Latest Drugwonks' Blog
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?
Pfizer is yanking the Jarvik Lipitor ad. Done in, it seems, by “OarGate.â€
Commenting on the withdrawal of the Jarvik advertising and promotion, Pfizer’s President of Worldwide Pharmaceutical Operations Ian Read said:
“ … the way in which we presented Dr. Jarvik in these ads has, unfortunately, led to misimpressions and distractions from our primary goal of encouraging patient and physician dialogue on the leading cause of death in the world -- cardiovascular disease. We regret this. Going forward, we commit to ensuring there is greater clarity in our advertising regarding the presentation of spokespeople.â€
In other words, the frivolous brouhaha over whether or not Dr. Jarvik can row. A bad creative decision? Certainly. But what are the unintended consequences of this pseudo-debate and Pfizer’s decision to pull the ad? First, it further feeds the resolve of the “Ban DTC†bund and, secondly and more importantly, may very well negatively impact current statin compliance levels while detering people from asking their physicians about high cholesterol.
And so the question to those enjoying the media feeding frenzy on this issue is -- are the negative public health consequences worth it?
Commenting on the withdrawal of the Jarvik advertising and promotion, Pfizer’s President of Worldwide Pharmaceutical Operations Ian Read said:
“ … the way in which we presented Dr. Jarvik in these ads has, unfortunately, led to misimpressions and distractions from our primary goal of encouraging patient and physician dialogue on the leading cause of death in the world -- cardiovascular disease. We regret this. Going forward, we commit to ensuring there is greater clarity in our advertising regarding the presentation of spokespeople.â€
In other words, the frivolous brouhaha over whether or not Dr. Jarvik can row. A bad creative decision? Certainly. But what are the unintended consequences of this pseudo-debate and Pfizer’s decision to pull the ad? First, it further feeds the resolve of the “Ban DTC†bund and, secondly and more importantly, may very well negatively impact current statin compliance levels while detering people from asking their physicians about high cholesterol.
And so the question to those enjoying the media feeding frenzy on this issue is -- are the negative public health consequences worth it?
From The Riverside Press-Enterprise ...
For safety's safe, keep out drug imports
Sunday, February 24, 2008
By PETER PITTS
A couple of weeks ago, the Government Accountability Office delivered an alarming message to a congressional panel -- the Food and Drug Administration lacks the resources to ensure the safety of the nation's food, drugs and medical devices.
Congress has vowed to fix the FDA. It plans to boost its funding, which is a good start. But those efforts will be more than undermined if Congress legalizes drug importation, which it may try to do this month. Attempting to screen imported prescription drugs would stretch the FDA's abilities to their breaking point.
Just as the agency's workload has surged, its budget has shrunk. The FDA's congressional appropriations have declined $400 million in inflation-adjusted dollars in the last 14 years. But its responsibilities have increased substantially, thanks to more than 100 congressional measures expanding its regulatory scope over the last two decades.
Those budget cuts translate to 1,311 fewer workers today overseeing an ever-expanding territory. About 80 percent of all drugs sold in the U.S. are manufactured abroad, but the FDA has only 380 inspectors -- a decline of 28 percent since 2003.
Consequently, the FDA cannot inspect the factories of foreign drug makers as frequently as it should. According to the GAO, only 7 percent of the more than 3,000 foreign drug factories registered with the FDA are inspected in any given year -- which means that more than 13 years could pass between inspections.
By contrast, domestic drug makers receive at least one FDA inspection every two years.
The FDA's inability to monitor the 714 Chinese drug makers subject to agency rules is especially worrisome. Just 13 of them -- 1.8 percent -- were inspected in 2007, according to the GAO.
That's not comforting news for American patients. The World Health Organization estimates that 10 percent of the world's drug supply is counterfeit, and many, if not most, of these fakes are made in China.
For example, it was recently reported that a Chinese drug company manufactured an anti-leukemia drug that left nearly 200 Chinese injured. Ordinarily, this would not have raised headlines in America. But the Chinese firm in question was also the sole supplier of the abortion pill RU-486 to the U.S.
