In Amazon, a frustrated search for cancer cures
By Stuart Grudgings Stuart Grudgings Tue Nov 17, 2:11 pm ET
SAO SEBASTIAO DE CUIEIRAS, Brazil (Reuters) – The task of harvesting the secrets of Brazil's vast Amazon rain forest that could help in the battle against cancer largely falls to Osmar Barbosa Ferreira and a big pair of clippers.
In jungle so dense it all but blocks out the sun, the lithe 46-year-old shimmies up a thin tree helped by a harness, a strap between his feet, and the expertise gained from a lifetime laboring in the forest.
A few well-placed snips later, branches cascade to a small band of researchers and a doctor who faithfully make a long monthly trip to the Cuieiras river in Amazonas state in the belief that the forest's staggeringly rich plant life can unlock new treatments for cancer.
They may be right.
About 70 percent of current cancer drugs are either natural products or derived from natural compounds, and the world's largest rain forest is a great cauldron of biodiversity that has already produced medicine for diseases such as malaria.
But finding the right material is no easy task in a forest that can have up to 400 species of trees and many more plants in a 2.5-acre (1-hectare) area, and in a country where suspicion of outside involvement in the Amazon runs strong.
"If we had very clear rules, we could attract scientists from all over the world," said the doctor, Drauzio Varella, with a mix of enthusiasm and frustration. "We could transform a big part of the Amazon into an enormous laboratory."
As it stands, though, foreigners are barred from helping oncologist Varella and the researchers from Sao Paulo's Paulista University, who are among a tiny handful of Brazilian groups licensed to study samples from the Amazon.
Varella, 66, believes his high profile has helped. He is a well-known writer and television personality who shot to fame in 1999 with a book and subsequent hit movie based on his work as a doctor in a brutal Sao Paulo prison called Carandiru.
But a move by his team in the 1990s to partner with the U.S. National Cancer Institute produced a storm of accusations of "bio-piracy" and for years it has been blocked from the international cooperation and funding that could increase the chances of finding the Holy Grail of a cancer cure.
Their work has also been regularly delayed by bureaucratic demands, once stopping their collections for two years.
In more than a decade of searching, the group has brought back 2,200 samples from this tributary of the mighty, tea-dark Rio Negro (Black River) to its laboratory in Sao Paulo, of which about 70 have shown some effect against tumors. Just those samples have given the team enough analysis work for 20 years, said Varella, a lanky marathon runner whose younger brother died of cancer.
"If we can find 70, imagine what a big university with international resources could do -- they could screen for an absurd amount of diseases," said Varella, who still spends part of his time treating prisoners in Sao Paulo.
"As well as the impact this could have on human health, it could bring resources for preservation and to improve the quality of life of people who live here."
Ironically, it was a foreigner who inspired Varella to begin his search. Robert Gallo, a U.S. researcher and leading AIDS expert who co-discovered the HIV virus, asked Varella during a trip to the Amazon in the early 1990s if anyone was researching the medical potential of the forest.
JIGSAW PUZZLE
Among the natural products being used to fight cancer today is Taxol, a chemotherapy drug that comes from the bark of the Pacific yew tree.
David Newman, head of the Natural Products Branch of the U.S. National Cancer Institute, said several promising cancer drugs derived from natural sources as varied as a deep-water sponges and microbes are currently going through clinical trials. Often the natural compounds are tweaked or mimicked to better fight cancer cells.
"It's a detective story and a jigsaw puzzle, but you don't know how many pieces there are or what the picture looks like," he said. "In one teaspoon of soil from the Amazon, you find over a thousand microbes that have never been isolated."
Out of an estimated 80,000 species of flower-bearing plants in the Amazon, only about a fifth have been identified.
Newman said progress in Brazil has been greatly hampered by the inability of companies to patent a natural product under legislation passed in the 1990s, leaving no incentive to invest in research.
He cited the example of a Brazilian viper snake whose venom proved vital to the development of blood pressure drug captopril in the 1970s, a find that might not have happened under today's laws.
Further analysis of the promising compounds found by Varella's team has been held up while the university waits for access to a nuclear-magnetic resonance machine that can isolate the active elements.
"We're still a long way from discovering an actual medicine that could cure a type of cancer but we have strong signs that some plants have substances that inhibit the growth of tumors," said Mateus Paciencia, a bearded 34-year-old botanist.
