Latest Drugwonks' Blog
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
Meat and milk from cloned animals! Calls for absurd, unscientific labeling!
Just another day at the FDA.
According to the FDA, “the meat and milk from cattle clones and their offspring are as safe as that from conventionally bred animals." In other words – GRAS.
Does this mean cloned beef in your burger? No. At tens of thousands of dollars per “founder†clone this is hardly likely (at least in the foreseeable future). So, unless you’re in the market for a $25,000 Big Mac, relax.
You want fries with that?
In the future, if and when the technology for animal cloning becomes more cost-efficient, it is possible that the meat of clone progeny could be available at retail. And milk from clones is certainly on the way a lot sooner.
By promulgating this new rule, FDA is working to advance the science of cloning -- an important advance towards creating a better, safer 21st century food supply.
"Cloning allows the possibility of identifying the healthiest and the superior sires or boars that are going to be used for breeding purposes," said Barb Glenn of the Biotechnology Industry Organization.
Dairy producers are worried about what might happen if "clone-free" products start showing up in supermarkets. "We have concerns where people are going to try to draw distinctions and differences where none exist," said Chris Galen, spokesman for the National Milk Producers Federation.
Perhaps this cause will be taken up by a new consumer advocacy organization – MOOveOn.org.
(Sorry about that.)
Just another day at the FDA.
According to the FDA, “the meat and milk from cattle clones and their offspring are as safe as that from conventionally bred animals." In other words – GRAS.
Does this mean cloned beef in your burger? No. At tens of thousands of dollars per “founder†clone this is hardly likely (at least in the foreseeable future). So, unless you’re in the market for a $25,000 Big Mac, relax.
You want fries with that?
In the future, if and when the technology for animal cloning becomes more cost-efficient, it is possible that the meat of clone progeny could be available at retail. And milk from clones is certainly on the way a lot sooner.
By promulgating this new rule, FDA is working to advance the science of cloning -- an important advance towards creating a better, safer 21st century food supply.
"Cloning allows the possibility of identifying the healthiest and the superior sires or boars that are going to be used for breeding purposes," said Barb Glenn of the Biotechnology Industry Organization.
Dairy producers are worried about what might happen if "clone-free" products start showing up in supermarkets. "We have concerns where people are going to try to draw distinctions and differences where none exist," said Chris Galen, spokesman for the National Milk Producers Federation.
Perhaps this cause will be taken up by a new consumer advocacy organization – MOOveOn.org.
(Sorry about that.)
Eureka! It works.
Attention Speaker Pelosi ...
ASSOCIATED PRESS
WASHINGTON – At first, Ruth Goundry wasn't sure about participating in the new Medicare drug benefit. It was too confusing, she said. But in the end, she gave it a try. She's glad she did.
As the program's first year draws to a close, Goundry estimates that she saved about $150 a month on her five medicines, compared with what she was spending before Medicare Part D began. “I would say I'm very impressed with the whole thing. I have no complaints,†said Goundry, a resident of Chesapeake Beach, Md. “It's meant a tremendous savings. I know other people who are saved by it. I mean that. They don't hardly pay anything.â€
Goundry is like millions of seniors who say they are happy with the benefit, which cost the federal government about $30 billion in 2006. But the program affects seniors and the disabled differently, depending upon their income and health. There are many people who believe the program could be improved.
Just down the street, at the Chesapeake Care Pharmacy, Wesley Copeland is not so impressed. In August, he began picking up all the cost of his medicine – about $300 a month. Plus, he had to continue paying his monthly premium of $38. That gap in coverage is called the doughnut hole. “We've got a lot of people in my neighborhood who are seniors like me on retirement. We have to stretch pennies, so when it gets to that doughnut hole, we have to scramble like hell to keep going,†Copeland said.
Goundry and Copeland represent the millions of stories surrounding the addition of a drug benefit to Medicare this past year. The drug coverage has often been described as the biggest change in Medicare in the program' 40 years. Under the program, seniors and the disabled enroll in a private plan. They pay a monthly premium to the plan. The government also pays the plan.
