Latest Drugwonks' Blog
Previously on drugwonks.com we’ve asked what the difference is between “universal†health care and “government†health care.
We also sent our intrepid intern (dressed as a pill) out to the Macy’s Thanksgiving Day Parade to ask average citizens the same question.
Here's a link to our podcast:
http://www.cmpi.org/OnthestreetDetail.asp?contentdetailid=595&contenttypeid=16
The answer is that the only difference is a rhetorical one.
But in the United Kingdom – there’s a tragic difference, NHS “government care†isn’t universal at all when it comes to the ability of a physician to prescribe the most effective medicine for a patient – because they can’t choose from a “universe†of treatments.
Consider these paragraphs this from today’s New York Times:
Paying Patients Test British Health Care System
LONDON — Created 60 years ago as a cornerstone of the British welfare state, the National Health Service is devoted to the principle of free medical care for everyone. But recently it has been wrestling with a problem its founders never anticipated: how to handle patients with complex illnesses who want to pay for parts of their treatment while receiving the rest free from the health service.
Although the government is reluctant to discuss the issue, hopscotching back and forth between private and public care has long been standard here for those who can afford it. But a few recent cases have exposed fundamental contradictions between policy and practice in the system, and tested its founding philosophy to its very limits.
One such case was Debbie Hirst’s. Her breast cancer had metastasized, and the health service would not provide her with Avastin, a drug that is widely used in the United States and Europe to keep such cancers at bay. So, with her oncologist’s support, she decided last year to try to pay the $120,000 cost herself, while continuing with the rest of her publicly financed treatment.
By December, she had raised $20,000 and was preparing to sell her house to raise more. But then the government, which had tacitly allowed such arrangements before, put its foot down. Mrs. Hirst heard the news from her doctor.
“He looked at me and said: ‘I’m so sorry, Debbie. I’ve had my wrists slapped from the people upstairs, and I can no longer offer you that service,’ †Mrs. Hirst said in an interview. “I said, ‘Where does that leave me?’ He said, ‘If you pay for Avastin, you’ll have to pay for everything’ †-- in other words, for all her cancer treatment, far more than she could afford.
Officials said that allowing Mrs. Hirst and others like her to pay for extra drugs to supplement government care would violate the philosophy of the health service by giving richer patients an unfair advantage over poorer ones.
Patients “cannot, in one episode of treatment, be treated on the N.H.S. and then allowed, as part of the same episode and the same treatment, to pay money for more drugs,†the health secretary, Alan Johnson, told Parliament.
But Mrs. Hirst, 57, whose cancer was diagnosed in 1999, went to the news media, and so did other patients in similar situations. And it became clear that theirs were not isolated cases. In fact, patients, doctors and officials across the health care system widely acknowledge that patients suffering from every imaginable complaint regularly pay for some parts of their treatment while receiving the rest free.
“Of course it’s going on in the N.H.S. all the time, but a lot of it is hidden — it’s not explicit,†said Dr. Paul Charlson, a general practitioner in Yorkshire and a member of Doctors for Reform, a group that is highly critical of the health service. Last year, he was a co-author of a paper laying out examples of how patients with the initiative and the money dip in and out of the system, in effect buying upgrades to their basic free medical care.
“People swap from public to private sector all the time, and they’re topping up for virtually everything,†Dr. Charlson said in an interview. For instance, he said, a patient put on a five-month waiting list to see an orthopedic surgeon may pay $250 for a private consultation, and then switch back to the health service for the actual operation from the same doctor.
“Or they’ll buy an M.R.I. scan because the wait is so long, and then take the results back to the N.H.S.,†Dr. Charlson said.
In his paper, he also wrote about a 46-year-old woman with breast cancer who paid $250 for a second opinion when the health service refused to provide her with one; an elderly man who spent thousands of dollars on a new hearing aid instead of enduring a yearlong wait on the health service; and a 29-year-old woman who, with her doctor’s blessing, bought a three-month supply of Tarceva, a drug to treat pancreatic cancer, for more than $6,000 on the Internet because she could not get it through the N.H.S.
Asked why these were different from cases like Mrs. Hirst’s, a spokeswoman for the health service said no officials were available to comment.
Karol Sikora, a professor of cancer medicine at the Imperial College School of Medicine and one of Dr. Charlson’s co-authors, said that co-payments were particularly prevalent in cancer care. Armed with information from the Internet and patients’ networks, cancer patients are increasingly likely to demand, and pay for, cutting-edge drugs that the health service considers too expensive to be cost-effective.