Their main hope is that growing concern over the environment and increasing government efforts to slow the destruction of the Amazon by ranchers and loggers will turn the tide in favor of sustainable forest industries, of which they say their work is a prime example.
"There is nothing more sustainable than this," said Paciencia. "We take a kilogram worth of samples from a tree that weighs a ton and get an extract that lasts 10 years."
As he hung from a tree trunk, Ferreira said his relationship with the forest had been transformed by his job. He used to cut down trees with a chainsaw and sell the lumber in the city of Manaus, about 80 km (50 miles) down river from the research site.
"I think we'll find a medicine, and it won't take too long," he said. "If I deforest, I'm killing not just one plant but destroying a lot of other plants as well. So the job we're doing here is much better."
Wednesday, November 18, 2009
Wednesday, November 11, 2009
'Made in India' dominates US AIDS scheme
P B Jayakumar / Mumbai October 16, 2009,
Business Standard (India)
Indian drug companies have cornered an overwhelming majority of drug approvals under the US President's Emergency Plan for AIDS Relief (Pepfar).
Out of the 100 approvals by the US drug regulator Food and Drug Administration (FDA) so far, close to 95 per cent are for Indian companies.
Aurobindo leads the list with 34 approvals, followed by Cipla and US-based Mylan Laboratories' Indian arm Matrix Laboratories with about 15 approvals each. Companies such as Strides, Emcure and Hetero also would supply about 5-15 drugs each under the programme.
The Pepfar programme, started in 2003, aimed at the prevention, treatment, and care of people infected with HIV/AIDS worldwide.
On October 6, the FDA approved the 100th anti-retroviral drug under the Pepfar programme.
"It is a service to the society and we are happy to be the leader in supplying anti-retrovirals, at one-third of the prices of original drugs under the programme," said K Nityananda Reddy, managing director of Hyderabad-based Aurobindo.
The service to society makes business sense, too, for the drug companies. Pepfar is the largest commitment ever by any nation for an international health initiative dedicated to a single disease and is focused on 15 of the hardest-hit countries in Africa, Asia, and the Caribbean.
These countries are Botswana, Cote d'Ivoire, Ethiopia, Guyana, Haiti, Kenya, Mozambique, Namibia, Nigeria, Rwanda, South Africa, Tanzania, Uganda, Vietnam and Zambia. In May 2007, then US President George W Bush reauthorised the programme by increasing procurement of generic drugs and offered another $30 billion, in addition to the initial $15 billion commitment made in 2003.
“On average, we have earned $20 million to $25 million (Rs 92 crore to Rs 115 crore) annually in the last few years from Pepfar supplies. I anticipate a slight plus or minus revenue to this figure in the coming years from this programme,” said Amar Lulla, joint managing director of Mumbai-based Cipla, another major supplier.
As on September 30, 2008, the most recent figure available, Pepfar supported life-saving antiretroviral treatment for more than 2.1 million living with HIV/AIDS. In 2008, it provided nearly $1.6 billion in support of treatment programmes, including antiretroviral drugs and services.
“There is no separate data on the spend for drug procurement under the programme. Companies involved in the programme do not reveal their revenues separately. Supplies are staggered and procurement takes months or quarters later from the date the orders are placed,” said Ranjit Kapadia, vice president, institutional research with HDFC Securities.
"It is estimated that FDA’s actions are allowing Pepfar to spend $150 million (Rs 690 crore) more each year on patient access to care,” US FDA Commissioner Margaret A. Hamburg said in a statement.
The approval process for drugs is rapid. Even patent-protected drugs are procured for supply with a tentative approval in the countries covered under the programme.
The goal of the programme is to support treatment of at least 3 million people, prevention of 12 million new infections, and providing care for more than 12 million HIV-infected and affected people by 2013. In addition, Pepfar will support training for at least 140,000 health care workers in HIV/AIDS prevention, treatment, and care.
Business Standard (India)
Indian drug companies have cornered an overwhelming majority of drug approvals under the US President's Emergency Plan for AIDS Relief (Pepfar).
Out of the 100 approvals by the US drug regulator Food and Drug Administration (FDA) so far, close to 95 per cent are for Indian companies.
Aurobindo leads the list with 34 approvals, followed by Cipla and US-based Mylan Laboratories' Indian arm Matrix Laboratories with about 15 approvals each. Companies such as Strides, Emcure and Hetero also would supply about 5-15 drugs each under the programme.
