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John J. ParisFebruary 12, 2001

Arlo Guthries classic 1960s folk song, which told us you could get anything you want at Alices Restaurant, has its 90s counterpart on the Internet. There you can visit Go Ask Alice, Columbia Universitys funky site for straight shooting, nonjudgmental answers concerning your physical, emotional, and spiritual health. With just a click of the mouse, the Internet offers a world where answers about everything from sexual dysfunction to death are available.

What do you want? Scientific evidence, educational materials, online doctors, offshore pharmacies, alternative remedies, advocacy groups, support circles, chat rooms or online counseling? From Medline and MD Consult, where you can get the most up-to-date data from the best texts and leading journals, to Shrink Links, which provides a certified therapist for $45 per half hour, everything is but a click away. And every site is almost always surrounded by ads, banners, e-commerce and enticements designed with you in mind.

The most direct service offered by the Internet is e-mail communication with your physician. As Jerome Kassirer comments in a recent editorial in The New England Journal of Medicine, e-mail has the potential to induce cultural changes in the delivery of care even more revolutionary than any restructuring that is going on today. This new technology, as is true of the fax, cell phone and answering machine, holds not only promise but potential peril. Messages may be misdirected, printed, rerouted and read by unintended recipients. Moreover, e-mail may be stored indefinitely and recovered even after it has been deleted.

Privacy, confidentiality and security of files present new and not necessarily easily resolved problems for the physician. When the messages are sent by the patient on office e-mail, there is yet a further threat to privacy: The employer has immediate and continuing access to the files.

The Internet not only provides direct access to your physician, it also allows you to locate and communicate with a physician from anywhere in the world. You are in Bangkok and experience a medical difficulty? No problem. You can check in for advice with Ask the Doc, a service offered free by AmericasDoctor.com. This service, though, will only give advice. In its words, they will not engage in any conduct that involves the practice of medicine. Nor will they diagnose illness, prescribe medication, keep a medical record of the conversation or even reveal the identity of its physicians. Need more than advice? CyberDocs to the rescue. CyberDocs.comwhere the doctor is always in 24 hours a day, 7 days a weekdescribes itself as the premiere Internet site for providing live patient care on the World Wide Web.

For a fee ranging from $50 to $100, this Web site will provide an appointment with a board certified specialist who will make a virtual house call to treat minor illness. At that site, doctors can and do prescribe all drugs except controlled substances. This service, which provides immediate round the clock access to physicians from anywhere in the world, helps patients with minor medical needs get quick attention without the long delay or shuffle-in-and-out routine common in managed care environments. That it is filling a perceived need is shown by the 100,000 hits per month and 3,000 scheduled online visits made per day to its Web site.

Along with e-mail access to a physician, there is the even more convenient online access to the pharmacy. Of all the users of online medical informationit is estimated that nearly one-quarter of all Web users seek medical information at least once a monththe thing people are most interested in, according to a survey done by Bio Informatics, is information on drugs. Using services like the Internet Drug Index (www.Rxlist.com), anyone can access information that was once the exclusive preserve of physicians and pharmacists. They can find out what drugs to use, what the drugs do, their side effects and possible interactions. There are even discussion groups dedicated to specific drugs available online.

All of this information, though, is insignificant in comparison to the quandary of online sale of drugs. Viagra running low? Your e-pharmacy will refill the prescription anonymously, quickly and cheaply with overnight delivery. Though you could have your physician call in or e-mail a prescription, there is no need to see a physician before ordering the impotency drug. In an article in The New England Journal of Medicine, Katrina Armstrong identifies 86 sites that will deliver sildenafil (Viagra) to consumers without a visit to a physician. Some of these e-pharmacies require consumers to undergo an online medical evaluation consisting of a written questionnaire that is reviewed for a fee of $60 to $75. Fewer than half the sites specified that the reviewer would be a physician. At 31 of the sites, the purchaser can obtain the drug without any evaluation at all. All that is required for the shipment of this prescription drug is a credit card number.

