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01/16/2008 08:14 PM |
From an editorial in the American Journal of Psychiatry.
Editorial
Demonstrating Drug Action
Carol A. Tamminga, M.D.
The questions that have arisen in the public and scientific literature lately about the use of SSRIs in children and adolescents are addressed for one of the currently available SSRIs by Wagner et al. The issue of whether it is effective to use SSRIs in childhood and adolescent depression has been repeatedly raised over the last years in the context of our field failing to produce clear efficacy answers in children. Depressed children are being treated with SSRIs in greater and greater numbers, without demonstrated efficacy in the age group. The difficulty of demonstrating efficacy with tricyclic antidepressants in children has fueled suspicions that there may exist an age-dependent resistance to treatment. The importance of this well-designed large study for therapeutic strategies in children and adolescents cannot be overstated. It is important that the methodology of this study is solid and the numbers adequate to test the efficacy question asked. The result that citalopram reduced depression more than placebo in this child and adolescent population provides a clear answer for physicians that will (in combination with results from additional studies) guide treatment decisions. It is especially gratifying to see an early onset of action at 1 week of treatment, suggesting an advantage that can be followed up in future studies. This study also set a high methodologic standard for psychiatric diagnosis in pediatric studies. It would be an understatement to say that more such studies are needed.
One would always wish for more in terms of information from drug trials in psychiatric diseases. A common physician complaint about these trials is that they fail to sufficiently inform clinical practice because of restricted entry criteria, fixed-dose design, and limited duration of treatment. It is true that initial registration trials have a goal of demonstrating superiority over placebo to become approved for the market. But this does not rule out additional Phase 4 studies done in large enough patient cohorts to fully inform pressing clinical issues. How do comorbid conditions alter drug response? What treatments are effective in medication nonresponders? What kinds of actions can be expected with long-term treatment? It will be important for industry to address these kinds of Phase 4 questions for clinical use as well as the registration trials.
One particular issue in our field makes informative clinical trials particularly difficult. This is that we do not know what exactly we are treating in terms of its biology. Psychiatric diagnoses are not based on molecular pathology (rather, phenomenology), and new drugs are not directed toward known, disease-related molecules (rather, toward hypotheses). Therefore, we may not be recruiting the correct patient populations for a particular treatment nor have a drug directed toward the disease pathophysiology. Moreover, we may not be measuring anywhere near the optimal outcome measures in our trials (e.g., consider the constraint of only measuring "fatigue" in the treatment of anemia, and not having a RBC count). Nonetheless, even though we do not yet have our molecular targets, we cannot give up on drug development. Indeed, we already have treatments for our diseases, and these may be better treatments than we deserve, based on the state of our knowledge. We need now to hone the treatments that we have and develop the valuable clinical trial methodologies to carry us into the future. Meanwhile, we need to translate the rich basic knowledge accumulating in neuroscience into advances for therapeutics.
http://ajp.psychiatryonline.org/cgi/content/full/161/6/943?etoc Read More & Comment...
Editorial
Demonstrating Drug Action
Carol A. Tamminga, M.D.
The questions that have arisen in the public and scientific literature lately about the use of SSRIs in children and adolescents are addressed for one of the currently available SSRIs by Wagner et al. The issue of whether it is effective to use SSRIs in childhood and adolescent depression has been repeatedly raised over the last years in the context of our field failing to produce clear efficacy answers in children. Depressed children are being treated with SSRIs in greater and greater numbers, without demonstrated efficacy in the age group. The difficulty of demonstrating efficacy with tricyclic antidepressants in children has fueled suspicions that there may exist an age-dependent resistance to treatment. The importance of this well-designed large study for therapeutic strategies in children and adolescents cannot be overstated. It is important that the methodology of this study is solid and the numbers adequate to test the efficacy question asked. The result that citalopram reduced depression more than placebo in this child and adolescent population provides a clear answer for physicians that will (in combination with results from additional studies) guide treatment decisions. It is especially gratifying to see an early onset of action at 1 week of treatment, suggesting an advantage that can be followed up in future studies. This study also set a high methodologic standard for psychiatric diagnosis in pediatric studies. It would be an understatement to say that more such studies are needed.
One would always wish for more in terms of information from drug trials in psychiatric diseases. A common physician complaint about these trials is that they fail to sufficiently inform clinical practice because of restricted entry criteria, fixed-dose design, and limited duration of treatment. It is true that initial registration trials have a goal of demonstrating superiority over placebo to become approved for the market. But this does not rule out additional Phase 4 studies done in large enough patient cohorts to fully inform pressing clinical issues. How do comorbid conditions alter drug response? What treatments are effective in medication nonresponders? What kinds of actions can be expected with long-term treatment? It will be important for industry to address these kinds of Phase 4 questions for clinical use as well as the registration trials.
One particular issue in our field makes informative clinical trials particularly difficult. This is that we do not know what exactly we are treating in terms of its biology. Psychiatric diagnoses are not based on molecular pathology (rather, phenomenology), and new drugs are not directed toward known, disease-related molecules (rather, toward hypotheses). Therefore, we may not be recruiting the correct patient populations for a particular treatment nor have a drug directed toward the disease pathophysiology. Moreover, we may not be measuring anywhere near the optimal outcome measures in our trials (e.g., consider the constraint of only measuring "fatigue" in the treatment of anemia, and not having a RBC count). Nonetheless, even though we do not yet have our molecular targets, we cannot give up on drug development. Indeed, we already have treatments for our diseases, and these may be better treatments than we deserve, based on the state of our knowledge. We need now to hone the treatments that we have and develop the valuable clinical trial methodologies to carry us into the future. Meanwhile, we need to translate the rich basic knowledge accumulating in neuroscience into advances for therapeutics.
http://ajp.psychiatryonline.org/cgi/content/full/161/6/943?etoc Read More & Comment...
01/16/2008 07:45 PM |
Can the NY Times be anymore hypocritical pontificating about drug companies cooking the books on clinical trials when it has transparently done so with respect in it's efforts to depict our soldiers as homicidal maniacs?
And this is not the first time that a so-called objective source has fudged numbers in favor of an agenda. A Soros-funded researcher was behind the oft-stated, inaccurate, but never retracted number of 450,000 deaths due to the Iraq war that ran in Lancet. Read this article from the National Journal about this debacle. In the report the authors also note a study that ran in Lancet by a guy who fakes a story on the heels of the Vioxx scare about the risks of other anti-inflammatory meds. The media bought it hook line and sinker because it wasn't pharma funded. I am sure Health Care ReSewer commented favorably.