The Pepfar programme, started in 2003, aimed at the prevention, treatment, and care of people infected with HIV/AIDS worldwide.
On October 6, the FDA approved the 100th anti-retroviral drug under the Pepfar programme.
"It is a service to the society and we are happy to be the leader in supplying anti-retrovirals, at one-third of the prices of original drugs under the programme," said K Nityananda Reddy, managing director of Hyderabad-based Aurobindo.
The service to society makes business sense, too, for the drug companies. Pepfar is the largest commitment ever by any nation for an international health initiative dedicated to a single disease and is focused on 15 of the hardest-hit countries in Africa, Asia, and the Caribbean.
These countries are Botswana, Cote d'Ivoire, Ethiopia, Guyana, Haiti, Kenya, Mozambique, Namibia, Nigeria, Rwanda, South Africa, Tanzania, Uganda, Vietnam and Zambia. In May 2007, then US President George W Bush reauthorised the programme by increasing procurement of generic drugs and offered another $30 billion, in addition to the initial $15 billion commitment made in 2003.
“On average, we have earned $20 million to $25 million (Rs 92 crore to Rs 115 crore) annually in the last few years from Pepfar supplies. I anticipate a slight plus or minus revenue to this figure in the coming years from this programme,” said Amar Lulla, joint managing director of Mumbai-based Cipla, another major supplier.
As on September 30, 2008, the most recent figure available, Pepfar supported life-saving antiretroviral treatment for more than 2.1 million living with HIV/AIDS. In 2008, it provided nearly $1.6 billion in support of treatment programmes, including antiretroviral drugs and services.
“There is no separate data on the spend for drug procurement under the programme. Companies involved in the programme do not reveal their revenues separately. Supplies are staggered and procurement takes months or quarters later from the date the orders are placed,” said Ranjit Kapadia, vice president, institutional research with HDFC Securities.
"It is estimated that FDA’s actions are allowing Pepfar to spend $150 million (Rs 690 crore) more each year on patient access to care,” US FDA Commissioner Margaret A. Hamburg said in a statement.
The approval process for drugs is rapid. Even patent-protected drugs are procured for supply with a tentative approval in the countries covered under the programme.
The goal of the programme is to support treatment of at least 3 million people, prevention of 12 million new infections, and providing care for more than 12 million HIV-infected and affected people by 2013. In addition, Pepfar will support training for at least 140,000 health care workers in HIV/AIDS prevention, treatment, and care.
Tuesday, October 27, 2009
More Republican Meddling in the NIH Grant Process
From Drugmonkey
.... Reps Joe Barton (R; TX) and Greg Walden (R; OR) who are asking the new NIH director, Francis Collins, to come clean about a list of grants.
With that in mind, Barton and Walden are puzzled by some of the grants that were approved: "Impact of Dragon Boat Racing on Cancer Survivorship"; "Substance Use and HIV Risk Among Thai Women"; "The Healing of the Canoe"; "Patterns of Drug Use and Abuse in the Brazilian Rave Culture".
"We do not doubt that there may be some degree of scientific benefit to be gained from these studies," Barton and Walden wrote. "However, given the number of urgent public health issues facing the NIH, such as cancer, heart disease, diabetes, and pandemic disease, we question how peer review panels determined these projects to have 'high scientific caliber' and how they are particularly relevant to the NIH Institute and Center research priorities."
It is the usual blowhard posturing.
The full letter is linked here as a pdf. Let me quote the complaint:
..........
They insist on a detailed explanation of the merit and review of 12 specific funded grant projects (including the three which bothered Rep Issa, btw).
Six of these projects are directed at HIV/AIDS. I kid you not. In some areas of the world HIV/AIDS is a pandemic disease, lab partners! What do they want, funding for theoretical, feared pandemics like SARS and swine flu? HIV is totally and completely relevant to the mission of the NIH and we know this because of the Congressional mandate about HIV/AIDS funding! A seventh study (1G13LM009601-01A1) has, right in the abstract, the observation that "The study also examines how health campaigns contributed to the elimination and reduction of epidemic diseases". I am not making this up, I swear.
Two studies have to do with cancer- one on exercise helping with survivorship / quality of life and one to do with soy-bread as a complimentary therapy. I can tell right from this that there is some potential for health-relevant positive outcome (even if it is debunking soy-bread)...and that these CongressCritters don't have the expertise to judge the merit. But still, these guys listed cancer as one of their approved health concerns...so what gives?