“You have a population that is informed and consumerist about how it behaves about health care information, and an N.H.S. that can no longer afford to pay for everything for everybody,†he said.
In any case, he said, the health service is riddled with inequities. Some drugs are available in some parts of the country but not in others. Waiting lists for treatment vary wildly from place to place. Some regions spend $280 per capita on cancer care, Professor Sikora said, while others spend just $90.
But in a final irony, Mrs. Hirst was told early this month that her cancer had spread and that her condition had deteriorated so much that she could have the Avastin after all — paid for by the health service. In other words, a system that forbade her to buy the medicine earlier was now saying that she was so sick she could have it at public expense.
Mrs. Hirst is pleased, but up to a point. Avastin is not a cure, but a way to extend her life, perhaps only by several months, and she has missed valuable time. “It may be too bloody late,†she said.
Here’s a link to the complete article:
http://www.nytimes.com/2008/02/21/world/europe/21britain.html?_r=1&scp=4&sq=avastin&st=nyt&oref=slogin
As our presidential candidates talk about health care reform here at home, let’s hold their feet to the fire over what “government care†really means.
We also sent our intrepid intern (dressed as a pill) out to the Macy’s Thanksgiving Day Parade to ask average citizens the same question.
Here's a link to our podcast:
http://www.cmpi.org/OnthestreetDetail.asp?contentdetailid=595&contenttypeid=16
The answer is that the only difference is a rhetorical one.
But in the United Kingdom – there’s a tragic difference, NHS “government care†isn’t universal at all when it comes to the ability of a physician to prescribe the most effective medicine for a patient – because they can’t choose from a “universe†of treatments.
Consider these paragraphs this from today’s New York Times:
Paying Patients Test British Health Care System
LONDON — Created 60 years ago as a cornerstone of the British welfare state, the National Health Service is devoted to the principle of free medical care for everyone. But recently it has been wrestling with a problem its founders never anticipated: how to handle patients with complex illnesses who want to pay for parts of their treatment while receiving the rest free from the health service.
Although the government is reluctant to discuss the issue, hopscotching back and forth between private and public care has long been standard here for those who can afford it. But a few recent cases have exposed fundamental contradictions between policy and practice in the system, and tested its founding philosophy to its very limits.
One such case was Debbie Hirst’s. Her breast cancer had metastasized, and the health service would not provide her with Avastin, a drug that is widely used in the United States and Europe to keep such cancers at bay. So, with her oncologist’s support, she decided last year to try to pay the $120,000 cost herself, while continuing with the rest of her publicly financed treatment.
By December, she had raised $20,000 and was preparing to sell her house to raise more. But then the government, which had tacitly allowed such arrangements before, put its foot down. Mrs. Hirst heard the news from her doctor.
“He looked at me and said: ‘I’m so sorry, Debbie. I’ve had my wrists slapped from the people upstairs, and I can no longer offer you that service,’ †Mrs. Hirst said in an interview. “I said, ‘Where does that leave me?’ He said, ‘If you pay for Avastin, you’ll have to pay for everything’ †-- in other words, for all her cancer treatment, far more than she could afford.
Officials said that allowing Mrs. Hirst and others like her to pay for extra drugs to supplement government care would violate the philosophy of the health service by giving richer patients an unfair advantage over poorer ones.
Patients “cannot, in one episode of treatment, be treated on the N.H.S. and then allowed, as part of the same episode and the same treatment, to pay money for more drugs,†the health secretary, Alan Johnson, told Parliament.
But Mrs. Hirst, 57, whose cancer was diagnosed in 1999, went to the news media, and so did other patients in similar situations. And it became clear that theirs were not isolated cases. In fact, patients, doctors and officials across the health care system widely acknowledge that patients suffering from every imaginable complaint regularly pay for some parts of their treatment while receiving the rest free.
“Of course it’s going on in the N.H.S. all the time, but a lot of it is hidden — it’s not explicit,†said Dr. Paul Charlson, a general practitioner in Yorkshire and a member of Doctors for Reform, a group that is highly critical of the health service. Last year, he was a co-author of a paper laying out examples of how patients with the initiative and the money dip in and out of the system, in effect buying upgrades to their basic free medical care.
