The Online Sale of Prescription Drugs

November 1, 2002

The Internet has often been likened to the Wild West: there are few established laws, and the regulatory bodies that do exist have little power to enforce them. There have been a number of high profile cases of Internet crime in the past few years, several of which have resulted in prison sentences for the accused. Less well publicised has been the recent increase in Web sites illegally selling prescription drugs online.

The Internet has rapidly become a major channel for all kinds of commerce. E-commerce now enables consumers to buy books, software, CDs and DVDs, flights and holidays and even food from their local supermarket, all without ever leaving their house. For most goods and services, there is little for authorities to worry about in this development. However, a large number of Web sites are now available which sell prescription and non-prescription drugs to consumers. Often these drugs are sold on the basis of an ‘online checkup’, where a doctor remotely diagnoses a patient’s condition and prescribes medication without the need for a personal visit. Some Web sites operate with yet looser restrictions, and appear to be able to sell drugs to anyone willing to tick a box proclaiming that they are allowed to take such medicines.

There are, of course, a number of legitimate online pharmacies (for instance, www.drugstore.com in the United States). Some of these pharmacies require a purchaser to fax or send a valid prescription; others employ properly qualified doctors who give prescriptions on the basis of an online discussion. These legitimate sites aim to sell the drugs only to people for whom the drugs are necessary. Unfortunately, as with many other things on the Internet, it has proved very easy to take advantage of the system.

The Scale of the Problem

A recent survey carried out by Envisional showed that several hundred Web sites now exist that sell prescription drugs online, flouting local restrictions and selling potentially dangerous drugs without requiring a prescription or a proper examination by a doctor. The Table shows the most common drugs found in the survey being sold in this way. Unsurprisingly, the majority of these drugs relate to problems such as erectile disfunction (Viagra), hair loss (Propecia) and weight loss (Xenical). These are the kinds of issues that patients might prefer to deal with anonymously over the Internet, rather than face the potential embarrassment of discussing the problem with a doctor – or, more seriously, drugs which they may suspect that their doctor would not prescribe the drug but they wish to obtain it against medical advice.

The potential risks are great. A person who is advised by their doctor not to take a particular drug such as Viagra or Propecia can simply turn to the Internet to buy the drug without difficulty. In 2000, the FDA Consumer Magazine reported that an American man who had a history of chest pain and whose family had a history of heart disease died of a heart attack after using Viagra bought from a pharmacy Web site. The pharmacy sold the drug without requiring or giving a prescription. Although there was no evidence in this case that the Viagra had caused the heart attack, the man’s doctor might have advised against the drug given his medical history – had he been consulted.

Jeffrey Shuren, MD, medical officer in the FDA’s Office of Policy, Planning and Legislation commented about this issue: “This practice undermines safeguards of direct medical supervision and a physical evaluation performed by a licensed health professional. The Internet makes it easy to bypass this safety net.” In addition, the FDA article points out, consumers who buy drugs from online pharmacies run the risk of buying contaminated, counterfeit or outdated drugs: “Web sites that prescribe based on a questionnaire raise additional health concerns. Patients risk obtaining an inappropriate medication and may sacrifice the opportunity for a correct diagnosis or the identification of a contraindication to the drug.”

Ease of Use and Ease of Abuse

Consumers are attracted to online pharmacies by their ease of use. Anyone who has access to an Internet terminal can find an online pharmacy with a few clicks from any search engine, fill in a few boxes on a well-designed Web site, and have the drugs delivered to their front door. Indeed, many people probably do so assuming that the whole process is quite legitimate, as the sites often shy away from explaining the fine details of the laws and regulations concerning prescription drugs.

Many online pharmacies advertise themselves aggressively. Junk e-mails are sent to hundreds of thousands of individuals. This one came from a company that claims to sell drugs such as Viagra, Propecia and Xenical:

No waiting rooms, drug stores, or embarrassing conversations.

Our U.S. licensed pharmacists will have your order to you by tomorrow!

Click this link to get started today!

As well as the bulk direct mail advertising, many pharmacies have bought high profile advertising on search engines such as Google. Entering the keyword query ‘Viagra’ in Google brings up ads for 10 Web sites that offer to sell the drug. Marketing like this helps to improve the impression of legitimacy in the minds of most consumers.

As well as the potential for misuse by the companies selling the drugs, it is relatively easy for an individual who knows that they should not use a particular drug for medical or legal reasons to lie to an online pharmacist. Even if the site requires the consumer to fill in their medical history and details of their complaint, a little research could help any determined person buy Viagra, for example, against the advice of their doctor.

A paper published in 1999 by the Journal of Medical Internet Research (JMIR) tested a number of online pharmacies, and found that some would sell Viagra without any kind of prescription. A number of other Web sites sold the drug after a medical questionnaire was filled in – even when the questionnaire indicated that the person buying the drug was a 69-year-old obese woman with coronary artery disease and hypertension! According to the report, the researchers “ordered a total of 66 pills worth US$ 1,802.84. Three companies delivered within 6, 10, and 34 days respectively, despite Viagra being clearly contraindicated.” The report concluded: “The public should be alerted to the risks involved with prescription drug prescribing and dispensing via the Internet.” A further report from the JMIR published in January 2001 estimated that there were at least 150 companies selling Viagra over the Internet. This number is increasing rapidly, according to Envisional’s recent study.

