Paula Cofer, Patient Rep, presents concerns about LASIK to the FDA

Posted on 12/17/2009

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 Truth Behind LASIK Satisfaction


Patient satisfaction after LASIK, as measured by unvalidated surveys or questionnaires, is neither scientific nor a reliable indicator of LASIK safety or efficacy.  LASIK surgeons report high patient satisfaction even in cases with poor night vision and sight-threatening complications. The “Hawthorne effect” 1 proposes that patients may rate their level of satisfaction with the LASIK procedure higher in an effort to please their physician.

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 potentially debilitating complications of LASIK.  Although Solomon 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 ( 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.


  1. Mayo E. The Human Problems of an Industrial Civilization. New York, NY, MacMillan, 1933.
  1. Accessed 10/12/2009 at
  1. 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.
  1. Akhaury RK, Verma NP, Kumar R. Patient motivation for laser in situ keratomileusis in the state of Bihar. J Refract Surg. 2004;20(suppl):S727-9.
  1. 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.
  1. EyeWorld Week Vol. 13 No. 7 March 10, 2008. Accessed 10/11/2009 at
  1. Maguire LJ. Keratorefractive surgery, success, and the public health. Am J Ophthalmol. 1994 Mar 15;117(3):394-8.

FDA Public Health Advisory Sought on LASIK Hazards

Reprinted with permission from

“The FDA’s mission is to serve and protect the public, not to serve industry,” says a 126-signatory letter to CDRH acting director Jeffrey M. Shuren, seeking a public health advisory on “the high incidence of adverse events and long-term consequences associated with LASIK surgery.” The five-page 11/2 letter, signed mainly by injured patients, says that when FDA approved the LASIK indication for several excimer lasers in 1998, “little was known about long-term safety and efficacy of the procedure.” It cites former CDRH ophthalmic surgical branch chief Morris Waxler as saying FDA was under enormous industry pressure to approve LASIK and the agency “failed to require proper scientific assessment of long-term safety and efficacy … in an apparent attempt to appease powerful ophthalmologists who lobbied for approval.”

The letter cites a 2007 published study of 12 Summaries of Safety and Effectiveness for laser approved between 1998 and 2004, which found that six months after LASIK, 17.5% of patients reported halos, 19.7% glare, 19.3% night-driving problems, 21% dry eyes worse than before surgery. FDA last year denied a citizen petition for a LASIK ban based on these data, contending that it contained no data and the agency was precluded by law from acceding to petitions seek enforcement action.

The letter contends that the body of literature on adverse LASIK events has been growing for the past 10 years, and that a “huge disconnect” exists between ophthalmologists who perform LASIK and the LASIK patient population regarding what constitutes a LASIK-related adverse event. “What a patient considers a bad outcome is often dismissed as an expected ‘side effect’ by the surgeon who performed the procedure,” the letter says, adding: “Risk of intractable dry eyes after LASIK is downplayed in the informed consent process.”

The letter says research published in 2005 and 2007 now demonstrates that in 100% of eyes treated, the corneal flap never fully heals, “exposing patients to life-long risk of traumatic flap dislocation and increased risk of eye infection.” In addition, a 2006 study demonstrated that “Biomechanical strength of the cornea is reduced after LASIK, which may lead to sight-threatening corneal ectasia months or years after surgery.”

Intraocular pressure measurements are falsely low after LASIK, according to a 2008 study, leading to possibility of vision loss from undiagnosed glaucoma. “LASIK causes error in calculation of lens power for cataract surgery, exposing patients to poor vision after cataract extraction,” the letter says, citing a 2007 study.

Citing widespread, heavy advertising of LASIK to the public, the letter says there “has been little, if any enforcement of regulations governing LASIK advertising. The overwhelming majority of LASIK advertising is misleading and unsubstantiated.”

List of FDA warning letters to LASIK clinics

Latest FDA Warning Letters


Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking the link following each company name.

