Big Tobacco's Striking Parallels with Big LASIK

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

• For many years, the tobacco industry depended heavily on advertising.  Big Tobacco marketed smoking as hip and cool.  The LASIK industry also depends heavily on advertising.  Big LASIK marketing portrays glasses and contact lenses as uncool and restrictive.  



• Big Tobacco relies on peer-pressure from young people to entice their friends into the deadly habit of smoking.  Big LASIK relies on testimonials and word-of-mouth promotion.  LASIK patients are encouraged, and sometimes even paid, to refer friends and family members to have a medically unnecessary and risky surgery.



• Big Tobacco sold a product which contains dangerous chemicals and an addictive drug, nicotene, which gives instant pleasure and satisfaction to users. Big LASIK sells a harmful surgery which gives patients an immediate sense of joy and excitement (wow factor) when they realize they can see without glasses or contacts, leading to a high initial rate of satisfaction.   



• Big Tobacco manipulated medical studies about the dangers of smoking. Big LASIK manipulates medical studies and publishes junk science to cover up the dangers of LASIK.



• Big Tobacco said that drinking one to two glasses of whole milk a day was riskier than second-hand smoke. Big LASIK says that wearing contact lenses is riskier than having LASIK surgery. 



• Big Tobacco advertised low-tar cigarettes as "the cigarette that takes the FEAR out of smoking." Big LASIK currently advertises blade-free LASIK as the technology that takes the FEAR out of LASIK.



• Big Tobacco said that "unhappiness causes cancer." Big LASIK says that patient personality factors are to blame for LASIK dissatisfaction.



• Big Tobacco attempted to silence and discredit its critics. Tobacco industry whistleblowers were threatened and harassed. Big LASIK attempts to discredit outspoken critics of LASIK.  LASIK patients who speak out about problems with the procedure are threatened and harassed. 



• Big Tobacco lied before Congress about the harmful health effects of smoking. Big LASIK lied before the Food and Drug Administration about the harmful effects of LASIK.



• Smoking can lead to cataracts, the number one cause of vision loss in the world. LASIK can lead to cataracts.  Also, steriods drops routinely prescibed after LASIK may hasten onset of cataracts.  Ironically, LASIK complicates cataract surgery. 



• The damaging health effects of smoking are slow and insidious.  Smokers may not realize or acknowledge harm from cigarette use for years; nonetheless, the damage is there. LASIK patients may suffer obvious and immediate complications, but some universal adverse effects of LASIK are insidious.  LASIK patients may not realize or acknowledge the harm they suffered from LASIK for years; nonetheless, the damage is there. 



• Tobacco use is the number one cause of preventable death in America. LASIK is becoming a leading cause of preventable vision loss in America.

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.