Thais Help U.S. Stem Internet Sales of Medicines

by Robert Pear

Washington - Federal officials said today that they had, for the first time, shut down foreign Web sites involved in the fast-growing business of selling prescription drugs over the Internet to American consumers.

Agents of the United States Customs Service joined Thai authorities in raiding online pharmacies based in Thailand, which officials say is a major overseas source of powerful steroids, tranquilizers and other drugs that can be bought in the United States only with a prescription. Twenty-two people were arrested in Thailand and accused of violating Thai drug laws and export laws. Six people were arrested in Albany, accused of buying drugs from a Thai online pharmacy. Thai officials are also investigating possible violations of a new Thai money-laundering law.

American officials said they alerted Thai authorities to the problem and received excellent cooperation from Thai narcotics and police officers, as well as from the government agency that regulates food and drug products in Thailand.

American and Thai officials said they had raided offices and warehouses used by online pharmacies in Bangkok and Chiang Mai, in northwest Thailand. They seized 20 computers, 245 parcels ready for shipment to the United States and more than 2.5 million doses of drug products. The drugs included anabolic steroids, Valium, Viagra, fen-phen and Tylenol with codeine, as well as Xanax, a tranquilizer, and Rohypnol, a powerful sedative sometimes described as a "date rape" drug.

The actions are the latest effort by the United States to deal with the explosive growth of electronic commerce in prescription drugs. American officials said they planned to use the Thai operation as a model for cooperation with law-enforcement agencies in other countries with online pharmacies.

Federal officials said they were concerned about drugs imported from dozens of online pharmacies in Mexico, Switzerland, Britain, New Zealand and elsewhere. It is unclear whether those countries will cooperate with American investigators.

Raymond W. Kelly, the commissioner of the Customs Service, said: "Many of these Internet pharmacies are fly-by-night operations set up overseas to avoid U.S. law. They have little regard for patient safety."

In December, President Clinton urged Congress to regulate the sale of drugs over the Internet. His proposals focused on companies based in the United States. He did not say what he would do about foreign online pharmacies, which may pose bigger problems because they are less likely to demand a prescription before selling drugs to Americans.

In 1999, the Customs Service seized 9,725 packages with prescription drugs mailed to the United States -- about 4.5 times as many as in the previous year. In the last six months, customs agents in New York, Los Angeles and Washington have seized more than 2,600 parcels of prescription drugs bought from Internet pharmacies in Thailand.

One of the main targets of the Thai raids was Vitality Health Products, in Bangkok, whose Web site promised "prescription-free pharmaceuticals by e-mail at incredibly low prices."

Investigators at the Customs Service office in Albany said the agency had intercepted many drug shipments from Vitality, and the Albany office is leading the American side of the investigation, with computer experts from the "cybersmuggling center" of the Customs Service in Fairfax, Va.

An investigator from the smuggling center is in Thailand, sifting through computer records.

In an interview today, Kevin A. Delli-Colli, director of the center, said: "Eighty percent of the customers we identified from the Thai data are in the United States. The average order was for $200."

Vitality seemed to have a medicine for every malady:

"Hair loss? Try Minoxidil and Finasteride (Propecia). Erection problems? Try Viagra, Yohimbine and Trazodone. Aging skin? Try Retin-A and AHA creams. Poor memory, I.Q.? Try Piracetam, Hydergine and Vinpocetine. Hormone replacement? Check out testosterone & Premarin."

At its Web site, Vitality said, "We guarantee to send your order discreetly packed, without any reference to the contents on the outside of the packet." The company even had a Web page on "customs problems," which told consumers what to do if an order was seized. 

Customs officials said Vitality filled Internet orders with drugs obtained from what appeared to be a legitimate pharmacy in Bangkok. College-age employees took orders from the Web site, addressed envelopes, wrapped the drugs in newspaper and stuffed them inside greeting cards. Parcels were sent by mail with no return addresses.

Thomas M. Virgilio, head of the Customs Service office in Albany, said investigators had arrested at least six people in the Albany area who bought drugs from Vitality.

"These are not major smugglers, but they generally know that what they're doing is illegal," Mr. Virgilio said.

