Latest Drugwonks' Blog
Hybrid Molecule Causes Cancer Cells To Self-destruct
Science Daily — By joining a sugar to a short-chain fatty acid compound, Johns Hopkins researchers have developed a two-pronged molecular weapon that kills cancer cells in lab tests. The researchers cautioned that their double-punch molecule, described in the December issue of the journal Chemistry & Biology, has not yet been tested on animals or humans. Nevertheless, they believe it represents a promising new strategy for fighting the deadly disease.
Could we link a sugar to Pelosi's price control plan for seniors and get the same therapeutic explosion. Heck, I would even support Byron Dorgan in opposing stuffed molasses in from Canada at a lower price for that to happen... apparently the Senator who supports using price controls from Canada on medicines opposes reimportation of stuffed molasses from the same country to get around sugar tariffs imposed on behalf of sugar producers in the US, particularly in Lousiana, home of Senator David Vitter who courageously blocked a vote to confirm Andy von Eschenbach in order to bar customs officials from seizing counterfeit drugs at the Canadian border.
Science Daily — By joining a sugar to a short-chain fatty acid compound, Johns Hopkins researchers have developed a two-pronged molecular weapon that kills cancer cells in lab tests. The researchers cautioned that their double-punch molecule, described in the December issue of the journal Chemistry & Biology, has not yet been tested on animals or humans. Nevertheless, they believe it represents a promising new strategy for fighting the deadly disease.
Could we link a sugar to Pelosi's price control plan for seniors and get the same therapeutic explosion. Heck, I would even support Byron Dorgan in opposing stuffed molasses in from Canada at a lower price for that to happen... apparently the Senator who supports using price controls from Canada on medicines opposes reimportation of stuffed molasses from the same country to get around sugar tariffs imposed on behalf of sugar producers in the US, particularly in Lousiana, home of Senator David Vitter who courageously blocked a vote to confirm Andy von Eschenbach in order to bar customs officials from seizing counterfeit drugs at the Canadian border.
CMPI's Dr. Bob Goldberg, as quoted in today's Wall Streeet Journal Review and Outlook editorial:
The need for scrutiny is even more compelling on price controls for Medicare prescription drugs. Under the Medicare Part D benefit that took effect last year, private companies negotiate prices. Democrats want to allow the government to deal directly with drug companies. They argue that this would lead to lower prices for medicines, but the more likely outcome is fewer drug choices and price controls.
Democrats point to the Department of Veteran Affairs as a model, but we doubt seniors will like that story when they learn about it. The government already negotiates drug prices directly with the VA. But as Robert Goldberg wrote last month in the Weekly Standard, "Far from negotiating prices, the VA imposes them. Federal law requires companies to sell to the VA at 24% below wholesale price. If they won't, they are banned from selling medicines to Medicaid, Medicare and the public health service."
The VA has created a list of approved drugs for its patients. Companies that don't pay the VA price don't make the list, and a slew of drugs fall into that category. They include Azilect and Tysabri, two of the newest therapies for Parkinson's and multiple sclerosis, respectively. That's what happens when keeping prices down takes priority over getting the best available medicines to patients. Both drugs are available through Medicare Part D, by the way. Maybe Congress ought to debate this.
The need for scrutiny is even more compelling on price controls for Medicare prescription drugs. Under the Medicare Part D benefit that took effect last year, private companies negotiate prices. Democrats want to allow the government to deal directly with drug companies. They argue that this would lead to lower prices for medicines, but the more likely outcome is fewer drug choices and price controls.
Democrats point to the Department of Veteran Affairs as a model, but we doubt seniors will like that story when they learn about it. The government already negotiates drug prices directly with the VA. But as Robert Goldberg wrote last month in the Weekly Standard, "Far from negotiating prices, the VA imposes them. Federal law requires companies to sell to the VA at 24% below wholesale price. If they won't, they are banned from selling medicines to Medicaid, Medicare and the public health service."
The VA has created a list of approved drugs for its patients. Companies that don't pay the VA price don't make the list, and a slew of drugs fall into that category. They include Azilect and Tysabri, two of the newest therapies for Parkinson's and multiple sclerosis, respectively. That's what happens when keeping prices down takes priority over getting the best available medicines to patients. Both drugs are available through Medicare Part D, by the way. Maybe Congress ought to debate this.
You know the joke.
The other joke is how Senators can be for unfair trade practices (like "drugs from Canada") one day, and against them (like, for example, "lumber from Canada") the next . The difference? You guessed it -- politics.
Many thanks to the drugwonks reader who sent in the following US Senate "colloquy" between Senators Baucus and Crapo. Here's how you play: Whenever you see the words "Canadian lumber," replace them with "Canadian drugs."
(And if you'd like more Senatorial Inconsistencies, check out Senator Byron "Mr. Importation" Dorgan's statements on Canadian wheat.) Talk about Washington DC log rolling!
CANADIAN SOFTWOOD LUMBER DISPUTE -- (Senate - January 24, 2005)
Mr. CRAIG. Mr. President, I rise today to discuss the latest developments regarding the Canadian softwood lumber dispute. With yet another curious and ultimately inconsequential lumber unfair trade determination due today at the behest of a NAFTA dispute panel, it is important to place this matter in proper perspective.
