The danger of fake remedies
Author: Francisco Alves Filho and Gustavo de Almeida
Source: IstoÉ, 23/05/2009
MISTAKE
(Photo) On the label, the false hormone is indicated for horses. This is done to circumvent enforcement, which focuses on medicines for human use
"My father lost sight of an eye because of an unregistered medication"
Julio Cahuano, on the problem that hit his father, Cezar Cahuano, after receiving illegal medication after cataract surgery
The Brazilian population is among those that most consume fake medicines worldwide. The World Health Organization (WHO) identifies in this category pirated and contraband drugs and those that are not registered with the responsible agency (in the case of Brazil, the approval and release of medications is done by the National Health Surveillance Agency, Anvisa). According to the agency, 20% of the medicines sold in the national territory fall into these classes. A survey by the Etco Institute - a business entity that fights tax evasion - reveals an even more frightening scenario: 30% of the market is made up of irregular drugs.
In the first four months of this year alone, Anvisa seized 170 tons of illegal drugs. Eight and a half times the total number of seizures carried out during 2008. The events have been so frequent that only one specialized police station in Rio de Janeiro even opened 112 investigations last year - one every three days.
It is a “business” with an equal ratio between cruelty and profit. While deceiving sick people and causing serious damage to health, the fake drug mafia generates an estimated value, according to the Etco Institute, of up to US $ 4 billion. The high consumption is explained by the lower prices and the possibility of buying without a prescription - since many are sold on the internet or in street vendors.
According to Anvisa and the Rio Civil Police, the most pirated drugs are those indicated for the treatment of erectile dysfunction (Cialis, Viagra and Pramil), those that help with weight loss (Sibutramine) and some used as anabolics (Hemogenin, Durateston and Deca Durabolin) ). Regardless of whether they have been falsified, smuggled or have no commercial record, the products offer immense health risk. Counterfeits, for example, do not contain the active substance of the original. In its place, either an innocuous thing, like some flour, or a substance that can do harm due to its toxicity is placed.
In both cases it is a disaster. In the first situation, obviously the medicine will not work. This means that the disease will continue its course of destruction of the organism without anything that contains it. In the second, in addition to the disease becoming uncontrolled, the body is still at risk of being attacked by a harmful compound. "Some of the illegal drugs for weight loss, for example, contain high doses of hormones", explains endocrinologist Walmir Coutinho, a member of the Brazilian Association for the Study of Obesity. "This can lead to tachycardia, arrhythmia or even cardiac arrest." In other words, the possibility of death is concrete.
Among contraband drugs, many are also counterfeit or out of date on the black market. “Overdue substances can also cause harmful effects or death”, explains biologist Oscar Berro, representative of the Ministry of Health in Rio. And those that circulate without registration are often manufactured in precarious conditions or have never had their effectiveness recognized by an organ competent. The worst is that it is difficult for the consumer to associate an adverse symptom or ineffectiveness of the medication with the correct cause - the use of an illegal product.
"The most common thing is to think that it is a side effect or a doctor's error," says Jorge Darze, president of the Rio de Janeiro Doctors' Union. “Therefore, the medical profession has the greatest interest in the fact that the groups that put these products on the market are disbanded.”
Piracy even reaches drugs bought directly by hospitals - such as Citotec, sold in street vendors as an abortion, and methylcellulose, a protective eye drop used in cataract surgeries. This last medication caused the loss of vision in the left eye of the Ecuadorian Cezar Augusto Cahuano. In 2003, his son, engineer Julio Cahuano, who has lived in Rio de Janeiro since 1994, decided to bring him to the city to have him undergo a cataract operation at Santa Casa da Misericórdia.
