Violative Medical Device Ads: Why FDA Doesn’t Act

Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission.
01/04/2017

(Report by Jim Dickinson) FDA has statutory authority to regulate the advertising and promotion of “restricted” medical devices, but even in the face of injured patient complaints, it’s an authority it rarely uses. That’s probably because in the broad sweep of device safety issues and recalls that grab headlines and congressional attention, complaints about ads from injured patients directly to the agency’s Center for Devices and Radiological Health are few and far between. And that’s probably because injured patients don’t know that CDRH is supposed to be regulating violative device ads.

One injured patient, however, does know and in November she complained to CDRH about a violative ad by LASIK (laser-assisted in-situ keratomileusis ) eye surgeon T. Hunter Newsom, in Tampa, FL. A former FDA advisory committee consumer member, injured Tampa LASIK patient Paula Cofer complained that Newsom’s Web site omitted all risk information in extolling the benefits of his new Wavelight laser by Alcon Laboratories. CDRH regulatory counsel Deborah Wolf responded that she’d referred the complaint to the Allegations of Regulatory Misconduct Branch, with the suggestion that Cofer communicate directly with them.

When Cofer did so, she got an email form letter saying “FDA does not provide information on ongoing investigations. Such information can be obtained pursuant to a Freedom of Information Act (FOIA) request once an investigation is closed … Please note that on average, investigations take a minimum of six (6) months to complete.” There was no information on how Cofer could learn of the investigation’s completion, other than the unsaid implication that she could begin inquiring on her own schedule after the minimum six months.

For the FDA-savvy Cofer, this was “Unbelievable!” For injured patients without FDA familiarity it would likely be plain impossible, given (a) their unawareness that FDA even has a role in false or misleading medical device promotional claims enforcement, and (b) their inability to discover who at FDA might handle such complaints.

There was a time when CDRH took this issue a little more seriously than it does now. In September 2011, hard on the heels of an acrimonious campaign by injured LASIK patients against LASIK surgeons’ violative promotions, then-CDRH compliance director Steven Silverman issued a Dear Eye Care Professional letter politely urging them to be mindful of the law. In it, he reminded them that this was the second time in two years that FDA had taken this direct approach to their promotional practices. He gave them 90 days to comply with the law.

“After that time,” Silverman wrote, “the FDA may take regulatory action against eye care professional whose advertisements or promotional materials violate the FD&C Act. Agency actions may include Warning Letters, product seizures, injunctions and civil money penalty proceedings.”

Actually, this was CDRH’s third attempt to bring the LASIK practitioner community into compliance. The Center sent a similar letter separately to the community’s national body, the American Society of Cataract and Refractive Surgery.

Cofer and the earlier prolific complainers among the LASIK injured patient community say these efforts had no effect on the number of deceptive promotions and advertising by practitioners. Indeed, since Cofer complained about Newsom, she says she has found three additional active violative Web sites belonging to the 37-state, 68-center LASIK Vision Institute, California-based Saroudi Advanced Lasik and Eye Centers, and surgeon Manoj Motwani.

For ongoing and proliferating violations dating back more than seven years, why doesn’t FDA do more than say it can’t confirm or deny the existence of its investigations and invite FOIA requests after an investigation is complete? Probable explanations include ꟷ if the agency allowed itself to publicly discuss the matter: (1) Lack of resources to prosecute so many cases which have comparatively few reports of actual harm; (2) the agency’s dismal track record in court cases involving First Amendment issues (which LASIK surgeons would surely invoke if prosecuted); (3) the need to defend its failure to aggressively address the related issue of permanent eye injuries in a small minority of LASIK patients who were deceived; and (4) lack of congressional and media interest.

While LASIK may be dismissed as an isolated case because of its elective nature, other areas of violative promotional activity among users of restricted devices may be encouraged by its example. That’s a bet FDA appears to be confident in making.