The Bush administration estimates that the coverage saves the average beneficiary about $1,200. But many in Washington, particularly Democratic lawmakers, say the savings could be greater if the government were allowed to negotiate with drug manufacturers concerning the cost of medicine rather than leaving that chore to the plans.
Overall, about 22.5 million people enrolled in private plans during the programs first year. Nearly 7 million more people get their medicine through their employer, and those employers get a tax credit for providing that coverage. That total of nearly 30 million getting coverage through Part D is much less than was originally projected. However, analysts also didn't realize that so many seniors had insurance coverage for their medicine through other programs.
The Bush administration acknowledges the program got off to a rough start as hundreds of thousands of people showed up in pharmacy computers as not being enrolled in a plan. Beverly Dillon, a pharmacy technician in Chesapeake Beach, said that in the program's early weeks, her store advanced about 75 to 100 patients medicine to help them get by. “We would not let patients go without their medication,†she said.
The state of Maryland also stepped in to pick up the cost of medicine for poor beneficiaries, she noted. Most other states did as well. “January and February were absolutely crazy,†she said. “I would say that around March, or late February, things started to calm down.†She said many seniors are still confused about the program. To prove her point, a customer came into the store to get a refill. Dillon noted that she was in a Part D plan, but the customer was insistent that she was not and that she had coverage through another program. Dillon relented, not wanting to upset her.
Dillon said most customers who did not have insurance coverage prior to the past year are saving money. She has noticed that the checks they write to the pharmacy now are much smaller. “There's definitely a significant savings,†she said. “(But) the program just got off to such a bad start in the beginning, it just has not been smooth.â€
Dillon is bracing for some rough spots in the coming weeks too. That's because some seniors are switching plans. Others have been automatically enrolled in new plans. Herb Kuhn, deputy administrator at the Centers for Medicare and Medicaid Services, said that he believes the federal government learned many lessons from the past year that will make this year's startup run more smoothly. “We have a much more sophisticated and built up infrastructure from a year ago,†Kuhn said.
Kuhn said his biggest concern going into the new year are those beneficiaries who waited until the final days of the open-enrollment period to change drug plans. He said seniors should bring to the pharmacy any kind of identification or acknowledgment letter from their plan that would show proof of membership.
Overall, Kuhn said that 2006 was a good year for beneficiaries. “We believe it's been a very positive year for Part D,†he said. “As a result of the new program, beneficiaries are living better. They're saving money.â€
Attention Speaker Pelosi ...
ASSOCIATED PRESS
WASHINGTON – At first, Ruth Goundry wasn't sure about participating in the new Medicare drug benefit. It was too confusing, she said. But in the end, she gave it a try. She's glad she did.
As the program's first year draws to a close, Goundry estimates that she saved about $150 a month on her five medicines, compared with what she was spending before Medicare Part D began. “I would say I'm very impressed with the whole thing. I have no complaints,†said Goundry, a resident of Chesapeake Beach, Md. “It's meant a tremendous savings. I know other people who are saved by it. I mean that. They don't hardly pay anything.â€
Goundry is like millions of seniors who say they are happy with the benefit, which cost the federal government about $30 billion in 2006. But the program affects seniors and the disabled differently, depending upon their income and health. There are many people who believe the program could be improved.
Just down the street, at the Chesapeake Care Pharmacy, Wesley Copeland is not so impressed. In August, he began picking up all the cost of his medicine – about $300 a month. Plus, he had to continue paying his monthly premium of $38. That gap in coverage is called the doughnut hole. “We've got a lot of people in my neighborhood who are seniors like me on retirement. We have to stretch pennies, so when it gets to that doughnut hole, we have to scramble like hell to keep going,†Copeland said.
Goundry and Copeland represent the millions of stories surrounding the addition of a drug benefit to Medicare this past year. The drug coverage has often been described as the biggest change in Medicare in the program' 40 years. Under the program, seniors and the disabled enroll in a private plan. They pay a monthly premium to the plan. The government also pays the plan.
The Bush administration estimates that the coverage saves the average beneficiary about $1,200. But many in Washington, particularly Democratic lawmakers, say the savings could be greater if the government were allowed to negotiate with drug manufacturers concerning the cost of medicine rather than leaving that chore to the plans.