Lasik Vision Institute
Carmel, IN
(10/9) Misbranded: FDA determined that the facility is a medical device user facility that is subject to the statutory reporting requirements of the Medical Device Reporting (MDR) regulation. The facility failed to develop, maintain, and implement written MDR procedures, etc. (ophthalmic laser); FDCA 502(1)(2), 519, 21 CFR 803 (No code)

Lasik Vision Institute
Altamonte Springs, FL

Lasik Vision Institute
Brookfield, WI

LCA Vision Inc. [LasikPlus]
Rockville, MD

LCA Vision Inc. dba LasikPlus
Maple Grove, MN

LasikPlus Vision Center
Chicago, IL

LCA Vision Inc. dba LasikPlus
Edina, MN

TLC Laser Eye Centers
Rockville, MD

LasikPlus Vision Center
Lakewood, CO

LasikPlus Vision Center
Raleigh, NC

LasikPlus Vision Center
Indianapolis, IN

Lasik Vision Institute
Phoenix, AZ

LasikPlus Vision Center
Louisville, KY

Laser Eye Care of California
Encino, CA

TLC Laser Eye Centers
Edgewater, MD

TLC Laser Eye Centers
McLean, VA

TLC Laser Eye Center
Sewickley, PA

TLC Eye Care
Lansing, Michigan

Lasik Plus
Houston, Texas

LCA Vision Inc
Lexington, Kentucky

LasikPlusVision Center
Sugar Land, Texas

FDA Issues Warning Letters to LASIK Facilities

For Immediate Release: Oct. 15, 2009

Media Inquiries: Peper Long, 301-796-4671,
Consumer Inquiries: 1-888-INFO-FDA

FDA Announces Plans for LASIK Quality of Life Project
Agency also Announces Warning Letters Issued to LASIK Facilities

The U.S. Food and Drug Administration today announced the launch of a collaborative study with the National Eye Institute and the U.S. Department of Defense to examine the potential impact on quality of life from Laser-Assisted In Situ Keratomileusis (LASIK), a surgical procedure that uses an eximer laser to permanently change the shape of the cornea.

The goal of the LASIK Quality of Life Collaboration Project is to determine the percentage of patients with significant quality of life problems after LASIK surgery and identify predictors of these problems.

Funded by the government agencies, the project is composed of three phases. The objective of Phase 1, which began in July 2009, is to design and implement a Web‑based questionnaire to assess patient-reported outcomes and evaluate quality of life issues post-LASIK, some of which may relate to the safety of the lasers used in the LASIK procedure.

Phase 2 will evaluate the quality of life and satisfaction following LASIK as reported by patients in a select, active duty population treated at the Navy Refractive Surgery Center.

Phase 3 will be a national, multi-center clinical trial and will study the impact of the procedure on quality of life following LASIK in the general population. Patient enrollment in Phases 2 and 3 have yet to begin but plans are underway. Phase 3 is expected to end in 2012.

The results of the project will help identify factors that can affect quality of life following LASIK and potentially reduce the risk of adverse effects that can impact the surgical outcome. If any of these factors are related to the safety or effectiveness of the lasers used in LASIK surgery, the FDA will evaluate whether any action is necessary. The project is part of the FDA’s ongoing effort to better monitor and improve the safety and effectiveness of the lasers used in LASIK surgery.

“This study will enhance our understanding of the risks of LASIK and could lead to a reduction in patients who experience adverse effects from the procedure,” said Dr. Jeffrey Shuren, acting director of the FDA’s Center for Devices and Radiological Health.

The FDA also announced that it issued warning letters to 17 LASIK ambulatory surgical centers after inspections revealed inadequate adverse event reporting systems at all the centers. The inspections did not identify problems with the use of the LASIK devices at these facilities.

Under legislation passed in 1990, user facilities, which include nursing homes, outpatient clinics and ambulatory surgical centers, must report device-related deaths to the FDA and to the device manufacturer. They also must report device-related serious injuries to the manufacturer or to the FDA if the manufacturer is not known. Requirements include having a written protocol for adverse event reporting.

The FDA inspected ambulatory surgical facilities that perform LASIK over the past several months and additional inspections are pending. The FDA regulates ophthalmic lasers used in LASIK, including monitoring their continued safety and effectiveness by analyzing reports on their post-market use.

“Many people in the U.S. undergo LASIK procedures,” said Shuren. “Ambulatory surgical centers that perform LASIK must maintain a robust reporting system as required by law. Reporting adverse events to the FDA is critical to better understand the safety and effectiveness of ophthalmic lasers used in LASIK procedures and to enable the FDA to take appropriate actions where the lasers do not meet safety and effectiveness requirements.”