Given how few foreign inspections the FDA conducts -- especially in China, where the risks are greatest -- the likelihood of a medical calamity befalling Americans is far too high. How can Congress possibly believe drug importation would be safe? Foreign-made pills would flood U.S. borders.
That means even more foreign packages potentially containing fake or harmful drugs will enter the country without being inspected. The John F. Kennedy Airport Mail Facility receives about 40,000 foreign shipments thought to contain drugs each day. Only 500 to 700 of them are inspected. It makes no sense to expand inspection responsibilities when the FDA can't cover its current ones.
Approving the drug-importation bill might push the agency over the edge. Now is not the time to saddle it even further with the impossible task of adequately screening drug imports. Americans can't afford it.
Peter Pitts is president of the Center for Medicine in the Public Interest and a former FDA associate commissioner.
For safety's safe, keep out drug imports
Sunday, February 24, 2008
By PETER PITTS
A couple of weeks ago, the Government Accountability Office delivered an alarming message to a congressional panel -- the Food and Drug Administration lacks the resources to ensure the safety of the nation's food, drugs and medical devices.
Congress has vowed to fix the FDA. It plans to boost its funding, which is a good start. But those efforts will be more than undermined if Congress legalizes drug importation, which it may try to do this month. Attempting to screen imported prescription drugs would stretch the FDA's abilities to their breaking point.
Just as the agency's workload has surged, its budget has shrunk. The FDA's congressional appropriations have declined $400 million in inflation-adjusted dollars in the last 14 years. But its responsibilities have increased substantially, thanks to more than 100 congressional measures expanding its regulatory scope over the last two decades.
Those budget cuts translate to 1,311 fewer workers today overseeing an ever-expanding territory. About 80 percent of all drugs sold in the U.S. are manufactured abroad, but the FDA has only 380 inspectors -- a decline of 28 percent since 2003.
Consequently, the FDA cannot inspect the factories of foreign drug makers as frequently as it should. According to the GAO, only 7 percent of the more than 3,000 foreign drug factories registered with the FDA are inspected in any given year -- which means that more than 13 years could pass between inspections.
By contrast, domestic drug makers receive at least one FDA inspection every two years.
The FDA's inability to monitor the 714 Chinese drug makers subject to agency rules is especially worrisome. Just 13 of them -- 1.8 percent -- were inspected in 2007, according to the GAO.
That's not comforting news for American patients. The World Health Organization estimates that 10 percent of the world's drug supply is counterfeit, and many, if not most, of these fakes are made in China.
For example, it was recently reported that a Chinese drug company manufactured an anti-leukemia drug that left nearly 200 Chinese injured. Ordinarily, this would not have raised headlines in America. But the Chinese firm in question was also the sole supplier of the abortion pill RU-486 to the U.S.
Given how few foreign inspections the FDA conducts -- especially in China, where the risks are greatest -- the likelihood of a medical calamity befalling Americans is far too high. How can Congress possibly believe drug importation would be safe? Foreign-made pills would flood U.S. borders.
That means even more foreign packages potentially containing fake or harmful drugs will enter the country without being inspected. The John F. Kennedy Airport Mail Facility receives about 40,000 foreign shipments thought to contain drugs each day. Only 500 to 700 of them are inspected. It makes no sense to expand inspection responsibilities when the FDA can't cover its current ones.
Approving the drug-importation bill might push the agency over the edge. Now is not the time to saddle it even further with the impossible task of adequately screening drug imports. Americans can't afford it.
Peter Pitts is president of the Center for Medicine in the Public Interest and a former FDA associate commissioner.
For those who believe drug companies are disease mongering....
Memory Loss And Other Cognitive Impairment Becoming Less Common In Older Americans
Memory loss and thinking problems are becoming less common among older Americans. (Credit: iStockphoto)
ScienceDaily (Feb. 23, 2008) — Although it's too soon to sound the death knell for the "senior moment," it appears that memory loss and thinking problems are becoming less common among older Americans. A new nationally representative study shows a downward trend in the rate of "cognitive impairment" -- the umbrella term for everything from significant memory loss to dementia and Alzheimer's disease -- among people aged 70 and older.
