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

09/25/2024

[Analysis by Jim Dickinson] Physician-attorney Jeff Shuren is gone from CDRH but his hand-picked interim successor, deputy director Michelle Tarver, continues his cozy-with-industry corruption of FDA’s patient safety mission at the Center. A troubling part of their legacy is the broken lives of patients devastated by medical devices that entered the market through slipshod scrutiny of their safety, as seen in such cases as LASIK (laser-assisted in situ keratomileusis), mercury-laced dental amalgam, cancer-linked breast implants and power morcellators.

That is exactly what former CDRH advisory panel member Paula Cofer sees in Tarver’s current appointment as interim CDRH director. Center media officer Kristina Wieghmink told FDA Webview Tarver “has and continues to adhere to the FDA’s stringent ethics requirements”. Shuren’s 15-year leadership of CDRH was characterized by repeated ethical questions about his relationships with medical device companies, especially those associated with his wife Allison’s lobbying activities at the powerful Arnold & Porter law firm, the focus of a hard-hitting New York Times exposé last month. Similar concerns have been leveled at Tarver, an ophthalmologist with strong connections to the Bowie, MD-based LASIK-promoting eye surgery firm of Solomon Eye Physicians and Surgeons, whose Web site advertises her availability for consultations. As physicians, Shuren and Tarver are permitted to see private patients when not on duty at FDA provided that this doesn’t create a perception of a conflict of interest. In Tarver’s case such a perception might be created when she is simultaneously working on medical device company regulatory issues at CDRH.

CDRH media officer Kristina Wieghmink told FDA Webview Tarver “has and continues to adhere to the FDA’s stringent ethics requirements. She recuses herself as required under the applicable provisions of the conflict of interest law or where there may be an appearance of a conflict.”

A Tampa, FL victim of LASIK surgery, Cofer says she has spent “considerable time” researching refractive surgery, vision disorders, eye disease, and post-refractive surgery visual rehabilitation. She served as the patient representative on an FDA advisory panel on LASIK issues in 2008. In 2014, Cofer started the LASIK Complications Support Group on Facebook. In 2018, she and four of her colleagues gave presentations on LASIK problems to several FDA officials at FDA headquarters. She started the patient education and support organization, Vision Advocacy, Inc., in 2021. Cofer appears in the 2024 LASIK documentary, Broken Eyes, which is showing at film festivals around the country. She volunteers much of her time to helping patients with refractive surgery complications, and she has given numerous media interviews for reports on LASIK.

In 2008 FDA commissioned the Patient Reported Outcomes with Lasik (PROWL) study by the U.S. Navy and NIH which Cofer says was ”set up to make LASIK look good.” Tarver collaborated with CDRH director of ophthalmology devices Malvina Eydelman in a 11/23/2016 JAMA Ophthalmology article on PROWL’s assessment of patient satisfaction with LASIK. The visual “complications” from the LASIK procedure that PROWL focused on were double images, glare, halos, and starbursts.

In a statement to FDA Webview, Cofer wrote:

“When I think of PROWL, I think of ‘lies, damned lies, and statistics.’

“FDA officials have worked hand-in-glove with representatives of the LASIK industry from the beginning. They prioritize the LASIK industry’s financial interests over protecting the public from harmful LASIK devices. Moreover, biased LASIK surgeons on the PROWL steering committee had too much influence.

“The authors did not control for pre-op dry eye symptoms due to contact lens wear, which is reversible with discontinuation of lens wear, and they did not control for visual symptoms due to pre-op refractive error, which resolves with glasses. These flaws in the design of the PROWL questionnaire led to under-reporting of LASIK-induced dry eye symptoms and visual symptoms.

“Also, because the PROWL authors reported ‘overall’ symptoms post-operatively, they gave the LASIK industry a misleading marketing soundbite to hide the percentage of subjects with new symptoms after surgery. (If 49% of subjects said that they were worse after surgery, but 51% said that they were better, you can technically say that ‘overall patients were better after surgery,’ which sells more surgery than citing the actual percentages).

“Quote from the manuscript: ‘Overall, the prevalence of visual symptoms and dry eye symptoms decreased…’ LASIK surgeons don’t include the rest of that sentence in the soundbite, which states: ’although a substantial percentage of participants reported new visual symptoms after surgery’ (up to 46% at three months). LASIK advertisers also fail to mention that 28% of subjects without dry eyes before LASIK developed dry eye symptoms at three months post-op. And remember, both of those stats are based on their false positive data due to manipulation of the questionnaire. The true percentage of new symptoms is likely much higher.

“According to PROWL, patients with the least problems before LASIK have the greatest risk of new problems after LASIK. I think prospective LASIK patients would like to know that.

“Lastly, the word ‘pain’ (or ‘painful’) is nowhere to be found in the manuscript, although the questionnaire asks how often the subject has painful or sore eyes. I absolutely do not believe that no subject reported pain after LASIK, and that’s one reason why further analysis of the raw data is important. A recent peer-reviewed study by academic researchers reported that eye pain increased after laser eye surgery (LASIK or PRK) from 7% pre-op to 23% at three months and 24% at six months. Did the PROWL authors simply choose to leave the pain data out of the manuscript? I don’t know.”

After he retired from FDA, former CDRH branch chief for ophthalmic devices Morris Waxler re-examined safety data that had encouraged him to approve femtosecond and excimer lasers for LASIK procedures. He found that instead of the LASIK industry’s vaunted “less than 1%” complication rate from the procedure, the actual rate was 10-30%, depending on the laser used. Waxler petitioned FDA in 2011 to withdraw the LASIK approvals. The agency took three years under Shuren’s influence to deny his petition.

Cofer’s group continued their pressure and in July 2022 the agency proposed to issue a LASIK labeling draft guidance containing several of the group’s stronger warning recommendations This was vigorously opposed by the LASIK industry as “inaccurate, factually incorrect, not supported in the literature and a misrepresentation of current factual credible data and information concerning the modern LASIK procedure.”

In the face of this, the draft guidance has since remained in limbo.