Of course the research was not paid for by Pharma so there is no bias.
More on so-called objective no-ax to grind types who criticize us that receive Soros and tort lawyer funding later. Read More & Comment...
And this is not the first time that a so-called objective source has fudged numbers in favor of an agenda. A Soros-funded researcher was behind the oft-stated, inaccurate, but never retracted number of 450,000 deaths due to the Iraq war that ran in Lancet. Read this article from the National Journal about this debacle. In the report the authors also note a study that ran in Lancet by a guy who fakes a story on the heels of the Vioxx scare about the risks of other anti-inflammatory meds. The media bought it hook line and sinker because it wasn't pharma funded. I am sure Health Care ReSewer commented favorably.
Of course the research was not paid for by Pharma so there is no bias.
More on so-called objective no-ax to grind types who criticize us that receive Soros and tort lawyer funding later. Read More & Comment...
01/16/2008 06:13 PM |
The NEJM of medicine recycles the old story that many of negative studies about antidepressants were not published. That doesn't affect whether the drugs work or not. It does add to the distortion of what a negative study is and why they are negative. Most of the time they are negative because they simply confirm the hypothesis. Other times they are poorly designed or small studies of little statistical power. They don't prove that the drugs fail. There is a difference. Taken together they can often help guide who responds to what medicines or why not...which again is why we need the Critical Path.
To suggest that the failure to publish negative studies is part of a coverup is wrong and leads to fearmongering once again. We have been down this road. And journalists are once again raising unfounded fears about the safety and efficacy of drugs...leading people to die because they stop taking medicines because of the fearmongering the media has engaged in regarding vaccines, SSRIs, Avandia, Vioxx and Vytorin. As for the public relations benefit of publishing negative studies...there is none. Just the opposite. I am afraid the willingness to confuse negative studies with "doesn't work" will lead to further congressional and media assaults on the scientific process. We will all be sicker and more imperiled for it.
To wit:
Lawmakers Have Vytorin Questions
By ANNA WILDE MATHEWS
January 16, 2008 5:08 p.m.
Congress is investigating advertising for the cholesterol-busting drug Vytorin in the wake of a study that suggested the pill may have no advantage over a generic cholesterol-lowering medicine.
In letters dated today and addressed to Schering-Plough Corp. and Merck & Co., which jointly sell Vytorin, and to the U.S. Food and Drug Administration, Reps. John Dingell and Bart Stupak, Michigan Democrats, raised questions about the ads for the medicine. The news was first reported in The Wall Street Journal' Health Blog.
In the letter to the companies, the congressmen wrote that the House of Representatives' Committee on Energy and Commerce and its Subcommittee on Oversight and Investigations are probing the "withholding of clinical trial data that may significantly affect the medical management of hypercholesterolemia, as well as the use of misleading statement in direct-to-consumer advertisements for prescription medicines."
Vytorin is in the news this week after the results of a long-awaited study, called Enhance, indicating that the drug may be no better than a generic statin at slowing the progression of heart disease.
http://online.wsj.com/article/SB120051737443695313.html?mod=googlenews_wsj
Or this...courtesy of Time magazine via fearmonger Steve Nissen:
Tuesday, Jan. 15, 2008
Is Vytorin a Failure?
By Alice Park
After nearly two years of waiting, the results came out on Monday on the long-awaited heart drug Vytorin — and the news wasn't good. Vytorin's manufacturers, Merck and Schering-Plough, announced that while the drug reduced levels of LDL, or bad cholesterol, in a group of 750 patients, the medication, which has been on the market since 2004, had little effect on the buildup of plaque in the arteries, a harbinger of heart attack and stroke.
To many experts, the results were both a surprise and a warning. "The fact that the trial showed a huge LDL" — or bad cholesterol — "reduction, and that things were still going the wrong way [as far as plaque buildup went] is stunning," says Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic and an outspoken critic of the delay in the release of the study results. "This study shows that it matters how you lower cholesterol, not just how much you lower cholesterol."
Right. It pays to release negative studies. At least the researchers put their name on the study. The same thing can't be said about Nissen.
http://www.time.com/time/health/article/0,8599,1703827,00.html Read More & Comment...
To suggest that the failure to publish negative studies is part of a coverup is wrong and leads to fearmongering once again. We have been down this road. And journalists are once again raising unfounded fears about the safety and efficacy of drugs...leading people to die because they stop taking medicines because of the fearmongering the media has engaged in regarding vaccines, SSRIs, Avandia, Vioxx and Vytorin. As for the public relations benefit of publishing negative studies...there is none. Just the opposite. I am afraid the willingness to confuse negative studies with "doesn't work" will lead to further congressional and media assaults on the scientific process. We will all be sicker and more imperiled for it.
To wit:
Lawmakers Have Vytorin Questions
By ANNA WILDE MATHEWS
January 16, 2008 5:08 p.m.
Congress is investigating advertising for the cholesterol-busting drug Vytorin in the wake of a study that suggested the pill may have no advantage over a generic cholesterol-lowering medicine.
In letters dated today and addressed to Schering-Plough Corp. and Merck & Co., which jointly sell Vytorin, and to the U.S. Food and Drug Administration, Reps. John Dingell and Bart Stupak, Michigan Democrats, raised questions about the ads for the medicine. The news was first reported in The Wall Street Journal' Health Blog.
In the letter to the companies, the congressmen wrote that the House of Representatives' Committee on Energy and Commerce and its Subcommittee on Oversight and Investigations are probing the "withholding of clinical trial data that may significantly affect the medical management of hypercholesterolemia, as well as the use of misleading statement in direct-to-consumer advertisements for prescription medicines."
Vytorin is in the news this week after the results of a long-awaited study, called Enhance, indicating that the drug may be no better than a generic statin at slowing the progression of heart disease.
http://online.wsj.com/article/SB120051737443695313.html?mod=googlenews_wsj
Or this...courtesy of Time magazine via fearmonger Steve Nissen:
Tuesday, Jan. 15, 2008
Is Vytorin a Failure?
By Alice Park
After nearly two years of waiting, the results came out on Monday on the long-awaited heart drug Vytorin — and the news wasn't good. Vytorin's manufacturers, Merck and Schering-Plough, announced that while the drug reduced levels of LDL, or bad cholesterol, in a group of 750 patients, the medication, which has been on the market since 2004, had little effect on the buildup of plaque in the arteries, a harbinger of heart attack and stroke.
To many experts, the results were both a surprise and a warning. "The fact that the trial showed a huge LDL" — or bad cholesterol — "reduction, and that things were still going the wrong way [as far as plaque buildup went] is stunning," says Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic and an outspoken critic of the delay in the release of the study results. "This study shows that it matters how you lower cholesterol, not just how much you lower cholesterol."