“People swap from public to private sector all the time, and they’re topping up for virtually everything,†Dr. Charlson said in an interview. For instance, he said, a patient put on a five-month waiting list to see an orthopedic surgeon may pay $250 for a private consultation, and then switch back to the health service for the actual operation from the same doctor.
“Or they’ll buy an M.R.I. scan because the wait is so long, and then take the results back to the N.H.S.,†Dr. Charlson said.
In his paper, he also wrote about a 46-year-old woman with breast cancer who paid $250 for a second opinion when the health service refused to provide her with one; an elderly man who spent thousands of dollars on a new hearing aid instead of enduring a yearlong wait on the health service; and a 29-year-old woman who, with her doctor’s blessing, bought a three-month supply of Tarceva, a drug to treat pancreatic cancer, for more than $6,000 on the Internet because she could not get it through the N.H.S.
Asked why these were different from cases like Mrs. Hirst’s, a spokeswoman for the health service said no officials were available to comment.
Karol Sikora, a professor of cancer medicine at the Imperial College School of Medicine and one of Dr. Charlson’s co-authors, said that co-payments were particularly prevalent in cancer care. Armed with information from the Internet and patients’ networks, cancer patients are increasingly likely to demand, and pay for, cutting-edge drugs that the health service considers too expensive to be cost-effective.
“You have a population that is informed and consumerist about how it behaves about health care information, and an N.H.S. that can no longer afford to pay for everything for everybody,†he said.
In any case, he said, the health service is riddled with inequities. Some drugs are available in some parts of the country but not in others. Waiting lists for treatment vary wildly from place to place. Some regions spend $280 per capita on cancer care, Professor Sikora said, while others spend just $90.
But in a final irony, Mrs. Hirst was told early this month that her cancer had spread and that her condition had deteriorated so much that she could have the Avastin after all — paid for by the health service. In other words, a system that forbade her to buy the medicine earlier was now saying that she was so sick she could have it at public expense.
Mrs. Hirst is pleased, but up to a point. Avastin is not a cure, but a way to extend her life, perhaps only by several months, and she has missed valuable time. “It may be too bloody late,†she said.
Here’s a link to the complete article:
http://www.nytimes.com/2008/02/21/world/europe/21britain.html?_r=1&scp=4&sq=avastin&st=nyt&oref=slogin
As our presidential candidates talk about health care reform here at home, let’s hold their feet to the fire over what “government care†really means.
One important point to clear up per the Supreme Court’s 8-1 decision in the Medtronic pre-emption case -- when product manufacturers provide fraudulent information to FDA, or deliberately withhold information about safety problems associated with their products, preemption doesn’t offer them protection and they can and should be held accountable.
The problem is that the current liability system doesn’t reward lawyers who focus on these real public health concerns. Instead, the most experienced and well-financed law firms know that the biggest payouts regularly go to those who take advantage of the FDA’s best efforts to promote the safe and effective use of medications and medical technology. More and more often, these “mass tort†firms specialize in taking a new product warning label or withdrawal decision by the FDA, and view it as a signal to go forward with all guns blazing. Their bullets, unfortunately but not unpredictably, hit multiple innocent targets and result in a wounded American health care system.
Upon hearing the Court’s verdict, Senator Kennedy said, “In enacting legislation on medical devices, Congress never intended that F.D.A. approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices.†And Representative Waxman, America’s Oversighter-in-Chief commented that, “The Supreme Court’s decision strips consumers of the rights they’ve had for decades. 'This isn’t what Congress intended, and we’ll pass legislation as quickly as possible to fix this nonsensical situation."
“Nonsensical?†To the contrary, entirely sensical. Hence 8-1.
The problem is that the current liability system doesn’t reward lawyers who focus on these real public health concerns. Instead, the most experienced and well-financed law firms know that the biggest payouts regularly go to those who take advantage of the FDA’s best efforts to promote the safe and effective use of medications and medical technology. More and more often, these “mass tort†firms specialize in taking a new product warning label or withdrawal decision by the FDA, and view it as a signal to go forward with all guns blazing. Their bullets, unfortunately but not unpredictably, hit multiple innocent targets and result in a wounded American health care system.
Upon hearing the Court’s verdict, Senator Kennedy said, “In enacting legislation on medical devices, Congress never intended that F.D.A. approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices.†And Representative Waxman, America’s Oversighter-in-Chief commented that, “The Supreme Court’s decision strips consumers of the rights they’ve had for decades. 'This isn’t what Congress intended, and we’ll pass legislation as quickly as possible to fix this nonsensical situation."
