Latest Drugwonks' Blog
Regular readers of DrugWonks.com know that when pundits and pols call for FDA reform, we urge them to "Show me the money" that such efforts deserve. Mostly, we're still waiting.
Now my former FDA colleague (and current CMPI Board of Advisors member) Tomas Philipson (along with two of his colleagues from the University of Chicago) asks, in a terrific guest editorial in current edition of Health Economics, "Where is the science?"
He refers, of course, to the recent IOM study which places politics before science and rhetoric before reality.
Here's a link to the editorial:
Download file
Thoughts and comments appreciated.
Now my former FDA colleague (and current CMPI Board of Advisors member) Tomas Philipson (along with two of his colleagues from the University of Chicago) asks, in a terrific guest editorial in current edition of Health Economics, "Where is the science?"
He refers, of course, to the recent IOM study which places politics before science and rhetoric before reality.
Here's a link to the editorial:
Download file
Thoughts and comments appreciated.
In my column, Antidote, for M, M & M this month, I discuss Tekturna, the first in a very promising new class of hypertensive drugs. It is no accident that this drug has come in "under the radar" at a time when so much of the main stream media appetite involves bashing drugs and drug companies, rather than championing great discoveries. Of course this climate, while making companies paranoid to dot every "I" and cross every "T" can also negatively effect drug research both short and long term.
Happy Passover to all.
Here's the column:
ANTIDOTE: 4-07 by Marc Siegel MD
Novartis has a new drug that has just been approved by the FDA. It’s called Tekturna. It’s the first new class of hypertensive drugs in ten years, something well worth celebrating. But it’s “coming out party†has received little medical attention.
Why?
It’s not for lack of importance. Tekturna is a first of its kind once a day renin blocker. Hypertension afflicts close to one billion people worldwide, and is uncontrolled in 70%, leading to heart disease, kidney failure, and stroke.
Renin is a crucial hormonal trigger of the renin-angiotensin system which ultimately leads to the production of the important adrenal hormone aldosterone, while at the same time constricting the body’s arteries.
In a clinical trial involving 6,400 patients, Tekturna significantly lowered blood pressure for 24 hours and was also effective in combination with other medications. Considering that the renin-angiotensin system is an essential cause of high blood pressure and heart disease, and that the blockers already on the market that interfere with angiotensin-converting enzyme or block the receptor for angiotensin II have been highly successful and life saving, the need for an effective renin blocker is undisputed.
So now along comes the first drug of its kind, potentially the most powerful drug in the angiotensin axis, and no one pays attention. Is the blood thirsty zeal of drug company attackers so potent that it overwhelms and obscurs all positive reports about a new class of drugs? I’m afraid so. Is it more important to attack Merck over the rare side affect of Vioxx than to champion Novartis for breaking through with a new discovery? I definitely don’t think so.
If we want our drug companies to thrive and spend the billions necessary to break through with a new category of drugs, the least we can do is congratulate them when one succeeds. Those who make an unremitting habit of bashing drug companies about unforeseen side effects could cost them so much money and public embarrassment that it takes the legs out of important projects like the one that led to the birth of Tekturna. In the current climate, it is probably no coincidence that it took ten years to come up with a new category of blood pressure drugs.
Happy Passover to all.
Here's the column:
ANTIDOTE: 4-07 by Marc Siegel MD
Novartis has a new drug that has just been approved by the FDA. It’s called Tekturna. It’s the first new class of hypertensive drugs in ten years, something well worth celebrating. But it’s “coming out party†has received little medical attention.
Why?
It’s not for lack of importance. Tekturna is a first of its kind once a day renin blocker. Hypertension afflicts close to one billion people worldwide, and is uncontrolled in 70%, leading to heart disease, kidney failure, and stroke.
Renin is a crucial hormonal trigger of the renin-angiotensin system which ultimately leads to the production of the important adrenal hormone aldosterone, while at the same time constricting the body’s arteries.
