THE GREAT CONTACT LENS CON

...The report was noteworthy because cases are ordinarily entered in the registry one at a time, as they occur-and because the registry had not received previous reports of infections associated with the tablets...

...Scafidi and Bruch are under investigation by the FDA and by the inspector general of the Department of Health and Human Services for possible violation of conflict-of-interest rules...

...Norman Lent of New York, the ranking Republican on the subcommittee, asked Scafidi if he had transcribed the notebooks all at one sitting...

...Bausch & Lomb sells one of these preservative-free solutions under its own name, but it is manufactured by a contractor...

...Scafidi explained that he was required by federal law t o protect the confidentiality of patients’ names, so he never even wrote them down...

...Although the letter did not name the company with whom Bausch & Lomb had contracted for the solution, the supplier was the same company whose solution Bausch & Lomb’s laboratory had concluded in 1977 was not compatible with SOFLENS: Burton-Parsons...

...Scafidi told the investigators that for four years he had carried a notebook with him at professional meetings, at the office, and at home...

...At the hearing, Gore asked Scafidi about the notebook...

...A reasonable person might conclude that this large notebook was fabricated by you in response to persistent pressure from people who were having to pay too much money for this substitute product, and that you used this fabricated notebook to justify the earlier decision...

...It was already salt water, and included preservatives so it didn’t have to be mixed fresh every night...

...Two days later, the FDA notified Burtonuse with Bausch & Lomb’s lenses, over Bausch & Lomb’s objections...

...Scafidi and Bruch informed the Bausch & Lomb officials that their new package wouldn’t even be considered for use with salt pills...

...She concluded that “the techniques used in this study are disgraceful...

...Although the FDA letter was signed by David Link, then director of the Bureau of Medical Devices, it was written by Mary Bruch...

...Burton- Parsons’ application had been granted three-and-a-half months after it was submitted...

...The salt pills were unsafe, the two FDA officials contended...

...In fact, all the notebook contained was single-line entries on each of the cases listing the nature of the infection, whether it was cultured by the doctor, what was prescribed for it, and how the case was resolved...

...Within five months Scafidi’s opinion changed dramatically...

...On May 8, the subcommittee staff obtained the notebook and used the serial numbers on the cover to determine when it was made, distributed, and first became available to FDA employees...

...Thus in 1971, when the FDA approved the first soft contact lens, it approved a complete package, including a system for disinfecting the lenses by boiling them in a saline solution...

...Bausch & Lomb’s changeover from salt pills was not complete until the winter of 1978, but even so Burton- Parsons sales for the entire year, as measured by wholesale sales to drugstores nationwide, increased by 108 percent...

...My first responsibility is health...

...The doctor also could not remember how many small notebooks he had tranthe number was closer to one or twenty...

...The trail led their inquiries to the FDA’s softcontact experts, Scafidi and Bruch, who assured all parties that salt pills had indeed been a disaster and had exposed users to a risk”of serious eye infections...

...The Switch Three weeks later, Bausch & Lomb finally came around...

...In fact, the hotel registry listed her as if she were an employee of the company...

...Scafidi later explained that he had forgotten to make hotel reservations five weeks earlier when he had registered for the convention, and figured that since Burton-Parsons had probably reserved a block of rooms, his friend Laufer might be able to help him out...

...The letter urges pharmacists to “check with your malpractice insurance carrier...

...It didn’t list the names of the doctors who had reported the cases, nor could Dr...

...When questions arose in the fall of 1979 about salt tablet safety, he said, he had transcribed all the small notebooks into the large brown spiral notebook...

...Considering the growing number of soft-contact users, it is estimated that during the first year and a half after the salt tablets were removed from the market, the extra cost t o consumers added up to between $300 and $500 million...

...Scafidi’s brown spiral notebook, however, struck the subcommittee’s investigators as a most unimpressive artifact...

...Gore: Where are the small notebooks you carried with you from which you transcribed the data...

...The company was sold last year to Alcon Laboratories of Fort Worth, a subsidiary of Nestle SA., for an undisclosed sum...

...One day in the summer of 1979, as this discontent was simmering, Dr...

...Approved preserved saline solution manufacturers have assured us that they now have adequate production capacity to supply the needs of current Bausch & Lomb lens wearers and newly-fitted patients...

...The smaller manufacturers of salt tablets were upset as well...

...There is every indication that the recent years have seen similar increases...