The prevalence of cognitive impairment in this age group went down by 3.5 percentage points between 1993 and 2002 -- from 12.2 percent to 8.7 percent, representing a difference of hundreds of thousands of people.
And while the reasons for this decline aren't yet fully known, the authors say today's older people are much likelier to have had more formal education, higher economic status, and better care for risk factors such as high blood pressure, high cholesterol and smoking that can jeopardize their brains.
In fact, among the 11,000 people in the study, those with more formal education and personal wealth were less likely to have cognitive problems.
Interestingly, the more-educated seniors who had cognitive impairment were more likely to die within two years. But the researchers say this may actually result from a protective effect of better education on a person's "cognitive reserve" -- their ability to sustain more insults to their brain before significant thinking problems arise.
The study is published February 20 online in the journal Alzheimer's and Dementia by a team led by two University of Michigan Medical School physicians and their colleagues. The study is based on data from the Health and Retirement Study (HRS), a national survey of older Americans funded by the National Institute on Aging and based at the U-M Institute for Social Research (ISR)....
.....At the same time, the use of cholesterol-lowering drugs, blood pressure medications and other preventive cardiovascular medications and strategies increased dramatically in the 1990s. These factors may have helped protect seniors' brain function by decreasing the incidence of vascular dementia -- cognitive problems brought on by mini-strokes, strokes and decreased blood flow to and within the brain due to "hardened" or clogged arteries.
Better living through chemistry.
http://www.sciencedaily.com/releases/2008/02/080220121317.htm
Memory Loss And Other Cognitive Impairment Becoming Less Common In Older Americans
Memory loss and thinking problems are becoming less common among older Americans. (Credit: iStockphoto)
ScienceDaily (Feb. 23, 2008) — Although it's too soon to sound the death knell for the "senior moment," it appears that memory loss and thinking problems are becoming less common among older Americans. A new nationally representative study shows a downward trend in the rate of "cognitive impairment" -- the umbrella term for everything from significant memory loss to dementia and Alzheimer's disease -- among people aged 70 and older.
The prevalence of cognitive impairment in this age group went down by 3.5 percentage points between 1993 and 2002 -- from 12.2 percent to 8.7 percent, representing a difference of hundreds of thousands of people.
And while the reasons for this decline aren't yet fully known, the authors say today's older people are much likelier to have had more formal education, higher economic status, and better care for risk factors such as high blood pressure, high cholesterol and smoking that can jeopardize their brains.
In fact, among the 11,000 people in the study, those with more formal education and personal wealth were less likely to have cognitive problems.
Interestingly, the more-educated seniors who had cognitive impairment were more likely to die within two years. But the researchers say this may actually result from a protective effect of better education on a person's "cognitive reserve" -- their ability to sustain more insults to their brain before significant thinking problems arise.
The study is published February 20 online in the journal Alzheimer's and Dementia by a team led by two University of Michigan Medical School physicians and their colleagues. The study is based on data from the Health and Retirement Study (HRS), a national survey of older Americans funded by the National Institute on Aging and based at the U-M Institute for Social Research (ISR)....
.....At the same time, the use of cholesterol-lowering drugs, blood pressure medications and other preventive cardiovascular medications and strategies increased dramatically in the 1990s. These factors may have helped protect seniors' brain function by decreasing the incidence of vascular dementia -- cognitive problems brought on by mini-strokes, strokes and decreased blood flow to and within the brain due to "hardened" or clogged arteries.
Better living through chemistry.
http://www.sciencedaily.com/releases/2008/02/080220121317.htm
Connecting the dots cuts both ways. But we bet we won't see or hear much response...from any quarter. Sometimes shame can be measured in silence.
http://www.washingtontimes.com/article/20080222/EDITORIAL/967933181/1013
Tabloid medicine
February 22, 2008
By Robert Goldberg and Peter J. Pitts
After serving for more than 12 years in the Army and the Army Reserves, 32-year-old Julianna Gehant enrolled at Northern Illinois University last fall. This week she was laid to rest along with four other victims of Steven Kazmierczak's killing spree. To add to the already tragic nature of the story, a former professor described Kazmierczak as a most gentle, quiet guy in the world. Harder still to assign blame or responsibility. Or is it?