Three projects are on substance use and four of the HIV/AIDS ones focus on substance abuse issues in the context of HIV/AIDS as well. Perhaps not a pandemic but a serious public health issue, as my Readers are aware. This is why we have both NIDA and NIAAA, my friends-are you planning to defund whole Institutes next? Because that would make more sense than picking on a handful of projects under the guise of more deserving "urgent public health issues"...
In short, these clowns have no genuine concern with health relevance or the NIH mission of various ICs or quality science that I can detect. Because they select grants that hit on the very "relevance" topics that they cite, ones that fit obviously and clearly within general NIH IC mandates and also with specific add-ons from Congress (when it comes to HIV/AIDS). The only issues that seem to coherently link the selected projects are deduced from the observation that these Congressmen apparently don't like studies on HIV, drugs of abuse and especially non-white and/or foreign populations. This sounds like a social conservative political, rather than a scientific or even a good stewardship-of-public-funds, agenda to me.
Finally there is a structural angle to the posturing which makes me wonder if they are even remotely serious about this. They list three R03's and two R21's in their final year of funding by year-code! What possible impact is there of demanding that the NIH Director tell them how these grants got approved?? There is no time to halt the projects. And they know this...don't they? Are CongressCritters really so dense as to specifically go after the final year of a non-renewable (and dinky) award? Or are they doing it with cynicism knowing they can't possibly make real steps to defund the project?
Ok, Ok, so this is only an effort to question the NIH about their practices. Not one of those Toomey/Issa style efforts to actually amend the budget or anything. But still, this is ridiculous. At best it is cynical science-bashing to play to the social-conservative base. At worst, they really do mean to put Congressional fingers right into the grant evaluation process and decide funding based on politics, rather than science.
.... Reps Joe Barton (R; TX) and Greg Walden (R; OR) who are asking the new NIH director, Francis Collins, to come clean about a list of grants.
With that in mind, Barton and Walden are puzzled by some of the grants that were approved: "Impact of Dragon Boat Racing on Cancer Survivorship"; "Substance Use and HIV Risk Among Thai Women"; "The Healing of the Canoe"; "Patterns of Drug Use and Abuse in the Brazilian Rave Culture".
"We do not doubt that there may be some degree of scientific benefit to be gained from these studies," Barton and Walden wrote. "However, given the number of urgent public health issues facing the NIH, such as cancer, heart disease, diabetes, and pandemic disease, we question how peer review panels determined these projects to have 'high scientific caliber' and how they are particularly relevant to the NIH Institute and Center research priorities."
It is the usual blowhard posturing.
The full letter is linked here as a pdf. Let me quote the complaint:
..........
They insist on a detailed explanation of the merit and review of 12 specific funded grant projects (including the three which bothered Rep Issa, btw).
Six of these projects are directed at HIV/AIDS. I kid you not. In some areas of the world HIV/AIDS is a pandemic disease, lab partners! What do they want, funding for theoretical, feared pandemics like SARS and swine flu? HIV is totally and completely relevant to the mission of the NIH and we know this because of the Congressional mandate about HIV/AIDS funding! A seventh study (1G13LM009601-01A1) has, right in the abstract, the observation that "The study also examines how health campaigns contributed to the elimination and reduction of epidemic diseases". I am not making this up, I swear.
Two studies have to do with cancer- one on exercise helping with survivorship / quality of life and one to do with soy-bread as a complimentary therapy. I can tell right from this that there is some potential for health-relevant positive outcome (even if it is debunking soy-bread)...and that these CongressCritters don't have the expertise to judge the merit. But still, these guys listed cancer as one of their approved health concerns...so what gives?
Three projects are on substance use and four of the HIV/AIDS ones focus on substance abuse issues in the context of HIV/AIDS as well. Perhaps not a pandemic but a serious public health issue, as my Readers are aware. This is why we have both NIDA and NIAAA, my friends-are you planning to defund whole Institutes next? Because that would make more sense than picking on a handful of projects under the guise of more deserving "urgent public health issues"...
In short, these clowns have no genuine concern with health relevance or the NIH mission of various ICs or quality science that I can detect. Because they select grants that hit on the very "relevance" topics that they cite, ones that fit obviously and clearly within general NIH IC mandates and also with specific add-ons from Congress (when it comes to HIV/AIDS). The only issues that seem to coherently link the selected projects are deduced from the observation that these Congressmen apparently don't like studies on HIV, drugs of abuse and especially non-white and/or foreign populations. This sounds like a social conservative political, rather than a scientific or even a good stewardship-of-public-funds, agenda to me.