For more information:

The FDA’s Web site on LASIK:

FDA Guidance: Medical Device Reporting for User Facilities:


This press release is published on the FDA web site at:

Related links:

FDA Warning Letters Target MDR Reporting at LASIK Sites

Reprinted with permission from
17 Warning Letters Target MDR Reporting at LASIK Sites

FDA says it has issued Warning Letters to 17 LASIK ambulatory surgical centers after recent inspections revealed that they had inadequate systems for reporting adverse events related to the vision correction surgery. FDA has recently ramped up its enforcement efforts, and CDRH compliance director Timothy Ulatowski publicly predicted that this week will be a “Warning Letter Event.” The agency says additional inspections of ambulatory surgical centers are pending.

The inspections presumably were in response to growing criticism of FDA’s oversight of the LASIK usage and mounting complaints by injured LASIK vision-correction patients. One such patient filed a citizen petition earlier this year (see story) just days after FDA principal deputy commissioner Joshua Sharfstein launched an investigation into the complaints. The petition seeks sanctions against LASIK clinics that have not reported adverse events as required under the medical device reporting (MDR) regulation. The petitioner, former Long Island (NY) restaurateur and LASIK patient advocate Scott A. Tolchin, also asked the agency to inspect clinics and to “ensure” their compliance with FDA’s user facility reporting regulation. Tolchin told FDA Webview he has been on disability for a year due in part to his LASIK-related problems which worsened since his 1997 surgery.

The 17 Warning Letters, which were issued 10/9, did not identify problems with the devices themselves, and will be posted 10/20 along with other FDA Warning Letters routinely released each week. FDA Webview has obtained two templates of the Warning Letters — one for those that received an FDA-483 and one for those that did not. Each letter cites a firm for failing “to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17.”

Additionally, in order to get a better handle on LASIK-related injuries, FDA says it has begun a “collaborative study with the National Eye Institute and the U.S. Department of Defense to examine the potential impact on quality of life…” The project’s goals are to determine the percentage of patients with significant quality of life problems after having vision-correction surgery and to identify predictors of these problems.

The project, which will run until the end of 2012, will consist of three phases:

Phase 1, which began in July, is to design and implement a Web-based questionnaire to assess patient-reported outcomes and evaluate quality of life issues post-LASIK

Phase 2 will evaluate the quality of life and satisfaction following LASIK as reported by patients in a select, active duty population treated at the Navy Refractive Surgery Center

Phase 3 will involve a national clinical trial and will study the impact of the procedure on quality of life following LASIK in the general population.

“The results of the project will help identify factors that can affect quality of life following LASIK and potentially reduce the risk of adverse effects that can impact the surgical outcome,” FDA says. “If any of these factors are related to the safety or effectiveness of the lasers used in LASIK surgery, the FDA will evaluate whether any action is necessary.”

Injured LASIK patient and activist Paula Cofer was skeptical about FDA’s quality-of-life study with the Defense Department. In a comment to FDA Webview, she said:

“In my opinion, the Department of Defense has demonstrated bias in favor of LASIK. For example, Dr. Steven Schallhorn who directed the largest refractive surgery program within the Department of Defense until his recent retirement, is a paid medical malpractice defense expert witness, has made public statements and published literature denying connection between a poor LASIK outcome and diminished quality of life, and is currently medical director of one of the largest corporate providers of LASIK in the world. Schallhorn co-authored studies favorable to LASIK with current Department of Defense LASIK surgeons.

“Several Department of Defense LASIK surgeons testified in favor of LASIK at an FDA hearing in April 2008.

“Furthermore, I feel that FDA’s earlier partnership with organized ophthalmology was inappropriate, and that the planned prospective quality of life after LASIK study is simply a strategy to stall for several more years while refractive surgeons either upgrade existing technology or prepare to market alternative technologies for refractive surgery.”

Group Asks for Recall of ‘All-laser LASIK’ Devices

Reprinted with permission from

LASIK Surgery Watch (LSW) says FDA should recall laser keratome devices used for LASIK flap recreation due to its negligence in clearing them without rigorous clinical trials. In a 10/10 letter to CDRH Office of Device Evaluation (ODE) director Donna-Bea Tillman, LSW cites a 10/14/08 letter from CDRH scientists and physicians to Rep. John Dingell (D-MI) on abuse of the 510(k) program by clearing devices that were never evaluated for safety and effectiveness.

LSW also tells Tillman it was “pleased to learn of your personal effort as director of the Office of Device Evaluation at FDA to address ‘integrity’ problems of the beleaguered 510(k) program.”