...The FDA, for its part, is reconsidering its stand against salt pills...

...The solution was made by dissolving ordinary salt tablets in distilled water...

...Laufer and Scafidi were, in the latter’s words, “good personal friends...

...Scafidi: If I did, I do not remember or they must have misunderstood me...

...Scafidi remember any of the namesalthough he explained that he wasn’t very good with names, and that a number of the cases were reported by doctors who wouldn’t give their names and who intentionally muffled their voices over the phone so as not to be identified (which Scafidi said was a n effort to avoid malpractice suits...

...He had compiled all the cases in the notebook...

...Then you took all these small notebooks and sat down and compiled that data in a larger notebook and changed pens every few entries...

...Lent: Yet you used different colored inks...

...But, from the regulators’ point of view, the issue was not an economic one...

...The FDA had effectively destroyed an entire market for their product...

...Did you not tell the staff that...

...On December 9, 1976, with its application still pending, Bausch & Lomb promised the FDA officials, in a letter, that it would phase out the use of salt tablets, and replace them with a preserved saline solution as soon as one was approved for use with Bausch & Lomb lenses...

...Albert Gore, Jr...

...The registry, as its name implies, is a government-funded clearinghouse to which eye doctors around the country report problems that may have been caused by drugs...

...All Boil’n’Soak users had to do was put the lenses in the solution in the heating gizmo that was sold as part of the Hydrocurve package...

...Scafidi had apparently used a number of different colored pens and pencils in making the entries, which seemed to confirm his claim of accumulating the cases over four years, the notebook looked practically new...

...It was this notebook which was the basis for the 196 cases he had sent in to the National Registry the previous summer...

...It just came and went...

...Some complained about the increased costs...

...A bottle of pre-mixed solution has replaced them...

...It did not contain the names of any of the patients who had suffered the adverse reactions- although Dr...

...nor were the dangers of the salt pills publicized to the millions of contact wearers who were already using them...

...Imagine the day an interprising car radio manufacturer finds out that General Motors wants to use its radios in all GM cars...

...While the customer slept, the gizmo disinfected, leaving the lenses ready for wear in the morning...

...Bruch’s memo was dated May 10,1977...

...I don’t check the color...

...Susan Leal, a lawyer-investigator for the subcommittee, noticed something else about the notebook...

...But let's start at the beginning...

...as an American Political Science Association Congressional Fellow...

...Although Dr...

...Scafidi: I most certainly am...

...The company that received permission to market the first soft lenses in America (trademark named SOFLENS) was Bausch & Lomb of Rochester, N.Y...

...With An Explanation Rep...

...Salt pills, said Bruch, were a “disaster...

...If that is what I said, I said that, but it certainly is not what I meant to say...

...Nor could he remember when he did the transcribing...

...That’s what I answer to is health...

...Unfortunately, it is the most expensive method of treating soft lenses, costing up to $140 a year in some parts of the country...

...Unfortunately, many customers who were forced by the FDA action to switch from salt pills (with which they had had no problems) to preserved saline have had allergic reactions to the Thimerosal, which so irritates their eyes that they can’t wear their contacts...

...The number indicated Dr...

...This change has cost soft contact wearers about $500 million...

...In April of 1974, Continuous Curve, Inc...

...But in July of 1976 Scafidi reviewed the existing data on the safety of Bausch & Lomb’s device, including the salt pills and other accouterments...

...But Bausch & Lomb had other ideas...

...Scafidi had not participated in the initial decision to approve Bausch & Lomb’s SOFLENS kit...

...Scafidi said it was...

...One of the inconveniences of soft contacts is that they must be disinfected every night to avoid accumulation on the lens of bacteria and fungi that can cause serious eye infections...

...Although it still sells salt tablets to soft-contact wearers in Canada, the company recently sent a letter to pharmacists in the United States that warned of “serious eye problems [that] have been reported” as a result of misuse of salt tablets...

...HHS and the Oversight subcommittee are also investigating for possible perjury...

...She added that since she and her friend, Thomas Manfuso, good wine, they occasionally exchanged gifts of wine...

...Scafidi could not have come into possession of the notebook before March 1, 1979...

...From a marketing standpoint, Burton- Parsons had a couple of disadvantages in its competition with Bausch & Lomb’s salt pills...

...The FDA officials admitted, however, that there had never been a really thorough clinical study done on the question, and that the articles on the subject in ophthalmic journals didn’t say that salt tablets were the cause of the problems discussed-but they could be...

