Latest Drugwonks' Blog
Anyone who has taken a look at the recent research review Comparative Effectiveness of Therapies for Clinically Localized Prostate Cancer should say a prayer that the EBM thought police do not get control over the practice of medicine in America under the banner of cost containment OR conflict of interest. The "guidelines", if you can call them that, are drivel, essentially conceding two points: First, that patient and tumor characateristics heavily influence treatment selections and do so over the course of disease. Second -- and by extension -- that clinical expertise matters. But of course many oncologist with the best expertise fail the holier than thou COI standard imposed by those who hide their agenda under the purity banner (the capitalism=corruption=corrupt medicine coalition). As the panels to decide what is best practice are picked, you can be sure that their will be tribunals, inquests, witchhunts and general suppression of the ability of any one who consults with pharma or biotech companies, anyone who has a research contract or runs a clinical trial for a drug company will be purged of participation. This is nothing short than an attack on intellectual freedom as harsh and as unrelenting as anything seen in the sciences or liberal arts in recent years. And this is not a matter of forcing college kids to do research on reasons why Bush should be impeached. This boils down to a bunch of autocrats trying to dictate to the rest of us a politically correct form of medicine....
For a taste of force-fed medicine to come:
http://effectivehealthcare.ahrq.gov/healthInfo.cfm?infotype=rr&ProcessID=9&DocID=79
For a taste of force-fed medicine to come:
http://effectivehealthcare.ahrq.gov/healthInfo.cfm?infotype=rr&ProcessID=9&DocID=79
The President's new budget for the FDA allocates $68 million more for drugs and biologics in FY 2009. Backing out user fees which that's a real increase of $10 million. So core functions are finally getting user fee money and some real inflation adjusted increase. But it's not enough. That just allows the FDA to begin to dig into the science deficit years of political neglect have piled on the agency. There is still no additional money for Critical Path or other efforts that actually focus on improving the scientific integrity of the agency.
For starters we could take all the Ag Approp earmarks flowing into the the district of Rosa DelLauro who chairs that subcommittee and who has as her informal science advisers the anti-medical progress Center for Science in the Public Interest and Union of Conceited Scientists. DeLauro hogged $25.4 million in earmarks for herself last session while cutting funding for the Reagan Udall foundation that is established to help the FDA find ways to speed up the translation of basic research into personalized tools for testing cures for cancer and other illnesses that apparently can't be earmarked. DeLauro's earmarks are twice the increase the President has allocated for FDA core operations.
No that earmarks alone would be enough. I think we are coming to a time when the user fee program has outlived it's usefulness in its current structure. This last go round showed that user fee money is better used for Critical Path activities and that the user fee process dwells on the cause de jour to a more orderly and integrated oversight and funding of FDA operations. Maybe that's a starting point for everyone agreeing on a better, less political way to address the FDA's -- and the public's -- long term public health needs.
For starters we could take all the Ag Approp earmarks flowing into the the district of Rosa DelLauro who chairs that subcommittee and who has as her informal science advisers the anti-medical progress Center for Science in the Public Interest and Union of Conceited Scientists. DeLauro hogged $25.4 million in earmarks for herself last session while cutting funding for the Reagan Udall foundation that is established to help the FDA find ways to speed up the translation of basic research into personalized tools for testing cures for cancer and other illnesses that apparently can't be earmarked. DeLauro's earmarks are twice the increase the President has allocated for FDA core operations.
No that earmarks alone would be enough. I think we are coming to a time when the user fee program has outlived it's usefulness in its current structure. This last go round showed that user fee money is better used for Critical Path activities and that the user fee process dwells on the cause de jour to a more orderly and integrated oversight and funding of FDA operations. Maybe that's a starting point for everyone agreeing on a better, less political way to address the FDA's -- and the public's -- long term public health needs.
And speaking of surveys …
Another "survey" came out today -- the President’s budget proposal. No line for Critical Path – and, considering inflation, a decrease in federal appropriations for human drugs.
Here’s what Commissioner von Eschenbach had to say, ““This budget enables us to continue development of the staff and programs necessary to safeguard the food we eat and improve the safety and development of drugs, vaccines, devices, and other medical products.â€
I don’t think so -- and Happy Talk isn't helping.
Another "survey" came out today -- the President’s budget proposal. No line for Critical Path – and, considering inflation, a decrease in federal appropriations for human drugs.