Finally there is a structural angle to the posturing which makes me wonder if they are even remotely serious about this. They list three R03's and two R21's in their final year of funding by year-code! What possible impact is there of demanding that the NIH Director tell them how these grants got approved?? There is no time to halt the projects. And they know this...don't they? Are CongressCritters really so dense as to specifically go after the final year of a non-renewable (and dinky) award? Or are they doing it with cynicism knowing they can't possibly make real steps to defund the project?
Ok, Ok, so this is only an effort to question the NIH about their practices. Not one of those Toomey/Issa style efforts to actually amend the budget or anything. But still, this is ridiculous. At best it is cynical science-bashing to play to the social-conservative base. At worst, they really do mean to put Congressional fingers right into the grant evaluation process and decide funding based on politics, rather than science.
Barton and Walden feature in Hypocrisy Hall of Fame
House Republicans Hypocrisy Hall of Fame
Posted by DCCC Press
The DCCC has unveiled the latest entries into the House Republicans Hypocrisy Hall of Fame, which has now grown to 67 Members. These Republicans have been caught trying to celebrate the benefits of projects they opposed in President Obama's recovery bill, the 2009 Omnibus Appropriations bill, and the Omnibus Public Land Management Act.
"With the economy showing early signs of recovery, it's no wonder that more and more House Republicans are scrambling to take credit for the benefits they opposed," said Ryan Rudominer, National Press Secretary for the Democratic Congressional Campaign Committee. "Times are tough. Hardworking Americans need solutions, not more hypocrisy from the Republican Party of No."
Representative Greg Walden (OR-02) - "I figure my job is to try and do whatever I can to clear the hurdles and get the projects going and the people back to work using these funds." [Mail Tribune; 2/19/09]
Representative Joe Barton (TX-06) - Representative Joe Barton showed his hypocrisy after asking the Obama Administration for three billion in funds for NASA from the economic recovery act, which he voted against. Members of the Texas delegation signed the letter, including two Republican Senators and 19 House Republicans who all voted against the recovery act in February. [Texas delegation wants stimulus money for NASA, Houston Chronicle, 10/5/09]
-----------------
TX-06: Barton’s Gravy Train
Share
Posted by Brandon English
Jan 20, 2006
There’s one man who does not count on Tom DeLay for oil industry connections.
Anna says…
MMmmmmm…. I love the smell of corruption in the morning! Congressman Joe Barton embarks today on what his re-election staff has dubbed “Joe Barton’s 2006 Texas Train Ride”. We prefer to call it what it is: a Gravy Train.
For the low, low price of $2000, individual donors can hobnob with Chairman Barton (as the invitation flyer emphasises) for several hours. Entertainment includes a Saturday brunch, an “after hours tour of the Alamo”, “cocktails”, and an old GOP favorite: gambling (quick, someone call Jack Ambramoff!). The invitation promises that “During the ride, we’ll have lots of time to talk”. Even better, if you’re a PAC representative, all this access can be yours for the bargain bin price of $5000.
Joe Barton on climate
Joe Baron Blocks Generic Medicines
Joe Barton on Gas Prices
Posted by DCCC Press
The DCCC has unveiled the latest entries into the House Republicans Hypocrisy Hall of Fame, which has now grown to 67 Members. These Republicans have been caught trying to celebrate the benefits of projects they opposed in President Obama's recovery bill, the 2009 Omnibus Appropriations bill, and the Omnibus Public Land Management Act.
"With the economy showing early signs of recovery, it's no wonder that more and more House Republicans are scrambling to take credit for the benefits they opposed," said Ryan Rudominer, National Press Secretary for the Democratic Congressional Campaign Committee. "Times are tough. Hardworking Americans need solutions, not more hypocrisy from the Republican Party of No."
Representative Greg Walden (OR-02) - "I figure my job is to try and do whatever I can to clear the hurdles and get the projects going and the people back to work using these funds." [Mail Tribune; 2/19/09]
Representative Joe Barton (TX-06) - Representative Joe Barton showed his hypocrisy after asking the Obama Administration for three billion in funds for NASA from the economic recovery act, which he voted against. Members of the Texas delegation signed the letter, including two Republican Senators and 19 House Republicans who all voted against the recovery act in February. [Texas delegation wants stimulus money for NASA, Houston Chronicle, 10/5/09]
-----------------
TX-06: Barton’s Gravy Train
Share
Posted by Brandon English
Jan 20, 2006
There’s one man who does not count on Tom DeLay for oil industry connections.