During surgery, a bacterium found in methylcellulose caused an infection and later blindness in Cezar's eye. The bacteria also impaired the vision of the other eye, which remains damaged to this day. “A tragedy ended up affecting my family,” says Julio. At the time, he did not formally record the occurrence at Anvisa. In addition to his father - who lives in Ecuador and never wanted to return to Brazil -, 12 other patients undergoing cataract surgery suffered intoxication with the medicine distributed by the company Mediphacos and which would have been produced by a manufacturer that was not registered with the Brazilian regulatory agency. “The distributor was wrong when buying a pirated product, and Santa Casa was wrong, which operated on my father and used medicine without proper control”, says the engineer.
Mediphacos denies that methyl cellulose was from an unregistered manufacturer. The company's industrial director, Marcelo Camargus, claims that they even won the lawsuit filed by Santa Casa. "We have strict control," he said. Sought, Santa Casa da Misericórdia had not responded until the closing of this edition.
Cancer drugs are also targeted by the bad guys. A little over a year ago, the Federal Police (PF) found the counterfeiting of the drug Glivec, indicated for the treatment of chronic myeloid leukemia. The medicine is a milestone in the history of the fight against the disease: before it, the survival was at most five years. Today, there are patients living for seven, ten years, thanks to its peculiar mode of action (it attacks only cancer cells, sparing healthy tissues).
For this reason, Glivec is widely consumed. Many patients go to court to have the right to receive their medication free of charge. But those who for some reason do not get this benefit are forced to pay R $ 5 to buy just a box of pills. It is clear that the drug mafia saw a perfect situation there to increase their sales: people extremely anxious for a life expectancy, but unable to buy it at the legal market price. In the packages seized by the PF in Rio de Janeiro, in Vitória and Porto Alegre, however, the products contained a mixture of flour and dye.
The sale of illegal drugs is in the hands of organized crime. The reception, transport and distribution network is the same used in several other marginal modalities, such as the smuggling of weapons, drugs, cars or pirated CDs. "Criminals already have the infrastructure set up and use it also to distribute the medicines," says Ronaldo Pires, legal manager of the Pharmaceutical Research Industry Association. "The structure of the gangs already has the sophistication of the gangs formed by drug traffickers", says Dirceu Raposo, president of Anvisa.
Chief Police Officer Marcos Cipriano, director of Polinter and until two weeks ago head of the Police Department for the Suppression of Crimes against Public Health in Rio de Janeiro, cites a case that illustrates well the pattern reached by the drug thugs. “In one of the gangs, the big boss went to Paraguay in a chartered jet to collect more than R $ 200 thousand in anabolic steroids to distribute in gyms in Rio”, he says.
Most of the illegal products come from Paraguay (other strong suppliers are in Bolivia, Argentina and also China). In general, they are unloaded in Mato Grosso and, from there, they go to large Brazilian cities and reach the consumer offered at street vendor stalls, internet sites or in pharmacies, mostly those in the periphery, less inspected.
From what is known so far, the main means of selling pirated drugs is the internet. The offer of medicines on websites with no security is multiplied on the network, in which high demand brands are sold for half the price or even less. To combat this crime, the Brazilian Association of Software Companies took down 5,4 thousand web pages where illegal pharmaceutical products were sold. “On the internet, commercialization is made easier because the identification of the criminal and the control of sales are even more difficult”, explains Luiz Paulo Barreto, president of the National Council to Combat Piracy. The same anonymity that protects the criminal in some cases stimulates the consumer, as in the purchase of products against erectile dysfunction, for example.
Those looking for a street vendor also find it easy to buy. In camelódromos, such as the one in the city center of Rio de Janeiro, for example, it is easy to reach the supplier of medicines to lose weight. A few questions are enough for street vendors and soon someone appears offering an illegal product.
In pharmacies - theoretically the safest place - the buyer needs to be aware. Many establishments have already been caught by the police selling irregular medicines. Although this is more common in establishments far from city centers and less supervised, Anvisa officials admit that sometimes pirated medicines reach consumers, even through the counters of regularized establishments.
The pharmacist Jaldo Santos, president of the Federal Pharmacy Council, recognizes that the number of professionals who respond, in the entity, to processes for sale of illegal drugs has increased. "There were around 100 in the last five years," he says. He, however, defends the class: "Most of the time, the irregularity is committed by the owner of the pharmacy and the pharmacist doesn't even know", he says.