...of San Diego received FDA approval to sell the Hydrocurve lens, the second soft contact on the market...

...Meanwhile, the value of the Burton- Parsons Company has continued to grow by virtue of its strategic position in the soft lens solution market...

...Consumer-Oriented Actually, two friends...

...For the past year he has been a legislative aide to Rep...

...But if Bausch & Lomb would switch entirely to a preserved saline solution, the FDA regulators implied, its application would be given expedited consideration...

...For example, there was Scafidi’s relationship with Burton-Parsons official Chet Laufer...

...Scafidi: No...

...FDA would appreciate communication from you to develop a schedule with you for the immediate withdrawal of the salt tablets from the marketplace...

...t o see if you are personally liable, should an adverse reaction, such as loss of an eye, occur...

...Gore: You are telling us a story that is impossible for a reasonable person to believe...

...If Bausch & Lomb wanted to continue selling soft lenses, they would need a preserved saline solution, and the only one approved for use with soft lenses was the one made by Burton-Parsons...

...More cases...

...The past two years have seen a subtle transformation in this ritual...

...True, preserved saline would be four to ten times as expensive as the salt tablets, which Bausch & Lomb still maintained were perfectly safe...

...We are satisfied that this particular solution is compatible with our SOFLENS Contact Lens...

...Boil’n’Soak saved users the trouble of dissolving a salt pill in distilled water...

...Although Bausch & Lomb will not confirm that it was interested in another product, it is clear that the company did not want to adopt the Burton-Parsons solution, because it sent the FDA results of an analysis done in its laboratory which concluded that the Burton-Parsons solution was not compatible with Bausch & Lomb’s lenses...

...The first was Dr...

...When Bruch saw the Bausch & Lomb lab report, she responded witha memo, the tone of which can only be described as scathing...

...According to their boss, Dr...

...Bausch & Lomb was already a giant in the lens industry, and from 1971 to 1974, the company not only enjoyed a lucrative monopoly of the soft lens market, it also was the only firm authorized to sell salt pills for the care of soft lenses...

...At the same convention, Mary Bruch also stayed in a hotel room that was reserved for her by Burton-Parsons, as she had done at two or three other professional meetings in Las Vegas...

...He concluded that the clinical data didn’t contain anything new or remarkable...

...Nevertheless, in a June 1978 letter, Bausch & Lomb informed the FDA it was prepared to proceed with the removal of the salt pills from the market...

...Bausch and Lomb had applied for approval of a revised softlens regimen, including a new disinfecting gizmo...

...It was about this time, too, that the saltpill controversy began to attract the attention of congressmen and their staffs-particularly the staff members of the Over- . sight Subcommittee of the House Commerce Committee, which has jurisdiction over the FDA...

...Less than two months later, on January 31, 1977, Burton-Parsons petitioned the FDA for specific approval to have its premixed solution used with Bausch & Lomb’s SOFLENS...

...Soft lenses now account for about two thirds of all contact lenses sold...

...But considering that about two million pairs of lenses had been dispensed during the year under study, Dr...

...A spokesman for Bausch & Lomb declined to reveal the name of the supplier...

...There was no public announcement of the agreement with Bausch & Lomb...

...The lenses and the salt water were then heated up in a little electric gizmo that was sold as part of the package...

...In the months that followed the switch, hundreds of consumers wrote to Bausch & Lomb, to the FDA, and to their congressmen to protest the action...

...Scafidi asked, since he was just trying to keep informal track of the number of cases...

...Scafidi’s recording contained what he said were 196 cases of various corneal infections, some of them very serious, experienced by patients who used salt tablets...

...Is that what you did...

...Bruch characterized some of the results as “disconnected,” and the conclusions as “gratuitous...

...On October 27, 1978, Bausch & Lomb’s vice president for marketing sent a mass mailing to pharmacists and eye doctors announcing that, at the request of the FDA, the company would no longer sell salt tablets for use with its lenses, but that the Bausch & Lomb (Trademark) Sterile, Preserved Saline Solution was available as a replacement...

...others complained that they were having irritating eye problems since switching to the preserved saline...

...Scafidi replied that he had carried small notebooks with him at all times, and that he used them to record the cases as he learned of them...

...Instead of using home-mixed salt water to soak, store and disinfect these new lenses, wearers were to boil them in a so-called preserved saline solution, called Boil’n’Soak, which was manufactured by a small Maryland company named Burton-Parsons...

