Consumers the Real Losers in Pharma Wars

http://www.thejakartaglobe.com/business/consumers/article/484.html

Hera Diani and Teguh Prasetyo

After bickering between Indonesia, the United States and World Health Organization over bird flu virus sample sharing this year, Health Minister Siti Fadilah Supari is waging a fresh war against the “new imperialism” by issuing a decree that could kick foreign pharmaceutical companies out of the country unless they build factories here.

A ministerial decree on drug registration, announced on Nov. 3, annuls licenses held by foreign wholesale pharmaceutical companies to import products under their brand names.

The decree targets overseas pharmaceutical companies that do not manufacture drugs in Indonesia, and instead import and distribute their medications from factories abroad. These companies would have two years to transfer their distribution licenses to local pharmaceutical companies and leave the country, or else start manufacturing drugs here.

The Health Ministry had refused to send bird flu samples to the WHO for fear that the development of a bird flu vaccine would primarily be handled by major pharmaceutical companies. The refusal, however, led to accusations that Siti was putting the world in danger of a pandemic by not supporting the global effort to find a vaccine.

Although the WHO’s intention was to protect developing countries, the Health Ministry said, it would actually make a bird flu vaccine more expensive because foreign drug companies would charge high prices that could be too costly for many patients.

Pharmaceutical company stakeholders said that the timing of the decree during the financial crisis was unfortunate, adding that it was sending the wrong message to international investors.
Siti said that her office was trying to protect local drug makers and reduce dependency on imports, as well as limiting the availability of counterfeit drugs.

“If companies want to sell drugs in this country, they have to build factories in Indonesia to create jobs,” she said on Wednesday. “My policy is to protect the economy in this time [of crisis]. We are a market for pharmaceutical companies, so they should share their profits.”

The decree has sparked protests from foreign drug makers. Fourteen pharmaceutical companies — including Eli Lily and Co., Wyeth, Roche, AstraZeneca PLC and Merck Sharp & Dohme — have threatened to leave the country.

Siti dismissed the threats, saying dozens of drug manufacturers were lining up to get into the country.

“If the companies leave, then we will import the drugs,” she said. “No lives would be endangered because the government imports medications for critical diseases through special access. Drugs are not just about trading; there is a social aspect to it.”

The pharmaceutical industry in Indonesia is complicated by an absence of regulation and monitoring, and a single ministerial decree would likely not do much to solve the problem.

Tadjuddin Noer, an executive at the Business Competition Supervisory Commission, or KPPU, said his office suspected that the pharmaceutical scene in this country was marred by monopolies, cartels and other suspect practices.

He said the pharmaceutical industry should not just be regulated by the Health Ministry, but must also receive oversight from the ministries of industry and trade.

“The industry is a mess; it lacks regulation,” he said. “There is no mechanism to set costs, so producers are slapping ridiculously high prices on drugs, sometimes 300 percent higher than in other countries. Consumers also don’t have the right to obtain certain drugs, such as certain bone medications that can only be bought abroad.”

Tadjuddin also pointed out that some local companies give commissions to doctors so that they will only prescribe their drugs, creating prescription monopolies.

Marius Widjajarta of the Indonesian Health Consumer Empowerment Foundation said that there should be an additional decree to regulate drug prices.

He said that pharmaceutical companies often created so-called “branded generic drugs” by repackaging and marketing generic drugs under a different name in order to exact higher prices.
“In other countries,” Widjajarta said, “branded generics are sometimes twice as expensive as non-branded generics. But here, they can be 40 to 200 times higher.”

For example, the antibiotic amoxycillin costs 3 cents per tablet to produce, but is sold in Indonesia for as much as 25 cents.

“Consumers are in no position to bargain as it is a life-and-death situation. And Indonesia is such a lucrative market,” he said, adding that drug producers refuse to produce here for fear of low profit margins.

Local and foreign drug companies have said that the Indonesian market is less competitive than other countries in the region, such as Singapore and Thailand, due to a lack of regulation. They have also blamed the arduous drug-registration process at the Food and Drug Monitoring Agency, or BPOM.

