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This article originally appeared in the January-February 2000 FDA Consumer. The version below is from a reprint of the original article and contains revisions made in June 2000.
Buying Drugs Online:
It's Convenient and Private, but Beware of 'Rogue Sites'
by John Henkel

The scene is becoming increasingly common in the United States: Consumers are replacing a trip to the corner drugstore with a click onto the Internet, where they find hundreds of Websites selling prescription drugs and other health products.
Many of these are lawful enterprises that genuinely offer convenience, privacy, and the safeguards of traditional procedures for prescribing drugs. For the most part, consumers can use these services with the same confidence they have in their neighborhood pharmacist. In fact, while some are familiar large drugstore chains, many of these legitimate businesses are local "mom and pop" pharmacies, set up to serve their customers electronically.

But consumers must be wary of others who are using the Internet as an outlet for products or practices that are already illegal in the offline world. These so-called "rogue sites" either sell unapproved products, or if they deal in approved ones, often sidestep established procedures meant to protect consumers. For example, some sites require customers only to fill out a questionnaire before ordering prescription drugs, bypassing any face-to-face interaction with a health professional.

"This practice undermines safeguards of a direct medical supervision and physical evaluation performed by a licensed health professional," says Jeffrey Shuren, M.D., medical officer in the Food and Drug Administration's Office of Policy, Planning and Legislation. "The Internet makes it easy to bypass this safety net."

Skirting the system this way sets the stage for problems that include dangerous drug interactions and harm from contaminated, counterfeit or outdated drugs. "Websites that prescribe based on a questionnaire raise additional health concerns," says Shuren. "Patients risk obtaining an inappropriate medication and may sacrifice the opportunity for a correct diagnosis or the identification of a contraindication to the drug."

To date, FDA has received only a few reports of adverse events related to Internet drug sales, but some of these cases point out the potential danger of buying prescription drugs on the basis of just a questionnaire. For example, a 52-year-old Illinois man with episodes of chest pain and a family history of heart disease died of a heart attack in March 1999 after buying the impotence drug Viagra (sildenafil citrate) from an online source that required only answers to a questionnaire to qualify for the prescription. Though there is no proof linking the man's death to the drug, FDA officials say that a traditional doctor-patient relationship, along with a physical examination, may have uncovered any health problems such as heart disease and could have ensured that proper treatments were prescribed.

FDA is investigating numerous pharmaceutical Websites suspected of breaking the law and plans to take legal action if appropriate. The agency has made Internet surveillance an enforcement priority, targeting unapproved new drugs, health fraud, and prescription drugs sold without a valid prescription.

A Brave New World

More and more consumers are using the Internet for health reasons. According to the market research firm Cyber Dialogue Inc., health concerns are the sixth most common reason people go online. Internet drugstores, however, won't make "brick and mortar" pharmacies obsolete anytime soon. Over 3 billion prescriptions were dispensed in 1999, and though no reliable figures gauging total online sales are yet available, industry sources say that number is likely still fairly small.

For some people, buying prescription drugs online offers advantages not available from a local drugstore, including:
greater availability of drugs for shut-in people or those who live far from the pharmacy 
the ease of comparative shopping among many sites to find the best prices and products 
greater convenience and variety of products 
easier access to written product information and references to other sources than in traditional storefront pharmacies 
the ability for consumers to order products and consult with a pharmacist in the privacy of their homes 

Internet drug shopping also purports to save consumers money. In some cases this is true. A survey in the fall of 1999 by Consumer Reports showed that buyers could save as much as 29 percent by obtaining certain drugs online. But another study, conducted in 1999 by the University of Pennsylvania and published in the Annals of Internal Medicine, tracked Internet sales of Viagra and Propecia and found that the two drugs were an average of 10 percent more expensive online than at local Philadelphia-area pharmacies.

In another part of that study, researchers Bernard Bloom, Ph.D., and Ronald Iannocone found that 37 of the 46 sites they examined either required a prescription from a personal physician or offered to prescribe a medication based solely on a questionnaire. But nine sites, all based outside the United States, did not require a prescription. The researchers also found that even when Websites offered a questionnaire with the promise that a physician would review the form, nothing was generally known about the doctor's qualifications, and it was easy for users to provide false information to obtain a prescription.