“Nonsensical?†To the contrary, entirely sensical. Hence 8-1.
Diabetes Treatment Risk Not Found in 2nd Study
By Rob Stein
Washington Post Staff Writer
Thursday, February 14, 2008; Page A03
"One week after U.S. researchers announced that pushing down blood sugar levels as close as possible to normal might be dangerous for high-risk diabetes patients, a preliminary analysis of a similar international study has found no such risk."
http://www.washingtonpost.com/wp-dyn/content/article/2008/02/13/AR2008021302722.html
I know why people died in the US study...more drug companies were involved.. More drug companies, more conflicts, more conflicts, less concern for patients. It's all so simple when you don't let science clog up your blog. And connecting the dots -- sort of like accusing someone of a crime without all the facts. Fun!
http://www.washingtonpost.com/wp-dyn/content/article/2008/02/13/AR2008021302722.html
By Rob Stein
Washington Post Staff Writer
Thursday, February 14, 2008; Page A03
"One week after U.S. researchers announced that pushing down blood sugar levels as close as possible to normal might be dangerous for high-risk diabetes patients, a preliminary analysis of a similar international study has found no such risk."
http://www.washingtonpost.com/wp-dyn/content/article/2008/02/13/AR2008021302722.html
I know why people died in the US study...more drug companies were involved.. More drug companies, more conflicts, more conflicts, less concern for patients. It's all so simple when you don't let science clog up your blog. And connecting the dots -- sort of like accusing someone of a crime without all the facts. Fun!
http://www.washingtonpost.com/wp-dyn/content/article/2008/02/13/AR2008021302722.html
Are we devoid of any sense of irony?
Rob Stein of the Washington Post pens an article that begins:
One week after U.S. researchers announced that pushing down blood sugar levels as close as possible to normal might be dangerous for high-risk diabetes patients, a preliminary analysis of a similar international study has found no such risk.
And then two days ago writes with a surge of certainty and finality...
"A series of surprising findings about some of the most widely accepted assumptions in medicine has renewed debate about how aggressively doctors use drugs to prevent and treat some of the nation's leading health problems.
In addition to casting doubt on notions such as lowering cholesterol to prevent heart disease and normalizing blood sugar to protect diabetics, the studies involving well-known drugs such as Avandia and Vytorin have also rekindled concern about whether new medications are being tested adequately before being allowed on the market."
Diabetes and cholesterol drugs are the most widely and heavily studied drugs on the planet next to blood pressure meds. Should every one of those studies been done in clinical trials prior to market? And does Stein see the difference in how he covers the diabetes story --government studies -- and the Vytorin and Avandia cases? I bet he doesn't. What about the Avastin story, the drug left for dead by the FDA and Wall Street only to become a blockbuster?
http://www.washingtonpost.com/wp-dyn/content/article/2008/02/13/AR2008021302722.html
Science is full of surprises...that is the essence of it's enterprise. What's changed is we now have a Tabloid medicine industry comprised of the media, Congress, instant experts like Steve Nissen and nut cases on the Net that seizes on every surprise and turns it into a scandal that was deliberately "hidden" by those conflict-ridden types who conducted the experiment and by the FDA who knew but are too cozy with industry to care.
http://www.washingtonpost.com/wp-dyn/content/article/2008/02/18/AR2008021801942.html
Rob Stein of the Washington Post pens an article that begins:
One week after U.S. researchers announced that pushing down blood sugar levels as close as possible to normal might be dangerous for high-risk diabetes patients, a preliminary analysis of a similar international study has found no such risk.
And then two days ago writes with a surge of certainty and finality...
"A series of surprising findings about some of the most widely accepted assumptions in medicine has renewed debate about how aggressively doctors use drugs to prevent and treat some of the nation's leading health problems.
In addition to casting doubt on notions such as lowering cholesterol to prevent heart disease and normalizing blood sugar to protect diabetics, the studies involving well-known drugs such as Avandia and Vytorin have also rekindled concern about whether new medications are being tested adequately before being allowed on the market."
