Reprinted with permission from www.fdaweb.com
10/19/2010

A year after announcing a study to determine the percentage of LASIK laser vision-correction patients with significant quality of life problems after having the surgery and to identify predictors of these problems, FDA 10/19 provided an update on its plans for the three-part study that will run until the end of 2012. Details of the study have been kept under wraps, with numerous requests for information practically being ignored by the agency.

The study was originally announced presumably to quell growing criticism of FDA’s oversight of LASIK’s promotion and usage, and mounting complaints by injured LASIK patients (see earlier story). On the day it announced the study, the agency also 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. It has provided no information on follow-ups, if any, to those letters.

FDA says that in the first part of its study, a Web-based questionnaire was designed and developed “to evaluate patient-reported outcomes that could impact quality of life after LASIK surgery, some of which may be related to the safety of the lasers used in this procedure. The second phase involves a clinical study called Patient-Reported Outcomes with LASIK (PROWL-1), where U.S. military personnel electing LASIK will complete the questionnaire preoperatively (before surgery) and at one, three, and six months postoperatively (after surgery). Enrollment for PROWL-1 is slated to begin within the next three months.” This study portion will be conducted at the Naval Medical Center San Diego, where it has conducted more than 50 clinical trials and published 28 papers on refractive surgery. The final phase of the project, the PROWL-2 study, will be a national, multicenter clinical study with a protocol based on the experience from PROWL-1, according to the agency.

Activist members of various injured LASIK patient networks allege that the Naval Medical Center San Diego is staffed by ophthalmic surgeons who are biased in favor of the LASIK procedure, some of whom have testified positively on it at various forums, including a 2008 FDA Ophthalmic Devices Panel meeting which took public testimony from LASIK patients. Commenting on FDA’s update, Florida-based injured patients spokesman Dean Kantis said: “Nothing new here, just the same old stuff. Navy overseeing (fixed studies) and continued non-involvement by the hurt advocates. So they can continue to dupe everybody (but us, of course). We are the enemy, and we’re working for free, right? If it wasn’t corrupt, why not involve us?”

The current study update could be seen as the agency becoming more comfortable with its obligations to be more transparent. Up until now, details of this study have been kept practically secret. Innumerable requests from FDA Webview since March for the names and affiliations of its principal researchers and for a copy of its protocol have gone unanswered by FDA’s Press Office.

Meanwhile, former CDRH chief of ophthalmic devices Morris Waxler has been waging a public awareness battle to discredit the device’s approval under his watch (see story). Most recently, Waxler appeared on CNN to challenge the safety and effectiveness of the LASIK procedure. The segment opened with Waxler saying LASIK’s approval was mistaken because his review team focused on making sure there was no loss of visual acuity from the procedure and did not pay enough attention to other problems like post-procedure glare, halos and night driving problems. His examination of post-approval FDA experience reports showed that only 60% of patients were able to get rid of the glasses and contact lenses — this, plus the level of adverse events, demonstrated to him that LASIK is “a failure.”

Reprinted with permission from www.fdaweb.com
9/28/2010

Former CDRH chief of ophthalmic devices Morris Waxler and leading Houston, TX ophthalmic surgeon Stephen G. Slade came to a televised Mexican stand-off 9/28 on the safety and effectiveness of elective LASIK vision correction. After the seven-minute CNN segment, anti-LASIK activists accused Slade of making false statements in it.

The segment opened with Waxler saying LASIK’s approval was mistaken because his review team focused on making sure there was no loss of visual acuity from the procedure and did not pay enough attention to other problems like post-procedure glare, halos and night driving problems. His examination of post-approval FDA experience reports showed that only 60% of patients were able to get rid of the glasses and contact lenses — this, plus the level of adverse events demonstrated to him that LASIK is “a failure,” Waxler said.

Slade disagreed, calling LASIK “arguably the most-studied elective procedure in the U.S.” with over 16,000 eyes “extensively studied” for the issues cited by Waxler –“The science is there. All branches of the military have approved it, including the astronauts.”

Waxler responded that he “heartily disagreed” with Slade’s comments, though he respected him “a great deal.” He said he had looked at the PMAs and confirmed that patient problems remain after a year, for a failure rate of over 50%, counting failure to be able to discard glasses and contact lenses, 18% reporting glare, halos, and dry eyes. “It took me 2-3 years to figure out I was wrong to discount haze, halo, glare … people have a miserable time with their LASIK.”

The studies cited by Slade, Waxler said, were done by “people who have a financial interest in the outcome. Not one independent study has been done. … some of the military ophthalmologists have a side business in doing this … they have profited mightily. LASIK has been promoted as if it was like having your fingernails manicured or your hair curled. It’s not. You’re taking a perfectly formed cornea, messing it up by making a slice, putting a flap over … you have a lot of problems.”

