A middle-level bureaucrat in the Food and Drug Administration can take credit for the amazing success story of a Washington-area company -- but in the process, she allegedly cost American's soft contact lens wearers millions of dollars.
The story began in 1974 when Mary K. Bruch, a 50-year-old microbiologist with the Food and Drug Administration, literally snatched away control over soft lens products from her supervision at the agency's Bureau of Anti-infective Drug Products.
During the next three years, before her control over the industry was abruptly ended, Bruch forced the removal from the market of an inexpensive salt tablet used to store soft contact lenses in favor of a more expensive cleansing solution for the nation's 20 million soft lens users.
Ener Burton-Parsons & Co. of Seat Pleasant. As a direct result of Burch's decisions at the FDA, the then-tiny Burton-Parsons gained a virtual monopoly in the manufacture and marketing of various cleansing and purifying solutions which must be used by wearers of soft contact lenses. Questions surrounding Bruch's rule over the soft lens industry are still being asked today.
In July, the House subcommittee on oversight and investigations held a one-day hearing on alleged FDA mismanagement of soft contact lens regulation. Last week, a committee source said that another hearing was tentatively scheduled for next month. That hearing reportedly will probe alleged preferential treatment by the FDA toward Burton-Parsons when the company got quick approval of a new lens it was producing in a joint venture with another company.
At the July hearing, Acting committee chairman Albert Gore Jr. (D-Tenn.) grilled Bruch about why she caused a process using the simple salt tablets to be removed from the market in the fall of 1978 on the basis of highly questionable scientific evidence. The purported evidence to support Bruch's decision was gathered by an FDA Opthomologist, Dr. Arnauld Scafidi, who did not document his conclusions for the committee.
Gore claimed that the decision cost consumers $200 million because they were forced to buy more expensive solutions. The FDA was flooded with hundreds of letters from irate soft lens wearers complaining about the salt tablet ban. A few months ago, the FDA withdrew its objection to salt tablets.
According to industry estimates when Mary Bruch began overseeing the soft lens industry in 1974, privately owned Burton-Parsons had annual sales of about $5 million. Last year, the owners of Burton-Parsons, the Manfuso family, sold their company to Alcon Laboratories of Ft. Worth which, in turn, is owned by Nestle S.A. of Switzerland. The reliably reported sales price: about $110 million.
The relations between the Manfusos and Bruch was the talk of competing companies which, records show, were having their product applications ignored or questioned by Bruch while she was approving those of Burton-Parsons.
Bruch became extremely close to the Manfusos whose fortunes were dependent on her decisions. She also accepted entertainment from other companies.
For example, Bruch was taken to Georgetown's lavish Rive Gauche by a lens company executive for a $150 dinner, according to congressional testimony. She said she dined "maybe 10" times with the Manfusos, although it was never established who paid for the meals. She also told the congressional committee that she exchanged vintage wine with one of the Manfusos who shared her interest in fine wine.
The congressional staff found that Burton-Parsons often made hotel reservations for Bruch and Scafidi, at the convention of the American Academy of Ophthalmology in San Francisco he shared a room with a Burton-Parsons executive when the hotel was sold out. In one unfortunate slip, Bruch was registered in a San Francisco hotel as a Burton-Parsons employe. But there was no evidence that the company ever paid the hotel bills of either FDA employe.
To the new industry, which was inexperienced to the ways of the federal bureaucracy, Bruch was treated as a celebrity -- an attitude she openly encouraged. She rarely missed an industry convention, where she invariably was a center of attention. For example, at the 1977 convention of the American Academy of Ophthalmology at the Fairmont Hotel in Dallas, she was introduced to gathering of 1,500 as "the first lady of contact lenses," according to one participant.
As a result of the congressional investigation, the Department of Health and Human Resource's Inspector General's office began a probe of Bruch's dealings with the industry in general and the Manfusos in particular. Apparently the probe hasn't made much progress. FDA officials say that none of the principals in the affair has even been questioned.
John A. Manfuso Jr., who has run the company along with his brother Robert since their father retired, refused to be interviewed for this article. "I'm really out of it. I don't have anything to say anymore. Sorry, old buddy," Manfuso said.
Bruch and Scafidi, who are still FDA employes, also declined to be interviewed.
Soft contact lenses were developed in 1960 at the Institute of Micromolecular Chemistry, Prague, Czechoslovakia, and were brought to the U.S. in 1964 by the National Development Patent Corp. The company apparently acquired the Western Hemisphere rights to the plastic material known as Hydroxyethyl Methacrylate (HEMA) which is used in the lenses. In 1964, National Development licensed Bausch and Lomb Inc. of Rochester, N.Y., to manfacture soft lenses using the HEMA material.
