Oil Spill Has a Lesson for FDA: Federal Impotence

05/25/2010

[Analysis by Jim Dickinson*] Some sides see it as that old Washington blame game -- the Gulf of Mexico oil spill is "Obama's Katrina." That may be so, but nevertheless, there is a sobering message for FDA in this disaster.

If only it could be as small as Katrina! It may be an oily albatross around Obama's neck that could outlast Katrina and the Bush era by decades and saddle the President with a legacy more humbling than Jimmy Carter's: in a word, public ineffectuality.

It seems that almost everything Obama has attempted has been either over-reach or much less than it seems -- in other words, ineffectual in the Carter sense. It is very hard, 30 years out, to remember what Carter's presidency left us. Like other one-term presidents, perhaps it was just that he was a good-hearted, idealistic leader who left no lasting marks on government.

At FDA, this may be what the Obama administration also will leave us. To say this is not to demean the dedication of the true believers Obama sent to FDA, or their sincerity. Instead, it is to recognize what is so evident in the Gulf of Mexico: the ineffectuality of the federal government when crises erupt and defy distant, central control.

As it was in Bush's time, so it also is in Obama's: Central control, seemingly effective in other countries that have foreign histories, doesn't work in the decentralized American culture. Our culture was uniquely born in defiance of central control; it will not easily be "Europeanized."

U.S. Coast Guard Commander Thad Allen told the media 5/24 he would not recommend government takeover of the oil spill in the Gulf. His main reason was that the expertise to handle it lay beyond federal hands.

Similarly, in combating the illegal immigration invasion of our border with Mexico, and its ruthless and parallel bloody drug war, the federal government has shrunk so much from the challenge that 17 states are reportedly following Arizona's example in trying to intrude on a federal responsibility.

So it may be with FDA's inability to discharge the unprecedented burdens placed on it, as a central authority in charge of how health products enter the U.S. market, and in charge of what is said about them and their effects. For many years as an economy measure the agency has been outsourcing much of the scientific and technical expertise on which its decision-making may rely. Does this unavoidably lessen its control over the factors impacting regulatory decisions?

One-fourth of the U.S. economy is regulated by FDA, yet the agency seems increasingly unable to prevent catastrophic accidents like tainted heparin from China, food and drug contamination from multiple other sources, data fraud in clinical trials and reckless/negligent manufacturing practices both at home and abroad.

As such incapacities provoke public criticism, FDA has answered by applying central control over the news media, lest lack of confidence in its mission be spread. As just one example, our questions since mid-March to find out who is conducting the joint FDA-Department of Defense study of LASIK post-surgical outcomes and the study's protocol have been routinely deflected by the FDA Press Office, the sole entry-point into the agency for the news media.

Why? Nobody, not even principal deputy commissioner Joshua Sharfstein, who heads the agency's much-promoted Transparency Task Force, will answer. The hypothesis this presents is: Was the FDA-DoD LASIK outcomes study given to pro-LASIK Navy surgeons to achieve a biased result that would (a) vindicate CDRH's 1997 approval of the LASIK indication despite the chief approver's public recanting of that decision since, and (b) rescue an entire industry from liability lawsuits?

Other examples of FDA ineffectuality have been long documented on this Web site, including the agency's failure to master the regulatory science on mercury evident in last year's dental amalgam rule, the disarray in the 510(k) program, the agency's dependency on industry in the BPA controversy, its humiliation in the Plan B fiasco, and numerous others -- all the result of apparent inner weakness in the face of outside, publicly unaccountable special interests. To this list could be added the less-visible sheltering of agency officials from public accountability, a byproduct of undocumented restrictive media access policies since the preceding Administration erected unconstitutional barriers that many vulnerable managers welcomed.

If this sounds a little like the oversight that the U.S. Minerals Management Service was supposed to exercise over BP in the Gulf of Mexico but didn't, it is meant to. "Over time," writes Atlanta Journal-Constitution blogger Jay Bookman, "MMS became captive to the industries it was supposed to regulate, serving as an advocate for industry interests and an apologist for its excesses and repeatedly siding with the industry over the taxpayer on financial issues." A 5/25 posting on MMS' parent Department of the Interior Web site discloses management and staff misconduct reminiscent of FDA's own generic drug scandal 20 years ago, only more blatant and imbedded.