Overall, about 22.5 million people enrolled in private plans during the programs first year. Nearly 7 million more people get their medicine through their employer, and those employers get a tax credit for providing that coverage. That total of nearly 30 million getting coverage through Part D is much less than was originally projected. However, analysts also didn't realize that so many seniors had insurance coverage for their medicine through other programs.
The Bush administration acknowledges the program got off to a rough start as hundreds of thousands of people showed up in pharmacy computers as not being enrolled in a plan. Beverly Dillon, a pharmacy technician in Chesapeake Beach, said that in the program's early weeks, her store advanced about 75 to 100 patients medicine to help them get by. “We would not let patients go without their medication,†she said.
The state of Maryland also stepped in to pick up the cost of medicine for poor beneficiaries, she noted. Most other states did as well. “January and February were absolutely crazy,†she said. “I would say that around March, or late February, things started to calm down.†She said many seniors are still confused about the program. To prove her point, a customer came into the store to get a refill. Dillon noted that she was in a Part D plan, but the customer was insistent that she was not and that she had coverage through another program. Dillon relented, not wanting to upset her.
Dillon said most customers who did not have insurance coverage prior to the past year are saving money. She has noticed that the checks they write to the pharmacy now are much smaller. “There's definitely a significant savings,†she said. “(But) the program just got off to such a bad start in the beginning, it just has not been smooth.â€
Dillon is bracing for some rough spots in the coming weeks too. That's because some seniors are switching plans. Others have been automatically enrolled in new plans. Herb Kuhn, deputy administrator at the Centers for Medicare and Medicaid Services, said that he believes the federal government learned many lessons from the past year that will make this year's startup run more smoothly. “We have a much more sophisticated and built up infrastructure from a year ago,†Kuhn said.
Kuhn said his biggest concern going into the new year are those beneficiaries who waited until the final days of the open-enrollment period to change drug plans. He said seniors should bring to the pharmacy any kind of identification or acknowledgment letter from their plan that would show proof of membership.
Overall, Kuhn said that 2006 was a good year for beneficiaries. “We believe it's been a very positive year for Part D,†he said. “As a result of the new program, beneficiaries are living better. They're saving money.â€
In the heydays of “drugs from Canada,†there were news stories aplenty about the “Winnipeg Wunderkids,†the young pharmacists who were selling drugs to Americans and driving around in Dodge Viper sportscars. These reports rarely mentioned that they were trafficking in illegal merchandise. And there was a lot of talk of “it’s not about the money, it’s about helping people.â€
That, as it turned out, was soooo 2004. Today they going out of business and, well, it’s all about the money. People are losing their jobs – but it doesn’t seem that those who got rich quick are doing anything to help those they led down the primrose path of ill-gotten gains – except maybe letting their former employees wash their fancy cars.
Here’s the story as reported in the Winnipeg Free Press.
MINNEDOSA -- The Internet pharmacy pioneers who gave birth to a half-billion-dollar industry in Canada, most of it in Manitoba, are exiting the industry. MediPlan, founded almost six years ago by four Winnipeg wunderkids ages 21 to 26, will close its doors at the end of this month here, 200 kilometres northwest of Winnipeg. About 75 people are being thrown out of work.
At its peak, MediPlan employed 170 people in Minnedosa. "There's nobody here... We're just winding down," said a woman in the human resources department on the MediPlan's second floor last week.
CanadaDrugs.com in Winnipeg has purchased MediPlan and the jobs will move to the capital city. At least 30 new employees will be needed at CanadaDrugs, a spokesman said. As the industry leader for much of its run, MediPlan, which also goes by RxNorth, had been the prime target for opponents like non-Internet pharmacies, the drug giants, and Canadian and American governments.
A person who knows MediPlan president Andrew Strempler said Strempler simply got worn down from fighting. "It was just time to get out to capture as much value as possible," the person said.
The final salvo came this summer when the United States Food and Drug Administration alleged MediPlan and another Internet pharmacy had sold counterfeit drugs into the U.S. Strempler and the Internet pharmacies association vehemently denied the claims. However, MediPlan drug shipments began being seized at the U.S. border.