It asks that ODE review the appropriateness of the 510(k) approval process for femtosecond ophthalmic laser keratomes, which have been cleared as substantially equivalent to predicate IntraLase lasers that were approved as substantially equivalent to a metal blade keratome and an obsolete dissimilar ophthalmic laser.

“While the intended use of both blade and laser keratomes is to create a flap in the cornea, technological characteristics of these two devices are not similar as required under 510(k) guidelines,” the letter says.

LSW says that an obvious omission in the marketing of all-laser LASIK is the new technology’s “spectrum of new complications” that were never encountered with blade keratomes. The group says that peer-reviewed literature of IntraLase LASIK reveals numerous reports of complications unique to laser keratomes, as well as flap complications similar to those associated with metal blade keratomes. And it says that FDA’s MedWatch shows complications associated with laser keratomes, including some that are unique to the device. But LSW claims that the true incidence of IntraLase complications isn’t known due to the widespread failure of LASIK surgeons to file adverse event reports and the ignorance of affected consumers that they can file their own reports.

FDA’s Culture of Secrecy Will Beat Obama

Reprinted with permission from

[Analysis by Jim Dickinson*] Forget “open government,” especially at FDA. As the Obama administration visibly wilts under national security objections to a reporter’s shield law and resists a federal judge’s order that it release an FBI interview with former vice president Dick Cheney about who “outed” secret agent Valerie Plame, other less-visible wilting is undermining its transparency ambitions at one of the most secretive agencies of all — FDA.

Since the Reagan Revolution, concealing and withholding information has been infused into FDA’s virtual DNA by successions of conservative appointees, none more effectively than Bush chief counsel Dan Troy, who famously kept no records of his meetings with outside parties — all the better for deflecting Freedom of Information Act (FOIA) requests.

Defying the spirit of Obama first-days-in office Executive Orders and Attorney General memos that all agencies err on the side of disclosure when asked for internal documents — thus reversing equivalent Bush Administration directives — FDA is so far clinging to its extra-legal secret ways. Its track record says it will win.

Last month, in response to a Freedom of Information Act (FOIA) request from Moms Against Mercury national counsel Charlie Brown for internal, predecisional deliberative documents leading to the 8/4 final rule on dental amalgams, FDA released a 23-megabyte file of massively redacted records, including no less than 75 pages withheld under the FOIA’s Exemption 5. That exemption states:

Privileged Interagency or Intra-Agency Memoranda or Letters. This exemption protects “inter-agency or intra-agency memorandums of letters which would not be available by law to a party …in litigation with the agency.” As such, it has been construed to “exempt those documents, and only those documents, normally privileged in the civil discovery context.”

The unredacted remnants of the agency’s disclosures in that package were, effectively and no doubt intentionally, worthless to Brown — and to anyone else who hopes for FDA openness. Specifically, the Exemption 5 excisions were false, according to well-known medical device lawyer and former FDA compliance director for medical devices Larry Pilot, who has first-hand knowledge from defeating the agency in court on this issue. He tells us that the documents requested on the completed amalgam rulemaking would be available by law in litigation with the agency, so this nondisclosure is illegal.

FDA’s new leadership will not discuss this, referring Brown and all other interested inquirers to the agency’s long dysfunctional appeals mechanism which for decades has serially found in favor of the agency through all review levels up to U.S. District Court, usually a forum that is too expensive for most protesters to engage.

At the risk of sounding like a special pleader for the anti-amalgam cause, which I am not (although I have publicly stated that the final rule is FDA’s worst in 33 years), another FDA exposition of inapposite legal excuses to avoid the issue occurred when CDRH ombudsman Les Weinstein declined to let the amalgam issue go to his Center’s Alternative Dispute Resolution Panel.

While I have the deepest respect and admiration for the majority of FDA employees who are tireless in their dedication to public health and safety, and I separate them from the exterior-insulating “culture” which dominates them, both the FOIA denial and Weinstein’s rejection are good examples of that hostile culture. Since Reagan, it has grown up under, between and over FDA’s diligent public servants to oppose daylight-seeking external constituencies’ objections to internal decision-making.

Each of the foregoing examples cited inapposite grounds, and each were consequently tacit admissions of no reliable grounds. This has become a management pattern.