Would the distinguished Senator from Montana and my colleague from Idaho engage in a colloquy with me concerning the Canadian softwood lumber dispute?
Mr. BAUCUS. I would be pleased to engage in such a colloquy.
Mr. CRAPO. I would also like to join my colleagues in a colloquy on this matter.
Mr. CRAIG. The Commerce Department has found repeatedly that Canadian lumber is subsidized and dumped. World Trade Organization and NAFTA dispute settlement panels have definitively rejected Canada's long-time arguments that its underpricing of timber cannot be deemed a subsidy. The panels have also upheld findings that Canadian lumber is unfairly dumped in the U.S. market. The International Trade Commission has found repeatedly that the unfair imports threaten our industry with harm.
President Bush was well prepared to answer the Canadian Prime Minister when they last met. The President told the Prime Minister that the problem of subsidies and dumping is caused by Canada, and the solution lies with Canada, unless Canada wants the solution to be permanent duties to offset the subsidies and the dumping. In over two decades, Canadian officials have not gotten the message, at least not in a way that takes, that this problem will not be resolved by Canada's investing hundreds of millions of dollars in legal fees on more than 30 Washington law firms to circumvent U.S. laws in countless appeals to the WTO, to NAFTA panels and to the U.S. courts--several more were filed just this month. And it will not be solved by the cottage industry that has grown up in Canada to mount PR campaigns in the United States.
The U.S. timber industry vigorously supports the administration's view that the unfair Canadian lumber problem could most appropriately and productively be resolved through negotiations--although perhaps there just ought to be permanent duties in place. But the U.S. timber industry is taking the statesmanlike high road, and I support it. Some vested interests in Canada do not see this, and prefer endless litigation, probably based on misguided advice that this will be productive from those who have made a living defending Canadian subsidies.
Mr. CRAPO. Specifically, the problem remains that the market is grossly distorted by Canadian unfair trade practices. Absent termination of or an offset to the unfair practices, the U.S. timber industry will be severely impacted by subsidized and dumped Canadian imports. We in the Congress have been assured that those responsible in the administration will not allow this further injury to our industry occur.
A solution can be either border measures imposed by the United States or Canadian border measures agreed to with the United States pending adequate Canadian timber policy reforms.
The Bush administration has concluded that the November 2004 determination of the International Trade Commission that Canadian imports threaten the U.S. industry with injury--the ``Section 129'' determination--represents an independent basis authorizing and necessitating retention of the countervailing and antidumping duty orders. The United States has faith in winning the NAFTA Extraordinary Challenge Committee proceeding on the injury issue, but even a negative outcome before the committee would not be the end of the matter.
The Bush administration has concluded that duty deposits, amounting to approximately $3 billion and growing daily, cannot and will not be returned absent a negotiated settlement between the Canadian and U.S. Governments. The panels can provide prospective but not retroactive relief. In any event, these funds are rightly due under U.S. law to the injured domestic timber industry. If there is a negotiated solution, the funds can be apportioned fairly as part of the settlement.
There is zero likelihood that the countervailing duty, antisubsidy, order will disappear absent settlement of the lumber subsidy and dumping issues, no matter how often a NAFTA panel tries to achieve this outcome.
The U.S. right to challenge Canadian log export restrictions at the WTO is clear under the WTO, and Canada is clearly in violation of its WTO obligations. I understand that the Bush administration is evaluating this issue.
I also understand that the U.S. timber industry intends to bring a constitutional challenge to NAFTA dispute settlement if the lumber dumping issue is not resolved. The future of U.S. sawmills and millworkers cannot be allowed to be ruined by outlandish decisionmaking by NAFTA dispute panels and a panelist's service with an obvious, undisclosed conflict of interest.
Mr. BAUCUS. I agree completely with my colleagues. As suggested, a NAFTA dispute panel is requiring that the Commerce Department issue today yet another revised version of the original 2002 lumber-subsidy determination. Given the panel's pattern of overreaching, it may be a relatively low subsidy estimate. If so, this will be trumpeted in headlines across Canada as a victory for Canada's lumber policies. Before all those editorial writers seize on this supposed ``victory,'' they should understand that this determination will have absolutely no legal effect. It is the Commerce Department's December 2004 findings of a subsidy of over 17 percent and dumping of 4 percent that controls. Hyping the January 24 decision as having any meaning performs a disservice to Canadian interests, which lie in a mutually beneficial negotiated settlement.
Nothing can change the facts. The Canadian provinces provide timber to their lumber companies for a fraction of its value. This harms not only U.S. sawmills, millworkers and family forest landowners, but also the Canadian forest. Environmental groups have long decried the overharvesting of timber caused by undervaluing the resource.
The other joke is how Senators can be for unfair trade practices (like "drugs from Canada") one day, and against them (like, for example, "lumber from Canada") the next . The difference? You guessed it -- politics.
Many thanks to the drugwonks reader who sent in the following US Senate "colloquy" between Senators Baucus and Crapo. Here's how you play: Whenever you see the words "Canadian lumber," replace them with "Canadian drugs."