Mulyono, marketing manager for medical equipment firm PT Jala Indonesia Tritama, said that his company had backed off attempts to distribute foreign medicines.

“It takes up to a year to register a drug manufactured from other countries,” he said. “For local drugs, it takes around five to six months.”

Mulyono added that paying middlemen inside the BPOM would expedite the process.
“It is now even more difficult to register foreign-manufactured drugs, because the process should be handled by local importers or distributors,” he said.

BPOM head Husniah Rubiana Thamrin Akib was not available for comment. But Yeni Pangaribuan of the agency’s drug registration department said that the long registration process was due to hundreds of pharmaceutical companies trying to register their drugs.

“We’re understaffed for handling so many cases,” she said.

Singapore businessman Tonny Siva, who owns Indonesia-based Sai Med, said that it takes a long time to establish a drug company here. An Indian pharmaceutical firm that he partners with dropped plans to register its medicines, he said.

“Indian distributors would help provide cheaper drugs in this country because 50 percent of Indonesian pharmaceutical companies’ drug materials are imported from China and India,” Siva said.

He believes that local companies are afraid that competition would lower drug prices. “I also heard that there are cartel practices among local pharmaceutical companies,” he continued. “So if there is new player or competitor wanting to get into the business but not through the local firms, the new player would not have access to the market or government tenders.”

Amir Pane, spokesman for local pharmaceutical association GP Farmasi, denied rumors that it has tried to block foreign investment.

“We have no capacity to lobby for that,” he told the Jakarta Globe. “And it doesn’t make sense. We are part of a global community. We buy materials from other countries.”

“Eighty percent of domestic demand can be met by local companies, although the materials are still imported,” Amir said.

According to data from the Clinton Foundation, the price of the antiretroviral drug Neviral in the United States was $3.75 a bottle in April. The same medication produced by Indonesian state-owned firm PT Kimia Farma Tbk. costs Rp 219,450 ($19.95).

Parulian Simanjuntak from the International Pharmaceutical Manufacturers Group, or IPMG, said that the priority should be developing the market, which currently stands at $2.5 billion.

“Our country’s drug consumption per capita is only $10 to $11 a year, which is lower even than Vietnam’s,” he said. “Indonesia’s consumption is a health indicator that shows that many people still don’t get drugs they need.” Vietnam has a population of 85 million with per capita drug consumption of $13.50.

Parulian said that IPMG would appeal to the health minister to annul the decree because it could disrupt the drug supply.

“Local pharmaceutical companies don’t have research capacity,” he said. “If foreign companies leave, we will have difficulty obtaining innovative drugs to treat critical diseases like cancer and AIDS.”

Tadjuddin Noer of the KPPU said that the commission was monitoring the drug industry, with a report due in the next three months about the industry’s practices. “The country is a mere market in the medicine world,” he said. “We have no clear national strategy and policy.”

Labels: drugs, pharmaceutical

Posted by hera at 7:50 PM | Permalinks | Comments

Overmedication of children does more harm than good

Tuesday, February 14, 2006
Hera Diani, The Jakarta Post, Jakarta

Whether it's a simple case of the sniffles or the worrying onset of
diarrhea, parents here are likely to trust a doctor and his prescription
pad to put their children right.

Yet it's children who stand to suffer the most as victims of the
chaotic drug situation in the country.

With doctors prescribing them medicines they do not need, and the
danger of significant side effects, the country's kids are considered
overmedicated.

In a society with a tradition of self-medication, a recent study showed
about 70 percent of parents gave their toddlers more than four kinds of
drugs at one time to treat their illnesses.

More than 35 percent of toddlers were taking from five to seven
different kinds of medicine, according to Foundation of Concerned Parents'
spokeswoman Purnamawati S. Pujiarto.

Moreover, 85 children in the study had taken antibiotics, on the advice
of doctors, for every malady they suffered.

"This phenomenon is dangerous. First, not all diseases can be treated
with medicines -- like influenza, for example. Second,
such an amount of consumed drugs could harm our children's
health, especially their livers," said the pulmonary specialist.

Pharmacologist and physician Iwan Darmansjah said there were few
clinical trials -- tests done on humans to determine the efficacy of a new
drug -- specifically for children.