In the face of the giant nature of the problem, companies and the federal government are mobilizing to try to stop it. The Pfizer laboratory, for example, has just changed the packaging of Viagra a lot (see table on the left). In addition to the security seal required by the legislation, the company Eli Lilly, manufacturer of Cialis, provided the product packaging with additional guarantees, such as a tape that when rubbed by a metal shows the name of the laboratory, and a special holographic seal.
Anvisa, in turn, invests in new technology so that it is possible to fight pirates more effectively. Starting next year, a new anti-counterfeiting scheme based on a two-dimensional dot code, a drug tracking and identification system that appears to be the last word in the fight against piracy will be put into operation. Something similar to the barcode, with information such as lot, dates and places of sale.
The children of the flour pill
"I had a stabilized financial condition and after becoming pregnant I was forced to sell the car and other belongings"
Paloma Trepin, mother of Emily and Evelyn, 10
The threat to the drug user can come from several sources - sometimes even from the original manufacturer itself. It happened in 1998, when the Schering-Plow laboratory produced a batch of the Microvlar birth control pill containing flour. The pills, which were a test of the production line, ended up reaching the market by mistake and women from various parts of Brazil became pregnant after taking the fake medicine. “I had just opened a beauty salon, I was in debt.
She already had a son and did not have the economic means to have another one, ”Roselane Alves Vieira, a resident of Volta Redonda, a city in the south of Rio de Janeiro, told ISTOÉ, who, due to the laboratory failure, became pregnant with the twins Caio and Lara. Today, the two are 10 years old. "I was forced to sell the salon four months after opening it to pay the expenses." Roselane, now 43, filed a lawsuit against the laboratory and won the case in the first two instances, but the lawsuit is under appeal.
"This delay is absurd," says Roselane. Worse was another victim from the same city, Paloma Trepin. She became pregnant after using the fake pill and gave birth to twins Emily and Evelyn. He received alimony from the manufacturer for about six years, his benefit was stopped and the lawsuit was closed. "I had a stabilized financial condition and after becoming pregnant I was forced to sell the car and other belongings," says Paloma. "Now I have little hope of achieving a victory in court."
With this method, all medicine boxes manufactured in Brazil will have their “fingerprint”. The Etco Institute participated in the studies for the implementation of the system. Its chief executive, businessman André Montoro, suggests other ideas. “A good proposal would be to develop a minimum ICMS quota for medicines. The huge tax burden influences the increase in this black market ”, he says. In other words, by making the original medicine cheaper, the difference in price of illegal products would no longer be an attraction for the consumer. With these measures, illegal agents would be more effectively combated.
The penalty for counterfeit drugs is also tougher than that imposed on anyone who copies CDs or DVDs. Anyone caught manufacturing, falsifying or selling illegal medicine is at risk of being imprisoned for 15 to XNUMX years. “The offense was included in the category of heinous crime,” explains federal delegate Adílson Bezerra, head of intelligence at the National Health Surveillance Agency. The penalty for counterfeiting a DVD, for example, ranges from two to four years.
RELATED
The danger of fake remedies
Author: Francisco Alves Filho and Gustavo de Almeida
Source: To the Pharmacist, 26/05/2009
The country's generic drug market, which this week completes its first decade of existence, continues to rise. The figures for the first quarter of 2009 show an increase of 19% over the same period last year and confirm the positive indicators of the segment, which, in 2008, grew 18,9%, exceeding the average of the pharmaceutical market, which was 7,9 , XNUMX%.
Generics already represent around 18% of the total of drugs sold in Brazil. In addition to savings, greater reliability in terms of the safety and efficacy of these drugs, together with the continued growth of the portfolio, explain the sector's performance.
In the generics sector in the country since 2002, Medley - a company of the sanofi-aventis Group - currently has a portfolio of 127 products, among which, five of the ten best-selling generics in the country.
