Latest Drugwonks' Blog
UPitt Law Prof. Janice Mueller writes in the NEJM in mild favor of India's attempt to seize the Novartis patent for Gleevec. She notes that India has a world class generic drug industry and that Indian generics companies, for instance, supply 84% of the AIDS drugs that Doctors without Borders uses to treat 60,000 patients in more than 30 countries.
http://content.nejm.org/cgi/content/full/356/6/541?query=TOC
Wow. That's almost .005 percent of all HIV positive patients in all countries.
She goes on to note that under TRIPS WTO members have the flexibility to fine-tune what they define as inventive-step criteria to reflect national socioeconomic conditions. Which means that if NGOs and their fellow travelers want to argue that Gleevec is not really that much of a breakthrough for purposes of compulsory licensing that's ok. Which is pretty funny when you realize that the purpose of TRIPs according to NGOs is to make breakthrough drugs available to the poor.
But does it? Where is the evidence that compulsory licensing has really made a difference in improving health or making medicines available. The fact is, partnerships in improving infrastructure and in the development and production of new medicines are more productive than confiscation. And the fact is, patents are essential to bringing new products online every step of the way in most countries.
And what about the consequences of undermining innovation. What will happen to patented drugs in the future when they come from Indian, Singapore, China or partnerships formed by universities and the Gates Foundation?
The debate about IP and global health -- whatever that means -- has been polarized. I place most of the blame on the NGO class that is more interested in killing IP than in saving the lives of people on this planet. Drug companies have their own problems but the fact it is, the future of global health now rests in the hands of partnerships and new generation so global health entrepreneurs who most be the focus of our attention.
To this end, the following observation from www.ipgh.com is highly relevant.
We believe, under certain circumstances, that patents (as one form of IP), used solely to help achieve global health objectives, can and will speed delivery of affordable and accessible global health solutions. We also believe, under different circumstances, that patents will not help achieve these objectives and/or will hinder their attainment. Our responsibility, as IP managers and in consultation with cross-functional teams working to bring these solutions to fruition, is to determine which scenario (or ones in between) apply. When we get it "right", we save lives.
What's needed is not more interchange as to whether IP rights are "good" or "bad"; they are neither. Instead, we need to turn our attentions to how they can be used and answering highly project- and situation-specific questions like:
* Based on our experience and what we know now, can we use IP to help attain our global health objectives for this specific endeavor? If so, how?
* Might third party IP prevent us from achieving our objectives and if so, what can we do about it and when?
* What can we learn from the IP record about competitors and potential partners?
* How might we use IP management to make data and information sharing easier and hence accelerate development?
http://content.nejm.org/cgi/content/full/356/6/541?query=TOC
Wow. That's almost .005 percent of all HIV positive patients in all countries.
She goes on to note that under TRIPS WTO members have the flexibility to fine-tune what they define as inventive-step criteria to reflect national socioeconomic conditions. Which means that if NGOs and their fellow travelers want to argue that Gleevec is not really that much of a breakthrough for purposes of compulsory licensing that's ok. Which is pretty funny when you realize that the purpose of TRIPs according to NGOs is to make breakthrough drugs available to the poor.
But does it? Where is the evidence that compulsory licensing has really made a difference in improving health or making medicines available. The fact is, partnerships in improving infrastructure and in the development and production of new medicines are more productive than confiscation. And the fact is, patents are essential to bringing new products online every step of the way in most countries.
And what about the consequences of undermining innovation. What will happen to patented drugs in the future when they come from Indian, Singapore, China or partnerships formed by universities and the Gates Foundation?
The debate about IP and global health -- whatever that means -- has been polarized. I place most of the blame on the NGO class that is more interested in killing IP than in saving the lives of people on this planet. Drug companies have their own problems but the fact it is, the future of global health now rests in the hands of partnerships and new generation so global health entrepreneurs who most be the focus of our attention.
To this end, the following observation from www.ipgh.com is highly relevant.
