Latest Drugwonks' Blog
I agree with Bob Goldberg's recent post refering to the uses of anti-psychotics and how they might have helped control the Virginia Tech killer, if they were taken, a big IF.. I also believe that universities should be able to mandate ongoing psychiatric care for someone like this - "if you don't like it, then leave the university."
which is not the say that a treating psychiatrist would have been able to intervene in time. It is not for sure that the killer would have revealed his plan beforehand. But if he had, then the treating psychiatrist would have had an obligation to admit him for acute homicidal ideation. It is also obvious that a person like this, with such a known psych history, especially with violent ideation, should not be allowed to purchase guns, and certainly computers could be used to create such a useful databank that gun stores could adhere to.
There is another issue to address - one that I have written extensively about in my book False Alarm: the Truth About the Epidemic of Fear.
Namely that it is too easy to personalize what you see in the news, too easy to attach yourself voyeuristically to a crime like Columbine or this one and feel as if it is going to happen to you.
THis kind of fear is infectious, and the killer knew this, which was one of the reasons he may have chosed a Columbine-like model.
My friend Gary Baumgarten of Paltalk, formerly of CNN radio, has written about this fear factor today in his blog and cited my book.
http://www.paltalk.com/newstalk/msiegel_041907_archive.shtml#comments
which is not the say that a treating psychiatrist would have been able to intervene in time. It is not for sure that the killer would have revealed his plan beforehand. But if he had, then the treating psychiatrist would have had an obligation to admit him for acute homicidal ideation. It is also obvious that a person like this, with such a known psych history, especially with violent ideation, should not be allowed to purchase guns, and certainly computers could be used to create such a useful databank that gun stores could adhere to.
There is another issue to address - one that I have written extensively about in my book False Alarm: the Truth About the Epidemic of Fear.
Namely that it is too easy to personalize what you see in the news, too easy to attach yourself voyeuristically to a crime like Columbine or this one and feel as if it is going to happen to you.
THis kind of fear is infectious, and the killer knew this, which was one of the reasons he may have chosed a Columbine-like model.
My friend Gary Baumgarten of Paltalk, formerly of CNN radio, has written about this fear factor today in his blog and cited my book.
http://www.paltalk.com/newstalk/msiegel_041907_archive.shtml#comments
She writes about a new drug designed to reduce the number of times a woman menstruates as if this were something drug companies were trying to take away from women or make them ashamed of. Why can't women choose to take control of their bodies? And incredibly THIS gets front page coverage at the NYT but not the article about the benefits of antidepressants. In fact the NYT did not assign a staff reporter to that important story. Disgusting.
http://www.nytimes.com/2007/04/20/health/20period.html?_r=1&oref=slogin
http://www.nytimes.com/2007/04/20/health/20period.html?_r=1&oref=slogin
Why? Because they support Medicare advantage plans that give low income and chronically ill seniors more benefits at a cost with free drugs.... (Refer to Peter's post on Mark McClellan on how this happened..)
Krugman always writes like someone who finds it helpful to grind his axe on the necks of others. This piece is no different. Read all about it in his latest meltdown....
The Plot Against Medicare
"The plot against Social Security failed: President Bush's attempt to privatize the system crashed and burned when the public realized what he was up to. But the plot against Medicare is faring better: the stealth privatization embedded in the Medicare Modernization Act, which Congress literally passed in the dead of night back in 2003, is proceeding apace.
Worse yet, the forces behind privatization not only continue to have the G.O.P. in their pocket, but they have also been finding useful idiots within the newly powerful Democratic coalition. And it's not just politicians with an eye on campaign contributions. There's no nice way to say it: the NAACP and the League of United Latin American Citizens have become patsies for the insurance industry. "
Krugman always writes like someone who finds it helpful to grind his axe on the necks of others. This piece is no different. Read all about it in his latest meltdown....
The Plot Against Medicare
"The plot against Social Security failed: President Bush's attempt to privatize the system crashed and burned when the public realized what he was up to. But the plot against Medicare is faring better: the stealth privatization embedded in the Medicare Modernization Act, which Congress literally passed in the dead of night back in 2003, is proceeding apace.
