Wednesday, November 18, 2009
The Drug Industry Cashes In
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.
Cancer cures in the Amazon?
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
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
.... 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:
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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
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]
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TX-06: Barton’s Gravy Train
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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
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
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.
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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.
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Tuesday, August 25, 2009
Push to revive Thailand's vaccine industry
The Nation
The Public Health Ministry will ask the government to set up a national institute to develop a vaccine against deadly diseases including dengue hemorrhagic fever and Japanese encephalitis which affect thousands of victims every year.
"Vaccine development is a national agenda.... [its]direction... in the long term must be addressed by the government," Public Health Minister, Witthaya Kaewparadai said yesterday.
He was speaking after a national vaccine committee meeting on vaccine development, which was abandoned 20 years ago.
He said currently Thailand has only a national vaccine committee office operating under the Department of Disease Control, which is not flexible enough.
Moreover,Thailand wastes money importing vaccines from pharmaceutical companies - such as the Japanese encephalitis vaccine - which is required for over 800,000 children.
" If we could develop vaccines by ourselves, that would mean standing on our own feet and no longer depending on other countries for imported vaccine," he said.
National Vaccine Committee Office directorgeneral, Dr Jarung Moungchana said the committee will ask the government to budget Bt100 million to support the building of a pilot plant to conduct clinical trials and produce dengue hemorrhagic fever and Japanese encephalitis vaccines.
It will be established by the Government Pharmaceutical Organisation (GPO), Mahidol University, and the Department of Medical Science.
These three institutes will develop a cellbased vaccine production technology which would respond more rapidly to a pandemic, rather than the decadesold traditional method of producing it in chicken eggs.
He said if this pilot plant meets World Health Organisation certification, it could produce vaccine for export to other countries facing outbreaks of either disease.
The committee also approved plans to expand a BCG vaccine production plant run by Thai Red Cross Society's Queen Saovabha Memorial Institute. It would produce tuberculosis vaccine on an industrial scale for export to Asia and Africa, where the disease is spreading widely.
The committee has given the green light to a plan to develop a vaccine cocktail against diphtheria, whooping cough, and tetanus and a new and more effective tuberculosis vaccine.
The development of the TB vaccine is now in phase two in tests in Europe and United States - and Jarung said Thailand would produce its vaccine from these two regions' research.
Next month, GPO will undertake human trials on a liveattenuated vaccine against the typeA (H1N1) virus. It is expected to produce 2.8 million doses of flu mist nasal spray by the end of this year.
Meanwhile, a "Mister Health" campaign will soon be launched in Bangkok to educate workers in large companies about dengue fever, deputy Bangkok governor Malinee Sukkhavejworrakij said. Part of the campaign will involve the mass sanitisation of markets in Bangkok,both privatelyrun and those operated by the city administration.
She said the fatality rate from 2009 influenza in Bangkok had now reached 22, including three in the previous week, with 590 cases still receiving hospital treatment.
Saturday, January 31, 2009
From Davos: U.S. funds executive bonuses but breaks health promises
Seattle Times
by Kristi Heim
While U.S. bailout funds will help pay $18 billion in holiday bonuses for Wall Street executives, the U.S. has broken its promise to fund a global health program that saves millions of lives.
That was the scathing assessment of Jeffrey Sachs, director of the Earth Institute at Columbia University and special adviser to the U.N. Secretary General, speaking on a conference call this morning.
The economic crisis has resulted in a $5 billion funding gap for the Global Fund because countries, led by the U.S., are falling short on their pledges, Sachs and others said.
The Global Fund to Fight AIDS, TB & Malaria is the main source of finance for programs to prevent and treat the three diseases. The fund gathers money from donor countries and provides a quarter of all international financing for AIDS, two-thirds for tuberculosis and three quarters for malaria.
"I would suggest the U.S. reclaim those bonuses, which are absolutely unjustified and completely unconscionable, and put the money in the Global Fund immediately," Sachs said.
