Question: What do the LASIK industry and the tobacco industry have in common? Answer: A smokescreen to hide the truth.
Thousands of lives have been wrecked by LASIK, an unnecessary, irreversible, harmful surgery that is marketed as if it's as safe as a haircut. Representatives of the LASIK industry attempt to stifle free speech regarding LASIK risks and long-term adverse effects through a campaign of harassment, surveillance, background investigations, publication of personal identification information, character assassination, criminal acts, and malicious lawsuits against LASIK critics. The public perception of LASIK is formed by marketing hype and happy patient testimonials, while accounts of patients who suffer debilitating dry eyes, visual impairment, and diminished quality of life are swept under the rug.
We present striking parallels between Big Tobacco and the lucrative business of LASIK. For example, seven tobacco industry executives testified before a Congressional subcommittee in 1994 that "nicotene is not addictive". Even more shocking, a tobacco company executive said on camera that smoking is safe for pregnant women. The Big Tobacco cover-up foreshadowed the Big LASIK cover-up. In 2008, LASIK industry representatives testified at an FDA hearing that LASIK is safe, and described LASIK complications as rare, temporary "side effects". Talking points heard from LASIK proponents included blaming complications on older technology, consistent with talking points advancing elective eye surgery over the past 20 years. As problems of one technology emerge, it is replaced with another technology, and the cycle is repeated. RK (radial keratotomy) was abandoned in favor of PRK, which was abandoned in favor of LASIK, which has already been abandoned by some surgeons in favor of a re-branded form of PRK or intraocular lenses.
Former tobacco industry insider, turned whistleblower, Jeffrey Wigand, PhD.
Jeffrey Wigand, PhD exposed the dirty secrets of the tobacco industry, which led to the historic $368 billion settlement between the Attorneys General of 40 States and Big Tobacco. The tobacco industry tried to destroy him. Dr. Wigand knows that he did the right thing and has no regrets. He is a national hero.
Former FDA insider, turned whistleblower, Morris Waxler, PhD.
In 2009 Morris Waxler, PhD, a former FDA official who played a key role in FDA-approval of LASIK lasers, began speaking out about LASIK risks after learning of widespread adverse effects of the procedure. Waxler reviewed the data from LASIK clinical trials, including newer laser technologies, and found that the true incidence of complications -- buried within the data -- approximated 20 percent, which failed to meet safety requirements for approval. In early 2011, Waxler filed a citizen's petition with the FDA requesting that the agency withdraw approval for all LASIK devices and issue a Public Health Advisory with a voluntary recall of LASIK devices. Waxler wrote in the petition, "The urgency and enormity of the threat of LASIK devices to public health and safety indicate further need for involvement of FDA's Office of Criminal Investigation (OCI), the House Energy and Commerce Committee's oversight and investigations subcommittee and other congressional leaders in this matter." Six months later the FDA sent an interim response advising Waxler that the agency needed more time for "further review and analysis". While the FDA drags its feet, each year hundreds of thousands of U.S. citizens will undergo LASIK believing the procedure to be safe. The LASIK industry has tried to destroy Dr. Waxler's reputation, but he has not backed down. He is a hero to many damaged LASIK patients.
You Know Big Tobacco, Now Meet Big LASIK
LASIK industry representatives testified at an April 2008 FDA hearing on LASIK
Excerpts from summary minutes of FDA hearing:
Dr. Peter McDonnell spoke on behalf of the International Society of Refractive Surgeons of the American Academy of Ophthalmology (ISRS of AAO). He said LASIK is the most studied elective ophthalmic procedure, that it has benefited millions of patients, and that there have been incremental improvements to the procedure. He also said that most complications can be treated without any vision loss, and that side effects resolve after 3 to 6 months.
Dr. Eric Donnenfeld spoke for the American Society of Cataract and Refractive Surgery (ASCRS). He said that the majority of patients see better after the surgery than they did with glasses or contacts* and that the lifetime risk of infection with contact lenses is over 100 times higher than with LASIK. Donnenfeld said that the LASIK Task Force of the ASCRS reviewed the world's literature on dry eye and found that 35 percent of patients had dry eye after the procedure, but 32 percent had it before the procedure. He said that severe dry eye following LASIK is rare.
*Editor's note: This claim is inconsistent with statements by U.S. Army LASIK surgeon, Lt. Col. Scott Barnes, who stated that 50% of soldiers have worse vision after LASIK than they did with their contacts. Source
Dr. Steve Schallhorn spoke for the American Academy of Ophthalmology (AAO). He said that LASIK is safe and effective and that patient satisfaction is excellent. In response to questions from the FDA panel chairperson, Dr. Schallhorn said that disabling complications are "very, very rare", "much less than one percent". Link to transcript, page 201.
Watch videos of McDonnell, Donnenfeld, and Schallhorn testifying at the April 2008 FDA hearing on LASIK.
Editor's note: Pay close attention to financial disclosures given at the beginning of the doctors' testimony. Also, for your information, Dr. Steve Schallhorn is a paid medical malpractice defense expert witness, and has made public statements and published literature denying connection between a poor LASIK outcome and diminished quality of life. Dr. Schallhorn is currently medical director of one of the largest corporate providers of LASIK in the world.
Websites like this one branded "malicious"?
"An estimated 8 million Americans have had a successful LASIK procedure, and most are anxious to discuss their results with friends and family. This positive word of mouth will offset the negative impact of distorted media reporting and malicious Web sites."
Source: Harmon, David. "The LASIK Market: Yesterday's Technology or Poised for Recovery?" Cataract & Refractive Surgery Today Aug 2011. Accessed 21 Aug 2011 at http://bmctoday.net/crstoday/2011/08/article.asp?f=the-lasik-market-yesterdays-technology-or-poised-for-recovery
Summary: Big LASIK is selling a harmful, unnecessary surgery, and covering up the truth about LASIK risks and long-term adverse effects. Don't let Big LASIK blow smoke in your eyes.