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After a delicious buffet lunch of tunafish and ice tea, the inaugural meeting of the FDA's Risk Communications Advisory Committee returned to begin the second half of Day One with the open public comment portion of the program.
The first person to speak was a free-lance reporter who bitterly complained about the agency's "permission to speak" rule. This means that FDA employees cannot speak to reporters without permission.
Her main beef was that her calls were not returned promptly (if at all) and that access was often not granted -- at the discretion of a press officer and without explanation or justification.
Okay, a couple of points here.
First, of course FDA employees need permission before they speak to the press. This is appropriate otherwise chaos ensures. However, access should be denied only under the most limited circumstances -- and that denial should not be at the discretion of a press officer. In any event, access should be granted (broadly) or denied (rarely) with alacrity.
When I was at FDA, the press office reported to me. I held a meeting with all of the press officers and my prop was a telephone. I held it up and pointed out to the staff that the phone came with buttons "at no additional charge." My point was that reporter calls should be returned as soon as humanly possible.
A few years later, shortly after I announced that I was leaving the agency, I received a call from an FDA beat reporter who said she was sad I was leaving because, "I returned her calls."
Talk about a low bar.
It's not about "permission to speak," it's about permission to speak regularly -- and on deadline.
The first person to speak was a free-lance reporter who bitterly complained about the agency's "permission to speak" rule. This means that FDA employees cannot speak to reporters without permission.
Her main beef was that her calls were not returned promptly (if at all) and that access was often not granted -- at the discretion of a press officer and without explanation or justification.
Okay, a couple of points here.
First, of course FDA employees need permission before they speak to the press. This is appropriate otherwise chaos ensures. However, access should be denied only under the most limited circumstances -- and that denial should not be at the discretion of a press officer. In any event, access should be granted (broadly) or denied (rarely) with alacrity.
When I was at FDA, the press office reported to me. I held a meeting with all of the press officers and my prop was a telephone. I held it up and pointed out to the staff that the phone came with buttons "at no additional charge." My point was that reporter calls should be returned as soon as humanly possible.
A few years later, shortly after I announced that I was leaving the agency, I received a call from an FDA beat reporter who said she was sad I was leaving because, "I returned her calls."
Talk about a low bar.
It's not about "permission to speak," it's about permission to speak regularly -- and on deadline.
While Peter was trying to calm the risk communication waters..here's my suggestion about embedding reporters: Don't.
There was some important research in JAMA about how 60 percent of adolescents don't respond to the first anti-depressants they receive but respond well to the second line of meds and cognitive behavioral therapy. That jives with earlier results of cross-over studies that demonstrate about 60 percent failure rate among depressed adults and their first SSRIs.
Read More
Of course that could explain why, in many studies, you get the zero effect vs placebo. That, and as Fred Goodwin has pointed out, the FDA refuses to allow crossover designs (adaptive trials of a sort) in neuropharm. And of course as genetic testing gets closer in antidepressants, as David Meltzer and others noted at a conference held by the ...that trial, error and miss approach to medication might be history.
But you had to search mightily for that story yesterday in the media or the blogosphere.
Instead, it was a sloppy meta-analysis (meta, as in sort of, analysis as in let the computer do it) of lots of placebo controlled trials of varying quality, design, exclusivity criteria that seemed to suggest what anyone who has taken an antidepressant knows is crap: they don't work. And of course while the media and the blogosphere sneer at the source research funding they are willfully blind to the incredibly poor study design of the meta-analysis in question as well as the limits of meta-analysis in general. Here's one of many hard sci bloggers piling on the silly stew of studies that was passed off as science.
"Way too loose of p-values for false positives in studies, in medicine (and social sciences) compared to natural sciences, is one reason to not read too much into any individual study that claims antidepressants are ineffective, like the Public Library of Science meta-analysis of individual studies did.
P-values of the same looseness as in medicine/social sciences have been used to claim intercessory prayer actually works on sick people (http://www.religioustolerance.org/medical6.htm), for example, or here (http://skepdic.com/refuge/bunk21.html)
"I’m not saying that the results of a meta-analysis are no stronger than the weakest study in its umbrella. I am saying that, with p values as loose as they are in health/medicine (and social sciences), is that no massive amount of individual research studies being included under one meta-analysis will make the meta-analysis’ results anything more than a little bit stronger than the best individual study.
