Amman- Dunia Azzam.
(Part1) Placebo tablets devoid of any effective contents for the treatment of five main life-threatening diseases– namely, cardiac (heart), diabetes, cholesterol, hypertension (blood pressure) and inflammations, are scattered inside three warehouses sealed with red wax in the first case involving the manufacture of unlicensed drugs in Jordan.
The Jordanian Court of Conciliation is examining the latter case in a country where its authorities have begun to deal with the growing challenge of smuggled and counterfeit medicines. These medicines; that are crossing the borders in the suitcases of travellers, in rubber tyres, car upholstery and commercial containers, have little or no medical benefit.
However, they are competing with expensive drugs manufactured globally and imported by local agents who register these trade marks at Jordan’s Food and Drug Administration (FDA). The three warehouses, located in the Eastern suburbs of Amman, were closed down on July 25, 2007, after security officers, FDA inspectors, and officers of the anti-corruption department at the General Intelligence Department, seized thousands of tablets of counterfeit medications similar to the foreign-made ones.
The tablets were scattered among primitive packaging machines on filthy floors. These tablets were placed in plastic and cardboard packages, and their stamps showed that they were manufactured for the highest international and local specifications. Yet, the laboratory tests showed they were medically ineffective, stuffed with powdered sugar, or a mixture of flour and white powder, according to an FDA report. The FDA was established in 2003 to control pharmaceutical quality and combat smuggling and counterfeiting of medicines.
Closure of Pharmacies and Drug Stores The FDA estimates the value of smuggled and counterfeit medicines that were seized in Jordan during the year 2007 was around 10 JD million; equalling 2% of the volume of the general consumption of imported medications which stood at 191 JD million in the same year. This phenomenon has increased to the point where the FDA has closed down 56 pharmacies for periods not exceeding one month in the year 2007, compared to 10 in 2006, and only one pharmacy in 2004, for selling smuggled and counterfeit drugs.
In 2007, Jordanian law courts also dealt with 51 cases lodged by drugstores, agents of pharmaceutical companies, and the FDA, but the courts have not received any complaints from citizens until the completion of this investigative report for the al-Arab, and al-Yawm newspaper in mid-March. Most of the smuggled and counterfeit drugs are to be used for long-term consumption by patients suffering from chronic diseases such as cardiac, hypertension, cholesterol, diabetes and inflammations. Medicines for these five groups of diseases were the focus of this investigation. But this phenomenon also includes other groups of expensive medications used for psychiatric treatment, weight reduction, prevention of miscarriage, sexual stimulation, and cancer treatment.
It also includes small groups of original drugs, smuggled from neighboring countries where they are less expensive than those sold locally, thus providing a larger profit margin for the pharmacist. Most of the smuggled and counterfeit medicines can be found at pharmacies all over Jordan, with the knowledge of the responsible pharmacist or his assistant– since they are both responsible for purchasing their stocks.
These medicines are bought without official invoices and are not registered on the pharmacies’ invoices. Hence, no income or sales taxes are paid on them. Thus, encouraging profits.
FDA Director General Prof. Mohammad Rawashdeh states that “These drugs get to the pharmacies through ruthless persons, who do not believe in the profession (pharmacy), and with the knowledge of both the buyer and seller.
They are bought at prices set by either the FDA or the party licensed to sell officially registered drugs”. Targeting of Expensive Medicines According to the estimates of the FDA, the Union of Pharmacists, and importers of pharmaceutical drugs, the pharmacist purchases smuggled or counterfeit post-stint deployment drugs for 5 JD per package, even though it only costs one JD. Each package is then sold for the same price as the original effective drug which is estimated to be around 70 JD. Hence, providing a net profit of 1300%. On the other hand, the pharmacist who is not involved with dealing smuggled or counterfeit drugs, purchases the same drug from the exclusive agents against official invoices, along with incentives that ensure a profit margin between 30% and 40%.
