunce requesting information about the company's involvement in the heparin recall

April 2, 2008 response »
March 31, 2008 response »

March 6, 2008 Letter to FDA Commissioner von Eschenbach in regard to a class of drugs known as Erythropoiesis-Stimulating Agents

April 16, 2008 response »

March 5, 2008 Letter to HHS Secretary Leavitt in regard to the Agency's offer to access records related to Dr. von Eschenbach's testimony before the Committee March 22, 2007
Feb. 21, 2008 Letter to Baxter International Inc in regard to Baxter International's manufactured blood-thinning drug Heparin

March 4, 2008 response »

Feb. 21, 2008 Letter to HHS Secretary Leavitt in regard to Baxter International's manufactured blood-thinning drug Heparin

May 15, 2008 FDA response »
April 17, 2008 response »

February 25, 2008 response »
 

Feb. 21, 2008 Letter to FDA Commissioner von Eschenbach in regard to Baxter International's manufactured blood-thinning drug Heparin
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 FDA Commissioner von Eschenbach in regard to a Chinese facility which produces a drug that has been associated with hundreds of adverse events

April 24, 2008 response »
March 5, 2008 response »

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

April 28, 2008 response »
March 18, 2008 response »

Feb. 11, 2008 Letter to FDA Commissioner von Eschenbach requesting further information regarding the ENHANCE trial

April 10, 2008 response »
March 20, 2008 response »
March 3, 2008 response »

Feb. 7, 2008 Letter to FDA Commissioner von Eschenbach requesting further information regarding findings by the Science Board
Jan. 24, 2008 Letter to Schering-Plough Corporation and Merck & Co., Inc. in regard to the withholding of clinical data during the ENHANCE trial
Jan. 24, 2008 Letter to American College of Cardiology CEO Lewin in regard to the withholding of clinical data during the ENHANCE trial

February 11, 2008 response »

Jan. 24, 2008 Letter to American Heart Association CEO Wheeler in regard to the withholding of clinical data during the ENHANCE trial
Jan. 22, 2008 Letter to Schering-Plough Corporation and Merck and Co., Inc. in regard to the Committee's ongoing investigation into Vytorin and the ENHANCE trial
Jan. 22, 2008 Letter to Health and Human Services in regard to the Committee's ongoing investigation into Vytorin and the ENHANCE trial

February 11, 2008 response »

Jan. 22, 2008 Letter to FDA Commissioner von Eschenbach in regard to the Committee's ongoing investigation into Vytorin and the ENHANCE trial
Jan. 16, 2008 Letter to GAO Comptroller General Walker requesting more information on a possible third class of "Behind-the-Counter" drugs

January 24, 2008 response »

Jan. 16, 2008 Letter to Schering-Plough Corporation and Merck and Co., Inc. in regard to concerns about misleading stat aments in Direct-to-Consumer advertisements of prescription drugs
Jan. 16, 2008 Letter to FDA Commissioner von Eschenbach in regard to concerns about misleading stat aments in Direct-to-Consumer advertisements of prescription drugs

February 1, 2008 response »

Jan. 7, 2008 Letter to CEO and Chairman of the Board Kindler of Pfizer, Inc., in regard to Dr. Robert Jarvik's endorsement of the drug Lipitor
Dec. 13, 2007 Letter to HHS Secretary Leavitt in regard to the recently signed Memorandum of Agreements between China and the United States
Dec. 11, 2007 Letter to Schering-Plough Corporation and Merck & Co., Inc. in regard to withholding of clinical trial data relating to the medical management of hypercholesterolemia
Nov. 26, 2007 Letter to FDA Commissioner von Eschenbach in regard to a report linking use of the the drug Trasylol with increased risk of renal failure and mortality

March 25, 2008 response »
February 6, 2008 response »

Oct. 30, 2007 Letter to Housing and Urban Development Inspector General in regard to allegations of misconduct at the FDA
Oct. 12, 2007 Letter to FDA Commissioner von Eschenbach in regard to observations from a Committee staff oversight trip to China and India
Oct. 2, 2007 Letter to FDA Commissioner von Eschenbach in regard to imported prescription drugs and concerns about their ingredients
Oct. 1, 2007 Letter to CDC Director Gerberding in regard to the continued indiscriminate use of animal antibiotics

Dec. 7, 2007 response »

Aug. 20, 2007 Letter to FDA Commissioner von Eschenbach in regard to FDA inspections of drug manufacturing plants in China and India
Aug. 1, 2007 Letter to GAO Comptroller General Walker requesting a GAO report on the FDA's ability to assure the safety of the drug supply

Aug. 16, 2007 response »

July 5, 2007 Letter to FDA Commissioner von Eschenbach in regard to the conduct of FDA officials in the Avandia matter

August 23, 2007 response »

