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Copyright 1999 The New York Times Company  
The New York Times

September 5, 1999, Sunday, Late Edition - Final

NAME: C. Everett Koop

SECTION: Section 1; Page 1; Column 1; National Desk

LENGTH: 2794 words

HEADLINE: E-MEDICINE -- A special report.;
Hailed as a Surgeon General, Koop Is Faulted on Web Ethics

BYLINE:  By HOLCOMB B. NOBLE

BODY:
During the eight years he held the post of United States Surgeon General, Dr. C. Everett Koop became one of the country's most authoritative and recognizable public figures on the subject of health.

But more than a decade after leaving office, Dr. Koop, now 82, is facing criticism, from medical ethicists, including two representatives of the American Medical Association, consumer advocates and others.

Among the complaints are that his hugely popular health information Web site, DrKoop.com, has frequently blurred the line between its objective information and its advertising or promotional content, and that his ties to business have not been properly disclosed.

Until recent days, for example, the Web site did not give notice of an arrangement that entitled the company and Dr. Koop himself to a commission on products and services sold because of the Web site. Dr. Koop gave up those commissions on Aug. 27.

Web sites devoted to health and medicine -- some providing information and advice, others selling medications -- have been among the hottest Internet properties this year, and DrKoop.com is one of the most heavily trafficked.

Indeed, with the explosion of E-commerce, the distinction between objective information and advertising has blurred across much of the Web, as newspapers and newer types of information providers struggle to capitalize on the information they gather, and as other businesses try to use the new technology to connect with new customers. Many sites, for example, receive a commission for referring their users to on-line merchants, and what would be called advertisers in other media are often labeled "partners."

But Dr. Koop's site and his role in it have come under particular scrutiny not only because of his stature but also because what is involved is the public's health. There is, too, the matter of the traditionally strict regulation of medical practices and advertising -- an issue that the profession and the Federal Government have yet to fully address in cyberspace.

The critics of the former Surgeon General say that he has done nothing illegal but that he has -- knowingly or not -- engaged in activities that amount to a conflict of interest, or the appearance of one. Some say Dr. Koop, who became a role model to young physicians with his campaigns to deter cigarette smoking and to raise AIDS awareness, has in effect traded on his respected name to his financial gain, and to the gain of the new health-information corporation, DrKoop.com.

"He's certainly a very honorable man," said Dr. Robert M. Tenery Jr., a former chairman of the A.M.A.'s council on ethics and judicial affairs, when asked to comment on the criticisms. "But to claim that you're the nation's family doctor, well, perhaps he's not tainted, but the picture is colored somewhat by his relations to vested interests."

In interviews over the last few weeks, Dr. Koop said he would be making changes in his financial arrangements and on the Web site; some of those changes have already taken effect. In response to his critics, Dr. Koop said that he had done nothing wrong and that he remained devoted to educating the public about health issues. He cannot help it, he said, that some people are bothered by the idea of a former public servant's making money.

"I have never been bought," he said. "I cannot be bought. I am an icon, and I have a reputation for honesty and integrity, and let the chips fall where they may."
 
The Web Site
Building on Power Of a Trusted Name


Dr. Koop and other investors started the Web site in 1998 and took it public with an initial offering of stock in June, quickly joining the ranks of Internet multimillionaires. Dr. Koop is chairman of DrKoop.com and a major shareholder in the company. On paper, the stock he held at the time of the initial offering is worth more than $47 million today. As chairman, he draws an annual salary of $135,000 plus other payments like speaking fees.

On its 80,000 electronic pages, DrKoop.com offers information on medical conditions like heart disease and anorexia, features an Ask the Expert column and includes advice on topics like buying health insurance and participating in clinical trials of new drugs.

As chairman, Dr. Koop says he takes overall responsibility for DrKoop.com. But the day-to-day operations are managed by executives and staff members at the company's headquarters in Austin, Tex. Dr. Koop lives in Hanover, N.H., where he runs the Koop Institute, a research center connected with the Dartmouth Medical School.

The power of Dr. Koop's name and his ranking in opinion polls as the nation's most trusted health authority appear to have been very much on the minds of the former Surgeon General and his business advisers in founding DrKoop.com. In a prospectus filed June 8 with the Securities and Exchange Commission, the company said its goal was to "establish the DrKoop.com brand so that consumers associate the trustworthiness and credibility of Dr. C. Everett Koop with our company."

The prospectus states that the Web site is permitted to use Dr. Koop's "image, name and likeness in connection with health-related services and products," subject to his prior approval of the products. In return, Dr. Koop was entitled to receive 2 percent of DrKoop.com revenues "derived from sales of our current products and up to 4 percent of our revenues derived from sales of new products." The prospectus says the site deals in a wide variety of such health products and services, including prescription drugs, nonprescription drugs, vitamins, nutritional supplements and health insurance offered by outside parties.