Mr. Virgilio said the imported drugs were potentially dangerous because the controls over quality were lax. "A lot of this stuff is being cooked up in somebody's back room in Thailand," he said. "The drugs from overseas may be laced with all sorts of contaminants."

In addition, Mr. Virgilio said, some of Vitality's customers were taking dangerous combinations of drugs without a doctor's supervision.

In Chiang Mai, Thai authorities, accompanied by United States customs agents, arrested eight people working in a warehouse for an online pharmacy. After downloading orders from computers, the authorities said, the employees hid drugs in hollowed-out books, picture frames and jigsaw puzzle boxes, before shipping them to the United States, Germany, France and Japan.

Source: The New York Times, 

               March 20, 2000


 

FDA Moves to Control Online Drug Sales

by Amy Goldstein

The Clinton administration will announce a new initiative today aimed at  cracking down on illegal sales of prescription drugs over the Internet that  for the first time would require all Web sites that dispense medicine to be regulated by the federal government. 

The plan would allow the Food and Drug Administration to start verifying the  quality of hundreds of online companies that have sprung up in the last year,  allowing consumers to fill prescriptions without going to a traditional drugstore.

If approved by Congress, the administration's proposal also would create  federal fines of as much as $500,000 for Web sites that sell drugs without  first obtaining a valid prescription from the online buyer and would expand  the FDA's powers to investigate sites that are suspected of operating fraudulently.

The initiative represents the government's first attempt to harness this new  industry that is allowing consumers to obtain medicine in a convenient new  manner but that also has the potential to harm patients who order drugs  through unscrupulous operators. 

According to administration officials, the proposal will be part of the 2001  budget request that President Clinton is to submit to Congress next month –  and is one of the first aspects of that budget that the White House has disclosed. In addition to seeking congressional approval to broaden the FDA's authority and to impose the new civil penalties, the White House also will  seek $10 million for what FDA Commissioner Jane Henney yesterday called a  "first investment" to acquire the staff and technology necessary to help root  out illegal online sales. 

Even though pharmacies in general are licensed by states and are exempt from  FDA regulation, Henney said the administration would like to begin requiring  the pharmaceutical Web sites to be certified by the federal government. As  part of that process, states or independent entities would inspect each site  to, among other things, make sure that it had a state license and to monitor  the pharmacists and physicians who work for the site. 

In describing the steps the administration wants to take, Henney was careful  to emphasize that the recent proliferation of companies selling drugs via  computer has many advantages for patients, especially those who are disabled,  live far from traditional pharmacies or simply are too sick to go out. But she said, "we are trying to sort out the bad actors." 

Although it is evident that new Web sites selling medicine are coming into  existence each week, no one knows how many consumers are buying medication  from them. Nor is it clear how many have received drugs that were  contaminated or not approved for use in this country – or how many have sold  drugs without first being shown a prescription. 

Anecdotally, evidence is starting to surface that the largely unregulated  world of online drug sales can sometimes prove dangerous, particularly since  consumers often have little way to discern reputable companies from fly-by-night operators. 

Patients and government regulators at a House Commerce Committee hearing last  summer both extolled the convenience of ordering medicine electronically and  described how slippery this new industry can be. For instance, Web sites do  not always bother to get pharmacy licenses in every state in which their  customers live – and the most fraudulent sites sometimes vanish and resurface under a different name before regulators can step in to investigate a complaint. 

These "virtual pharmacies," when they are reputable, are similar to mail-order pharmaceutical companies. Patients send in prescriptions from  their doctors, and the companies mail the medicine to patients' homes. 

Jeffrey Shuren, medical officer of the FDA's Office of Policy, said yesterday  the agency is investigating hundreds of reports of Web sites that write  prescriptions and dispense drugs solely based on a written questionnaire that  consumers fill out. The patient does not necessarily have to visit a doctor  in person to make sure they need the drug they want and can use it safely. 

Other Web sites, Shuren said, sell drugs that are not approved for use in the  United States. The FDA recently took action against a company, Lane Labs,  that was selling shark cartilage as a cancer cure, even though the National  Institutes of Health are only beginning to explore whether the substance has  any benefit as a cancer therapy. Other companies mislabel drugs, and reports  have surfaced in other countries – though not in the United States – of Web  sites that have dispensed fake versions of Viagra, the popular treatment for  impotence. 