Right. It pays to release negative studies. At least the researchers put their name on the study. The same thing can't be said about Nissen.
http://www.time.com/time/health/article/0,8599,1703827,00.html Read More & Comment...
01/16/2008 01:35 PM |
A non-addictive drug for chronic pain? A breakthrough that sounds too good to be true. And to make matters worse, it's an "just" an "incremental improvement on an existing medication." And horrors of horrors, the brains behind this Clifford Woolf -- one of the world's experts on the molecular pathways of pain -- has been (sorry to say) a consultant to several drug companies.
So obviously nothing he develops can be trusted. Particularly if it relies on techniques developed through partnerships created to promote the Critical Path via the Reagan Udall Foundation.
A poisoned source will only produce poison. Especially if the funding is from Big Pharma at any point in time it's forever tainted and untrustworthy. Everything else said and done and funded from all other sources can be relied on without a doubt.
So the rule of thumb(s) should be. Let us call them the Poses Postulates in honor of Roy Poses MD of the Health Care Renewal bog who believes that anyone who receives any funding from Pharma cannot be trusted.
Don't trust Pharma research or the researchers they pay.
Don't trust the drugs they produce or market since the FDA is nothing but a tool or client of Pharma.
Don't use any drugs, especially those developed since PDUFA was enacted since that institutionalized the incest.
So if and when these new pain drugs come out...those who abide by this ideological approach to prescribing should avoid these treatments out of precaution and principle.
Read More
Right Dr. Poses? Read More & Comment...
So obviously nothing he develops can be trusted. Particularly if it relies on techniques developed through partnerships created to promote the Critical Path via the Reagan Udall Foundation.
A poisoned source will only produce poison. Especially if the funding is from Big Pharma at any point in time it's forever tainted and untrustworthy. Everything else said and done and funded from all other sources can be relied on without a doubt.
So the rule of thumb(s) should be. Let us call them the Poses Postulates in honor of Roy Poses MD of the Health Care Renewal bog who believes that anyone who receives any funding from Pharma cannot be trusted.
Don't trust Pharma research or the researchers they pay.
Don't trust the drugs they produce or market since the FDA is nothing but a tool or client of Pharma.
Don't use any drugs, especially those developed since PDUFA was enacted since that institutionalized the incest.
So if and when these new pain drugs come out...those who abide by this ideological approach to prescribing should avoid these treatments out of precaution and principle.
Read More
Right Dr. Poses? Read More & Comment...
01/16/2008 12:05 PM |
Who do you trust? The New York Times editorial page or the consensus statement of the American College of Cardiology which said with regard to Vytorin:
"The study involved 720 patients with heterozygous familial hypercholesterolemia and showed no significant difference in the primary endpoint between patients treated with ezetimibe and simvastatin versus patients treated with simvastatin alone over a two-year period. The study was designed to prove that Vytorin could slow the growth of plaque in carotid arteries supplying the brain more than simvastatin alone. Media reports indicate that the results of the trial show no benefit from the combination of ezetimibe (Zetia) and simvastatin (sold together as Vytorin) over simvastatin alone.
The American College of Cardiology recommends that major clinical decisions not be made on the basis of the ENHANCE study alone."
According to the American College of Cardiology (ACC), this study deserves serious thought and follow-up. The overall incidence rates of cardiac events were nearly identical between both treatment groups, and both medicines were generally well tolerated. There should no be reason for patients to panic. The difference in IMT changes between the simvastatin group and the Vytorin group was 0.006 mm vs. 0.011 mm.
Health care professionals should speak to their concerned patients using this drug. The ACC is also releasing a public statement explaining that this is not an urgent situation and patients should never stop taking any prescribed medications without first discussing the issue with their health care professional. Further research will be needed in this area to provide conclusive evidence about which lipid lowering strategy is preferred (statin alone vs. statin plus ezetimibe).
Furthermore, the ACC notes that this trial is an imaging study and not a clinical-outcome study. Conclusions should not be made until the three large clinical-outcome trials are presented within the next two to three years. The ACC recommends that Zetia remain a reasonable option for patients who are currently on a high dose statin but have not reached their goal. The ACC also notes that Zetia is a reasonable option for patients who cannot tolerate statins or can only tolerate a low dose statin.
On the subject of endpoints and markers. The Critical Path is not about using surrogate endpoints. Anyone who has listened to Dr. Woodcock more than once knows it is about finding and qualifying biomarkers -- molecular and imaging -- that predict disease progression and outcome as well as response to treatment -- as well as developing novel statistical ways that can be deployed across divisions and technologies to advance understanding of technology impact on disease.
The issue in the ENHANCE study was whether or not imaging studies were accurate measures of disease progression in this small population. Nothing more or less. In this regard, development of better standards and predictive imaging studies will help advance their use in clinical trials. Also let's remember that Dr. Nissen, who has trashed the results might be a bit biased since his own imaging studies demonstrated a regression of atherosclerosis by reducing LDL levels with another drug, something the NY Times failed to point out. And let's remember Dr. Nissen also tossed out imaging studies in another clinical trial looking at plaque regression because they were unreadable, so he just looked at the results of the readable ones.
At the risk of repeating myself again and again -- here's a link to the story we repeated when the MSM was looking for a Vytorin coverup months ago.
http://www.thestreet.com/pf/comment/adamfeuerstein/10195643.html
The problem with the Atherogenic drug that Nissen worked on was the same one -- more or less -- the scientists running the ENHANCE study struggled with. Namely, the statistical correlation was hard to measure because of the unwieldy nature of the biomarker. In each study, patients taking the drug did better than patients taking a placebo on most endpoints, just not on the endpoint most difficult to measure. But unlike the Nissen re-analysis, ENHANCE did not do an interim analysis with fewer patients to produce a benefit. The debate was whether or not to chuck the analysis altogether because of questions about the reliability of the biomarker.
Which is what the Critical Path is all about.
No need to panic or disregard your doctor in favor of the medical advice dispensed by the fearmongers and Pharm-haters on the NY Times editorial page. Read More & Comment...
"The study involved 720 patients with heterozygous familial hypercholesterolemia and showed no significant difference in the primary endpoint between patients treated with ezetimibe and simvastatin versus patients treated with simvastatin alone over a two-year period. The study was designed to prove that Vytorin could slow the growth of plaque in carotid arteries supplying the brain more than simvastatin alone. Media reports indicate that the results of the trial show no benefit from the combination of ezetimibe (Zetia) and simvastatin (sold together as Vytorin) over simvastatin alone.
