When Charles Casebeer began the PMA presentation to the FDA panel, he stated he had "...no financial interest in any of the products involved..."

But!  Did Casebeer have a financial interest in any related product?  Namely the LaserSight microkeratome?

Do you find it odd that in the fall of 1998, Dr. Casebeer speaks of his part in developing a keratome that was marketed by LaserSight in the article on the Refractive Eye Care website?

http://refractiveeyecare.com/0205-casebeer.pdf

"I put almost two years into helping to develop the Ruiz disposable keratome (now being marketed by LaserSight as the Automated Disposable Keratome [ADK])"

What was Dr. Casebeer's connection to LaserSight when he presented the PMA to the FDA panel on July 22, 1999?  Doesn't it seem likely that Dr. Casebeer had a financial interest in getting the VISX approval for LASIK in that it would create a huge need in the industry for microkeratomes?  Read from the LaserSight Technologies website under press releases.  This press release is dated 7/27/99 -- just 5 days after Casebeer made the VISX LASIK presentation to the FDA Ophthalmic Devices Panel.

LASERSIGHT BEGINS SHIPMENT OF KERATOME BLADES
Winter Park, FL (07/27/99)

Winter Park, FL, (July 27, 1999) -- LASERSIGHT INCORPORATED (Nasaq:LASE) announced today that it began shipment of its ULTRA EDGE™ Keratome Blades in the United States, Canada and other international markets. The shipment marks LASERSIGHT's entry into the market for per- procedure laser vision correction products on a value-added basis to physicians and patients. The keratome is an instrument used to cut a thin corneal flap just prior to the LASIK procedure. These blades are the product of a joint venture between LASERSIGHT and Becton Dickinson, Inc. (NYSE: BDX). As previously announced, LASERSIGHT and Becton Dickinson Ophthalmic Systems entered into an exclusive agreement to develop, manufacture and distribute keratome blades. The market for laser vision correction is rapidly expanding, with the number of laser vision correction procedures in the United States expected to exceed 800,000 in 1999 and 1.2 million in 2000. Becton Dickinson Ophthalmic Systems is the worldwide leader in the manufacture and sales of surgical blades and ophthalmic cannula under the Beaver and Visitec brands. The keratome blades are automatically processed and manufactured utilizing surgical grade stainless steel. Becton Dickinson's long history of manufacturing expertise should allow the venture to effectively respond to market demand for the product. Production is targeted to be in the range of 15,000 blades per month starting in August 1999. The Company will continue to closely monitor market demand and adjust production accordingly. The ULTRA EDGE™ Keratome Blades are manufactured utilizing a proprietary process and a material selected to yield a blade with superior cutting efficiency. Sharpness and cutting efficiency have been validated at the manufacturing source. Stephen A. Updegraff, M.D., a refractive surgeon practicing in St. Petersburg, FL, was one of a group of refractive surgeons who tested the keratome blades. Dr. Updegraff commented, "The blades represent a new standard of quality, and I am very impressed with the fact that they are manufactured from surgical grade stainless steel." Michael R. Farris, chief executive officer of LASERSIGHT, commented, "The launch of the keratome blades is a key element of our business plan as it is consistent with our stated strategy of bringing to market new products that complement our existing laser technology. In addition, the product enables us to tap into a recurring revenue stream that will be generated from replacement sales of a single use product into an expanding and growing market." Mr. Farris continued, "We are encouraged by the enthusiastic responses expressed by the surgeons who have used the product and believe our focus on quality and reliability will enable us to continue to gain market recognition. Going forward, we are uniquely positioned to meet the growing demand of this rapidly expanding market." LASERSIGHT INCORPORATED provides quality technology solutions for laser refractive surgery and other innovative applications, mainly in the vision correction industry. The Company sells its products in more than 30 countries. In the United States, LASERSIGHT 's refractive scanning laser system has a pending pre-market approval application with the U.S. Food and Drug Administration and is not yet commercially available in this market. This press release contains forward-looking statements regarding future events and future performance of the Company, including statements with respect to anticipated sales revenue, which involves risks and uncertainties that could materially affect actual results. Investors should refer to documents that the Company files from time-to-time with the Securities and Exchange Commission for a description of certain factors that could cause the actual results to vary from current expectations and the forward looking statements contained in this press release. Such filings include, without limitation, the company's Form 10-K, Form 10-Q and Form 8-K reports.    

From the FDA website:

http://www.fda.gov/cder/present/dia698/diafda2/sld005.htm http://www.fda.gov/cder/present/dia698/diafda2/sld007.htm http://www.fda.gov/cder/present/dia698/diafda2/sld008.htm http://www.fda.gov/cder/present/dia698/diafda2/sld009.htm

Shorts Have Dim View of Sunrise Technologies' Success

"It's unknown how the panel will react to the fact that nine of the 11 chief clinical investigators listed on its own Web site have purchased sizable stakes in Sunrise, which was brought to light by TSC.

I'm Not Just an Investigator, I'm Also an Investor

Nine of 11 main investigators on Sunrise's farsightedness laser have investments in the company.

Investigators Common shares granted*
David C. Brown 2,481,847
Donald R. Sanders 2,283,519
Alan B. Aker 1,948,109
Manus C. Kraff 1,003,931
Robert Gale Martin 677,840
Paul H. Ernest 77,353
Douglas G. Koch 13,500
Sandra C. Belmont 7,500
Peter J. McDonnell 5,000
*Beneficially owned. Source: Sunrise, SEC document of September 1998.

Coghlan sees no problem. "Does anyone really think that any of our clinical investigators, who are among the most respected names in ophthalmology, would do anything to hurt their reputations?" he asks.

Well, the FDA, for one, thinks it possible. In an overhaul of its policy on financial disclosure by clinical investigators, the agency wrote in March that it "has become increasingly aware of the existence of potentially problematic compensation arrangements between sponsors of FDA-regulated products and clinical investigators. ... These arrangements clearly have the potential to bias the results of clinical studies."

From http://www.thestreet.com/stocks/biotech/764869.html

New Disclosure Rules for Medical Investigators Won't Apply to PR

Financial conflicts of interest involving clinical investigators of medical products are so common that starting in February the Food and Drug Administration will require all medical companies to disclose investments by investigators that are worth more than $50,000.

What won't be required, however, is disclosure of the investments held by supposed experts quoted in company press releases.

Take the case of Sunrise Technologies (SNRS:Nasdaq - news), the maker of an eye laser to treat farsightedness. The company points out in a recent registration statement that more than half of its clinical investigators are also investors in the company. (That's more than the norm, according to several industry observers, but at least it's disclosed.)

However, unless you read the company's Securities and Exchange Commission filings, you'd never know that Dr. Donald Sanders, who runs the Center for Clinical Research in Elmhurst, Ill., owns more than 5% of the firm. Sanders was quoted liberally in Sunrise's recent press release announcing that it had filed an application for FDA approval of its laser. Quoted in the same release: Dr. Douglas Koch of Baylor College of Medicine, a clinical investigator who, according to the registration statement, is also a Sunrise investor.

Shift over to Staar Surgical (STAA:Nasdaq - news), which makes implantable contact lenses, and there's Dr. Sanders being quoted again. (No mention that he's a director of the company as well as an investor.)

And it's all legit. All the FDA requires is that the comments be factual.

Neither officials from Staar nor Sunrise could be reached, but Sanders, whose firm consults on regulatory projects, sees nothing wrong with the lack of disclosure. Why? "It's not standard practice, that's why."

From: http://www.thestreet.com/comment/herbonthestreet/185120.html