Kazmierczak had a history of mental illness, including institutionalization. He did not take his medication regularly, and weeks before the killings he went off his antidepressants.
Much like the killer at Virginia Tech, the signs were all there. So, too, was the groundwork laid by the media, freelance pundits and by some in Congress to irresponsibly scare people away from taking the medicines that very well could have kept such anti-social homicidal behavior in check.
Less then four years ago, there was plenty of media airtime and political effort invested on Capitol Hill trying to scare teenagers and their parents from taking the most commonly prescribed anti-depressants — selective serotonin reuptake inhibitors (SSRI), such as Prozac, Paxil and Zoloft. It was alleged by Rep. Bart Stupak and Sen. Charles Grassley that there was conspiracy of silence between drug companies and the Food and Drug Administration to hide information about SSRIs turning otherwise happy kids into potential suicides.
Here's an inconvenient truth: Suicide is a leading cause of death among young people. The good news is that it's both treatable and preventable — particularly with the timely and appropriate use of antidepressants. But what parent or troubled kid would, in the wake of the concerted campaigns of Messrs. Stupak and Grassley, want to do so? In 2004, for instance, at a hearing where the FDA was accused of conspiring with drug companies to hide data about how SSRIs caused suicides, Mr. Stupak threatened to introduce legislation banning the prescribing of antidepressants to anyone under age 18 "if the FDA didn't act forcefully and swiftly to protect America's children."
Indeed, Mr. Grassley claimed there was a coordinated effort by the Food and Drug Administration to suppress the truth about the suicide risks of antidepressants. He gave top billing to internal FDA studies that looked at the relationship between SSRIs and suicidal thoughts but claimed it looked at suicide.
And so the New York Times dutifully reported the "risks of suicide" posed by SSRI and the Los Angeles Times claimed "Suicide Risk to Children Affirmed."
Not surprisingly, the hearings and the coverage lead to panic and, predictably, noncompliance. Ultimately, the FDA accepted an advisory committee recommendation to require that all antidepressants carrying a Black Box warning that they increase the "risk of suicidal thinking and behavior ... in children and adolescents" with depression and other psychiatric disorders. A decline in SSRI prescriptions followed.
Then, last year, Robert D. Gibbons, director of the Center for Health Statistics at the University of Illinois at Chicago, found that suicide rates among American youths dramatically increased from 2003 to 2004, coinciding with a steep drop in antidepressant use.
The 19 percent increase in suicides among those 19 and younger is the biggest year-to-year increase seen since the Centers for Disease Control and Prevention started tracking the data in 1979. A similar jump in suicide — and decline in antidepressant use — was found in Europe over the same period of time.
Curiously, neither Mr. Stupak nor Mr. Grassley commented on this connection and it was all but ignored by the media and other self-appointed guardians of medical truth.
The FDA's black box is not killing kids. But the collective actions and rhetoric that lead up to it are. Darryl Regier, the former director of the National Institute of Mental Health, notes, "Contrary to expectations, other treatments, such as alternative medicines or psychotherapy, which have limited effects on childhood depression, did not increase to fill the gap."
That gap was created by Congress and irresponsibly spread by sensationalist media coverage. When senior leaders within the FDA to tried to balance benefits and risks on antidepressants they were savaged by Messrs. Stupak and Grassley. And when the FDA tries to explain the complexities of Ketek or Avandia, Mr. Stupak demands resignations — in speeches that still include the claim that that antidepressants cause suicides. Drug-company lobbyists counsel cowardly silence. Science and common sense give way to tabloid medicine.