The American College of Cardiology recommends that major clinical decisions not be made on the basis of the ENHANCE study alone."
According to the American College of Cardiology (ACC), this study deserves serious thought and follow-up. The overall incidence rates of cardiac events were nearly identical between both treatment groups, and both medicines were generally well tolerated. There should no be reason for patients to panic. The difference in IMT changes between the simvastatin group and the Vytorin group was 0.006 mm vs. 0.011 mm.
Health care professionals should speak to their concerned patients using this drug. The ACC is also releasing a public statement explaining that this is not an urgent situation and patients should never stop taking any prescribed medications without first discussing the issue with their health care professional. Further research will be needed in this area to provide conclusive evidence about which lipid lowering strategy is preferred (statin alone vs. statin plus ezetimibe).
Furthermore, the ACC notes that this trial is an imaging study and not a clinical-outcome study. Conclusions should not be made until the three large clinical-outcome trials are presented within the next two to three years. The ACC recommends that Zetia remain a reasonable option for patients who are currently on a high dose statin but have not reached their goal. The ACC also notes that Zetia is a reasonable option for patients who cannot tolerate statins or can only tolerate a low dose statin.
On the subject of endpoints and markers. The Critical Path is not about using surrogate endpoints. Anyone who has listened to Dr. Woodcock more than once knows it is about finding and qualifying biomarkers -- molecular and imaging -- that predict disease progression and outcome as well as response to treatment -- as well as developing novel statistical ways that can be deployed across divisions and technologies to advance understanding of technology impact on disease.
The issue in the ENHANCE study was whether or not imaging studies were accurate measures of disease progression in this small population. Nothing more or less. In this regard, development of better standards and predictive imaging studies will help advance their use in clinical trials. Also let's remember that Dr. Nissen, who has trashed the results might be a bit biased since his own imaging studies demonstrated a regression of atherosclerosis by reducing LDL levels with another drug, something the NY Times failed to point out. And let's remember Dr. Nissen also tossed out imaging studies in another clinical trial looking at plaque regression because they were unreadable, so he just looked at the results of the readable ones.
At the risk of repeating myself again and again -- here's a link to the story we repeated when the MSM was looking for a Vytorin coverup months ago.
http://www.thestreet.com/pf/comment/adamfeuerstein/10195643.html
The problem with the Atherogenic drug that Nissen worked on was the same one -- more or less -- the scientists running the ENHANCE study struggled with. Namely, the statistical correlation was hard to measure because of the unwieldy nature of the biomarker. In each study, patients taking the drug did better than patients taking a placebo on most endpoints, just not on the endpoint most difficult to measure. But unlike the Nissen re-analysis, ENHANCE did not do an interim analysis with fewer patients to produce a benefit. The debate was whether or not to chuck the analysis altogether because of questions about the reliability of the biomarker.
Which is what the Critical Path is all about.
No need to panic or disregard your doctor in favor of the medical advice dispensed by the fearmongers and Pharm-haters on the NY Times editorial page. Read More & Comment...
01/16/2008 10:58 AM |
As Mark Twain -- an author of choice here at drugwonks -- once said: "Presume you were an idiot. Then presume you were a member of Congress. But I repeat myself."
Can any be so stupid and petty as to quibble about having the inventor of the artificial heart promoting as important a drug as Lipitor?
Apparently Bart Stupak and John Dingell think it rises to a high enough crime to demand a congressional investigation. And Katie Watson of the Medical Humanities and Bioethics Program at Northwestern University agrees: "To have a celebrity physician associated with cardiac health telling me I need Lipitor and when it costs significantly more than a generic alternative that might be appropriate for me— that's a physician motivated by a paycheck, not by patient health."
Let it be noted that Ms. Watson is famous for her lecture "Playing Doctor: Improvisational Theater & the Medical Encounter" which was presented at the Searle Seminar Room in the Medical Humanites and Bioethics building. That's Searle, as in the drug company, better known as Pharmacia which is now part of...you guessed it...Pfizer.
But I digress. So apparently it is unethical to have a famous doctor who does not practice medicine promoting a brand drug that works. It is ethical to have someone playing doctor promote a generic drug that doesn't? Or how about a Nobel Prize Winner who is no longer licensed promoting a new drug? And how does Ms. Watson know if the Nobel Prize winner is motivated by a paycheck and not patient health? Is it wrong to accept a paycheck in the process of advancing patient care by being a spokesperson.
Back to Ms. Watson. " Katie is also the author of the screenplay Sperm Daddy, and a contributor to the TimeOut Chicago humor back page and the WBEZ news magazine 848." I wonder if she is motivated by a paycheck or patient health?
http://www.sirensimprov.com/katie.html Read More & Comment...
Can any be so stupid and petty as to quibble about having the inventor of the artificial heart promoting as important a drug as Lipitor?
Apparently Bart Stupak and John Dingell think it rises to a high enough crime to demand a congressional investigation. And Katie Watson of the Medical Humanities and Bioethics Program at Northwestern University agrees: "To have a celebrity physician associated with cardiac health telling me I need Lipitor and when it costs significantly more than a generic alternative that might be appropriate for me— that's a physician motivated by a paycheck, not by patient health."
Let it be noted that Ms. Watson is famous for her lecture "Playing Doctor: Improvisational Theater & the Medical Encounter" which was presented at the Searle Seminar Room in the Medical Humanites and Bioethics building. That's Searle, as in the drug company, better known as Pharmacia which is now part of...you guessed it...Pfizer.
But I digress. So apparently it is unethical to have a famous doctor who does not practice medicine promoting a brand drug that works. It is ethical to have someone playing doctor promote a generic drug that doesn't? Or how about a Nobel Prize Winner who is no longer licensed promoting a new drug? And how does Ms. Watson know if the Nobel Prize winner is motivated by a paycheck and not patient health? Is it wrong to accept a paycheck in the process of advancing patient care by being a spokesperson.
Back to Ms. Watson. " Katie is also the author of the screenplay Sperm Daddy, and a contributor to the TimeOut Chicago humor back page and the WBEZ news magazine 848." I wonder if she is motivated by a paycheck or patient health?
http://www.sirensimprov.com/katie.html Read More & Comment...
