Latest Drugwonks' Blog
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?
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.
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.