Consumers seeking health products online can find dozens of sites that FDA officials say are legally questionable. A number of them specialize in providing drugs such as Viagra, the baldness therapy Propecia (finasteride), or the weight-loss treatment Xenical (orlistat). Others, based in foreign countries, promise to deliver prescription drugs at a much cheaper price than their domestic cost, but the drugs may be different from those approved in the United States or may be past their expiration dates. Still other sites make fraudulent health claims or blatantly advertise that a customer can buy drugs with no prescription. Online drug sites can now be located in nearly any state or country having phone lines.
Some feel new laws will be needed to improve this situation. "Currently, there is nothing to require a drug-dispensing Website to disclose anything to the public," says Rep. Ron Klink (D-Pa.), who is sponsoring Internet pharmacy 
legislation. "Buyers have no way of knowing whether a site is licensed or if the site uses licensed doctors or pharmacists or even in what state they are located." Klink's bill would require Internet-based pharmacies to list the name, address and phone number of the principal place of business, the name of each pharmacist and health professional who provides medical consultation, and the states where the pharmacy, pharmacists, and other health professionals are licensed.
Certain pharmacy industry representatives oppose legislation or additional powers for regulatory agencies on the premise that current laws are sufficient to address the problem. "There are [controls] already in place for regulating pharmaceutical sales," says Mary Ann Wagner, vice president of pharmacy regulatory affairs for the National Association of Chain Drug Stores. "That hasn't changed."

Overseeing Online Sales

Whether new legislation will improve oversight of online pharmacies remains to be seen. For the moment, regulators have entered what FDA's Shuren calls "a whole new ball game" that cuts across the limited jurisdictions of several federal and state agencies. State medical boards regulate medical practice, while state pharmacy boards oversee pharmacy practice. FDA and the Federal Trade Commission ensure that drug sellers make legal claims for their products. Numerous other agencies such as the U.S. Customs Service and the U.S. Postal Service enforce laws regarding the shipment of drug products.

FDA regulates the safety, effectiveness and manufacturing of pharmaceutical drugs, as well as a part of the prescribing process. "It is a violation of the Food, Drug, and Cosmetic Act to sell a prescription drug without a valid prescription," says Shuren. "Therefore, FDA can take action against sites that bypass this requirement." He adds that the advantage of FDA being involved is that states have difficulty enforcing their laws across state boundaries. If one state successfully shuts down an illegal Website within its borders, the site theoretically still has 49 other potential locales in which to sell. However, if the federal government shuts down an illegal Website, that operation is out of business.

In July 1999, FDA announced that it was joining forces with state regulatory agencies and law enforcement groups to combat illegal domestic sales of prescription drugs. The agency signed agreements with the National Association of Boards of Pharmacy and the Federation of State Medical Boards. These organizations have made a commitment to help enforce federal and state laws against unlawful Internet sellers and prescribers of drugs in the United States.

Though regulating Internet sales of health products is still fairly new, FDA has successfully taken action in the past against illegal sites. For example, a California company called Lei-Home Access Care in 1996 and 1997 used the Internet to sell a home kit advertised as a blood test for the AIDS virus. Not only was the kit unapproved, but the maker also fabricated test results given to users who submitted a drop of blood. After an extensive FDA investigation, the site was shut down, and its operator, Lawrence Greene, was sentenced to more than five years in prison.

In July 1999, the Federal Trade Commission announced a program called "Operation Cure.All," which aims to stop bogus Internet claims for products and treatments touted as cures for various diseases. Over two years, the FTC identified about 800 sites and numerous Usenet newsgroups containing questionable promotions.

"Miracle cures, once thought to be laughed out of existence, have found a new medium," says Jodie Bernstein, director of FTC's Bureau of Consumer Protection. "Consumers now spend millions on unproven, deceptively marketed products on the Web."

As part of the program, four companies settled FTC charges of deceptive health claims. These included sites that claimed to cure arthritis with a fatty acid derived from beef tallow, to treat cancer and AIDS with a Peruvian plant derivative, and to treat cancer and high blood pressure with magnetic devices. FDA is working closely with FTC on Operation Cure.All and has taken its own regulatory actions, such as sending warning letters to help ensure that false and misleading statements are removed from the Internet.

More than a dozen states also have taken some kind of action against Internet pharmacies, including Kansas, which in 1999 prohibited several pharmacies from operating illegal Web-based businesses within the state.