Anna says…
MMmmmmm…. I love the smell of corruption in the morning! Congressman Joe Barton embarks today on what his re-election staff has dubbed “Joe Barton’s 2006 Texas Train Ride”. We prefer to call it what it is: a Gravy Train.
For the low, low price of $2000, individual donors can hobnob with Chairman Barton (as the invitation flyer emphasises) for several hours. Entertainment includes a Saturday brunch, an “after hours tour of the Alamo”, “cocktails”, and an old GOP favorite: gambling (quick, someone call Jack Ambramoff!). The invitation promises that “During the ride, we’ll have lots of time to talk”. Even better, if you’re a PAC representative, all this access can be yours for the bargain bin price of $5000.
Joe Barton on climate
Joe Baron Blocks Generic Medicines
Joe Barton on Gas Prices
Sunday, October 18, 2009
Commercial focus 'is harming scientific research'
• Scientists warn lower funding will hit environmental research
• Report calls for Lord Mandelson's department to be broken up
Katie Allen
The Guardian
12 October 2009
Pressure on scientists to deliver commercial benefits is compromising research, marginalising blue skies work and making universities behave more like businesses, according to a report published today .
The independent group Scientists for Global Responsibility argues that government policy has "driven a corporate agenda into the heart of universities", undermining their openness and independence. It calls for Lord Mandelson's newly formed Department for Business, Innovation and Skills to be broken up.
"There is very obviously a trend pushing in the direction of commercialisation. It is as strong under Labour as it was under the Conservatives," said Stuart Parkinson, co-author of the report, Science and the Corporate Agenda. "We have gathered extensive evidence of the damaging effects of the commercial influence. Urgent action – by government and others – is needed to resolve these problems. The trustworthiness of science and scientists is at stake."
The report also raises concerns that commercial funding of research often results in only findings favourable to the funder being reported. It explored commercial influences on research in pharmaceuticals, oil and gas, defence, biotechnology and tobacco. In pharmaceuticals researchers found industry influence can lead to a focus on treatments for wealthier communities, rather than more common global diseases. Oil and gas industry influence "can lead to a focus on fossil fuel-based technologies or controversial biofuels" rather than controlling energy demand.The report chimes with concerns raised by a growing number of academics over the government's emphasis on science's role in a knowledge-based economy. Scientists and universities are worried that the recession has intensified the focus on short-term commercial benefits from science and that blue skies research will suffer as public spending gets tighter.
Parkinson warned that funding constraints will also affect basic research with social and environmental goalsenvironmental research.
"Science is about establishing knowledge, understanding how things work," he says. "Our understanding of issues like climate change and biodiversity is important in helping decrease our environmental impact," he said.
He cited two instances of the government's drive to commercialise research. First, the merger this year of the Department for Innovation, Universities and Skills with the Department for Business, Enterprise & Regulatory Reform to form Mandelson's BIS department. It has been criticised by academics who believe higher education should be in a department dedicated to education, not commerce. Secondly, the two most recent appointments as science minister: Lord Sainsbury and Lord Drayson. "[They are] scientists who have made a lot of money out of the commercialisation of science and want to see this agenda pushed further forward."
The Report (pdf)
EU raids drugs companies
Pharmaceutical firms suspected of breaching antitrust rules
Richard Wachman
The Guardian
6 October 2009 18.03
European Union regulators today raided several drugmakers on suspicion that the companies may have breached EU antitrust rules. Inspections were carried out at half a dozen offices in several countries and documents seized.
The raids come after a report from the European commission in the summer found that generic drugmakers faced delays in getting medicines to market, sometimes because of stalling tactics employed by big pharmaceutical companies.
Groups selling lucrative patented drugs were accused of trying to protect patents for as long as possible, sometimes deploying "phoney" litigation, as well as other questionable practices, according to lawyers.
A spokesman for the EC said it had reason to believe that certain companies may have infringed EU competition rules that prohibit restrictive business techniques. Firms are also suspected of abusing their dominant market position.
France's Sanofi-aventis confirmed that it had been raided and that it was collaborating with EU antitrust officials, although there is no suggestion that it is one of the guilty parties. An industry source said three other drugmakers were believed to have been inspected.