Does daylight-shielded MMS sound a teensy bit like daylight-shielded FDA? Or like most other daylight-shielded federal departments and agencies whose performance under stress repeatedly leaves the U.S. public disillusioned with Washington? Does their stovepiped work environment in bureaucratic silos prevent them from seeing and learning from other agencies' seemingly dissimilar issues?

Could FDA be held hostage like MMS to private-sector expertise on regulated health products that is held only in a regulated company, and an ineffectively regulated one at that, like BP?

Sent a pre-publication draft of this report, principal deputy commissioner Sharfstein delegated it to an unnamed subordinate who did not respond before deadline.

* Jim Dickinson is FDA Webview's editor.

From the letter: "I am Morris Waxler, Ph.D., former Food and Drug Administration (FDA) official in charge of approving laser vision correction (LASIK) devices between 1996-2000 (resume attached). Thanks to pointed questioning by LASIK-injured patients, I have re-examined the data FDA used to approve LASIK devices as well as the data from subsequent scientific studies and now conclude that LASIK-induced risks of permanent loss of vision overwhelm the temporary benefit of visual acuity improvement." 

Read letter

Former FDA LASIK Chief Calls Clinical Trial 'Unethical'

05/07/2010
 
Former CDRH chief of ophthalmic devices Morris Waxler, who was in charge of evaluation LASIK devices approved between 1996 and 2000, told the American Society of Cataract and Refractive Surgeons (ASCRS) 5/7 its proposed Phase 2 keratectasia trial on LASIK effects is unethical and "I will do everything I can to block approval of such a study." Waxler, who has recently said the agency's approval of LASIK devices was a mistake, defined keratectasia as "a rare but serious complication of laser vision correction of any refractive errors."
 
Waxler's criticism came in a three-page letter to ASCRS president Doyle Stulting, in which he said keratectasia affects at least 1% of LASIK patients. "In addition," he wrote, there is a high probability of many other permanent vision and ocular health problems. LASIK eye surgery complications are already a major public health problem. Hundreds of thousands of eyes are permanently injured each year for a 60% chance of a couple of years free from glasses and contact lenses, and a 40% chance of little or no freedom from spectacles or contact lenses at all. Fifteen to thirty per cent of LASIK patients suffer from eye pain, glare, halos, dry eyes, night vision and other problems, even if their visual acuity is normal."
 
Waxler told Stulting that FDA is "complicit" with LASIK manufacturer, ASCRS and others in minimizing the seriousness of multiple permanent vision complications. He asked for Stulting's cooperation in helping to eliminate unnecessary LASIK through more transparency about the short-term "wow" effects versus the reality of permanent eye injury and achieving "clear and complete informed consent documents comparing percentage risks and benefits of LASIK versus glasses or contact lenses." 

Waxler said he planned to publish an open letter to FDA commissioner Margaret Hamburg in major U.S. newspapers this summer, urging specific actions by the agency to "stem the tide of unnecessary LASIK eye injuries."

LASIK Activists Seek Hill Hearings on FDA Inaction
 
03/30/2010

The organizers of two Internet-based LASIK patients' protest groups wrote 14 Capitol Hill lawmakers 3/29 asking for a hearing on FDA's "egregious" approval of the laser devices used in this booming eye-surgery retail industry. Stressing the elective, cosmetic nature of the procedure, Fort Lauderdale, FL-based Dean Kantis and Paula Cofer say in the letters that "FDA approved the LASIK indication for excimer lasers despite an approximate 20% incidence of adverse events such as dry eyes and night vision problems which persist beyond the endpoint of clinical trials."

They quote former CDRH ophthalmic surgical devices branch chief Morris Waxler as publicly faulting the agency for not taking the side effects seriously enough under "enormous pressure from organized ophthalmology to approve LASIK." Further, they say, CDRH used the "same since-discredited 510(k) expedited process" to clear the newest LASIK corneal flap-cutting devices as was used in the "now notorious Menaflex case" citing "inappropriate" devices for "new technology that is not similar or substantially equivalent to the named predicate device as required by the Food, Drug and Cosmetic Act."