...Both Bausch & Lomb and the Food and Drug Administration feel a sterile premixed solution is desirable for your patients for a number of reasons,” the letter stated...

...And Bausch & Lomb has swung 100 percent behind the more expensive preserved saline solution...

...Eric Black is a reporter for The Minneapolis Tribune...

...We have recently completed arrangements with another company for distribution of an approved preserved saline solution under the Bausch & Lomb label,” the letter said...

...Since 1971, when "soft" contacts (so-called because they are made of softer plastics than other lenses) became available, they have become increasingly popular because for many customers they are more comfortable, more practical, and less trouble than the alternatives...

...I happen to be a nut on colored pens...

...Gore: Are you a nut on pencils also...

...A year’s supply of salt tablets and distilled water would cost a typical customer less than $10 a year and, if used according to the directions, appeared to offer a safe and effective method of disinfecting the lenses...

...that‘ stress should be placed on the proper care of the lenses...

...It's the sort of business success you'd read about in Fortune—except for the suspicions that began cropping up last spring, which led to the investigations and finally to one of the rare congressional hearings in the past few years that would have been fun to attend...

...When distribution of this product in retail outlets is complete, we will discontinue domestic marketing of salt tablets...

...A subsequent press release by the company documents the incidence of eye problems: “Recently,” the release reads, “the National Registry of Drug-Induced Ocular Side Effects reported that more than 200 cases of corneal infections were seen in patients using salt tablets...

...Once I accumulated all this data I threw them away...

...As a result, the lenses and the various whatchamajiggers needed to care for them are regulated by the Food and Drug Administration (FDA...

...Gore: Of course, you told the staff something different...

...It was also true that the FDA’s own Drug Experience Network, the in-house repository for reports of adverse drug reactions, didn’t include any cases of reactions to salt pills...

...Another large drug company called Allergan had developed a preserved saline solution and would soon apply to the FDA to have its product approved for use with SOFLENS...

...A few smaller firms were still distributing salt pills, but the FDA ordered them to remove any reference to contact lenses from the labels and to stop distributing them to ophthalmologists, because to do so suggested they could be used with contacts...

...Inaddition to Laufer, Scafidi estimated that he considered as many as a dozen Burton-Partons officials his personal friends...

...The change has also meant instant prosperity for the little-known company that produces the solution, prosperity that could hardly have been expected six years ago when the firm first set out to break into the market...

...In fact, as many as 20 reaction and many of them have had to throw away their lenses because it has proven too difficult to remove all traces of the Thimerosal...

...Not that everyone was happy about the new state of affairs...

...Also, it costs $40 to $100 a year to care for lenses with preserved saline, campared to $10 a year with salt pills...

...But that, they explained, was only because Dr...

...The second was Mary Bruch, a microbiologist who had been with the division longer than Scafidi and helped analyze applications for soft contact-related drugs...

...However, because Bausch & Lomb’s withdrawal was voluntary, and becau“se Scafidi and Bruch had not attempted to actually revoke FDA approval for salt pills, the agency officials were not required to produce the evidence of eye damage to back up their conviction that the pills were a menace...

...and that lens wearers who sky-dive should be advised to wear goggles when doing so...

...The inexpensive disinfecting tablets that used to sit on the bathroom shelf are gone...

...some said they didn’t believe there was anything wrong with the salt tablets...

...The company continued to assert that its salt tablets were a safe and effective means of caring for soft contacts if used according to the instructions on the label...

...Then there was the question Mr...

...Scafidi felt that the 85 cases of reported eye problems associated with the product should be considered few, and that no detailed analysis was warranted...

...The Race After the December agreement, Burton- Parsons found itself in an enviable position...

...Scafidi had never sent his own agency the 200 cases he had accumulated...

...And over that period doctors had told him of almost 200 cases of infections, some of them extremely serious, attributable to the use of salt pills with soft contacts...

...Contact lens wearers couldn’t be trusted to follow the directions, and as a result there was a risk of serious eye infections, even blindness...

...Meanwhile, Bausch & Lomb still wasn’t making good its promise to remove salt tablets from the market, and the FDA sent it a letter in May of 1978 that basically told the company to quit shilly-shallying...

...Scafidi provided free ophthalmic care to Laufer’s farnily and, when Scafidi attended the 1979 convention of the American Academy of Ophthalmology in San Francisco, he stayed in Laufer’s hotel room...

