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

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Written by Administrator   
Friday, 18 October 2013 23:52

A VERY CORRUPT AND INFILTRATED FDA!
  

Friday, October 18, 2013 by: Ethan A. Huff, staff writer
  
(NaturalNews) It is now an undeniable fact that the pharmaceutical industry weaseled its way onto key U.S. Food and Drug Administration (FDA) advisory panels, which were instrumental in shaping the way drugs are safety tested and approved. According to The Washington Post (WP), a recent public records request has revealed that drug companies purchased special access onto these panels, where they were given the keys to the kingdom in swaying decision-makers about official drug policy.

Based on critical information gathered from hundreds of leaked emails, pharmaceutical companies have doled out hundreds of thousands of dollars over the years to attend private meetings with the FDA, many of which were geared towards the regulation and approval of painkiller drugs. Drug companies would reportedly shell out upwards of $25,000 or more per meeting to have their voices heard, a small price to pay for direct access to the $9 billion American painkiller market.

According to the WP, officials from both the FDA and the U.S. National Institutes of Health (NIH) would regularly meet with pharmaceutical representatives in private to discuss regulatory protocols, co-write scientific papers and collaborate on various ways to help streamline the drug approval process. And the only parties who actually paid to attend such meetings were the drug companies, a fact that one official from the NIH expressed serious concerns about in an email, referring to the whole scheme as a "pay to play process."

Others who have since reviewed the emails agree, noting that, while the FDA did not necessarily benefit financially from these private meetings, many FDA officials went on to work as pharmaceutical consultants. In other words, FDA staff who agreed to grease the palms of the drug industry during these private meetings were later rewarded with high-paying positions in the drug industry. This is just one glaring example of how the line between the regulator (FDA) and the regulated (pharmaceutical companies) has been blurred beyond recognition.

"These e-mails help explain the disastrous decisions the FDA's analgesic division has made over the last 10 years," said Craig Mayton, the Columbus, Ohio, attorney who made the public records request to the University of Washington, to the WP. "Instead of protecting the public health, the FDA has been allowing the drug companies to pay for a seat at a small table where all the rules were written."

Big Pharma, FDA corruption runs deepIt is no longer a conspiracy theory, then, that the drug industry owns the FDA. In this particular case, it was two academics by the names of Robert Dworkin, from the University of Rochester, and Dennis Turk, from the University of Washington, who allegedly orchestrated the painkiller plot. But there have been many other plots with the same ultimate end, a fact that NaturalNews and many others in the so-called "alternative" media have been shouting from the rooftops for years, but that the mainstream media has ignored, until now.

"Shame on the FDA and NIH for sending representatives to this panel, cooked up by two unethical professors and their drug company cronies," wrote one WP commenter about the scandal. It should be noted that FDA officials actively participated in the painkiller scheme, all the while knowing full well that the private meetings they attended were hatched by Big Pharma. "Congress should come down hard on both agencies for participating in what was clearly pay-to-play, with awful consequences for the health of many suffering Americans."

Such consequences include a flood of dangerous analgesic drugs to the market that were approved based on questionable or flawed safety studies. According to MedpageToday.com, the drug industry was successful during these meetings in convincing the FDA to adopt an "enriched enrollment" guidance for safety trials that eliminated patients who experienced adverse reactions.
These and other modifications made it much easier for drugs to be declared safe and effective, and thus gain rapid approval.

Sources for this article include:
 
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Petition to Ban LASIK

Human Geneticist and Biochemist Lauranell Burch has filed a petition with the FDA to ban LASIK. If you have complications from LASIK, you will want to comment. Be sure to include any deception in how LASIK was sold to you, inadequacy of informed consent, denial of your problems by your surgeon and second opinion surgeon, your vision immediately after your surgery and your vision now, and any feelings of depression and suicidal ideation, since these are common in patients with severe complications. You can comment here.

Due to enormous public outcry, the FDA is at last formally receiving general comments on LASIK here.

NOTICE:The FDA is currently assisting the LASIK industry in its medical coverup by censoring many patient comments to the petition, in clear violation of Federal Law. If you do not see your comment reflected, you now know why.

You know Big Pharma, now Meet Big Lasik

The pharmaceutical industry has pushed new drugs on physicians and an unsuspecting public for years, while covering up risks and failures, often with the implicit cooperation of the FDA. What you may not realize is that many medical device manufacturers are now doing exactly the same.

One of the most lucrative markets for medical devices is laser eye surgery, also known as "Big Lasik." According to the LASIK industry and the FDA, the popular eye surgery is both "safe and effective." If this is true, then why are there so many patients with complications? Why do so many patients want to commit suicide because of bad LASIK?


Dr. Michael Mullery: "The refractive surgery industry has known since it's inception that LASIK surgery carries a risk of depression and suicide..."


Dr. Terrilyn Bankes: "I fail to understand how the ophthalmologic community can defend the continuing production of life altering complications, and I view it as a true disgrace of modern medicine."


Edward Boshnick, OD: "I feel at the present time LASIK presents a significant public health crisis."


David Hartzok, OD: (Presented by Glenn Hagele) "The loss of visual quality reduces patients' overall sense of well-being and leads to depression and chronic anxiety."


Roger Davis, PhD: "While Director of Research, we submitted a study on depression and suicidal thoughts to a major refractive surgery journal. Among 58 patients admitting suicidal ideation, 83 percent stated they were told they were a success by their surgeon.


Diana Zuckerman, PhD: "Research that was just published this year in the American Journal of Ophthalmology reported that 28 percent -- 28 percent of eyes corrected through LASIK needed re-treatment within 10 years...


Michael Patterson, PhD: "The FDA states safety was determined with a risk/benefit analysis, but where is it? Make the formal risk/benefit analyses public. ...Quality of vision and Dry Eye risks were not evaluated. I believe no risk/benefit analysis was actually done.