This dispensing of a patient-physician relationship as a prerequisite for obtaining prescription drugs could have lethal consequences. Though sildenafil poses a known serious risk to some patients, including potentially life-threatening hypertension when taken with nitrates, it is readily available from offshore pharmacies without any need for physician examination or even a medical assessment of contra-indications.

The bypassing of the physician or any other learned intermediary, such as a pharmacist or nurse practitioner, means that there is no one between the patient and the drug except the clerk who fills the order. The potential risk to the health of the one seeking the potent and possibly lethal drug is seen in the case of a 16-year-old boy with high blood pressure whose mother complained to the F.D.A. that he had obtained Viagra on the Internet without any questions asked about his health profile or possible contra-indications for its usage.

Though responsible physicians like Nancy Dickey, the president of the American Medical Association, decry the practice, and the A.M.A. Council on Ethical and Judicial Affairs insists that under no circumstances should medications be prescribed without the benefit of a physical examination or even a face-to-face meeting with the caller, at present no physician is necessary to obtain a desired drug on the Web.

William Stallknecht, the founder of the highly popular Web site Pill Box Pharmacy in San Antonio, Tex., takes the position that we do not need regulation of Internet sale of common drugs. He believes that patients have the right to select certain drugs such as Viagra or the anti-baldness pill Propecia without the hassle or embarrassment of in-person visits to a doctor. In his words, We take the care necessary by requiring online health questionnaires reviewed by staff doctors. But as a recent report in The British Medical Journal notes, not all Web sites take such care. Among those who do not is Direct Response Marketing, based in the Channel Islands. Its managing director is quoted as stating: Our business is to sell lifestyle treatments to people who have proven their intelligence by accessing the Internet and owning a credit card (www.directresponsemarketing.co.uk). Under that standard, the only requirement of informed consent is the ability to access the Internet. As the A.M.A.s Board of Trustees notes, such sites potentially render the whole concept of prescription-only drugs meaningless in the United States.

In response to such threats, President Clinton has proposed requiring Internet sites to obtain federal approval for selling prescription drugs in cyberspace or face fines of upward of $500,000. There would also be fines for selling drugs to someone without a valid prescription. In a similar move, the attorney general of Michigan ordered 10 online companies to stop dispensing drugs in that state without a Michigan license and an appropriate doctors prescription. Rx Direct, one of the companies targeted by the Michigan Attorney General, filed a countersuit in the United States District Court in Roanoke, Va., claiming that there is no law that says they [doctors] have to see a patient before writing a prescription.

These attempts by the state and federal authorities to regulate pharmaceutical sales on the Internet conflict with the reality that many of these sales occur at off-shore locations. As such, they are beyond the reach of local or even national rules and regulations. Milton Friedmans exhortation in Capitation and Freedom that the marketplacenot regulation or licensingshould control medicine is the reality of the Internet. In such a situation the only protection is caveat emptor.

What Can You Get on the Internet?

There is apparently nothing that cannot be purchased on the Internet: books, CDs, cars, homes. Want to Make a Baby? Click on Me. An article with this title in Redbook magazine on new forms of reproduction that are available on the Internet lays it all out in graphic detail. RonsAngels.com will set you up with eggs from beautiful models. The starting price of $15,000 per egg is a relative bargain in an era when an infertile California couple is offering $100,000 for an egg donor under 30, Caucasian of proven college level athletic ability. Alternatively, if you need sperm: Meet Robert. He is at Surrogate Mothers Online under Potential Donors. Though Xytex, the nations largest sperm bank, now offers essays, photos and videos of those participating in its artificial insemination donor program, Robert goes one better. As he put it on his personal Web page: I do not do A.I. What Robert means, explains Redbook magazine is that Robert will have sex with youfor free, hes careful to noteif you can swing a trip to his home in Virginia.

What does this power of the Internet mean with regard to some 15,000 health care sites that receive 22 million hits per month? And how, asks George Lundberg, the former editor of JAMA, do we separate the good from the bad amid all that clutter? How do we distinguish the gems from the junk in a setting that is constantly putting forth information, much of which, as Lundberg notes, is incomplete, misleading or inaccurate.