"The reality is that Andrew Strempler is a man of integrity, and is committed to patient safety and patient care, and the truth of the matter is if a patient can't receive safe and affordable medication on time, then they are at risk," said CanadaDrugs spokesman Troy Harwood-Jones.
So, Strempler phoned friend Kris Thorkelson, CanadaDrugs owner. Although competitors, Strempler and Thorkelson have always maintained a friendship and mutual respect. Initially, Thorkelson agreed to take over just MediPlan's distribution practices so MediPlan drugs could reach patients. That caused the layoff of 15 people in Minnedosa in September. "As things went along, it became obvious it was a great business opportunity" for Thorkelson to purchase all of MediPlan, said Harwood-Jones.
CanadaDrugs is the largest Internet pharmacy in Canada with about 250 employees, and was 50 per cent larger than MediPlan at the time. Jobs have been offered to MediPlan employees, but Harwood-Jones didn't know if anyone had accepted. As for Strempler, he's out of the business he founded. "He's a young guy (about 32) and he's been very successful and I'm very confident he will be very successful again," Harwood-Jones said.
Strempler bought out partners Mark and Chantelle Rzepka in an amicable settlement last year. Phone messages left with Strempler's lawyer requesting an interview with Strempler weren't answered.
MediPlan was highly aggressive from start, taking out pricey full-page ads in major American dailies like the New York Times and publishing complete lists of their cheaper drugs. They also charmed many people along the way. MediPlan customers, mostly American senior citizens with chronic ailments, received their medicines in flowery pastel wrapping, with little handwritten thank-you notes attached -- more like presents at a baby shower. It was the idea of "the girls," Catherine Strempler and Chantelle Rzepka, the wives of the two pharmaceutical degree graduates.
It said much about the foursome: young, naive, energetic, idealistic, respectful, smart. Their employees were nearly all older than they were and the fresh-faced bosses were more apt to treat them like aunts and uncles.
No question, the four original partners in MediPlan walked away multimillionaires. Projections from someone inside the industry suggest MediPlan owners may have made anywhere from $10 million to $30 million. "Anyone worth their salt was making millions of dollars," during the past five years, said the Internet pharmacist, who did not wish to be named.
Mark and Chantelle Rzepka, before their marriage dissolved last year, purchased a new $2-million, 6,800-square-foot home in East St. Paul. Andrew and Catherine Strempler recently purchased Leonard Asper's $2-million, 6,500-square-foot home on Wellington Crescent. But that kind of money also presented life-in-the-fast-lane temptation. Strempler nearly killed himself when he ran his Dodge Viper sports car into a tree on the Yellowhead Highway within Neepawa town limits.
For Minnedosa and the surrounding area, MediPlan's demise is a bit like Dorothy and Toto waking up back in bed in Kansas. Six years ago, MediPlan fell into Minnedosa's lap. No one knew what it was. Almost overnight, it became the area's biggest employer and payroll. Not only were many of the jobs well-paying, but they were "clean jobs," as one person put it, meaning you didn't have dirt under your fingernails at the end of the day.
Minnedosa businesses are bracing for the fallout. Second Century Furniture and Appliance just closed its doors, but it isn't known if MediPlan is a factor. Minnedosa businesses face stiff competition from new big box stores in Brandon.
"It's almost like a gold mine strike," said Minnedosa chief administrator Ken Jenkins. "It's here, and then one day it's gone. But while it was here, it sure was nice."
MediPlan's local philanthropy will also be missed. Robert Dunston, mayor of the town of Neepawa, where the Stremplers still own a house, recalls one time when Andrew Strempler showed up unexpectedly at an annual banquet of the Neepawa Natives of the Manitoba Junior Hockey League.
The banquet always includes a fundraiser where players' sweaters are auctioned off. The auctioneer started off by asking who wanted to give him $1,000 for the first sweater. It was a joke. Sweaters might go for $300 tops.
"I do," Strempler piped up. The room went completely silent. Dunston said it was the first time he'd seen an auctioneer speechless.
However, there is some anger in Minnedosa at the federal government for not doing more to protect their biggest employer.
"The disappointment is it wasn't a business demise. It was political. For Minnedosa, that was the biggest disappointment," said John Mendrikis, who runs John's Tax Service and Accounting in Minnedosa.