The Brazilian population is among those that most consume fake medicines worldwide. The World Health Organization (WHO) identifies in this category pirated and contraband drugs and those that are not registered with the responsible agency (in the case of Brazil, the approval and release of medications is done by the National Health Surveillance Agency, Anvisa). According to the agency, 20% of the medicines sold in the national territory fall into these classes. A survey by the Etco Institute - a business entity that fights tax evasion - reveals an even more frightening scenario: 30% of the market is made up of irregular drugs.
In the first four months of this year alone, Anvisa seized 170 tons of illegal drugs. Eight and a half times the total number of seizures carried out during 2008. The events have been so frequent that only one specialized police station in Rio de Janeiro even opened 112 investigations last year - one every three days.
It is a “business” with an equal ratio between cruelty and profit. While deceiving sick people and causing serious damage to health, the fake drug mafia generates an estimated value, according to the Etco Institute, of up to US $ 4 billion. The high consumption is explained by the lower prices and the possibility of buying without a prescription - since many are sold on the internet or in street vendors.
According to Anvisa and the Rio Civil Police, the most pirated drugs are those indicated for the treatment of erectile dysfunction (Cialis, Viagra and Pramil), those that help with weight loss (Sibutramine) and some used as anabolics (Hemogenin, Durateston and Deca Durabolin) ). Regardless of whether they have been falsified, smuggled or have no commercial record, the products offer immense health risk. Counterfeits, for example, do not contain the active substance of the original. In its place, either an innocuous thing, like some flour, or a substance that can do harm due to its toxicity is placed.
In both cases it is a disaster. In the first situation, obviously the medicine will not work. This means that the disease will continue its course of destruction of the organism without anything that contains it. In the second, in addition to the disease becoming uncontrolled, the body is still at risk of being attacked by a harmful compound. "Some of the illegal drugs for weight loss, for example, contain high doses of hormones", explains endocrinologist Walmir Coutinho, a member of the Brazilian Association for the Study of Obesity. "This can lead to tachycardia, arrhythmia or even cardiac arrest." In other words, the possibility of death is concrete.
Among contraband drugs, many are also counterfeit or out of date on the black market. “Overdue substances can also cause harmful effects or death”, explains biologist Oscar Berro, representative of the Ministry of Health in Rio. And those that circulate without registration are often manufactured in precarious conditions or have never had their effectiveness recognized by an organ competent. The worst is that it is difficult for the consumer to associate an adverse symptom or ineffectiveness of the medication with the correct cause - the use of an illegal product.
"The most common thing is to think that it is a side effect or a doctor's error," says Jorge Darze, president of the Rio de Janeiro Doctors' Union. “Therefore, the medical profession has the greatest interest in the fact that the groups that put these products on the market are disbanded.”
Piracy even reaches drugs bought directly by hospitals - such as Citotec, sold in street vendors as an abortion, and methylcellulose, a protective eye drop used in cataract surgeries. This last medication caused the loss of vision in the left eye of the Ecuadorian Cezar Augusto Cahuano. In 2003, his son, engineer Julio Cahuano, who has lived in Rio de Janeiro since 1994, decided to bring him to the city to have him undergo a cataract operation at Santa Casa da Misericórdia.
During surgery, a bacterium found in methylcellulose caused an infection and later blindness in Cezar's eye. The bacteria also impaired the vision of the other eye, which remains damaged to this day. “A tragedy ended up affecting my family,” says Julio. At the time, he did not formally record the occurrence at Anvisa. In addition to his father - who lives in Ecuador and never wanted to return to Brazil -, 12 other patients undergoing cataract surgery suffered intoxication with the medicine distributed by the company Mediphacos and which would have been produced by a manufacturer that was not registered with the Brazilian regulatory agency. “The distributor was wrong when buying a pirated product, and Santa Casa was wrong, which operated on my father and used medicine without proper control”, says the engineer.