So-called hard lenses, made of rigid plastic material, date back to the 1940s. While hard lenses are cheaper and easier to maintain than the soft variety, new wearers usually find them uncomfortable at first. Often they grow impatient and put them aside. By contrast, soft lenses when immersed in a special solution become soft, malleable, and easy for new wearers to adjust to.
In 1968, to the dismay of the young industry, the FDA declared that soft lenses were a drug. This meant they had to be tested for safety before they could be marketed. The FDA had not seen fit to regulate the less complex hard lenses. However, the agency decided that the soft, water-filled lenses were breeding grounds for bacteria that could cause serious eye infections.
In those early years, the daily care of soft lenses was somewhat cumbersome. The lenses were placed in a case with distilled water and a salt tablet, which was then submerged in boiling water for 10 minutes.
Soft lenses didn't fit comfortably in the FDA organizational chart, so they were relegated temporarily to the division of dental and surgical adjuncts bureau of drugs. The division spent two years considering Bausch & Lomb's application, but in 1971 the FDA gave approval to the company's lens.
It was worth the wait for Bausch & Lomb. The company was permitted to make and sell soft lenses, and it enjoyed a virtual monopoly for three full years while FDA mulled over a slew of other applicants to manufacture and market the lenses.
In 1974, responsibility for soft contact lenses was switched to the Bureau of Drugs' division of anti-infective drug products -- where Mary Bruch was a microbioligist and executive secretary.
From interviews with industry executives and FDA sources, it's clear that from the beginning Bruch was vocal about her unhappiness with the use of salt tablets as sterlizing agents. Her concern, apparently, was that users might fail to use distilled water or might not heat the lenses properly.
One executive recalls, "As early as 1974, Bruch was saying publicly she was going to see to it that Bausch & Lomb would stop using salt tablets. she made the case, but she could introduce no scientific proof at all."
In April 1974, four months after responsibility for the lenses was shifted to Bruch's section, FDA approved a second lens for public sale. Manufactured by San Diego-based Continuous Curve Inc. the so-called Hydracurve lens was approved for use with a preserved saline solution called Boil-n-Soak.
The solution was manufactured by Burton-Parsons. At the time, according to a knowledgeable analyst, Burton-Parsons "wasn't even a factor in the industry." That changed quickly with the introduction of Boil-n-Soak. When soft lens customers bought a Hydracurve lens, the directions said the purifying solution "approved for use" with the lens was Boil-n-Soak.
The good news for lens wearers was that the Boil-n-Soak preserved solution was convenient. The bad news was that it cost $40 or four times the price of the solution made with salt tablets.
It as an important step toward outlawing the salt tablets mix sought by Bruch, who apparently lacked faith that soft lens users would follow the simple directions for using salt tablets to rid their lenses of eye-damaging germs.
Under the FDA rules at the time, companies that were testing new lenses had to submit a package marketing application. A company would submit test results using a particular saline solution. For example, Bausch & Lomb's lens was cleared by the FDA to be sold with a salt tablet produced by Barnes-Hind Co. Most of the small companies developing new lenses to compete with Bausch and Lomb's had done their testing with what they thought was the acceptable solution made with salt tablets.
But at this very time, Bruch, who was effectively running the FDA division even though she was essentially a technician, was heading a campaign against salt tablets.
According to industry sources, when a company came to Bruch and inquired about gaining approval of new lenses tested with salt tablets, Bruch told the company that it was wasting time testing with salt tablets. One industry executive said that Bruch advised him that if his company wanted its new lens application approved it would have to switch from salt tablets to a Burton-Parsons solution, the only approved solution at the time.
Indeed, two companies, Union Optics Corp. of Scottsville, N.Y., and Calcon of Elmonte, Calif., in 1974 and 1975 submitted new lenses using salt tablets. But when the submissions were finally approved in 1976 and 1977, the package included Burton-Parsons' Boil-n-Soak solution instead of salt tablets.
In fact, every one of the half-dozen new lens applications that were approved in that same period included Boil-n-Soak.
Dr. Scafidi joined the bureau of anti-infective drugs in 1975 as its expert on products sold for use with soft lenses. A normally pleasant and relaxed individual, Scafidi has confided to industry executives and government interviewers that he bridled under Bruch's self-appointed management. But as the congressional hearing last summer showed, Scafidi not only went along with her theories on salt tablets, but may well have ignored the lack of scientific proof for Bruch's case.