(And if you'd like more Senatorial Inconsistencies, check out Senator Byron "Mr. Importation" Dorgan's statements on Canadian wheat.) Talk about Washington DC log rolling!
CANADIAN SOFTWOOD LUMBER DISPUTE -- (Senate - January 24, 2005)
Mr. CRAIG. Mr. President, I rise today to discuss the latest developments regarding the Canadian softwood lumber dispute. With yet another curious and ultimately inconsequential lumber unfair trade determination due today at the behest of a NAFTA dispute panel, it is important to place this matter in proper perspective.
Would the distinguished Senator from Montana and my colleague from Idaho engage in a colloquy with me concerning the Canadian softwood lumber dispute?
Mr. BAUCUS. I would be pleased to engage in such a colloquy.
Mr. CRAPO. I would also like to join my colleagues in a colloquy on this matter.
Mr. CRAIG. The Commerce Department has found repeatedly that Canadian lumber is subsidized and dumped. World Trade Organization and NAFTA dispute settlement panels have definitively rejected Canada's long-time arguments that its underpricing of timber cannot be deemed a subsidy. The panels have also upheld findings that Canadian lumber is unfairly dumped in the U.S. market. The International Trade Commission has found repeatedly that the unfair imports threaten our industry with harm.
President Bush was well prepared to answer the Canadian Prime Minister when they last met. The President told the Prime Minister that the problem of subsidies and dumping is caused by Canada, and the solution lies with Canada, unless Canada wants the solution to be permanent duties to offset the subsidies and the dumping. In over two decades, Canadian officials have not gotten the message, at least not in a way that takes, that this problem will not be resolved by Canada's investing hundreds of millions of dollars in legal fees on more than 30 Washington law firms to circumvent U.S. laws in countless appeals to the WTO, to NAFTA panels and to the U.S. courts--several more were filed just this month. And it will not be solved by the cottage industry that has grown up in Canada to mount PR campaigns in the United States.
The U.S. timber industry vigorously supports the administration's view that the unfair Canadian lumber problem could most appropriately and productively be resolved through negotiations--although perhaps there just ought to be permanent duties in place. But the U.S. timber industry is taking the statesmanlike high road, and I support it. Some vested interests in Canada do not see this, and prefer endless litigation, probably based on misguided advice that this will be productive from those who have made a living defending Canadian subsidies.
Mr. CRAPO. Specifically, the problem remains that the market is grossly distorted by Canadian unfair trade practices. Absent termination of or an offset to the unfair practices, the U.S. timber industry will be severely impacted by subsidized and dumped Canadian imports. We in the Congress have been assured that those responsible in the administration will not allow this further injury to our industry occur.
A solution can be either border measures imposed by the United States or Canadian border measures agreed to with the United States pending adequate Canadian timber policy reforms.
The Bush administration has concluded that the November 2004 determination of the International Trade Commission that Canadian imports threaten the U.S. industry with injury--the ``Section 129'' determination--represents an independent basis authorizing and necessitating retention of the countervailing and antidumping duty orders. The United States has faith in winning the NAFTA Extraordinary Challenge Committee proceeding on the injury issue, but even a negative outcome before the committee would not be the end of the matter.
The Bush administration has concluded that duty deposits, amounting to approximately $3 billion and growing daily, cannot and will not be returned absent a negotiated settlement between the Canadian and U.S. Governments. The panels can provide prospective but not retroactive relief. In any event, these funds are rightly due under U.S. law to the injured domestic timber industry. If there is a negotiated solution, the funds can be apportioned fairly as part of the settlement.
There is zero likelihood that the countervailing duty, antisubsidy, order will disappear absent settlement of the lumber subsidy and dumping issues, no matter how often a NAFTA panel tries to achieve this outcome.
The U.S. right to challenge Canadian log export restrictions at the WTO is clear under the WTO, and Canada is clearly in violation of its WTO obligations. I understand that the Bush administration is evaluating this issue.
I also understand that the U.S. timber industry intends to bring a constitutional challenge to NAFTA dispute settlement if the lumber dumping issue is not resolved. The future of U.S. sawmills and millworkers cannot be allowed to be ruined by outlandish decisionmaking by NAFTA dispute panels and a panelist's service with an obvious, undisclosed conflict of interest.
Mr. BAUCUS. I agree completely with my colleagues. As suggested, a NAFTA dispute panel is requiring that the Commerce Department issue today yet another revised version of the original 2002 lumber-subsidy determination. Given the panel's pattern of overreaching, it may be a relatively low subsidy estimate. If so, this will be trumpeted in headlines across Canada as a victory for Canada's lumber policies. Before all those editorial writers seize on this supposed ``victory,'' they should understand that this determination will have absolutely no legal effect. It is the Commerce Department's December 2004 findings of a subsidy of over 17 percent and dumping of 4 percent that controls. Hyping the January 24 decision as having any meaning performs a disservice to Canadian interests, which lie in a mutually beneficial negotiated settlement.
Nothing can change the facts. The Canadian provinces provide timber to their lumber companies for a fraction of its value. This harms not only U.S. sawmills, millworkers and family forest landowners, but also the Canadian forest. Environmental groups have long decried the overharvesting of timber caused by undervaluing the resource.