July 2, 2007 Letter to FDA Commissioner von Eschenbach announcing an investigation of FDA inspections of foreign manufacturing facilities
June 15, 2007 Letter to HHS Secretary Leavitt regarding concerns about Erythropoiesis-Stimulating Agents (ESAs) when used at higher than recommended doses

June 2, 2008 response »
April 17, 2008 response »
January 10, 2008 response »
September 27, 2007 response »

March 28, 2007 Letter to HHS Secretary Leavitt in regard to the accuracy of FDA Commissioner von Eschenbach's testimony at the Committee's March 22, 2007 hearing

April 11, 2007 response »
June 7, 2007 response »

March 20, 2007 Letter to Amgen Chairman, CEO, and President Sharer in regard to the increased risk of blood clots and tumor growths for patients taking the drugs trade-named Aranap and Epogen

April 18, 2007 response »

March 20, 2007 Letter to Johnson & Johnson Chairman and CEO Weldon in regard to the increased risk of blood clots and tumor growths for patients taking the drug trade-named Procrit

April 18, 2007 response »
August 10, 2007 response »

 

March 14, 2007 Letter to David Ross in regard to additional questions for the record from the Feb. 13, 2007 Drug Safety hearing
March 14, 2007 Letter to John Powers in regard to additional questions for the record from the Feb. 13, 2007 Drug Safety hearing
March 14, 2007 Twenty organizations and individuals write open letter to Congress in regard to events at the FDA and the implications on the nation's health
March 9, 2007 Letter to Group Pharmaceutical Activities Chairman Rothwell in regard to the circumstances surrounding the FDA's approval of the Sanofi-Aventis antibiotic Ketek

June 1, 2007 response »

March 9, 2007 Senator Grassley writes FDA Commissioner von Eschenbach in regard to an FDA employees testifying before Congress
March 6, 2007 Letter from witness, Ann Marie Cisneros in response to questions posed by Ranking Member Barton regarding additional questions for the record from the Feb. 13, 2007 Drug Safety hearing

 

April 25, 2007 Letter to GAO Director for Public Health and Military Health Care Issues Crosse in regard to additional questions for the record from the March 22, 2007 Drug Safety hearing

response »

 

April 25, 2007 Letter to University of Washington Professor Psaty in regard to additional questions for the record from the March 22, 2007 Drug Safety hearing

May 1, 2007 response »

 

April 25, 2007 Letter to the FDA Commissioner von Eschenbach in regard to additional questions for the record from the March 22, 2007 FDA Drug Safety hearing

May 30, 2007 response »

 

April 24, 2007 Letter to Wake Forest University Professor Furberg in regard to additional questions for the record from the March 22, 2007 FDA Drug Safety hearing

May 7 , 2007 response »
response »

 

April 24, 2007 Letter to the Critical Path Institute President and CEO Woosley in regard to additional questions for the record from the March 22, 2007 FDA Drug Safety hearing

response »

 

April 18, 2007 Letter to Commissioner von Eschenbach in regard to the risks associated with antibiotic-treated animals entering the food supply

June 5, 2007 response »

Feb. 27, 2007 Letter to Copernicus Group Chairman and CEO Hill in regard to circumstances surrounding the FDA's approval of the Sanofi-Aventis antibiotic Ketek
Feb. 27, 2007 Letter to PPD CEO Eshelman in regard to circumstances surrounding the FDA's approval of the Sanofi-Aventis antibiotic Ketek

April 13, 2007 response »
March 30, 2007 response
»
March 28, 2007 response »

March 22, 2007 response »

March 15, 2007 response »

March 8, 2007 response »

Feb. 16, 2007 Letter to HHS Secretary Leavitt in regard to the management of drug safety issues specific to the drug Ketek

July 24, 2007 response »
July 19, 2007 response
»
May 17, 2007 response »

April 25, 2007 response »
April 4, 2007 response »

March 29, 2007 response »
March 1, 2007 response »

Jan. 29, 2007 Letter to FDA Commissioner von Eschenbach in regard to the adequacy of resources devoted to the Office of Generic Drugs

 

News Releases

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

"GAO Report Finds FDA’s Foreign Drug Inspection Program Needs Significant Improvement" -- October 22, 2008

"Dingell, Stupak Again Question Whether FDA Knowingly Allowed Dangerous Drugs to be Sold to U.S. Consumers" -- October 8, 2008

"Committee Expands Ranbaxy Probe to Include PEPFAR Program" -- September 19, 2008

"Dingell, Stupak Respond to FDA’s Ranbaxy Announcement" -- September 16, 2008

"Dingell, Stupak Write Schering-Plough and Merch on Vytorin-Cancer Link" -- September 2, 2008

"Dingell, Stupak Question Drug Makers on Safety of Vytorin and Conflicting Study Data; Recent Study Links Vytorin to Increased Cancer Risk" -- August 21, 2008