01/16/2008 10:10 AM |
Have a look at today’s New York Times house editorial, “Cholesterol Drug Bombs.â€
http://www.nytimes.com/2008/01/16/opinion/16wed2.html?_r=1&ref=opinion&oref=slogin
There are a number of issues going on here, but pay particular attention to these two paragraphs:
“There are reasons to be cautious about interpreting these results. The number of patients was relatively small. And many of them may have used different drug treatments for years before entering the trial, possibly diminishing the effectiveness of adding Zetia …
The findings also raise doubts about the current belief that lowering cholesterol is the key to cardiovascular health. The study showed that Vytorin reduced bad cholesterol significantly more than Zocor alone. The problem was that it failed to reduce the formation of plaque.â€
Here’s what well-respected cardiologist (and CMPI board chairman) Dr. Michael Weber has to say:
“The study with Vytorin looked only at surrogate endpoints, not morbidity and mortality. The ongoing clinical outcomes trials will answer the questions definitively. We must hope that the alarmist comments by certain opinion leaders quoted in the lay press will not compromise the integrity of these critical studies by intimidating the patients who have been enrolled. We should not forget that many people simply cannot use statins in full doses due to side effects, so properly studying Zetia and Vytorin is absolutely vital.â€
As to whether or not clinical data was withheld (or as the Times writes, “cynically" sat on) is another issue altogether and cannot be allowed to muddy the far more important clinical questions. Read More & Comment...
http://www.nytimes.com/2008/01/16/opinion/16wed2.html?_r=1&ref=opinion&oref=slogin
There are a number of issues going on here, but pay particular attention to these two paragraphs:
“There are reasons to be cautious about interpreting these results. The number of patients was relatively small. And many of them may have used different drug treatments for years before entering the trial, possibly diminishing the effectiveness of adding Zetia …
The findings also raise doubts about the current belief that lowering cholesterol is the key to cardiovascular health. The study showed that Vytorin reduced bad cholesterol significantly more than Zocor alone. The problem was that it failed to reduce the formation of plaque.â€
Here’s what well-respected cardiologist (and CMPI board chairman) Dr. Michael Weber has to say:
“The study with Vytorin looked only at surrogate endpoints, not morbidity and mortality. The ongoing clinical outcomes trials will answer the questions definitively. We must hope that the alarmist comments by certain opinion leaders quoted in the lay press will not compromise the integrity of these critical studies by intimidating the patients who have been enrolled. We should not forget that many people simply cannot use statins in full doses due to side effects, so properly studying Zetia and Vytorin is absolutely vital.â€
As to whether or not clinical data was withheld (or as the Times writes, “cynically" sat on) is another issue altogether and cannot be allowed to muddy the far more important clinical questions. Read More & Comment...
01/16/2008 06:04 AM |
Representative Rosa DeLauro has introduced the Cloned Food Labeling Act, which would require the FDA and the Department of Agriculture (USDA) to mandate that all food derived from cloned animals be labeled.
She’s not happy with the FDA’s stance on the safety of food:
“The studies on which the FDA is basing its assessment include very little information on the specific question of whether food from cloned animals is safe."
But, according to the FDA, the agency has "studies that show that the meat and milk from cattle clones and their offspring are as safe as that from conventionally bred animals."
The agency has been studying this issue in great detail for a very long period of time. In fact, many of the world's leading experts on this issue work at the FDA's Center for Veterinary Medicine. During my tenure at the FDA (which ended in 2004), this issue was already being deeply investigated and intensely debated.
Representative DeLauro, rather than shooting from the hip, should call the FDA and ask for a briefing. Read More & Comment...
She’s not happy with the FDA’s stance on the safety of food:
“The studies on which the FDA is basing its assessment include very little information on the specific question of whether food from cloned animals is safe."
But, according to the FDA, the agency has "studies that show that the meat and milk from cattle clones and their offspring are as safe as that from conventionally bred animals."
The agency has been studying this issue in great detail for a very long period of time. In fact, many of the world's leading experts on this issue work at the FDA's Center for Veterinary Medicine. During my tenure at the FDA (which ended in 2004), this issue was already being deeply investigated and intensely debated.
Representative DeLauro, rather than shooting from the hip, should call the FDA and ask for a briefing. Read More & Comment...
01/15/2008 01:51 PM |
How can we trust that the drugs will be safe or effective? Since Gates Foundation President Yamada is under investigation by Senator Grassley and Cong. DeLauro for his role in talking to Dr. John Buse about Avandia nearly a decade ago, obviously any money he doles out while at Gates must be considered tainted and therefore the results of any studies cannot be trusted. And if the orphan drug for sleeping sickness uses Critical Path steps developed by the Reagan Udall Foundation how do we know they actually are not steps that weaken standards of safety and efficacy to simply line the pockets of the company that the Gates Foundation gave the grant to? We all know that's what the Critical Path is all about: watering down standards so that foundations can give grants to companies who in turn can develop at cost an orphan drug that is neither safe or effective because it uses biomarkers.
http://www.nytimes.com/2008/01/08/health/research/08slee.html?_r=1&ref=health&oref=slogin Read More & Comment...
http://www.nytimes.com/2008/01/08/health/research/08slee.html?_r=1&ref=health&oref=slogin Read More & Comment...
01/15/2008 01:39 PM |
I took Senator Grassley to task for suggesting that unhappy reviewers and other malcontents air the grievances and differences with FDA division decisions at AdComm meetings a while back. Now from the other side, people and companies who complain about the lack of consistent or guidance from the FDA regarding the reason for holding up an approval also want transparency.
Transparency is the refuge of those who, short of being able to control the outcome, want to at least try to control perception. The FDA needs less transparency and more consistency based on better science. And it needs leadership regarding the question of "Whose life and health care decision is it anyway?" The Critical Path is designed to help shift that decisionmaking to doctors and individuals.
What I'd like to know is, where do the presidential candidates stand on The Critical Path? Do they care? Or are they more interested in making sure there are cheap knock offs of old drugs and faster FDA inspections for UPS shipments of medicines ordered online?
http://www.fool.com/investing/high-growth/2008/01/14/score-one-for-dendreon-and-disclosure.aspx Read More & Comment...
Transparency is the refuge of those who, short of being able to control the outcome, want to at least try to control perception. The FDA needs less transparency and more consistency based on better science. And it needs leadership regarding the question of "Whose life and health care decision is it anyway?" The Critical Path is designed to help shift that decisionmaking to doctors and individuals.
What I'd like to know is, where do the presidential candidates stand on The Critical Path? Do they care? Or are they more interested in making sure there are cheap knock offs of old drugs and faster FDA inspections for UPS shipments of medicines ordered online?
http://www.fool.com/investing/high-growth/2008/01/14/score-one-for-dendreon-and-disclosure.aspx Read More & Comment...