Diabetes and cholesterol drugs are the most widely and heavily studied drugs on the planet next to blood pressure meds. Should every one of those studies been done in clinical trials prior to market? And does Stein see the difference in how he covers the diabetes story --government studies -- and the Vytorin and Avandia cases? I bet he doesn't. What about the Avastin story, the drug left for dead by the FDA and Wall Street only to become a blockbuster?
http://www.washingtonpost.com/wp-dyn/content/article/2008/02/13/AR2008021302722.html
Science is full of surprises...that is the essence of it's enterprise. What's changed is we now have a Tabloid medicine industry comprised of the media, Congress, instant experts like Steve Nissen and nut cases on the Net that seizes on every surprise and turns it into a scandal that was deliberately "hidden" by those conflict-ridden types who conducted the experiment and by the FDA who knew but are too cozy with industry to care.
http://www.washingtonpost.com/wp-dyn/content/article/2008/02/18/AR2008021801942.html
Anna Mathews puff piece on Bart Stupak paints him as a sometimes overzealous crusader seeking to right wrongs at an out of control FDA...Good thing she didn't include this stirring Stupak statement -- from an LA Times article -- about why Andy von Eschenbach, Sandy Kweder, Janet Woodcock and the FDA's cafeteria guy should resign...
"The drug companies know that this administration ... will do nothing to them. There is no fear of the FDA. With this culture with laissez faire oversight and regulation, I think they should be gone. If we get rid of them, it will put the drug companies on notice."
Is there such a thing as laissez faire regulation?
Last time I checked, drug approvals were at an all-time low and the percentage of IND getting through the FDA had gone from 11 percent to 8 percent over a ten year period. The percent of drugs withdrawn has remained the same over that same time period. Laissez faire?
Oh and has anyone given one tenth of the coverage to the fact that the NIH pulled the plug on the ACCORD study that killed people compared to the ENHANCE trial that did not? In both cases the protocols were changed midstream and ACCORD even had a data safety monitoring board.
I don't see Stupak holding a hearing on that. Maybe it's not a case of laissez faire regulation. Or maybe it's just that you get less media coverage.
http://online.wsj.com/article/SB120347636748679131.html?mod=home_health_right
"The drug companies know that this administration ... will do nothing to them. There is no fear of the FDA. With this culture with laissez faire oversight and regulation, I think they should be gone. If we get rid of them, it will put the drug companies on notice."
Is there such a thing as laissez faire regulation?
Last time I checked, drug approvals were at an all-time low and the percentage of IND getting through the FDA had gone from 11 percent to 8 percent over a ten year period. The percent of drugs withdrawn has remained the same over that same time period. Laissez faire?
Oh and has anyone given one tenth of the coverage to the fact that the NIH pulled the plug on the ACCORD study that killed people compared to the ENHANCE trial that did not? In both cases the protocols were changed midstream and ACCORD even had a data safety monitoring board.
I don't see Stupak holding a hearing on that. Maybe it's not a case of laissez faire regulation. Or maybe it's just that you get less media coverage.
http://online.wsj.com/article/SB120347636748679131.html?mod=home_health_right
No, not a new horror movie, a new op-ed from today's edition of The Detroit News:
Bureaucrats threaten personalized medical breakthroughs
American health care has come to a fork in the road.
On the one hand, science is opening up exciting possibilities. The booming field of "personalized" medicine recognizes that every one of us is unique -- not just in some sort of philosophical sense, but in the ways we get sick and the ways we get better.
Personalized medicine can size up our gene sequences to find out what ailments we're likely to get, and even prescribe preventative treatment.
Cancer doctors can now look for "biomarkers" on proteins to detect disease early and determine which treatments are most likely to work.
And this same science can help our doctors understand what medicines are wrong for us, avoiding unnecessary pain, suffering - and expense.
Unfortunately, just as these groundbreaking therapies are coming within reach of consumers, politicians and bureaucrats are threatening to make them off limits. As science makes ever-more-targeted treatment possible, politics could drag us right back to a one-size-fits-all system."
Here's the rest of the story:
http://www.detnews.com/apps/pbcs.dll/article?AID=/20080220/OPINION01/802200397/1008
And to further entice you, here's the concluding paragraph:
We hear a lot about sustainability these days. We want our ecosystem and our economy to be hale and hearty over the long term. But we also need a health care system that creates sustainable individuals. A market-driven system can do that, by bringing all the latest treatments to the public and letting competition drive down prices. Bureaucracies, by contrast, are mainly in the business of sustaining themselves. A move to government health care will take us down the wrong path.
Bureaucrats threaten personalized medical breakthroughs
American health care has come to a fork in the road.
