Latest Drugwonks' Blog
How is it that every time the debate on treating AIDS pops up (in this case triggered by a military junta in Thailand seeking to deflect criticism of its regime) it is always a re-run of the drug price issue?
Drugs are the smallest part of the cost of treating people with HIV and countries that do not improve their public health systems or increase spending on training, facilities and infrastructure will not get pills to patients. Similarly, countries that rush pills into production will promote drug resistance...
Here's a great article by Hudson Institute's Jerry Norris that makes the case against deja vu on HIV:
http://www.chinapost.com.tw/editorial/detail.asp?onNews=&GRP=i&id=96521
Drugs are the smallest part of the cost of treating people with HIV and countries that do not improve their public health systems or increase spending on training, facilities and infrastructure will not get pills to patients. Similarly, countries that rush pills into production will promote drug resistance...
Here's a great article by Hudson Institute's Jerry Norris that makes the case against deja vu on HIV:
http://www.chinapost.com.tw/editorial/detail.asp?onNews=&GRP=i&id=96521
You mean working at a pharmaceutical company isn't all about the money?
The Role of Scientific Reseachers in Pharmaceutical R&D
Source: Clinical Discovery Magazine By Jim Loftus and Dr. Mark Edwards; January/February 2007
Introduction
The road to a more effective, new medicine for use by patients is necessarily long, complex and fraught with pitfalls. For every 40 potential new drugs that show promise in vitro, only 1 or 2 ultimately become “approved†medicines 10-15 years later. It is therefore not surprising that pharmaceutical companies demand the highest calibre scientists to work in their R&D groups. In this article, we describe the roles and the potential career development opportunities within pharmaceutical R&D for two types of researcher; the Research Biologist and the R&D Clinician.
The Research Biologist
Preclinical drug discovery and development offer numerous opportunities for well trained life scientists. For any drug it is important to establish that it works, is safe for patients to take, and what happens to it once it’s administered. This is broadly the remit of Discovery Biology, Drug Safety R&D (DSRD) and Pharmacokinetics, Dynamics and Metabolism (PDM).* Entry to careers in these departments is possible at a number of levels, from school leaver to graduate to PhD, and at more senior levels. Although these departments will recruit biologists from a range of backgrounds (including Pharmacology, Physiology, Biochemistry and Molecular Biology), roles for Biomedical Scientists can be found in all departments working as part of multidisciplinary teams. Examples include histologists working in discovery programmes looking at tissue changes in disease models and the ability of experimental drugs to prevent these. In drug safety they look for drug related histopathology. Scientists with a clinical chemistry background have skills relevant to bioanalytical roles analysing pre-clinical and clinical samples for drug levels and therefore enabling pharmacokinetic profiles to be analysed. Their skills and knowledge are also useful in identifying and analysing potential efficacy and safety biomarkers, which is an area of great importance in modern drug discovery and development. Toxicology labs also have a requirement for trained pathologists to diagnose histological changes in preclinical toxicology.
For graduate entry level positions a usual requirement is a 2:1 honours degree with some practical experience. Occasionally vacancies will arise for experienced graduates with transferable skills and a flexible attitude. Factors affecting availability of these positions will be the structure of the individual company and where and how it does its research. It’s worth investigating websites of pharmaceutical companies and CROs (contract research organisations) to see what potential opportunities there are. If a lack of research or industrial experience hinders your job search, and you don’t have the opportunity to pursue this in your current environment, one solution might be to find contract work through an agency, although there is no guarantee of permanent employment at the end of a contract.
Once employed by a pharmaceutical company your career path can take various directions. Flexibility is a key word – my career took me from being a histologist (I trained in a hospital pathology laboratory) to carrying out in vitro biochemistry experiments looking at cellular metabolites, to research looking at whole animal disease models, and eventually out of the lab altogether into a training and recruitment role. Other people build their careers moving up the research ladder into roles of increasing scientific impact and responsibility. Others use their scientific training to move into any of a multitude of roles available in the pharmaceutical industry, including some of those described in the next section on clinical research.
*The names of departments with similar functions will vary from company to company. A search of individual websites is a useful way of orientating yourself to their structures and terminology.