Take the case of LASIK vision enhancement patients who say they were denied informed consent by their surgeons and consequently suffered disabling permanent injuries from devices that the FDAer in charge at the time now says in retrospect should not have been approved for that procedure. As thousands of eye surgeons around the country continue to violate FDA cautions issued last May, the agency says only that it will give “appropriate” review to their promotional activities and declines to say whether it will investigate ambulatory surgical facilities for compliance with Medical Device Reporting (MDR) requirements for adverse events. “FDA can neither confirm nor deny the existence of an investigation,” its press office repeatedly says.

FDA silence about its own investigations is discretionary, not required. When the public and President Obama were upset about contaminated peanut butter, the agency fell over itself to talk about its diligent investigations into Peanut Corporation of America. Beyond the limelight, however, small enforcement matters that millions don’t care about are routinely hidden because the agency’s culture is more comfortable with not having to explain itself.

Yet another example of this, still pending before the U.S. Court of Appeals for the Tenth Circuit, involves civil money penalties assessed by FDA against TMJ Implants Inc. for not submitting 17 disputed MDRs. In this long-running dispute, Weinstein’s office failed miserably, as did all internal appeal levels including FDA’s geriatric and dependent administrative law judge, Daniel Davidson, and the HHS Departmental Appeals Board. The company simply wanted FDA to explain scientifically why the 17 incidents required MDRs, and all FDA could do was recite CFR passages.

Four years ago, we asked our thousands of readers to tell us if they knew of a case in which FDA had reversed a decision it had made. Nobody responded, inviting us to draw the conclusion that the agency never has changed its mind. This conclusion agrees with the uniform experience we’ve had over the years whenever we have appealed an FOIA denial and also agrees with infrequent but high-profile cases of companies that have tried to persuade the agency that it interpreted inspection findings or product submission data incorrectly.

The net effect of all of the above experiences plus many others over 20-plus years has been to strengthen the FDA bureaucracy’s culture of effective immunization against external criticism and protest. “Commissioners come and commissioners go,” gloated one long-time FDA compliance branch chief when I mentioned former commissioner Arthur Hull Hayes’ ongoing transition, “but we stay here.” The opportunity for such a conversation could not occur today because the access that allowed it has vanished.

The implication of the comment could not have been more memorable: down in the bowels of the agency where the day-to-day decisions are made, commissioners and their helpers don’t matter — the permanent bureaucracy runs itself in myriad personal fiefdoms, clandestine and informal laws unto themselves. Division directors have little incentive to challenge branch chief sign-offs, nor have office directors reason to up-end the sign-offs of division directors, and above the fray Center directors want to keep things moving. The higher a matter rises in the organization, the more irreversible it becomes.

The public policy line of fire floats in the remote upper echelons at the politico-bureaucrat interface. Eventually, the politico is usually captured by the bureaucracy that he/she has been sent in to tame, and becomes an advocate/apologist for the status quo.

Thus, initial low-level decisions, however flawed, effectively become final agency decisions, serially blessed as such at each level of administrative review and appeal until, if seriously questioned, they face the U.S. District Court level, where few ever venture because of the expense or loss of interest due to the time that has elapsed.

An important factor to consider when it is a regulated company that has been denied, is that company’s fear of FDA employee retaliation in its unavoidable future interactions with them — discretion easily becomes the better part of valor. Few companies with shareholder responsibilities and an acute eye to the next quarterly report are willing to engage FDA’s recalcitrant bureaucracy on a point of regulatory principle.

Ultimately, it all gets down to money. Where is the money? That is where the regulatory solution usually lies.

Forget openness at FDA. Different constituencies have different meanings for that trite word, and the new-age reformers must balance all of them against each other. Public interest activists and the news media want industry blood. Industry wants protection from those muckrakers. Injured patients want compensation. Care providers and insurance companies want the opposite. Congressional overseers want re-election. Most FDA bureaucrats want to stay under cover and do what they’ve always done.

Commendably, Obama’s principal deputy commissioner Joshua Sharfstein, a refreshingly energetic and dedicated public health aficionado with an accomplished record as Baltimore City’s health commissioner, has initiated a transparency task force project at FDA that is still gathering public input.

One thing is already apparent from this project: Every constituency has its own, and often self-serving, idea of transparency. Regulated industry, for example, tends to see FDA transparency as a quality in the agency’s closed communications with sponsors that optimally exposes evolving review issues in the most helpful way.

The news media, on the other hand, see transparency as free access to every FDA employee without having to go through the controlling filter of the FDA Press Office, which monitors all their interviews and gathers their news for them at a bureaucratic pace, expressing its findings in press office-approved words. Current controls on internal FDA newsgathering, introduced during the Bush administration, homogenize the language of FDA journalism, blurring the stylistic and often the substantive differences between competing media reports on the same FDA topic.