I am so tired of people claiming we pay for drugs twice. A quick look at the grants given out by NIH to investigators in academic researchers demonstrates that the money is given to pre-clinical activities. The track record of academics moving something into clinic is quite poor for a variety of reasons that have much to do with with quality of the translational research. That's where venture capital, biotech, and pharma comes in. And indeed without such investment -- which comes earlier than ever before in the discovery process -- taxpayer support for NIH would not be worth the effort. It's the private investment -- which by the way is now increasingly translational in nature and now involves the development of new drug development tools -- that enhances the NIH investment. Without the private sector we would not have any drugs to pay for at all.
Indeed, without contracts and contracting out in key areas such as genomics, proteomics, high throughput screening, biomarker development, the NIH would not be relevant. It needs and has relied upon constant collaboration with the private sector at all levels. In fact, efforts to bar NIH scientists from consulting and working with private companies has lead to a massive exodus of key researchers to for profit companies where there is more freedom and resources.
The point is, making medicine more altruistic will only make the NIH less vibrant and reduce the number of new drugs.
I wish people would grow up. Things worth having are worth paying for.
Indeed, without contracts and contracting out in key areas such as genomics, proteomics, high throughput screening, biomarker development, the NIH would not be relevant. It needs and has relied upon constant collaboration with the private sector at all levels. In fact, efforts to bar NIH scientists from consulting and working with private companies has lead to a massive exodus of key researchers to for profit companies where there is more freedom and resources.
The point is, making medicine more altruistic will only make the NIH less vibrant and reduce the number of new drugs.
I wish people would grow up. Things worth having are worth paying for.
Per my most recent post (“Reference Pricing without the Referenceâ€), a couple of readers have commented that Americans are “paying for drugs twice†– meaning that we pay taxes that go towards medical research and then pay for the drugs we purchase on top of that. Well, not so fast. Please note that only about 3 percent of drugs brought to market have significant involvement by government researchers.
U.S. Representative (“Mr. Televisionâ€) Rahm Emanuel (D-IL) has announced that he will offer legislation aimed at “driving down the price of prescription drugs.†The only thing such legislation would accomplish would be the “driving down†of pharmaceutical innovation.
The NewSpeak-named “Pharmaceutical Market Access and Drug Safety Act, will be cosponsored in the House of Representatives by U.S. Representative Jo Ann Emerson (R-MO) and in the United States Senate by Senators Byron Dorgan (D-ND) and Olympia Snowe (R-ME). What else do these legislators have in common? That’s right – they’ve all been calling for the legalization of drug importation. And since the American public has accepted (albeit reluctantly) the many hard facts that explain why importation is neither safe nor effective, these fine members of the United States Congress have moved on to another simplistic and unworkable scheme.
According to Emanuel, et al., this legislation will “allow American consumers, pharmacists and wholesalers access to Food and Drug Administration (FDA)-approved prescription drugs at world market prices.â€
Mr. Emanuel and crew may come from different states, but they are all firmly in residence on Fantasy Island if they think, with the stroke of a pen, “world prices†can become “American prices.†Are there world prices for hotel rooms or airplane tickets? What about Big Macs or automobiles? Of course not. In fact, there isn’t a world price for anything – except perhaps a barrel of oil. And we all know how well that’s working out.
Perhaps what Mr. Emanuel’s Frustrated Four mean is that the US should mandate what is known as “reference pricing,†a system that compares the prices of drugs among a number of developed nations and then chooses an “average†or “reference†price. This is what’s done in the European Union and Canada for example.
That sounds fair, right? Well, not really when you consider that the reason these nations can get away with reference pricing is because they threaten pharmaceutical companies with patent expropriation is they don’t knuckle under to these dictated terms. So while these nations all say that prices are “negotiated†with pharmaceutical firms, that’s just not so. It’s not even a take-it-or-leave it proposition. It’s a take-it-or we’ll-take-it-from-you shake down.
So couldn’t we do that too? If the Europeans and Canadians can dictate prices why shouldn’t we do the same? The answer is that we cannot and should not and here’s why – the prices Americans pay for medicines fuel global research and development. Those nations with reference pricing schemes are getting if not a free ride, then a highly subsidized one on the backs of the American health care consumer. That’s not fair, and it’s not just, and it’s not sustainable – but it’s a fact. And they don’t even say “thank you.â€
So what would happen if we Rahm through “world pricing?†21st century pharmaceutical research and redevelopment would grind to a halt for lack of dollars to fund it. Just last month the Government Accountability Office reported that annual research and development spending by the pharmaceutical industry increased 147 percent, to $60 billion, between 1993 and 2004. At the same time, the number of new drug applications to the Food and Drug Administration grew by only 38 percent and about two-thirds of the new applications were for drugs that represent modifications to existing medicines, while 32 percent were for potentially innovative new drugs.
What Mr. Emanuel and friends don’t seem to understand is that 21st drug development is ever more complex and complicated as we move from small to large molecules and begin to aggressively research practical and personalized applications of the human genome. Here’s a fact that you won’t find out from The New Man from Illinois – over the last 50 years the average American lifespan has increased by 10 years – a full decade, due largely to the impact of pharmaceutical research and development.