We believe, under certain circumstances, that patents (as one form of IP), used solely to help achieve global health objectives, can and will speed delivery of affordable and accessible global health solutions. We also believe, under different circumstances, that patents will not help achieve these objectives and/or will hinder their attainment. Our responsibility, as IP managers and in consultation with cross-functional teams working to bring these solutions to fruition, is to determine which scenario (or ones in between) apply. When we get it "right", we save lives.
What's needed is not more interchange as to whether IP rights are "good" or "bad"; they are neither. Instead, we need to turn our attentions to how they can be used and answering highly project- and situation-specific questions like:
* Based on our experience and what we know now, can we use IP to help attain our global health objectives for this specific endeavor? If so, how?
* Might third party IP prevent us from achieving our objectives and if so, what can we do about it and when?
* What can we learn from the IP record about competitors and potential partners?
* How might we use IP management to make data and information sharing easier and hence accelerate development?
Perhaps the most important announcement emanating from the FDA is the past month has been the appointment of Dr. Janet Woodcock as the agency's chief medical officer.
Janet can now focus her laser-beam attention and prodigious talents towards, among other things, making the Critical Path program a major cornerstone of a 21st Century FDA.
And she will.
Janet can now focus her laser-beam attention and prodigious talents towards, among other things, making the Critical Path program a major cornerstone of a 21st Century FDA.
And she will.
A couple of months ago was attacked by a group called Breast Cancer Action for their scaremongering about the risks of mammograms for women under 50. Now it seems like that organization's efforts are also paying off:
Fewer Mammograms Means More Breast Cancer Deaths
It is a small statistic in a straightforward report. But its impact and implications are potentially huge.
From 2000 to 2005, the percentage of women age 40 and over who received a mammogram within the previous two years fell from 76.4 percent to 74.6 percent — a 1.8 percent drop.
Because in real terms, this means that thousands of women may have undetected breast cancer and could potentially miss the opportunity to save their own lives.
This wasn't really unexpected by those of us who try to keep up with current mammography practices.
My colleagues at the American Cancer Society noted a year ago that there had been a decline in mammography-screening compliance. We were also aware that there appeared to be a decline in mammography in women on Medicare, a group that is at particularly high risk of developing breast cancer."
I would like to attribute the decline to complacency (mammograms are paid for) or a fear of finding out but studies suggest otherwise. Instead, the small fall off reflects an offshoot of a growing trend of people getting medical advice from scam artists and enemies of medical progress who themselves have a financial or ideological agenda....
Now, who would you trust? Organizations that ultimately have a goal in making people healthy who make money in the process or people who make their money and get their publicity by scaring people away from seeking out and obtaining care that can save their lives? (Scientologists, Breast Cancer Action, Joseph Mercola, Kevin Trudeau, Public Citizen)
Fewer Mammograms Means More Breast Cancer Deaths
It is a small statistic in a straightforward report. But its impact and implications are potentially huge.
From 2000 to 2005, the percentage of women age 40 and over who received a mammogram within the previous two years fell from 76.4 percent to 74.6 percent — a 1.8 percent drop.
Because in real terms, this means that thousands of women may have undetected breast cancer and could potentially miss the opportunity to save their own lives.
This wasn't really unexpected by those of us who try to keep up with current mammography practices.
My colleagues at the American Cancer Society noted a year ago that there had been a decline in mammography-screening compliance. We were also aware that there appeared to be a decline in mammography in women on Medicare, a group that is at particularly high risk of developing breast cancer."
I would like to attribute the decline to complacency (mammograms are paid for) or a fear of finding out but studies suggest otherwise. Instead, the small fall off reflects an offshoot of a growing trend of people getting medical advice from scam artists and enemies of medical progress who themselves have a financial or ideological agenda....