Tests showing the different reactions of the drugs in adults and
children, whose smaller body mass would affect how they were absorbed, are
also extremely rare.

"It was only in 1998 and 1999 that the FDA required pharmaceutical
companies to do the study on all medicines for children," the professor
emeritus at the University of Indonesia said, referring to the U.S. food
and drug regulating body.

"Before then, the data was always based on adults. It's not like a
child is a small adult that you can just halve the adult dosage the
dosage."

There have been a few studies since, he said, but none conducted in
developing countries.

"That's why children in Jakarta go to the same doctor every
two weeks, with the same disease, to receive the same, wrong
medication which reduces their immunity," he said.

"Ninety-five percent of the children are suffering from cough,
fever and cold, which should've been treated with a symptomatic
drug instead of stuffing them with antibiotics."

Executive director of the International Pharmaceutical
Manufacturers Group Parulian Simanjuntak said that clinical
trials of children were difficult to conduct due to ethical
concerns.

"A trial must be carried out voluntarily, where a person knows
what s/he is doing, the risks and so on. It is still being
debated whether children can give informed consent, as an adult
could, or whether parents can decide for the children. That's why
studies on children are not as wide as adults," Parulian said.

"And it's why pharmaceutical industries estimate the dosage
for children based on the dosage for adults."

Parulian said developed countries have discussed "assent
consent", where children can say yes or no about participating in
trials.

"But so far, it's still only under discussion."

Labels: drugs, health

Posted by hera at 8:59 PM | Permalinks | Comments

Embattled BPOM chief says agency doing its job to monitor drugs

Tuesday, February 14, 2006

Although known for his Javanese politeness and fine manners, Food and Drug Monitoring Agency (BPOM) chief Sampurno was clearly irritated when asked about criticism his organization has failed to properly monitor and regulate the pharmaceutical industry.
"It's all talk with no proof," he said.

After the flak BPOM received last month, when carcinogenic formaldehyde was found being used to preserve tofu and other food, his sensitivity is understandable.
Many also fault the agency for the haphazard drug situation in the country, which is not limited to high pricing and overdosage.

Prof. Iwan Darmansjah of the University of Indonesia's medical school said the local market was awash with useless drugs which drained the funds of unwitting consumers.
"False drug claims and wrong doses are blatantly condoned and fill the pages of the formal drug information (guide) called MIMS Indonesia," said the pharmacologist and doctor.

For those who like to self medicate, cheap drugs are readily available on the black market, such as Pasar Pramuka in East Jakarta and Pasar Senen in Central Jakarta. There are dozens of drug stores, selling products of questionable quality, safety and efficacy over the counter.

Cases of fake drugs are rampant, as well as substandard drugs, which contain less active compounds than defined on their labeling.

"In Indonesia, governance of drugs has never been well organized. The BPOM never had the manpower and the organization to protect the public from the presence of bad drugs on the market. The BPOM has been closer to and more protective of the industry than the public," Iwan said.

Marius Widjajarta of the Indonesian Health Consumer Empowerment Foundation said the situation worsened after the BPOM was removed from the auspices of the Health Ministry in 2001.

The agency was separated to become a stronger, independent body (the only other country to do this is China) after butting heads with the ministry on authority.

"The agency liked to usurp the ministry's authority, from drug registration to
issuing permits to build pharmaceutical factories. From 2002 through 2004, the agency approved 240 import licenses, which they had no right to do. Monitoring drugs is already a gargantuan task, so why trespass on other's authority?" he said, adding the agency should be moved back to the health ministry.

Sampurno defended his ministry against all the allegations, saying the BPOM did its job. He noted it was selected the fourth best agency in the world according to the 2005 audit of WHO.

He denied drugs were too pricey here, saying there was a wide selection of products available with a varied price range but of similar quality.

"When it comes to generic drugs, it's very competitive. The key is to exercise patients' rights, so they don't just bow to doctors' prescription prices," Sampurno said.

Effectiveness of drugs, he added, was a subjective matter.
He also termed "an emotional recommendation" the calls to return the BPOM to the Health Ministry.