Kantis and Cofer tell the lawmakers that the agency has "refused to say what, if any follow-up action it is taking" after issuing more than 17 Warning Letters last year to surgical facilities that inspections had found were not complying with the Medical Device Reporting regulation. They allege that over 1,000 adverse events have been filed with FDA, "most of which were filed by injured patients. ... We suspect that the number of Warning Letters issued [21] reflects the total number of facilities inspected -- in other words, we believe that virtually 100% of LASIK clinics do not report adverse events," they say.

They also cite an alleged lack of FDA enforcement action pursuant to a 5/09 "reminder letter" sent by CDRH compliance director Timothy Ulatowski to eye care professionals about requirements for LASIK advertising to the public -- "The overwhelming majority of LASIK advertising continues to be misleading and unsubstantiated."

Finally, Kantis and Cofer say that FDA has been unresponsive to patient groups' complaints. Seven petitions since 2003 have "gone unanswered or have been denied," they say, and "countless" emails and letters have not had responses. Cofer sent FDA Webview a list of seven letters to FDA since 10/09 that she said had been unanswered:

"10/10/2009 -- Letter to CDRH director Jeffrey Shuren. requesting withdrawal of the approval of LASIK lasers.

"10/10/2009 -- Letter to ODE director Donna-Bea Tillman, requesting recall of femtosecond keratomes cleared under 510(k) and require clinical trials.

"11/3/2009 -- Letter to Jeffrey Shuren, requesting an "FDA News Release" to correct false information disseminated to the public that only 140 reports of LASIK dissatisfaction have been reported to the FDA.

"11/3/2009 -- Letter to Jeffrey Shuren, requesting a public health advisory notifying LASIK patients that they need to obtain a copy of their LASIK medical file for future cataract surgery, and requesting a meeting with FDA officials to discuss this.

"Also, LSW sent 3 letters dated 10/30/2009 reporting advertising violators. The FDA did not acknowledge any of these letters.

"I would also like to add that the FDA ignored every single recommendation of the FDA patient rep (me) at the FDA panel meeting in April, 2008."

Kantis told us he had sent 150 letters and emails to the agency in the past 16 months, and none of them had been answered.

CDRH's inertia on this topic was excoriated in a recent letter to Ulatowski from Panama City former mayor Lauren DeGeorge, who says her eyesight was permanently damaged during intraocular lens implantations solicited by false and deceptive advertising: "I have written the FDA from early on with no response; so, I have no faith in you or anyone at FDA to do a thing about this huge cover-up in America. You are responsible for approving these procedures and should be held accountable. Shame on you for not removing them until further research is done -- like I suggested in my first correspondence to you over two years ago!"

Asked for comment on these allegations, FDA press officer Peper Long sent a brief e-mail: "The FDA is aware of many requests made by many interested members of the public regarding LASIK. We keep the LASIK section of our Web site updated with recent, public information we think should be helpful. As far as enforcement actions we may be considering, they are often not subject to disclosure and we may not be able to discuss them."

As FDA Awaits LASIK Study, Lawsuit Hits Big Player
 
03/18/2010
 
As FDA continues to await the results of a nationwide collaborative study on after-effects of LASIK eye surgery, due in 2012, injured patients have begun filing lawsuits based on their discontent with those after-effects -- chronic and painful dry eyes, halos, starbursts, worsened vision, even suicide. At issue is whether these after-effects come to only 1% of patients as some LASIK surgery companies claim, or in excess of 20%, as injured patient activists claim. Former CDRH branch chief for diagnostic and surgical devices Morris Waxler, on whose watch LASIK devices were approved, now says the agency "screwed up" in not setting a limit for adverse events from this elective cosmetic surgical procedure.