Peter J. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest. Robert Goldberg is vice president for research programs at the Center for Medicine in the Public Interest.
http://www.washingtontimes.com/article/20080222/EDITORIAL/967933181/1013
Tabloid medicine
February 22, 2008
By Robert Goldberg and Peter J. Pitts
After serving for more than 12 years in the Army and the Army Reserves, 32-year-old Julianna Gehant enrolled at Northern Illinois University last fall. This week she was laid to rest along with four other victims of Steven Kazmierczak's killing spree. To add to the already tragic nature of the story, a former professor described Kazmierczak as a most gentle, quiet guy in the world. Harder still to assign blame or responsibility. Or is it?
Kazmierczak had a history of mental illness, including institutionalization. He did not take his medication regularly, and weeks before the killings he went off his antidepressants.
Much like the killer at Virginia Tech, the signs were all there. So, too, was the groundwork laid by the media, freelance pundits and by some in Congress to irresponsibly scare people away from taking the medicines that very well could have kept such anti-social homicidal behavior in check.
Less then four years ago, there was plenty of media airtime and political effort invested on Capitol Hill trying to scare teenagers and their parents from taking the most commonly prescribed anti-depressants — selective serotonin reuptake inhibitors (SSRI), such as Prozac, Paxil and Zoloft. It was alleged by Rep. Bart Stupak and Sen. Charles Grassley that there was conspiracy of silence between drug companies and the Food and Drug Administration to hide information about SSRIs turning otherwise happy kids into potential suicides.
Here's an inconvenient truth: Suicide is a leading cause of death among young people. The good news is that it's both treatable and preventable — particularly with the timely and appropriate use of antidepressants. But what parent or troubled kid would, in the wake of the concerted campaigns of Messrs. Stupak and Grassley, want to do so? In 2004, for instance, at a hearing where the FDA was accused of conspiring with drug companies to hide data about how SSRIs caused suicides, Mr. Stupak threatened to introduce legislation banning the prescribing of antidepressants to anyone under age 18 "if the FDA didn't act forcefully and swiftly to protect America's children."
Indeed, Mr. Grassley claimed there was a coordinated effort by the Food and Drug Administration to suppress the truth about the suicide risks of antidepressants. He gave top billing to internal FDA studies that looked at the relationship between SSRIs and suicidal thoughts but claimed it looked at suicide.
And so the New York Times dutifully reported the "risks of suicide" posed by SSRI and the Los Angeles Times claimed "Suicide Risk to Children Affirmed."
Not surprisingly, the hearings and the coverage lead to panic and, predictably, noncompliance. Ultimately, the FDA accepted an advisory committee recommendation to require that all antidepressants carrying a Black Box warning that they increase the "risk of suicidal thinking and behavior ... in children and adolescents" with depression and other psychiatric disorders. A decline in SSRI prescriptions followed.
Then, last year, Robert D. Gibbons, director of the Center for Health Statistics at the University of Illinois at Chicago, found that suicide rates among American youths dramatically increased from 2003 to 2004, coinciding with a steep drop in antidepressant use.
The 19 percent increase in suicides among those 19 and younger is the biggest year-to-year increase seen since the Centers for Disease Control and Prevention started tracking the data in 1979. A similar jump in suicide — and decline in antidepressant use — was found in Europe over the same period of time.
Curiously, neither Mr. Stupak nor Mr. Grassley commented on this connection and it was all but ignored by the media and other self-appointed guardians of medical truth.
The FDA's black box is not killing kids. But the collective actions and rhetoric that lead up to it are. Darryl Regier, the former director of the National Institute of Mental Health, notes, "Contrary to expectations, other treatments, such as alternative medicines or psychotherapy, which have limited effects on childhood depression, did not increase to fill the gap."
That gap was created by Congress and irresponsibly spread by sensationalist media coverage. When senior leaders within the FDA to tried to balance benefits and risks on antidepressants they were savaged by Messrs. Stupak and Grassley. And when the FDA tries to explain the complexities of Ketek or Avandia, Mr. Stupak demands resignations — in speeches that still include the claim that that antidepressants cause suicides. Drug-company lobbyists counsel cowardly silence. Science and common sense give way to tabloid medicine.
Peter J. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest. Robert Goldberg is vice president for research programs at the Center for Medicine in the Public Interest.
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.