Are you willing to trade tomorrow’s new cures and treatments for “world prices†today?
Because that’s precisely what will happen if we allow “world prices†for prescription medicines to be Rahmed down our throats.
The NewSpeak-named “Pharmaceutical Market Access and Drug Safety Act, will be cosponsored in the House of Representatives by U.S. Representative Jo Ann Emerson (R-MO) and in the United States Senate by Senators Byron Dorgan (D-ND) and Olympia Snowe (R-ME). What else do these legislators have in common? That’s right – they’ve all been calling for the legalization of drug importation. And since the American public has accepted (albeit reluctantly) the many hard facts that explain why importation is neither safe nor effective, these fine members of the United States Congress have moved on to another simplistic and unworkable scheme.
According to Emanuel, et al., this legislation will “allow American consumers, pharmacists and wholesalers access to Food and Drug Administration (FDA)-approved prescription drugs at world market prices.â€
Mr. Emanuel and crew may come from different states, but they are all firmly in residence on Fantasy Island if they think, with the stroke of a pen, “world prices†can become “American prices.†Are there world prices for hotel rooms or airplane tickets? What about Big Macs or automobiles? Of course not. In fact, there isn’t a world price for anything – except perhaps a barrel of oil. And we all know how well that’s working out.
Perhaps what Mr. Emanuel’s Frustrated Four mean is that the US should mandate what is known as “reference pricing,†a system that compares the prices of drugs among a number of developed nations and then chooses an “average†or “reference†price. This is what’s done in the European Union and Canada for example.
That sounds fair, right? Well, not really when you consider that the reason these nations can get away with reference pricing is because they threaten pharmaceutical companies with patent expropriation is they don’t knuckle under to these dictated terms. So while these nations all say that prices are “negotiated†with pharmaceutical firms, that’s just not so. It’s not even a take-it-or-leave it proposition. It’s a take-it-or we’ll-take-it-from-you shake down.
So couldn’t we do that too? If the Europeans and Canadians can dictate prices why shouldn’t we do the same? The answer is that we cannot and should not and here’s why – the prices Americans pay for medicines fuel global research and development. Those nations with reference pricing schemes are getting if not a free ride, then a highly subsidized one on the backs of the American health care consumer. That’s not fair, and it’s not just, and it’s not sustainable – but it’s a fact. And they don’t even say “thank you.â€
So what would happen if we Rahm through “world pricing?†21st century pharmaceutical research and redevelopment would grind to a halt for lack of dollars to fund it. Just last month the Government Accountability Office reported that annual research and development spending by the pharmaceutical industry increased 147 percent, to $60 billion, between 1993 and 2004. At the same time, the number of new drug applications to the Food and Drug Administration grew by only 38 percent and about two-thirds of the new applications were for drugs that represent modifications to existing medicines, while 32 percent were for potentially innovative new drugs.
What Mr. Emanuel and friends don’t seem to understand is that 21st drug development is ever more complex and complicated as we move from small to large molecules and begin to aggressively research practical and personalized applications of the human genome. Here’s a fact that you won’t find out from The New Man from Illinois – over the last 50 years the average American lifespan has increased by 10 years – a full decade, due largely to the impact of pharmaceutical research and development.
Are you willing to trade tomorrow’s new cures and treatments for “world prices†today?
Because that’s precisely what will happen if we allow “world prices†for prescription medicines to be Rahmed down our throats.
An article in the journal of the National Cancer Institute will send chills down the spines of those who want to simply measure the value of new cancer medicines in terms of survival (as we search for better ways to target drugs to the right patients):
Here's Lauren Neergard's article from the AP
http://news.yahoo.com/s/ap/20070103/ap_on_he_me/cancer_time_lost
"The hours spent sitting in doctors' waiting rooms, in line for the CT scan, watching chemotherapy drip into veins: Battling cancer steals a lot of time — at least $2.3 billion worth for patients in the first year of treatment alone.
So says the first study to try to put a price tag to the time that people spend being treated for 11 of the most common cancers.
Even more sobering than the economic toll are the tallies, by government researchers, of the sheer hours lost to cancer care: 368 hours in that first year after diagnosis with ovarian cancer; 272 hours being treated for lung cancer, 193 hours for kidney cancer.
That doesn't count the days spent home in bed recovering from surgery or weak from chemo, just time spent actively getting care — chemo or radiation therapy, blood tests or cancer scans, surgery or checkups, driving to medical appointments and waiting your turn."
Too bad the study didn't calculate the value of time wasted listening to people explain why we can't afford new cancer drugs that aren't cost effective.
Here's a link to the article by Larry Kessler of the FDA and Scott Ramsey of the Fred Hutchinson Center
http://jnci.oxfordjournals.org/cgi/reprint/99/1/2
Here's Lauren Neergard's article from the AP
http://news.yahoo.com/s/ap/20070103/ap_on_he_me/cancer_time_lost
"The hours spent sitting in doctors' waiting rooms, in line for the CT scan, watching chemotherapy drip into veins: Battling cancer steals a lot of time — at least $2.3 billion worth for patients in the first year of treatment alone.
So says the first study to try to put a price tag to the time that people spend being treated for 11 of the most common cancers.