On 3/17, one of the nation's largest chains of refractive eye surgery facilities, TLC LASIK Centers, was sued 3/17 in South Carolina federal court by attorneys for 181 injured patients alleging breach of contract, conspiracy, Racketeer Influenced and Corrupt Organization (RICO) violations. The company, whose parent corporation, TLC Vision Corp., is in Delaware Bankruptcy Court under Chapter 11, received five of 17 FDA Warning Letters sent to LASIK ambulatory surgical facilities 10/9/09 for failure to file required MDRs on adverse events. The new lawsuit is based on injuries it says TLC knew about and deliberately concealed.

As it announced those 17 Warning Letters, FDA also its extensive study of LASIK's after-effects, in collaboration with the National Eye Institute and the Department of Defense. Expected not to report until 2012, the patient-experience parts of the study have not yet begun, but an agency statement 3/18 said the protocol for the phase involving the experience of military LASIK patients "has been developed by federal experts in clinical research and has been reviewed and approved by an independent committee comprised of patient representatives and experts in refractive surgery, clinical research, and questionnaire development. The protocol is ready for institutional review board submission."

The concluding phase "will be a national, multi-center clinical study to determine the percentage of patients in a general LASIK population with significant symptoms and functional limitations after LASIK surgery, as well as explore possible contributing factors to poor outcomes. The protocol for Phase 3 is under development; therefore, enrollment into this study has not yet begun."

Seeking a total $180 million in damages, the South Carolina class action complaint names as defendants 29 TLC LASIK surgical facilities in various states, 24 TLC clinical directors, 34 TLC LASIK surgeons and four corporate managers, including vice president for patient care John Potter. It alleges that they conspired to fraudulently extend post-operative, lifetime ocular health care until the injured patients' statute of limitations right to sue ran out -- usually two years.

"This enterprise which manifested itself in both the implementation of and contribution to an illegal, subverted database for a period of at least eight years, with both the enterprise and database being implemented through the use of mail and wire fraud, involving hundreds and potentially thousands of victims," the complaint says. "The above scheme amounted to a pattern of racketeering activity and continues to pose a threat of continued criminal activity. A second prong of the scheme used to facilitate the concealment of the patient's surgically created condition, was the marketing and implementation of the Lifetime Commitment Contract ... [which] merely offered benefits to the extent it would prolong or prevent the patients from discovering the surgically created conditions."

The complaint alleges that each of the defendants represented to patients "they had good ocular health, that new equipment and procedures were being approved in the immediate future which would resolve their condition and further concealed that the various visual disorders were surgically created." These representations were allegedly intended to placate and deceive TLC's injured patients and caused them to decide not to seek intervening medical treatment or legal remedies.

The plaintiffs are seeking lifetime ocular health care for all class members, payment for past and future medical expenses, waiver of statutes of limitation, disclosure of all medical records to plaintiffs, compensatory and punitive damages, attorney fees and statutorily trebled damages and costs.
 

2/25/2010

In his first television interview on the subject, former CDRH branch chief for diagnostic and surgical devices Morris Waxler says that the agency didn't pay enough attention to negative side effects in some patients. Speaking in an exclusive on ABC's Good Morning America, Waxler said the staff didn't know what to do with data showing potential problems.

"I wouldn't say it was pooh-poohed, so much as it was just shoved aside as the kind of, we don't know what to do with that data," he said. "It's right there in the record. The agencies and the refractive surgeons, people knew these problems occur and there doesn't seem to be a plan to handle some of the more difficult problems that are created." Reported adverse effects, including cases in which the problems are permanent, include starbursts, halos, glare double-vision, and night blindness.

Waxler said he feels bad when he hears of patients' bad experiences. "One of the patients asked me, 'Don't you feel bad?' and I said, 'I did the best I could with the folks that were all around us,'" he said. "But in hindsight, it wasn't good enough. It wasn't good enough." He says he now believes that FDA erred in not setting tougher standards for LASIK outcomes, but doesn't think the devices should be pulled from the market. However, he called on FDA to make manufacturers and surgeons be more forthcoming with patients about potential side effects.