Though, the FDA sets the profit margin for each package at 22%. These legal transactions can be monitored through checking the name and batch number of each drug, as well as the price stamped by the Ministry of Health (MoH) and the Union of Pharmacists’. For example, the FDA inspector can learn whether that drug is registered by entering the name of the drug into the website of the FDA. Official statistics released by the FDA do not reflect the true volume of the drugs seized in Jordan, nor do they reflect the volume of the smuggled and counterfeit drugs because they are based only on the seized goods.
In other words, they do not include the quantities entering the country illegally through international smuggling operations, which are estimated by the World Health Organisation (WHO) at around 32$ billion annually.
These smuggling operations mostly target developing countries, due to legal loopholes, weak legislations, low level of education, and differences in adherence to the ethics of the pharmaceutical profession. Risking Patients’ Lives The WHO reports also show that 60% of smuggled and counterfeit medicines globally, include antibiotics used to treat inflammations– some 20% are tablets. As Prof. Rawashdeh states “Smuggled and counterfeit drugs on the Jordanian pharmaceutical market are still below the world average of 15%, but they are on the decrease because of the efforts from all concerned parties.” He adds that “the seized quantities cannot be compared with those entering the country illegally and are not seized.” Nidal Sukhtian, President of the Board of Directors of the Sukhtian Drug Stores– an exclusive agent of a group of international drug manufacturing companies, including post stint deployment medications that are often counterfeited explains that “The quantity of seized goods reflects an extremely high and dangerous percentage compared to the number of citizens of Jordan (standing at 6.2 million), the numbers of patients and the volume of the drug market.
“In an interview with Al-Arab Al-Yawm, Sukhtian added that ” The problem does not lie in the percentage of numbers but in their actual value, as they can cause death because they are given to those in dire need of a medical intervention to save their lives.” He also said that “This challenge must be fought by limiting the sale of drugs between the exclusive distributor (agent) registered with the MoH, and the responsible pharmacist against official invoices that must be produced for the inspection and control teams.” According to FDA officials, the average annual per capita expenditure of a Jordanian on medicines is JD 132.
Furthermore, 199 brands of medicines from a total of 6,000 imported brands, were found to be counterfeited– this in a country that exports JD 210 million worth of pharmaceutical drugs which are produced locally. Further compounding the problem is a sharp rise in the cost of living, and the inability of most people to differentiate between the concept of replicated drugs which are manufactured locally and registered with the FDA, and those smuggled and/or counterfeit drugs which are of little medical use, and that do not carry a registered trade mark. A physician, who preferred to remain anonymous recalls how he fell victim to a lady patient who sold him a heart drug for less than half the market price. He bought five packages at JD 25 each, against the market price of JD 70 for each pack of the original drug he bought from the pharmacy.
“The patient told me the drugs belonged to her recently deceased mother, and she knew of no one who could benefit from buying them from her at less than the original cost,” the doctor said. “I believed her and bought the medicine, but she never returned to see me again.” A few days later, this doctor read the new reports of the seizure of a shipment of counterfeit heart drugs. He called his friend, who is the exclusive agent of the same medicine he had bought, and asked him to test it. Tests found out that it was totally ineffective.
Another case involved a lady in her forties suffering from high cholesterol, which had to have regular laboratory tests. A technician at the lab advised her to use a medication for her chronic disease, which he said he had obtained from a friend who had large quantities of American drugs and others from the MoH, and wanted to sell them at less than the market price in order to benefit both himself, and the buyer. The lady bought the package at JD 20, when it cost JD 50 in pharmacies.
The next time, the technician raised the price to JD 25/package, but she still bought it to save money. “God’s protection saved me,” said the lady. She said the technician called to tell her that he suspected that the drug he had sold her was counterfeit. “I did not inform the authorities cause I did not want him to lose his job, as I believe he acted in good faith.” A lawyer expert in intellectual property rights cases, and agent of one of the pharmaceutical companies, said that “One of the stamps most faked is the price list of the Pharmacists Union, which is not aware of this fact, as well as those of drug stores, but the price on the label of the MoH is not faked” Most of the empty capsules used in the counterfeiting operation that were seized in the three warehouses came from illegal factories in neighboring Arab countries.