Worse yet, the forces behind privatization not only continue to have the G.O.P. in their pocket, but they have also been finding useful idiots within the newly powerful Democratic coalition. And it's not just politicians with an eye on campaign contributions. There's no nice way to say it: the NAACP and the League of United Latin American Citizens have become patsies for the insurance industry. "
"Competence Man" as dubbed by Kim Strassel, is Mark McClellan (dubbed by Drugwonks as "the hardest working man in health care"). Here's what she had to say in today's Wall Street Journal:
Competence Man
By KIMBERLEY STRASSEL
Republicans won a big victory this week, shooting down a Democratic plan for more government-run health care. The GOP victors, and free-marketeers, might send their thank-you notes to Dr. Mark McClellan.
Dr. McClellan is the 43-year-old internist who, until recently, held the thankless job of running Medicare. He was handed the further thankless task of designing and implementing Congress's tepid 2003 Medicare reform. And he's the big brain who then wrung every last ounce out of that authority to create a striking new model for Medicare competition that is today not only performing beyond expectations, but is changing the political health-care debate.
High praise, yes, but borne out by this week's GOP defeat of a bill to allow the government to fix Medicare drug prices. That was a top Democratic promise this last election, as the party sought to play off public anger over health-care costs. Liberals saw it as an important step toward their all-government, health-care nirvana. Nancy Pelosi and Harry Reid also felt this was an issue on which they could once again roll Republicans, by flashing the impoverished-senior-citizens card.
Instead, Dr. McClellan's new model came online and wowed the older class. Private companies have flocked to offer a drug benefit, giving most seniors a choice of 50 innovative plans. The competitive jockeying has slashed prices from an expected $37-a-month premium to an average $22. The cost of Medicare Part D for taxpayers was 30% below expectations its first year -- unheard of in government. And Medicare Advantage, which allows seniors to choose between private insurers, has grown to encompass nearly one in five beneficiaries.
This success has rebutted Democratic criticisms of the drug benefit and shown up those who tar the Bush administration as incompetent. The program's success emboldened Republicans to vote for free-market health care this week. Democrats have seen flagging public support for their program of more government and fewer drugs. While Mr. Reid held his caucus together this week, some are worried about bashing a drug benefit that has an 80% senior approval rating. "Congress only wishes it had an 80% approval rating," chuckles former Democratic Sen. John Breaux, an author of the 2003 reform. "A lot of folks campaigned last year on 'We're going to fix this program,' only to be told by seniors, 'Wait a minute, it ain't broke.'"
None of this was inevitable, but goes back to the competent Dr. McClellan. President Bush came to town pushing Medicare reform, and had a shot at an historic overhaul. The GOP could offer the carrot of a new drug benefit, in return for opening the entire decrepit program to private competition. Instead, Bush and Co. became more interested in claiming credit for an $8 trillion entitlement, and settled for meager reform.
Dr. McClellan nonetheless took this pared-down opportunity and used it to show private competition can work. His success, in particular with the drug benefit, rests in two broad ideas. The first was to design a program that immediately attracted a critical mass of private players to provide price and choice competition. At the time, nobody thought that possible. Mr. Breaux remembers Congress worrying that so few private players would participate that whole areas of the country would lack private drug plans.
Dr. McClellan's solution was a program that gave companies maximum freedom to design plans, bundle drugs and turn a profit. He was a salesman, talking up the opportunities and even traveling to New York to reassure Wall Street. It worked, and by the first days of business most seniors were being courted by anywhere from 11 to 23 plan sponsors. Those numbers have only grown, creating so much competition that sponsors are eliminating deductibles, lowering premiums, offering more drugs. It's also led to smart cost-cutting and efficiencies; an estimated 60% of Medicare prescriptions are now for generics.
Dr. McClellan's other strategy -- and the flip side of the coin -- was to get seniors enrolled quickly. His team designed an Internet program that allowed seniors to punch in their information and examine the best plans. His agency reached out to local organizations -- church groups, community centers -- and enlisted their aid in explaining details. A call center at one point handled 400,000 plan questions a day. Today, some 90% of Medicare recipients are enrolled in the benefit, numbers that have further attracted private players, further spurred competition, further lowered prices. "This is how you come in under budget, increase satisfaction," says the man himself, Dr. McClellan. He adds, humbly, "Nobody should think this is perfect yet, but it's clearly accomplishing some good things."