In a clinical trial involving 6,400 patients, Tekturna significantly lowered blood pressure for 24 hours and was also effective in combination with other medications. Considering that the renin-angiotensin system is an essential cause of high blood pressure and heart disease, and that the blockers already on the market that interfere with angiotensin-converting enzyme or block the receptor for angiotensin II have been highly successful and life saving, the need for an effective renin blocker is undisputed.
So now along comes the first drug of its kind, potentially the most powerful drug in the angiotensin axis, and no one pays attention. Is the blood thirsty zeal of drug company attackers so potent that it overwhelms and obscurs all positive reports about a new class of drugs? I’m afraid so. Is it more important to attack Merck over the rare side affect of Vioxx than to champion Novartis for breaking through with a new discovery? I definitely don’t think so.
If we want our drug companies to thrive and spend the billions necessary to break through with a new category of drugs, the least we can do is congratulate them when one succeeds. Those who make an unremitting habit of bashing drug companies about unforeseen side effects could cost them so much money and public embarrassment that it takes the legs out of important projects like the one that led to the birth of Tekturna. In the current climate, it is probably no coincidence that it took ten years to come up with a new category of blood pressure drugs.
The decision by the advisory committee to both approve Provenge using subpopulation data that ODAC did not readily provide and do so by rewriting the question provided by the FDA (asking if the drug for prostate cancer was effective as opposed to asking was the drug was substantially effective for an entire population.)
And it did so despite the fact that develop Dendreon has hardly begun to enroll patients in the post market trials the FDA and its safety mongering overlords in Congress such Ed Markey, Henry Waxman and Chuck Grassley are demanding.
For this round score it: Cancer patients 1 Postuing fearmongering pols and CYA bureaucrats 0
And it did so despite the fact that develop Dendreon has hardly begun to enroll patients in the post market trials the FDA and its safety mongering overlords in Congress such Ed Markey, Henry Waxman and Chuck Grassley are demanding.
For this round score it: Cancer patients 1 Postuing fearmongering pols and CYA bureaucrats 0
Some key take-aways from yesterday’s joint Center for Medicine in the Public Interest/Old Dominion University conference on Comparative Effectiveness:
• My opening question to the panel was whether or not comparative effectiveness (aka evidence-based medicine, aka healthcare technology assessment, aka rational use of medicine) was focusing on cost rather than care. Practice variation vs. patient variation.
•Carolyn Clancy (Director of AHRQ) remarked that we need to capture clinical data from off-label prescribing.
• Scott Gottlieb pointed out that the value of studying Avastin vs. Erbitux or Actos vs. Januvia is of no value – but that studying Avastin+ Erbitux and Actos + Januvia would yield important clinical information.
In short – if you don’t ask the right questions, you won’t necessarily get the wrong answers – but you won’t get the answers that will help improve patient care on the clinical level.
There was much conversation about the relative benefits of RCTs vs real life epidemiological data (like off-label prescribing outcomes). Look at it this way – consider each separate pieces of software designed for different purposes. Both are relevant to any discussion of comparative effectiveness – but only one “software†is used – RCTs (by DERP, Consumers Union, etc.). We need to design a software interface that will allow these two data sets to “talk†with each other.
The time for puritanical allegiance to RCTs is coming to an end.
Panelists were also brutally honest when it came to the question of cost-over-care, the new health care realpolitk, agreeing that when it comes to Washington, DC – cost containment will win out over patient care every time.
Unfortunately I agree – that’s the way it is right now. But that has to change. As John Bridges (Johns Hopkins Bloomberg School of Public Health) commented, “There is no health care without the patient.â€
When it comes to changing the short term, politically-driven cost-over-care debate to a long term, patient-focused right-care-for-the-right-patient at-the-right-time paradigm, yesterday’s debate wasn’t the end, or even the beginning of the end but, hopefully, the end of the beginning.
And, when that day comes, it will indeed be health care's finest hour.
• My opening question to the panel was whether or not comparative effectiveness (aka evidence-based medicine, aka healthcare technology assessment, aka rational use of medicine) was focusing on cost rather than care. Practice variation vs. patient variation.
•Carolyn Clancy (Director of AHRQ) remarked that we need to capture clinical data from off-label prescribing.