Previously, reporters and others who were sufficiently interested could roam FDA’s halls at will, knock on any door, gather their own news and legally accessible documents without FDA management supervision, and build their own confidential “contacts” lists comprising authoritative employees who would freely talk about their work within legal limits in exchange for effective anonymity.

Those freewheeling days are gone, shuttered by the Bush administration on both policy and convenient security grounds. Obama’s team won’t disturb that, either. “Give a press secretary power to control the press, and you think he’s going to give it up?” asks a highly respected former associate commissioner, incredulously. No matter, apparently, that the First Amendment prohibits such government power — or that conservatives and Blue Dog Democrats alike fear similar power being turned onto health care, which enjoys no such Constitutional protection.

By law, FDA is required to protect industry secrets entrusted to it in various product applications. It also has other statutory secrets to protect, including those within investigatory files against regulated entities, and intimate patient medical histories in the data supporting product applications. It also must protect its own employees’ personal information from outside probes.

Expanding upon those legitimate and minimal protections, FDA has for more than 20 years vastly over-interpreted FOIA’s exemptions and exceptions to public disclosures to the point where many today consider it among the government’s most secretive agencies. FOIA’s exemptions have consumed the spirit of the Act at the agency, a knowledgeable lawyer observes.

Where the FOIA’s exemptions and exceptions are usually permissive — that is, optional for the agency to impose or not impose — FDA’s virtual DNA compels it to opt for non-disclosure as if that is the safest default position to adopt. This is diametrically opposed to the “err on the side of disclosure” memo to all agencies from attorney general Eric Holder last March, when he cautioned: “First, an agency should not withhold information simply because it may do so legally.”

A growing us-vs.-them sentiment seems to guide FDA public communications policy. Last week, when someone inside CDRH leaked to the Wall Street Journal an internal memo written by Office of Device Evaluation director Donna-Bea Tillman, it took a full day of arm-twisting to convince FDA’s Office of Public Affairs to release that memo more generally. In pre-Bush days, prior office policy would have automatically released any leaked document on the theory it had entered the public domain.

But, in this case, the memo reflected credit on the agency, and so it was released with its author’s consent. This is FDA’s new disclosure policy, according to assistant commissioner for public affairs George Strait, whose own professional goal is unabashedly to spread the good news about FDA. Had the internal memo reflected discredit on the agency and the author had opposed its release, it probably would not have been released. After all, we’re all only human, aren’t we?

On a related issue, when we requested the official FDA memorandum of a meeting 8/31 between the agency’s high command and the medical device industry on strengthening the 510(k) review process, Strait sent an email two days later saying “we are researching” the request. Previously, memos of such meetings were routinely available from the office of the first-listed FDA participant or the agency’s Executive Secretariat.

And so the openness of former days at FDA will not return. The culture set its increasingly secretive course over 20 years ago and no amount of well-intentioned reform will change the virtual DNA that conceals and withholds.

* Editor, FDA Webview

NRC for Women & Families, FDA LASIK docket comment

Posted 9/26/2009
Document ID: FDA-2008-N-0488-0024

September 14, 2009

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Comments of the National Research Center for Women & Families on
“Medical Devices: Ophthalmic Devices; Laser-Assisted In Situ Keratomileusis (LASIK) Devices; Establishing a Docket”
[Docket No. FDA-2009-N-0488]

The National Research Center for Women & Families submits the following comments regarding the laser-assisted in situ keratomileusis (LASIK) and the post market experience associated with the use of LASIK devices.

More than 8 million people in the U.S. have had vision-corrective LASIK procedures. Despite its popularity, the surgery has serious risks such as impaired vision, chronic dry eye and pain, and other eye injuries. Although a 95% satisfaction rate has been reported, that figure is not scientifically valid for several reasons. For example, “satisfaction ratings” reported to the providers of medical treatment are notoriously biased by patients who want to stay on good terms with their health care providers, and underreporting of problems is inevitable because problems that are thought to be temporary may instead be chronic. In addition, sometimes weeks, months, or even years go by before complications are obvious.

Moreover, even a 5% dissatisfaction rate would translate to 400,000 people–a major public health concern.