Good things or no, the reforms are still at risk. There was a time when Democrats believed in Medicare reform, but now most prefer it as a political stick to beat President Bush. There are also liberals -- Henry Waxman, Pete Stark -- who understand this is a crucial moment in the national debate over government-versus-private health care, and will do what they can to sabotage the reforms.
Expect, therefore, more votes over Medicare's right to price-fix. If a broad bill can't pass, liberal politicians will instead target individual, high-cost drugs, arguing that since Medicare foots most of the bill for these products, it should have the right to "negotiate." The real goal will be to get any foot in the price-setting door, making it harder for private companies to craft flexible drug packages, and laying the groundwork for more price-setting down the road.
Expect, too, a push to starve the competitive programs of cash. Critics know how effective this is, having siphoned dollars out of the old Medicare Advantage program in the 1990s, causing private plans to drop out, and giving the program a bad name. Dr. McClellan's reforms, and a Republican Congress, have re-energized the program, but the key to future success is in the budget. Republicans would do well to spend more time touting the competition successes of the reform, rather than the drug giveaway.
In a perfect world, the Bush administration would never have swallowed that entitlement in the first place. In our imperfect world, it at least had the wisdom to hand the reform challenge to a guy who was able to demonstrate the merits of health-care competition, and optimistically, pave the way for broader reform down the road.
Great op-ed.
"Confidence Man" (like in FlimFlam Man") is Paul "Imus" Krugman of the New York Times. He earns this moniker because of the dishonest way he portrays the Part D benefit in today's edition of the Gray Lady, and his assertions that the NAACP and the League of United Latin American Citizens just aren't smart enough to know what's in their own best interests.
Competence Man
By KIMBERLEY STRASSEL
Republicans won a big victory this week, shooting down a Democratic plan for more government-run health care. The GOP victors, and free-marketeers, might send their thank-you notes to Dr. Mark McClellan.
Dr. McClellan is the 43-year-old internist who, until recently, held the thankless job of running Medicare. He was handed the further thankless task of designing and implementing Congress's tepid 2003 Medicare reform. And he's the big brain who then wrung every last ounce out of that authority to create a striking new model for Medicare competition that is today not only performing beyond expectations, but is changing the political health-care debate.
High praise, yes, but borne out by this week's GOP defeat of a bill to allow the government to fix Medicare drug prices. That was a top Democratic promise this last election, as the party sought to play off public anger over health-care costs. Liberals saw it as an important step toward their all-government, health-care nirvana. Nancy Pelosi and Harry Reid also felt this was an issue on which they could once again roll Republicans, by flashing the impoverished-senior-citizens card.
Instead, Dr. McClellan's new model came online and wowed the older class. Private companies have flocked to offer a drug benefit, giving most seniors a choice of 50 innovative plans. The competitive jockeying has slashed prices from an expected $37-a-month premium to an average $22. The cost of Medicare Part D for taxpayers was 30% below expectations its first year -- unheard of in government. And Medicare Advantage, which allows seniors to choose between private insurers, has grown to encompass nearly one in five beneficiaries.
This success has rebutted Democratic criticisms of the drug benefit and shown up those who tar the Bush administration as incompetent. The program's success emboldened Republicans to vote for free-market health care this week. Democrats have seen flagging public support for their program of more government and fewer drugs. While Mr. Reid held his caucus together this week, some are worried about bashing a drug benefit that has an 80% senior approval rating. "Congress only wishes it had an 80% approval rating," chuckles former Democratic Sen. John Breaux, an author of the 2003 reform. "A lot of folks campaigned last year on 'We're going to fix this program,' only to be told by seniors, 'Wait a minute, it ain't broke.'"
None of this was inevitable, but goes back to the competent Dr. McClellan. President Bush came to town pushing Medicare reform, and had a shot at an historic overhaul. The GOP could offer the carrot of a new drug benefit, in return for opening the entire decrepit program to private competition. Instead, Bush and Co. became more interested in claiming credit for an $8 trillion entitlement, and settled for meager reform.