• Scott Gottlieb pointed out that the value of studying Avastin vs. Erbitux or Actos vs. Januvia is of no value – but that studying Avastin+ Erbitux and Actos + Januvia would yield important clinical information.
In short – if you don’t ask the right questions, you won’t necessarily get the wrong answers – but you won’t get the answers that will help improve patient care on the clinical level.
There was much conversation about the relative benefits of RCTs vs real life epidemiological data (like off-label prescribing outcomes). Look at it this way – consider each separate pieces of software designed for different purposes. Both are relevant to any discussion of comparative effectiveness – but only one “software†is used – RCTs (by DERP, Consumers Union, etc.). We need to design a software interface that will allow these two data sets to “talk†with each other.
The time for puritanical allegiance to RCTs is coming to an end.
Panelists were also brutally honest when it came to the question of cost-over-care, the new health care realpolitk, agreeing that when it comes to Washington, DC – cost containment will win out over patient care every time.
Unfortunately I agree – that’s the way it is right now. But that has to change. As John Bridges (Johns Hopkins Bloomberg School of Public Health) commented, “There is no health care without the patient.â€
When it comes to changing the short term, politically-driven cost-over-care debate to a long term, patient-focused right-care-for-the-right-patient at-the-right-time paradigm, yesterday’s debate wasn’t the end, or even the beginning of the end but, hopefully, the end of the beginning.
And, when that day comes, it will indeed be health care's finest hour.
Attention Drugwonks:
The Congressional Budget Office has lowered the 10 year cost projection of the Medicare drug benefit by $387.2 billion or 32.3 percent as compared to last year's 10 year projection.
The learning is that competition and private negotiations are saving taxpayers and beneficiaries far more money than our worthy, non-partisan government actuaries had anticipated.
And in congressional testimony before the House Budget Committee, CBO Director Orzag recentlsaid that actual prescription drug plan bids for 2007 were 15 percent lower than the bids in 2006.
Imagine that -- a government program that, per capita, actually decreases in cost from year-to-year.
Competition works.
The Congressional Budget Office has lowered the 10 year cost projection of the Medicare drug benefit by $387.2 billion or 32.3 percent as compared to last year's 10 year projection.
The learning is that competition and private negotiations are saving taxpayers and beneficiaries far more money than our worthy, non-partisan government actuaries had anticipated.
And in congressional testimony before the House Budget Committee, CBO Director Orzag recentlsaid that actual prescription drug plan bids for 2007 were 15 percent lower than the bids in 2006.
Imagine that -- a government program that, per capita, actually decreases in cost from year-to-year.
Competition works.
The Washington Times
www.washingtontimes.com
Restricted treatment
By Robert Goldberg
Published March 29, 2007
Advertisement
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This week there were two bits of news that reminded most of us that when it comes to medicine, the real crisis is not safety but the lack of treatments to prevent or at least battle disease effectively.
First, the Alzheimer's Association released revised estimates showing that the number of Americans with Alzheimer's jumped from 4 million to 5 million over the past decade, a trend which, if left unabated by new medicines, will triple to 16 million by 2030.
Second, Elizabeth Edwards and Tony Snow announced that their respective breast and colon cancers had come back and spread. The likelihood of each's survival depends on a complex combination of factors that are increasingly understood, which has translated into better drugs and longer lives. As Allan Lichter, president of the American Society of Clinical Oncologists, said recently, "in the years ahead, doctors will be able to detect cancer early with a blood test, a blood signature, if you will." The same knowledge used to detect cancers at their earliest stage will be used to develop drugs to treat them at that nascent and intimate level, making them increasingly curable. The same goes for Alzheimer's. If caught early, it can possibly be delayed for years.
Don't count on these breakthroughs anytime soon. It is taking longer than ever to bring new medicines to market. The Enhancing Drug Safety and Innovation Act currently under consideration in Congress will ensure that millions of Americans will die waiting for medicines that politicians purport to protect them from.