Shuren Promises Action on Suicidal LASIK Patient

Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission.
6/10/2016

Although CDRH has repeatedly refused in the face of mounting adverse reaction/injury reports to remove the LASIK indication from lasers labeled for that vision-enhancement indication, Center director Jeffrey Shuren 6/10 took less than 40 minutes to tell a LASIK activist CDRH would “look into” a patient’s report that he/she was considering suicide because of LASIK injuries. The call on Shuren came in an email from LASIK injured patient/activist and former CDRH advisory committee consumer representative Paula Cofer, who in two months ago launched a nationwide Internet petition for Congress to fire Shuren over the LASIK issue and his purported “capture” by industry. Continue reading

Hundreds Petition Congress to Fire CDRH’s Shuren

04-14-2016
Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission.

An Internet petition to Congress authored by LASIK injured patient/activist and former CDRH advisory committee consumer representative Paula Cofer has drawn more than 270 signatures from across the country in its first 24 hours, demanding the removal of CDRH director Jeffrey Shuren from office. Last October, Cofer and some of the current signatories were involved in a 1,500-message email blitz of Shuren’s government in-box calling on him to resign. Shuren and FDA shrugged off that campaign. Now Cofer and her supporters want Shuren fired by Congress. Their petition charges that his leadership has seen the Center “become mission-corrupted, placing industry interests over public health.

“Failures of the CDRH,” it continues, “have harmed countless people and led to many preventable deaths. CDRH is ‘captured’ by industry. Division managers at the CDRH have close working relationships with representatives of medical device manufacturers. Fraud and data tampering occurs regularly in FDA clinical trials of medical devices. The CDRH’s oversight of device trials is weak and ineffective, leading to approval or clearance of unsafe devices.

“Post-market surveillance by CDRH is lax,” the petition goes on. “Problems with medical devices go undetected, which leads to injuries to unsuspecting American citizens. Patient advocacy groups and whistle-blowers who reach out to the CDRH to raise a red flag about problems with a medical device have been shut out or ignored. MedWatch reports of device-related injuries fall into a black hole at the agency.

“We call on the United States Congress to remove CDRH director Jeffrey Shuren from the FDA so that a new leader can take his place. A new CDRH leader must honor the agency’s mission to protect and promote the public health.”

Among numerous comments signatories have posted to the petition are some Cofer characterizes as “brutal” about Shuren. They include this from a Tara Howie in New Jersey:

“In 2011 Shuren, when asked about the 510(k) process, Shuren said he doesn’t know where precisely it is going, but it certainly won’t be scrapped. He believes the system works well, although he knows there are those in the industry with ‘angst’ about the program — and he has seen this concern increasing. But the largest challenges pertain only to a small minority.

“This is my biggest problem with Shuren,” Howie’s comment continues, “the 510(k) process is a legal loophole for untested devices to go straight to market without any pre-market testing, simply based on the fact the device resembles a predicate device. Having had a device implanted that was based on a predicate device that was pulled from the market, yet the devices in me were not shows exactly where a huge problem exists.

“Is Shuren that shortsighted? I think not. In his time at the CDRH he has lied (kinda) under oath, he has pushed his agenda, one that benefits him, yet leaves the consumer, frankly, screwed. The ‘small minority’ Shuren speaks of is not too small actually. Perhaps in his limited view of everything that doesn’t pertain to him, or the lobbyists he’s been making extremely happy, it is small, but if you ask thousands and thousands of consumers what they think of the way Shuren has decided to run the CDRH, they will undoubtably tell you there are many, many problems. Not only ‘minor’ ones.

“How can anyone within the FDA, or specifically the CDRH, be trusted when they work so closely with representatives from medical device manufacturers? The writing is on the wall so to speak. And it’s well past time to make the changes necessary to protect the consumers, and not the wallets of the medical device industry. Greed in this country is putting dollars before clear, rational thinking. And it’s time to change this, along with the leadership at the CDRH, beginning with Shuren, and all of his cronies. Let’s put people back into the conversation, the consumers, the patients…But, don’t ask the thousands of already deceased ones, just ask their families.”

Cofer says her petition is being followed by Pennsylvania Republican congressman Mike Fitzpatrick, and she hopes he will bring it to the attention of his colleagues. Fitzpatrick has strongly supported injured patients’ criticisms of Shuren and CDRH safety management in the power morcellator and Essure birth control controversies.

FDA spokesman Eric Pahon would say only that the agency “is aware of the petition.”

Despite Protests, FDA Hangs Tough on LASIK

9/9/2015

Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission.