Mendrikis added: "The perception out there is that large companies influence policy, and this plays into that."
No, not political. Financial. They took the money and ran.
That, as it turned out, was soooo 2004. Today they going out of business and, well, it’s all about the money. People are losing their jobs – but it doesn’t seem that those who got rich quick are doing anything to help those they led down the primrose path of ill-gotten gains – except maybe letting their former employees wash their fancy cars.
Here’s the story as reported in the Winnipeg Free Press.
MINNEDOSA -- The Internet pharmacy pioneers who gave birth to a half-billion-dollar industry in Canada, most of it in Manitoba, are exiting the industry. MediPlan, founded almost six years ago by four Winnipeg wunderkids ages 21 to 26, will close its doors at the end of this month here, 200 kilometres northwest of Winnipeg. About 75 people are being thrown out of work.
At its peak, MediPlan employed 170 people in Minnedosa. "There's nobody here... We're just winding down," said a woman in the human resources department on the MediPlan's second floor last week.
CanadaDrugs.com in Winnipeg has purchased MediPlan and the jobs will move to the capital city. At least 30 new employees will be needed at CanadaDrugs, a spokesman said. As the industry leader for much of its run, MediPlan, which also goes by RxNorth, had been the prime target for opponents like non-Internet pharmacies, the drug giants, and Canadian and American governments.
A person who knows MediPlan president Andrew Strempler said Strempler simply got worn down from fighting. "It was just time to get out to capture as much value as possible," the person said.
The final salvo came this summer when the United States Food and Drug Administration alleged MediPlan and another Internet pharmacy had sold counterfeit drugs into the U.S. Strempler and the Internet pharmacies association vehemently denied the claims. However, MediPlan drug shipments began being seized at the U.S. border.
"The reality is that Andrew Strempler is a man of integrity, and is committed to patient safety and patient care, and the truth of the matter is if a patient can't receive safe and affordable medication on time, then they are at risk," said CanadaDrugs spokesman Troy Harwood-Jones.
So, Strempler phoned friend Kris Thorkelson, CanadaDrugs owner. Although competitors, Strempler and Thorkelson have always maintained a friendship and mutual respect. Initially, Thorkelson agreed to take over just MediPlan's distribution practices so MediPlan drugs could reach patients. That caused the layoff of 15 people in Minnedosa in September. "As things went along, it became obvious it was a great business opportunity" for Thorkelson to purchase all of MediPlan, said Harwood-Jones.
CanadaDrugs is the largest Internet pharmacy in Canada with about 250 employees, and was 50 per cent larger than MediPlan at the time. Jobs have been offered to MediPlan employees, but Harwood-Jones didn't know if anyone had accepted. As for Strempler, he's out of the business he founded. "He's a young guy (about 32) and he's been very successful and I'm very confident he will be very successful again," Harwood-Jones said.
Strempler bought out partners Mark and Chantelle Rzepka in an amicable settlement last year. Phone messages left with Strempler's lawyer requesting an interview with Strempler weren't answered.
MediPlan was highly aggressive from start, taking out pricey full-page ads in major American dailies like the New York Times and publishing complete lists of their cheaper drugs. They also charmed many people along the way. MediPlan customers, mostly American senior citizens with chronic ailments, received their medicines in flowery pastel wrapping, with little handwritten thank-you notes attached -- more like presents at a baby shower. It was the idea of "the girls," Catherine Strempler and Chantelle Rzepka, the wives of the two pharmaceutical degree graduates.
It said much about the foursome: young, naive, energetic, idealistic, respectful, smart. Their employees were nearly all older than they were and the fresh-faced bosses were more apt to treat them like aunts and uncles.
No question, the four original partners in MediPlan walked away multimillionaires. Projections from someone inside the industry suggest MediPlan owners may have made anywhere from $10 million to $30 million. "Anyone worth their salt was making millions of dollars," during the past five years, said the Internet pharmacist, who did not wish to be named.
Mark and Chantelle Rzepka, before their marriage dissolved last year, purchased a new $2-million, 6,800-square-foot home in East St. Paul. Andrew and Catherine Strempler recently purchased Leonard Asper's $2-million, 6,500-square-foot home on Wellington Crescent. But that kind of money also presented life-in-the-fast-lane temptation. Strempler nearly killed himself when he ran his Dodge Viper sports car into a tree on the Yellowhead Highway within Neepawa town limits.
