Latest Drugwonks' Blog
Sanofi Aventis' vaccine division received approval for the first vaccine to protect against bird flu. According to the FDA the vaccine, has been approved for use only in adults aged 18-64 who are at a greater risk of being affected by the bird flu virus. The patients will receive a 90 microgram of shot initially and then another 90 microgram after 28 days.
Given that bird flu was first detected a few years ago, the speed with which a vaccine was developed is truly a marvel. And most of the vaccine will be donated or sold at cost. But don't expect any articles on that. Rather, expect a rash of media stories on whether the vaccine is being marketed to the right people and whether the researchers conducting studies on the vaccine's effectiveness received money from SA.
As I always say, no good deed goes unpunished.
Given that bird flu was first detected a few years ago, the speed with which a vaccine was developed is truly a marvel. And most of the vaccine will be donated or sold at cost. But don't expect any articles on that. Rather, expect a rash of media stories on whether the vaccine is being marketed to the right people and whether the researchers conducting studies on the vaccine's effectiveness received money from SA.
As I always say, no good deed goes unpunished.
For those of you out there (yes, that means you Marcia Angell) who think we have "too many me-too drugs," consider yesterday's FDA adcomm vote on Avalide.
FDA advisers voted 7-0 in favor of approving the drug for use in controlling high blood pressure. (Avalide was initially approved only for hypertension patients who have failed other types of treatment.)
You've heard of hypertension, right? It's one of those made-up lifestyle diseases.
If the Me-Tooers were running the show, would Avalide have been approved in the first place? After all, do we really need another drug that treats hypertension?
Indeed we do -- and now physicians have a new, valuable, and on-label weapon in their fight against a major public health enemy -- high blood pressure.
FDA advisers voted 7-0 in favor of approving the drug for use in controlling high blood pressure. (Avalide was initially approved only for hypertension patients who have failed other types of treatment.)
You've heard of hypertension, right? It's one of those made-up lifestyle diseases.
If the Me-Tooers were running the show, would Avalide have been approved in the first place? After all, do we really need another drug that treats hypertension?
Indeed we do -- and now physicians have a new, valuable, and on-label weapon in their fight against a major public health enemy -- high blood pressure.
From the FBI.... I might be wrong but I don't see "taking an SSRI" on the list
1. A history of violence and/or being victimized
2. Threats of violence
3. An obsessive interest in weapons
4. A tendency to be isolated
5. The inability to get along with others
6. Excessive anger
7. Job loss
8. Breakup of a relationship
9. Alcohol and drug usage
10. Intolerance of differences
11. Gang affiliation
12. Poor attachment to school
13. Exhibiting impulsive behavior
14. Making violent drawings or writings
1. A history of violence and/or being victimized
2. Threats of violence
3. An obsessive interest in weapons
4. A tendency to be isolated
5. The inability to get along with others
6. Excessive anger
7. Job loss
8. Breakup of a relationship
9. Alcohol and drug usage
10. Intolerance of differences
11. Gang affiliation
12. Poor attachment to school
13. Exhibiting impulsive behavior
14. Making violent drawings or writings
As this story unfolds drugwonks will highlight what appears to be the critical factor in this tragedy in order to stave off the j'accuse from the anti-medication mob who are quick to blame ever senseless act of adolescent violence on the use of drugs to treat mental illness. Now in this case it would appear that the killer was psychotic -- not depressed -- and had been through the entire judicial-mental health system before being allowed go "outpatient" where he completely lost contact with any systematic care.
So we will be interested to see how that squares with efforts by the mob and the media to draw a direct link between a single medication that may or may not have been in his system at the time he carried out his plot and the massacre.
The lunatic fringe, led by Scientologists and quacks peddling 'natural cures' for everything from Alzheimer's to schizophrenia, are already polluting the blogosphere with lies and half truths claiming that Cho Seung-Hui was on SSRIs.
http://vitalvotes.com/blogs/public_blog/Could-Antidepressants-Explain-the-Virginia-Tech-Massacre--10928.aspx
http://winnipeg.indymedia.org/item.php?5048S
As countless studies show, such medications will make people with tendencies towards violence, less not more so.
So we will be interested to see how that squares with efforts by the mob and the media to draw a direct link between a single medication that may or may not have been in his system at the time he carried out his plot and the massacre.
The lunatic fringe, led by Scientologists and quacks peddling 'natural cures' for everything from Alzheimer's to schizophrenia, are already polluting the blogosphere with lies and half truths claiming that Cho Seung-Hui was on SSRIs.
http://vitalvotes.com/blogs/public_blog/Could-Antidepressants-Explain-the-Virginia-Tech-Massacre--10928.aspx
http://winnipeg.indymedia.org/item.php?5048S
As countless studies show, such medications will make people with tendencies towards violence, less not more so.