The $5 billion shortfall is less than one-half of one percent of what G8 countries have approved to bail out failing banks in the last three months, he added. The Merrill Lynch bonuses alone would be enough to close the gap in U.S. contributions, Sachs said.
The Fund projects it will need $8 billion to continue its work in 2009 and 2010, yet current pledges total only $3 billion. The U.S. and other donor countries pledged to support all valid Global Fund programs by committing about 0.7 of 1% of GNP in aid.
Despite a 2002 pledge made by the Bush Administration to honor that commitment, "the United States is not only not on track; it's fallen back to become the donor with the smallest donation as a share of income of all the rich countries," said Sachs. "We're at 0.16 of 1% of our income for development assistance. It's the lowest level of all 22 donor countries."
As a result, the Fund is delaying programs and cutting costs, and using this week's World Economic Forum to call attention to the issue.
The world shouldn't squander progress on major diseases for short term gains, said Peter Chernin, president of News Corp. and chairman of Malaria No More.
Goals include guaranteeing global access to antiretroviral drugs for HIV by 2010 and reducing malaria deaths to near zero by 2012.
Malaria control is an example of a good return on investment, Chernin said.
Programs are showing real results such as a 66 percent drop in malaria-related deaths in Rwanda in one year following increased use of bednets to prevent bites and treatment with effective medicine.
"In today's uncertain marketplace," Chernin said, the Global Fund "delivers proven results in both economic and humanitarian terms." Malaria alone costs Africa $12 billion a year in lost productivity, he noted.
Chernin said he's working to boost donations to the fund from the private sector.
Chevron was the first private company to step up, with a $30 million donation, said Rajat Gupta, a McKinsey senior partner who chairs the Global Fund. The (Product) Red project has raised about $150 million.
Tomorrow, Chernin will join with Exxon Mobil and Standard Charter Bank to launch a campaign to raise $100 million from private companies, primarily for malaria programs funded through the Global Fund. The campaign will also ask companies to provide technical and business assistance, such as logistics for bed net delivery and marketing efforts to increase the use of bed nets.
Millions to get malaria help by 2010
AFP
DAVOS, Switzerland (AFP) — Hundreds of millions of mosquito nets and anti-malaria kits are to be distributed by 2010, officials behind a campaign to halt about one million malaria deaths a year said Saturday.
But they urged donors not to ditch the campaign because of the economic crisis, saying there was a real chance the malaria epidemic could be eliminated in coming years.
"The resources to attack this problem -- to eliminate malaria deaths -- is there. We can achieve universal distribution of bed nets, of malaria medicine, of indoor spraying within 2010," said Rajat Kumar Gupta, who chairs the Global Fund to Fight Aids, Tuberculosis and Malaria.
In sub-Saharan Africa alone, some 600 million people are said to be at risk from the disease. Scott Case, a campaigner, said this means 300 million bed nets are required in the region.
Corporate leaders from Standard Chartered Bank, ExxonMobil and News Corporation have come together to launch a 100-million-dollar (78-million-euro) fund-raising campaign.
"We had a good start ... 40 million dollars of the 100 million dollars has been committed," said Rex Tillerson, ExxonMobil chairman and chief executive officer.
He said he thinks funding can be found despite the economic crisis, if the campaign can "demonstrate to donors that their investment for eradication has a return."
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Pfizer faces NY lawsuits over human medical tests
Friday, January 30, 2009
NEW YORK: Nigerian families can sue Pfizer in U.S. courts with claims that the giant drug maker violated international law banning involuntary medical experimentation on humans when it tested an antibiotic to treat meningitis, an appeals court ruled Friday.
The 2nd U.S. Circuit Court of Appeals overturned rulings by a lower court judge who had tossed out the lawsuits in litigation that began in 2001.
The lawsuits sought unspecified damages on behalf of children and infants who were part of a 1996 study of the oral antibiotic Trovan. The testing occurred during a meningitis epidemic that killed more than 15,000 Africans.