The R&D Clinician
Clinicians working in pharmaceutical R&D usually have a medical degree with a postgraduate qualification (e.g. MRCP, MD, PhD) or a biomedical PhD with experience in clinical research. Clinical experience may be broad or highly specialised within a specific disease area.
Within the Clinical R&D department of a large company conducting research into many therapeutic areas, a clinician will gain a broad range of professional and research experience. Working within large multidisciplinary drug development teams, the central role of these “clinical research†doctors is to bring their clinical perspective to all research and development activities.
Before human clinical studies commence, the clinician must work with other research colleagues (e.g. Discovery Biology) to ensure that an appropriate level of prospective scientific thinking goes into understanding the clinical development strategy for an investigational drug. For example, is the unmet medical need fully understood i.e. which patients will potentially benefit from this new medicine? what does preclinical data suggest about the potential efficacy, tolerability and safety profiles in humans?; how will biomarkers be developed and validated?; how will theoretical, potential or actual risks be assessed and appropriately communicated? In essence, their role is to develop the clinical aspects of a “product profile†to ensure all feasible clinical uses for the new drug have been considered. This maximises the potential benefit of the medicine to patients and society.
The clinical trial is the fundamental tool of clinical research and in collaboration with colleagues in other specialties the R&D clinician is responsible for their design. Clinical trials must be designed with the highest scientific rigour as they generate the data that underpin both internal decision-making as well as approval of a new medicine by regulatory agencies. The clinician is also responsible for understanding and communicating the emerging benefit-risk of a new medicine as it progresses through the stages of clinical development.
Hopefully this gives some flavour as to how varied the role of a research clinician may be. There are various career paths for an R&D clinician that will usually depend on an individual’s area of interest. For example, someone with a good balance of technical and people-management skills could pursue either clinical team leadership or therapy area management opportunities. However, those whose interests remain more firmly centred in science and technology would probably have opportunities as senior “scientific advisersâ€. Alternatively their scientific expertise and background in “clinical application†may be usefully transferred to other departments (e.g. Discovery).
The Medical Marketing group is often the beneficiary of clinicians with R&D experience, especially if that person has taken the drug through its development to regulatory approval. In this instance the R&D clinician often brings years of medical therapy area and drug knowledge that can readily be applied to the development of marketing strategies. They can understand the totality of the research results for a medicine and ensure that product strategy and marketing is supported by a good quality evidence base. Here, the clinician would also be responsible for product positioning via the review and approval of promotional materials, interactions with key opinion leaders, sales force training and the design, medical execution and interpretation of phase 4 clinical trial programmes.
Pharmacovigilance (drug safety) is another area where clinicians with R&D experience may find career development opportunities. The ongoing review of safety data throughout a clinical programme is fundamental to the identification, assessment and management of emerging safety signals, as is the timely and comprehensive regulatory reporting of serious adverse events. These data form a pivotal component of the clinical safety summaries that are submitted to regulators as part of their review and approval process for a new medicine.
Finally, possessing a clinical background can also provide complementary skills sets to departments that are not primarily clinically or medically focussed. As well as Discovery, other departments within pharmaceutical R&D where clinicians may find rewarding development opportunities include Regulatory Affairs, Clinical/Development Operations and Science Policy and Public Affairs. A career in this industry is varied and rarely dull. Clinicians work at the cutting edge of science - interpreting this and translating it into medicines that bring benefit to patients and society. Biology is unpredictable; the attrition in our industry is high. No two days are the same and problems are often those that have never been faced before. The intellectual challenge is great. The reward when a successful medicine reaches the patient is fantastic.
Summary
The research and development of new medicines in the pharmaceutical industry is a challenging and highly rewarding career option for research scientists. Pharmaceutical R&D requires scientists of the highest calibre and while specific skills sets are needed for some individual tasks, a successful outcome i.e. the delivery of a new therapy for patients, will only happen as a consequence of integrated working within a multidisciplinary development team over a lengthy period of time. Opportunities for career development are extremely varied and reflect the multiple skills needs that a successful R&D company must have. For an individual scientist, no career path should ever be thought to be impassable or closed.