For Minnedosa and the surrounding area, MediPlan's demise is a bit like Dorothy and Toto waking up back in bed in Kansas. Six years ago, MediPlan fell into Minnedosa's lap. No one knew what it was. Almost overnight, it became the area's biggest employer and payroll. Not only were many of the jobs well-paying, but they were "clean jobs," as one person put it, meaning you didn't have dirt under your fingernails at the end of the day.
Minnedosa businesses are bracing for the fallout. Second Century Furniture and Appliance just closed its doors, but it isn't known if MediPlan is a factor. Minnedosa businesses face stiff competition from new big box stores in Brandon.
"It's almost like a gold mine strike," said Minnedosa chief administrator Ken Jenkins. "It's here, and then one day it's gone. But while it was here, it sure was nice."
MediPlan's local philanthropy will also be missed. Robert Dunston, mayor of the town of Neepawa, where the Stremplers still own a house, recalls one time when Andrew Strempler showed up unexpectedly at an annual banquet of the Neepawa Natives of the Manitoba Junior Hockey League.
The banquet always includes a fundraiser where players' sweaters are auctioned off. The auctioneer started off by asking who wanted to give him $1,000 for the first sweater. It was a joke. Sweaters might go for $300 tops.
"I do," Strempler piped up. The room went completely silent. Dunston said it was the first time he'd seen an auctioneer speechless.
However, there is some anger in Minnedosa at the federal government for not doing more to protect their biggest employer.
"The disappointment is it wasn't a business demise. It was political. For Minnedosa, that was the biggest disappointment," said John Mendrikis, who runs John's Tax Service and Accounting in Minnedosa.
Mendrikis added: "The perception out there is that large companies influence policy, and this plays into that."
No, not political. Financial. They took the money and ran.
Woke up this morning early from a recurring dream. Something to do with suiting up with a new bunch of team mates and an old high school football coach. I want to show them I can still grind out the yardage. No sense of frustration, just hope and confidence.
Don't know what to feel as I see the first headlines of the new year. I careen between frustration and hope about breaking through...not in terms of getting people to agree with what we write here but at least to be more well-rounded and less beholden to the MSM echo chamber.
So here's my opening take on 2007, borne both of hope and frustration. From the Pink Sheet:
Medicaid AMPs May Include More PBM Discounts, If CMS Can Figure Out How
CMS wants to include a broader array of pharmacy benefit manager price concessions in calculating Medicaid average manufacturer prices for reimbursing outpatient prescription drugs.
Compare this lead to the Page One story in the WSJ on the health "middlemen", the final (thankfully) installment of this seris on "Health Care Gold Mines":
"Chicken producer Perdue Farms Inc. used to hire a big health insurer to bargain with doctors. Gradually, over a decade it cut out the middleman, dealing directly with doctors and hospitals just as Wal-Mart Stores Inc. often buys directly from manufacturers instead of using wholesalers. That has helped Perdue keep its health costs below the national average."
Really? How much? Does Perdue have an open or closed formulary. What else is Perdue doing? It just received an award for innovation in health care promotion and prevention. That might have something to with it to especially since drugs are only a small percentage of a health plans cost......
I am waiting for the first Democrat to use Perdue as the example for why Medicare should "negotiate" directly with drug companies. But in fact, government already does negotiate directly with drug companies through Medicaid. It just happens to do than PBMs on most drugs (atypicals seem to be the exception) but CMS can't figure out how to shift Medicaid into the marketplace. And of course no one ever counts the cost of restrictive formularies and prescription limits on Medicaid patients.
So are PBM's saving money or not? Compared to government price controls, the answer is markets move faster and generate discounts more effectively without restricting choice. There's a value to that. The WSJ articles on PBMs glance over the most important point: PBMs are simply paid to save money on drugs, not on health care costs. They are not disease managers and have no stake or ability to prevent or predict disease at an individual level. What's more important: price or value? Do we want to "squeeze" or "eliminate" firms or individuals that can provide such insight? Do we want to replace PBMs with one big government PBM that is just obsessed with drug costs? Then we are back to the Medicaid model and one size fits all drug dispensing and we move away from patient-centric medicine.