Here’s what Commissioner von Eschenbach had to say, ““This budget enables us to continue development of the staff and programs necessary to safeguard the food we eat and improve the safety and development of drugs, vaccines, devices, and other medical products.â€
I don’t think so -- and Happy Talk isn't helping.
A new national survey shows that Americans overwhelmingly support the FDA’s Critical Path Initiative. The survey was comprised of a nationally representative sample of 1,049 adults and conducted by Opinion Research Corporation. It was commissioned by the Center for Medicine in the Public Interest and iGuard Inc.
When asked about Critical Path, nine in 10 Americans expressed support. The Critical Path Initiative was launched by the FDA in 2004 to streamline drug development.
The survey also examined attitudes regarding key features of Critical Path. When asked about the FDA's efforts to expand the use of biomarkers to identify which drugs are best for individual patients, 78 percent of those surveyed were supportive.
The survey also found that 77 percent of the public supports partnerships between private companies, the FDA, and academics to create new approaches to drug evaluation and development.
And nearly 80 percent want their member of Congress to support Critical Path.
Survey respondents also expressed support for a voluntary, confidential, online portal where patients could share information about their reactions to different drugs. 87 percent said such a program would boost their confidence in drug safety, and 50 percent said they would take part.
Day in and day out, congressional lawmakers bash the FDA. That may score political points, but the public’s support for this program should send a strong message to Congress: Don’t cut funding from the Critical Path Initiative.
For the full report, click below
http://www.cmpi.org
And then under "Reports" click on "Critical Path National Research Report."
When asked about Critical Path, nine in 10 Americans expressed support. The Critical Path Initiative was launched by the FDA in 2004 to streamline drug development.
The survey also examined attitudes regarding key features of Critical Path. When asked about the FDA's efforts to expand the use of biomarkers to identify which drugs are best for individual patients, 78 percent of those surveyed were supportive.
The survey also found that 77 percent of the public supports partnerships between private companies, the FDA, and academics to create new approaches to drug evaluation and development.
And nearly 80 percent want their member of Congress to support Critical Path.
Survey respondents also expressed support for a voluntary, confidential, online portal where patients could share information about their reactions to different drugs. 87 percent said such a program would boost their confidence in drug safety, and 50 percent said they would take part.
Day in and day out, congressional lawmakers bash the FDA. That may score political points, but the public’s support for this program should send a strong message to Congress: Don’t cut funding from the Critical Path Initiative.
For the full report, click below
http://www.cmpi.org
And then under "Reports" click on "Critical Path National Research Report."
Yes, Virginia, while some media will exploit public health myths for their own venal purposes, others can play an important role in advancing the public health.
By now you are certainly familiar with the controversy surrounding the ABC program “Eli Stone†– where the title character (an attorney who has spiritual visions) goes to court to prove that childhood vaccinations cause autism.
Well, rather than piling on to the already crowded anti-pharma bandwagon, here is what the New York Times said in an editorial:
“Nevermind that such authoritative bodies as the Institute of Medicine of the National Academy of Sciences, the Centers for Disease Control and Prevention and the World Health Organization have found no evidence of a causal link. Nevermind that the incidence of autism continued to rise even after mercury preservatives were phased out of almost all childhood vaccines. As far as Eli Stone is concerned, you can’t just rely on science. Sometimes you have to go on faith.
The American Academy of Pediatrics tried unsuccessfully to get the episode canceled, fearing that it could deter parents from getting their children vaccinated, exposing them to far greater dangers from disease. Let’s hope that any parents who watched don’t make that mistake. And let’s hope that in future episodes, Eli Stone and ABC show better judgment in picking causes.â€
Here is a link to the editorial in its entirety:
http://www.nytimes.com/2008/02/02/opinion/02sat4.html?_r=1&ref=opinion&oref=slogin
And James Oliphant (Baltimore Sun) points out that good television shouldn’t be driven by bad science:
"In a statement yesterday, the association’s president, Sherman “Tiger†Joyce, said the show has the potential to scare millions of parents away from having their children properly vaccinated against dangerous diseases.â€
Joyce cited a report from the Center for Medicine in the Public Interest’s, which offers case studies of real-life personal injury lawyers endangering public health by disseminating unfounded information that convinces some people to avoid drugs or other medical treatments that could improve their health or even save their lives. Now, Hollywood’s latest make-believe lawyer is getting in on the act, too."
