Thailand Blacklisted From Receiving New AIDS Drugs

[Jai Dee]

AIDS Healthcare Foundation 'Horrified' as Abbott Blacklists Thailand From New Drugs

In Response to the Thai Government's Recent Move to Issue a Compulsory License for Abbott's Kaletra, a Move Intended to Save the Lives of Its People, Drug Giant Refuses to Issue Any New Drugs in Country Already Hard-Hit by AIDS Epidemic

US' Largest HIV/AIDS Healthcare, Prevention and Education Provider Says Abbott's Cold-Hearted Move Punishes Poor People in Need; Underscores Drug Company's Greed

AIDS Healthcare Foundation (AHF), the US' largest HIV/AIDS healthcare, prevention and education provider, which operates free AIDS treatment clinics in the US, Africa, Latin America/Caribbean and Asia, today excoriated US drug giant, Abbott Laboratories for its heartless decision to blacklist the country of Thailand by withdrawing its new drugs' applications from that country's government review process -- a move which in essence deprives Thailand and its citizens of access to any new Abbott medications. Abbott's move came as a mean-spirited retaliation following Thailand's recent move to issue compulsory licenses on some lifesaving drugs, including Kaletra, an anti-retroviral drug manufactured by Abbott that is used in the treatment of HIV/AIDS. World Trade Organization (WTO) regulations include flexibilities and provisions that allow governments to issue compulsory licenses without consulting the foreign patent owner if the country deems it necessary and appropriate to protect the health of its citizens.

"This is a new low, and I am horrified that Abbott would deprive poor people in need of lifesaving medications, particularly for those living with HIV/AIDS, in a country as hard-hit by the epidemic as Thailand," said Michael Weinstein, AIDS Healthcare Foundation's President. "The Wall Street Journal recently ran a blistering expose on Abbott on the front page which revealed just how down and dirty this company gets to keep its market share and drive business to its overpriced drugs and products. In Washington, a congressional oversight committee is moving toward an investigation of Abbott's price gouging and policies. At the same time, Abbott has the hubris to blacklist a courageous country like Thailand simply trying to do the right thing for its people. Astounding."

After Thailand issued the compulsory license for Kaletra earlier this year, Abbott began negotiating price reductions with Thai officials. Thailand appeared to be willing to engage in negotiations, but Abbott would only take $200US off the $2,200US price (per patient yearly). It is estimated that with Thailand's compulsory license, a generic version of Kaletra can be produced for around $1,000 per patient yearly.

The initial impact of Abbott's move to block its new drugs from being approved for use in Thailand could be devastating. The urgent issue for HIV/AIDS patients revolves around the heat-stable form of Abbott's drug, Kaletra, (called Aluvia), which is currently in the process of being approved for use in Thailand. With today's decision, Abbott is likely to revoke the application for governmental approval for that drug in Thailand.

"Without Aluvia in the arsenal of drugs to fight HIV/AIDS, Thailand will now have to maintain expensive cold storage for the drug, and poorer infected populations, who often cannot afford refrigeration, will continue to go without access to any form of Kaletra," said Homayoon Khanlou, MD, AIDS Healthcare Foundation's Associate Director of Medicine. "With drug resistance a major concern for those living with HIV, consistent access to such lifesaving medications is crucial."

"It is our understanding that in issuing the compulsory license, the Government of Thailand acted in accordance with all international regulations, including paying a royalty to Abbott for all sales of generic Kaletra," said Terri Ford, AIDS Healthcare Foundation's Director of Global Advocacy. "AIDS Healthcare Foundation treats people all over the world in our free clinics, and we know how desperately these drugs are needed. I am saddened by this heartless move by Abbott, and urge the company to consider keeping their lifesaving drugs available to those whose lives are actually in need of saving in Thailand and elsewhere."

In the Asia-Pacific region, AIDS Healthcare Foundation currently provides free anti-retroviral treatment through its clinics in India, China and Cambodia, and is opening a center in Vietnam.

Source: AIDS Healthcare Foundation (AHF) - 14 March 2007

[jdinasia]

I am betting that Abbott backs down on this FAST .... a total PR fiasco for them!

[Mid]

Capitalism at it's WORST ........................

[Prakanong]

Well they are free to do what they like with their products but I thought they would not make this move due to public image and CSR.