Even more sobering than the economic toll are the tallies, by government researchers, of the sheer hours lost to cancer care: 368 hours in that first year after diagnosis with ovarian cancer; 272 hours being treated for lung cancer, 193 hours for kidney cancer.
That doesn't count the days spent home in bed recovering from surgery or weak from chemo, just time spent actively getting care — chemo or radiation therapy, blood tests or cancer scans, surgery or checkups, driving to medical appointments and waiting your turn."
Too bad the study didn't calculate the value of time wasted listening to people explain why we can't afford new cancer drugs that aren't cost effective.
Here's a link to the article by Larry Kessler of the FDA and Scott Ramsey of the Fred Hutchinson Center
http://jnci.oxfordjournals.org/cgi/reprint/99/1/2
I saw the article in the Guardian about "ethical pharmaceuticals" later than did Peter. This is the same Guardian that finds Israeli responses to terrorist attacks as "disproportionate" while running articles that portray Hamas as becoming more warm and cuddly.
The pegylation process that Professor Sunil Shaunak from the Hammersmith campus of Imperial College London and Professor Steve Brocchini from the London School of Pharmacy have developed is novel but not new. PEGylation is the process of attaching a large sugar molecule to a protein so it is harder to breakdown. In essence, a little less medicine goes a longer way. You save money - in theory -- by using a PEGylated product.
What the two have done -- through their own brand new private company -- is develop a new way to attach the PEG to the protein.
This is great for monoclonal antibodies but not much else. In any event, the firm is now partnering with an Indian company whose product has been approved in India but nowhere else to make a more cost-effective product.
Will it be more cost-effective or cheaper compared to other interferons? It might be. Their products might be considered follow products or bio-generics in Europe depending upon the formulation.
But let's be clear. This is not the Holy Grail for drug discovery and development the Guardian makes it out to be. Polytherics is not validating targets, testing validated target and trying to come up with a molecule that might inhibitor a pathway or shut down replication of a protein and then seeing if it works at a specific dose. They are adding -- in a new way -- a sugar to proteins to make them more bioavailable. This is interesting but not revolutionary.
All this noise about conducting clinical trials in India to save money is garbage. Everyone is doing that. It's the cost of investing in one failure after another or finding a way to reduce that cost or the number of failures...now that would be a real contribution. Now as for being holier than thou these ethical scientists apparently have no problem hiring the same lawyers who represent the monpolistic drug companies they hate to protec their own IP. Haven't they heard about shareware?
Meanwhile, Polytherics have no guarantee that producing companies won't just mark up the price of these drugs -- if they ever pass legal muster -- and continue to give the shaft to the poor in developing lands. That is, all they are doing is giving generic firms another way to exploit the poor and make profits without really adding much to innovation. There is no guarantee that this product will work as promised either.
Perhaps it was best said, as a Financial Times article today notes, by Jean-François Dehecq, the chairman of Sanofi-Aventis of France.
Dehecq said he was "scandalised" by generic groups producing low-cost medicines in poor countries to sell to patients in rich nations.
Not as scandalised as he will be by Polytheric partnering with said generic firms to develop another way to screw the poor and use them as human lab rats purely for profit.
Maybe Jamie Loves wants to give these guys part of his Genius Award or create a new category:
Best New Way To Use the Poor As An Excuse To Attack Big Bad Pharma And Exploit Them in the Process.
The pegylation process that Professor Sunil Shaunak from the Hammersmith campus of Imperial College London and Professor Steve Brocchini from the London School of Pharmacy have developed is novel but not new. PEGylation is the process of attaching a large sugar molecule to a protein so it is harder to breakdown. In essence, a little less medicine goes a longer way. You save money - in theory -- by using a PEGylated product.
What the two have done -- through their own brand new private company -- is develop a new way to attach the PEG to the protein.
This is great for monoclonal antibodies but not much else. In any event, the firm is now partnering with an Indian company whose product has been approved in India but nowhere else to make a more cost-effective product.
Will it be more cost-effective or cheaper compared to other interferons? It might be. Their products might be considered follow products or bio-generics in Europe depending upon the formulation.
But let's be clear. This is not the Holy Grail for drug discovery and development the Guardian makes it out to be. Polytherics is not validating targets, testing validated target and trying to come up with a molecule that might inhibitor a pathway or shut down replication of a protein and then seeing if it works at a specific dose. They are adding -- in a new way -- a sugar to proteins to make them more bioavailable. This is interesting but not revolutionary.
All this noise about conducting clinical trials in India to save money is garbage. Everyone is doing that. It's the cost of investing in one failure after another or finding a way to reduce that cost or the number of failures...now that would be a real contribution. Now as for being holier than thou these ethical scientists apparently have no problem hiring the same lawyers who represent the monpolistic drug companies they hate to protec their own IP. Haven't they heard about shareware?
Meanwhile, Polytherics have no guarantee that producing companies won't just mark up the price of these drugs -- if they ever pass legal muster -- and continue to give the shaft to the poor in developing lands. That is, all they are doing is giving generic firms another way to exploit the poor and make profits without really adding much to innovation. There is no guarantee that this product will work as promised either.