Here’s a link to the complete Oliphant piece:
http://weblogs.baltimoresun.com/news/politics/blog/2008/01/a_trial_lawyer_as_a_ood_guy.html
ABC needs a lesson on public responsibility -- and Eli Stone needs to lose his Joan of Arc complex.
By now you are certainly familiar with the controversy surrounding the ABC program “Eli Stone†– where the title character (an attorney who has spiritual visions) goes to court to prove that childhood vaccinations cause autism.
Well, rather than piling on to the already crowded anti-pharma bandwagon, here is what the New York Times said in an editorial:
“Nevermind that such authoritative bodies as the Institute of Medicine of the National Academy of Sciences, the Centers for Disease Control and Prevention and the World Health Organization have found no evidence of a causal link. Nevermind that the incidence of autism continued to rise even after mercury preservatives were phased out of almost all childhood vaccines. As far as Eli Stone is concerned, you can’t just rely on science. Sometimes you have to go on faith.
The American Academy of Pediatrics tried unsuccessfully to get the episode canceled, fearing that it could deter parents from getting their children vaccinated, exposing them to far greater dangers from disease. Let’s hope that any parents who watched don’t make that mistake. And let’s hope that in future episodes, Eli Stone and ABC show better judgment in picking causes.â€
Here is a link to the editorial in its entirety:
http://www.nytimes.com/2008/02/02/opinion/02sat4.html?_r=1&ref=opinion&oref=slogin
And James Oliphant (Baltimore Sun) points out that good television shouldn’t be driven by bad science:
"In a statement yesterday, the association’s president, Sherman “Tiger†Joyce, said the show has the potential to scare millions of parents away from having their children properly vaccinated against dangerous diseases.â€
Joyce cited a report from the Center for Medicine in the Public Interest’s, which offers case studies of real-life personal injury lawyers endangering public health by disseminating unfounded information that convinces some people to avoid drugs or other medical treatments that could improve their health or even save their lives. Now, Hollywood’s latest make-believe lawyer is getting in on the act, too."
Here’s a link to the complete Oliphant piece:
http://weblogs.baltimoresun.com/news/politics/blog/2008/01/a_trial_lawyer_as_a_ood_guy.html
ABC needs a lesson on public responsibility -- and Eli Stone needs to lose his Joan of Arc complex.
Talk about tabloid medicine:
"On Nov. 20, 2007, FDA issued an Early Communication to the public and health care providers that the agency was evaluating postmarketing adverse event reports on Chantix related to changes in behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior.
As the agency's review of the adverse event reports proceeds, it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms. As a result, FDA has requested that Pfizer, the manufacturer of Chantix, elevate the prominence of this safety information to the warnings and precautions section of the Chantix prescribing information, or labeling. In addition, FDA is working with Pfizer to finalize a Medication Guide for patients. This is an example of FDA working with drug manufacturers throughout products' lifecycles to keep health care professionals and patients informed of new and emerging safety data."
No, this is an example of an agency that has been unfairly beaten to a pulp and is now trying to cover it's behind.
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01788.html
Here's an idea: how about a science-based approach to the issue of smoking and suicide before we jump to any conclusions about broad effects based on "appearances"...
So for instance:
"Cigarette smoking is associated with a higher risk for suicide and attempted suicide, but psychopathological or biological explanations for this association have not been explored. Lower serotonin function and impulsive/aggressive traits are associated with suicidal acts, including completed suicide. The authors hypothesized that the relationship that may exist between cigarette smoking and suicidal behavior may be associated with lower serotonin function and the presence of impulsive/aggressive traits."
Rihmer Z, Döme P, Gonda X, Kiss HG, Kovács D, Seregi K, Teleki Z.
Cigarette smoking and suicide attempts in psychiatric outpatients in Hungary.
Neuropsychopharmacol Hung. 2007 Jun;9(2):63-7.
Or
"The presence of associations between prior smoking and subsequent suicidality, in concert with the lack of associations between prior suicidality and subsequent smoking suggests the existence of an independent pathway from smoking to suicidality."
Bronisch T, Höfler M, Lieb R.
Smoking predicts suicidality: Findings from a prospective community study.
J Affect Disord. 2007 Nov 14; [Epub ahead of print]
Or
"Current daily smoking, but not past smoking, predicted the subsequent occurrence of suicidal thoughts or attempt, independent of prior depression and substance use disorders (adjusted odds ratio, 1.82; 95% confidence interval, 1.22-2.69). Additionally, current daily smoking, but not past smoking, predicted the subsequent occurrence of suicidal thoughts or attempt, adjusting for suicidal predisposition, indicated by prior suicidality, and controlling for prior psychiatric disorders (adjusted odds ratio, 1.74; 95% confidence interval, 1.17-2.54)."