01/15/2008 01:26 PM |
While lots of folks are making much ado about whether or not to readjust the athero endpoint of the Vytorin study because of hard to read ultrasounds (remember Steve Nissen and Atherogenics?) the the results of the study demonstrate, once again, just how hard it is to use statins to get reversal of plaque. We need better drugs. Good article from cnn.com on what the study shows and don't. Ignore the Congressional witchhunt threats and the whining of the "Kill Pharma Even If People Die" bloggers...
http://money.cnn.com/news/newsfeeds/articles/djf500/200801141513DOWJONESDJONLINE000640_FORTUNE5.htm Read More & Comment...
http://money.cnn.com/news/newsfeeds/articles/djf500/200801141513DOWJONESDJONLINE000640_FORTUNE5.htm Read More & Comment...
01/15/2008 12:42 PM |
My book review of Embryo: A Defense of Human Life...
http://www.nypost.com/seven/01132008/postopinion/postopbooks/the_born_identity_433669.htm Read More & Comment...
http://www.nypost.com/seven/01132008/postopinion/postopbooks/the_born_identity_433669.htm Read More & Comment...
01/15/2008 12:09 PM |
Here are two of the qualities Leon Wieseltier in The New Republic like about about John McCain that make him a nearly ideal presidential candidate. "anxiety over the environment and contempt for pharmaceutical companies."
Contempt for pharmaceutical companies? And how does that translate into good public policy? Pushing for drug reimportation? Patent seizures?
I think there is a bit of projection on Leon's part but what prompts this hatred? What did drug company's do wrong that deserves contempt? I know this will tick off the whack jobs that equate anything that is sponsored by drug companies as a pollutant or a criminal activity, but I really would like to know. Read More & Comment...
Contempt for pharmaceutical companies? And how does that translate into good public policy? Pushing for drug reimportation? Patent seizures?
I think there is a bit of projection on Leon's part but what prompts this hatred? What did drug company's do wrong that deserves contempt? I know this will tick off the whack jobs that equate anything that is sponsored by drug companies as a pollutant or a criminal activity, but I really would like to know. Read More & Comment...
01/15/2008 09:07 AM |
The U.S. Supreme Court has, without comment, opted not to accept an appeal of Abigail Alliance v. von Eschenbach. This means the federal appeals court ruling that patients do not have a constitutional right to experimental drugs stands.
This is a tough, emotional issue and, with such heated rhetoric on both sides, it's easy to lose sight of the fact that everyone wants the same thing -- expanded access to drugs under clinical investigation.
That's precisely why, when I was at the FDA, we stopped calling clinical trials "compassionate use." It sounded too paternalistic. Allowing desperately ill patients into clinical trial programs shouldn't be an act of noblesse oblige it should be an act of civil society.
The question is, how to do so with greater alacrity and responsible, robust oversight.
When it comes to pharmaceutical safety, pure libertarianism isn't in the best interests of the public health. Expanded access to experimental drugs simply can't and shouldn't morph into total, unfettered access.
That doesn't mean the status quo is working. What it means is that the FDA needs to figure out a way to dramatically broaden and facilitate expanded access to experimental drugs under its review. And the Abigail Alliance and its supporters need to keep up the pressure to reform the current system.
We believe this is best done in a spirit of collegiality rather than a confrontational courtroom or in Congress.
And we believe the time for all parties to sit down for serious discussions is immediately. Lives hang in the balance. Read More & Comment...
This is a tough, emotional issue and, with such heated rhetoric on both sides, it's easy to lose sight of the fact that everyone wants the same thing -- expanded access to drugs under clinical investigation.
That's precisely why, when I was at the FDA, we stopped calling clinical trials "compassionate use." It sounded too paternalistic. Allowing desperately ill patients into clinical trial programs shouldn't be an act of noblesse oblige it should be an act of civil society.
The question is, how to do so with greater alacrity and responsible, robust oversight.
When it comes to pharmaceutical safety, pure libertarianism isn't in the best interests of the public health. Expanded access to experimental drugs simply can't and shouldn't morph into total, unfettered access.
That doesn't mean the status quo is working. What it means is that the FDA needs to figure out a way to dramatically broaden and facilitate expanded access to experimental drugs under its review. And the Abigail Alliance and its supporters need to keep up the pressure to reform the current system.
We believe this is best done in a spirit of collegiality rather than a confrontational courtroom or in Congress.
And we believe the time for all parties to sit down for serious discussions is immediately. Lives hang in the balance. Read More & Comment...
01/14/2008 07:52 AM |
Page One story in today's New York Times continues the debate over whether or not fibromyalgia is a "real" disease. After all -- it's just a "women's problem," right?
Why is this on Page One? Surprise! Because one of the storylines is about how evil drug companies (in cahoots with the FDA) are spending money creating and promoting drugs for this faux syndrome.
But there is one paragraph worth sharing. The focus is on why the FDA chose to approve Lyrica (pregabalin) -- with an indication for treating fibromyalgia -- over the objection of some (unnamed) junior reviewers.
“While pregabalin does present a number of concerns related to its potential for toxicity, the overall risk-to-benefit ratio supports the approval of this product,†Dr. Bob Rappaport, the director of the F.D.A. division reviewing the drug, wrote in June 2004.
Risk. Benefit. Fibromyalgia. Millions of women. Millions of dollars. After all, if Pharma can help -- then there must be a hidden agenda. Ergo, pitch it for Page One, baby.
Nonsense. What would Hillary say? Someone should ask her about this during the next debate?
At the end of the day, it's a balanced article and an interesting issue. Alex Berenson does a nice job. But there's nothing new. Isn't there any real news that can be reported on the wood of our nation's newspaper of record? Read More & Comment...
Why is this on Page One? Surprise! Because one of the storylines is about how evil drug companies (in cahoots with the FDA) are spending money creating and promoting drugs for this faux syndrome.
But there is one paragraph worth sharing. The focus is on why the FDA chose to approve Lyrica (pregabalin) -- with an indication for treating fibromyalgia -- over the objection of some (unnamed) junior reviewers.
“While pregabalin does present a number of concerns related to its potential for toxicity, the overall risk-to-benefit ratio supports the approval of this product,†Dr. Bob Rappaport, the director of the F.D.A. division reviewing the drug, wrote in June 2004.
Risk. Benefit. Fibromyalgia. Millions of women. Millions of dollars. After all, if Pharma can help -- then there must be a hidden agenda. Ergo, pitch it for Page One, baby.
Nonsense. What would Hillary say? Someone should ask her about this during the next debate?
At the end of the day, it's a balanced article and an interesting issue. Alex Berenson does a nice job. But there's nothing new. Isn't there any real news that can be reported on the wood of our nation's newspaper of record? Read More & Comment...