...The notebook didn’t even list the dates on which the cases had occurred, or on which they had been reported-but what difference did the dates make, Dr...

...But, according to industry gossip, Burton- Parsons also had an advantage over the competition: It had a friend at the FDA...

...When the subcommittee staff told Gore what it had found, he agreed to chair a July 1 hearing on the salt tablet controversy...

...Scafidi sat down with a tape recorder and dictated a report to a n organization called the National Registry of Drug-Induced Ocular Side Effects...

...Our desire to have preserved saline solutions available as a replacement for salt tablets for Bausch & Lomb lenses has been discussed with you on a number of occasions,” the letter said...

...Bruch asserts that her “onlyconcern was the welfare of the consumer who [if allowed to continue using salt tablets] would bi: exposed to potential risk of serious eye infection and potential loss of eye, based on very good microbiological data...

...I just put them together...

...Success Burton-Parsons Company had arrived...

...Its product was approved for use only with Hydrocurve, which had a minority share of the soft lens market...

...So on April 21, and again on May 6 in front of a number of other witnesses, Leal asked Scafidi: Is this the exact notebook you have used for four years...

...Bausch & Lomb was committed to removing from the market the only substitute for Burton-Parsons’ product...

...The letter didn’t mention the name of the approved preserved saline manufacturer that had given the FDA assurances it could handle all the business Bausch & Lomb could throw its way, but there was still only one manufacturer with a solution approved for use with SOFLENS...

...But, Crout would later acknowledge, “because of their personal contacts with friends in certain drug firms, particularly at professional meetings, they may have created an appearance of too close a relationship with industry...

...You told them that you had compiled the large notebook for a period of four years...

...She said the experiment seemed to have been designed just to prove that the Burton-Parsons product was inadequate, and she accused the study of disregarding any indications to the contrary...

...Side-Effects The preservative used in preserved saline is Thimerosal, a mercury compound...

...Scafidi: Right...

...Although they are not, in common parlance, a food or a drug, soft contacts can be distributed only with a doctor's prescription...

...To a typical consumer, the changeover from salt tablets and distilled water to preserved saline solution was expensive...

...I cannot always be involved first with costs, then with health,” Scafidi would say...

...Luckily for these people, two companies, including Burton-Parsons, now make a preservative-free saline solution that is safe for people who are allergic to Thimerosal...

...Allergan’s application would be considered for 19-and-a-half months before finally being approved...

...Albert Gore, Jr., a second-term Democrat from Tennessee and a member'l of the subcommittee, had already tangled~ , with the FDA on a couple of occasions...

...Arnauld Scafidi who, as the only ophthalmologist in the FDA’s Bureau of AntiInfective Drugs, has been, since 1975, the agency’s expert on the safety and effectiveness of products sold for use with soft contacts...

...With its preserved saline solution prescribed as part of the regimen for all Bausch & Lomb soft lenses, its market share soared...

...he noted...

...Contact lenses were developed in the 1940s and are now worn by an estimated 10 million near- and far-sighted Americans...

...There were beginning to drive me out of the office...

...Drug director Crout strongly hinted at the hearings that the agency will reverse itself shortly, and approve salt tablets if they are accompanied by more stringent instructions...

...Within four years of its entry into the industry, over the objections of a giant manufacturer, Burton-Parsons had advanced to a commanding position in that industry...

...Furthermore, there were indications that Bausch & Lomb wanted to adopt the Allergan solution for inclusion in its recommended SOFLENS regimen...

...Scafidi: I don’t remember...

...You’re tellingus that you compiled three years’ worth of reports, given you by doctors who were afraid to give their names, and you didn’t get any of the relevant data associated with these reports...

...It's enough to bring tears to 20 million eyes THE GREAT CONTACT LENS CON by Eric Black Every night, millions of people who wear "soft" contact lenses pop the tiny plastic discs out of their bleary eyes and drop them into small basins of disinfectant for the night...

...J. Richard Crout, director of the FDA’s Bureau of Drugs, Scafidi and Bruch had a conservative in their safety judgments, highly knowledgeable and competent, hardworking, not easily swayed from their convictions, and honest...

...Scafidi: In the trash can...

...Later, Bruch would testify that she didn’t know how many times she had been out to dinner with Burton-Parsons employees, but she supposed it was about ten...

...were being added all the time as he received reports...