Am J Psychiatry. 2003 Apr;160(4):773-9.
Cigarette smoking, suicidal behavior, and serotonin function in major psychiatric disorders.
Malone KM, Waternaux C, Haas GL, Cooper TB, Li S, Mann JJ.
Could Chantix be associated with increased suicidal behavior? Of course. But the key is to focus on what biological pathways would be implicated and identify people most at risk based on their illness, age, family history, etc. I hope Pfizer agrees. And I hope the FDA does too. I am not so sure about about tort lawyers, Senator Grassley, Public Citizen, George Soros or others who regularly dump on the drugwonks blog. They are too giddy about the presence of more pharma blood in the water and the opportunity perhaps to push another drug off the market even if it means -- because of the link between smoking and suicides -- more people dying. I would be delighted to be proven wrong on this latter score.
"On Nov. 20, 2007, FDA issued an Early Communication to the public and health care providers that the agency was evaluating postmarketing adverse event reports on Chantix related to changes in behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior.
As the agency's review of the adverse event reports proceeds, it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms. As a result, FDA has requested that Pfizer, the manufacturer of Chantix, elevate the prominence of this safety information to the warnings and precautions section of the Chantix prescribing information, or labeling. In addition, FDA is working with Pfizer to finalize a Medication Guide for patients. This is an example of FDA working with drug manufacturers throughout products' lifecycles to keep health care professionals and patients informed of new and emerging safety data."
No, this is an example of an agency that has been unfairly beaten to a pulp and is now trying to cover it's behind.
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01788.html
Here's an idea: how about a science-based approach to the issue of smoking and suicide before we jump to any conclusions about broad effects based on "appearances"...
So for instance:
"Cigarette smoking is associated with a higher risk for suicide and attempted suicide, but psychopathological or biological explanations for this association have not been explored. Lower serotonin function and impulsive/aggressive traits are associated with suicidal acts, including completed suicide. The authors hypothesized that the relationship that may exist between cigarette smoking and suicidal behavior may be associated with lower serotonin function and the presence of impulsive/aggressive traits."
Rihmer Z, Döme P, Gonda X, Kiss HG, Kovács D, Seregi K, Teleki Z.
Cigarette smoking and suicide attempts in psychiatric outpatients in Hungary.
Neuropsychopharmacol Hung. 2007 Jun;9(2):63-7.
Or
"The presence of associations between prior smoking and subsequent suicidality, in concert with the lack of associations between prior suicidality and subsequent smoking suggests the existence of an independent pathway from smoking to suicidality."
Bronisch T, Höfler M, Lieb R.
Smoking predicts suicidality: Findings from a prospective community study.
J Affect Disord. 2007 Nov 14; [Epub ahead of print]
Or
"Current daily smoking, but not past smoking, predicted the subsequent occurrence of suicidal thoughts or attempt, independent of prior depression and substance use disorders (adjusted odds ratio, 1.82; 95% confidence interval, 1.22-2.69). Additionally, current daily smoking, but not past smoking, predicted the subsequent occurrence of suicidal thoughts or attempt, adjusting for suicidal predisposition, indicated by prior suicidality, and controlling for prior psychiatric disorders (adjusted odds ratio, 1.74; 95% confidence interval, 1.17-2.54)."
Am J Psychiatry. 2003 Apr;160(4):773-9.
Cigarette smoking, suicidal behavior, and serotonin function in major psychiatric disorders.
Malone KM, Waternaux C, Haas GL, Cooper TB, Li S, Mann JJ.
Could Chantix be associated with increased suicidal behavior? Of course. But the key is to focus on what biological pathways would be implicated and identify people most at risk based on their illness, age, family history, etc. I hope Pfizer agrees. And I hope the FDA does too. I am not so sure about about tort lawyers, Senator Grassley, Public Citizen, George Soros or others who regularly dump on the drugwonks blog. They are too giddy about the presence of more pharma blood in the water and the opportunity perhaps to push another drug off the market even if it means -- because of the link between smoking and suicides -- more people dying. I would be delighted to be proven wrong on this latter score.