Now, who would you trust? Organizations that ultimately have a goal in making people healthy who make money in the process or people who make their money and get their publicity by scaring people away from seeking out and obtaining care that can save their lives? (Scientologists, Breast Cancer Action, Joseph Mercola, Kevin Trudeau, Public Citizen)
I guess Gardiner Harris, the Scientologists, Eliot Spitzer, Shankar Vendantam, The New York Times editorial page, the British Medical Journal, David Graham, and everyone else who hyperventilated about the link between SSRI's and suicide were right, finally. It was hard work but it all paid off.
According to Drug Benefit Trends.."data from Medco Health Solutions showed that at the end of the first quarter of 2004, the number of persons younger than 18 receiving antidepressants declined by 18% compared with the fourth quarter of 2003; the number dropped another 5% in the second quarter of 2004.[1] This decline contrasts sharply with what had been a 77% increase in the number of filled prescriptions for antidepressants and other psychotropic medications for children and adolescents from 2000 to 2003."
http://www.medscape.com/viewarticle/504164
The result?
Kids' Suicides Rise, CDC Report Finds
By LINDSEY TANNER Tuesday, February 06, 2007
CHICAGO - New government figures show a surprising increase in youth suicides after a decade of decline, and some mental health experts think a drop in use of antidepressant drugs may be to blame.
The suicide rate climbed 18 percent from 2003 to 2004 for Americans under age 20, from 1,737 deaths to 1,985. Most suicides occurred in older teens, according to the data _ the most current to date from the federal Centers for Disease Control and Prevention.
By contrast, the suicide rate among 15- to 19-year-olds fell in previous years, from about 11 per 100,000 in 1990 to 7.3 per 100,000 in 2003.
Suicides were the only cause of death that increased for children through age 19 from 2003-04, according to a CDC report released Monday. (It should be noted that many in the media confused suicidality with suicide and never explained the difference thereafter in fanning the flames of fear.)
Here's the link to the AP article:
http://www.casperstartribune.net/articles/2007/02/06/ap/health/d8n3tp7o0.txt
According to Drug Benefit Trends.."data from Medco Health Solutions showed that at the end of the first quarter of 2004, the number of persons younger than 18 receiving antidepressants declined by 18% compared with the fourth quarter of 2003; the number dropped another 5% in the second quarter of 2004.[1] This decline contrasts sharply with what had been a 77% increase in the number of filled prescriptions for antidepressants and other psychotropic medications for children and adolescents from 2000 to 2003."
http://www.medscape.com/viewarticle/504164
The result?
Kids' Suicides Rise, CDC Report Finds
By LINDSEY TANNER Tuesday, February 06, 2007
CHICAGO - New government figures show a surprising increase in youth suicides after a decade of decline, and some mental health experts think a drop in use of antidepressant drugs may be to blame.
The suicide rate climbed 18 percent from 2003 to 2004 for Americans under age 20, from 1,737 deaths to 1,985. Most suicides occurred in older teens, according to the data _ the most current to date from the federal Centers for Disease Control and Prevention.
By contrast, the suicide rate among 15- to 19-year-olds fell in previous years, from about 11 per 100,000 in 1990 to 7.3 per 100,000 in 2003.
Suicides were the only cause of death that increased for children through age 19 from 2003-04, according to a CDC report released Monday. (It should be noted that many in the media confused suicidality with suicide and never explained the difference thereafter in fanning the flames of fear.)
Here's the link to the AP article:
http://www.casperstartribune.net/articles/2007/02/06/ap/health/d8n3tp7o0.txt
Here's a story about the regime that is seizing drug patents in Thailand. It's clear to me that the junta is taking a page from Hugo Chavez and trying to win support internationally from NGO's and liberal Dems event as popular support at home plummets. As soon as the junta, which has suppressed political freedoms and individual liberties, announced it was taking drug patents NGOs led by Jamie Love and Dems lead by Henry Waxman applauded, ignoring the lack of democracy and bolstering the junta in the process.
http://www.worldpoliticswatch.com/article.aspx?id=468
http://www.worldpoliticswatch.com/article.aspx?id=468
The real story about Thailand's seizure of drug patents is that support for the military junta that took power and imposed martial law in 2006 is collapsing under is misrule, corruption and oppression. The compulsory licensing moves are an effort to win support for the regime from human rights groups, NGOs and the international press who see any attempt to nationalize industries or seize IP, particularly pharmaceutical IP, as a strike against globallization and capitalism.
