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Q & A : RICHARD HAMILL : Firm Hopes to Pass Drug Test : Hycor Biomedical Looks for Ways to Grow With Demand

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Times staff writer

Last year, 15 million Americans, from airline pilots to schoolteachers, were tested for drug use, and even more are expected to face screening this year.

As drug testing becomes more common in our society, questions about the accuracy of test results persist, and the debate over an individual’s right to privacy versus the public’s interest in a drug-free workplace continues.

One small company that has grown along with demand for drug testing is Hycor Biomedical Inc. in Garden Grove, a maker of such laboratory control products as specimen samples used to determine test reliability in the screening process.

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Hycor President Richard Hamill concedes that the reliability and credibility of drug testing remains problemtic. At the same time, his firm is developing a new generation of products that could greatly expand the use of drug tests in this country.

Hycor’s new “pinch test” will allow people to conduct a drug test and see the results on site. An athletic coach or job supervisor, for instance, could administer the test in the field and learn the results within minutes.

Hamill, 50, a former executive at G.D. Searle & Co. and Baxter International, recently spoke with Times staff writer John Charles Tighe about the reliability of drug tests, whether the industry should be regulated and the legal challenges to testing.

Q. The National Institute on Drug Abuse, an agency of the Department of Health and Human Services, last year for the first time developed standards for drug testing laboratories. Why did they do this?

A. The government got very concerned about the variables of drug testing and the credibility of test results that were coming out of the laboratories. There wasn’t uniformity. At one laboratory, 200 nanograms (a billionth of a gram) of cocaine in the specimen would be viewed as a positive. At another lab it might be viewed as a negative. The standard couldn’t be zero because there are so many factors that can interfere with the results, from foreign materials to over-the-counter drugs that the person has taken, or the very test itself in the way it’s performed. So the test result could come out 100 or 200, without the person ever consuming the drug.

Q. What happened after the standards were established?

A. Last year, 150 laboratories signed up to get certified by NIDA, and only 25 of those laboratories passed. NIDA sent samples to all the labs, who ran tests on the samples and returned them to NIDA, but most labs didn’t meet the newly created standards.

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Q. What is the standard?

A. For cocaine, for instance, they’ve determined the cutoff is 300 nanograms, which is an amount that rules out a lot of variables, and above that number we say the person is positive for cocaine.

Q. Why did so many laboratories not meet the standards?

A. A lot of it gets down to the laboratory. How it performs. How its people perform. These are big variables in results. In the labs, there are people, there is equipment and there are reagents, and each of those can vary during the course of the day.

Q. What level of credibility do tests have?

A. There still is a problem. I think until all of the laboratories that are doing drug testing are certified by NIDA, there remains the question about the credibility of the results that the laboratories report. The certification procedure that NIDA went through or that 150 labs went through says something about the improvement that is still possible.

Q. Does part of the problem come from false positives--that is, when an interfering material incorrectly triggers a positive test for drugs?

A. Yes. That’s still a problem. I think individuals that are tested should be interviewed about what other drugs they might be taking. Those medications can be as simple as over-the-counter items. That speaks to the technology and the limitations of the technology itself.

Q. How can laboratories improve?

A. They can make sure their people are adequately trained and performing their jobs correctly, they can use control products and use them frequently during the day to ensure that the results are good, that the process is in control. And they can apply to NIDA for certification to get that kind of outside review of their facilities, their equipment, their people, their training and the kinds of reagents they use.

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Q. What’s the role of drug testing control products like the ones you make?

A. The controls are substitutes for patient urine specimens. In the clinical laboratory many years ago, laboratory directors realized that they could run controls through their system periodically during the day and that these controls would be in line with the results they were getting from their actual patient tests. Then the patient samples had a known level of reliability.

Q. Because the federal government doesn’t regulate the testing firms that perform job-related drug tests, does this mean anyone can enter the business?

A. That’s right. But because of the competition in the services sector, with some very well-established large laboratories, I would think that at this point in time, they would have to do a pretty good selling job to convince some major customers, like industry or the military, that they were capable.

Q. Does the industry need to be regulated?

A. No. I think that with the involvement of NIDA and the involvement of the professional societies, like the College of American Pathologists, and with the American Assn. of Clinical Chemists who run proficiency tests and encourage their member laboratories to keep certain standards, the profession manages itself. Laboratories are motivated to put out good results.

Q. You have developed your “pinch test” that takes a tiny sample of blood and determines drug content. What impact is this test likely to have on the future of drug testing?

A. It really gets to the issue of sample integrity. If a test could be performed, let’s say, in a locker room, as opposed to being put in a container and then shipped somewhere else, then there is the opportunity to thwart the steps that come between the test site and when the test is performed in the laboratory.

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Our pinch test is designed for those environments outside the laboratory. I think there’s a nice area of growth that we’ve identified.

Q. Are you concerned that the test might be considered an invasion of an individual’s rights?

A. I think that now that tests are going to be more easily performed, it is a fact of life that a person is going to be subjected to frequent tests. So I’m not sure I want to comment on the civil rights issue because our society now requires drug testing.