"Dingell, Stupak Applaud FDA for ESA Label Change" -- August 5, 2008

"Dingell, Stupak Comment on Latest Developments in FDA Salmonella Investigation" -- July 21, 2008

"Dingell, Stupak to Investigate Ranbaxy Drug Approvals" -- July 22, 2008

"Dingell, Stupak Comment on Results of New Vytorin Study" -- July 22, 2008

"Dingell, Stupak Question Whether FDA Knowingly Allowed Potentially Unsafe & Ineffective Drugs into the U.S. Marketplace" -- July 17, 2008

"Dingell, Stupak Question FDA’s Re-approval of ProHeart6" -- June 25, 2008

"After Review of ENHANCE Trial Documents, Dingell, Stupak Express 'Serious Concerns'" -- April 15, 2008

"Committee Panel to Hold Hearings on Heparin Failures" -- March 19, 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, 2008
read the letter to Committee Chairmen »
read the FDA's Science Board Report »

"Continues Investigation into Celebrity Drug Endorsements" -- February 7, 2008

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

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

"Dingell, Stupak Question Merck/Schering-Plough’s Sponsorship of American College of Cardiology and American Heart Association" -- January 24, 2008

"Dingell, Stupak Comment on Decision to Pull Vytorin Ads" -- January 23, 2008

"Dingell, Stupak Raise Concerns, Questions on ENHANCE Trial" -- January 16, 2008

"Dingell, Stupak to Continue ENHANCE Trial Investigation" -- January 14, 2008

"Dingell, Stupak Not Satisfied With FDA Response to Committee Requests; Will Consider Other Options to Fulfill Requests" -- May 24, 2007

"Dingell, Stupak Question FDA & Glaxo for Failing to Warn Diabetics of Dangers of Avandia" -- May 21, 2007

"Dingell, Stupak Call on Amgen, Johnson & Johnson to Suspend Direct-to-Consumer Marketing for Anemia Drugs" -- March 21, 2007

Hearing Materials

April 29, 2008 The Heparin Disaster: Chinese Counterfeits and American Failures (Witness List & Testimony)

Powerpoint slides »


 

February 12, 2008 Ketek Clinical Study Fraud: What Did Aventis Know?
(Witness List & Testimony)

Exhibit Binder »


 

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

 


 

November 1, 2007 FDA Foreign Drug Inspection Program: A System at Risk
(Witness List & Testimony)

 

March 22, 2007 The Adequacy of FDA to Assure the Safety of the Drug Supply - Part II (Witness List & Testimony)

Pediatric Exclusivity Labeling Changes »

February 13, 2007 The Adequacy of FDA Efforts to Assure the Safety of the Drug Supply (Witness List & Testimony)

Statements

May 8, 2008 Chairman Stupak at the hearing entitled "Direct-to-Consumer Advertising: Marketing, Education, or Deception?"
May 8, 2008 Chairman Dingell at the hearing entitled "Direct-to-Consumer Advertising: Marketing, Education, or Deception?"
April 29, 2008 Chairman Dingell at the hearing entitled "The Heparin Disaster: Chinese Counterfeits and American Failures"
April 29, 2008 Chairman Stupak at the hearing entitled "The Heparin Disaster: Chinese Counterfeits and American Failures"
April 22, 2008 Chairman Stupak at the hearing entitled "FDA’s Foreign Drug Inspection Program: Weaknesses Place Americans at Risk"
April 22, 2008 Chairman Dingell at the hearing entitled "FDA’s Foreign Drug Inspection Program: Weaknesses Place Americans at Risk"
February 12, 2008 Chairman Dingell at the hearing entitled "Ketek Clinical Study Fraud: What Did Aventis Know"
February 12, 2008 Chairman Stupak at the hearing entitled "Ketek Clinical Study Fraud: What Did Aventis Know"
January 29, 2008 Chairman Dingell at the hearing entitled "Science and Mission at Risk: FDA’s Self-Assessment"
January 29, 2008 Chairman Stupak at the hearing entitled "Science and Mission at Risk: FDA’s Self-Assessment"
March 22, 2007 Chairman Dingell at the hearing entitled "The Adequacy of the FDA Efforts to Assure the Safety of the Drug Supply Part II"
March 22, 2007 Chairman Stupak at the hearing entitled "The Adequacy of the FDA Efforts to Assure the Safety of the Drug Supply Part II"
February 13, 2007 Chairman Stupak at the hearing entitled "The Adequacy of FDA Efforts to Assure the Safety of the Drug Supply"
February 13, 2007 Chairman Dingell at the hearing entitled "The Adequacy of FDA Efforts to Assure the Safety of the Drug Supply"
November 1, 2007 Chairman Dingell at the hearing entitled "FDA Foreign Drug Inspection Program: A System At Risk"
November 1, 2007 Chairman Stupak at the hearing entitled "FDA Foreign Drug Inspection Program: A System at Risk"

 

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