We add a new category to our posts called "Tabloid Medicine" so we can highlight instances where bloggers, trial lawyers, policians and the media sensationalize and distort medical risks in order to undermine trust in science or medicines.
So here we go again on how drugs being used to treat mental illness "cause" suicides:
Here's the worst offender: Fierce Pharma
"The FDA issued a sobering warning yesterday: the risk of suicide and suicidal behavior doubles for patients taking epilepsy drugs. Millions are--they're prescribed not only for the seizure disorder but for pain and psychiatric illnesses. The 11 drugs affected include such big-name meds as Pfizer's Lyrica, Abbott Laboratories' Depakote and OrthoMacNeil's Topamax."
First...the study, prompted by a lawyer suing Pfizer, looks at suicidal behavior and thoughts which are NOT associated with suicides. So my friends at FP are wrong. And to associate one drug with increased risk of suicide particularly in a patient population such as individuals suffering with bipolar disorders and comorbidities is just sloppy. But they are not the only ones as we shall see...
Second. Yes, the risk appears to have doubled. But from .022 on placebo to .043 if you are on an anticonvulsant. That means your chance of having nothing go wrong in terms of suicidal thoughts or behavior goes from 99.978 percent on placebo to 99.975 percent. Further, it is unclear from these studies whether patients were receiving other drugs. Most bipolar patients do not receive an anticonvulsant only. There is often combination with lithium, an antidepressant or other medications. So these studies by themselves are not indicative. A better question is what drug combination or what drug best reduces the risk of suicide among people with bipolar conditions.
Here's a much better approach to the subject from the NY Times
F.D.A. Finds Increase in Suicide Symptoms for Patients Using Seizure Medications
By GARDINER HARRIS and BENEDICT CAREY
Published: February 1, 2008
Drugs for epilepsy, bipolar illness and mood problems double the risks of suicidal thoughts and behavior, and patients taking them should be watched for sudden behavioral changes, drug regulators have said.
The increased risks, while double in relative terms, are small. The Food and Drug Administration undertook a combined analysis of 199 clinical trials with 43,892 patients and found 4 suicides and 105 reports of suicidal symptoms among the 27,863 patients who were given the drugs compared to no suicides and 35 reports of suicidal symptoms among the 16,029 patients treated with placebos.
Gardiner Harris and Bennett Carey play it straight and gives patients just the facts.
Good for them and the public.
http://www.nytimes.com/2008/02/01/us/01suicide.html?_r=1&ref=us&oref=slogin
And last and certainly least...we have one of those phony consumer webzines that are set up by and for trial attorneys to haul in clients with scary headlines. They include newsinferno.com which sadly Fiercepharma cites in their blog. This one is called consumer news weekly and it has fresh story about loved ones losing their lives due to suicides triggered by Topamax...
http://www.consumernewsweekly.com/
All we need now is a press release from Grassley's office or Stupak's calling for an investigation. But it's Friday.
So here we go again on how drugs being used to treat mental illness "cause" suicides:
Here's the worst offender: Fierce Pharma
"The FDA issued a sobering warning yesterday: the risk of suicide and suicidal behavior doubles for patients taking epilepsy drugs. Millions are--they're prescribed not only for the seizure disorder but for pain and psychiatric illnesses. The 11 drugs affected include such big-name meds as Pfizer's Lyrica, Abbott Laboratories' Depakote and OrthoMacNeil's Topamax."
First...the study, prompted by a lawyer suing Pfizer, looks at suicidal behavior and thoughts which are NOT associated with suicides. So my friends at FP are wrong. And to associate one drug with increased risk of suicide particularly in a patient population such as individuals suffering with bipolar disorders and comorbidities is just sloppy. But they are not the only ones as we shall see...
Second. Yes, the risk appears to have doubled. But from .022 on placebo to .043 if you are on an anticonvulsant. That means your chance of having nothing go wrong in terms of suicidal thoughts or behavior goes from 99.978 percent on placebo to 99.975 percent. Further, it is unclear from these studies whether patients were receiving other drugs. Most bipolar patients do not receive an anticonvulsant only. There is often combination with lithium, an antidepressant or other medications. So these studies by themselves are not indicative. A better question is what drug combination or what drug best reduces the risk of suicide among people with bipolar conditions.
Here's a much better approach to the subject from the NY Times
F.D.A. Finds Increase in Suicide Symptoms for Patients Using Seizure Medications
By GARDINER HARRIS and BENEDICT CAREY
Published: February 1, 2008
Drugs for epilepsy, bipolar illness and mood problems double the risks of suicidal thoughts and behavior, and patients taking them should be watched for sudden behavioral changes, drug regulators have said.