On the one hand, science is opening up exciting possibilities. The booming field of "personalized" medicine recognizes that every one of us is unique -- not just in some sort of philosophical sense, but in the ways we get sick and the ways we get better.
Personalized medicine can size up our gene sequences to find out what ailments we're likely to get, and even prescribe preventative treatment.
Cancer doctors can now look for "biomarkers" on proteins to detect disease early and determine which treatments are most likely to work.
And this same science can help our doctors understand what medicines are wrong for us, avoiding unnecessary pain, suffering - and expense.
Unfortunately, just as these groundbreaking therapies are coming within reach of consumers, politicians and bureaucrats are threatening to make them off limits. As science makes ever-more-targeted treatment possible, politics could drag us right back to a one-size-fits-all system."
Here's the rest of the story:
http://www.detnews.com/apps/pbcs.dll/article?AID=/20080220/OPINION01/802200397/1008
And to further entice you, here's the concluding paragraph:
We hear a lot about sustainability these days. We want our ecosystem and our economy to be hale and hearty over the long term. But we also need a health care system that creates sustainable individuals. A market-driven system can do that, by bringing all the latest treatments to the public and letting competition drive down prices. Bureaucracies, by contrast, are mainly in the business of sustaining themselves. A move to government health care will take us down the wrong path.
The Tufts Center for Drug Development -- enemy territory for drugwonks because of its concentration of RedSox rooters -- held a session on business models to improve R and D productivity recently...The takeaway point:
“No company – big, medium, or small pharma, or biotech – will develop new drugs entirely alone,” claimed the Center’s director, Kenneth Kaitin, at a recent panel meeting of industry executives in the US.
“Increasingly, R&D productivity gains will depend on developers focusing on what they contribute best to the drug development value chain and partnering with organisations that provide capabilities that are too expensive to develop or maintain internally, or are outside of the company’s core competence,” he added.
Read More
Meanwhile the Institute on Medicine as Profession, which is leading the purge of all contacts between industry and academia has a new program designed to cut the private sector out of drug development altogether. It is being lead by one of the leaders in drug discovery, David Rothman, PhD. ....Where would the government -- yes the government would be in charge -- get the money? What's in your wallet?
Read More
“No company – big, medium, or small pharma, or biotech – will develop new drugs entirely alone,” claimed the Center’s director, Kenneth Kaitin, at a recent panel meeting of industry executives in the US.
“Increasingly, R&D productivity gains will depend on developers focusing on what they contribute best to the drug development value chain and partnering with organisations that provide capabilities that are too expensive to develop or maintain internally, or are outside of the company’s core competence,” he added.
Read More
Meanwhile the Institute on Medicine as Profession, which is leading the purge of all contacts between industry and academia has a new program designed to cut the private sector out of drug development altogether. It is being lead by one of the leaders in drug discovery, David Rothman, PhD. ....Where would the government -- yes the government would be in charge -- get the money? What's in your wallet?
Read More
At a recent London policy conference on parallel trade, Heinz Kobelt (Secretary General of the European Association of Euro-Pharmaceutical Companies – EAEPC) discussed his association’s credo of “know your customer.†This was during a discussion of how parallel trade can actually help to enhance drug safety and security. (More on that absurd canard in a moment.)
But, during the ensuing Q&A it turns out that “know your customer†actually means “don’t ask/don’t tell†when it comes to one of their most important and largest category of customers – wholesalers, specifically those shady entrepreneurs who go beyond legal EU parallel trade into the clearly illegal realm of marketing non-approved drugs to North America.
Case in point: Rimonabant.
Licensed and legally marketed in the EU under the brand name “Acomplia,†this medicine is not approved for use in the United States. But type “Acomplia†into any US search engine and you’ll find no shortage of Canadian internet pharmacies ready, willing, and able to sell it to any American with a credit card.
How is this possible? Because these pharmacies are buying their supplies from European wholesalers – wholesalers who are getting their supplies (legally) from within the EU and then selling them (illegally) outside the confines of the Treaty of Rome.
When confronted with this shady behavior, Mr. Kobelt was at a loss for words, finally saying that it was an issue that should be brought up with the wholesalers.
Heinz – you can’t have 57 flavors of “know your customer,†choosing to "know them" only when it's convenient is a policy that is neither sound nor honest.
As to parallel trade enhancing safety and security, here’s how Heinz spins that one.
