By JUDY SIEGEL-ITZKOVICHping pong balls viagra 248.88(photo credit: Pharmaceutical Crime Unit )
Medications and food supplements that should be treating human ills are instead being counterfeited, often with the wrong ingredients or without active ones, in incorrect amounts or under unsuitable conditions. Carried out solely for the huge profits, these pharmaceutical crimes are leading to an untold amount of suffering and death.
This type of illegal activity became significant within the past 15 years, when the Internet became a widely used service and an easy way for customers to place orders - and when anti-impotency medications that are expensive and embarrassing to ask a doctor for were put on the market. Nevertheless, it was only two years ago that the Health Ministry established its Pharmaceutical Crime Unit, at the initiative of Mickey Arieli, a Chicago-born political science and pharmacy graduate who came on aliya nearly four decades ago.
"Unit" is a big word for a tiny two-room office in the ministry's National Pharmaceutical Lab headed by Dr. Mimi Kaplan in Jerusalem's Givat Shaul quarter, and with only two other employees besides Arieli. They are a former head of a national police unit and a man with a doctorate in pharmacy who writes expert opinions. The unit no longer has a van for its sole use, the three men instead use their private cars, for which they receive monthly expenses. Yet representatives of pharmaceutical crime units around the world who know of their activities and expertise from conferences and ongoing cooperation - members of the Permanent Forum of International Pharmaceutical Crime (PFIPC), for example - think Arieli has dozens of staffers. Facing the huge global threat from criminal activity in pharmaceuticals, one would have expected the government to allocate 100 manpower slots for the task.
ARIELI, WHOSE father was a pharmacist and who himself was a community pharmacist and the ministry's Tel Aviv deputy district pharmacist, says in an interview with The Jerusalem Post that he has long had a talent for detective work and an interest in working with the police. In fact, the Israel Police nabs the suspects while the ministry trio coordinates the intelligence work and testing of medications they seize, as well as appear in court. He says he received support for the unit's establishment from former ministry director-general Prof. Avi Yisraeli and other senior ministry officials Dr. Michael Dor, Dr. Yoel Lipschitz and Dr. Osnat Luxenburg.
"This job was natural for me, as when I was deputy district pharmacist and spent time at the customs office at Ben-Gurion Airport, I noticed the confiscated drugs that people had tried to smuggle in. I wanted to find out more about pharmaceutical crime," says Arieli, "so I wrote to the US Office of Criminal Investigation. I was invited to represent Israel as an observer even before I established the unit. This coming June, the PFIPC will hold an official meeting of a few dozen people, including representatives of Interpol, at Foreign Ministry headquarters in Jerusalem."
THE ISRAELI pharmaceutical industry - both manufacturers and importers - gave the new unit some support but not a great deal because its effort was focused on protecting public health rather than the industry's intellectual property. "We work with them, but they do not have a unit of their own, even though criminal activity obviously hurts them."
Arieli soon began to realize that pharmaceutical crime involves not just counterfeiting prescription drugs.
"There are food supplements claimed to be 100 percent herbal, but we find they are not. There are manufacturers of illegal drugs and supplements who falsely present their contents, who made them and what they do. A 'herbal' food supplement may be comprised totally of active pharmaceutical ingredients [APIs]. Generic drugs from India falsely claimed to have sildenafil - the API in erectile-dysfunction [ED] drugs like Viagra or Cialis - are sold over the Internet. Other products are not necessarily counterfeit; they may be stolen. But if they are not sold with the correct name, package, instruction leaflet and so on, they are unauthorized drugs without a ministry license."
As an example of the harm illegal products can do, Arieli offers the story of a dozen deaths in Singapore that resulted when counterfeit food supplements and sildenafil were consumed: The packages contained diabetes medications meant to reduce blood glucose.
"This is a life-and-death business," said the unit chief.
TOGETHER WITH the police, and with approval from the State Attorney's Office, the unit makes raids on sex stores, investigates ads in Hebrew and other papers selling "V" or "The Pill" (referring to Viagra) and kiosks dispensing dangerous pills. Even haredi newspapers accept illegal ads touting "The Pill for Family Serenity," but customers can't be sure if they are useless sugar pills, indeed contain sildenafil, or have another chemical inside. Some who take them may have heart conditions, or take prescription medications that make the use of sildenafil potentially dangerous. Arieli has seen kiosks (called pitzutziot in Hebrew) selling not only counterfeit ED drugs but also amphetamines ("poppers") popular among youngsters.
"Lifestyle drugs" such as those for ED, balding and losing weight are the biggest now, he says. "Even lifesaving drugs such as those to treat cancer may be counterfeit, fraudulent or diverted. That means people who buy illicit oncology drugs will not be getting what they need to fight their tumors." Some drugs are stolen from well-known pharmaceutical companies and sold illegally, while others are illicit because they combine two legal drugs. A routine sinus drug meant for Africa was instead shipped to South America and the US to turn into methamphetamine.
Counterfeit Tamiflu, the anti-viral drug given to minimize the risk of influenza in people with complications, has been intercepted. There is also an illegal trade in Ritalin for attention-deficit hyperactivity, which can make people who don't suffer from ADHD get "high."
Arieli says the Hizbollah terror organization in Lebanon uses counterfeit drugs to finance its activities. Pharmaceutical crime is also "big money for organized crime. We believe that organized crime has realized the potential of this sector." The unit recently received information about counterfeit Plavix (a drug to reduce clots in heart and stroke patients) in the Palestinian Authority. "We did a trial buy on the West Bank and found that even though there was international packaging, the pills contained none of the active ingredient."