Industry Polices Itself

At the same time that regulatory agencies are stepping up enforcement efforts against illegal online drug sales, professional organizations are launching programs with the goal of cleaning house from within. In late 1999, the National Association of Boards of Pharmacy (NABP) unveiled its Verified Internet Pharmacy Practice Sites (VIPPS) program, which provides consumers valuable information about the credentials of online pharmacies.

VIPPS is a voluntary certification program. The fairly rigid conditions the online pharmacy must agree to for acceptance into the program include:
maintaining all state licenses in good standing 
allowing information about the pharmacy to be posted and maintained on the VIPPS Website (http://www.nabp.net/vipps/intro.asp) 
allowing an NABP-sanctioned team to inspect its operations, given reasonable notice 
displaying and maintaining the VIPPS seal with a link to the VIPPS Website 

VIPPS officials say the program is especially beneficial to seniors. "There is particular concern among the elderly population, which is often the target of unscrupulous marketing ploys," says Kevin Kinkade, NABP executive committee chairman. "VIPPS will be of tremendous benefit to consumers who need to be certain that the prescription medications they receive are from legitimate online pharmacies." To date, six businesses have been awarded VIPPS certification: drugstore.com, Merck-Medco Managed Care L.L.C., planetRx.com, familymeds.com, CVS Washington Inc., and Tel-Drug Inc.

At its June 1999 annual meeting, the American Medical Association adopted guidelines for doctors that specifically address Internet prescriptions. These voluntary principles recommend that doctors who prescribe over the Internet follow minimum standards of care. This includes examining a patient to determine the medical problem, discussing the risks and benefits of a drug with the patient, and following up to ensure the patient does not experience serious side effects.
Many in the pharmaceutical industry back the AMA's action. "The relationship between physician and patient is critically important, " says Martin Hirsch, public affairs director for Roche Laboratories Inc., maker of Xenical. "We support guidelines that will ensure that this relationship continues."

With regulatory and voluntary actions in full swing, it still will be hard to stay on top of illegal Internet drug sales. "Even if the state boards, FDA, and others do their jobs, consumers are going to need to be educated about the issue," says Wagner of the National Association of Chain Drug Stores.

FDA plans to help increase public awareness with an education campaign that informs consumers about the health, economic and legal risks of online sales of medical products. The campaign also will target health-care practitioners and industry. Other federal and private groups are conducting similar outreach.

"Consumers need to know the risks of buying prescription drugs online so they can remain vigilant," says FDA's Shuren, " The public also needs to know," he adds, "that there's a price to pay for operating an illegal Internet pharmacy. Even bringing a few highly publicized cases into the public eye will send a powerful message that these illegal sites will not be tolerated."

John Henkel is a member of FDA's Website Management Staff.

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Notes and Insights:

Happy Birthday!
Happy Birthday to Blondie and Jodi! Check out all the birthdays at community/birthday/ and make sure to send them an arthritis-friendly e-card: cgi-bin/postcards/postcard.pl 

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Write an article! We always need articles on all subjects relating to arthritis. 
C'mon folks, we can't do this without you.

Gimpfest 2001-Chicago here we come! 
Gimps from all over will invade Chicago in May! There will be fun, food and a whole lot of laughing going on! It's a chance to meet your online support pals in person, a chance to get some real hugs from your chat room pals. A good time will be had by all! For all the details see http://fadedjeans.com/chicago

New Sponsor!
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Special Offers for Arthritis Insight Members
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Weekly News Summary
Robin Mayhall

REMICADE POSSIBLY LINKED TO TUBERCULOSIS
Twenty-eight people throughout North America and Europe have developed tuberculosis--and one patient died--soon after they were given the anti-inflammatory monoclonal antibody Remicade (infliximab).
http://orthopedics.medscape.com/32014.rhtml?srcmp=orth-010501 
(Requires free registration to access.)

RHEUMATOID ARTHRITIS ITSELF A RISK FACTOR FOR OSTEOPOROSIS IN MEN
Reduced bone mineral density (BMD) in men with rheumatoid arthritis (RA) is common, according to a report in the December issue of the Journal of Rheumatology.
http://orthopedics.medscape.com/32007.rhtml?srcmp=orth-010501 
(Requires free registration to access.)

HIGH SOY INTAKE INCREASES BONE MASS IN POSTMENOPAUSAL WOMEN
Postmenopausal Japanese women who consume high amounts of soy products have increased bone mass, according to a report in the January issue of Obstetrics and Gynecology.
http://orthopedics.medscape.com/32009.rhtml?srcmp=orth-010501 
(Requires free registration to access.)