Confronted with proliferating online sales, a pharmacy trade group has encouraged Web sites to meet a set of quality standards. But the FDA's Henney  said that private effort does not go far enough because it is voluntary.

 

Source: Washington Post Staff Writer
               Monday, December 27, 1999 


1999 The Washington Post Company 

 


 

State, federal officials seek rules for Internet drugs

 

Washington -- While buying prescription drugs online can benefit consumers in terms of convenience and information, unscrupulous sellers are threatening the public health and require stepped up regulations, federal and state officials told a Senate committee Tuesday.

``Unfortunately, the vast majority of the companies operating online pharmacies are not following the law. In fact, the ratio is about 400 to 6,'' Kansas Attorney General Carla Stovall told the Senate Health, Education, Labor and Pensions Committee. Stovall told of cases in which a 16-year-old, who provided his true age on a questionnaire, was nevertheless able to obtain Viagra over the Internet, while in another case, a reporter was able to obtain the drug for her cat, despite noting on the form that the animal had been neutered.

Unless Congress acts to curb such activities, agreed FDA Commissioner Jane Henney, ``I honestly believe it will become an increasingly serious problem.''

Henney said that her agency is concerned about three different types of online providers. Of the most concern, she said, are sites that ``aren't pharmacies at all,'' but which sell products like GHB, a ``date-rape'' drug that was recently made a Schedule I controlled substance.

Also a problem are sites, many of them located outside the United States, that sell counterfeit, misbranded or out-of-date drugs. Finally of concern are sites that sell drugs without appropriate oversight by a health professional.

``It is fair to say that the speed and ease of ordering products on the Internet that attracts consumers can likewise entice unscrupulous sellers to use the Internet as their new medium of choice,'' Henney testified.

The Clinton administration's proposal, which Henney said would be ready to send to Congress in legislative form in the next few weeks, calls for Internet pharmacies to post on their sites information about their ownership, state licensure, name of the pharmacist in charge and a phone number where consumers can contact the pharmacist.

State officials, however, said that Congress should not federalize the issue. ``States have historically had the dominant role in regulating doctors and pharmacies for the protections of local citizens,'' testified Stovall. Congress, she said, ``should strengthen, not diminish that role.''

One important way Congress could do that, she said, would be to give states the ability to obtain national injunctions against illegal operators, much as Congress has already granted states for illegal telemarketing schemes. Such authority would allow states to not duplicate each other's efforts.

Advising against new rules at the hearing was Peter Neupert, president and CEO of drugstore.com. Said Neupert in his testimony, ``Additional regulatory burdens placed on legitimate Internet pharmacies would only make it more difficult to operate a legitimate online pharmacy and potentially diminish the consumer benefit of such valid Internet pharmacies.''

 

Source: Reuters Health

              Mar 21 , 2000

 

 


 

Internet Drugstores


BALTIMORE (Johns Hopkins) - Easy, cheaper, convenient -- three reasons many Americans are flocking to online drugstores. But buyer beware: the practice can be dangerous.

Many online pharmacies are perfectly legitimate, insisting on a doctor's prescription before the order is dispensed. But there are certain red flags that may tipoff a consumer to potential problems. If the online pharmacy can't be found through a major search engine, for instance. Or if it requires linking to another site to purchase the drug. The lack of a U.S. telephone number and address can also be a warning.

"There are a lot of shady sites out there. These sites might actually provide illegal drugs; they'll provide medications to patients without prescriptions. Sometimes people will provide you simply just sugar pills, pills that just look like what you think you're getting, but in fact they're not that medicine at all," says Dr. Bob Feroli, associate director of the Johns Hopkins Department of Pharmacy.

There is a new certification program for online pharmacies. Sites can display seals confirming their membership.

Source: Johns Hopkins University

October 22, 1999


Report Cautions Consumers of Internet Availability of Prescription Pharmaceuticals

BETHESDA, MD, 7 October 1999 - A new study of 46 Web sites that sell prescription drugs directly to the public carries a message warning the public of "ominous dangers posed by Internet drug purchases." The report will be published in the December Annals of Internal Medicine, but was released late last month and made available on the Internet because the editor thought the public should have the information immediately. As noted in the accompanying editorial, one of the key drawbacks to ordering online was the possibility that a site does not offer access to a registered pharmacist. The study and the accompanying editorial by officials of the Food and Drug Administration can be found at http://www.acponline.org/journals/annals.