"Come on, compare the performance of the agency (now) to when it was still part of the ministry. You can see that we perform better as an independent body." -- JP/Hera Diani

Labels: drugs, health

Posted by hera at 8:51 PM | Permalinks | Comments

Pill-popping public 'victims of unregulated market'

Tuesday, February 14, 2006
Hera Diani, The Jakarta Post, Jakarta

If you are a health consumer in Indonesia some of these situations may be familiar to you.

-- You go to a doctor instead of self-medicating for your cold and fever and end up with three different types of medicines, plus vitamins, which cost you a cool Rp 400,000 (US$43.50).

-- You are stuck in an emergency room of a hospital with a bad case of food poisoning, when you get another reason to vomit -- the price of your bill for the medicines is Rp 700,000. Then the doctor gives you a shot and you feel fine, but annoyed.

-- You take your toddlers to the pediatrician almost every month, forking out good money for many packets of medicines to treat the same reoccurring cold and flu symptoms. Your pocket hurts and you worry about the effect the many pills are having on your children's development.

-- Unable to afford your medical bills, you pay half -- and get only half -- of the prescribed drugs. Or you risk all and go to the Pramuka black market in East Jakarta for cheaper medicine.

Health is wealth, as the saying goes, which in this country could translate to mean "getting sick can rob you blind".

Experts say doctors here often overprescribe drugs to unwary patients, who are also paying too much for medicines -- a situation they say is caused by a lack of regulations and monitoring.

University of Indonesia medical school professor and pharmacologist Dr. Iwan Darmansjah said an absence of regulations governing the retail prices of prescription drugs here had caused some doctors and companies to inflate prices to ridiculous, rip-off levels.

"The amoxycillin antibiotic, which in other countries only costs between Rp 400 and Rp 500 (about 4 U.S. cents) a tablet, is being sold here by several companies for as much as Rp 2,800 a pill. That's deceiving, unfair business," Iwan said.

Health Ministry rational drug use department director Husniah Rubiana Th-Akib said manufacturers were also taking advantage of the erroneous public perception that generic drugs were less effective than their patented counterparts.

Husniah said all drugs were categorized as either generic or patented. Patented drugs were generally the latest generation of a drug, and were usually more expensive. But generic drugs -- often made specifically for low-income consumers -- should be no less effective and prices should be considerably cheaper in most cases, she said.

Patented drugs have only a 2 to 3 percent market share but make up 15 percent of national drug revenue.

"What manufacturers do, however, is take a generic drug, make it more appealing with packaging and everything, and then slap a 'brand' and a high price on it. We can call this type of drug a 'branded' generic drug," Husniah said.

"For amoxycillin, for example, there are over 100 brands on the market, with (wildly) fluctuating prices, while the content (in the tablets) is the same."
Often cheaper generic drugs are sold at the same price as patented drugs -- or worse, were packaged as such, she said.

Marius Widjajarta of the Indonesian Health Consumer Empowerment Foundation said drug prices should not fluctuate much.

"(Prices) tend to decline because newer, more sophisticated drugs enter the market."
However, international Pharmaceutical Manufacturers Group director Parulian Simanjuntak said drug prices here were based on the simple market mechanisms of supply and demand.

Because health insurance is not common in Indonesia, about 80 percent of drugs are being bought by individuals or companies, Parulian said.

Large insurers, as big buyers of drugs, could help set market limits on prices, he said.

With a total market value of about $2 billion a year, many companies here are involved in drug manufacturing -- 34 multinational companies and another 170 local ones, according to data from the group.

In such a competitive market, companies often pay doctors commissions to prescribe drugs, meaning patients often get medicines they do not need.

Indonesian Doctors Association chairman Farid Anfasa Moeloek said the government should subsidize drugs for low-income groups, who were supposed to get free medical treatment.

Farid said the unregulated system, not doctors, was to blame for the high prices.
Husniah, meanwhile, said the Health Ministry planned to regulate the packaging of drugs to ensure consumers could easily tell the difference between generic and patented medicines.

Branding on generic packaging would be 20 percent smaller and retail prices and ingredients would also be listed, she said.