FDA told the network that it "considers LASIK to be reasonably safe and effective when used as intended," and said it disagreed with Waxler's contention that problems were overlooked at the time the procedure was approved. The agency also said it has been cracking down on false and misleading advertising and will be following up with providers who have inadequate adverse event reporting systems.

Last year, Waxler told FDA Webview that CDRH "screwed up" in not establishing a standard for acceptable adverse events reported from clinical studies (see story). The problem, he said, was that CDRH lacked in-house LASIK expertise and incorrectly judged the significance of adverse events, which an advisory committee had said should be less than 1% of all procedures, but turned out to be higher than 5%.

"We were getting advice from very renowned ophthalmologists, more renowned than anyone we had in the agency," he said. "We dropped the ball with regard to re-treatments with in excess of 10% re-treatment rates because there was a great deal of pressure from individual doctors who said they had the freedom as a physician to re-treat when they felt it was necessary for the sight of the patient. We waffled on that, we collapsed on that issue. In some of the clinical trials we were very tough on particular companies that came in with high re-treatment rates, and none of that got translated into a requirement for all the manufacturers. So I think we screwed up. It's very difficult to get them to admit there's been an error. I just think that's not going to happen until there's such a crisis that they're forced to do so."

Watch video:

February 19, 2010

From the article: A state regulatory agency is barring a Chicago ophthalmologist from performing Lasik eye surgeries in Illinois, one of a number of disciplinary actions taken against the doctor on Friday.

After finding that Dr. Nicholas Caro had engaged in unprofessional conduct and gross negligence, the Illinois Department of Financial and Professional Regulation suspended his medical license for 30 days, placed him on probation for a minimum of 3 years and banned him from performing procedures aimed at changing the curvature of the cornea, which includes Lasik surgeries.

The agency also fined him $10,000, the maximum allowed per violation.

Read article at www.chicagotribune.com/news/local/ct-met-bad-eye-doctor-20100219,0,2101781.story

Learn more about Nicholas Caro, M.D. at:
Dean Andrew Kantis
Founder
www.LifeAfterLasik.com
"Hurt LASIK Patient Network"

Laurie Shrieves v. Quentin Franklin, M.D., and LCA-Vision, Inc. d/b/a LASIKPlus
Virginia Circuit Court for the City of Chesapeake

Case No. CL 10000278-00

DR. QUENTIN FRANKLIN AND LASIKPLUS SUED FOR LASIK MALPRACTICE - On February 5, 2010, plaintiff, Laurie Shrieves, filed suit against Quentin Franklin, M.D., and LCA-Vision, Inc., d/b/a LASIKPlus, in the Virginia Circuit Court for the City of Chesapeake, for the negligent performance of LASIK surgery on Ms. Shrieves. On June 29, 2008, Ms. Shrieves came under the care and treatment of Dr. Franklin for the purpose of having LASIK surgery on both eyes at LCA-Vision, Inc., d/b/a LASIKPlus. The complaint alleges, among other things, that Dr. Franklin was negligent when he performed the LASIK surgery more than three millimeters off center of the pupil. As a result, Ms. Shrieves' cornea became abnormal and developed a decentered ablation. A decentered ablation refers to when the laser treatment removes tissue from an area outside of the intended surgical zone. Laser ablations that are off-center can cause visual symptoms, including glare, halos, ghost images, and blurred vision. Consequently, Ms. Shrieves' vision has suffered severely.

The plaintiffs are represented by Todd J. Krouner, from Pleasantville, New York, and Thomas Shuttleworth of Shuttleworth, Ruloff, Swain, Haddad & Morecock, P.C., from Virginia Beach, Virginia. Mr. Krouner represents victims of LASIK surgery throughout the United States. Mr. Shuttleworth has extensive experience in litigating medical malpractice actions.

A copy of plaintiffs' complaint is available at www.krounerlaw.com. For further information, please contact Todd J. Krouner, Esq., at (914) 238-5800, or Thomas Shuttleworth, Esq., at (757) 671-6020.