On the other hand - if Thailand is producing generic Kaletra more cheaply how is this preventing poor people from getting the drugs?

Can not have it both ways!

[Prakanong]

I am a little confused here - the piece says Abbot will revoke the licensing application (From the Thai FDA) - that would mean it is not licensed yet for use in Thailand so how is it available?

As for cold storage - where would it be stored now?

If this is a drug that requires a "Cold Chain" then specialist fridges should be used and not home sets - same as for vaccines.

[Mid]

now your getting there ................

the implications are NO NEW DRUGS .........................

[A_Traveller]

My view is that this is part of a coordinated PR campaign against Thailand after their HIV/AIDS drug decision. The 'hostages' story being in the same vein. More to come.

Regards

[jdinasia]

now your getting there ................

the implications are NO NEW DRUGS .........................

nah ... just means that Abbott will never make any $$ here .... pick up the meds .. copy them here (LEGALLY) and Abbott loses out both ways (short run and long run)

[Dupont]

Gotta look at the source of this information.

Its not a balance report, but an emotional outburst against the traditional enemies of the left, the USA, business and anybody with any money.

Without business and profit from previous drugs, there would be no new drugs of this kind for anyone at any price.

Not trendy, but it is true! Sorry

[jdinasia]

Gotta look at the source of this information.

Its not a balance report, but an emotional outburst against the traditional enemies of the left, the USA, business and anybody with any money.

Without business and profit from previous drugs, there would be no new drugs of this kind for anyone at any price.

Not trendy, but it is true! Sorry

Not true since the VAST majority of R&D for AIDS meds are publicly funded ... not funded by Abbott Merck and Phizer etc

[garro]

Without business and profit from previous drugs, there would be no new drugs of this kind for anyone at any price.

Not trendy, but it is true! Sorry

This is a typical excuse given to justify the extremes of capitalism which puts profits before lives. It wrongly assumes that if there is no wealth incentives that people would quit looking for cures for diseases. What a load of bulls**t.

New drugs would be developed without these greed driven multinational pharmeucitical companies. The fact that these companies have been allowed to hold the world hostage is a disgrace.

[Prakanong]

Without business and profit from previous drugs, there would be no new drugs of this kind for anyone at any price.

Not trendy, but it is true! Sorry

This is a typical excuse given to justify the extremes of capitalism which puts profits before lives. It wrongly assumes that if there is no wealth incentives that people would quit looking for cures for diseases. What a load of bulls**t.

New drugs would be developed without these greed driven multinational pharmeucitical companies. The fact that these companies have been allowed to hold the world hostage is a disgrace.

Explain how they would be developed please - I am not talking about primary research here but the develpment and getting them through all the trial, regulatory procedures etc to get to the market?

Many countris require the trials to have data from their own countries and will not accept data from other studies - who is going to run these trials?

Anybody can enter the market if they want - go ahead

[garro]

Without business and profit from previous drugs, there would be no new drugs of this kind for anyone at any price.

Not trendy, but it is true! Sorry

This is a typical excuse given to justify the extremes of capitalism which puts profits before lives. It wrongly assumes that if there is no wealth incentives that people would quit looking for cures for diseases. What a load of bulls**t.

New drugs would be developed without these greed driven multinational pharmeucitical companies. The fact that these companies have been allowed to hold the world hostage is a disgrace.

Explain how they would be developed please - I am not talking about primary research here but the develpment and getting them through all the trial, regulatory procedures etc to get to the market?

Many countris require the trials to have data from their own countries and will not accept data from other studies - who is going to run these trials?

Anybody can enter the market if they want - go ahead

The drugs industry should be nationalised (but not belonging to any one nation) and kept away from market forces. Not only would drugs end up costing less but there would also be less temptation to create new drugs which are practically worthless. The focus could return to helping people and not satisfying greed.

[Dupont]

Without business and profit from previous drugs, there would be no new drugs of this kind for anyone at any price.

Not trendy, but it is true! Sorry

This is a typical excuse given to justify the extremes of capitalism which puts profits before lives. It wrongly assumes that if there is no wealth incentives that people would quit looking for cures for diseases. What a load of bulls**t.

New drugs would be developed without these greed driven multinational pharmeucitical companies. The fact that these companies have been allowed to hold the world hostage is a disgrace.