The lawsuits claimed Pfizer violated international law, federal regulations and medical ethics by rushing to test the experimental antibiotic without their consent or knowledge an assertion Pfizer denies.
Pfizer said it "remains confident that it will prevail in these cases, and is weighing its options on how to best respond to this decision."
Peter Safirstein, a plaintiffs' lawyer who argued the appeal, called the ruling "very, very important."
The lawsuits were dismissed on grounds they could not be pursued under the Alien Tort Statute, an 18th century law that allows foreigners to sue in U.S. courts over international law violations.
The appeals panel ruled 2-to-1 Friday that the statute can be used.
It cited international law banning the nonconsensual medical experimentation on humans that was established with the war crimes trials at Nuremberg, where 15 doctors were convicted of war crimes and crimes against humanity for conducting medical experiments without consent. Seven of the doctors were sentenced to death and eight were sent to prison.
In 1996, Pfizer sent three American physicians to work with four Nigerian doctors to experiment with Trovan on children who were hospital patients in Kano, Nigeria.
The lawsuits say the two-week experiment on 200 sick children led to 11 deaths and left many others blind, paralyzed or brain-damaged.
The plaintiffs said Pfizer, working with the Nigerian government, failed to secure the informed consent of either the children or their guardians and failed to disclose or explain the experimental nature of the study or the serious risks involved.
In its statement, Pfizer said the 1996 clinical study was conducted with the approval of the Nigerian government and consent of the participants' parents or guardians and was consistent with both international and Nigerian laws.
"Pfizer has great sympathy for everyone who suffered during the devastating meningitis epidemic in 1996," it said. "The company has said all along that all clinical evidence points to the fact that any deaths or injuries were the direct result of the illness, and not the treatment provided to patients in the Pfizer study."
The company said Trovan helped save lives with a survival rate of 94.4 percent, compared to a survival rate of slightly less than 90 percent for those who did not participate in the study.
In ruling, the appeals court said pharmaceutical companies had greatly increased the number of drug trials in poor countries in the last two decades, allowing life saving drugs to be developed faster and at less cost while providing developing countries with cutting edge medicines and treatments.
However, it said large-scale drug trials without informed consent "threatens these efforts because such conduct fosters distrust and resistance to international drug trials, cutting edge medical innovation and critical international public health initiatives in which pharmaceutical companies play a key role."
See also "Suits Saying Pfizer Experimented on Nigerian Children"
Thursday, January 29, 2009
Women Are Not “Pork”
January 28, 2009
by Ruth Rosen
Responding to President Obama's request, House Democrats cut a provision from the stimulus package that would expand contraceptive family planning for Medicaid patients-usually poor women and girls.
Why did this happen?
For years, reproductive justice activists have argued that the religious right's real agenda is not just to eliminate abortion, but to end the historic rupture between sex and reproduction that took place in the 20th century.
I understand why that rupture is unsettling. Ironically, I was on my way to lecture about Margaret Sanger in my history course at UC Berkeley when I heard the news. Sanger was vilified for wanting to give women the choice of when or whether to bear children. In short, she challenged all of human history by proposing an historic rupture between sexuality and the goal of reproduction. But if reproduction ceased to be the goal, sexuality might become yoked to pleasure.
That is the legacy the religious right has fought against, and it's that agenda that cut funding for family planning.
House Minority Leader John Boehner (R-OH) said, "How you can spend hundreds of millions of dollars on contraceptives? How does that stimulate the economy?"
Well, here's the answer. Consider the teenage girl who's sexually active. What happens to the economy when she bears a child without the means to support it? Conversely, what happens when she finishes her education, enters the labor force, earns a salary, and pays taxes? Do we want an unemployed poor woman to have more children than she can already feed, or do we want her to have access to contraception, get her life back on track, and hopefully find work instead of raising another child she cannot afford at this time?
The Congressional Budget Office also reported that by the third year of implementation, the measure would actually save $200 million over five years by preventing unwanted pregnancies and avoiding the Medicaid cost of delivering and then caring for these babies. The same CBO report found the House version of the stimulus would have a "noticeable impact on economic growth and employment in the next few years, with much of the mandatory spending for Medicaid and other programs likely to occur in the next 19 to 20 months." During the first three years, the CBO report said, the cost and savings are negligible.