Slade responded that he disagreed with everything Waxler said. Night vision for driving “is better after LASIK than before LASIK,” Slade contended, adding that “FDA agrees with this.” Some of Waxler’s data come from 20-year-old technology, Slade said, challenging viewers to think what their laptops and cell phones were like 20 years ago. LASIK is no longer performed by “slicing” the cornea but by use of lasers. As for dissatisfied patients, “we will do everything we can for them.” Ectasia (corneal scarring) rates are far lower than Waxler said, and there a now new drugs for dry eye, Slade told CNN.

In on-line reactions to the CNN segment, injured LASIK patient Paula Cofer said it was “a lie” that LASIK surgeons “are very interested in helping patients with LASIK complications. … For one thing, they have NEVER reached out to us, and for another, they know there’s nothing they can do for us. I’ve been to several of the so-called ‘best’ surgeons in the country and even Canada and the UK. They just want us to shut up and go away. Their latest line of defense is saying that all of the problems occurred on the old technology. That’s another lie. I hear from patients almost daily who were injured on the ‘latest’ technology.”

Cofer challenged Slade or one of his colleagues to debate her in an open public forum on the risks vs. “supposed benefits of LASIK. Slade says the science is not there to support Dr. Waxler’s statements. I’ll prove that it is.”

Another patient alleged “industry retaliation” against patients who publicly complain.”We were targeted, stalked and harassed by the LASIK industry and its agents because we spoke out about problems with LASIK publicly,” this person wrote in an e-mail. “The industry, surgeons and their thugs were willing to ruin us to shut us up. This is what happens when individuals speak out against multi-billion dollar industries.”

Injured patient Dean Kantis, operator of the Life After LASIK Web site, told his email network that he had been called by Slade after the CNN segment aired to argue issues Kantis had emailed to him. During the conversation, Kantis wrote, Slade contended “more than once” that the LASIK flap does heal. This is a contentious issue in the LASIK community; Kantis said he told Slade that the post-LASIK flap loses 98% of its strength and as reported in Scientific literature never heals. Slade ended the conversation quickly after that, Kantis said.

Texas patient Sylvia Stephens emailed the network after seeing the segment. “I’ve had 2 procedures on my left eye and 3 on my right eye, all done by Dr. Slade. My left eye is not perfect, but I’m satisfied with it; however, my right eye had very bad double vision after an enhancement. I had the 3rd procedure to try to correct the double vision. The doubling is not as bad now but I cannot see clearly out of that eye at any distance – near or far. It bothers me constantly as it is my dominant eye. I regret having the surgery. And in my opinion, Dr. Slade is one of those doctors who will never admit a mistake or that something may be wrong. He was recommended to me as being ‘the very best.’ I beg to differ.”

8/16/2010

The Food and Drug Administration has slapped several more LASIK facilities with warning letters for violations of the medical device reporting (MDR) regulations. Federal law requires surgical facilities to track and report adverse events related to FDA-regulated medical devices such as those used to perform LASIK. Critics of the LASIK procedure have long accused the LASIK industry and LASIK surgeons of systematically hiding widespread LASIK problems and ignoring the federal law. They point to common “side effects” such as chronic dry eyes and night vision problems, as well as risk of delayed complications such as flap dislocation, infection, and corneal ectasia. Ectasia results from weakness of the surgically-thinned cornea to maintain its shape, leading to progressive vision loss. Ectasia is generally treated by corneal transplantation. LASIK surgeons continue to deny the frequency and severity of these problems.

Links to recent FDA warning letters:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm220385.htm

Saint Vincent Surgery Center
312 West 25th Street
Erie, Pennsylvania 16502

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm220384.htm

LasikPlus Vision Center
1390 Willow Pass Road, Suite 120
Concord, California 94520-7986

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm220664.htm

Vision Care Holding, LLC dba Lasik Vision Institute
3801 South Congress Avenue
Lake Worth, Florida 33461

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm220344.htm

TLC Vision Corporation dba TLC Plymouth Meeting
600 Germantown Pike Suite 160
Plymouth Meeting, Pennsylvania 19462

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm220354.htm

Vision Care Holdings, Inc. dba The LASIK Vision Institute
4771 McKnight Road
Pittsburgh, Pennsylvania 15237-3424

Also see: List of FDA Warning Letters to LASIK Clinics

Reprinted with permission from www.fdaweb.com
05/25/2010
Oil Spill Has a Lesson for FDA: Federal Impotence

[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.

Reprinted with permission from www.fdaweb.com
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.”

Reprinted with permission from www.fdaweb.com
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.”

Reprinted with permission from www.fdaweb.com

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.

Reprinted with permission from www.fdaweb.com

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.”