Authors
Jim Loftus GIBiol, Discovery Recruitment Manager, Pfizer Global Research and Development, Sandwich Laboratories
Dr Mark Edwards BSc MB BS FRCA, Senior Director Science Policy, Pfizer Global Research and Development, Sandwich Laboratories
The Role of Scientific Reseachers in Pharmaceutical R&D
Source: Clinical Discovery Magazine By Jim Loftus and Dr. Mark Edwards; January/February 2007
Introduction
The road to a more effective, new medicine for use by patients is necessarily long, complex and fraught with pitfalls. For every 40 potential new drugs that show promise in vitro, only 1 or 2 ultimately become “approved†medicines 10-15 years later. It is therefore not surprising that pharmaceutical companies demand the highest calibre scientists to work in their R&D groups. In this article, we describe the roles and the potential career development opportunities within pharmaceutical R&D for two types of researcher; the Research Biologist and the R&D Clinician.
The Research Biologist
Preclinical drug discovery and development offer numerous opportunities for well trained life scientists. For any drug it is important to establish that it works, is safe for patients to take, and what happens to it once it’s administered. This is broadly the remit of Discovery Biology, Drug Safety R&D (DSRD) and Pharmacokinetics, Dynamics and Metabolism (PDM).* Entry to careers in these departments is possible at a number of levels, from school leaver to graduate to PhD, and at more senior levels. Although these departments will recruit biologists from a range of backgrounds (including Pharmacology, Physiology, Biochemistry and Molecular Biology), roles for Biomedical Scientists can be found in all departments working as part of multidisciplinary teams. Examples include histologists working in discovery programmes looking at tissue changes in disease models and the ability of experimental drugs to prevent these. In drug safety they look for drug related histopathology. Scientists with a clinical chemistry background have skills relevant to bioanalytical roles analysing pre-clinical and clinical samples for drug levels and therefore enabling pharmacokinetic profiles to be analysed. Their skills and knowledge are also useful in identifying and analysing potential efficacy and safety biomarkers, which is an area of great importance in modern drug discovery and development. Toxicology labs also have a requirement for trained pathologists to diagnose histological changes in preclinical toxicology.
For graduate entry level positions a usual requirement is a 2:1 honours degree with some practical experience. Occasionally vacancies will arise for experienced graduates with transferable skills and a flexible attitude. Factors affecting availability of these positions will be the structure of the individual company and where and how it does its research. It’s worth investigating websites of pharmaceutical companies and CROs (contract research organisations) to see what potential opportunities there are. If a lack of research or industrial experience hinders your job search, and you don’t have the opportunity to pursue this in your current environment, one solution might be to find contract work through an agency, although there is no guarantee of permanent employment at the end of a contract.
Once employed by a pharmaceutical company your career path can take various directions. Flexibility is a key word – my career took me from being a histologist (I trained in a hospital pathology laboratory) to carrying out in vitro biochemistry experiments looking at cellular metabolites, to research looking at whole animal disease models, and eventually out of the lab altogether into a training and recruitment role. Other people build their careers moving up the research ladder into roles of increasing scientific impact and responsibility. Others use their scientific training to move into any of a multitude of roles available in the pharmaceutical industry, including some of those described in the next section on clinical research.
*The names of departments with similar functions will vary from company to company. A search of individual websites is a useful way of orientating yourself to their structures and terminology.
The R&D Clinician
Clinicians working in pharmaceutical R&D usually have a medical degree with a postgraduate qualification (e.g. MRCP, MD, PhD) or a biomedical PhD with experience in clinical research. Clinical experience may be broad or highly specialised within a specific disease area.
Within the Clinical R&D department of a large company conducting research into many therapeutic areas, a clinician will gain a broad range of professional and research experience. Working within large multidisciplinary drug development teams, the central role of these “clinical research†doctors is to bring their clinical perspective to all research and development activities.
Before human clinical studies commence, the clinician must work with other research colleagues (e.g. Discovery Biology) to ensure that an appropriate level of prospective scientific thinking goes into understanding the clinical development strategy for an investigational drug. For example, is the unmet medical need fully understood i.e. which patients will potentially benefit from this new medicine? what does preclinical data suggest about the potential efficacy, tolerability and safety profiles in humans?; how will biomarkers be developed and validated?; how will theoretical, potential or actual risks be assessed and appropriately communicated? In essence, their role is to develop the clinical aspects of a “product profile†to ensure all feasible clinical uses for the new drug have been considered. This maximises the potential benefit of the medicine to patients and society.