American Medical Association moves to regulate prescribing on the Internet

by Douglas Carnall

Prescribing drugs on the internet by relying solely on the completion by the patient of an on-line questionnaire "falls well below a minimum standard of medical care," according to an interim report issued last week by the Board of Trustees of the American Medical Association, and action should be taken against doctors who fail to meet this standard.

At least 10 state legislatures are investigating doctors who have prescribed in this way, among them the Washington Medical Quality Assurance Commission, which has initiated a licensure action against a Seattle doctor reportedly earning $5000 (3125) a month from on-line sales of sildenafil (Viagra).

The report estimated that at least 400 "instant prescription" websites exist, which usually require the buyer to acknowledge a liability waiver, select a quantity of the drug to be purchased, and complete a short on-line questionnaire.

Among them is Direct Response Marketing, based in the Channel Islands (www.direct-responsemarketing.co.uk), which is typical in offering sildenafil for impotence, orlistat (Xenical) for weight loss, finasteride (Propecia) for hair loss, and bupropion (Zyban) as an aid to stopping smoking. Its managing director, Tom O'Brien, is not medically qualifiedhe started out in the mail order drugs business 11 years ago selling minoxidil through press advertising but has no qualms about the ethics of his business. "Our business is to sell lifestyle treatments to people who have proven their intelligence by accessing the internet and owning a credit card. We pay two independent doctors on a percentage deal to assess the web forms." He added: "We have regular inspections by the medical authorities here on Jersey, and they are quite happy with our procedures."

The American Medical Association's board maintains that the terms used in such questionnaires are often beyond the technical comprehension of a lay person and that no mechanism exists to ensure that the questions have been answered correctly or to confirm the history by physical examination. But the board recognises that the Food and Drug Administration has limited powers to influence overseas businesses, accepting that "such sites potentially render the whole concept of prescription only drugs meaningless in the United States."

The board recognises that, despite potential dangers, there are potential benefits of the internet for prescribing and dispensing drugs. In the board's view, legitimate uses include transmission of prescriptions to a pharmacy at the conclusion of a traditional face to face consultation and the ordering of repeat prescriptions for chronic conditions.

Insistence on the importance of physical examination between doctor and patient is one of the keystones of the report, but it does recognise that this might sometimes be unnecessary.

The report urged state medical boards and societies to investigate local doctors who breach its guidelines, and it stated that efforts will continue to develop model legislation to regulate internet prescribing. The board also has plans to develop a programme of "verified internet pharmacy practice sites" in association with the National Association of Boards of Pharmacy.

Source: BMJ
July 24, 1999;319:213


Kansas sues internet medicine suppliers

by Fred Charatan , Florida

The US state of Kansas is taking legal action against companies selling prescription-only medicines on the internet, in the first action of this kind.

The Kansas attorney general, Carla Stovall, has joined the Kansas State Board of Healing Arts and the Kansas Board of Pharmacy to file consumer protection lawsuits and restraining orders against seven companies selling prescription-only drugs on the internet. According to Attorney General Stovall, at least "a couple of hundred" websites sell prescription drugs without the buyer being examined by a doctor licensed to practise in Kansas or obtaining a prescription (among them, CybRxpress, at www.cybrxpress.com, and Online Physicians, at www.stiverson.com).

During a "sting" operation, a minor, acting under the direction of the attorney general's Consumer Protection Division, was able to buy the diet drug sibutramine (Meridia) and sildenafil by filling out an on-line application, using his true age, 16, and his mother's credit card.

Commenting on the case, Steven Varady, of University Urologists in Palm Beach, warned: "Viagra is a potentially lethal medication when taken in conjunction with nitrate preparations. Hopefully, the prescribing physician, or even the responsible pharmacist filling a prescription will offer warnings to the patient seeking the medication. With internet sale, both of these `screens' are bypassed. Danger lurks."

Source: BMJ
June 26, 1999