Explain how they would be developed please - I am not talking about primary research here but the develpment and getting them through all the trial, regulatory procedures etc to get to the market?

Many countris require the trials to have data from their own countries and will not accept data from other studies - who is going to run these trials?

Anybody can enter the market if they want - go ahead

Ususal flames from the left I'm afraid.

Their system whereby Governments do everything good for the population, where individualism and creativity are frowned upon, business taxed so heavily nobody bothers to get out there and try anything other than get through the day has been well tried and tested.

Its was called Communism! Great success i don't think so. Anybody wanna live in a Commie State? Not even the Commies these days it seems and even the Chinese have learned this.

Don't forget, this business developed this drug at great expense, and through the profits will be trailing and developing new drugs to take over when this is obsolete, new Anti Biotics as we are running low on effective ones thanks to drug resistance.

Should you fall ill, you have the free choice to NOT use any products manufactured by any of these imperialist, capitalist monsters! My bet is that you won't boycott any drugs and your Leftist priciples will fly out the window at the first sign of illness

Edited March 14, 2007 by Dupont

[garro]

The drug companies waste a lot of their resorces on making slight modifications (with no therapeutic effect) to already available drugs so as to prolong their patents. This should be stopped.

[Prakanong]

Without business and profit from previous drugs, there would be no new drugs of this kind for anyone at any price.

Not trendy, but it is true! Sorry

This is a typical excuse given to justify the extremes of capitalism which puts profits before lives. It wrongly assumes that if there is no wealth incentives that people would quit looking for cures for diseases. What a load of bulls**t.

New drugs would be developed without these greed driven multinational pharmeucitical companies. The fact that these companies have been allowed to hold the world hostage is a disgrace.

Explain how they would be developed please - I am not talking about primary research here but the develpment and getting them through all the trial, regulatory procedures etc to get to the market?

Many countris require the trials to have data from their own countries and will not accept data from other studies - who is going to run these trials?

Anybody can enter the market if they want - go ahead

The drugs industry should be nationalised (but not belonging to any one nation) and kept away from market forces. Not only would drugs end up costing less but there would also be less temptation to create new drugs which are practically worthless. The focus could return to helping people and not satisfying greed.

Nationalised - you are talking about Internationalisation - that would b a gret laugh

Something like a UN set-up for drugs and you think the costs would be less - get real please.

Just how would this be set up?

Do you have the barest knowledge of the drugs development process from pre-clinical through phases 1-iv human trials then regulatory approval and post marketing safety monitoring?

Tell me another industry where this works internationally in the public domain?

Lets have a world government while we are at it as well then ;-)

[garro]

Without business and profit from previous drugs, there would be no new drugs of this kind for anyone at any price.

Not trendy, but it is true! Sorry

This is a typical excuse given to justify the extremes of capitalism which puts profits before lives. It wrongly assumes that if there is no wealth incentives that people would quit looking for cures for diseases. What a load of bulls**t.

New drugs would be developed without these greed driven multinational pharmeucitical companies. The fact that these companies have been allowed to hold the world hostage is a disgrace.

Explain how they would be developed please - I am not talking about primary research here but the develpment and getting them through all the trial, regulatory procedures etc to get to the market?

Many countris require the trials to have data from their own countries and will not accept data from other studies - who is going to run these trials?

Anybody can enter the market if they want - go ahead

Ususal flames from the left I'm afraid.

Their system whereby Governments do everything good for the population, where individualism and creativity are frowned upon, business taxed so heavily nobody bothers to get out there and try anything other than get through the day has been well tried and tested.

Its was called Communism! Great success i don't think so. Anybody wanna live in a Commie State? Not even the Commies these days it seems and even the Chinese have learned this.

Don't forget, this business developed this drug at great expense, and through the profits will be trailing and developing new drugs to take over when this is obsolete, new Anti Biotics as we are running low on effective ones thanks to drug resistance.

Should you fall ill, you have the free choice to NOT use any products manufactured by any of these imperialist, capitalist monsters! My bet is that you won't boycott any drugs and your Leftist priciples will fly out the window at the first sign of illness

The over prescribing of anti-biotics has been encoraged by the drug companies and this has led to the rise of not only MRSA but Vacomycin RSA.There is no cure for VRSA. As somebody who handled anti-biotics daily for many years I am probably resistant to most anyway.