The act requires that before any drug is approved, a risk-management program (RiskMap) be created. As former FDA Deputy Commissioner Scott Gottlieb points out, this "legislative proposal extends the FDA's ability to restrict which physicians can prescribe a medicine, and which pharmacies can dispense it." Mr. Gottlieb notes that the FDA now limits RiskMaps to about two dozen drugs with very serious or poorly understood side effects. Getting these drugs is burdensome for patients who want them. Severe penalties await doctors and physicians who prescribe and dispense them outside of FDA guidelines.
But Congress wants to extend RiskMAPs in order to prevent possible rare side effects by limiting who can prescribe new drugs, for what uses and to whom. Under the current legislation, doctors and pharmacists who violate a RiskMap are subject to civil penalties. No doubt being accused will lead to criminal proceedings and personal injury cases. All of this means that the current legislation takes the off-label prescribing of new drugs -- though such prescribing is standard for breast cancer, Alzheimer's and mental illness -- and virtually makes it a criminal activity.
I once supported the act, known as Kennedy-Enzi. That was before its authors decided that the best way to protect the public from adverse drug events is to replicate clinical trial conditions in the real world. RiskMap could create the equivalent of a prescription-drug police state, complete with computerized monitoring by the FDA of who gets what. My friend's father was locked out -- literally -- by a computer from receiving a cancer drug on a clinical trial because his pulse was less than a tenth of second off the interval set by the FDA. No access. No treatment. If the doctor had tried giving him the drug, it would have triggered an investigation and closed down the entire trial.
This approach could be applied to millions of Americans as doctors, hospitals and pharmacists, terrified by the threat of FDA oversight, congressional hearings and lawsuits, are bludgeoned into practicing cookbook medicine. Which health plan would dare to pay for a drug that doesn't meet RiskMap mettle? The legislative push is already slowing drug approvals because FDA drug reviewers are afraid of second-guessing by the media and Congress. A new drug for diabetes-related blindness to be approved this year may now be delayed for three more years of study. A drug to treat gram-negative sepsis that was supposed to be tested against the current medicine must now be tested with a group of patients that get a placebo (a sugar pill) to satisfy the demands of Rep. Henry Waxman. Yet, in many cases, gram-negative sepsis is 100 percent fatal.
The FDA is already delaying accelerated approvals of cancer drugs until dying patients are enrolled in double-blind, randomized, placebo-controlled, post-market studies. Kennedy-Enzi wants to make this practice mandatory. That means no accelerated approval at all for cancer or Alzheimer's.
These restrictions will choke off hope, scare off innovation, give trial attorneys control over the health-care system and deny many of us longer life. The congressional assault on medical innovation is not a presidential campaign issue yet. Perhaps, thanks to the courage of Mr. Snow and Mrs. Edwards, it will be.
Robert Goldberg is vice president of the Center for Medicine in the Public Interest..
www.washingtontimes.com
Restricted treatment
By Robert Goldberg
Published March 29, 2007
Advertisement
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This week there were two bits of news that reminded most of us that when it comes to medicine, the real crisis is not safety but the lack of treatments to prevent or at least battle disease effectively.
First, the Alzheimer's Association released revised estimates showing that the number of Americans with Alzheimer's jumped from 4 million to 5 million over the past decade, a trend which, if left unabated by new medicines, will triple to 16 million by 2030.
Second, Elizabeth Edwards and Tony Snow announced that their respective breast and colon cancers had come back and spread. The likelihood of each's survival depends on a complex combination of factors that are increasingly understood, which has translated into better drugs and longer lives. As Allan Lichter, president of the American Society of Clinical Oncologists, said recently, "in the years ahead, doctors will be able to detect cancer early with a blood test, a blood signature, if you will." The same knowledge used to detect cancers at their earliest stage will be used to develop drugs to treat them at that nascent and intimate level, making them increasingly curable. The same goes for Alzheimer's. If caught early, it can possibly be delayed for years.
Don't count on these breakthroughs anytime soon. It is taking longer than ever to bring new medicines to market. The Enhancing Drug Safety and Innovation Act currently under consideration in Congress will ensure that millions of Americans will die waiting for medicines that politicians purport to protect them from.