According to officials, pharmacists and importing drug store owners, the packaged smuggled goods, came from China, Korea, India and other Eastern Asian countries. Four years ago, the Jordanian public was shocked to learn of the first case involving the seizure of 1,000 cases of a counterfeit medicine used as a pain killer and temperature reducer. Two years later, the case of the sale of counterfeit “Plavix”– used for post-deployment of stints became public following the case of the weight-reducing medicine “Reductil.” Importers of drugs, amongst them the Sabbagh Drug Store, complain of the adverse effect of smuggled and counterfeit drugs on their annual sales. Year after year, in a country where the Department of Statistics and the MoH state that cardiac diseases top of the list of fatal diseases from which Jordanians suffer. The periodic National Survey of the Behavior and Factors of Risk in Chronic Diseases in Jordan for the year 2007 shows a rise in the average of the prevalence of non-infectious diseases, such as diabetes, cholesterol and hypertension (blood pressure.)
The survey was completed both through personal interviews and through a questionnaire that was filled by 3688 persons, 2,587,997 Jordanians over the age of 18, who number 5,224,734. The result showed that 16% of them suffer from diabetes, and 23% of them are pre-diabetic. The study was done by the Directorate of Disease Control at the MoH, in cooperation with WHO and the Center for Disease Control (CDC) in Atlanta, Georgia (USA), also showed that 36.1% of Jordanians suffer from high blood cholesterol and 26% from hypertension.
According to the survey, 80.5% of diabetics, 60% of those with high cholesterol and 84% of those with hypertension take prescribed medication. A recent study on 12,000 cases of death in the country made public by the Department of statistics and the MoH showed that 40 per cent of them died from cardiac diseases. Consultant Cardio-vascular specialist Hatem Al – Tarawneh said that harm from the intake of counterfeit medication on the life of patients was a certain death for patients suffering from heart disease. He said that cardiological drugs are considered vital and necessary after deployment of stints, adding that “The drug used by such patients helps maintain the deployment of the stint, which, in turn, prevents clotting.” Dr. Tarawneh adds that if these drugs are stopped for five or six days, clotting may form in the stint, causing a myocardial infarction (heart attack), which, if occurs within the stint, has a 25 % higher incidence of death over the first attack. Dr. Tarawneh said that stopping the medication in the case of cholesterol, hypertension and antibiotics will not lead to the immediate death of the patient, but will delay the healing Endocrinologist Nadim Jarrah says that one out of three Jordanians over the age of 25 are pre-diabetic and require diabetes reducing tablets instead of insulin injections. He said this average is among the highest in the region. “One out of five in this bracket suffers from obesity and cholesterol, while one out of six suffers from hypertension,” Dr. Jarrah added. Bitter Experiences Rania Jaber, secretary of a charitable organisation, recalled her experience with counterfeited antibiotics which she took for inflammations. “I did not benefit from it, so I visited my doctor again to get a prescription for another drug, after he assured me that the first drug I used was counterfeit, a mere placebo.” Hamzah Ali, owner of a tile and marble factory, recalls his bitter experience with counterfeit drugs that he used after a stint deployment surgery following a heart attack. He did not improve much. He visited his doctor again and found out that he was taking useless capsules filled with starch which were imported from a neighboring country and sold at a local pharmacy. “I began to suspect the pharmacist who used to tell me to return for picking up the drug in two days, as it was not available,” Ali said. “The last time I went there, I asked the pharmacist to give me a receipt with the name of the medicine and the price. Then I lodged a complaint with the FDA, which followed up the matter with the pharmacist, sued him and closed down his pharmacy.”
“The drug was tested in the laboratory and proved ineffective, and on the basis of Ali’s complaint, we took the necessary measures against the pharmacist, his pharmacy was closed down and he was taken to court,” according to Head of inspection & monitoring at the FDA, ph. Tahseen Abbadi.
This Investigation was completed with support from Arab Reporters for Investigative Journalism under the supervision of Rana Sabbagh.