PROCOLLAGEN IIC-PEPTIDE IN SYNOVIAL FLUID A MARKER OF EARLY OSTEOARTHRITIS
Abnormal mechanical stress, such as that induced by obesity or varus alignment, increases the synthesis of procollagen IIC-peptide in synovial fluid in the knee.
http://orthopedics.medscape.com/31920.rhtml?srcmp=orth-010501 
(Requires free registration to access.)

FDA APPROVES CENTOCOR'S REMICADE AS FIRST-LINE RHEUMATOID ARTHRITIS THERAPY
The FDA has approved Centocor Inc.'s Remicade (infliximab) for combination use with methotrexate as a first-line therapy to inhibit the progression of structural damage in patients with rheumatoid arthritis.
http://orthopedics.medscape.com/32017.rhtml?srcmp=orth-010501 
(Requires free registration to access.)

PSORIATIC ARTHRITIS
1. ''Dear Doctor'' feature answers specific questions about psoriatic arthritis at http://www.healthtalk.com/rain/mease/01.html 

MAJOR REVIEW REVEALS THAT OSTEOARTHRITIS IS A COMPLEX DISEASE WITH NEW SOLUTIONS
A multidisciplinary group of scientists has declared that osteoarthritis (OA), the most common form of arthritis, is "surprisingly complex," but has outlined a number of new approaches to its understanding, prevention and treatment. Their report, a review by 28 researchers at 17 academic and government institutions, cites over 250 published articles and is presented in two parts in the Annals of Internal Medicine.
http://www.nih.gov/news/pr/jan2001/niams-05.htm 

CLINTON UNVEILS FINAL RULES ON PRIVACY OF MEDICAL RECORDS
The regulations require patients' consent for use of their medical information for such routine tasks as treatment and billing.
http://www.ama-assn.org/sci-pubs/amnews/pick_01/gvl10115.htm 

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A Closing Thought

I WANT WHAT SHE'S HAVING

I have a new delightful friend,
I am most in awe of her.
When we first met I was impressed,
By her bizarre behavior.

That day I had a date with friends,
We met to have some lunch.
Mae had come along with them,
All in all ... a pleasant bunch.

When the menus were presented,
We ordered salads, sandwiches, and soups.
Except for Mae who circumvented,
And said, Ice Cream, please: two scoops.

I was not sure my ears heard right,
And the others were aghast.
Along with heated apple pie,
Mae added, completely unabashed.

We tried to act quite nonchalant,
As if people did this all the time.
But when our orders were brought out,
I did not enjoy mine.

I could not take my eyes off Mae,
As her pie a-la-mode went down.
The other ladies showed dismay,
They ate their lunches silently, and frowned.

Well, the next time I went out to eat,
I called and invited Mae.
My lunch contained white tuna meat,
She ordered a parfait.

I smiled when her dish I viewed,
And she asked if she amused me.
I answered, Yes, you do,
But also you confuse me.

How come you order rich desserts,
When I feel I must be sensible?
She laughed and said, with wanton mirth,
I am tasting all that's possible.

I try to eat the food I need,
And do the things I should.
But life's so short, my friend, indeed,
I hate missing out on something good.

This year I realized how old I was,
She grinned, I've not been this old before.
So, before I die, I've got to try,
Those things for years I had ignored.

I've not smelled all the flowers yet,
There's too many books I have not read.
There's more fudge sundaes to wolf down,
And kites to be flown overhead.

There are many malls I have not shopped,
I've not laughed at all the jokes.
I've missed a lot of Broadway Hits,
And potato chips and cokes.

I want to wade again in water,
And feel ocean spray upon my face.
Sit in a country church once more,
And thank God for It's grace.

I want peanut butter every day,
Spread on my morning toast.
I want un-timed long-distance calls,
To the folks I love the most.

I've not cried at all the movies yet,
Nor walked in the morning rain.
I need to feel wind in my hair,
I want to fall in love again.

So, if I choose to have dessert,
Instead of having dinner.
Then should I die before night fall,
I'd say I died a winner.

Because I missed out on nothing,
I filled my heart's desire.
I had that final chocolate mousse,
Before my life expired.

With that, I called the waitress over,
I've changed my mind, it seems.
I said, I want what she is having,
Only add some more whipped-cream!

~Author Unknown
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Arthritis Insight Newsletter Copyright 2001

Staff
Page last updated on January 10, 2001