Our colleague Ed Silverman generated a lot of controversy with his post that rumors that the VA Tech killer was on medication at some point might trigger another attack on drug companies about the alleged dangers of SSRIs.
Here's my take:
While I pin the blame on the media for over-hyping and misrepresenting the risks of SSRI's -- particularly the clinical trials involving children who have co-morbidities, misdiagnoses, etc. -- the fact is tha fear sells paper just as violence sells video games. The fact is, that as horrible as this campus shooting is, school related shootings are rare and violence on college campuses has declined because of increased security, increased counseling, etc., etc. And moreover, according to FBI crime stats, a college campus is ten times safer than than the US as a whole.
While I am on the subject, and excuse me for saying it and maybe I have a little more leeway for saying this because of my own family experience, but I am tired of the press using perpetually enraged parents who blame the death of their kid's on prescription drugs. There are thousands of children who take their own lives who who never get medication and thousands more who have pulled themselves from the abyss because of such drugs. Who are they to lecture the rest of us about the motives of drug companies and science of medicine. I am sorry for their loss but I have been through hell too. They have no monopoly on sorrow and portraying them as victims of antidepressants is inaccurate and unfair. Give it a rest!
You don't want your kids to be on anti-depressants. Fine. But stop pouring gasoline on a subject with ignorance and fear. And don't exploit a tragedy by using it to scare other parents into seeking appropriate care for their kids. As for the media, you have the facts now. Use them.
Here's my take:
While I pin the blame on the media for over-hyping and misrepresenting the risks of SSRI's -- particularly the clinical trials involving children who have co-morbidities, misdiagnoses, etc. -- the fact is tha fear sells paper just as violence sells video games. The fact is, that as horrible as this campus shooting is, school related shootings are rare and violence on college campuses has declined because of increased security, increased counseling, etc., etc. And moreover, according to FBI crime stats, a college campus is ten times safer than than the US as a whole.
While I am on the subject, and excuse me for saying it and maybe I have a little more leeway for saying this because of my own family experience, but I am tired of the press using perpetually enraged parents who blame the death of their kid's on prescription drugs. There are thousands of children who take their own lives who who never get medication and thousands more who have pulled themselves from the abyss because of such drugs. Who are they to lecture the rest of us about the motives of drug companies and science of medicine. I am sorry for their loss but I have been through hell too. They have no monopoly on sorrow and portraying them as victims of antidepressants is inaccurate and unfair. Give it a rest!
You don't want your kids to be on anti-depressants. Fine. But stop pouring gasoline on a subject with ignorance and fear. And don't exploit a tragedy by using it to scare other parents into seeking appropriate care for their kids. As for the media, you have the facts now. Use them.
What if fewer people find out about important new medicines while at the same time critics pan new products and scaremongers push panic about side effects leading to those quacks who sell to good to be true cures to rake in profits at the expense of the sick and scared?
Power abhors a vacuum. So does information.
Power abhors a vacuum. So does information.
In the wake of the terrible tragedy at Virginia Tech comes yet another study demonstrating that the use of anti-depressants in adolescents -- carefully monitored -- are useful in treating various forms of depression, anxiety, panic disorder, etc. No major paper or media outlet which gave David Graham or others front page coverage of the threats or the misrepresentation of the dangers of SSRIs are now giving the benefits of these medications the same top of the fold treatment.
For those of you who want to see how such fear mongering can lead to a decline in the use of effective treatment and therefore an increase in violent behavior that in fact leads to suicide and tragic death, we now present one Graham's typical statements on SSRI's
"With the SSRIs [Selective Serotonin Re-Uptake Inhibitors, the class of antidepressants including Prozac and Paxil], I think FDA pulled a fast one on the American people. Because they said, �we are using our most powerful labeling, our most powerful medicine: we�re putting a black box around it.� But it doesn�t change physician behavior. People are as unsafe after the labeling goes into effect as they were before.
With the SSRI labeling, people are actually more deceived. Because the labeling says that the risk of suicidal thoughts and behavior in children is 1-2 percent. But FDA�s own senior managers admitted at an open public advisory committee meeting that our clinical trials don�t capture suicidal thoughts and behavior. So what we know about it is what has been voluntarily reported. There are lots more out there, we just didn�t measure them. They have evidence from an NIH clinical trial that the risk is more like 8 percent. "
http://multinationalmonitor.org/mm2004/122004/interview-graham.html
Members of Congress and senior officials of the FDA should be ashamed of themselves for giving Graham the chance to not only rant on about Vioxx and SSRIs but to make the same claims about Ketek and drugs for schizophrenia.