Perhaps it was best said, as a Financial Times article today notes, by Jean-François Dehecq, the chairman of Sanofi-Aventis of France.
Dehecq said he was "scandalised" by generic groups producing low-cost medicines in poor countries to sell to patients in rich nations.
Not as scandalised as he will be by Polytheric partnering with said generic firms to develop another way to screw the poor and use them as human lab rats purely for profit.
Maybe Jamie Loves wants to give these guys part of his Genius Award or create a new category:
Best New Way To Use the Poor As An Excuse To Attack Big Bad Pharma And Exploit Them in the Process.
Excellent "special report" on counterfeit prescription medicines in the December 18, 2006 edition of BusinessWeek.
Here's the link:
http://www.businessweek.com/magazine/content/06_51/b4014064.htm
Two snippets to whet your appetite for more ...
First, as to the scope of the problem:
* Based on a study of 185 sites, Columbia University's National Center on Addiction & Substance Abuse reports that only 11% of Internet pharmacies require customers to provide a prescription. All the rest, an astounding 89%, appear to operate illegally. Conservative estimates of the number of dubious sites reach into the tens of thousands, according to Internet Crimes Group Inc., a corporate consulting firm.
And second, to those politicians and pundits who claim that counterfeiting is nothing but a Big Pharma "scare tactic," a cautionary tale:
* Craig Schmidt fell victim to questionable Internet medicine in April, 2004. The Chicago plastics salesman, then 30, was feeling the stress and back pain of long workweeks often spent on the road. Checking his e-mail one day, he noticed ads for Xanax and the painkiller Ultram. He placed $400 in orders without ever speaking to a doctor. When the pills arrived, he took one tablet of each drug and headed for an errand at the hardware store. The next thing he remembers is waking up three weeks later in the hospital. It turned out that each Xanax tablet contained 2 mg of the drug, or quadruple the usual starting dosage. The combination apparently caused him to black out and wreck his car. He had a heart attack, fell into a coma, and suffered brain damage. After an extraordinary recovery, he still takes medication to prevent severe leg spasms. "Don't do what I did," he says. "It's like playing Russian roulette."
BusinessWeek also ordered some "product" from selected websites. The Xanax the investigative team ordered had zero active ingredient, as did the Lipitor it purchased.
Well say it again -- counterfeiting of prescription medicines is nothing short of international prescription drug terrorism.
Here's the link:
http://www.businessweek.com/magazine/content/06_51/b4014064.htm
Two snippets to whet your appetite for more ...
First, as to the scope of the problem:
* Based on a study of 185 sites, Columbia University's National Center on Addiction & Substance Abuse reports that only 11% of Internet pharmacies require customers to provide a prescription. All the rest, an astounding 89%, appear to operate illegally. Conservative estimates of the number of dubious sites reach into the tens of thousands, according to Internet Crimes Group Inc., a corporate consulting firm.
And second, to those politicians and pundits who claim that counterfeiting is nothing but a Big Pharma "scare tactic," a cautionary tale:
* Craig Schmidt fell victim to questionable Internet medicine in April, 2004. The Chicago plastics salesman, then 30, was feeling the stress and back pain of long workweeks often spent on the road. Checking his e-mail one day, he noticed ads for Xanax and the painkiller Ultram. He placed $400 in orders without ever speaking to a doctor. When the pills arrived, he took one tablet of each drug and headed for an errand at the hardware store. The next thing he remembers is waking up three weeks later in the hospital. It turned out that each Xanax tablet contained 2 mg of the drug, or quadruple the usual starting dosage. The combination apparently caused him to black out and wreck his car. He had a heart attack, fell into a coma, and suffered brain damage. After an extraordinary recovery, he still takes medication to prevent severe leg spasms. "Don't do what I did," he says. "It's like playing Russian roulette."
BusinessWeek also ordered some "product" from selected websites. The Xanax the investigative team ordered had zero active ingredient, as did the Lipitor it purchased.
Well say it again -- counterfeiting of prescription medicines is nothing short of international prescription drug terrorism.
How about this for a solution to drug prices -- let's trash intellectual property rights. (Now why haven't I thought of that before? I know -- because it's a very bad idea for about 1000 reasons with Reason #1 being that it would end pharmaceutical innovation and Reason #2 being it would seriously -- very seriously -- impact quality control. Reasons #3 - 1000, as Rabbi Hillel might have said, are just commentary.
Not surprisingly, this article (from today's Manchester Guardian) came my way via a bizzarro Jamie Love listserve. At the end of the day, you can call it anything you want, but what it boils down is cost-centric versus patient-centric medicine. "Ethical pharmaceuticals" indeed!
Scientists find way to slash cost of drugs
Indian-backed approach could aid poor nations and cut NHS bills
Two UK-based academics have devised a way to invent new medicines and get them to market at a fraction of the cost charged by big drug companies, enabling millions in poor countries to be cured of infectious diseases and potentially slashing the NHS drugs bill. Sunil Shaunak, professor of infectious diseases at Imperial College, based at Hammersmith hospital, calls their revolutionary new model "ethical pharmaceuticals".
Improvements they devise to the molecular structure of an existing, expensive drug turn it technically into a new medicine which is no longer under a 20-year patent to a multinational drug company and can be made and sold cheaply.