Despite continued agitation on the part of patient activists claiming injuries from LASIK vision correction procedures, FDA said 9/9 it has “not found any new safety concerns associated with LASIK devices to lead it to believe that there is no longer a reasonable assurance that these devices are safe and effective under the conditions of use in the labeling of the device.” The statement came after FDA Webview asked why the agency had not responded to a 5/8 letter from LASIK activist Paula Cofer to acting commissioner Stephen Ostroffthat attached 1,073 electronic signatures supporting reconsideration of FDA’s denial of a LASIK ban petition from former CDRH ophthalmic devices chief Morris Waxler.

Cofer herself chided Ostroff for his non-response in a second letter attaching an investigative report in the September issue of Consumers Digest and advising him that two more ex-FDA officials are now speaking out against LASIK: Former CDER ophthalmic division deputy director Everett Beers, quoted in Consumers Digest as supporting Waxler’s assertion that LASIK should not have been approved, and former medical device compliance director Larry Pilot, quoted in the same article as saying, “When it comes to LASIK, it isn’t that the agency has dropped the ball, it’s that they never even moved it.”

Cofer’s second letter to Ostroff told him: “For years we’ve been complaining to the FDA about this issue. In 2008 your agency said you would reevaluate the safety of LASIK. It’s been seven and one-half years, and nothing has changed except for the growing number of injured LASIK patients. Now it’s your watch, Dr. Ostroff. Are we to expect more of the same treatment ─ injured citizens shut out of the regulatory process? Or will you do what’s right and respond to our grievances and concerns?”

FDA’s response to FDA Webview said the agency entered Cofer’s 5/8 letter to Ostroff as a public comment to the docket to Waxler’s 7/22/14 petition for reconsideration, and the agency’s failure to notify her of this was an “oversight.” As for Cofer’s latest letter, “it is currently under review. The FDA will respond directly to Ms. Cofer if necessary.”

1,073 LASIK Victims Ask FDA to Reconsider Petition Denial

Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission.

05-08-2015

Attaching 1,073 signatures mostly from other purported victims of LASIK eye surgery, activist Paula Cofer 5/8 asked FDA acting commissioner Stephen Ostroff to reopen for consideration a petition from former CDRH ophthalmic device branch chief Morris Waxler that was denied last summer. The petition sought the market withdrawal of LASIK-indicated device and a public health advisory. In her letter, Cofer alleges that the denial was “presumably” directed by CDRH ophthalmic devices director Malvina Eydelman who, she wrote, “has a history of protecting industry interests over public health … It is clear that under the leadership of ophthalmologist Malvina Eydelman, MD, the FDA division that oversees LASIK devices has been ‘captured’ by industry.”

The letter says Waxler asserted that “LASIK manufacturers and their collaborators successfully pressured FDA to classify surgically-induced vision problems (halos, starburst, ghosted images and glare) and chronic dry eyes as mere ‘symptoms’ so that manufacturers could claim that the adverse event rate is less than 1%. ‘The true adverse event rate six months or more post-LASIK is at least 20 times the FDA approvable rate of 1%,’ he says.”

Cofer says FDA “has failed to take action on several other citizen petitions asking for a variety of actions against LASIK, several reports of LASIK-related suicides, numerous letters and emails from the public concerning LASIK problems, countless false and misleading LASIK ads promoting specific LASIK devices, and hundreds of LASIK-injury reports filed with the agency by LASIK patients through MedWatch.”

“What seems to be lost in the LASIK controversy,” the letter concludes, “is the simple fact that LASIK is unnecessary. Visual refractive error is not a disease requiring surgical treatment. Safer alternatives ─ namely glasses and contact lenses ─ are widely available.”

FDA Panel to Consider Corneal Collagen Cross-linking

Tuesday, February 24, 2015

By Richard Smith

          As with many regulatory proceedings, a Food and Drug Administration hearing today will have effects reaching far beyond its official topic. An FDA scientific advisory panel is gathering to consider a new treatment for keratoconus, a rare but potentially disabling eye disorder. How the FDA responds could launch a new phase of the Lasik eye surgery boom–with an add-on technology that’s marketed as enhancing patient safety but that in fact greatly increases patient risk.

