Group warns of unlawful Web sales of fertility drugs

An alert issued by a national advocacy group shines the spotlight on a growing problem: unlawful medication sales over the Internet.

By Deborah L. Shelton, AMNews staff. July 10/17, 2000. Additional information

Apparently to save money, some patients are purchasing fertility drugs on the Web from unlicensed sellers that include overseas companies and individuals selling their leftover medications.

Responding to what they view as a worsening problem, the American Infertility Assn., a nonprofit advocacy organization, issued an alert last month warning physicians and consumers about the potential dangers posed by medications of uncertain content and quality.

It's unclear how many people are buying fertility drugs from these sources, but messages from people advertising fertility medications have been popping up on Internet message boards and chat rooms for the past two years. Pamela Madsen, AIA executive director, said the number of ads appears to have increased over the past year. "It didn't hit me in the face that this was such a serious problem until I was spending my day deleting messages people were posting on our site," she said.

Even after a banner was added asking sellers not to advertise fertility medications there, "I still delete at least three daily," Madsen said. Similar messages also are sprouting up regularly on other fertility-related sites, she added.

"What we don't want is patients gaining access to these drugs and not using them in the proper fashion," said Jeffrey Chang, MD, president of the American Society of Reproductive Medicine and professor of reproductive medicine at the University of California-San Diego. "There are significant risks to using these medicines if they are not carefully monitored."

A study by Canadian researchers in the June issue of the clinical journal Fertility & Sterility reported that 19% of patients undergoing treatment for infertility at two reproductive technology clinics in Toronto had purchased drugs over the Internet. The researchers didn't ask patients if the purchases were from licensed sellers.

"The Internet is just another tool for accessing providers. The question is whether the provider is a legitimate one," said Russell Gellis, RPh, president of Althorp Pharmacy in New York, a leading provider of fertility medication. "When someone goes on the Internet, they need to make sure they are dealing with a pharmacy that is licensed in the United States."

Some legitimate specialist pharmacies offer fertility drugs at discounted prices over the Internet. Althorp Pharmacy, for example, operates a licensed Internet fertility medication prescription service.

The availability of fertility drugs is another example of what has become a far-reaching problem: the appearance of rogue prescription drugs on the Web. Lawmakers and state and federal regulators have been struggling to identify ways to sort out legitimate pharmaceutical outlets and products from illegal ones.

But even after a series of Capitol Hill hearings and efforts to fine-tune the federal government's enforcement effort by agencies such as the Food and Drug Administration, the Federal Trade Commission, the U.S. Customs Service and the Dept. of Justice, there's still no consensus about how to best protect public health without stifling legitimate commerce.

Buyer beware

One patient Madsen knows collects names of people buying and selling over the Internet and then matches them for free. The woman, who is infertile herself, has collected about 150 names and believes she is performing a good deed, Madsen said.

"We teach children not to take candy from strangers, yet we have adults purchasing medications from strangers even though they don't know how these medications are stored, what their expiration dates are, whether they have been tampered with or even if they are the correct medications," Madsen said.

To add to the confusion, some medications that are supplied by foreign companies are packaged in different dose sizes than those produced in the United States.

When the drugs are shipped long distances, they are subject to extreme variances in temperature, Gellis said.

"Physicians should be aware that some fertility drugs, such as those that stimulate the ovaries, are peptides -- proteins which are much more sensitive to variations in temperature -- and if placed or stored in the sun or heat, can be inactivated," said Zev Rosenwaks, MD, director of the Center for Reproductive Medicine and Infertility at New York Presbyterian Hospital in New York City.

And because quality-control standards vary from country to country, drugs manufactured overseas might not meet the stringent requirements set here. "There have been instances where drugs have been adulterated or counterfeited," Gellis said.

A desperate demand

Physicians are being advised to ask patients if they know how they're paying for their treatment, to warn them about buying fertility drugs from unlicensed sellers, and to be prepared to direct them to legitimate discount pharmacies.

The bottom line is that sellers are responding to a demand created by couples shopping for lower drug prices.

"Ampoules of infertility medication that can be purchased in France or Australia for $10 per ampoule are selling for $50 per ampoules in the United States. That's why people are willing to buy from a foreign source," said Philip McNamee, MD, president of the Society for Assisted Reproductive Technology, which oversees all in vitro clinics in the United States.

"You have these couples who don't have coverage and have to pay upwards of $60 an amp for the medications," Madsen said. "On average, patients take around 30 amps, which could amount to a couple thousand dollars for a treatment cycle. Plus there's the cost of physicians, monitoring, lab bills and everything that goes along with high-tech fertility treatment."

Madsen said only 13 states mandate insurance coverage of any kind for infertility treatment.

"You don't see chemotherapy meds posted on cancer-related Web sites," she said. "This is Third World stuff, people using other people's drugs. It's only because we don't have coverage, and fertility treatment is considered a luxury in this country."

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The American Infertility Assn. has compiled a list of recommendations for buying fertility drugs that physicians can relay to their patients.

Do:

• Buy from a licensed U.S. pharmacy using a prescription obtained from a physician.
• Look for the National Assn. of Boards of Pharmacy's Verified Internet Pharmacy Practice Sites seal of approval. (Note: The seal was developed in 1999 and not all specialty pharmacies have it yet.)
• Buy from a pharmacy that specializes in fertility medication for accurate counseling and low prices.
• Look for a pharmacy that accepts your prescription insurance program.
• Call the AIA help line at (888) 917-3777 for a list of pharmacies specializing in fertility.

Don't:

• Choose cheaper substitutes by buying from unlicensed sellers.
• Buy from a foreign supplier that might provide different doses or damaged or expired medications.
• Buy from an individual selling leftover or unused medications. It's illegal.
• Take medication advice from anyone other than your doctor.

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