This decision was an unnecessary political capitulation to Republicans. According to the AP and the Austin American-Statesman, the president was "courting Republican critics of the legislation" who had argued that contraception is not about stimulus or growth. Unfortunately, too many people have uncritically accepted that argument. But many others have noted that the package is filled with provisions for health care, which certainly includes family planning. Many other provisions, moreover, are also not growth-oriented, and yet it was poor women's bodies that Democrats bartered for the approval and votes from Republicans that they don't need and will seldom get.
That same morning, New York Times columnist Bob Herbert asked "Why anyone listens to [Republicans]?" Why, indeed. They want the Democrats to fail. They want the new president to fail. And so they described women's bodies as "pork" and asked that the funding be cut for contraception.
Women's groups are legitimately outraged at what has happened. The Planned Parenthood Federation of America called the measure a "victim of misleading attacks and partisan politics." Mary Jane Gallagher, president of the National Family Planning and Reproductive Health Association, said: "Family planners are devastated that President Obama and Congress have decided to take funding for critical family planning services out of the stimulus. Their willingness to abandon the millions of families across the country who are in need is devastating."
"The Medicaid Family Planning State Option fully belonged in the economic recovery package," said Marcia D. Greenberger, co-president of the National Women's Law Center. "The Republican leadership opposition to the provision shows how out of touch they are with what it takes to ensure the economic survival of working women and their families."
While Speaker of the House Nancy Pelosi (D-CA) defended the measure as recently as last Sunday, President Barack Obama and Rep. Henry Waxman (D-CA), chairman of the House Energy and Commerce Committee, bowed to Republican pressure and agreed to drop the measure. And although the Senate has not yet voted, it's unlikely that funding for expanded family planning will be approved. In short, the Democrats decided it just wasn't worth fighting about. According to the Washington Wire, one House Democratic aide said, "It ended up being a distraction and it will be removed."
So, poor women who want reproductive health care and contraception are both "pork" and a "distraction." Is this the change we have dreamed about?
President Obama certainly believes in contraception for poor women and girls on Medicaid. He won the election, as he recently pointed out. He doesn't have to cave in to Republican demands to restrict women's choices and health care.
The best way he and Democrats can handle this terribly misguided decision is to pass legislation to fund expanded family planning as soon as possible, before half the population wakes up and realizes that once again, women have been treated as expendable, and that their bodies have been bartered for political expediency.
Abortion Rights Go Global
By Michelle Goldberg
Slate
Jan. 29, 2009
In March 2007, the European Court of Human Rights ruled that Poland had to pay 25,000 euros to a woman who was prevented from having an abortion she needed to save her eyesight. When Alicja Tysiac, a severely nearsighted Polish mother of two, became pregnant for the third time in 2000, a series of ophthalmologists told her that she risked going blind should she bring another baby to term. But Tysiac couldn't get the authorization she needed to get around Poland's abortion restrictions. She had the baby and, as predicted, lost nearly all of her eyesight. But in winning her case before a European forum, she became part of a small cadre of women who are helping to forge a definition of abortion as a human right under international law.
The overseas battle over funding for family planning is a familiar one: In what has become a kind of ritual marking the arrival of a new party in the White House, Barack Obama last week lifted the ban on American aid to family-planning groups involved with abortion abroad. Little noticed in the United States is that abortion jurisprudence—the court cases that define rights and restrictions for the procedure—has increasingly gone global.
In the last four years, in addition to Tysiac's case, women and their lawyers have brought abortion actions before the U.N. Human Rights Committee and the Inter-American Commission on Human Rights, which investigates human rights violations in the Western hemisphere. Several times, women who've been denied abortions have won both compensation and an acknowledgment that their rights were violated. For feminists worldwide, this represents a great victory, since it elevates women's rights and safety above the often-sacrosanct principle of national sovereignty. Though back-alley abortions are largely a matter of history in the United States, botched terminations kill scores of women globally—nearly 70,000 annually, according to the World Health Organization. When governments don't respond, international courts can offer women another avenue of redress.