British drugmakers GlaxoSmithKline and AstraZeneca said they were not aware of any raids on their sites.
In July, the EC said that it would turn the spotlight on individual drugs companies after it published a report claiming that generic drugs were being delayed and costs to consumers increased unnecessarily.
The commission found that delays cost EU citizens 20% in extra spending. Pharmaceutical companies were singled out for deploying a variety of delaying tactics to protect patents, and in some cases, reaching restrictive settlement agreements out of court.
The European court of justice today told the EC to review a decision that prevented GlaxoSmithKline from setting higher prices in Spain to offset the effect of exceptionally ferocious competition.
Richard Wachman
The Guardian
6 October 2009 18.03
European Union regulators today raided several drugmakers on suspicion that the companies may have breached EU antitrust rules. Inspections were carried out at half a dozen offices in several countries and documents seized.
The raids come after a report from the European commission in the summer found that generic drugmakers faced delays in getting medicines to market, sometimes because of stalling tactics employed by big pharmaceutical companies.
Groups selling lucrative patented drugs were accused of trying to protect patents for as long as possible, sometimes deploying "phoney" litigation, as well as other questionable practices, according to lawyers.
A spokesman for the EC said it had reason to believe that certain companies may have infringed EU competition rules that prohibit restrictive business techniques. Firms are also suspected of abusing their dominant market position.
France's Sanofi-aventis confirmed that it had been raided and that it was collaborating with EU antitrust officials, although there is no suggestion that it is one of the guilty parties. An industry source said three other drugmakers were believed to have been inspected.
British drugmakers GlaxoSmithKline and AstraZeneca said they were not aware of any raids on their sites.
In July, the EC said that it would turn the spotlight on individual drugs companies after it published a report claiming that generic drugs were being delayed and costs to consumers increased unnecessarily.
The commission found that delays cost EU citizens 20% in extra spending. Pharmaceutical companies were singled out for deploying a variety of delaying tactics to protect patents, and in some cases, reaching restrictive settlement agreements out of court.
The European court of justice today told the EC to review a decision that prevented GlaxoSmithKline from setting higher prices in Spain to offset the effect of exceptionally ferocious competition.
Pay for Delay schemes being investigated by EU
Sanofi, Teva and Novartis raided in antitrust probe
By Nikki Tait in Brussels and Andrew Jack and Jane Croft in London
Published: October 6 2009 20:19
Financial Times
Sanofi-Aventis, the Paris-based pharmaceutical group, Israel’s Teva, the world’s largest generic drugs producer, and Novartis of Switzerland have all been raided by European competition officials in a fresh probe into suspected antitrust breaches believed to have occurred in France.
The European Commission said “surprise inspections” began at a number of pharmaceutical companies because of concerns about “possible anti-competitive business practices and/or abuse of a dominant position”.
The commission did not elaborate further, but the move comes less than three months after it completed a detailed 18-month probe into practices in the drugs sector. This concluded that the launch of generic rival drugs was being delayed and costs to consumers inflated. At the time, the commission claimed the patent-holding companies used various means to extend the commercial life of their products and delay generic entry for as long as possible – including lengthy litigation, restrictive settlement agreements and the filing of large “patent clusters” for a single medicine.
Although lawyers questioned whether such practices were necessarily illegal, the competition watchdog promised increased scrutiny of individual companies alongside a continuing probe it began against Servier of France early last year.
Only last week, Neelie Kroes, EU competition commissioner, told European lawmakers: “We are now capitalising on our pharmaceutical inquiry with new cases . . . Please look out for further news in the coming months.”
Sanofi has in the past negotiated “authorised generic” deals with low-cost drug producers once its patented drugs came under threat, although most such deals have been in the US. In Europe, it has been expanding its presence in generics through subsidiaries Winthrop and Zentiva.
The raids coincided with a keenly awaited ruling from Europe’s top court, broadly favouring GlaxoSmithKline in a long-running battle with the commission over so-called “parallel trade” in pharmaceuticals in Europe.
The court said the commission would need to reconsider its objections to GSK’s plan to raise some prices to Spanish wholesalers, to prevent them taking advantage of Spain’s low-price environment and export the drugs elsewhere in the EU.