If I were to become terminally ill I would probably crawl off to a cave as there would be less chance of catching something there which would hasten my death.

[Prakanong]

The drug companies waste a lot of their resorces on making slight modifications (with no therapeutic effect) to already available drugs so as to prolong their patents. This should be stopped.

You are now taling differently and even I may agree with you on this one.

It would be very easy for the FDA, NICE and EMEA and all other regulatory bodies to do.

They would just have to change their approval rules so the new drugs would only be approved if they have a more beneficial afect ie are better thn the old ones.

There are problems here as well though - some people may not react to a type of the same class of drug from one company but another companies drug works for them - which drug do you licence?

Then an example in vaccines - the Merck Gardasil vaccine works against two main types of HPV and stops genital warts. The GSK product soon on the market works against two main types of cancer causing HPV but no wart protection - however it is thought to give stronger anti-body protection.

Should only one vaccine be licensed or do we give people choice and have physicians educated as to pro's and cons - what would you do?

Then of course there is the free market and Dr's should educate themselves but of course many do not.

[garro]

Sorry Prakanong, but the problem is with Drs educating themselves. Drug companies provide lectures and seminars for doctors in which they give very biased information. Doctors are only too willing to go to these lectures as they usually also involve free holidays, golf trips and other forms of bribes.

[ChiangMaiAmerican]

Without business and profit from previous drugs, there would be no new drugs of this kind for anyone at any price.

Not trendy, but it is true! Sorry

This is a typical excuse given to justify the extremes of capitalism which puts profits before lives. It wrongly assumes that if there is no wealth incentives that people would quit looking for cures for diseases. What a load of bulls**t.

New drugs would be developed without these greed driven multinational pharmeucitical companies. The fact that these companies have been allowed to hold the world hostage is a disgrace.

Explain how they would be developed please - I am not talking about primary research here but the develpment and getting them through all the trial, regulatory procedures etc to get to the market?

Many countris require the trials to have data from their own countries and will not accept data from other studies - who is going to run these trials?

Anybody can enter the market if they want - go ahead

Ususal flames from the left I'm afraid.

Their system whereby Governments do everything good for the population, where individualism and creativity are frowned upon, business taxed so heavily nobody bothers to get out there and try anything other than get through the day has been well tried and tested.

Its was called Communism! Great success i don't think so. Anybody wanna live in a Commie State? Not even the Commies these days it seems and even the Chinese have learned this.

Don't forget, this business developed this drug at great expense, and through the profits will be trailing and developing new drugs to take over when this is obsolete, new Anti Biotics as we are running low on effective ones thanks to drug resistance.

Should you fall ill, you have the free choice to NOT use any products manufactured by any of these imperialist, capitalist monsters! My bet is that you won't boycott any drugs and your Leftist priciples will fly out the window at the first sign of illness

The over prescribing of anti-biotics has been encoraged by the drug companies and this has led to the rise of not only MRSA but Vacomycin RSA.There is no cure for VRSA. As somebody who handled anti-biotics daily for many years I am probably resistant to most anyway.

If I were to become terminally ill I would probably crawl off to a cave as there would be less chance of catching something there which would hasten my death.

Yes antibiotics are over prescribed. However, antibiotic resistance is caused by improper use of antibiotics like the patient not compeleting the prescribed cycle. That is due to a lack of proper patient education and patient non-compliance. Selling antibiotics over the counter compunds that problem in developing countries though the same problems exists to a somewhat lesser degree in deveoped countries. At present there is no vancomycin resistant superbug that cannot be handled by another line of treatment. It is possible one will evolve but it isn't here yet.

Edited March 14, 2007 by ChiangMaiAmerican

[cclub75]

Nothing is free.

Thailand wanted to play it the "hard way", like a small timer pirate.

Now, the country will be punished like a child. And that's good.

But of course, it will be bad for the people, who need new drugs.

However, the move from the labs are perfectly understandable.

Thailand needs to make sacrifice, it means accept to pay a little in order help its people. Instead of playing bravado in a field way too large for it.

The world is not like Bangkok, where a handfull of men in shiny uniform can play with things and people, without thinking about the consequences.

[Prakanong]

Sorry Prakanong, but the problem is with Drs educating themselves. Drug companies provide lectures and seminars for doctors in which they give very biased information. Doctors are only too willing to go to these lectures as they usually also involve free holidays, golf trips and other forms of bribes.