In other words, in medicine, and in social sciences, meta-analysis adds a very modest bump, nothing more. The problem is, most people believe it does much more than that when it doesn’t.
Or, to put it another way, meta-analysis is no better than the material it’s analyzing."
Read More
And here's another question: if they don't work, then why do they have such horrible but rare side effects? Is it really possible that drug companies just pumped drugs that were completely worthless except for the fact that they caused kids to commit suicide?
But that's precisely the mindset of the media and to even more greater extent http://www.pharmalot.com and http://www.fiercepharma.com. Both sites totally ignored the JAMA study and focused on the meta-analysis. The JAMA study was a randomized controlled trial and the meta-analysis...well what can I say except what my high school English teach used to say regarding the difference between Cliff Notes and a novel: that meta-analysis is to real research what masturbation is to sex. Does anyone do any analysis of related analysis anymore or are journalist and bloggers just posting the facts that fit their pre-conceived notions. Does it tell you anything that the meta-analyses are easy to churn out and rush into print just before, say, the next FDA meeting of import?
Such perspectives only encourage people not to take medicines or encourage them to stop taking them because they "don't work." It's irresponsible.
Oh yeah... Here's the study that made antidepressants worthless....
Read More
There was some important research in JAMA about how 60 percent of adolescents don't respond to the first anti-depressants they receive but respond well to the second line of meds and cognitive behavioral therapy. That jives with earlier results of cross-over studies that demonstrate about 60 percent failure rate among depressed adults and their first SSRIs.
Read More
Of course that could explain why, in many studies, you get the zero effect vs placebo. That, and as Fred Goodwin has pointed out, the FDA refuses to allow crossover designs (adaptive trials of a sort) in neuropharm. And of course as genetic testing gets closer in antidepressants, as David Meltzer and others noted at a conference held by the ...that trial, error and miss approach to medication might be history.
But you had to search mightily for that story yesterday in the media or the blogosphere.
Instead, it was a sloppy meta-analysis (meta, as in sort of, analysis as in let the computer do it) of lots of placebo controlled trials of varying quality, design, exclusivity criteria that seemed to suggest what anyone who has taken an antidepressant knows is crap: they don't work. And of course while the media and the blogosphere sneer at the source research funding they are willfully blind to the incredibly poor study design of the meta-analysis in question as well as the limits of meta-analysis in general. Here's one of many hard sci bloggers piling on the silly stew of studies that was passed off as science.
"Way too loose of p-values for false positives in studies, in medicine (and social sciences) compared to natural sciences, is one reason to not read too much into any individual study that claims antidepressants are ineffective, like the Public Library of Science meta-analysis of individual studies did.
P-values of the same looseness as in medicine/social sciences have been used to claim intercessory prayer actually works on sick people (http://www.religioustolerance.org/medical6.htm), for example, or here (http://skepdic.com/refuge/bunk21.html)
"I’m not saying that the results of a meta-analysis are no stronger than the weakest study in its umbrella. I am saying that, with p values as loose as they are in health/medicine (and social sciences), is that no massive amount of individual research studies being included under one meta-analysis will make the meta-analysis’ results anything more than a little bit stronger than the best individual study.
In other words, in medicine, and in social sciences, meta-analysis adds a very modest bump, nothing more. The problem is, most people believe it does much more than that when it doesn’t.
Or, to put it another way, meta-analysis is no better than the material it’s analyzing."
Read More
And here's another question: if they don't work, then why do they have such horrible but rare side effects? Is it really possible that drug companies just pumped drugs that were completely worthless except for the fact that they caused kids to commit suicide?
But that's precisely the mindset of the media and to even more greater extent http://www.pharmalot.com and http://www.fiercepharma.com. Both sites totally ignored the JAMA study and focused on the meta-analysis. The JAMA study was a randomized controlled trial and the meta-analysis...well what can I say except what my high school English teach used to say regarding the difference between Cliff Notes and a novel: that meta-analysis is to real research what masturbation is to sex. Does anyone do any analysis of related analysis anymore or are journalist and bloggers just posting the facts that fit their pre-conceived notions. Does it tell you anything that the meta-analyses are easy to churn out and rush into print just before, say, the next FDA meeting of import?