Dr. McClellan nonetheless took this pared-down opportunity and used it to show private competition can work. His success, in particular with the drug benefit, rests in two broad ideas. The first was to design a program that immediately attracted a critical mass of private players to provide price and choice competition. At the time, nobody thought that possible. Mr. Breaux remembers Congress worrying that so few private players would participate that whole areas of the country would lack private drug plans.
Dr. McClellan's solution was a program that gave companies maximum freedom to design plans, bundle drugs and turn a profit. He was a salesman, talking up the opportunities and even traveling to New York to reassure Wall Street. It worked, and by the first days of business most seniors were being courted by anywhere from 11 to 23 plan sponsors. Those numbers have only grown, creating so much competition that sponsors are eliminating deductibles, lowering premiums, offering more drugs. It's also led to smart cost-cutting and efficiencies; an estimated 60% of Medicare prescriptions are now for generics.
Dr. McClellan's other strategy -- and the flip side of the coin -- was to get seniors enrolled quickly. His team designed an Internet program that allowed seniors to punch in their information and examine the best plans. His agency reached out to local organizations -- church groups, community centers -- and enlisted their aid in explaining details. A call center at one point handled 400,000 plan questions a day. Today, some 90% of Medicare recipients are enrolled in the benefit, numbers that have further attracted private players, further spurred competition, further lowered prices. "This is how you come in under budget, increase satisfaction," says the man himself, Dr. McClellan. He adds, humbly, "Nobody should think this is perfect yet, but it's clearly accomplishing some good things."
Good things or no, the reforms are still at risk. There was a time when Democrats believed in Medicare reform, but now most prefer it as a political stick to beat President Bush. There are also liberals -- Henry Waxman, Pete Stark -- who understand this is a crucial moment in the national debate over government-versus-private health care, and will do what they can to sabotage the reforms.
Expect, therefore, more votes over Medicare's right to price-fix. If a broad bill can't pass, liberal politicians will instead target individual, high-cost drugs, arguing that since Medicare foots most of the bill for these products, it should have the right to "negotiate." The real goal will be to get any foot in the price-setting door, making it harder for private companies to craft flexible drug packages, and laying the groundwork for more price-setting down the road.
Expect, too, a push to starve the competitive programs of cash. Critics know how effective this is, having siphoned dollars out of the old Medicare Advantage program in the 1990s, causing private plans to drop out, and giving the program a bad name. Dr. McClellan's reforms, and a Republican Congress, have re-energized the program, but the key to future success is in the budget. Republicans would do well to spend more time touting the competition successes of the reform, rather than the drug giveaway.
In a perfect world, the Bush administration would never have swallowed that entitlement in the first place. In our imperfect world, it at least had the wisdom to hand the reform challenge to a guy who was able to demonstrate the merits of health-care competition, and optimistically, pave the way for broader reform down the road.
Great op-ed.
"Confidence Man" (like in FlimFlam Man") is Paul "Imus" Krugman of the New York Times. He earns this moniker because of the dishonest way he portrays the Part D benefit in today's edition of the Gray Lady, and his assertions that the NAACP and the League of United Latin American Citizens just aren't smart enough to know what's in their own best interests.
CMPI Board member Steve Sammut is holding a biotech bootcamp for entreprenuers at Bio 2007 in Boston on May 7. Another board member, Atlas Venture partner Bruce Booth is on one of the panels.
Disclosure: Drugwonks does not receive any compensation for this plug and was not invited to speak. In fact, we were specifically told to stay away. Ok, so there is a TRO banning us from being within 200 yards of the session.
http://www.bio2007.org/Attendees/educational_sessions/EntrepreneurshipBootCamp1.htm
Disclosure: Drugwonks does not receive any compensation for this plug and was not invited to speak. In fact, we were specifically told to stay away. Ok, so there is a TRO banning us from being within 200 yards of the session.
http://www.bio2007.org/Attendees/educational_sessions/EntrepreneurshipBootCamp1.htm
Here is Sheila Burke in her NEJM article describing the IOM Drug Safety panel she chaired:
"The IOM assembled a diverse panel of experts without ostensible bias or conflict of interest, none of whom were pharmaceutical industry employees."