Yes they organise Seminar's and the like and of course they want to educate Dr's but mainly KOL's (Key opinion leaders ie experts in their fields) about their own products. Dr's in the most part are not dummy's and should be able to answer searching questions about the data and they in fact do.

As for free holiday's and gifts they are a bit of thing of the past now in many companies - a company I know well ;-)) has a limit of 10 euro per gift

The hotels used as well are not the real top end ones and class of flights can be rstriced as well as partner trips.

There are however a multitude of other medical congress's, seminar's etc etc not organised by pharma companies and are quite independent where learned academic papers are given and studies - these are important i educationg Dr's

[garro]

Sorry chiangmaiamerican but I think that it is too easy to blame the patient. I have seen uncountable instances where surgeons have ordered 2 doses of vacomycyn pre and post surgery. I have also seen plastic surgeons use antibacterial creams for scar healing.

[ChiangMaiAmerican]

Sorry chiangmaiamerican but I think that it is too easy to blame the patient. I have seen uncountable instances where surgeons have ordered 2 doses of vacomycyn pre and post surgery. I have also seen plastic surgeons use antibacterial creams for scar healing.

And I have also stopped surgeons and other physicans from making potentially fatal drug errors. They usually thanked me. Any physician who orders double dosing of Vanco without levels is risking a lawsuit. A loading dose is another issue. I have a physicin ignore levels. I refused to adminster additional medicine. Someone else did. The patient became toxic and nearly lost their kidneys. Of course if I had ignored the situation my license would have been on the line too. When I used to practice in the US my primary source of referrals came from insurance companies that wanted me to take their non-compliant patients. I could usually get through to them. I have seen patients do things like share antibiotics with family members. The old I feel better now and don't need to finish taking my medicine is common. Without proper followup as is the case with most pharmacy prescribed antibiotics, the risk of non-compliance is greatly increased.

Edited March 14, 2007 by ChiangMaiAmerican

[Ijustwannateach]

... the problem with expecting to profit off the sickness of the poor and removing the treatment when they don't/can't pay, is that if the problem explodes and spreads it's kind of hard to prevent it from coming over the fence to your side of town. Ultimately, treatment for this worldwide problem should come from worldwide subsidy.

[ChiangMaiAmerican]

Presently there isn't the capacity to make enough vaccine for the entire world much less provide it for free. The WHO had plans drawn to attempt to limit a pandemic in the early stages. Neither Thailand nor any other country is excluded. The Thai official's remarks were uncalled for. Had he been a physician in a developed country his license might on the line for such remarks. He certainly would have been denounced by his peers.

Edited March 14, 2007 by ChiangMaiAmerican

[Acquiesce]

Thailands own fault i'm afraid, can't have your cake and eat it.

Poor Thailand, people moving the goalposts on them. Like they never do this sort of thing without regard for others.

[Prakanong]

... the problem with expecting to profit off the sickness of the poor and removing the treatment when they don't/can't pay, is that if the problem explodes and spreads it's kind of hard to prevent it from coming over the fence to your side of town. Ultimately, treatment for this worldwide problem should come from worldwide subsidy.

Good idea but I can just not see the USA taxpayer or any others wanting to subsidise drugs for HIV+ people in Africa or the like.

There is also the matter of the health care systems/infrastructure not being in plave for distribution and compliance checking which could make the problem worse in the long run.

If it were to happen massive cuts to the cost of drugs could be negotiated with say cost plus X dels to ensure nominal profits and thus ensure the develpment of new drugs as companies would have the confidence in high sales.

[Prakanong]

Presently there isn't the capacity to make enough vaccine for the entire world much less provide it for free. The WHO had plans drawn to attempt to limit a pandemic in the early stages. Neither Thailand nor any other country is excluded. The Thai official's remarks were uncalled for. Had he been a physician in a developed country his license might on the line for such remarks. He certainly would have been denounced by his peers.

Wrong thread? LOL

Yes there will not be enough flu pandemic vaccine to go around - prbably not even in developed countries eithr but there are other measures that can be taken.

Some countries have pre-ordered their vaccines - others might just have to take their place in the queue.

[Mid]

Good idea but I can just not see the USA taxpayer or any others wanting to subsidise drugs for HIV+ people in Africa or the like.