Like other commercial Web sites, DrKoop.com accepts advertising. But because Dr. Koop's name carries so much weight with the public, his critics argue, he has a special responsibility to keep the distinction between advertising and education clear.

"Based on his reputation," said Dr. Herbert Rakatansky, chairman of the A.M.A.'s ethics council, "he should disclose any financial interest or tie to those providing a medical service or treatment he or his Web site is recommending, or it is a betrayal of trust. He has to remain independent."

On Tuesday, an official at the Web site said Dr. Koop's contract had been changed to eliminate the provision under which he received a percentage of sales of health services or products generated by the site.
 
Financial Ties
Health Information Or Advertising?


The issue of compensation aside, critics say it has not always been clear whether information about health products or services on the DrKoop.com site are company promotions or advertising, or balanced medical and health information.

In one example, Dr. Joshua Hauser, a medical ethicist at the University of Chicago, said that when he visited the site two months ago he discovered a DrKoop.com Community Partners Program. It contained a list of hospitals and health centers described as "the most innovative and advanced health care institutions across the country." In fact, the list was an advertisement for 14 hospitals, each of which had paid a fee of about $40,000 to be included.

Troubled by the brevity and accuracy of the list, Dr. Hauser said he made repeated telephone calls and sent numerous E-mails to the DrKoop.com headquarters in Austin, asking whether what he read was advertising or editorial content. Finally, he said, he received an E-mail from a company official, who told him that the Community Partners were advertisers and assured him that this fact would be made clear on the site. But when he checked later, no such steps had been taken.

"On a site whose slogan was 'Your Trusted Health Network,' " Dr. Hauser said, he found "this blurring of the line between editorial content and advertising to be a problematic conflict of interest."

"Web sites like DrKoop.com have the potential to lead to better and faster information," he said. "But not if companies can buy their way onto sites."

Daniel W. Hackett, chief executive of DrKoop.com, said in an interview that he did not know why the changes had not been made. About 10 days ago, after the interview, the site was changed to say that the hospitals "represent prominent health care institutions across the country." A newly worded flag inviting visitors to "Find a health care provider near you" was labeled as an advertisement. And a notation was posted on the hospital listings saying that the institutions had paid a fee to be included.

Similarly, critics say, the Web site was slow to disclose financial ties with Quintiles Transnational Corporation, a Durham, N.C., company that manages clinical trials of new drugs for pharmaceutical companies and is using the Web site to recruit volunteers for the trials.

The Web site originally gave Quintiles space to declare itself "the world's leading clinical organization," but contained no mention of a financial agreement. But in separate interviews last Sunday and Monday, officials of DrKoop.com and Quintiles acknowledged that the Web site was entitled to receive a payment from Quintiles for each person enrolled in a trial through the site.

On Tuesday, DrKoop.com added to the Quintiles description a sentence saying that Quintiles "has entered into a relationship with DrKoop.com in which DrKoop.com is compensated for successfully recruiting qualified participants into clinical trials."

Though the Food and Drug Administration regards postings of future clinical trials to be advertising, the notices of trials are not labeled as such on DrKoop.com.

Even with the disclosure about the Quintiles arrangement, visitors to the Web site are not informed that the inspector general of the United States Department of Health and Human Services is conducting an inquiry into whether the newly evolving business of commercially run clinical trials of drugs properly protects the interests of patients and other potential test subjects.

Mr. Hackett said that in his view the Web site already carried a more than adequate description of risks associated with clinical trials.

The arrangement with Quintiles was one of the issues that has exposed Dr. Koop to criticism from medical association officials. Under the Web site's original operating plan, Dr. Koop would have been entitled to 2 percent of payments from Quintiles, Mr. Hackett said. Under A.M.A. rules, "payment by or to a physician solely for the referral of a patient is fee-splitting and is unethical."

When asked about a possible ethics violation, Dr. Koop said that he had received not "one dollar" from Quintiles because no referrals had yet resulted from the site, and that visitors to the Web site were not his "patients."

But Dr. Rakatansky said the ethics principle would apply if people visited the site and signed up because of their trust in Dr. Koop, and his connection with the company running the trials was not disclosed.

At Dr. Koop's request, his arrangement with the Web site has been altered, and his contract no longer calls for a percentage of revenues from all services or products, including those from Quintiles, Mr. Hackett said.
 
Industry Ties
Drawing Criticism In Political Arena


It is not just Dr. Koop's financial arrangements that have come under fire. He has also drawn criticism for forming a partnership with the American Council on Science and Health in May.