During his presentation he pointed out (correctly) that the recent spate of counterfeit drugs that had infiltrated legitimate UK pharmacies had been discovered by a parallel trader. And that’s true. But what he didn’t mention is that those same products had already passed through three other parallel traders without being found.
Some victory for drug safety and parallel trade.
Something else that Heinz didn’t share was that, when the parallel trader found the counterfeits, rather than calling the UK authorities as required (the MHRA in this instance), he called the company whose drug had been counterfeited – so that he could get his supplies replaced.
Parallel trade and altruistic commitment to drug safety? Sure.
But, during the ensuing Q&A it turns out that “know your customer†actually means “don’t ask/don’t tell†when it comes to one of their most important and largest category of customers – wholesalers, specifically those shady entrepreneurs who go beyond legal EU parallel trade into the clearly illegal realm of marketing non-approved drugs to North America.
Case in point: Rimonabant.
Licensed and legally marketed in the EU under the brand name “Acomplia,†this medicine is not approved for use in the United States. But type “Acomplia†into any US search engine and you’ll find no shortage of Canadian internet pharmacies ready, willing, and able to sell it to any American with a credit card.
How is this possible? Because these pharmacies are buying their supplies from European wholesalers – wholesalers who are getting their supplies (legally) from within the EU and then selling them (illegally) outside the confines of the Treaty of Rome.
When confronted with this shady behavior, Mr. Kobelt was at a loss for words, finally saying that it was an issue that should be brought up with the wholesalers.
Heinz – you can’t have 57 flavors of “know your customer,†choosing to "know them" only when it's convenient is a policy that is neither sound nor honest.
As to parallel trade enhancing safety and security, here’s how Heinz spins that one.
During his presentation he pointed out (correctly) that the recent spate of counterfeit drugs that had infiltrated legitimate UK pharmacies had been discovered by a parallel trader. And that’s true. But what he didn’t mention is that those same products had already passed through three other parallel traders without being found.
Some victory for drug safety and parallel trade.
Something else that Heinz didn’t share was that, when the parallel trader found the counterfeits, rather than calling the UK authorities as required (the MHRA in this instance), he called the company whose drug had been counterfeited – so that he could get his supplies replaced.
Parallel trade and altruistic commitment to drug safety? Sure.
Despite those who believe that the government should control what medical journal articles doctors can read, some courageous sanity from the FDA.
FDA to Guide Off-Label Drug Marketing
By MATTHEW PERRONE AP Business Writer
© 2008 The Associated Press
WASHINGTON — The government on Friday proposed guidelines for how pharmaceutical companies can use medical journal articles to market drugs for unapproved uses.
The Food and Drug Administration guidelines, criticized by some lawmakers as too lenient, have been eagerly anticipated by drug and device companies like Pfizer Inc. and Medtronic Inc. that often use medical literature for marketing.
Companies are not allowed to market products for "off-label" uses, or those that have not been cleared by the FDA as safe and effective. However, under a law that expired in 2006, the agency made an exception for reprints of medical journal articles, which sales people often give to physicians.
Off-label prescriptions account for an estimated 21 percent of overall drug use, according to a 2006 analysis in the Annals of Internal Medicine. The practice is common in treating conditions such as cancer, where doctors will prescribe drugs approved for one type of cancer for another.
"This guidance should reinforce the point that FDA has no business interposing itself between a doctor and scientific information," said Peter Pitts, president of the Center for Medicine in the Public Interest.
Rep. Henry Waxman released an earlier draft of the guidelines in November without FDA's permission. The California Democrat, who chairs the committee on oversight, said Friday FDA should not issue final guidelines until Congress makes sure the new standards will not jeopardize patients.
"This ill-advised guidance is great news for the drug industry but terrible for public health," Waxman said Friday.
But former FDA Deputy Commissioner Scott Gottlieb said getting the latest medical research to physicians is critical for the patients, since it can take months or even years to update drug labels.
Gottlieb points out that Genentech's breast cancer drug Herceptin showed breakthrough results in early-stage tumors as early as 2005, but wasn't approved for that use until late 2006.
Here’s a link to the FDA statement:
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01798.html
And here’s a link to the complete AP story:
http://www.chron.com/disp/story.mpl/ap/fn/5545881.html
Knowledge is power. And information saves lives.
FDA to Guide Off-Label Drug Marketing
By MATTHEW PERRONE AP Business Writer
© 2008 The Associated Press
WASHINGTON — The government on Friday proposed guidelines for how pharmaceutical companies can use medical journal articles to market drugs for unapproved uses.