Cincinnati.com 2/7/2010
By Laura Baverman

Excerpt:

Thomas plans to combat the decline in Lasik (Laser-Assisted In Situ Keratomileusis) procedures by adding new services such as in-depth eye exams, cosmetic eyelash enhancement and, potentially, cataract surgery... Compounding the economic problems, the U.S. Food and Drug Administration cracked down last year on Lasik reporting requirements. After visits to 14 LasikPlus centers, the agency requested that the company's policies for reporting side effects be expanded... Anti-Lasik activists are as vocal as ever. They insist corporations like LCA are out for profits at the expense of their patients' most vital sense. "These large Lasik mills have a lot at stake and great incentive to conceal side effects and problems," says Paula Cofer, a Florida woman who has spoken out against the surgery since hers went awry in 2000. "It's all about profit. It's not about treating a medical need. It's an unnecessary surgery."

Read article at: http://news.cincinnati.com/article/20100207/BIZ01/2070373/1076/biz/LCA-Vision+looks+for+light+at+end+of+economic+tunnel

A brief synopsis of my problems after Lasik surgery in May of 2009...

I was having trouble reading and using my computer at the age of about 43, I'm 48 now by the way and the problem became worse requiring me to constantly change to reading glasses throughout the day. I'm a reserve Deputy Sheriff and work full-time for [redacted] so I'm in the field all day and every day and changing from sun glasses to reading glasses started to become quite problematic. WOW,  what I would do to have those problems back after the absolute devastation to my life after being assured that the glasses would go and no contacts ever by my Lasik Doctor and her staff.

I was treated for Mono-vision by the Lasik Dr. and found out later that she should have tried contacts or glasses first before performing the lasik mono-vision correction which has completely ruined my life. The last 9 months of my life has been pure hell and nightmares.

I'm currently suffering from extreme dry-eye, red-eye, painful-eye, lost vision up close, lost vision at night and extreme sensitivity to sun light after I was assured how safe the procedure was and I was told their track record was perfect by the Dr. and her staff and I would be without glasses or contacts. This sure seemed like a great thing especially after reading all the wonderful lasik info (on-line) that I researched before going forward with the procedure. I'm sure no one chooses to get lasik to destroy their vision and comfort but that's what happened to me and now I'm suffering badly every day and need help.

My life as a respected Police officer and my hobbies of fishing, scuba diving, surfing, working out at the gym, bicycling and living my life happily are now over and its been all Doom and Gloom for me and I have even considered suicide but a very close and loving friend has kept me from doing this. I would rather go blind and live in pain and anguish than to not see her again. At least that's what I feel today but I came very close a few different nights.

I've read your web-site and spoke to you and hope you can help me to bring my life back on track.  I'm sickened and disturbed that lasik is continuing to go on in this country and apparently the FDA doesn't have a clue. I wish I knew all the facts beforehand but I didn't. I went by what was on the Radio, TV, the internet, the information provided by the Lasik Dr. and her staff and now I'm really suffering. Boy, what I would do for those reading glasses back!  Thank you for taking the time to listen....

Happy LASIK patients may not realize or acknowledge the harm they suffered from LASIK for years; nonetheless, the damage is there. Medical research demonstrates (a) that the LASIK flap never heals and may be accidentally dislodged for the rest of a patient's lifetime, (b) that the cornea is permanently weakened and may develop ectasia weeks, months, or years later, leading to vision loss, (c) that corneal nerves which stimulate tear production are severed and destroyed during LASIK, and that these nerves never fully recover -- potentially leading to permanent dry eye disease, (d) that having LASIK causes problems in the future for glaucoma screening and cataract surgery -- prompting the FDA to recommend that LASIK patients obtain a copy of their LASIK medical record, (e) persistent decrease in corneal cells (keratocytes) -- it is unknown how this decrease affects long-term viability of the cornea, and (f) that visual quality at night is permanently reduced after LASIK, even when the patient has 20/20 or better daytime vision. To add insult to injury, visual outcomes of LASIK decline over time. "LASIK success" is like saying "the surgery was a success but the patient died".