Unlike traditional publications with editors, peer review, standards and vigorous screening, the Web is a medium in which, to use Lundbergs words, anyone with a computer can serve simultaneously as an author, editor, publisher. And this can be done anonymously if so desired. There is little on the internet to distinguish those promoting informed discussion from those pushing a political agenda or merely trying to make a buck.

Philosophers have traditionally responded to queries about personal credibility with such questions as, Is the speaker knowledgeable and truthful? In medical literature this concern took the form of insistence on high quality, peer-reviewed evidence to substantiate claims made in the name of science. If an article appeared in prestigious journals like The New England Journal of Medicine, Science, Nature or The Lancet, it was thought of as science rather than opinion or hucksterism. With the distinction between scientific finding and quackery, medicine flourished. It did so because the authors of the articles were believed to be unbiased, objective observers who reported their findings accurately and honestly.

That trust in the objective, unbiased assessment of the data extended as well to the individual physicians judgment. It was his knowledge of science that gave the physician authority. Today information that was once the private preserve of physicians is now available to anyone with access to a computer. No medical issue, no matter how complex, ordinary or arcane is more than a few clicks away. Ataxia-telangiectasia, atelectasis, atherectomy, atherosclerosis, athletes foot, atopic dermatitis, atrial ectopic beatsall can be searched out and the latest finding reviewed at the Blue Cross/Blue Shield site, ahealthyme.com. The same is true at dozens of other information sites that compete for the publics attention. Eyeballs, not expertise, is what these sites seek.

As in the Wild West, where there was no way to assess the credentials of old Doc Jones, there is no accreditation agency, no standards, no norms on the Web. Who guarantees the accuracy of the information? The integrity of the claims? The promise of security? What guarantee of privacy is valid when such companies as Double Click assign a specific identifier on your computer to track your username, record the sites you visit and direct user-specific advertisement to your monitor?

The same motive that drove the hucksters of old drives todays search engines: moneylots of it. Who would believe even a decade ago that a physician in the United States would be paid $46 million simply for putting his name on a product and selling its services to the American public? Yet that is what C. Everett Koop received for putting his name on Drkoop.com. What was he marketing? His reputation. His advocacy against tobacco and his educational role concerning AIDS during his tenure as surgeon general translated into the belief that he was an exemplary figure, one who was knowledgeable, truthful and honest with the American people.

The Internet puts such claims to the test. That is why Arnold Relman, M.D., the former editor of The New England Journal of Medicine, adamantly opposes the recent proposal for a government sponsored E-Biomed site, on which scientists could post the results of their research directly on the Web without the lengthy peer review process now demanded before publication. Without that process, Relman protested, there is no way to prevent clinicians and the public from being inundated by misleading and inadequately evaluated information.

The truthfulness of the health sites is even more problematic. Patent-medicine salesmen did not go out of style with the Conestoga wagon. As Gina Kolatas lengthy front page New York Times story Hope For Sale: Business Thrives on Unproven Cases shows, sophisticated academic medical centers in this country are hell-bent on selling unproven interventions such as autologous bone marrow transplant for breast cancer as the last hope for patients. In doing so they are part of a multi-million dollar industry that sells experimental treatments as cures.

E-Commerce

The profit from experimental procedures, which has lured some physicians away from their commitment to serve as advocates for their patients well-being, pales in comparison to the money to be made on the Internet. There billions, not millions, is the coin of the realm. The recent merger of Healtheon and WebMD for example, is a $5.5 billion deal. What can that kind of money do to the truthfulness of a speaker? An insight can be found in the questions posed in the Visa/American Airlines Frequent Flyer Miles ad featuring expensive gifts: Was it love? Or was it the miles? In a world in which former Senator Robert Dolewhile his wife was running for president of the United Statesappeared in television ads discussing how he overcame problems with erectile dysfunction, one cannot be sure if it is love or love of money that is behind the act.