For those of you who want to see how such fear mongering can lead to a decline in the use of effective treatment and therefore an increase in violent behavior that in fact leads to suicide and tragic death, we now present one Graham's typical statements on SSRI's
"With the SSRIs [Selective Serotonin Re-Uptake Inhibitors, the class of antidepressants including Prozac and Paxil], I think FDA pulled a fast one on the American people. Because they said, �we are using our most powerful labeling, our most powerful medicine: we�re putting a black box around it.� But it doesn�t change physician behavior. People are as unsafe after the labeling goes into effect as they were before.
With the SSRI labeling, people are actually more deceived. Because the labeling says that the risk of suicidal thoughts and behavior in children is 1-2 percent. But FDA�s own senior managers admitted at an open public advisory committee meeting that our clinical trials don�t capture suicidal thoughts and behavior. So what we know about it is what has been voluntarily reported. There are lots more out there, we just didn�t measure them. They have evidence from an NIH clinical trial that the risk is more like 8 percent. "
http://multinationalmonitor.org/mm2004/122004/interview-graham.html
Members of Congress and senior officials of the FDA should be ashamed of themselves for giving Graham the chance to not only rant on about Vioxx and SSRIs but to make the same claims about Ketek and drugs for schizophrenia.
My latest oped on how Democrats (mostly, but not all) -- led by the incredibly clueless Debbie Stabenow -- are subverting medical science (and proper spelling) for the sake of ideology in the area of pharmaceutical regulation. And it's going to get worse this week and the next when the same Jacobins seek to destroy what is now sensible drug safety legislation with amendments on drug importation and other nonsense. Maybe AARP will offer me another pedometer for calling my Congressman on these important issues.
Or maybe not.
http://washingtontimes.com/op-ed/20070417-091721-8233r.htm
Or maybe not.
http://washingtontimes.com/op-ed/20070417-091721-8233r.htm
A new IMS Health report posits that, “The billions of dollars thrown at global health problems by the Bill & Melinda Gates Foundation are changing the game in drug discovery, posing big challenges to the world's top drug makers.â€
"Pharma companies need to develop an explicit strategy to deal with this phenomenon," IMS said in its annual Intelligence.360 report on factors shaping the industry.
According to the report, the foundation’s $60 billion gives it plentiful resources to compete in the medical research arena with both government-funded institutions and commercial pharmaceutical firms.
IMS believes that, even if drug companies succeed in making key discoveries first, they may still find it attractive to partner with the Gates Foundations, from a practical and public relations point of view.
Well, that’s all to the good – but what the report doesn’t mention is that discovery and development is still a very difficult proposition.
Drugwonks challenges the Gates Foundation to become a major player in the FDA’s Critical Path program – because the best way to get new cures to market faster is to develop the 21st tools required to expedite discovery and development.
Here’s the link to the Reuters story on the IMS report:
http://news.yahoo.com/s/nm/20070417/hl_nm/gates_pharmaceuticals_dc_1
"Pharma companies need to develop an explicit strategy to deal with this phenomenon," IMS said in its annual Intelligence.360 report on factors shaping the industry.
According to the report, the foundation’s $60 billion gives it plentiful resources to compete in the medical research arena with both government-funded institutions and commercial pharmaceutical firms.
IMS believes that, even if drug companies succeed in making key discoveries first, they may still find it attractive to partner with the Gates Foundations, from a practical and public relations point of view.
Well, that’s all to the good – but what the report doesn’t mention is that discovery and development is still a very difficult proposition.
Drugwonks challenges the Gates Foundation to become a major player in the FDA’s Critical Path program – because the best way to get new cures to market faster is to develop the 21st tools required to expedite discovery and development.
Here’s the link to the Reuters story on the IMS report:
http://news.yahoo.com/s/nm/20070417/hl_nm/gates_pharmaceuticals_dc_1
Late last month, an important study in JAMA showed that patients in a high LDL cholesterol group from 130 to 160 did not show a progression of carotid plaque when receiving rosuvastatin compared with control. This study was a breakthrough in terms of primary prevention though the results are not surprising, and many internists, myself included, were already treating many of the members of this group with statins. Carotid plaque is predictive of coronary plaque, and previous studies have shown plaque stabilization with atorvastatin in patients with heart disease leading to a diminishing of subsequent cardiac events. (secondary prevention)
Here is the new JAMA study on rosuvastatin - it would be interesting to follow this up with a study that looked at whether bringing down LDL to less than 80 with diet alone, gave the same results in terms of plaque as when a statin is used.
http://jama.ama-assn.org/cgi/content/full/297/12/1376
Here is the new JAMA study on rosuvastatin - it would be interesting to follow this up with a study that looked at whether bringing down LDL to less than 80 with diet alone, gave the same results in terms of plaque as when a statin is used.
http://jama.ama-assn.org/cgi/content/full/297/12/1376
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.