The Food and Drug Administration guidelines, criticized by some lawmakers as too lenient, have been eagerly anticipated by drug and device companies like Pfizer Inc. and Medtronic Inc. that often use medical literature for marketing.
Companies are not allowed to market products for "off-label" uses, or those that have not been cleared by the FDA as safe and effective. However, under a law that expired in 2006, the agency made an exception for reprints of medical journal articles, which sales people often give to physicians.
Off-label prescriptions account for an estimated 21 percent of overall drug use, according to a 2006 analysis in the Annals of Internal Medicine. The practice is common in treating conditions such as cancer, where doctors will prescribe drugs approved for one type of cancer for another.
"This guidance should reinforce the point that FDA has no business interposing itself between a doctor and scientific information," said Peter Pitts, president of the Center for Medicine in the Public Interest.
Rep. Henry Waxman released an earlier draft of the guidelines in November without FDA's permission. The California Democrat, who chairs the committee on oversight, said Friday FDA should not issue final guidelines until Congress makes sure the new standards will not jeopardize patients.
"This ill-advised guidance is great news for the drug industry but terrible for public health," Waxman said Friday.
But former FDA Deputy Commissioner Scott Gottlieb said getting the latest medical research to physicians is critical for the patients, since it can take months or even years to update drug labels.
Gottlieb points out that Genentech's breast cancer drug Herceptin showed breakthrough results in early-stage tumors as early as 2005, but wasn't approved for that use until late 2006.
Here’s a link to the FDA statement:
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01798.html
And here’s a link to the complete AP story:
http://www.chron.com/disp/story.mpl/ap/fn/5545881.html
Knowledge is power. And information saves lives.
Here's Bart Stupak, head of the Health subcommittee on Energy Commerce, who is running the series of show trials on the FDA and the pharmaceutical industry (only anti-industry and FDA malcontents need testify) on the "link" between SSRIs and suicide:
"SSRI’s have not been proven effective in treating adolescent
depression. To the contrary their use may actually increase the suicide rate of its young
patients. In response to these reports of increased suicide rates with SSRI use, FDA
officials suppressed their own post marketing surveillance, prohibited FDA employees
from discussing the report, and launched an investigation to find the person who leaked information to the press. Today, SSRI remain on the market without a clear medical benefit to the patient."
Setting aside the recent tragedy in Northern Illinois where the gunmen went off his meds, went on a shooting spree and killed himself. ...Stupak's statement is not only scientifically incorrect, it is downright misleading and dangerous. There should be a black box warning around everything Stupak says regarding medicines, particularly SSRIs which have been shown to benefit patients and are associated with a decline in suicides. And again, there is no link to SSRIs and in increase in suicides, rather some unclear evidence based on an unvalidated measure called suicidality that includes just talking about self harm in general.
Stupak held several fear-drenched hearing about antidepressants in 2003-2004. He is partially responsible for the decline in SSRI prescription use and the corresponding increase in adolescent suicide. So the question is:
And this guy is head of the Health subcommittee? Why is he being taken seriously? Why isn't he being held accountable?
Here's Bart Stupak on the "link" between SSRI's and suicide
"SSRI’s have not been proven effective in treating adolescent
depression. To the contrary their use may actually increase the suicide rate of its young
patients. In response to these reports of increased suicide rates with SSRI use, FDA
officials suppressed their own post marketing surveillance, prohibited FDA employees
from discussing the report, and launched an investigation to find the person who leaked information to the press. Today, SSRI remain on the market without a clear medical benefit to the patient."
Setting aside the recent tragedy in Northern Illinois where the gunmen went off his meds, went on a shooting spree and killed himself. ...Stupak's statement is not only scientifically incorrect, it is downright misleading and dangerous. There should be a black box warning around everything Stupak says regarding medicines, particularly SSRIs which have been shown to benefit patients and are associated with a decline in suicides. And again, there is no link to SSRIs and in increase in suicides, rather some unclear evidence based on an unvalidated measure called suicidality that includes just talking about self harm in general.
Stupak held several fear-drenched hearing about antidepressants in 2003-2004. He is partially responsible for the decline in SSRI prescription use and the corresponding increase in adolescent suicide. So the question is:
And this guy is head of the Health subcommittee? Why is he being taken seriously? Why isn't he being held accountable?
Here's Bart Stupak on the "link" between SSRI's and suicide
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.