Where does this fusion of e-commerce, marketing and money lead with regard to the credibility of health care information on the Internet? Even C. Everett Koop, that pillar of rectitude whose autobiography describes him as Americas family doctor, has been charged with selling out. One criticism in The British Medical Journal is that his Web site blurs information with advertising and promotional content. Another is that his ties to business have not been properly disclosed. For example, a list of hospitals described on Drkoop.com as the most innovative and advanced health care institutions in the country turned out to be an advertisement by institutions that had each paid $40,000 for the accolade.

To be financially viable, a health care site must have more than content and banner ads; it needs e-commerce. Drkoop.coms licensed content and e-commerce sets the pace for commercial involvement. Unmentioned on the site is the fact that his contract called for a 2 percent royalty on sales made on the Web, a figure that would increase to 4 percent on the sale of any new products added to the site. Nor was any mention made of the 2 percent commission he was to receive from a clinical trial referral service that was paid to sign up patients for experimental trials of new drugs. Though the Food and Drug Administration regards postings of future clinical trials to be advertising, there was no indication at Drkoop.com that the recruiting material was anything but medical information. Nor is there any attempt at the Web site to advise patients of the potential risks of participating in such experimental trials. All this from a site whose motto is Your Trusted Health Network.

Changes Brought by the Internet

One thing is certain: The Internet has changed the patient-physician relationship. Patients now have information or access to information once formerly restricted to physicians. That knowledge is power, and patients or families are making use of that power. They now come into the physicians office armed with reams of information culled from sources as diverse as Harrisons Textbook of Medicine to the latest gossip picked up in a chat room. Not all of that information is helpful, and some of it may be positively harmful. But there is no ignoring the fact that the information itself changes the doctor-patient relationship.

Areas of Ethical Concern

There are multiple areas of concern involving health resources on the Internet. Some of these, like the rupture of the patient-physician relationship or the exclusion of the need for a physician to obtain harmful drugs, apparently go beyond the range of any regulatory agencys control. There have been attempts, like those of the Quality Assurance Commission of the state of Washington, to prevent physicians from approving prescription sales of drugs like Viagra without an examination of the patient. But as The New England Journal of Medicines article on direct sale of Viagra to consumers makes clear, such regulatory action does not stop the sales; it merely drives the physician out of the transaction. The off-shore medical sites that arise to supply the desired services are cloaked with the same anonymity as that possessed by the off-shore institutions providing financial services. As we have learned from those institutions, you cannot regulate what you do not control.

In November 1999 more than a dozen of the leading online health information competitors, in response to a call from Dr. C. Everett Koop and the A.M.A.s Dr. George Lundberg, met to establish an alliance committed to an ethical code of conduct designed to protect Internet consumers. The group focused on three areas of concern: content, advertising and privacy. The alliance, inartfully called Hi-Ethics (Health Internet Ethics), wants to assure that the information provided on the Net is reliable, safe and trustworthy. The members state that they seek to provide the same high standards of ethics and privacy that patients receive in their doctors office.

That ideal, especially in the realm of privacy, may be difficult to achieve. As Mark Sieglers classic essay on the breakdown of confidentiality in the modern hospital notes, the image of private patient-private physician dyad, in which the physician alone had access to the patients secrets, is long gone. Today some 75 to 100 physicians, nurses, social workers, chaplains and billing clerks can have immediate and direct access to a hospitalized patients records. Add to that the insurance personnel, human resources staff and the myriad others who have need to know access to a patients records and the privacy of the doctors office is no longer a valid concept.

The problem is compounded if, as is frequently the case, the patient uses a workplace computer to communicate with his or her physician. As Ronald Theiman, who lost his position as dean of the Harvard Divinity School for downloading pornography onto his office computer, discovered, what is on your office computer is not protected property. Commenting on that reality in The National Law Journal, Wendy Leibowitz notes that courts for several years and in many jurisdictions have found that there is no reasonable expectation of privacy in e-mail sent, stored or received at work. As she bluntly summarized the law: The computer equipment belongs to the employer, and so does everything on it. Further, the American Management Association reports that 27 percent of companies it surveyed monitor employee e-mail. Among those who do so is The New York Times, which dismissed some 20 employees in its Virginia business office for circulating insensitive and offensive e-mail jokes on company computers.