The NGOs, led by Jamie Love, have taken the bait. They are giving aid and comfort to an increasingly repressive and unpopular regime, one that is succeeding in making all foreign investors nervous. (Leave it to Big Pharma to behave like is doing something wrong and nearly apologizing. When will it ever learn?) They are joined, incredibly by six Democratic members of Congress who are urging the administration to let the junta proceed with its seizure of the patent of Abbott's HIV drug Kaletra which has had it's own policy travails in the US.
Sadly, the NGOs are quite willing to allly themselves with any government willing to break patents. That is all they care about, human rights and democracy be damned. Sad to say, the same goes for certain members of Congress.
http://www.worldpoliticswatch.com/article.aspx?id=468
The NGOs, led by Jamie Love, have taken the bait. They are giving aid and comfort to an increasingly repressive and unpopular regime, one that is succeeding in making all foreign investors nervous. (Leave it to Big Pharma to behave like is doing something wrong and nearly apologizing. When will it ever learn?) They are joined, incredibly by six Democratic members of Congress who are urging the administration to let the junta proceed with its seizure of the patent of Abbott's HIV drug Kaletra which has had it's own policy travails in the US.
Sadly, the NGOs are quite willing to allly themselves with any government willing to break patents. That is all they care about, human rights and democracy be damned. Sad to say, the same goes for certain members of Congress.
http://www.worldpoliticswatch.com/article.aspx?id=468
The FDA fares fairly well in the President's 2008 budget. Critical path gets $6.8 mill and there is an increase for other initiatives tied to modernizing drug review. And from my perspective the user fee money is tied to Critical Path type projects. So as long as it user fees are not squandered on useless book-keeping activities proposed in Kenzi and devoted to activities that truly improve the risk-benefit profile of medicines the FDA should be in decent shape. Now it's time for industry to ramp up participation in programs that make adoption of CP tools possible at the reviewer level.
By comparison the proposals put forth to turn the FDA into a parcel inspection service and fencing operation for foreign drug wholesalers, or creating a whole new drug safety agency or creating what amounts to a Smithsonian Institution for data mining of HMO data for David Graham and other risk averse zealots (proposed by IOM )will never make it past congressional budgeteers.
By comparison the proposals put forth to turn the FDA into a parcel inspection service and fencing operation for foreign drug wholesalers, or creating a whole new drug safety agency or creating what amounts to a Smithsonian Institution for data mining of HMO data for David Graham and other risk averse zealots (proposed by IOM )will never make it past congressional budgeteers.
Four members of Congress have introduced bills to bar drug companies from introducing generic versions of their own drugs during the time another generic firm are marketing their own version of that drug during the so-called 180 day market exclusivity period. I call it so-called because two generic companies can already share that exclusivity and it is clear that the exclusivity only applies to a generic company's monopoly relative to other firms that seek to challenge an innovator patent. Authorized generics promotes competition which is what the original Hatch-Waxman bill sought to do. Are these elected representatives now doing the bidding of "Big Generics?"
I was struck by the petulance of the response of Kurt Strange, the Annals of Family Medicine's editor in response to John Kamp's letter criticizing a "content analysis" of DTC ads (one person's opinion of TV ads in plain English):
DTC ads are a "tremendous intrusion" into the clinician-patient relationship, he said.
These ads "suck precious time, motivation and energy from the patient visit, forcing clinicians to educate patients about why a slickly promoted drug is not as important as a less sexy lifestyle change or even a cheaper but equally effective alternative medication.