          First, the basics: Keratoconus affects about 174,000 Americans, with roughly 6,400 new cases a year.[1] An afflicted eye loses structural integrity, and the cornea bulges forward under the eyeball’s internal pressure. Vision may deteriorate severely as the eye gets more and more distorted.

          The procedure under review, corneal crosslinking, is simple compared to many ophthalmologic treatments. The eye is doused with a solution of riboflavin (Vitamin B2) and then exposed to ultraviolet light. This stiffens eye tissues containing collagen. (I imagine damp shoe-leather baking in harsh sunlight.)

          The idea is to help the eye hold its shape, but for minorities of patients the treatment causes problems, including significant loss of corrected distance vision in 2.9 percent; significant scarring, up to 8.6 percent; and corneal ulcers, 7.6 percent.[2] Long-term risks are unknown, but because crosslinking uses a range of ultraviolet light known to alter DNA,[3] there’s a chance it could trigger cancer.

          Such risks aren’t trivial. But the benefits may be substantial: halting the disease’s progression, which can lead to legal blindness, and avoiding corneal transplant, a frequent treatment for severe cases that is nobody’s idea of a picnic.

          But there’s more to the story. Crosslinking is being evaluated as a treatment not just for keratoconus but also for corneal ectasia. Ectasia is a kind of cousin, with the same basic symptoms and course, but unlike keratoconus its cause is known: the laser vision-correction surgery known as Lasik–a medical intervention widely touted as safe and effective.

          How can Lasik lead to ectasia? Refractive surgeries aim to improve vision by reshaping the eyeball so light focuses properly on the retina. Before Lasik, the laser was applied to the eye’s surface. Recovery was slow and painful. Lasik emerged as an easier sell: a thin flap of cornea is shaved and folded aside, underlying tissue is lasered, and the flap is flipped back into place, creating a natural bandage over the wound. Less pain, fast vision improvement–the so-called Lasik “wow!” effect.

          But the cornea doesn’t heal like most body tissues. In fact, the Lasik flap never really heals. In one study, the edge of the flap retained only 28.1 percent of its original tensile strength–and the central area only 2.4 percent.[4] That’s why, years after Lasik, a blow to the eye can knock the flap loose, like an unlatched door, and a surgeon “retouching” your Lasik can simply relift the original flap, like scraping an egg off a griddle.

          The flap’s failure to heal also leaves the cornea weaker–less resistant to the eye’s internal pressure. Sometimes the eye’s shape shifts enough to start undoing Lasik’s correction of vision. Worse corneal bulging can cause ectasia.

          How often this happens isn’t clear, as estimates vary and, as malpractice attorneys have found, some cases are hushed up.[5] Current statistics put the incidence below one percent.[6] That’s less frequent than some of Lasik’s other downsides, such as glare, halos, starbursts, ghosting, and dry eye.[7] But because such symptoms are classified by the FDA as less severe than ectasia, they’ve received less official attention and surgeons have been less concerned with them than with downplaying or even denying the risk of ectasia.[8]

          Now, however, with corneal crosslinking on the horizon, ectasia is back on their radar. In fact, some surgeons and industry leaders advocate adding crosslinking to Lasik as insurance against future deterioration. Avedro, whose procedure comes for FDA review today, is conducting a clinical trial of Lasik and corneal cross-linking performed simultaneously–a double-header already approved in Europe, where Avedro markets it under the trade name Lasik Xtra. Another company, CXLUSA, is running a trial of a Lasik-crosslinking combo for patients known to be at higher risk of ectasia.

          So let’s get this straight. The risk of ectasia after Lasik is less than one percent–way less, surgeons have insisted. But surgeons propose tacking on crosslinking, with risks several times greater than that of ectasia. And the risks of crosslinking would load on top of the known risks of Lasik. These risks have been hotly debated, but one review of FDA documents found that, across studies, 15 percent of Lasik patients had worse or significantly worse night vision than before surgery. Twenty percent had worse or significantly worse dry eye.[9] These outcomes can be far more disabling than they sound–for instance, when a Lasik patient driving at night must try to peer through streetlight starbursts that span the whole road, or when Lasik-induced dry eye hurts so much a person wants to gouge his eyes out.