01/14/2008 06:46 AM |
Click here:
http://www.kvue.com/video/index.html?vid=207443
Then look under "HealthVue Video: Experts: Know where your health info comes from."
And we do. Read More & Comment...
http://www.kvue.com/video/index.html?vid=207443
Then look under "HealthVue Video: Experts: Know where your health info comes from."
And we do. Read More & Comment...
01/11/2008 06:55 AM |
For those of you watching EU policy on information to patients (“ITP†in EU parlance), there are two documents worth discussing.
The first is “Communication from the Commission to the European Parliament and the Council Concerning the Report on Current Practice with Regard to Provisions of Information to Patients on Medicinal Products’
(I know, it sounds like the title of a Jonathan Swift essay)
I quote directly:
“The provision of information on medicinal products requires taking into consideration the needs of patients in the context of healthcare provision.â€
Once you get past all the banal bureaucratic gobbledygook, there’s some pretty interesting bureaucratic gobbledygook.
(Is there someone somewhere in a secret, secure location in Brussels named Werner van den Gobbledygook who edits all these EU documents?)
“Most sources available point to the increasingly active role of patients in this regard; patients have a right to be informed and in this context they should be able to access information about their health, medical conditions and the availability of treatments.â€
A crucial point – but if the delivery of information is placed in the hands of governments (aka "payors") – will “availability of treatments†be defined as “what will be reimbursed†or will the full panoply of options be presented to newly empowered European patients? This is not just a finesse question, but rather hits at the heart of the matter. He who controls the access to knowledge controls the knowledge.
“Patients are no longer simply taking what is prescribed for them, but are increasingly involved as manager of their health. They become intensely involved with their illness, show great interest in health issues and have a constantly growing need for information.â€
This is an elliptical way of saying that, when patients learn that they are being denied treatment because of cost-based vs. patient-centric government care schemes, they get upset – very upset.
And finally, “Recent evidence indicates that patients are however often unsuccessful in playing a larger role in their health decisions.â€
Even though government health care limits, by definition, many health care options, the lack of information adds to that dilemma. According to the report, “Although there is insufficient evidence published, an increase in the quality and appropriateness of information available to patients would be expected to contribute to achieve better health conditions and also to contribute to a more efficient use of resources. Better informed patients are expected to adhere better to treatments and to better understand clinical decisions. This should lead in the long term to social and economic benefits.â€
That’s right. And, once you plod your way through all the conditional phrasing, the report is saying that more information results in better outcomes which reduces costs. Amen. But when they say there is “insufficient evidence,†what they’re really saying is that there’s actually a lot of solid research – except that it pertains to the positive benefits of direct to consumer advertising. But at least they’ve embraced the concept that more information is better.
Unfortunately the report also calls for the EU to “keep the ban on direct to consumer advertising on prescription-only medicines.†(For more on this point, please see “Will Brussels DTC the Light?" at http://drugwonks.com/2006/10/will_brussels_dtc_the_light.html.) But that's another issue for another time.
Towards the end of the report, this refreshingly honest statement:
“Member States authorities may not be in a position to fully address patients’ needs in terms of the substance of information and the access via different means. In turn, the pharmaceutical industry possesses the key information on their medicines but this information can currently not be made available to patients and healthcare professionals throughout the EU.â€
So much for Health Action International (HAI) who claims, “There is no health information gap in Europe.â€
And then there’s the companion document, “Commission Staff Working Document: Background information supportive to the Communication from the Commission to the European Parliament and the Council concerning the Report on Current Practice with Regard to Provision of Information to Patients on Medicinal Products, in the form of different annexesâ€
(Indeed, the titles just keep getting sexier, pithier, and more lyrical).
Again, I quote directly:
“Pharmaceutical companies possess key information about their products which only in part (through leaflets and labels) is made available to the public. Consequently, the pharmaceutical industry has the potential to be an important source of information to respond to the growing demand for more and better information by patients and to help reduce the current information gap, provided that there will be adequate rules to ensure reliability, objectivity, and quality of information.â€
And, “Like many patient organizations most pharmaceutical companies argue that information should be of high quality and not be judged by its source. These companies want to be able to produce non-promotional information for patients about their own medicines and diseases and make it public.â€
EU Commission recognition that the pharmaceutical industry can be a valuable partner in the broader dissemination of timely and accurate health care information is an important step in the right direction.
And it’s about time because, as Julian Morris of the London-based International Policy Network quipped, “Europe is running out of failed alternatives.†Read More & Comment...
The first is “Communication from the Commission to the European Parliament and the Council Concerning the Report on Current Practice with Regard to Provisions of Information to Patients on Medicinal Products’
(I know, it sounds like the title of a Jonathan Swift essay)
I quote directly:
“The provision of information on medicinal products requires taking into consideration the needs of patients in the context of healthcare provision.â€
Once you get past all the banal bureaucratic gobbledygook, there’s some pretty interesting bureaucratic gobbledygook.
(Is there someone somewhere in a secret, secure location in Brussels named Werner van den Gobbledygook who edits all these EU documents?)
“Most sources available point to the increasingly active role of patients in this regard; patients have a right to be informed and in this context they should be able to access information about their health, medical conditions and the availability of treatments.â€
A crucial point – but if the delivery of information is placed in the hands of governments (aka "payors") – will “availability of treatments†be defined as “what will be reimbursed†or will the full panoply of options be presented to newly empowered European patients? This is not just a finesse question, but rather hits at the heart of the matter. He who controls the access to knowledge controls the knowledge.
“Patients are no longer simply taking what is prescribed for them, but are increasingly involved as manager of their health. They become intensely involved with their illness, show great interest in health issues and have a constantly growing need for information.â€
This is an elliptical way of saying that, when patients learn that they are being denied treatment because of cost-based vs. patient-centric government care schemes, they get upset – very upset.
And finally, “Recent evidence indicates that patients are however often unsuccessful in playing a larger role in their health decisions.â€
Even though government health care limits, by definition, many health care options, the lack of information adds to that dilemma. According to the report, “Although there is insufficient evidence published, an increase in the quality and appropriateness of information available to patients would be expected to contribute to achieve better health conditions and also to contribute to a more efficient use of resources. Better informed patients are expected to adhere better to treatments and to better understand clinical decisions. This should lead in the long term to social and economic benefits.â€
That’s right. And, once you plod your way through all the conditional phrasing, the report is saying that more information results in better outcomes which reduces costs. Amen. But when they say there is “insufficient evidence,†what they’re really saying is that there’s actually a lot of solid research – except that it pertains to the positive benefits of direct to consumer advertising. But at least they’ve embraced the concept that more information is better.