Two insights can be gleaned from this temper tantrum:
Strange would have been, is or was a lousy and imperious physician that takes any questions from patients a direct challenge to his authority. The scenario he sets up of patients coming in asking for a drug instead of a lifestyle change or a generic drug is a fantasy. As if everyone who needs medication is either taking it or taking it properly or if patients come in just asking for a drug without a diagnosis!
The idea that educating patients is not part of the physician's duty ultimately reflects the elitist and authoritarian view of Strange and his ilk. I am not a big fan of DTC ads in general but I would rather get information on my own than instruction from a physician who regards educating patients about new medicines he or she may have found out about on their own as a waste of time or as a sign of stupidy...
DTC ads are a "tremendous intrusion" into the clinician-patient relationship, he said.
These ads "suck precious time, motivation and energy from the patient visit, forcing clinicians to educate patients about why a slickly promoted drug is not as important as a less sexy lifestyle change or even a cheaper but equally effective alternative medication.
Two insights can be gleaned from this temper tantrum:
Strange would have been, is or was a lousy and imperious physician that takes any questions from patients a direct challenge to his authority. The scenario he sets up of patients coming in asking for a drug instead of a lifestyle change or a generic drug is a fantasy. As if everyone who needs medication is either taking it or taking it properly or if patients come in just asking for a drug without a diagnosis!
The idea that educating patients is not part of the physician's duty ultimately reflects the elitist and authoritarian view of Strange and his ilk. I am not a big fan of DTC ads in general but I would rather get information on my own than instruction from a physician who regards educating patients about new medicines he or she may have found out about on their own as a waste of time or as a sign of stupidy...
Today's New York Times editorial, "Moving Toward Greater Drug Safety," makes some good points and some bad ones.
On the "good" side, the editorial recognizes that "Congress needs to give the agency more money ..." Huzzah.
On the bad side, "... and more teeth: including explicit powers to impose conditions on drugs that begin to look risky, to require additional testing and even to yank drugs from the market."
Note to New York Times editorial board: The FDA already has all those powers.
But, I suppose, the Gray Lady feels that without some anti Big Pharma rhetoric an editorial on drug safety just wouldn't be an article on drug safety. Consider how the editorial characterizes clinical trials:
"The agency has traditionally focused on the drug-approval process to determine if a drug is safe and effective. Unfortunately, by that time a drug has typically been tested in only a few hundred or a few thousand patients — too few for many kinds of adverse effects to become apparent."
Um, how about, generally speaking, tens of thousands of patients for drugs with broad population indications.
But my particular favorite is the editorialist's view of patients, "But the changes fall far short of what’s needed to protect millions of unsuspecting patients whose adverse effects may show up only after years of use."
Unsuspecting? What does that mean? I find this particularly amusing in light of the views often expressed on the pages of the New York Times on issues relating to patient empowerment and education. Yes, I mean DTC.
But, hey, it's the editorial page right?
On the "good" side, the editorial recognizes that "Congress needs to give the agency more money ..." Huzzah.
On the bad side, "... and more teeth: including explicit powers to impose conditions on drugs that begin to look risky, to require additional testing and even to yank drugs from the market."
Note to New York Times editorial board: The FDA already has all those powers.
But, I suppose, the Gray Lady feels that without some anti Big Pharma rhetoric an editorial on drug safety just wouldn't be an article on drug safety. Consider how the editorial characterizes clinical trials:
"The agency has traditionally focused on the drug-approval process to determine if a drug is safe and effective. Unfortunately, by that time a drug has typically been tested in only a few hundred or a few thousand patients — too few for many kinds of adverse effects to become apparent."
Um, how about, generally speaking, tens of thousands of patients for drugs with broad population indications.
But my particular favorite is the editorialist's view of patients, "But the changes fall far short of what’s needed to protect millions of unsuspecting patients whose adverse effects may show up only after years of use."
Unsuspecting? What does that mean? I find this particularly amusing in light of the views often expressed on the pages of the New York Times on issues relating to patient empowerment and education. Yes, I mean DTC.
But, hey, it's the editorial page right?
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.