The act requires that before any drug is approved, a risk-management program (RiskMap) be created. As former FDA Deputy Commissioner Scott Gottlieb points out, this "legislative proposal extends the FDA's ability to restrict which physicians can prescribe a medicine, and which pharmacies can dispense it." Mr. Gottlieb notes that the FDA now limits RiskMaps to about two dozen drugs with very serious or poorly understood side effects. Getting these drugs is burdensome for patients who want them. Severe penalties await doctors and physicians who prescribe and dispense them outside of FDA guidelines.
But Congress wants to extend RiskMAPs in order to prevent possible rare side effects by limiting who can prescribe new drugs, for what uses and to whom. Under the current legislation, doctors and pharmacists who violate a RiskMap are subject to civil penalties. No doubt being accused will lead to criminal proceedings and personal injury cases. All of this means that the current legislation takes the off-label prescribing of new drugs -- though such prescribing is standard for breast cancer, Alzheimer's and mental illness -- and virtually makes it a criminal activity.
I once supported the act, known as Kennedy-Enzi. That was before its authors decided that the best way to protect the public from adverse drug events is to replicate clinical trial conditions in the real world. RiskMap could create the equivalent of a prescription-drug police state, complete with computerized monitoring by the FDA of who gets what. My friend's father was locked out -- literally -- by a computer from receiving a cancer drug on a clinical trial because his pulse was less than a tenth of second off the interval set by the FDA. No access. No treatment. If the doctor had tried giving him the drug, it would have triggered an investigation and closed down the entire trial.
This approach could be applied to millions of Americans as doctors, hospitals and pharmacists, terrified by the threat of FDA oversight, congressional hearings and lawsuits, are bludgeoned into practicing cookbook medicine. Which health plan would dare to pay for a drug that doesn't meet RiskMap mettle? The legislative push is already slowing drug approvals because FDA drug reviewers are afraid of second-guessing by the media and Congress. A new drug for diabetes-related blindness to be approved this year may now be delayed for three more years of study. A drug to treat gram-negative sepsis that was supposed to be tested against the current medicine must now be tested with a group of patients that get a placebo (a sugar pill) to satisfy the demands of Rep. Henry Waxman. Yet, in many cases, gram-negative sepsis is 100 percent fatal.
The FDA is already delaying accelerated approvals of cancer drugs until dying patients are enrolled in double-blind, randomized, placebo-controlled, post-market studies. Kennedy-Enzi wants to make this practice mandatory. That means no accelerated approval at all for cancer or Alzheimer's.
These restrictions will choke off hope, scare off innovation, give trial attorneys control over the health-care system and deny many of us longer life. The congressional assault on medical innovation is not a presidential campaign issue yet. Perhaps, thanks to the courage of Mr. Snow and Mrs. Edwards, it will be.
Robert Goldberg is vice president of the Center for Medicine in the Public Interest..
CMPI co-sponsored a National Forum on the role comparative effectiveness research should play in health care decisionmaking with Old Dominion University medical school today....
The take away message was put best by Johns Hopkins University professor John Bridges...there is no health care without patients. Any effort to impose a cost-driven comparative effectiveness research agenda on patients will fail. It was also put best by Scott Gottlieb who said comparative effectiveness is not about false choices between two drugs, choices driven by a political agenda.
In the end, the only research that matters of the comparative kind will help determine which treatment works best for which individual and help individuals shape the nature of treatment.
Politicians who proceed otherwise will proceed at their peril.
The take away message was put best by Johns Hopkins University professor John Bridges...there is no health care without patients. Any effort to impose a cost-driven comparative effectiveness research agenda on patients will fail. It was also put best by Scott Gottlieb who said comparative effectiveness is not about false choices between two drugs, choices driven by a political agenda.
In the end, the only research that matters of the comparative kind will help determine which treatment works best for which individual and help individuals shape the nature of treatment.
Politicians who proceed otherwise will proceed at their peril.
Merrill Matthews and I don't see eye-to-eye on everything when it comes to Medicare reform, but there's one thing we do agreed on ... it's working.