But while Arieli knows the global death toll from pharmaceutical crime is significant, he cannot say how many deaths have resulted in Israel. "I am in touch with doctors in emergency rooms. Men come in saying they took an ED drug or a pill they bought in a kiosk and do not feel well, but the doctors don't have the time to ask where they got them. We want to build up a resource center to increase awareness in emergency rooms, but the young doctors are so overburdened."
Only last week, the Israel Foundation for a Drug-Free World reported that kiosks in Tel Aviv were caught selling marijuana "candies" and seeds as if they were chocolates. Arieli's unit has identified the raw material for Viagra inside ping-pong balls it intercepted at the airport. During the war in Gaza, hand grenades sent from the West Bank to Gaza were confiscated that contained fake drugs. Arieli says most counterfeit drugs from abroad are manufactured in China, while most generic sildenafil and other drugs are made in India. "But in India, manufacturers are now crying that their generics are being counterfeited in China," he adds with some irony.
According to the WHO, the chances of buying over-the-counter or prescription drugs that are actually counterfeit is at least 10 percent globally, and much higher in places such as Pakistan, where it is estimated at 50%, compared to 1% in developed nations. When illicit medications are manufactured abroad or in Israel, the conditions under which they are made and stored are usually substandard - too hot or too humid, as well as unsterile - which can make the API inactive or dangerous.
WHILE NOT many counterfeit drugs are made in Israel, Arieli says Israelis - or former ones - are quite prominent among illegal businesses that market medications and supplements via the Internet. "The majority of these businesses have no actual contact with the drugs but just handle the advertising, administration and collection," he explains.
Last week, the US Food and Drug Administration issued warnings to 22 Web site operators about the illegal sale of unapproved or misbranded drugs. The International Internet Week of Action was intended to curb illegal actions involving medical products. The FDA targeted 136 Internet sites that appeared to be engaged in the illegal sale of unapproved or misbranded drugs to US consumers. As part of its participation in the campaign, the Health Ministry warned the public about the dangers of buying medications and food supplements via the Internet. More than half of these products are counterfeit, the ministry says.
The Customs Authority examined hundreds of mailed-in packages at four major postal sorting stations; out of 90 marked as medications or food supplements, 10 were found to contain counterfeit products totalling thousands of pills. One of the people refused permission to release his packages was identified as a professional licensed pharmacist.
Another popular scheme is diversion, in which millions of dollars' worth of subsidized drugs, such as those for AIDS patients, are supposed to get to desperate patients in Africa. Instead, says Arieli, they are taken to Europe and sold at much higher prices. A million people die of malaria around the world, but 250,000 die of counterfeit drugs that supposedly treat malaria, he adds. The counterfeits are mostly ordinary paracetamol pain killers and fever reducers.
"Being given that for malaria is homicide."
AS ISRAEL'S borders, especially in the south, are porous, the smuggling of medications is frequent, as are opportunities for diversion. "This situation includes not only Israel but also Jordan, Syria, Egypt, Gaza and Lebanon."
There are also drugs sent for destruction because the manufacturer decided they are not up to standard. Instead of being burned, some are found in Israeli pharmacies in counterfeit cartons to hide the batch numbers and expiration dates, Arieli said. "All the counterfeiting, diversion and outright fraud is black money, with thousands of people involved and no taxes reaching the Treasury."
The unit director says the haredi community in Jerusalem and other enclaves are especially susceptible to being fooled by illicit medications and supplements. "I recall a Jerusalemite who called to say his 'Cialis wasn't working. His health fund doctor had given him a phone number to purchase the ED drug without a prescription. I obtained some of the tablets and found they were fake. I asked him for information, but when he asked his rabbi for permission to cooperate, it was denied," Arieli recalled. There is a whole illegal trade in food supplements used by the haredi community, and "we don't know what these pills and drops contain. There is a whole culture; if a leading rabbi gives his OK, it doesn't matter to them if he knows the contents."
Arieli strongly opposes the charity organizations (gemachim) that collect unused prescription medications and supply them to people who can't afford them. "We have no idea where the medications really came from and under what conditions they were stored," he explains.
Another problem is the punishment for violations of the Pharmacy Law, which is now too lenient. "We are stymied at the Justice Ministry," Arieli insists. "Today, the punishment for a non-pharmacist selling prescription drugs is only six months in jail and a NIS 12,000 fine."
Although there have been some cases of licensed Israeli pharmacists in cahoots with thieves, the unit director assures Israelis that their pharmacies are "among the safest places to buy any pharmaceuticals."
"Buy all your prescriptions from a pharmacy licensed by the ministry whether within the Green Line or in Jewish settlements. Don't try to buy them cheap in Palestinian Authority pharmacies, which we do not license. Some people go to the territories to get medications cheaply, but this is a bad idea," warns Arieli.
Arieli urges customers to be alert when they purchase medications from any pharmacy and never to purchase anything via the Internet, newspaper ads or kiosks.
But even in licensed pharmacies, "don't be afraid to go into to your health fund or private pharmacy if a drug you've purchased looks odd or smells different than what you are used to," he concludes. Being sold without the instruction leaflet is a suspicious matter. "Very rarely are package holograms counterfeit as it is very expensive, but it can be done. We encourage the industry and and the Israel Chamber of Commerce to use new technologies to reduce fraud and counterfeiting. It is in the interest of all to fight pharmaceutical crime."
The Pharmacy Crime Unit, located at 9 Rehov Eliav, 91342 Jerusalem, will be glad to accept queries about medications suspected of being illegal. Call (02) 655-1772/4 or fax (02) 655-1776; the e-mail address is modin@eliav.health.gov.il.