The increased risks, while double in relative terms, are small. The Food and Drug Administration undertook a combined analysis of 199 clinical trials with 43,892 patients and found 4 suicides and 105 reports of suicidal symptoms among the 27,863 patients who were given the drugs compared to no suicides and 35 reports of suicidal symptoms among the 16,029 patients treated with placebos.
Gardiner Harris and Bennett Carey play it straight and gives patients just the facts.
Good for them and the public.
http://www.nytimes.com/2008/02/01/us/01suicide.html?_r=1&ref=us&oref=slogin
And last and certainly least...we have one of those phony consumer webzines that are set up by and for trial attorneys to haul in clients with scary headlines. They include newsinferno.com which sadly Fiercepharma cites in their blog. This one is called consumer news weekly and it has fresh story about loved ones losing their lives due to suicides triggered by Topamax...
http://www.consumernewsweekly.com/
All we need now is a press release from Grassley's office or Stupak's calling for an investigation. But it's Friday.
The three-year-old Medicare Part D drug program is seeing the number of its enrollees climb, even as costs for the program fall.
"Overall, costs for beneficiaries and taxpayers are considerably lower than originally projections, enrollment continues to rise and customer satisfaction remains very high," Kerry Weems, acting administrator at the U.S. Centers for Medicare and Medicaid Services (CMS), told reporters.
According to Weems, the projected cost for Medicare part D is $117 billion lower over the next decade than experts estimated just last summer. "This means that over the 10-year period [from] 2008 to 2017, the estimated $915 billion cost of Part D fell to $798 billion," he said.
At the same time, he reported, after the third open enrollment period that ended in December, the plan now has an additional 1.5 million people.
"Overall, there are about 25.4 million people enrolled in Part D," Weems said.
Most people surveyed today -- more than 85 percent -- are satisfied with the plan, Weems noted.
Can Part D be made even better -- absolutely. But this is good news worth sharing -- and not because it helps any particular partisan political agenda, but rather because it means that more Americans -- tens of millions of more Americans -- are getting access to the medicines (largely chronic medicines) that will help them live healthier lives. And this, in no small measure, significantly reduces more drastic medical intertventions -- which in turn reduces our overall national health care spending.
"Overall, costs for beneficiaries and taxpayers are considerably lower than originally projections, enrollment continues to rise and customer satisfaction remains very high," Kerry Weems, acting administrator at the U.S. Centers for Medicare and Medicaid Services (CMS), told reporters.
According to Weems, the projected cost for Medicare part D is $117 billion lower over the next decade than experts estimated just last summer. "This means that over the 10-year period [from] 2008 to 2017, the estimated $915 billion cost of Part D fell to $798 billion," he said.
At the same time, he reported, after the third open enrollment period that ended in December, the plan now has an additional 1.5 million people.
"Overall, there are about 25.4 million people enrolled in Part D," Weems said.
Most people surveyed today -- more than 85 percent -- are satisfied with the plan, Weems noted.
Can Part D be made even better -- absolutely. But this is good news worth sharing -- and not because it helps any particular partisan political agenda, but rather because it means that more Americans -- tens of millions of more Americans -- are getting access to the medicines (largely chronic medicines) that will help them live healthier lives. And this, in no small measure, significantly reduces more drastic medical intertventions -- which in turn reduces our overall national health care spending.
Much has been made about how great and definitive large head to head studies of drugs such as CATIE or ALLHAT are in guiding what drugs to us. We at CMPI have often bee criticized when we talk about diagnostics replacing one size fits all trials as saying such personalized medicine is not ready for prime time. But what if more research – such as larger observational studies or Bayesian analysis of social experiments -- allowed a closer and statistically meaningful look at patient differences and how drugs worked? Given all available drugs and subtracting the cost of additional research how valuable – measured in terms in years free of schizophrenia -- would research that allow doctors and patients to prescribe the right drug generate.
Using the CATIE results as a baseline, Anirban Basu, PhD, David Meltzer, MD, PhD and Herb Meltzer, MD of Vanderbilt University estimate that such personalized research would be worth $342 billion over the next 20 years assuming that each additionally additional year of life free of schizophrenia is worth $50000. The authors note that this estimate does not take into account the ability to assign patients to treatment using more highly predictive algorithms that could raise the value even more. The value to more precisely establishing the cost-effectiveness of typical/atypical antipsychotics by more precisely establishing differences in patients –even in the absence of genetically based diagnostics is enormous. Considering that CATIE cost $42 million and is justified largely in terms of saving money for government, the CATIE results should not be considered definitive.