A press release said the partnership was intended to provide consumers with "an unbiased, scientific analysis of the latest trends in health and medicine, as well as clarifications of health misinformation found in the mainstream press." Information from the council, which identifies itself as a nonprofit consumer advocacy organization and receives financing both from industry and from private foundations, is published on the Web site.

But other consumer advocates say the council is hardly unbiased. Rather, they say, the group consistently takes industry's side in disputes over product safety. The council, said Philip E. Clapp, president of the National Environmental Trust, "has never met a pesticide it didn't like."

An official of the council said those accusations were false, adding that the group's mission is to offer balanced, scientifically based analysis of health news. He said the council provided the information to the Web site free to carry out that mission.

Dr. Koop dismissed criticism of the council, saying it "takes positions based on science, not political correctness." He said it "often undertakes research on issues that the media have already decided are resolved," adding: "When they go against the popular story narrative, the media and activists get upset. Curiously, the media and activist groups don't bat an eye when a lurid allegation is made about a product's hazards by an unqualified source."

Some of Dr. Koop's activities in the political arena have also come under scrutiny.

In March Dr. Koop testified at a Congressional hearing about the contention that some latex gloves are causing life-threatening allergies. He said the claims were highly exaggerated and called them "borderline hysteria." Dr. Koop based his conclusions, he said, on a study by the Centers for Disease Control and Prevention, in Atlanta.

But Dr. Michele Pearson, the chief investigator of the C.D.C.'s latex-allergy inquiry, said that while the agency had collected raw data from blood samples, Dr. Koop's statement went beyond what the centers' data could show. Research paid for by the Allegiance Healthcare Corporation, a leading manufacturer of the latex gloves in question, reached identical conclusions to those cited by Dr. Koop, however.

Dr. Koop said that he was misled about the nature of the latex gloves study and was not aware of a connection between his comments and the analysis paid for by Allegiance.

In April, the former Surgeon General circulated a letter in Congress on behalf of legislation that could enable the Schering-Plough Corporation of Madison, N.J., the company that manufacturers the allergy drug Claritin, to extend its patent on the medicine by five years, an extension that could generate an estimated $6 billion in sales. The following month, Dr. Koop also met with members of the House Commerce Committee to defend the company's position on legislation involving another drug, used to treat hepatitis C.

The Star-Ledger of Newark reported in June, however, that Dr. Koop did not disclose that his nonprofit organization, the Koop Foundation, had earlier in the year received a $1 million grant from Schering-Plough. A spokesman for the drug company said there was no connection between the grant and Dr. Koop's efforts on Capitol Hill.

Dr. Koop acknowledged that his foundation had received the grant from Schering-Plough, but he said the company's money did not influence his public positions.

"I never disclosed the grant because I did not think it was an issue," he said. "I'm not a lobbyist, de facto or otherwise. I did not receive any payment for my work. Most foundations accept grants from private sources. There was no quid pro quo."

Dr. Koop said that he did not believe he had been involved in any conflicts of interest at all. "I didn't go into DrKoop.com to make money," he said. "I did it to change the way that medicine is practiced, to bring important information to patients faster and get them more involved in decisions about their health."

"It is true," he went on, "there are people in my situation who could not receive a million-dollar grant and stay objective. But I do. I was approached by people who asked me if I would represent the side of tobacco in the tobacco settlement and I refused. I can tell you it would have been very worth my while."

He said, too, that as chairman of DrKoop.com he was deeply committed to making it clear that he was not practicing medicine on the Web site and to keeping the lines between advertising and balanced content clear. "But I guess we have to redouble our efforts," he said.

Such statements, though, do not erase the sense many of his critics have that America's family doctor, as Dr. Koop referred to himself in a 1991 memoir, has put his credibility at risk. Some of those most critical were once Dr. Koop's most ardent admirers.

"Dr. Koop was much revered by the people he trained," said a Public Health Service doctor who spoke on condition of anonymity. "He inspired me to become a doctor in the first place. But many of these people believe now that the way he is acting is a big departure from what we saw in him as a public health leader -- and he was one of the great ones."

Dr. Koop, told of the physician's comment, offered a suggestion to his detractor. "He or she ought to come and talk to me about it," he said.
 

http://www.nytimes.com

GRAPHIC: Photos: Dr. C. Everett Koop faces questions about DrKoop.com. (Associated Press)(pg. 1); Critics say the DrKoop.com Web site blurs the line between information and promotion. Dr. C. Everett Koop, the former Surgeon General, is chairman of DrKoop.com, but he does not handle day-to-day operations. (pg. 20)

LOAD-DATE: September 5, 1999




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