Here's another one from the Pink Sheet:
Increasing Clinical Trial Failures Highlighted In GAO Report On Drug R&D
A “systematic analysis†of why drugs fail during clinical testing could help curb the rising number of trial failures and prevent companies from repeating others’ trial mistakes, the Government Accountability Office suggests in a recent report..
Duh.
Peter and I along with a great group of people that formed our 21st Century FDA Task Force (none of whom would have been allowed on the IOM Drug Safety Task Force, include Nobel Prize Winner Josh Lederberg because of conflicts alleged by IOMatrix Sheila Burke) came to that conclusion a year ago as did the FDA with its Critical Path report. And of course a systematic analysis could help reduce the number of rare adverse events in the post market but instead we are going to drink the IOM's kool-aid and spend millions on genomically and phenotypically insensitive claims data that might spot a safety signal years later.
Your PDUFA and tax dollars at work.
Don't know what to feel as I see the first headlines of the new year. I careen between frustration and hope about breaking through...not in terms of getting people to agree with what we write here but at least to be more well-rounded and less beholden to the MSM echo chamber.
So here's my opening take on 2007, borne both of hope and frustration. From the Pink Sheet:
Medicaid AMPs May Include More PBM Discounts, If CMS Can Figure Out How
CMS wants to include a broader array of pharmacy benefit manager price concessions in calculating Medicaid average manufacturer prices for reimbursing outpatient prescription drugs.
Compare this lead to the Page One story in the WSJ on the health "middlemen", the final (thankfully) installment of this seris on "Health Care Gold Mines":
"Chicken producer Perdue Farms Inc. used to hire a big health insurer to bargain with doctors. Gradually, over a decade it cut out the middleman, dealing directly with doctors and hospitals just as Wal-Mart Stores Inc. often buys directly from manufacturers instead of using wholesalers. That has helped Perdue keep its health costs below the national average."
Really? How much? Does Perdue have an open or closed formulary. What else is Perdue doing? It just received an award for innovation in health care promotion and prevention. That might have something to with it to especially since drugs are only a small percentage of a health plans cost......
I am waiting for the first Democrat to use Perdue as the example for why Medicare should "negotiate" directly with drug companies. But in fact, government already does negotiate directly with drug companies through Medicaid. It just happens to do than PBMs on most drugs (atypicals seem to be the exception) but CMS can't figure out how to shift Medicaid into the marketplace. And of course no one ever counts the cost of restrictive formularies and prescription limits on Medicaid patients.
So are PBM's saving money or not? Compared to government price controls, the answer is markets move faster and generate discounts more effectively without restricting choice. There's a value to that. The WSJ articles on PBMs glance over the most important point: PBMs are simply paid to save money on drugs, not on health care costs. They are not disease managers and have no stake or ability to prevent or predict disease at an individual level. What's more important: price or value? Do we want to "squeeze" or "eliminate" firms or individuals that can provide such insight? Do we want to replace PBMs with one big government PBM that is just obsessed with drug costs? Then we are back to the Medicaid model and one size fits all drug dispensing and we move away from patient-centric medicine.
Here's another one from the Pink Sheet:
Increasing Clinical Trial Failures Highlighted In GAO Report On Drug R&D
A “systematic analysis†of why drugs fail during clinical testing could help curb the rising number of trial failures and prevent companies from repeating others’ trial mistakes, the Government Accountability Office suggests in a recent report..
Duh.
Peter and I along with a great group of people that formed our 21st Century FDA Task Force (none of whom would have been allowed on the IOM Drug Safety Task Force, include Nobel Prize Winner Josh Lederberg because of conflicts alleged by IOMatrix Sheila Burke) came to that conclusion a year ago as did the FDA with its Critical Path report. And of course a systematic analysis could help reduce the number of rare adverse events in the post market but instead we are going to drink the IOM's kool-aid and spend millions on genomically and phenotypically insensitive claims data that might spot a safety signal years later.
Your PDUFA and tax dollars at work.
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.