Here is a description of Sheila Burke chairing the Smithsonian, which oversaw the conduct of Larry Small who used millions of taxpayer dollars to redo his home and hold lavish parties:
The Smithsonian Institution last year renewed a contract giving the Chubb Group more than a half-million dollars of insurance business annually while Lawrence M. Small, then the Smithsonian secretary, and Sheila P. Burke, the deputy secretary, held highly paid seats on Chubb's board of directors.
Small received cash and stock valued at $169,675 from Chubb last year, according to proxy statements filed with the Securities and Exchange Commission. He also received options to purchase 105,943 shares.
Burke received cash and stock valued at $194,676 from Chubb and options to purchase 56,000 shares, according to the SEC. Small and Burke sit on Chubb's compensation committee. Burke is also a member of Chubb's finance committee and pension and profit-sharing committee.
Small, who resigned late last month after seven years at the helm of the Smithsonian in the wake of questions about his salary and expenses, was set to receive $915,698 from the museum complex this year. Burke received $400,000 last year. A Senate committee holds hearings on Smithsonian compensation practices today. And another Senate committee investigation has raised questions about the Chubb-Smithsonian relationship."
Earlier this year Burke told me that a Nobel Prize winner would have been excluded from her IOM panel if he or she had worked for a drug company even if that person was an expert on drug safety. But I guess having someone rebuked by NIH for claiming a link between cancer and blood pressure meds and a hired gun for trial lawyers suing drug companies in drug safety cases is ok (Bruce Psaty) and taking money from a health insurer that would benefit from fewer new drug approvals is ok too.
Can we say ethically confused and compromised.
"The IOM assembled a diverse panel of experts without ostensible bias or conflict of interest, none of whom were pharmaceutical industry employees."
Here is a description of Sheila Burke chairing the Smithsonian, which oversaw the conduct of Larry Small who used millions of taxpayer dollars to redo his home and hold lavish parties:
The Smithsonian Institution last year renewed a contract giving the Chubb Group more than a half-million dollars of insurance business annually while Lawrence M. Small, then the Smithsonian secretary, and Sheila P. Burke, the deputy secretary, held highly paid seats on Chubb's board of directors.
Small received cash and stock valued at $169,675 from Chubb last year, according to proxy statements filed with the Securities and Exchange Commission. He also received options to purchase 105,943 shares.
Burke received cash and stock valued at $194,676 from Chubb and options to purchase 56,000 shares, according to the SEC. Small and Burke sit on Chubb's compensation committee. Burke is also a member of Chubb's finance committee and pension and profit-sharing committee.
Small, who resigned late last month after seven years at the helm of the Smithsonian in the wake of questions about his salary and expenses, was set to receive $915,698 from the museum complex this year. Burke received $400,000 last year. A Senate committee holds hearings on Smithsonian compensation practices today. And another Senate committee investigation has raised questions about the Chubb-Smithsonian relationship."
Earlier this year Burke told me that a Nobel Prize winner would have been excluded from her IOM panel if he or she had worked for a drug company even if that person was an expert on drug safety. But I guess having someone rebuked by NIH for claiming a link between cancer and blood pressure meds and a hired gun for trial lawyers suing drug companies in drug safety cases is ok (Bruce Psaty) and taking money from a health insurer that would benefit from fewer new drug approvals is ok too.
Can we say ethically confused and compromised.
Virginia Tech sorrow and media SSRI hysteria notwithstanding, some important new science ...
Authors of a new comprehensive analysis of antidepressants for children and teenagers say the benefits of treatment trump the small risk of increasing some patients' chances of having suicidal thoughts and behaviors.
The risk they found is lower than the one the Food and Drug Administration identified in 2004, the year the agency warned the public about the drugs' risks in children. After the warning, U.S. youth suicides increased and some mental health experts said reluctance to try antidepressants might be to blame.
The new analysis includes data from seven studies that were not part of the previous FDA analysis, including two large pediatric depression trials that were unavailable three years ago.
Researchers analyzed data on 5,310 children and teenagers from 27 studies. They found that for every 100 kids treated with antidepressants, about one additional child experienced worsening suicidal feelings above what would have happened without drug treatment. In contrast, the FDA analysis found an added risk affecting about two in 100 patients.