_____________
U.S., EU getting tough on "pay-for-delay"
By Tracy at Fierce Pharma
Jul 7 2009 - 10:04am
Forces are aligning against "pay-for-delay" patent settlements. After years of pooh-poohing the Federal Trade Commission's fight against the deals, the U.S. Justice Department now has signed up for the cause. In an appellate court filing, Justice said that it's unlawful for branded drugmakers to pay generic firms to stand down from patent challenges--unless the drugmakers can justify the deal.
The filing came in response to a request from the U.S. Court of Appeals in New York, which is hearing a case involving Bayer's antibiotic treatment Cipro. Bayer paid $398 million to Barr Laboratories in 1997 to keep a generic version off the market. Though the Justice Department wouldn't speak to the specifics of this case, it said that this particular appeals court has been too lenient in allowing pay-for-delay deals to stand. It, and other courts, have tended to uphold the deals as long as they don't extend past the drug patent's expiration date.
Meanwhile, the European Union may crack down on such deals. Antitrust regulators there have been probing the patent settlements for some 18 months, and in a preliminary report accused pharma firms of costing consumers billions by not only engaging in pay-for-delay deals, but with other tactics as well. Apparently investigators now are focusing on a few drugmakers and may be preparing antitrust actions against them. The antitrust agency plans to release another report tomorrow.
________________
By Nikki Tait in Brussels and Andrew Jack and Jane Croft in London
Published: October 6 2009 20:19
Financial Times
Sanofi-Aventis, the Paris-based pharmaceutical group, Israel’s Teva, the world’s largest generic drugs producer, and Novartis of Switzerland have all been raided by European competition officials in a fresh probe into suspected antitrust breaches believed to have occurred in France.
The European Commission said “surprise inspections” began at a number of pharmaceutical companies because of concerns about “possible anti-competitive business practices and/or abuse of a dominant position”.
The commission did not elaborate further, but the move comes less than three months after it completed a detailed 18-month probe into practices in the drugs sector. This concluded that the launch of generic rival drugs was being delayed and costs to consumers inflated. At the time, the commission claimed the patent-holding companies used various means to extend the commercial life of their products and delay generic entry for as long as possible – including lengthy litigation, restrictive settlement agreements and the filing of large “patent clusters” for a single medicine.
Although lawyers questioned whether such practices were necessarily illegal, the competition watchdog promised increased scrutiny of individual companies alongside a continuing probe it began against Servier of France early last year.
Only last week, Neelie Kroes, EU competition commissioner, told European lawmakers: “We are now capitalising on our pharmaceutical inquiry with new cases . . . Please look out for further news in the coming months.”
Sanofi has in the past negotiated “authorised generic” deals with low-cost drug producers once its patented drugs came under threat, although most such deals have been in the US. In Europe, it has been expanding its presence in generics through subsidiaries Winthrop and Zentiva.
The raids coincided with a keenly awaited ruling from Europe’s top court, broadly favouring GlaxoSmithKline in a long-running battle with the commission over so-called “parallel trade” in pharmaceuticals in Europe.
The court said the commission would need to reconsider its objections to GSK’s plan to raise some prices to Spanish wholesalers, to prevent them taking advantage of Spain’s low-price environment and export the drugs elsewhere in the EU.
_____________
U.S., EU getting tough on "pay-for-delay"
By Tracy at Fierce Pharma
Jul 7 2009 - 10:04am
Forces are aligning against "pay-for-delay" patent settlements. After years of pooh-poohing the Federal Trade Commission's fight against the deals, the U.S. Justice Department now has signed up for the cause. In an appellate court filing, Justice said that it's unlawful for branded drugmakers to pay generic firms to stand down from patent challenges--unless the drugmakers can justify the deal.
The filing came in response to a request from the U.S. Court of Appeals in New York, which is hearing a case involving Bayer's antibiotic treatment Cipro. Bayer paid $398 million to Barr Laboratories in 1997 to keep a generic version off the market. Though the Justice Department wouldn't speak to the specifics of this case, it said that this particular appeals court has been too lenient in allowing pay-for-delay deals to stand. It, and other courts, have tended to uphold the deals as long as they don't extend past the drug patent's expiration date.
Meanwhile, the European Union may crack down on such deals. Antitrust regulators there have been probing the patent settlements for some 18 months, and in a preliminary report accused pharma firms of costing consumers billions by not only engaging in pay-for-delay deals, but with other tactics as well. Apparently investigators now are focusing on a few drugmakers and may be preparing antitrust actions against them. The antitrust agency plans to release another report tomorrow.
________________
Subscribe to:
Posts (Atom)