The clinical trial is the fundamental tool of clinical research and in collaboration with colleagues in other specialties the R&D clinician is responsible for their design. Clinical trials must be designed with the highest scientific rigour as they generate the data that underpin both internal decision-making as well as approval of a new medicine by regulatory agencies. The clinician is also responsible for understanding and communicating the emerging benefit-risk of a new medicine as it progresses through the stages of clinical development.
Hopefully this gives some flavour as to how varied the role of a research clinician may be. There are various career paths for an R&D clinician that will usually depend on an individual’s area of interest. For example, someone with a good balance of technical and people-management skills could pursue either clinical team leadership or therapy area management opportunities. However, those whose interests remain more firmly centred in science and technology would probably have opportunities as senior “scientific advisersâ€. Alternatively their scientific expertise and background in “clinical application†may be usefully transferred to other departments (e.g. Discovery).
The Medical Marketing group is often the beneficiary of clinicians with R&D experience, especially if that person has taken the drug through its development to regulatory approval. In this instance the R&D clinician often brings years of medical therapy area and drug knowledge that can readily be applied to the development of marketing strategies. They can understand the totality of the research results for a medicine and ensure that product strategy and marketing is supported by a good quality evidence base. Here, the clinician would also be responsible for product positioning via the review and approval of promotional materials, interactions with key opinion leaders, sales force training and the design, medical execution and interpretation of phase 4 clinical trial programmes.
Pharmacovigilance (drug safety) is another area where clinicians with R&D experience may find career development opportunities. The ongoing review of safety data throughout a clinical programme is fundamental to the identification, assessment and management of emerging safety signals, as is the timely and comprehensive regulatory reporting of serious adverse events. These data form a pivotal component of the clinical safety summaries that are submitted to regulators as part of their review and approval process for a new medicine.
Finally, possessing a clinical background can also provide complementary skills sets to departments that are not primarily clinically or medically focussed. As well as Discovery, other departments within pharmaceutical R&D where clinicians may find rewarding development opportunities include Regulatory Affairs, Clinical/Development Operations and Science Policy and Public Affairs. A career in this industry is varied and rarely dull. Clinicians work at the cutting edge of science - interpreting this and translating it into medicines that bring benefit to patients and society. Biology is unpredictable; the attrition in our industry is high. No two days are the same and problems are often those that have never been faced before. The intellectual challenge is great. The reward when a successful medicine reaches the patient is fantastic.
Summary
The research and development of new medicines in the pharmaceutical industry is a challenging and highly rewarding career option for research scientists. Pharmaceutical R&D requires scientists of the highest calibre and while specific skills sets are needed for some individual tasks, a successful outcome i.e. the delivery of a new therapy for patients, will only happen as a consequence of integrated working within a multidisciplinary development team over a lengthy period of time. Opportunities for career development are extremely varied and reflect the multiple skills needs that a successful R&D company must have. For an individual scientist, no career path should ever be thought to be impassable or closed.
Authors
Jim Loftus GIBiol, Discovery Recruitment Manager, Pfizer Global Research and Development, Sandwich Laboratories
Dr Mark Edwards BSc MB BS FRCA, Senior Director Science Policy, Pfizer Global Research and Development, Sandwich Laboratories
I had to get that headline in there...
Pfizer sells Viagra in China as "Wan Ai Ke," but argued that it also is known as "Wei Ge," or "Mighty Brother," and other companies should be barred from using that name. A court in China stiffed Pfizer's challenge to have that a ruling against them overturned.
I think I will stop now.
Pfizer loses battle over Chinese name for Viagra
Pfizer sells Viagra in China as "Wan Ai Ke," but argued that it also is known as "Wei Ge," or "Mighty Brother," and other companies should be barred from using that name. A court in China stiffed Pfizer's challenge to have that a ruling against them overturned.
I think I will stop now.
Pfizer loses battle over Chinese name for Viagra
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.
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.