Yet as abortion rights go international, so does the anti-abortion backlash. The globalization of the abortion wars creates some of the same tensions—between universal human rights and community mores, between majority rule and the protection of individual liberty—as Roe v. Wade, on a larger scale. All over the world, in countries including Kenya, Poland, and Nicaragua, local anti-abortion movements (often working with American allies) rail against the meddling of powerful outsiders. In Poland, traditionalists who oppose abortion bemoan the loss of their country's Catholic values as it integrates into secular Europe. They speak about international human rights and the courts that enforce them with something of the frustrated anger that American conservatives sometimes direct at the federal government. "Abortion proponents cannot win elections on these issues, so they have to go through the least democratic bodies in the world, the United Nations, for instance, and the courts," says Austin Ruse, the president of the Catholic Family and Human Rights Institute, a pro-life organization active at the United Nations.
To be sure, no international court has ruled that countries must allow abortion on demand. These courts are, however, increasingly mandating that when countries restrict abortion, they allow a number of exceptions, grounding their findings in various human rights treaties. The cases date from 2005, when the U.N. Human Rights Committee ruled that Peru had violated the rights of a 17-year-old girl who was forced to carry to term an anencephalitic fetus, which was missing most of its forebrain and unable to survive outside the womb. The committee, which monitors countries' compliance with the International Covenant on Civil and Political Rights, ordered Peru to pay reparations and to establish a framework for women to access therapeutic abortions.
In 2006, in the settlement of a case before the Inter-American Commission on Human Rights, Mexico agreed to pay a 13-year-old rape victim who'd been prevented from terminating her pregnancy—and was by then a 19-year-old single mother—$40,000, plus a stipend for her son's education. A few months after that, Colombia's Supreme Court struck down that country's total abortion ban on the grounds that it violated both Colombia's Constitution and international law. "Sexual and reproductive rights of women have been finally recognized as human rights," said the court. "As such, they have entered the realm of constitutional law, which is the fundamental ground of all democratic states."
Such reasoning is making its way into legal documents worldwide. Recently, an African Union treaty became the first human rights covenant in the world specifically to include abortion rights. Abortion is highly restricted in most African countries; still, the treaty calls on state parties to "protect the reproductive rights of women by authorizing medical abortion in cases of sexual assault, rape, incest, and where the continued pregnancy endangers the mental and physical health of the mother or the life of the mother or the foetus." When Kenya's vice president spoke out in favor of ratifying the African Union's women's rights treaty, however, an op-ed headline in the Sunday Standard newspaper called the agreement a "Blatant Case of Neo-Colonialism."
More such clashes are on the horizon. A group of Irish women is challenging their country's abortion ban before the European Court of Human Rights. And in a case that's likely to get lots of attention, Nicaragua, which banned all abortion in 2006, may soon find itself before the Inter-American Commission on Human Rights. It was Sandinista leader Daniel Ortega, eager to return to power and hoping to co-opt his former foes in Nicaragua's Catholic Church, who championed the ban. Now, the same American conservatives who once backed the Contras insist that it's unfair for other countries to pressure the Sandinistas to change their ways.
For liberals, the globalization of abortion law presents other contradictions. These cases pit feminism and multiculturalism, both cherished values on the left, against each other. The struggle is over abortion, but it's also over something bigger. When women's rights and cultural freedom collide, who prevails, and who gets to decide?
Michelle Goldberg is an author and journalist based in New York. Her new book, The Means of Reproduction: Sex, Power, and the Future of the World, will be published in April.