From the article: But there have been an increasing number of complaints from unhappy patients who say they have experienced significant problematic complications after Lasik. They've been reporting that problems like dry eye, glare, double vision and starbursts (blurring around objects) have impaired their ability to function day-to-day and significantly affected their quality of life, says Dr. Malvina Eydelman of the Food and Drug Administration. In response, the FDA has decided to investigate further...Paula Cofer of Tampa, Fla., has experienced many of these problems.

Link to read/listen: http://www.npr.org/templates/story/story.php?storyId=122360078

Paula Cofer, FDA Patient Representative, served on the April 25, 2008 FDA Ophthalmic Devices Panel in Gaithersburg, MD.  The meeting was called to discuss issues concerning post-market experiences with LASIK. 

Ms. Cofer expressed several concerns about the safety and long-term consequences of LASIK, and asked for changes to the labeling of excimer lasers. 

Read some of Ms. Cofer's statements, which are found in the April 25, 2008 panel meeting transcript:  Click here

The FDA called a public meeting in April 2008 to discuss issues concerning patients' experiences with LASIK.  Several weeks prior to meeting, the American Society of Cataract and Refractive Surgery (ASCRS) -- a professional group of LASIK and cataract surgeons -- issued a press release² announcing findings of a literature review led by Kerry Solomon, M.D. alleging a "95.4% global LASIK satisfaction rate". The full text of the article was not published until April 2009.  Nineteen articles representing only 2,199 patients were retained by the authors in this "LASIK world literature review"³, although 16 million patients had undergone LASIK worldwide according to the press release. Eighty four percent (16/19) of the articles used questionnaires that were not validated.     

Solomon et al report; "Although this database [of 19 articles] also includes information on visual outcomes, night vision symptoms, and dry eyes, for the purpose of this paper, the analysis of the database focuses specifically on patient satisfaction and quality of life."  In other words, the authors chose not to disclose complication rates.  Only two articles in the literature review actually report quality of life after LASIK... one is a study of 100 patients in Bihar, India,⁴ and the other is a study of 49 patients in Ireland.⁵ In the study performed in India, the reason the females sought LASIK was to enhance marriage prospects. All levels of satisfaction in this review, ranging from "very" to "somewhat" were grouped and reported as "satisfied" patients.

An inspection of articles cited in the 'global LASIK literature review' reveals alarmingly high LASIK complication rates:

• "Twenty four percent of patients reported glare and night vision problems postoperatively." O'Doherty M, O'Keeffe M, Kelleher C. Five year follow up of laser in situ keratomileusis for all levels of myopia. Br J Ophthalmol 2006;90:20 -3.

• "Overall, 30.0% of the subjects reported experiencing halos, 27.2% reported glare, and 24.5% reported starbursts." Bailey MD, Mitchell GL, Dhaliwal DK, et al. Patient satisfaction and visual symptoms after laser in situ keratomileusis. Ophthalmology 2003;110:1371- 8.

• "Commonly reported symptoms included eye soreness in 43 patients (44.3%), tearing in 20 (20.8%), itching in 38 (39.6%), and moderate dryness or worse in 28 (20.8%)." Schmidt GW, Yoon M, McGwin G, et al. Evaluation of the relationship between ablation diameter, pupil size, and visual function with vision-specific quality-of-life measures after laser in situ keratomileusis. Arch Ophthalmol 2007;125:1037-42.

• "Night vision was considered worse or much worse than before surgery by 33.8% of patients....After surgery, 40.9% of patients reported experiencing more difficulty with night driving than before surgery." Tahzib NG, Bootsma SJ, Eggink FA, Nabar VA, Nuijts RM. Functional outcomes and patient satisfaction after laser in situ keratomileusis for correction of myopia. J Cataract Refract Surg. 2005 Oct;31(10):1943-51.

• "Twenty-nine percent reported reduced night vision clarity following LASIK and 27% noted more eye dryness following LASIK." CLAO J. 2001 Apr;27(2):84-8. Patient satisfaction after LASIK for myopia. Miller AE, McCulley JP, Bowman RW, Cavanagh HD, Wang XH.