Such perspectives only encourage people not to take medicines or encourage them to stop taking them because they "don't work." It's irresponsible.
Oh yeah... Here's the study that made antidepressants worthless....
Read More
Blogging to you directly from the glamorous Gaithersburg Hilton and the inaugural meeting of the FDA's Risk Communications Advisory Committee.
Star of the morning was FDA Commissioner von Eschenbach.
Andy pointed out that the committee's work was "central and core" to the mission of the FDA -- specifically because it speaks to how the FDA crafts messages for the general public. And to that end the Commissioner commented that the FDA has to learn "not only what is the right thing to do -- but how to do it the right way."
The Commissioner spent much of his remarks on the general theme of "putting things into the proper context for the patient," pointing out that "trust is built on communication and dialogue." And he acknowledged that this meeting is taking place "at a time when there is an erosion of consumer trust in the FDA."
Sometimes stating the obvious is the best place to start. Confession, after all, is good for the soul.
"Help us dialogue," the Commissioner asked the committee.
Communications hint to Commissioner: "Dialogue" is not a verb.
To that end he shared that he has floated the idea of "embedded" reporters at the FDA -- and shared that the concept "sent shudders" throughout the agency.
He addressed the need to better balance risk communications so as to avoid unintended consequences, specifically the need to better consider the desire to communicate earlier versus communicating with less evidence and certainty.
Andy also announced that the FDA world shortly announce more details on the Sentinel Network on post-market surveillance. That's good news and long overdue.
The Commissioner also staked a claim to FDA's leadership in educating the American public to what he called "the doctrine of risk," calling for a national dialogue.
Amen again-- and God's Speed.
Star of the morning was FDA Commissioner von Eschenbach.
Andy pointed out that the committee's work was "central and core" to the mission of the FDA -- specifically because it speaks to how the FDA crafts messages for the general public. And to that end the Commissioner commented that the FDA has to learn "not only what is the right thing to do -- but how to do it the right way."
The Commissioner spent much of his remarks on the general theme of "putting things into the proper context for the patient," pointing out that "trust is built on communication and dialogue." And he acknowledged that this meeting is taking place "at a time when there is an erosion of consumer trust in the FDA."
Sometimes stating the obvious is the best place to start. Confession, after all, is good for the soul.
"Help us dialogue," the Commissioner asked the committee.
Communications hint to Commissioner: "Dialogue" is not a verb.
To that end he shared that he has floated the idea of "embedded" reporters at the FDA -- and shared that the concept "sent shudders" throughout the agency.
He addressed the need to better balance risk communications so as to avoid unintended consequences, specifically the need to better consider the desire to communicate earlier versus communicating with less evidence and certainty.
Andy also announced that the FDA world shortly announce more details on the Sentinel Network on post-market surveillance. That's good news and long overdue.
The Commissioner also staked a claim to FDA's leadership in educating the American public to what he called "the doctrine of risk," calling for a national dialogue.
Amen again-- and God's Speed.
Two cheers for Congresswoman Rosa L. DeLauro for holding yesterday’s FDA oversight hearing.
Throughout her career, Representative DeLauro has expressed a brazen disregard for drug safety, continually calling on policymakers to open our borders to an uncontrollable influx of untested, impure, expired, and counterfeit drugs from around the world.
Today, however, drug importation was noticeably absent from the agenda.
Perhaps importation was left off the agenda because of the recent report that contaminated heparin, manufactured in China, is responsible for at least four deaths. Or perhaps she ignored importation because today’s hearing comes just one year after dozens of cats and dogs died of kidney failure after ingesting contaminated pet food -- and only one year after counterfeit Colgate toothpaste containing diethylene glycol infiltrated the U.S. market.
Regardless of her reasoning, it seems grossly irresponsible to grandstand for drug safety on one day and call for the importation of foreign drugs on another.
Let’s look at the facts. The World Health Organization estimates that eight to 10 percent of today’s global medicine supply chain is counterfeit. According to the Food and Drug Administration, that figure jumps to 50 percent or higher in some countries.
Without legalized prescription drug importation, the number of counterfeit drug investigations has increased four-fold since the late 1990s. Just imagine what will happen if such a thoughtless policy were codified.