Wednesday, January 28, 2009
Why Dybul Was Sacked: New Details Emerge
Jodi Jacobson on January 28, 2009 - 3:52pm
RH Reality Check
A furor has arisen among some right-wing conservatives and some AIDS treatment advocates regarding the departure of Mark Dybul as the US Global AIDS Coordinator. And because the right-wing sees two basic causal factors in every problem (taxes and sex), it has now become the cause celebre to fault reproductive health and prevention advocates for causing Dybul's dismissal.
Dybul not only did not advance, he set back efforts to prevent HIV infection, especially among women and youth---the groups most at risk in the AIDS epidemic---so it would be hard to say we're sad to see him go.
But for those still mourning Mark's empty chair, consider this:
Last week--after the new Administration had made plain that it was putting a halt to development of new regulations and new guidance until it could review both law and policy--Dybul was found on the Hill lobbying for a more restrictive interpretation of the PEPFAR conscience clause than currently exists, with the intention of placating the Catholic Church.
In the first phase of PEPFAR, a conscience clause existed that was in itself onerous enough. This first clause was written by conservatives to allow groups receiving PEPFAR funds to refuse to provide certain kinds of services. So, for example, Catholic Relief Services (CRS) or the United States Conference of Catholic Bishops (USCCB)--which rejects family planning, condoms for HIV prevention, GLBT people and....well many other things in the real world--could receive PEPFAR funding for prevention of sexual transmission but refuse to provide condoms.
The clause was, however, interpreted by saner heads still remaining somewhere in the Bush Administration apparatus to require some sort of referral on the part of these groups.
An example: Let's say that CRS or the Bishops were trying to prevent new infections within HIV-discordant couples (one spouse is positive, the other is not...they are married...we are not even talkin' unmarried people) under the original conscience clause.
Their answer would be: don't have sex. (Seriously...I was at a conference in Abuja, Nigeria where it was suggeted by PEPFAR-funded faith based groups that these couples, rather than using condoms, simply "find other means of expressing marital love than through physical affection....for the rest of their lives.")
Public health professionals within USAID recognized that increasingly it is women whose husbands are not down with this no-sex strategy who are getting infected all across Africa. So guidance was written to require groups "protected" by the conscience clause to offer referrals if they could not provide services. Under this interpretation, a group such as CRS would have to ensure that they were partnered with, or linked to, or could refer to an organization or program that would in fact counsel those discordant couples who desired to actually have sex on how to use condoms correctly and consistently, and actually provide condoms to them.
This "liberal interpretation" of the use of your taxpayer dollars irked the Catholic Church and many like-minded evangelical groups. So they fought for--and with Mark Dybul's help won--an even more restrictive policy in the PEPFAR reauthorization last year, guaranteeing for example that they need not even provide care to those people they did not like.
Now it appears that the groups in question, concerned that the Obama Administration and the Democratic Congress would more flexibly interpret the new and more restrictive conscience clause, went into action, again with Dybul as their personal savior (speaking rhetorically).
Several legislators knowledgable about the clause and its adverse impacts had indicated their willingness to soften it in forthcoming legislative action, with the "insidious" purpose of ensuring that all people have access to the services, information, and tools they need to prevent the next new HIV infection.
The thought of this was again too much for CRS, USCCB, and apparently for Mark Dybul, who in the last few weeks was reportedly working on guidance that would have made the conscience clause even more restrictive than the law (as he has done with the abstinence-until-marriage provision, the prostitution pledge and every other element of PEPFAR criticized by experts across the globe).
To help his friends, not only did Dybul begin drafting more restrictive guidance, underscoring that groups would no longer need to refer to nor partner with other programs to ensure individuals got everything they needed to protect themselves, but he went to Congress several times this month to make a case for this!
Without permission from the White House!
(Was he on the ballot in November? I can't remember. Or is he just answering to a higher power?)
Dybul, who may have gotten a little full of himself up there at OGAC with all that money at his disposal, seems to have been free-lancing in trying to head off efforts in the new Congress to moderate the public health and human rights abuses inherent in a conscience clause that actually denies people at risk evidence-based information.
Secretary Clinton knew exactly what she was doing and why it needed to be done.
Dybul defenders?
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More on Dybul