Mediphacos denies that methyl cellulose was from an unregistered manufacturer. The company's industrial director, Marcelo Camargus, claims that they even won the lawsuit filed by Santa Casa. "We have strict control," he said. Sought, Santa Casa da Misericórdia had not responded until the closing of this edition.
Medicine & Wellness
The danger of fake remedies
At least 20% of the drugs sold in Brazil are illegal. Counterfeit, smuggled or unregistered, they are life-threatening
VOLUME The total number of drugs seized this year by Anvisa is eight times higher than in 2008
"The drug mafia acts in an extremely sophisticated way"
Marcos Cipriano, director of Polinter, from Rio de Janeiro
During surgery, a bacterium found in methylcellulose caused an infection and later blindness in Cezar's eye. The bacteria also impaired the vision of the other eye, which remains damaged to this day. “A tragedy ended up affecting my family,” says Julio. At the time, he did not formally record the occurrence at Anvisa. In addition to his father - who lives in Ecuador and never wanted to return to Brazil -, 12 other patients undergoing cataract surgery suffered intoxication with the medicine distributed by the company Mediphacos and which would have been produced by a manufacturer that was not registered with the Brazilian regulatory agency. “The distributor was wrong when buying a pirated product, and Santa Casa was wrong, which operated on my father and used medicine without proper control”, says the engineer.
Mediphacos denies that methyl cellulose was from an unregistered manufacturer. The company's industrial director, Marcelo Camargus, claims that they even won the lawsuit filed by Santa Casa. "We have strict control," he said. Sought, Santa Casa da Misericórdia had not responded until the closing of this edition.
Cancer drugs are also targeted by the bad guys. A little over a year ago, the Federal Police (PF) found the counterfeiting of the drug Glivec, indicated for the treatment of chronic myeloid leukemia. The medicine is a milestone in the history of the fight against the disease: before it, the survival was at most five years. Today, there are patients living for seven, ten years, thanks to its peculiar mode of action (it attacks only cancer cells, sparing healthy tissues).
For this reason, Glivec is widely consumed. Many patients go to court to have the right to receive their medication free of charge. But those who for some reason do not get this benefit are forced to pay R $ 5 to buy just a box of pills. It is clear that the drug mafia saw a perfect situation there to increase their sales: people extremely anxious for a life expectancy, but unable to buy it at the legal market price. In the packages seized by the PF in Rio de Janeiro, in Vitória and Porto Alegre, however, the products contained a mixture of flour and dye.
The sale of illegal drugs is in the hands of organized crime. The reception, transport and distribution network is the same used in several other marginal modalities, such as the smuggling of weapons, drugs, cars or pirated CDs. "Criminals already have the infrastructure set up and use it also to distribute the medicines," says Ronaldo Pires, legal manager of the Pharmaceutical Research Industry Association. "The structure of the gangs already has the sophistication of the gangs formed by drug traffickers", says Dirceu Raposo, president of Anvisa.
Chief Police Officer Marcos Cipriano, director of Polinter and until two weeks ago head of the Police Department for the Suppression of Crimes against Public Health in Rio de Janeiro, cites a case that illustrates well the pattern reached by the drug thugs. “In one of the gangs, the big boss went to Paraguay in a chartered jet to collect more than R $ 200 thousand in anabolic steroids to distribute in gyms in Rio”, he says.
Most of the illegal products come from Paraguay (other strong suppliers are in Bolivia, Argentina and also China). In general, they are unloaded in Mato Grosso and, from there, they go to large Brazilian cities and reach the consumer offered at street vendor stalls, internet sites or in pharmacies, mostly those in the periphery, less inspected.
From what is known so far, the main means of selling pirated drugs is the internet. The offer of medicines on websites with no security is multiplied on the network, in which high demand brands are sold for half the price or even less. To combat this crime, the Brazilian Association of Software Companies took down 5,4 thousand web pages where illegal pharmaceutical products were sold. “On the internet, commercialization is made easier because the identification of the criminal and the control of sales are even more difficult”, explains Luiz Paulo Barreto, president of the National Council to Combat Piracy. The same anonymity that protects the criminal in some cases stimulates the consumer, as in the purchase of products against erectile dysfunction, for example.