"It's important for consumers to know what is in the tablets they buy," she said. If they had a choice between three chemically identical drugs, they could then choose the cheapest one, she said.

Manufacturers are opposed to the new labeling rules, which they say are against trade laws and will only increase their costs.

Parulian said international manufacturers already labeled their drugs clearly and included tablet ingredients.

"The plan would change the layout of the whole packaging. Besides, (the idea) goes against the regulation for Trade-Related Intellectual Property Rights on brands."
"We need brands, we invest in them. By including a drug's generic name, it will weaken our brands. We are going to protest this plan," Parulian said.

The industry has yet to make up its mind on price labeling, but Parulian believes it would be difficult to impose.

"Price labeling already exists on the primary packaging that (doctors' buy and) consumers do not see. If there was a change in prices, it would be impossible for manufacturers to relabel the old stock."

Labels: drugs, health

Posted by hera at 8:47 PM | Permalinks | Comments

Fewer takers for some drug rehab programs

Sunday, March 21, 2004

Father Johanness "Hanny" Osbourne Repi from Rumah Anak Panah drug rehabilitation center said there were fewer patients signing up for his drug treatment program.
"Most of them now prefer to do counseling instead of taking the whole program , which takes 14 months. It not only happens here but also at other centers," he said recently.
But drug addicts are not decreasing in number, shown by this year's survey by Yayasan Cinta Anak Bangsa (YCAB) in cooperation with the National Narcotics Board and the University of Indonesia's Institute of Applied Psychology.
The survey said that one in 10 families in Jakarta, a city with a populated estimated at 12 million, has a member involved in drug abuse, and that 97 percent of Jakartans surveyed know the danger of drugs yet 80 percent are still using.
Many of the families with drug users have monthly income below Rp 1 million. Financial constraints may also be a reason fewer people are signing up for the rehab.
"It seems that many parents don't care anymore. They're tired of being constantly disturbed by the drug problem, which costs them money, time and energy," said Hanny.
Many of the centers are forced to actively look for clients, he said.
"Budi", a patient at Nurul Alam mosque in Pedongkelan, North Jakarta, argued that many rehab centers only thought about the profits to be made.
"I've been in dozens of rehab centers, the famous ones -- you name it, I've been there," he said, mentioning some of the most prominent drug treatment centers in the country.
He recounted the terrible bullying at one Islamic drug rehab school.
"It's better here at Nurul Alam. It's free of charge, except for food which is up to us how much we give. It's better free but with benefits," Budi said.
Religious teacher Ridwan from Nurul Alam said that he does not care if people term his method ineffective.
Within the past three years, there have been around 100 drug addict and mentally ill people who have been treated at the mosque.
"There have been a few failures, sure. Most of them want to shorten the program. We can't force them. So far, I'm not looking for popularity. We don't set a high target. Look at this place, it's not even decent. We're just here to help," he said.
-- Hera Diani