          The Hippocratic Oath advises doctors, “First, do no harm.” Given that Lasik is medically unnecessary, maybe the simpler solution is not to do it in the first place.

          To make a case for Lasik plus crosslinking, surgeons have had to stop minimizing ectasia’s risks, instead maintaining that those risks justify adding crosslinking. Whatever net effect crosslinking brings to Lasik patients, it also gives crosslinking tech companies and Lasik surgeons a new option they can add to bills for some 600,000 Lasik customers a year. Big money isn’t in treating kerataconus but in promoting Lasik with crosslinking.

          That procedure will come up for FDA approval within the next few years. But if today’s advisory panel recommends approval for crosslinking, doctors could start slapping the procedure onto Lasik even before the safety and efficacy of the combo platter has been adequately studied. Doctors could claim a right to perform the procedure in what’s called an “off-label” use–that is, for purposes other than those officially sanctioned.

          The FDA regulates drugs and medical devices, not the practice of medicine,so it couldn’t stop off-label uses altogether. But what the agency can do is stipulate that crosslinking, if approved, can be marketed only for the approved purposes–treating keratoconus and ectasia. It could forbid doctors to promote crosslinking as a way to make Lasik safer. Such claims would constitute “misbranding”–essentially, misleading advertising that amounts to fraud. That might give the agency a chance to make a meaningful yes-or-no decision when Lasik Xtra and its competitors come up for approval. Otherwise, Lasik-plus-crosslinking could become so commonplace that future FDA approval would be a foregone conclusion.

          That’s how the Lasik boom got its start two decades ago. In the 1990s, Lasik became what its critics regard as a runaway train when lasers were FDA-approved for an earlier method of eye surgery, and surgeons began using them for Lasik as well–before anyone adequately studied Lasik’s safety and effectiveness. According to Morris Waxler, then branch chief of the FDA’s Center for Devices and Radiological Health, the agency got worried that Lasik was spreading without safety studies or rules, risking not only patients’ eyes but also the FDA’s reputation. So the agency tried to rush Lasik surgeons into the corral of government oversight.[10]

           Predictably, this rushed job was a botched job. For one thing, according to Waxler, the FDA allowed industry too much say in establishing official definitions of safety and effectiveness. Many of the ways Lasik can damage vision and eye health got downgraded from adverse event to complication or side effect–and thus didn’t affect Lasik’s official safety profile.

          The FDA advisory committees reviewing Lasik in the 1990s tried to slow things down. The first one voted the application under consideration nonapprovable–largely because the reported percentage of patients returning for followup evaluation was so low that the data looked cherry-picked. Nonetheless, the agency approved it, fearing a battle with the applicant’s formidable attorney (a former FDA chief counsel).[11]

          During the next round of hearings, NIH ophthalmologist Frederick Ferris acknowledged it was bizarre to see the FDA debating approval of a surgery already in widespread use: “…driving in here I heard a number of advertisements for this procedure…. I thought to myself, Well, people little note nor long remember what we do here because, as near as I know, this train is moving.”[12]

          Now another train is lurching into motion. The FDA needs to hit the brakes.

 


[1] Figures based on current estimated U.S. population and U.S. incidence rate of 0.002% and prevalence rate of 0.054% reported in Kennedy RH, Bourne WM, Dyer JA. A 48-year clinical and epidemiological study of keratoconus. Am J Ophthalmol. 1986;101:267-73.

[2] Raiskup, F, & Spoerl, E. Corneal Crosslinking with Riboflavin and Ultraviolet A. Part II. Clinical Indications and Results. The Ocular Surface, April 2013, Vol. 11, No. 2. pp. 93-108. p. 98.

[3] Steve Safran, quoted in eyeConnections: Queries about collagen cross linking. ASCRS EyeWorld, April 2010.

[4] Cohesive Tensile Strength of Human Lasik Wounds with HIstologic, Ultrastructural, and Clinical Correlations. Ingo Schmack, MD; Daniel G Dawson, MD; Bernard E McCary, PhD; George W Waring III, MD, FACS, FRCOphth; Hans E Grossniklaus, MD; Henry F Edelhauser, PhD. Journal of Refractive Surgery, 2005;21: 433-445.