Perhaps Representative DeLauro will take this opportunity to publicly denounce drug importation and take action to keep counterfeit drugs out of the U.S. medicine supply.
Perhaps not.
Throughout her career, Representative DeLauro has expressed a brazen disregard for drug safety, continually calling on policymakers to open our borders to an uncontrollable influx of untested, impure, expired, and counterfeit drugs from around the world.
Today, however, drug importation was noticeably absent from the agenda.
Perhaps importation was left off the agenda because of the recent report that contaminated heparin, manufactured in China, is responsible for at least four deaths. Or perhaps she ignored importation because today’s hearing comes just one year after dozens of cats and dogs died of kidney failure after ingesting contaminated pet food -- and only one year after counterfeit Colgate toothpaste containing diethylene glycol infiltrated the U.S. market.
Regardless of her reasoning, it seems grossly irresponsible to grandstand for drug safety on one day and call for the importation of foreign drugs on another.
Let’s look at the facts. The World Health Organization estimates that eight to 10 percent of today’s global medicine supply chain is counterfeit. According to the Food and Drug Administration, that figure jumps to 50 percent or higher in some countries.
Without legalized prescription drug importation, the number of counterfeit drug investigations has increased four-fold since the late 1990s. Just imagine what will happen if such a thoughtless policy were codified.
Perhaps Representative DeLauro will take this opportunity to publicly denounce drug importation and take action to keep counterfeit drugs out of the U.S. medicine supply.
Perhaps not.
During my tenure at Hudson Institute, we held a National Press Club shindig in honor of Barry Goldwater. Among those invited was William F. Buckley, Jr. -- and the RSVPs came to me.
Returning from lunch with my father, a "Big L" liberal, I quickly went to check my voicemail as he puttered around my office. The first message caught my Dad's attention.
"Hello Peter. This is William F. Buckley and I will certainly attend the event for Senator Goldwater."
My father just smiled and said that he was proud of me.
Thanks Bill.
Returning from lunch with my father, a "Big L" liberal, I quickly went to check my voicemail as he puttered around my office. The first message caught my Dad's attention.
"Hello Peter. This is William F. Buckley and I will certainly attend the event for Senator Goldwater."
My father just smiled and said that he was proud of me.
Thanks Bill.
According to a story in today’s Washington Post, “If it seems as though the Food and Drug Administration has been issuing a new drug safety warning almost every week, that's because, for the past three months, it has.â€
“The uptick in advisories doesn't mean that drugs are more dangerous, says Paul Seligman, director of the FDA's Office of Drug Safety; it simply marks the fulfillment of a 2005 promise by Secretary of Health and Human Services Mike Leavitt to notify the public sooner when the agency learns of adverse reactions to approved drugs.â€
"We are trying to act in a responsible way," Seligman says.
According to Representative John Dingell (D-Mich.), head of the House Energy and Commerce Committee, the recent increase in public communications "a quantum improvement." But as our friend Marc J. Scheineson, a former FDA deputy commissioner points out, now, the problem is the opposite, "so patients and their doctors will need to filter the news.''
And that’s the rub, because too much information can be as dangerous as too little.
According to the story in the Post, “Arthur Levin, head of the Center for Medical Consumers in New York, and other patient advocates welcome the information but worry that patients will simply stop taking a drug cited in an advisory. That's what many users of the diabetes drug Avandia did, according to Levin, after a well-publicized study several months ago warned that the drug might be tied to an increased risk of heart disease.â€
In other words, fear and misunderstanding leads to non-compliance – a very dangerous unintended (but not unexpected) consequence.
Listen to Richard Platt, a professor of medicine at Harvard Medical School and chairman of the FDA's new Drug Safety and Risk Management Advisory Committee. In most cases, failing to take prescribed drugs "poses a far higher risk of complications and death than staying on a drug about which a question has been posed.â€
Hopefully this and other crucial questions will begin to be addressed at tomorrow’s initial meeting of that advisory committee.
Here's a link to the complete article:
http://www.washingtonpost.com/wp-dyn/content/article/2008/02/22/AR2008022202686.html
“The uptick in advisories doesn't mean that drugs are more dangerous, says Paul Seligman, director of the FDA's Office of Drug Safety; it simply marks the fulfillment of a 2005 promise by Secretary of Health and Human Services Mike Leavitt to notify the public sooner when the agency learns of adverse reactions to approved drugs.â€
"We are trying to act in a responsible way," Seligman says.