Labels: drugs

Posted by hera at 2:11 AM | Permalinks | Comments

Hard line of religion used to treat addiction

Sunday, March 21, 2004
Hera Diani, The Jakarta Post, Jakarta

It was not a pretty picture: A shabby little mosque in a dark alley, filled with puddles of mud because of the heavy rain, with a foul odor emanating from the nearby river and traditional market.
Passing through the curved hole in the wall of an entrance, the sight inside was even more disturbing, with several men chained to poles on the mosque's verandah.
"Some are mentally ill, some are drug addicts," said Ridwan, 57, a religious teacher and "manager" of the Nurul Alam mosque in the Pedongkelan slum in North Jakarta -- notorious as a place for prostitutes, the homeless and criminals.
He denied that chaining the addicts was inhumane, and argued it was to ensure their proper supervision.
"It's actually inhumane if we set them free. The biggest obstacle for the addicts is their circle of friends, which will cause a relapse. A drug addict can be very destructive, they are no longer human," said the small man in between chess games and cigarettes.
So, chained they are, their heads shaved cleans and given saline solution to detoxify the body. The main focus is doing various religious activities, including communal praying, Koran reciting, sermons and religious retreats to other towns or province.
The most severe cases of addiction will be put into a one meter by one meter box to "contemplate, know their self and their enemies".
"They are told to have faith. All of those problems are rooted in a crisis in faith. People don't know about belief, sin ..."
In a country where religious values are brought in to many issues -- from the gyrating dance of dangdut singer Inul Daratista (sinful) to karaoke and ballroom dancing programs on local television (inappropriate) -- it is no wonder that people also turn to religion to treat drug addiction.
The oldest and most prominent institution running such a rehabilitation program is probably the Inabah teenage dormitory owned by Pesantren Suryalaya school of Koranic Studies in Tasikmalaya, West Java.
Established almost a century ago, the school started its drug rehabilitation program in 1970 and now has expanded to 19 centers all over the country.
The method is said to be taken from the Holy Koran which includes continual praying and taking a shower up to three times a day -- one in the middle of the night.
It is reported that up to 10,000 troubled teens have been treated in the dorm, with the success percentage said to be 90 percent.
Aside from Inabah, there are plenty of other schools all over the country offering a religious approach, for instance one in Bogor, West Java, owned by Muslim cleric Toto Tasmara.
Within Christian communities, prominent names include the Doulos Foundation owned by the leader of the Prosperous Peace Party (PDS) Ruyandi Hutasoit; Rumah Anak Panah rehabilitation center and Yayasan Anak Domba Allah (Lamb of God Foundation).
Father Johannes "Hanny" Osbourne Repi acknowledged that the religious approach can be a selling point for a drug rehabilitation center.
"Especially for parents, because of the security, faith and belief," said Hanny, who in 2001 was among the recipients of the National Figure of Drugs Awareness.
"We don't impose our beliefs, though, we just give them the picture. But in fact, miracles have occurred (in the treatment)."
Mere religious teaching, however, is not enough, Hanny said, as it has to be integrated with medical treatment, social activities and family counseling.
"Right now, however, we're more focused on an aftercare program and monitoring our clients -- we call them students, so that there will not be cases of relapse. It is important, because even those who have been clean for four years can go back to drugs," said Hanny at his office on Jl. Kran V No. 3 in Kemayoran, Central Jakarta.
Except at Nurul Alam, located at Jl. Perintis Kemerdekaan No. 1, the religious approach does not come for free.
Hanny charges Rp 2.5 million a month for the full 14-month program. On average, Rp 2.5 million to Rp 5 million is the fee charged by Islamic schools and other rehabilitation centers.
The Inabah dorm, meanwhile, charges Rp 50,000 a day.
"I give a cross subsidy for poor clients. However, many families pretend to be poor, perhaps because they have spent so much money to treat the drug addict," said Hanny.
Others contend that it takes more than religious teachings to completely wean drug addicts off their habit.
According to AIDS activist Nafsiah Mboi, whether the religious route works depends on the addicts' personalities and level of addiction.
"The higher the level, the more difficult it is to be treated, because there have been some changes in the brain. They easily miss the drugs, and if they come back to their fellow addicts, it easy to relapse," she said.
The religious approach will also not work if it is punitive and brands the addict a mere sinner, making them even more discouraged and depressed.
The important thing, she added, was a supportive environment.
Meanwhile, Ridwan from Nurul Alam mosque said the power of continual prayer was a way to teach orderliness, something that the addicts lose due to drug consumption.
"Prayer teaches discipline, order. We ask them to do pilgrimages, to get more insight into life, which is impossible to pursue by just staying home," said the elementary school graduate.
From the addicts' point of view, determination is most important in getting clean and staying that way.
Hafid Kurnia, 26, has been in and out of rehabilitation centers and hospitals ever since he started using drugs in 1996.
"I was sent to an Islamic school in Pekalongan (Central Java) which also focuses on prayer and dzikir (chanting God's name). But I managed to run away," said Hafid.
He added that Nurul Alam worked for him because it was run in a familiar way. But there is still a long way to go for Hafid, as he has only been treated for five months.
The real danger waits on the outside, and falling may into the abyss of addiction may cost him and millions of other young people their lives.

Labels: drugs, religion

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