[5] Interview with Todd Krouner 9-11-12

[6] Raiskup, F, & Spoerl, E. Corneal Crosslinking with Riboflavin and Ultraviolet A. Part II. Clinical Indications and Results. The Ocular Surface, April 2013, Vol. 11, No. 2. pp. 93-108. p. 98.

[7] LASIK Quality of Life Collaboration Project, FDA/NIH/DOD. Presentation by Malvina B. Eydelman, M.D., Director, Division of Ophthalmic and Ear, Nose, and Throat Devices. ODE/CDRH/FDA. Posted at http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/UCM421193.pdf.

[8] Stephen Slade, quoted in: CXL for Corneal Ectasia: Reshaping the Future of Treatment, by Annie Stuart. EyeNet Magazine, April 2014.

[9] Outcomes of Lasik of Myopia with FDA-Approved Lasers. Bailey, Melissa D, OD, PhD; Zadnik, Karla OD, PhD. Cornea, Vol. 26, No. 3 (April 2007), 246-254.

[10] Interviews with Morris Waxler, December 7, 8, and 9, 2012.

[11] Interviews with Morris Waxler, December 7, 8, and 9, 2012.

[12] FDA–Ophthalmic Devices Advisory Panel, 93rd meeting. July 22, 1999.

Device Maker Slammed by Injured Patients at FDA Meeting

Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission.

2/24/2015

Avedro Inc. CEO David Muller was verbally battered by several injured LASIK patients during public presentations 2/24 at a joint meeting of two FDA advisory committees as he led his company’s efforts to win an approval recommendation for a new drug/device combination to treat eye disorders progressive kerataconus and ectasia. Muller, the presenters charged, headed Summit Technology in the 1990s when it won a corrupt approval for the first LASIK-indicated excimer laser that permanently damaged their eyesight and “ruined” their lives.

Now he’s seeking approval for an “orphan”-designated NDA for riboflavin ophthalmic solutions with UVA irradiation by Avedro’s KXL System for use in corneal collagen cross linking for the treatment of the conditions underlying progressive keratoconus and corneal ectasia following refractive surgery. Despite its unapproved status in the U.S., the combination is already being promoted on Avedro’s Web site as an integrated enhancement of LASIK surgery outcomes, restoration of corneal strength, halting progression of keratoconus and ectasia, and slowing or eliminating the development of acute keratoconus.

Before they voted 10-4 with one abstention to recommend approval for the keratoconus indication and 6-4 with four abstentions for the ectasia following refractive surgery (LASIK) indication, the Dermatologic and Ophthalmic Drugs Advisory Committee and Ophthalmic Devices Panel of the Medical Devices Advisory Committee heard 14 public commenters give four-minute presentations. The first four urged approval, citing worldwide successful use of the new technology outside the U.S., and the suffering of an estimated 2 million keratoconus American victims who are without access to the therapy.

There were 1,268 corneal transplants performed in the U.S. in 2013, the Cornea Society’s David Glasser told the panel. “I couldn’t be happier if your votes today mean I will have performed my last corneal transplant,” he said.

But the remaining 10 public presenters, while frequently conceding the case for keratoconus victims in Avedro’s new technology, delivered a relentless stream of condemnations of the refractive surgery medical-industrial-FDA collaboration that they complained had ruined their lives, led to depression and suicide through an “epidemic” of dry eye, blurred vision, starbursts, haloes, night-driving difficulties and other vision problems.

The panel also heard a presentation, delivered in his absence, by former CDRH ophthalmic devices branch chief Morris Waxler, who led the team that approved the first Summit Technology LASIK device and has since recanted. Delivering for him, injured LASIK activist Paula Cofer slammed Muller’s role as Summit Technology CEO in introducing the first LASIK lasers through a corrupt FDA evaluation process. She alleged that he was responsible for “thousands, perhaps tens of thousands of LASIK patients who developed ectasia as a result of their trust” in the process. LASIK surgeons, she said, don’t report the ectasia cases they cause, and are complicit in an industry-wide cover-up. If FDA approves Avedro’s combination product, she predicted it will lead to off-label use of Avedro’s next enhancement, LasikExtra, already being promoted on its Web site and in the marketplace.