According to Representative John Dingell (D-Mich.), head of the House Energy and Commerce Committee, the recent increase in public communications "a quantum improvement." But as our friend Marc J. Scheineson, a former FDA deputy commissioner points out, now, the problem is the opposite, "so patients and their doctors will need to filter the news.''
And that’s the rub, because too much information can be as dangerous as too little.
According to the story in the Post, “Arthur Levin, head of the Center for Medical Consumers in New York, and other patient advocates welcome the information but worry that patients will simply stop taking a drug cited in an advisory. That's what many users of the diabetes drug Avandia did, according to Levin, after a well-publicized study several months ago warned that the drug might be tied to an increased risk of heart disease.â€
In other words, fear and misunderstanding leads to non-compliance – a very dangerous unintended (but not unexpected) consequence.
Listen to Richard Platt, a professor of medicine at Harvard Medical School and chairman of the FDA's new Drug Safety and Risk Management Advisory Committee. In most cases, failing to take prescribed drugs "poses a far higher risk of complications and death than staying on a drug about which a question has been posed.â€
Hopefully this and other crucial questions will begin to be addressed at tomorrow’s initial meeting of that advisory committee.
Here's a link to the complete article:
http://www.washingtonpost.com/wp-dyn/content/article/2008/02/22/AR2008022202686.html
"I think to do what we need to do requires substantially more dollars than what has been invested in the FDA thus far," Dr. von Eschenbach says. "This is a systemic overhaul that must go on over a period of years."
In the recent on-line version of Health Despair there were two reports that seemed to send the same old messages: more folks unable to pay for increasingly expensive health care premiums. As Boomers move into Medicare, the cost will be unsustainable.
Wrong on both counts.
The U.S. Economy And Changes In Health Insurance Coverage, 2000-2006
John Holahan * Allison Cook insists the eroding insurance coverage is a matter of eroding wages and rising premiums.
Not so simple. Insurance coverage increased for kids and when you back out illegal immigrants the number is of uninsured kids is even lower. (I thought there was a SCHIP crisis!)
During the 2000-2004 period studied, the greatest percentage increase in adult uninsurance was among rich and middle class folks. 3.4 million increase in uninsured adults and children between 2004 and 2006, 700,000 were middle-income Americans and 800,000 were higher-income Americans. The authors fail to point out that there was an increase in people receiving coverage in the private market from 2004-2006 which is about the time HSAs began to expand. All other categories of coverage experience a decline. Except government coverage.
http://content.healthaffairs.org/cgi/content/abstract/hlthaff.27.2.w135v1
Turning to the growth in medical spending in the article: Health Spending Projections
Through 2017: The Baby-Boom Generation Is Coming To Medicare
The article states: "The primary drivers of personal health care spending growth during the projection period are medical prices and utilization, followed by smaller impacts from population growth and the age-sex mix."
Gee, I thought it was disease.
"As a result, health is projected to consume an expanding share of the economy, which means that policymakers, insurers, and the public will face increasingly difficult decisions about the way health care is delivered and paid for."
But what about technologies that reduce the burden of disease even as they increase life expectancy? Here's what another article in Health Affairs noted:
"A sixty-five-year-old with a serious chronic illness spends $1,000-$2,000 more per year on health care than a similar adult without the condition. However, cumulative Medicare payments are only modestly higher for the chronically ill because of their shorter life expectancy."
http://content.healthaffairs.org/cgi/content/abstract/hlthaff.w5.r18
There are signals all over the place that our health care system has reached a tipping point on its own, pushed by consumers, mainly boomers, towards prevention, value, personalized care. The point would be to unleash this power by giving this generation and the next more control over the course of their health and care. Why not reward people for staying healthier, longer? Yet we are setting up a regulatory and reimbursement system that discourages such advances.
The closer we move to prevention and prediction, the more valuable health care becomes. The more we spend on more effective care the better off we are. If we spend 30 percent of out GDP on such things, isn't that better than spending 30 percent of it on services and technologies like heart and lung machines, drugs that only work half the time in half the people? Yet that is exactly where the command and control models of European, Canadian and Medicare want to take us.
Wrong on both counts.