Those looking for a street vendor also find it easy to buy. In camelódromos, such as the one in the city center of Rio de Janeiro, for example, it is easy to reach the supplier of medicines to lose weight. A few questions are enough for street vendors and soon someone appears offering an illegal product.
In pharmacies - theoretically the safest place - the buyer needs to be aware. Many establishments have already been caught by the police selling irregular medicines. Although this is more common in establishments far from city centers and less supervised, Anvisa officials admit that sometimes pirated medicines reach consumers, even through the counters of regularized establishments.
The pharmacist Jaldo Santos, president of the Federal Pharmacy Council, recognizes that the number of professionals who respond, in the entity, to processes for sale of illegal drugs has increased. "There were around 100 in the last five years," he says. He, however, defends the class: "Most of the time, the irregularity is committed by the owner of the pharmacy and the pharmacist doesn't even know", he says.
In the face of the giant nature of the problem, companies and the federal government are mobilizing to try to stop it. The Pfizer laboratory, for example, has just changed the packaging of Viagra a lot (see table on the left). In addition to the security seal required by the legislation, the company Eli Lilly, manufacturer of Cialis, provided the product packaging with additional guarantees, such as a tape that when rubbed by a metal shows the name of the laboratory, and a special holographic seal.
Anvisa, in turn, invests in new technology so that it is possible to fight pirates more effectively. Starting next year, a new anti-counterfeiting scheme based on a two-dimensional dot code, a drug tracking and identification system that appears to be the last word in the fight against piracy will be put into operation. Something similar to the barcode, with information such as lot, dates and places of sale.
The children of the flour pill
The threat to the drug user can come from several sources - sometimes even from the original manufacturer itself. It happened in 1998, when the Schering-Plow laboratory produced a batch of the Microvlar birth control pill containing flour. The pills, which were a test of the production line, ended up reaching the market by mistake and women from various parts of Brazil became pregnant after taking the fake medicine. “I had just opened a beauty salon, I was in debt.
She already had a son and did not have the economic means to have another one, ”Roselane Alves Vieira, a resident of Volta Redonda, a city in the south of Rio de Janeiro, told ISTOÉ, who, due to the laboratory failure, became pregnant with the twins Caio and Lara. Today, the two are 10 years old. "I was forced to sell the salon four months after opening it to pay the expenses." Roselane, now 43, filed a lawsuit against the laboratory and won the case in the first two instances, but the lawsuit is under appeal.
"This delay is absurd," says Roselane. Worse was another victim from the same city, Paloma Trepin. She became pregnant after using the fake pill and gave birth to twins Emily and Evelyn. He received alimony from the manufacturer for about six years, his benefit was stopped and the lawsuit was closed. "I had a stabilized financial condition and after becoming pregnant I was forced to sell the car and other belongings," says Paloma. "Now I have little hope of achieving a victory in court."
With this method, all medicine boxes manufactured in Brazil will have their “fingerprint”. The Etco Institute participated in the studies for the implementation of the system. Its chief executive, businessman André Montoro, suggests other ideas. “A good proposal would be to develop a minimum ICMS quota for medicines. The huge tax burden influences the increase in this black market ”, he says. In other words, by making the original medicine cheaper, the difference in price of illegal products would no longer be an attraction for the consumer. With these measures, illegal agents would be more effectively combated.
The penalty for counterfeit drugs is also tougher than that imposed on anyone who copies CDs or DVDs. Anyone caught manufacturing, falsifying or selling illegal medicine is at risk of being imprisoned for 15 to XNUMX years. “The offense was included in the category of heinous crime,” explains federal delegate Adílson Bezerra, head of intelligence at the National Health Surveillance Agency. The penalty for counterfeiting a DVD, for example, ranges from two to four years.
Source: Isto É