The FDA has approved lasers used in LASIK surgery that had reported complication rates of more than 20% in the clinical studies used to support their FDA approval applications. The clinical trials included no long-term follow up, thus leaving possibility of detecting any late-onset complications.

The FDA’s mission is to ensure that medical products are safe and effective. For LASIK, it is essential that we remember that safe alternatives–glasses and contact lens–are less expensive and readily available. The risks of LASIK have to be examined and understood by patients in that context.

In 2008, the FDA held a public hearing to listen to testimony from patients and doctors, including testimony from patients who reported that LASIK surgery left them with serious vision problems that could not be corrected with glasses or contact lenses, chronic pain, problems with night vision, and other debilitating complications.[1] The public testimony also included personal stories of depression, suicide or suicidal ideation, and other psychological problems that had been the results of unrelenting pain and other adverse LASIK outcomes. The FDA’s response to that meeting has been profoundly disappointing.

Research studies have documented difficulties with night vision and dry eyes, the latter of which can be extremely painful.[2] While one study found that approximately half of the LASIK patients experienced dry eyes within the first week,[3] a more worrisome research finding was that 20% of the LASIK patients had dry eyes for more than 6 months.[4]

An analysis of FDA Summaries of Safety and Effectiveness for the twelve LASIK lasers approved by the FDA from 1998 through 2004, found that six months after LASIK, 8% of patients reported halos, 20% reported glare, 19% reported night driving problems, and 21% reported dry eyes that were worse, or much worse, than before surgery.[5] Other complications have been reported, including infection, inflammation, haze, free caps (where the flap was completely cut off), flap striae (wrinkles), and flap dislocation. A 2008 study published in the American Journal of Ophthalmology by Dr. Jorge Alio and his colleagues reported that 28% of the eyes treated with LASIK needed re-treatment within 10 years because of under-correction, over-correction, or regression. The percentage of patients was even higher: 35%.[6]

Given the severe and potentially life-long nature of many of these complications, it is not surprising that reports have indicated elevated rates of suicide among LASIK patients. For example, in 2008, preliminary findings of an Emory Eye Center study suggested a four-fold increased suicide rate among cornea donors who had LASIK surgery, compared to cornea donors who had not had LASIK.[7] We have serious concerns about why that important study has not been published. It is not unusual for academic research to remain unpublished when findings are inconsistent with the financial interests of medical school faculty or administrators.

Recognizing the profound negative impact that LASIK can have on quality of life, some doctors have revised their post-operative information packets to include language regarding risk of possible psychological damage from a less-than-ideal LASIK procedure.[8]

Are patients adequately warned of these risks before deciding to have LASIK surgery? The problems are rarely publicized and patients tell us that they did not have adequate informed consent prior to undergoing LASIK surgery.

The FDA’s web page on LASIK provides important information, but most patients will never read the FDA web page. In addition, the FDA information on LASIK would better serve people considering LASIK surgery if the FDA placed the following statement in a more prominent spot (instead of at the bottom of a lengthy article): “It is also important to note that no laser company has presented enough evidence for the FDA to make conclusions about the safety or effectiveness of enhancement surgery.”[9]

To ensure informed consent, the FDA should reach out more effectively to mass media about their LASIK warnings and require that physicians using LASIK devices provide short-easy to understand booklets about LASIK risks at least one week prior to the procedure. The information in the booklets should be reiterated by the health professionals, not undermined with reassuring statements such as “this procedure is very safe” or “all my patients are very happy.”


Diana Zuckerman, President
National Research Center for Women & Families

The National Research Center for Women & Families is a nonprofit dedicated to improving the health and safety of adults and children by using research to develop more effective programs and policies. We do not accept funding from drug or medical device companies.

[1] FDA, 110th Meeting of the Medical Devices Advisory Committee, “Summary Minutes, Medical Devices Advisory Committee” April 25, 2008, available at

[2] Sugar A, et al., “Laser in situ keratomileusis for myopia and astigmatism: safety and efficacy: a report by the American Academy of Ophthalmology.” Ophthalmology. 2002 Jan; 109(1): 175-87.

[3] Hovanesian JA, Shah SS, Maloney RK, “Symptoms of dry eye and recurrent erosion syndrome after refractive surgery” Journal of Cataract & Refractive Surgery. 2001 Apr; 27(4): 577-584.

[4] Shoja & Beharati. European Journal of Ophthalmology. 2007 Jan-Feb;17(1):1-6.