The U.S. Economy And Changes In Health Insurance Coverage, 2000-2006
John Holahan * Allison Cook insists the eroding insurance coverage is a matter of eroding wages and rising premiums.
Not so simple. Insurance coverage increased for kids and when you back out illegal immigrants the number is of uninsured kids is even lower. (I thought there was a SCHIP crisis!)
During the 2000-2004 period studied, the greatest percentage increase in adult uninsurance was among rich and middle class folks. 3.4 million increase in uninsured adults and children between 2004 and 2006, 700,000 were middle-income Americans and 800,000 were higher-income Americans. The authors fail to point out that there was an increase in people receiving coverage in the private market from 2004-2006 which is about the time HSAs began to expand. All other categories of coverage experience a decline. Except government coverage.
http://content.healthaffairs.org/cgi/content/abstract/hlthaff.27.2.w135v1
Turning to the growth in medical spending in the article: Health Spending Projections
Through 2017: The Baby-Boom Generation Is Coming To Medicare
The article states: "The primary drivers of personal health care spending growth during the projection period are medical prices and utilization, followed by smaller impacts from population growth and the age-sex mix."
Gee, I thought it was disease.
"As a result, health is projected to consume an expanding share of the economy, which means that policymakers, insurers, and the public will face increasingly difficult decisions about the way health care is delivered and paid for."
But what about technologies that reduce the burden of disease even as they increase life expectancy? Here's what another article in Health Affairs noted:
"A sixty-five-year-old with a serious chronic illness spends $1,000-$2,000 more per year on health care than a similar adult without the condition. However, cumulative Medicare payments are only modestly higher for the chronically ill because of their shorter life expectancy."
http://content.healthaffairs.org/cgi/content/abstract/hlthaff.w5.r18
There are signals all over the place that our health care system has reached a tipping point on its own, pushed by consumers, mainly boomers, towards prevention, value, personalized care. The point would be to unleash this power by giving this generation and the next more control over the course of their health and care. Why not reward people for staying healthier, longer? Yet we are setting up a regulatory and reimbursement system that discourages such advances.
The closer we move to prevention and prediction, the more valuable health care becomes. The more we spend on more effective care the better off we are. If we spend 30 percent of out GDP on such things, isn't that better than spending 30 percent of it on services and technologies like heart and lung machines, drugs that only work half the time in half the people? Yet that is exactly where the command and control models of European, Canadian and Medicare want to take us.
My choice is Bill Clinton...for three reasons... He went off Lipitor only to have bypass surgery and secondly, who better than to correct "misimpressions" and appease Democrats. (Viagra would be a better choice but...let's keep it real.) Third, Jennifer Garner is way too young even though she can probably do her own rowing...
The American Diabetes Assn. cautions against making treatment changes based on the differing result of two large studies on glycemic control. So far no on has accused the ADA of making that statement because of their sponsors are. Why the same allegation leveled at specialty groups when it comes to the ENHANCE study. Because the conflict of interest police engage in pharmaceutical profiling...plain and simple.
Want more evidence?
COIPs ignore the conflicts of Steve Nissen because he is their tool.
And when it comes to policing academic conflicts why is it ok for IOM Prez Harvey Fineberg to take money and a free trip to the Caribbean from the same foundation that is underwriting the study on conflicts of interest for the IOM where he hung out with the some of the other people who are also underwriting the rest of the IOM's program in this area only to sit in judgment on the same issue. And these are the people and foundations that are setting the agenda on conflict of interest in continuing medical education? We should take their views on who gets to say what seriously?
And what does that say about those in the media and the bloggers who do nothinb but cover pharmaceutical conflicts?
Want more evidence?
COIPs ignore the conflicts of Steve Nissen because he is their tool.
And when it comes to policing academic conflicts why is it ok for IOM Prez Harvey Fineberg to take money and a free trip to the Caribbean from the same foundation that is underwriting the study on conflicts of interest for the IOM where he hung out with the some of the other people who are also underwriting the rest of the IOM's program in this area only to sit in judgment on the same issue. And these are the people and foundations that are setting the agenda on conflict of interest in continuing medical education? We should take their views on who gets to say what seriously?
And what does that say about those in the media and the bloggers who do nothinb but cover pharmaceutical conflicts?
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