The study was sponsored by Best Practice, Inc. with partial support from the Foundation for Education and Research on Mental Illness, Janssen Pharmaceuticals, and the Center for Medicine in the Public Interest.
For full study results go to
http://www.cmpi.org
And look under "Reports" for "Expected Value of Research on the Comparative Cost--effectiveness of Antipsychotics Drugs."
Important stuff.
Using the CATIE results as a baseline, Anirban Basu, PhD, David Meltzer, MD, PhD and Herb Meltzer, MD of Vanderbilt University estimate that such personalized research would be worth $342 billion over the next 20 years assuming that each additionally additional year of life free of schizophrenia is worth $50000. The authors note that this estimate does not take into account the ability to assign patients to treatment using more highly predictive algorithms that could raise the value even more. The value to more precisely establishing the cost-effectiveness of typical/atypical antipsychotics by more precisely establishing differences in patients –even in the absence of genetically based diagnostics is enormous. Considering that CATIE cost $42 million and is justified largely in terms of saving money for government, the CATIE results should not be considered definitive.
The study was sponsored by Best Practice, Inc. with partial support from the Foundation for Education and Research on Mental Illness, Janssen Pharmaceuticals, and the Center for Medicine in the Public Interest.
For full study results go to
http://www.cmpi.org
And look under "Reports" for "Expected Value of Research on the Comparative Cost--effectiveness of Antipsychotics Drugs."
Important stuff.
Important story in today’s Wall Street Journal on the topic of patients who suffer adverse events during clinical trials and the broader issue of informed consent. The article focuses largely on the story of Suzanne Davenport, a 71-year-old retired kindergarten teacher, diagnosed with Parkinson's in 1989.
Here’s a link:
http://online.wsj.com/article/SB120173515260330205.html?mod=hpp_us_pageone
One of the major issues discussed is standardization of consent forms. According to the Journal:
“Consent forms and compensation plans vary by institution. There have been sporadic calls to standardize these programs, but none have been widely adopted. The Institute of Medicine, a nonprofit group that advises the government on health policy, recommended in 2002 the creation of a "no fault" compensation system for injured subjects. The goal was to help trial participants resolve their claims quickly, without having to resort to lawsuits.â€
But a far more difficult question (not discussed in the WSJ article) is that of patient therapeutic misperception. Can a patient really make an informed decision about what risks he or she is willing to take in the face of serious disease?
To investigate what patients really understand about the trials in which they have enrolled, leading Parkinson’s Disease researchers, ethicists Kim and Kieburtz, have been awarded a 2007 Michael J. Foundation grant to study ongoing participants of PD clinical trials that involve sham surgery controls. They plan to assess, by structured interviews, the potential for the therapeutic misconception i.e., why and how PD patients make their decisions regarding participation in sham surgery controlled studies
Regardless of the outcome, the biggest question remains the concept of what desperate patients want to understand and what they will do for a glimmer of hope.
Here’s a link:
http://online.wsj.com/article/SB120173515260330205.html?mod=hpp_us_pageone
One of the major issues discussed is standardization of consent forms. According to the Journal:
“Consent forms and compensation plans vary by institution. There have been sporadic calls to standardize these programs, but none have been widely adopted. The Institute of Medicine, a nonprofit group that advises the government on health policy, recommended in 2002 the creation of a "no fault" compensation system for injured subjects. The goal was to help trial participants resolve their claims quickly, without having to resort to lawsuits.â€
But a far more difficult question (not discussed in the WSJ article) is that of patient therapeutic misperception. Can a patient really make an informed decision about what risks he or she is willing to take in the face of serious disease?
To investigate what patients really understand about the trials in which they have enrolled, leading Parkinson’s Disease researchers, ethicists Kim and Kieburtz, have been awarded a 2007 Michael J. Foundation grant to study ongoing participants of PD clinical trials that involve sham surgery controls. They plan to assess, by structured interviews, the potential for the therapeutic misconception i.e., why and how PD patients make their decisions regarding participation in sham surgery controlled studies
Regardless of the outcome, the biggest question remains the concept of what desperate patients want to understand and what they will do for a glimmer of hope.
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