[5] Bailey MD, Zadnik K. “Outcomes of LASIK for myopia with FDA-approved lasers.” Cornea. 2007 Apr; 26(3): 246-54.

[6] Alio J et al. “Ten-year follow up of laser in situ keratomileusis for myopia of up to – 10 diopters.” American Journal of Ophthalmology 2008; 145: 46-54.

[7] Sabine Vollmer, “Some link depression, failed LASIK.” (February 3, 2008, The News Observer) available at .

[8]Ocular Surgery News, “Surgeon Shares Refractive Surgery Trends in Clinic in Australia” (May 18, 2009) available at

[9] U.S. Food and Drug Administration (2009). What should I expect before, during, and after surgery?

Robert Selkin, MD Connected to LASIK Suicide

Posted 9/22/2009

FDA Hearing – April 25, 2008
Presentation of Todd Krouner, Esq.

MR. KROUNER: Good morning again. I am here on behalf of Amanda Campbell. My name is Todd Krouner. I was recently retained by her. She is a widow now in Brentwood, Tennessee, whose husband, Lawrence Campbell, a police officer with that police force, shot himself with his service revolver last month on March 16, 2008. Ms. Campbell regrets that, given her current circumstances, she is not able to afford the trip here to Maryland today.

In a March 25, 2008, article reported in the OSN supersite, Dr. Richard Lindstrom, who you know as President of ASCRS and OSN Chief Medical Editor, is quoted as asserting that there is no correlation whatsoever between adverse LASIK outcomes and suicide. Presumably, Dr. Lindstrom did not have the benefit of reading police officer Campbell’s suicide note.

In my April 15, 2008, written submission to the FDA, I referred to Dr. Lindstrom’s assertion, but in my letter I also questioned the integrity of certain Titans in the LASIK industry, and I want to be clear that none of those comments are meant to cast any such aspersion on Dr. Lindstrom. However, I respectfully disagree with his absolute position based on the explicit statements in police officer Campbell’s suicide note from just last month. He states: “No one knows what I am feeling, constant pain, blurred vision, stress that I never had before. If only Dr. Robert P. Selkin had done a pre-op and knew I was not a candidate for LASIK surgery. “No one understands truly my burden I carry, dry eyes, cannot light a fire, cannot stand in front of air conditioning, cannot cook without opening a window, cannot spray deodorant. The list goes on and on. “I just cannot burden my family for a poor decision, eye surgery, which Selkin knew was wrong but only wanted money, and I will not live on drugs, Xanax. I never used that drug wrong, a half a milligram at night and sparingly in the afternoon on a bad day. I am not a drug user. Never could I do this, as it has ruined so many lives.” He goes on to state, “Do not have LASIK surgery. Tell the media.”

On behalf of the Campbell family, that is why I am here on their behalf today. If there were any question about the cause of police officer Campbell’s suicide, he states explicitly: “To blame for this, Selkin eye surgery. Eye surgery has taken my life out of me. The pain, distorted vision, chronic dry eye is not bearable” — emphasis in original. Out of fairness to Dr. Robert P. Selkin, I do not know today if he committed medical malpractice in the tragic Campbell case. However, out of fairness to Lawrence Campbell’s widow and two children, to date inexplicably they have been denied access to eye records.

What is clear in this case — and I emphasize this one case — is that LASIK surgery clearly constituted a material contributing factor, if not the sole factor, to police officer Campbell’s suicide. To Mrs. Campbell’s knowledge, prior to his LASIK surgery she reports that her husband suffered from no mental illness whatsoever.

Now you have heard today and certainly recognize that LASIK surgery helps the vast majority of patients who have it. For a small minority, their regret is profound. For a smaller minority of patients still, depression associated with their visual disability is real. The association with suicide and bad LASIK outcomes, however rare, cannot be dismissed, and warrants further investigation.

As a final point, I would just like to call the FDA’s attention to its reporting obligations. The FDA’s work should be transparent and readily available to the public. It is not always. Nine months ago, my law firm served a Freedom of Information request to obtain information concerning the Administration’s recall of the Alcon LADARVision 6000. To date, we have still received no substantive response. Vindication of injured patients’ rights depends on timely disclosure of such information. Thank you.


Click here to read suicide note – Slide 6, 7 and 8.

Update May 28, 2011: 20/20 Hindsight on Canada’s GlobalTV program 16:9 The Bigger Picture features Larry Campbell’s story as told by his son.