Q. Is this test a replacement for lab tests?

A. No. It is an initial screening test that will be used in addition to a lab test, and the results could signal the need for a further lab screen test or a lab confirmation test. It’s really going to expand the market. This is because if a screening test says that there is a reason for concern, another test will be asked for, and that will be sent to another laboratory for confirmation testing. So we’re really going to expand and be a complement as opposed to being a competitor.

Q. Is the pinch test as reliable as laboratory screening products?

A. I don’t know the answer to that right now. Our expectations are that it will be, and we will have to demonstrate that with test results to the FDA before we get approval.

Q. What is the market for the test?

A. I think it has some potential anywhere that a quick indication is needed, whether it be in an emergency room, in an industrial employment situation, an athletic program or in probation departments. Those are all important markets for a quick, easy-to-use test system.

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Q. The inside cover of your annual report shows off the pinch test, and below it is a photo of a track athlete. Do you think coaches will buy the test to check their athletes before meets?

A. The athletic market is going to be one of the markets. I don’t know if it’s the ideal one.

Q. Where do you see the test to be particularly valuable?

A. Probation departments are an area we see as a real use for the product. This is an environment where individuals may be tested as frequently as weekly. Probation departments want to make sure that people on parole remain clean. Here they’re really looking for an indication. They want to confirm that the person is staying free of drugs.

So whether every test of parolees is a screening test or a confirmation test is not as significant, because there’s going to be a history of test results, and any one single test is probably not going to determine the course of events.

Q. What drugs will the tests detect?

A. We’re developing separate tests for cocaine, morphine, marijuana, amphetamines and PCP. The first one we will bring to the market will be cocaine. And for that one we will be submitting our application to the (Food and Drug Administration) in another month or so. Our results so far indicate that we have a very reliable test.

It’s a screening test, so it isn’t definitive. Therefore, the kinds of decisions that impact people’s lives are not going to depend upon our screening tests, whereas confirmation tests do provide that kind of assurance. Confirmation tests involve a more complex study, which merges two different research tools that provide very specific detection.

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Confirmation tests are very expensive. They run in the $100-to-$200 range. A screening test costs about $25 from the laboratory, and we’ll probably sell ours to our distributors for between $3 and $5.

Q. Your new test is very easy to perform and could be used by a job supervisor or a high school coach. Couldn’t anybody buy these tests and interpret their results in a broad manner beyond the initial screen that you intend them to be?

A. You’re probably right about that. In our labeling we will try to speak to that issue. I think the way to be careful and assure that the product is properly used and finds its place is through adequate labeling and very careful promotion.

Q. What will the labeling say?

A. The labeling will define the test’s use, which we are now studying, and provide some instruction to the user as to what significance he or she should place on the test results in the absence of further confirmation of that particular result. And it will contain a thorough direction insert.

Q. The courts are the main arena for the continuing debate over the privacy issues involved in drug testing. Might the courts finally decide how the results of rapid, on-site tests like yours can be interpreted and applied?

A. I think there is going to have to be a lot of thought about the procedure. For instance, if the result is positive in a screening test like this, can action be taken immediately to ban an individual? We don’t know how that’s going to work. Those are questions that have to be dealt with. And I would be flippant if I were to say those aren’t issues that have to be addressed.

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Q. Will there come a time when you’d be brought in to defend the results of your product and their consequences?

A. I think it’s possible. I don’t think it’s very likely because the product will be adequately labeled as a screening test and not a confirmation test. At this point we would rather the results be used as an indication, rather than an absolute. We would rather that the results be confirmed in a laboratory using an acceptable confirmation test. So I’m not sure that it’s going to be used before a track meet to say that if it’s positive you therefore can’t compete in the meet.

Q. Although you say you haven’t been involved in court battles over testing, to what extent are laboratories involved in the court issues?

A. Directors of the labs that do a significant amount of drug testing are in court weekly defending their test results, which is something that clinical laboratories did not have to do before drug tests.

Q. Is there a problem with corporations and others interpreting screening tests too broadly?

A. I don’t know the answer to that. I think this is an issue that NIDA is trying to address by developing standards and defining the rules.

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Q. Has drug testing caught on outside the United States?

A Elsewhere, drug testing is still not thought to be as necessary as it is here. As we go around Europe, the people essentially say, “You have a problem in the United States. We don’t have a problem here.” So, until Europeans perceive that the problem is greater than it is, drug testing will not grow and flourish and be an important part of decision-making there.

Q. Will drug testing continue to increase in popularity in America?

A Yes. The demand will continue to increase, perhaps limited only by reimbursement programs and the caps that may be applied to reimbursement programs.

Q. Who are the largest makers of lab drug testing products?

A. Ciba Co. and Abbot Laboratories are the largest producers of testing reagents for use in the laboratories. Most of the reagents are controlled by the two major companies, which are large, credible companies that are well motivated to provide laboratories with good quality material.

For smaller companies, the opportunities are to provide screening materials for off-site use and for products used before the screening.

Q. To what degree do you worry about these big companies trying to go after your smaller market?

A. It’s a concern. They are very formidable competitors. Should they decide to expand their product line and move into the pre-screen area, they would be tough to deal with.

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Q. Where do smaller companies like yours fit in?

A. We have to look for those little segments that we can do well in. For our company, we started by identifying segment in the drug testing area in the control side. As a small company we have to be careful about the markets we go after because we don’t want to go up against the major companies.

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