Envisional’s study also found that a number of online services exist that sell drugs without a prescription, in return for a nominal membership fee. In some cases, the pharmacies do require a prescription (for example sent by fax from the customer’s own doctor) but this method is obviously open to abuse – particularly internationally. A large number of online pharmacies offer an ordering system that is restricted to registered users – but in many cases the only requirement to become a registered user is to fill in a name and an e-mail address.

Envisional also found that performance-enhancing drugs (sometimes used by bodybuilders and athletes) were available on the Internet. Substances such as creatine, EPO, HGH (Human Growth Hormone), and norandrostenedione are readily available. Envisional’s research showed that it was easy to obtain such drugs from numerous online sources, both in Europe and abroad.

UK Law and Enforcement Issues

Under the Medicines Act of 1968, it is illegal to sell drugs over the Internet in this way without requiring a prescription. While this can in theory be enforced within the United Kingdom, the Medicines Control Agency (MCA) has to date not prosecuted a single case. The General Medical Council has had a doctor suspended for approving online requests for drugs, although the company for which he worked is still operational and is still selling drugs online.

A particular problem is caused by the lack of international boundaries in the online world. An individual based in South America can establish a company in the United States which has a Web site hosted in Russia and which sells drugs to consumers in the United Kingdom. Which country has jurisdiction in such a case? Which country’s authorities would or should take the effort to get the site shut down? Of course, even if the site is shut down, it is extremely easy for the owners to simply establish a new Web site, perhaps in yet another country.

TOP TEN PRESCRIPTION DRUGS AVAILABLE FROM ONLINE PHARMACIES

Product Used for:

1. Viagra erectile dysfunction

2. Xenical weight loss

3. Phentermine weight loss

4. Meridia weight loss

5. Bontril weight loss

6. Propecia hair loss

7. Prozac antidepressant

8. Celebrex to relieve the symptoms of osteoarthritis and

rheumatoid arthritis

9. Ionamin weight loss

10. Adipex weight loss

According to Clare Griffiths, of IP specialists Briffa, “One effective way to take these sites down may be to contact the ISPs hosting them, although without a concerted collaborative effort backed by sufficient resources, this is only likely to give an ad hoc solution. The problem is set to get worse since, under the government’s NHS plan, doctors will be encouraged to issue e-mail prescriptions and patients will have the right to take them to the cheapest pharmacy on the net.”

US Control

Although this is an issue that affects the whole world, the majority of sites selling drugs on the Internet appear to be based in the United States. In some cases, it can be a little hard to tell where they are based. One Web site, which is registered in the United States to an American company, claims to operate from the island of Sark in the Channel Islands. The company says it will send drugs such as Viagra and Prozac without prescription to any country in the world except the United Kingdom. It even suggests ways to avoid arousing the suspicions of customs officers.

As early as 1999, Bill Clinton issued the following statement concerning the sale of drugs online: “We are unveiling a proposal that sends a signal that we have zero tolerance for prescription drug Internet sites that ignore federal and state laws and harm patient safety and health. Dispensing medications through the Internet without prescriptions or licenses must stop.” The legislation that followed Clinton‘s announcement gave the FDA more powers, including the ability to impose fines of up to $500,000 for violations. A number of US states have already taken action against doctors who are involved with the process of selling prescription drugs over the Internet. Unfortunately, this does not address the problem of jurisdiction. The FDA has issued orders to a number of Web sites based around the world, warning them that by selling drugs online to US citizens they are violating US law. Yet enforcing this across international borders is almost impossible.

The FDA is developing relationships with similar agencies in other countries, which will certainly help to protect US businesses and consumers. However, while this international cooperation is encouraging, it will not provide a complete solution to the problem.

Sites that sell drugs legitimately on the Internet need to differentiate themselves from the cowboys. One way that these legitimate sites could protect themselves is by enforcing their trademark rights against illegitimate sites that misuse their brand names. As with many legal issues relating to the Internet, global legislation is needed to address a problem that affects the global marketplace. This kind of legislation is clearly not going to be created in the immediate future; in the meantime, the important course of action is to educate consumers in how to recognise legitimate Web sites, and how to perform routine checks to discover more about a particular Web site or company (such as ‘whois’ lookups, for instance).

In 1999, the USA‘s National Association of Boards of Pharmacy (NABP) set up the Verified Internet Pharmacy Practice Sites (VIPPS) programme, which aims to certify US-based pharmacies that meet certain criteria, and conform to their local state laws. To date only 13 Web sites have been given the VIPPS mark, and one of these awards has since been revoked. This is a step in the right direction – kite marks like VIPPS offer reassurance to consumers, and help to protect them from fraudulent sites.

Conclusion

There are claims that the online sale of prescription drugs will help to lower the prices of drugs for end-users, in the same way that it has brought consumers greater power and control over the books that they buy and the flights that they book. Yet drugs and medicines are significantly different from novels and holidays – anyone can recommend the best book to read on your last minute vacation, but only licensed professionals should recommend the correct treatment for a medical condition. Of course it would be highly desirable to see more mechanisms enabling people to buy drugs in a controlled fashion on the Internet, but this medium needs to be regulated carefully to ensure that consumers really are given a fair deal.

Ben Coppin is the Chief Operating Officer and co-founder of Envisional Limited (www.envisional.com), a software company that monitors the Internet for intellectual property infringements, with a particular emphasis on trademark and copyright infringement.