The process has the potential to undermine the monopoly of the big drug companies and bring cheaper drugs not only to poor countries but back to the UK.
Professor Shaunak and his colleague from the London School of Pharmacy, Steve Brocchini, have linked up with an Indian biotech company which will manufacture the first drug - for hepatitis C - if clinical trials in India, sponsored by the Indian government, are successful. Hepatitis C affects 170 million people worldwide and at least 200,000 in the UK.
Multinational drug companies put the cost of the research and development of a new drug at $800m (£408m). Professors Shaunak and Brocchini say the cost of theirs will be only a few million pounds.
Imperial College will hold the patent on the hepatitis C drug to prevent anybody attempting to block its development. The college employs top patent lawyers who also work for some of the big pharmaceutical companies.
Once the drugs have passed through clinical trials and have been licensed in India, the same data could be used to obtain a European licence so that they could be sold to the NHS as well.
Professor Shaunak says it is time that the monopoly on drug invention and production by multinational corporations - which charge high prices because they need to make big profits for their shareholders - was broken.
"The pharmaceutical industry has convinced us that we have to spend billions of pounds to invent each drug," he said. "We have spent a few millions. Yes, it will be a threat to the monopoly that there is.
"I'm not only an inventor of medicines - I'm an end user. We have become so completely dependent on the big pharmaceutical industry to provide all the medicines we use.
"Why should we be completely dependent on them when we do all the creative stuff in the universities? Maybe the time has come to say why can't somebody else do it? What we have been struck by is that once we have started to do it, it is not so difficult."
The team's work on the hepatitis C drug has impeccable establishment credentials, supported by a grant from the Wellcome Trust and help and advice from the Department for Trade and Industry and the Foreign and Commonwealth Office.
But the professors' ethical pharmaceutical model is unlikely to find much favour with the multinational pharmaceutical companies, which already employ large teams of lawyers to defend the patents which they describe as the lifeblood of the industry.
One industry insider envisaged legal challenges if the new drugs were not genuinely innovative. It could become "a huge intellectual property issue", he said.
Guardian Unlimited © Guardian News and Media Limited 2007
Not surprisingly, this article (from today's Manchester Guardian) came my way via a bizzarro Jamie Love listserve. At the end of the day, you can call it anything you want, but what it boils down is cost-centric versus patient-centric medicine. "Ethical pharmaceuticals" indeed!
Scientists find way to slash cost of drugs
Indian-backed approach could aid poor nations and cut NHS bills
Two UK-based academics have devised a way to invent new medicines and get them to market at a fraction of the cost charged by big drug companies, enabling millions in poor countries to be cured of infectious diseases and potentially slashing the NHS drugs bill. Sunil Shaunak, professor of infectious diseases at Imperial College, based at Hammersmith hospital, calls their revolutionary new model "ethical pharmaceuticals".
Improvements they devise to the molecular structure of an existing, expensive drug turn it technically into a new medicine which is no longer under a 20-year patent to a multinational drug company and can be made and sold cheaply.
The process has the potential to undermine the monopoly of the big drug companies and bring cheaper drugs not only to poor countries but back to the UK.
Professor Shaunak and his colleague from the London School of Pharmacy, Steve Brocchini, have linked up with an Indian biotech company which will manufacture the first drug - for hepatitis C - if clinical trials in India, sponsored by the Indian government, are successful. Hepatitis C affects 170 million people worldwide and at least 200,000 in the UK.
Multinational drug companies put the cost of the research and development of a new drug at $800m (£408m). Professors Shaunak and Brocchini say the cost of theirs will be only a few million pounds.
Imperial College will hold the patent on the hepatitis C drug to prevent anybody attempting to block its development. The college employs top patent lawyers who also work for some of the big pharmaceutical companies.
Once the drugs have passed through clinical trials and have been licensed in India, the same data could be used to obtain a European licence so that they could be sold to the NHS as well.
Professor Shaunak says it is time that the monopoly on drug invention and production by multinational corporations - which charge high prices because they need to make big profits for their shareholders - was broken.
"The pharmaceutical industry has convinced us that we have to spend billions of pounds to invent each drug," he said. "We have spent a few millions. Yes, it will be a threat to the monopoly that there is.
"I'm not only an inventor of medicines - I'm an end user. We have become so completely dependent on the big pharmaceutical industry to provide all the medicines we use.
"Why should we be completely dependent on them when we do all the creative stuff in the universities? Maybe the time has come to say why can't somebody else do it? What we have been struck by is that once we have started to do it, it is not so difficult."
The team's work on the hepatitis C drug has impeccable establishment credentials, supported by a grant from the Wellcome Trust and help and advice from the Department for Trade and Industry and the Foreign and Commonwealth Office.
But the professors' ethical pharmaceutical model is unlikely to find much favour with the multinational pharmaceutical companies, which already employ large teams of lawyers to defend the patents which they describe as the lifeblood of the industry.
One industry insider envisaged legal challenges if the new drugs were not genuinely innovative. It could become "a huge intellectual property issue", he said.
Guardian Unlimited © Guardian News and Media Limited 2007
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
