November 18, 2009
Editorial
New York Times
The drug industry has been ramping up its prices in advance of any health care reforms that might clamp down on its profits. The industry’s rapid price escalation over the past year threatens to make a mockery of its deal with the Senate Finance Committee and the Obama administration to contribute $80 billion over the next decade to help pay for covering tens of millions of uninsured Americans.
The industry’s contribution will consist of drug discounts to certain Medicare beneficiaries, larger rebates on drugs bought for Medicaid beneficiaries and new fees on the industry.
We complained earlier that the industry’s contribution looked small when measured against the $1 trillion needed to cover most of the uninsured or against the $3 trillion likely to be spent on drugs in this country over the next decade. The administration got political benefits from the deal: The drug industry has not opposed health care reform as it did in previous years and has actually run commercials supporting it.
But the deal looks mostly good for the drug companies. They stand to gain tens of millions of newly insured customers who will be able to buy medicines. And the discounts the companies will provide to Medicare beneficiaries who reach a gap in their drug coverage, known as the doughnut hole, will apply only to brand-name drugs, helping the manufacturers to lock in customers that might otherwise turn to cheaper generics.
Now come the price increases. As Duff Wilson reported in The Times on Monday, the industry has raised the wholesale prices of prescription drugs by about 9 percent in the past year. That appears to be the highest annual increase since 1992.
The industry contends that it must raise prices to finance research on new drugs, and that may hold some truth given the dearth of promising new drugs in the pipelines of major manufacturers. But the increases also look designed to establish a higher price base before reform bills, if passed, try to reduce drug spending.
The industry’s maneuver suggests that the Senate’s deal with the industry should be abandoned in favor of the much tougher demands in the reform bill passed by the House. The House bill requires rebates and discounts from drug makers that may save the government about $150 billion over 10 years, according to the chief actuary for the Center for Medicare and Medicaid Services. The House bill also authorizes the secretary of health and human services to negotiate with the companies to obtain lower prices for drugs sold to Medicare beneficiaries and to a new public plan if one is approved.
The government needs every penny it can get to help cover the uninsured. Given the industry’s last-minute price increases, it seems prudent to ignore the supposed deal and demand a greater contribution.
Wednesday, November 18, 2009
Cancer cures in the Amazon?
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."
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 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.
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