Unfortunately the report also calls for the EU to “keep the ban on direct to consumer advertising on prescription-only medicines.†(For more on this point, please see “Will Brussels DTC the Light?" at http://drugwonks.com/2006/10/will_brussels_dtc_the_light.html.) But that's another issue for another time.
Towards the end of the report, this refreshingly honest statement:
“Member States authorities may not be in a position to fully address patients’ needs in terms of the substance of information and the access via different means. In turn, the pharmaceutical industry possesses the key information on their medicines but this information can currently not be made available to patients and healthcare professionals throughout the EU.â€
So much for Health Action International (HAI) who claims, “There is no health information gap in Europe.â€
And then there’s the companion document, “Commission Staff Working Document: Background information supportive to the Communication from the Commission to the European Parliament and the Council concerning the Report on Current Practice with Regard to Provision of Information to Patients on Medicinal Products, in the form of different annexesâ€
(Indeed, the titles just keep getting sexier, pithier, and more lyrical).
Again, I quote directly:
“Pharmaceutical companies possess key information about their products which only in part (through leaflets and labels) is made available to the public. Consequently, the pharmaceutical industry has the potential to be an important source of information to respond to the growing demand for more and better information by patients and to help reduce the current information gap, provided that there will be adequate rules to ensure reliability, objectivity, and quality of information.â€
And, “Like many patient organizations most pharmaceutical companies argue that information should be of high quality and not be judged by its source. These companies want to be able to produce non-promotional information for patients about their own medicines and diseases and make it public.â€
EU Commission recognition that the pharmaceutical industry can be a valuable partner in the broader dissemination of timely and accurate health care information is an important step in the right direction.
And it’s about time because, as Julian Morris of the London-based International Policy Network quipped, “Europe is running out of failed alternatives.†Read More & Comment...
01/10/2008 03:23 PM |
We are used to the usual beside the point rejoinders when people disagree with us. I'm linking to this particular one because, well, it's so feisty and original. At least Dr. Poses actually read what I wrote and responded substantively. Like calling me a tool of Big Pharma. And we had a meeting of the minds on comparative effectiveness. Oh well.
Here's the post below...
http://hcrenewal.blogspot.com/2008/01/sceptical-look-at-dire-warning-is.html#links
That health care in the US is now in a crisis is now a cliche. Finding our way out of this crisis requires logical discussion based on evidence, not half-truths and irrelevancies promulgated by people with hidden financial ties.
What does promulgated mean? Is that how you get MRSA? Read More & Comment...
Here's the post below...
http://hcrenewal.blogspot.com/2008/01/sceptical-look-at-dire-warning-is.html#links
That health care in the US is now in a crisis is now a cliche. Finding our way out of this crisis requires logical discussion based on evidence, not half-truths and irrelevancies promulgated by people with hidden financial ties.
What does promulgated mean? Is that how you get MRSA? Read More & Comment...
01/10/2008 01:31 PM |
The organization formerly known as the Association of Trial Lawyers of America (ATLA) -- the NewSpeak-named American Association for Justice -- doesn’t like our study on the dangers of Internet health care information.
We must be doing something right.
According to the president of the association, Kathleen Flynn Peterson, “How can anyone take these groups seriously when they release studies based on a methodology of Google searches?â€
Kathy -- it was a study about Internet searches. Google -- get it?
Since we're asking questions, here's one for Ms. Peterson -- Why are tort lawyers masquerading as health care advocates on Google in the first place? Read More & Comment...
We must be doing something right.
According to the president of the association, Kathleen Flynn Peterson, “How can anyone take these groups seriously when they release studies based on a methodology of Google searches?â€
Kathy -- it was a study about Internet searches. Google -- get it?
Since we're asking questions, here's one for Ms. Peterson -- Why are tort lawyers masquerading as health care advocates on Google in the first place? Read More & Comment...
01/10/2008 09:26 AM |
The recent article in the NEJM has the results of a carefully researched genomic analysis that included scientists from several institutes. The study was elegant -- comparing families and children with autism spectrum disorder (all independently adjudicated) with controls that did not along with those that had a bipolar diagnosis and therefore shared a genetic duplication and deletion on Chromosome 16p11.2 The analysis was run a three platforms and cross referenced to assure inter-reliabiity of results The consortium found that "a region of chromosome 16p11.2 influences susceptibility to autism when it is either deleted or duplicated" in about 1 percent of all cases. This adds to the growing body of knowledge that autism has multiple genetic sources
But that won't stop the fanatics and their propagandists like David Kirby who claim that it is something else, even if it isn't thimerasol, just as long as it is something that corporations are pushing in a dark conspiracy with the government:
"All that said, thimerosal may well not be a factor in a single case of autism. But what if one day, we discovered it had caused, say, one percent of all cases? With estimates of autism as high as 1.5 million in the country, that would mean 15,000 Americans who were ravaged by thimerosal (not to mention everyone overseas).
But if thimerosal is vindicated, or shown to be a very minor player, then what about other vaccine ingredients? And what about the rather crowded vaccine schedule we now impose upon families of young children? And what about reports of unvaccinated children in Illinois, California and Oregon who appear to have significantly lower rates of autism? Shouldn't we throw some research dollars into studying them?
You can answer that, no, we shouldn't, because the vaccine-autism debate is over.
But I am willing to wager that it has only just begun."
I hear the black choppers whirling overhead.
http://content.nejm.org/cgi/content/full/NEJMoa075974 Read More & Comment...
But that won't stop the fanatics and their propagandists like David Kirby who claim that it is something else, even if it isn't thimerasol, just as long as it is something that corporations are pushing in a dark conspiracy with the government:
"All that said, thimerosal may well not be a factor in a single case of autism. But what if one day, we discovered it had caused, say, one percent of all cases? With estimates of autism as high as 1.5 million in the country, that would mean 15,000 Americans who were ravaged by thimerosal (not to mention everyone overseas).
But if thimerosal is vindicated, or shown to be a very minor player, then what about other vaccine ingredients? And what about the rather crowded vaccine schedule we now impose upon families of young children? And what about reports of unvaccinated children in Illinois, California and Oregon who appear to have significantly lower rates of autism? Shouldn't we throw some research dollars into studying them?
You can answer that, no, we shouldn't, because the vaccine-autism debate is over.
But I am willing to wager that it has only just begun."
I hear the black choppers whirling overhead.
http://content.nejm.org/cgi/content/full/NEJMoa075974 Read More & Comment...
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