In July, 1976, Scafidi prepared a report on the safety of Bausch & Lomb's soft lens package, including salt pills. He concluded that, considering the fact that 2 million people were then using the lenses, the 85 reported cases of eye problems were hardly worth worrying about. Scafidi made a similar finding about one year later. But even as he was making these findings, Scafidi was joining Bruch in pressing Bausch & Lomb not to use salt tablets with a new lens it was seeking to get approved. In a Dec. 9, 1976 letter to Dr. Merle L. Gibson, the director of the Anti-Infective Drug Bureau and ostensibly Bruch and Scafidi's boss, a Bausch & Lomb executive referred to a meeting with the two FDA officials. After the meeting, the Bausche & Lomb executive committed the company to using preserved solution instead of salt pills with the new lens.
Nevertheless, Bausch & Lomb made itclear to the FDA that it wasn't sold on Burton-Parson's preserved saline solution. But Burton-Parsons' was the only approved maker of preserved saline solution, so the Rochester company had no choice.
In May 1978, when the Bruch felt that Bausch & Lomb was dragging its feet on pulling the salt tablets from the market, the company got a pointed letter from another FDA official, David Link, then the director of the Bureau of Medical Devices. But the letter was actually written by Bruch. It said: "Approved preserved saline solution manufacturers have assured us that they now have adequate production capacity," and concluded by demanding "a schedule . . . for the immediate withdrawal of the salt tablets from the marketplace."
Link, who now is in private industry, says he never would have signed the letter if he had known how weak the case was against salt tablets.
Last July, during the congressional hearing, Scafidi was asked about a report he submitted in 1979 to the National Registry of Drug-Induced Ocular Side Effects. The registry is an FDA-financed clearing organization that accumulates histories of eye diseases and disorders from doctors.
Scafidi reported to the registry that he had accumulated 196 cases of eye disorders among users of solutions made with salt tablets. But at the hearing, when pressed by Rep. Gore for the name of a single doctor or one of the 196 cases, Scafidi demurred, claiming the Privacy Act barred him from providing the information.
Earlier, Scafidi had told three congressional staff members that he had accumulated the cryptic case studies over a three-year period in a notebook. But it turned out that a code number on the notebook indicated that it been manufactured only a few months earlier. Scafidi then changed his story, saying he had gathered the information in three separate notebooks, then transferred it to a single notebook.
Gore noted that Scafidi's 196 cases were given broad exposure when they were cited as fact in a February, 1980 article in the Journal of the American Adademy of Opthamology.
Said Gore: "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 the substitute product, and that you used this fabricated notebook to justify the earlier decision. Is that a fair conclusion?
Answered Scafidi: "To me it is not."
Ironically, the congressional hearing disclosed -- and even Bruch was forced to agree -- that the premixed solutions have resulted in mure documented complaints than were gathered from salt tablets users. But when users complained of eye irritation from the mercury-based perservative, Burton-Parsons came up with a unpreserved saline solution that the FDA also approved. The problem was that the retail price of the non-mercury-based solution was $140 a year, 14 times the price of salt tablets. n
Congressional testimony shows that Bruch sometimes went to extreme lengths on behalf of the Manfusos. For example, when the Baltimore FDA office found "serious deviations from good manufacturing practices" at a Burton-Parsons plant, she personally intervened to expedite a settlement.
In another curious incident, Bruch's husband, Dr. Carl Bruch, himself an FDA employe, was described to FDA inspectors as a "consultant" to Burton-Parsons by John Manfuso, according to an FDA document.
Carl Bruch, who is now separated from Mary, refused to be interviewed about the incident. But he said through an FDA spokesman that he had simply answered questions for Manfuso in the course of business. Other FDA officials said they thought that Manfuso was using the word "consultant" liberally in conversations with the FDA inspectors who wrote the memo.
An industry survey shows that during the period that Bruch was in charge, Burton Parsons got approval on virtually every soft contact lens product it submitted to the agency. Only two competing companies each got a product approved, but only after Burton-Parsons had at least a three-year lead in the market.
An example of what happened to Burton-Parsons competitors can be seen from the experience of Allergan, the Irvine, Calif., manufacturer of eye and skin care products. Back in 1975, Allergan submitted a cold disinfectant solution to the FDA for use with a Bausch & Lomb lens which was submitted for FDA approval at the same time. From the very beginning, said an industry source, the company fulfilled each request for new data from Bruch only to get more questions. Then, about three years ago, when Allergan still had not gotten approval of the product, the company was informed by Bausch & Lomb that it was switching to Burton-Parsons, which made the only cold disinfectant already approved at that time.
Finally, last month, Allergan's disinfectant product was approved for public sale. The company estimates that the product cost about $1 million to develop and that it lost $25 to 30 million in sales waiting for the FDA approval.
It is noteworthy that almost immediately after responsibility for soft lenses was transferred out of Bruch's section in October 1978, the FDA approved some 15 applications for lenses and solutions that had languished for as long as four years.
But a recently prepared industry survey shows the Burton-Parsons still dominates the solutions business.