Then it came Matt Kotsovolos’ turn [speaking for Dean Kantis] to lambaste Muller for “ruining” his vision through “huge” (reportedly $1 million) contributions to the late Sen. Edward Kennedy’s 1994 re-election campaign “in exchange for political FDA access” that led to the Summit device’s approval in October 1995. Kotsovolos also read from what he said was a transcript of a presentation to a professional group by the Cleveland Clinic Foundation’s Cole Eye Institute eye surgeon Ronald R. Krueger, in which he admitted that LASIK-caused ectasia occurred much more frequently than the procedure’s FDA-accepted 1% total adverse event rate.

Muller, who has long bragged about the closeness of his FDA relationships, took to the podium several times during the panel discussions, but he did not respond to his critics. In one appearance he explained that deficiencies in the clinical data supporting the KXL System application, pointed out by many panel members, resulted from data prepared by an unnamed “small German company” that developed the technology and ran out of money before it could complete the studies and Avedro acquired them as-is.

Among the Avedro data deficiencies mentioned by panelists were the NDA’s lack of patient satisfaction surveys, which CDRH ophthalmic devices director Malvina Eydelman told the meeting FDA was “committed to,” and the complete lack of any data from studies done with the KXL device itself ─ instead the panelists were forced to accept Avedro’s contentions that this device was to all important extents, identical to a different device, the UVX which was used in all the studies.

Despite these and other deficiencies, the panel voted with barely muted misgivings for the primary indication, progressive keratoconus, and much more reluctantly for the second ─ and reputedly far more profitable ─ ectasia after LASIK indication.

Ex-FDAer Waxler to Oppose Avedro NDA at Advisory Cte.

By Jim Dickinson

02/18/2015

Former CDRH ophthalmic devices branch chief Morris Waxler will next week oppose an Avedro Inc. NDA seeking approval for riboflavin ophthalmic solutions with UVA irradiation for use in corneal collagen cross linking for the treatment of the conditions underlying progressive keratoconus or corneal ectasia following refractive surgery. The venue: the 2/24 joint meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee and Ophthalmic Devices Panel of the Medical Devices Advisory Committee.

The basic issue in Waxler’s opposition is the failure of the applicant to demonstrate long-term product safety in a prior LASIK PMA application as Summit Technology in 1995, which Waxler approved as branch chief.

In a presentation to be delivered in his absence, Waxler says the NDA presents “at least two public health dilemmas” for the committees because the product masks “a high rate of LASIK-induced ectasia” when the true rate is unknown, and “how many legally blind people are acceptable to you for a few years of ’20-happy vision?'”

Waxler’s presentation says that FDA’s “collaboration with the refractive surgery industry has created a LASIK-induced epidemic of sick corneas…. The true rate of LASIK-induced ectasia will be buried forever if the panel recommends approval of FDA’s plans to approve products polymerizing sick corneas.”

Waxler, who unsuccessfully petitioned against his own approval of the LASIK indication for excimer lasers because of alleged data falsification he found later, says FDA leadership on LASIK products “has a long-standing collegial and professional bias towards ophthalmic professionals in the industry. They work out many issues in regular private meetings; I know because I led many of these meetings and know of many others.”

LASIK Activists Petition for Black Box Warning

Copyright Dickinson FDA Webview at www.fdaweb.com.
Republished by permission.
01/05/2015

Notwithstanding a recent FDA-NIH-U.S. Navy collaborative study that downplayed LASIK vision-altering surgery risks, three activists petitioned FDA commissioner Margaret Hamburg 12/24/2014 to add a black box warning to the labeling of lasers approved for the procedure. The petition alleges a “high incidence of induced visual symptoms (double vision/ghosting, starbursts, glare, and halos) and dry eyes” and asks the agency to send letters to professional organizations “to advise physicians of a black box warning on excimer lasers.”

The petition says the FDA-NIH-Navy study “demonstrated that three months after LASIK eye surgery, up to 45% of patients who had no visual symptoms before LASIK report [them] after LASIK, and up to 30% of patients who had no dry eye symptoms before LASIK report dry eyes after LASIK.” It cites a 2007 published review of data from 12 FDA clinical trials showing that six months after LASIK about 20% of patients reported that visual symptoms and dry eyes were worse than before surgery, much worse than before surgery, moderately severe after surgery, or severe after surgery.