As shown, articles in this 'global LASIK literature review' database that reported dry eyes and night vision problems confirm double-digit rates of these serious complications of LASIK.  Although Solomon et.al. did not report the incidence of dry eyes and night vision problems, they do state that poor quality of life scores after LASIK were associated with "regression, dry eye, poor vision in low light, and halos at night" -- a fact conveniently missing from Dr. Solomon's "95.4% of LASIK patients are satisfied" sound bite.  

Curiously, the FDA gave ASCRS advanced notice of the planned public meeting on LASIK⁶ - enough time to conduct a "LASIK world literature review" and prepare talking points for the media.  The spin generated by ASCRS surrounding this public meeting included misleading statements such as, "The FDA reaffirms that LASIK is both safe and effective".  At the public meeting, Dr. Solomon was asked by FDA consultant, Jayne Weiss, M.D., for clarification concerning FDA's role in ASCRS' public statement and literature review.  Dr. Solomon admitted, "This was independent from the FDA or the National Eye Institute. Yes, ma'am."

In 1994 as LASIK was being introduced, Dr. Leo Maguire of the Mayo Clinic cautioned against using patient satisfaction as a measure of success. He said: "A keratorefractive patient may simultaneously be happy with the result of surgery and have degraded vision - how can refractive surgery be a potential public health problem if patients are happy with the results?  Inherent in this question is the assumption that a patient without complaint is a patient without optical degradation. That argument does not hold up to closer scrutiny. The keratorefractive literature contains disturbing examples of patients who have visual handicaps that place themselves and others at significant risk for nighttime driving accidents and yet they are happy with the results."⁷

A Consumer Reports survey of LASIK patients finds that LASIK falls short of expectations for most who had the procedure. This Consumer Reports survey of laser eye surgery patients, which was published online in August 2009 (www.consumerreports.org) found that "nearly two-thirds said they were disappointed to find that they still had to wear glasses or contact lenses at least occasionally". Fifty-three percent of the respondents reported at least one side effect after surgery, and 22 percent were still experiencing side effects six months later. Nearly a quarter (24 percent) of "not highly satisfied" respondents said they regretted not learning more from people who had laser eye surgery before them.

Likely, surgeons are focusing on patient satisfaction to divert attention away from high complication rates inherent in the LASIK procedure.

Physicians have an obligation to place patient welfare over any personal profit motives. However, highly lucrative outpatient surgical procedures such as LASIK eye surgery have created a new breed of physician/entrepreneurs who are willing to simply sell what is profitable to a trusting and unsuspecting public. These 'salesmen' are masquerading as healers.

References

1. Mayo E. The Human Problems of an Industrial Civilization. New York, NY, MacMillan, 1933.

2. Accessed 10/12/2009 at

http://www.ascrs.org/press_releases/ASCRS-TO-PARTICIPATE-IN-AND-CO-FUND-STUDY-ON-POST-LASIK-QUALITY-OF-LIFE-WITH-US-FOOD-AND-DRUG-ADMINISTRATION.cfm.

3. Solomon KD, Fernández de Castro LE, Sandoval HP, Biber JM, Groat B, Neff KD, Ying MS, French JW, Donnenfeld ED, Lindstrom RL; Joint LASIK Study Task Force. LASIK world literature review: quality of life and patient satisfaction. Ophthalmology. 2009 Apr;116(4):691-701.

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Excerpt:

In the Federal Register of September 12, 2008 (73 FR 53028), FDA published a notice announcing the opening of a public docket to receive information and comments on the post market experience associated with the use of laser-assisted in situ keratomileusis (LASIK) devices, as well as information regarding potential barriers that may exist in providing the agency with feedback regarding LASIK procedures. Interested persons were invited to submit comments by September 14, 2009. At this time, the agency is reopening the docket to continue to receive public comments. Information and comments submitted to the docket will assist us in identifying ways in which we can improve our public outreach efforts regarding the safety and effectiveness of LASIK devices.

Link to notice: http://edocket.access.gpo.gov/2009/E9-27222.htm

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Editors note: The comment period has been extended to November 15, 2010.  Instructions for submitting comments to the public docket may be found at the following link:
http://www.lasikcomplications.com/FDA-LASIK-Docket.html