Here's a link to the AP story:
http://www.chron.com/disp/story.mpl/health/4729234.html
Authors of a new comprehensive analysis of antidepressants for children and teenagers say the benefits of treatment trump the small risk of increasing some patients' chances of having suicidal thoughts and behaviors.
The risk they found is lower than the one the Food and Drug Administration identified in 2004, the year the agency warned the public about the drugs' risks in children. After the warning, U.S. youth suicides increased and some mental health experts said reluctance to try antidepressants might be to blame.
The new analysis includes data from seven studies that were not part of the previous FDA analysis, including two large pediatric depression trials that were unavailable three years ago.
Researchers analyzed data on 5,310 children and teenagers from 27 studies. They found that for every 100 kids treated with antidepressants, about one additional child experienced worsening suicidal feelings above what would have happened without drug treatment. In contrast, the FDA analysis found an added risk affecting about two in 100 patients.
Here's a link to the AP story:
http://www.chron.com/disp/story.mpl/health/4729234.html
Sanofi Aventis' vaccine division received approval for the first vaccine to protect against bird flu. According to the FDA the vaccine, has been approved for use only in adults aged 18-64 who are at a greater risk of being affected by the bird flu virus. The patients will receive a 90 microgram of shot initially and then another 90 microgram after 28 days.
Given that bird flu was first detected a few years ago, the speed with which a vaccine was developed is truly a marvel. And most of the vaccine will be donated or sold at cost. But don't expect any articles on that. Rather, expect a rash of media stories on whether the vaccine is being marketed to the right people and whether the researchers conducting studies on the vaccine's effectiveness received money from SA.
As I always say, no good deed goes unpunished.
Given that bird flu was first detected a few years ago, the speed with which a vaccine was developed is truly a marvel. And most of the vaccine will be donated or sold at cost. But don't expect any articles on that. Rather, expect a rash of media stories on whether the vaccine is being marketed to the right people and whether the researchers conducting studies on the vaccine's effectiveness received money from SA.
As I always say, no good deed goes unpunished.
For those of you out there (yes, that means you Marcia Angell) who think we have "too many me-too drugs," consider yesterday's FDA adcomm vote on Avalide.
FDA advisers voted 7-0 in favor of approving the drug for use in controlling high blood pressure. (Avalide was initially approved only for hypertension patients who have failed other types of treatment.)
You've heard of hypertension, right? It's one of those made-up lifestyle diseases.
If the Me-Tooers were running the show, would Avalide have been approved in the first place? After all, do we really need another drug that treats hypertension?
Indeed we do -- and now physicians have a new, valuable, and on-label weapon in their fight against a major public health enemy -- high blood pressure.
FDA advisers voted 7-0 in favor of approving the drug for use in controlling high blood pressure. (Avalide was initially approved only for hypertension patients who have failed other types of treatment.)
You've heard of hypertension, right? It's one of those made-up lifestyle diseases.
If the Me-Tooers were running the show, would Avalide have been approved in the first place? After all, do we really need another drug that treats hypertension?
Indeed we do -- and now physicians have a new, valuable, and on-label weapon in their fight against a major public health enemy -- high blood pressure.
From the FBI.... I might be wrong but I don't see "taking an SSRI" on the list
1. A history of violence and/or being victimized
2. Threats of violence
3. An obsessive interest in weapons
4. A tendency to be isolated
5. The inability to get along with others
6. Excessive anger
7. Job loss
8. Breakup of a relationship
9. Alcohol and drug usage
10. Intolerance of differences
11. Gang affiliation
12. Poor attachment to school
13. Exhibiting impulsive behavior
14. Making violent drawings or writings
1. A history of violence and/or being victimized
2. Threats of violence
3. An obsessive interest in weapons
4. A tendency to be isolated
5. The inability to get along with others
6. Excessive anger
7. Job loss
8. Breakup of a relationship
9. Alcohol and drug usage
10. Intolerance of differences
11. Gang affiliation
12. Poor attachment to school
13. Exhibiting impulsive behavior
14. Making violent drawings or writings
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.