“With millions of people having undergone laser eye surgery with such frequent problems,” the petitioners write, “it follows that there is an epidemic of visual symptoms/night vision problems and dry eyes caused by this unnecessary surgery. Unless the FDA immediately begins to provide adequately strong black box warnings about the risks and adverse effects of laser eye surgery, the epidemic will continue to grow. There have already been several reports of LASIK-related suicide and countless reports of suicidal ideation. A black-box Warning would help reduce the number of such negative outcomes and therefore falls well within the FDA’s mandate of protecting and promoting public health.”

FDA Dims LASIK Harms it Found in ‘Life Quality’ Study

Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission.

October 20, 2014

In a long-awaited report on a collaborative study it conducted on the post-surgical quality of life of LASIK patients, FDA is downplaying the harms it found in up to 45% of 572 patients, adopting the industry-favored term “visual symptoms” vs. the agency’s former use of the terms “adverse reactions” or “adverse events.” Delivered by CDRH ophthalmic devices chief Malvina Eydelman at a LASIK-friendly forum staged by the American Academy of Ophthalmology (AAO) 10/17 in Chicago and posted on FDA’s Web site 10/20, FDA’s report said “some” patients in the study developed “problems” after surgery like “difficulty driving at night or in sunshine, [that] severely impacted a patient’s daily living, and included debilitating vision symptoms (seeing starbursts, glare, ghosting, or halos) and severe dry eye.” It says nothing about psychiatric problems, depression and suicide linked to adverse LASIK outcomes; its limited scope (three months post-surgery) and small subject base virtually assured it would not reach those associations.

FDA’s collaborators in the study were the National Eye Institute and the Department of Defense (especially the pro-LASIK Naval Medical Center in San Diego which encourages service personnel to undergo LASIK and performs most of the LASIK procedures that ensue). The overall study consisted of two underlying initial studies known as PROWL-1 and PROWL-2 (for Patient Reported Outcomes With LASIK), the former being among military personnel and the latter among patients of five commercial LASIK surgical facilities, one of which, the 20/20 Institute in Indianapolis, received an FDA warning letter during the course of PROWL-2 for failing to disclose LASIK risks and thereby misbranding the laser it used.

FDA’s report listed its main findings as follows:

  • Up to 45% of participants, who had no visual symptoms before surgery, reported at least one visual symptom at three months after surgery.
  • Participants who developed new visual symptoms after surgery, most often developed halos. Up to 35% of participants with no halos before LASIK had halos three months following surgery.
  • Up to 30% of participants with no symptoms of dry eyes before LASIK, reported dry eye symptoms at three months after their surgery. (This is consistent with previous studies.)
  • Less than 1% of study participants experienced “a lot of” difficulty with or inability to do usual activities without corrective lenses because of their visual symptoms (halos, glare, et al) after LASIK surgery.
  • Participants who were not satisfied with the LASIK surgery reported all types of visual symptoms the questionnaire measured (double vision/ghosting, starbursts, glare, and halos).

“The findings from this study will help to refine our current thoughts on the labeling for LASIK devices which will be incorporated into our patient labeling guidance,” the report says. “In addition, we will ensure our Web site reflects these findings to better inform consumers of the potential outcomes following LASIK.”

Commenting on Eydelman’s 10/17 AAO presentation, which closely tracked the report FDA subsequently posted to its Web site, LASIK-injured patient advocate Paula Cofer picked up on her admission that “dissatisfaction and disabling symptoms may occur in a significant number of patients.” In a Web posting on LASIK Newswire, Cofer quoted Eydelman as saying that further analyses should be done to explore “other associations” with [LASIK patient] dissatisfaction, and that additional longitudinal studies should be conducted to “explore the factors associated with and predictors of poor outcomes.”

“Remarkably,” Cofer comments, “six years and many tax-payer dollars later, Eydelman is suggesting ‘further analyses’ and additional studies. LASIK critics say Eydelman is a pawn of the LASIK industry and should be fired, and the FDA should take immediate action to protect the public by withdrawing its approval of LASIK. Although LASIK critics say they feel vindicated by the early reporting on the LASIK study, they doubt anything will change.”