Given the intensity of monitoring and scrutiny, there can be little expectation of protection of materials sent on company computers. Even on personal computers ones privacy is not fully protected. There is no way to secure medical records from the perusal of the technician called to fix a personal computer. Further, there is no professional obligation that binds the computer technician to confidentiality.

Even in the Hippocratic Oath, what is learned in the interaction of patient-physician relationship is not absolutely secret. The oath reads: Those things that I shall learn in my professional interactionwhich ought not be divulgedI will keep secret and tell no one. Some things such as gun shot wounds and suspected child abuse are reportable by statute. Others, as we learned in the California Supreme Courts duty to warn ruling in Tarasoffs v. Regents of the University of California, can be revealed if there is a serious and substantial danger of harm to an identifiable third party. What is the technicians duty to warn if he finds sexual solicitations of school children on a sixth-grade teachers personal computer? Suppose instead that the technician finds communication with a therapist about the teachers sexual fantasies involving the sixth-grade students? What binds the technician to protection of that information?

The first concern of the Hi-Ethics members, though, was not privacy but content. How, they ask, do we define standards for creating information that is evidence-based, sourced, current and trustworthy? Drummond Rennie, the Deputy Editor of JAMA, reports that we have not fully achieved that goal in the most rigorously peer-reviewed journals. Multiple reports on the same drug trial are published, and the evidence is that repeated use of the same data skews the balance in favor of new drugs. Several weeks previous to that editorial of Nov. 10, there was a report in JAMA that new drug trials are eight times more likely to be favorably reported if the research was sponsored by a pharmaceutical manufacturer than if it was unsponsored.

More revealing still of the distance we are from the ideal of unbiased information in medical publications is the mea culpa issued by the editor of The New England Journal of Medicine, Marcia Angell, that on some 19 different occasions solicited editorials in that prestigious journal were written by authors who had research sponsorship by a pharmaceutical or medical product manufacturer whose product was under review. If this is happening in the most carefully edited journals, imagine the difficulty Hi-Ethics faces in trying to control the quality of material appearing on the Internet.

The most intractable problem Hi-Ethics will face is advertising. How, with so much money and the opportunity for instant wealth so intense, will health information sites keep a bright line of separation between content and advertising? Is the banner ad for Claritin on Drkoop.coms Allergies page just advertising, or is it an implicit endorsement of one among the many drugs a physician might prescribe for allergies? Is it merely advertising to have Nicoderm patch ads on the Smoke Cessation web page?

Some enter the health networks to promote informed intelligent discussion, some to push a political agenda and some in the pursuit of a fast buck. For most the motives are mixed. And for some, self-delusion leads to the belief that they, unlike others, are not subject to the temptation to confuse the goals. Alexander Solzhenitsyns reminder in Gulag Archipelago that the world is not so easily divided into good and evil is a useful warning. As he put it: If it were only so simple! But the line dividing good and evil cuts through the heart of every human being. And who of us is willing to destroy a piece of his own heart?

Each of us, as did the editor of The New England Journal when she learned of the multiple failures of that prestigious journal, can learn from our experiences the truth of Solzhenitsyns insight. Such knowledge leads not to despair but, as was true in her case, to a greater realization of the complexity and difficulty of the task that lies ahead.

That difficulty is highlighted in the American Medical Associations recently published Guidelines for A.M.A. Web Sites. There, in the dense and turgid prose that marks regulatory standards, the A.M.A. attempts to address quality standards that should apply to content, advertising and sponsorship, privacy and confidentiality and e-commerce. The task, as its authors admit, is both daunting and ever evolvingone that will require ongoing reevaluation and frequent revision. It is, however tentative, the first step in acknowledging the challenge posed by cybermedicine.

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