Have a look:
http://www.mercurynews.com/search/ci_5537368/nclick_check=1
As always, looking forward to all your thoughts and comments.
Have a look:
http://www.mercurynews.com/search/ci_5537368/nclick_check=1
As always, looking forward to all your thoughts and comments.
To: Gilbert Ross, M.D.
Executive and Medical Director
American Council on Science and Health
New York
Dear Gil,
you did not read my oped carefully,
you have mischaracterized my argument for the benefit of your argument.
I never said that mortality wasn't a worthy endpoint warranting further study, i said it shouldn't be a "solo" endpoint.
I am also not alone among the thousands of internists and pulmonologists who use screening chest ct as part of a strategy for early detection, and then together with a team of top level radiologists, figure out what to do with the results. This is very clearly described in my oped, and you have distorted it.
You also should have admitted to the Journal that you know me personally, that I have done consulting work for your organization, and that this may have affected your motivation in writing this letter.
I have heard from many practicing physicians and top level researchers who have agreed with me and praised my oped. Everyone agrees that the great advances in CT technology have let to a situation where it is capable of diagnosing cancers before they leave the lung, and in the right hands, are much less likely to cause unmanageable false positives.
we can see the advantage of advanced technological screening of breast cancer, a less aggressive cancer, with the current news about MRI.
My core premise is that a practicing clinical physician like myself needs diagnostic tools like this in his arsenal that can be used in conjunction with a proper knowledge of the medical literature.
I always welcome debate with you, and appreciate your invitation for further debate, but i feel that should have occurred before you published an inaccurate letter.
Marc Siegel MD
Executive and Medical Director
American Council on Science and Health
New York
Dear Gil,
you did not read my oped carefully,
you have mischaracterized my argument for the benefit of your argument.
I never said that mortality wasn't a worthy endpoint warranting further study, i said it shouldn't be a "solo" endpoint.
I am also not alone among the thousands of internists and pulmonologists who use screening chest ct as part of a strategy for early detection, and then together with a team of top level radiologists, figure out what to do with the results. This is very clearly described in my oped, and you have distorted it.
You also should have admitted to the Journal that you know me personally, that I have done consulting work for your organization, and that this may have affected your motivation in writing this letter.
I have heard from many practicing physicians and top level researchers who have agreed with me and praised my oped. Everyone agrees that the great advances in CT technology have let to a situation where it is capable of diagnosing cancers before they leave the lung, and in the right hands, are much less likely to cause unmanageable false positives.
we can see the advantage of advanced technological screening of breast cancer, a less aggressive cancer, with the current news about MRI.
My core premise is that a practicing clinical physician like myself needs diagnostic tools like this in his arsenal that can be used in conjunction with a proper knowledge of the medical literature.
I always welcome debate with you, and appreciate your invitation for further debate, but i feel that should have occurred before you published an inaccurate letter.
Marc Siegel MD
April 1st 60 Minutes will do an "expose" timed to the release of a Center for Public Integrity report showing that the pharmaceutical industry spent nearly $900 million on lobbying and campaign contributions over the past decade. Sounds like a lot right?
But the industry doesn't come close to many others in trying to push their point in a political system that frankly requires money to move messages around. Case in point, Phrma the trade group is way down the list when it comes to spending on lobbying comparrd to many DC trade groups according to CPI.
Using CPI data (1998-2004), pharma (and I don't know if they count biotech in that mix) is about even when it comes to lobbying compared to the aggregated spending of other health care interests that have been under less scrutiny and attack. Both have spent about $650 million on lobbying during that time. Add insurance companies (life and health) and the whole health care financing and delivery system has spent twice as much on lobbying as drug companies and it trade group. Electric utilities alone spent $500 million. Add in all energy related lobbying and you are close to a $ 1 billion. Banking, financing, credit concerns spend as much as pharma. So do defense and aerospace companies.
And so do all manner of government, government officials, public unions,city, county, state, sewer authorities, foreign, you name it.
Lobbying has a Jack Abrahamoff taint to it. And granted there are there are plenty of folks who set up shop and sell themselves and justify a large monthly retainer because they are able to get that all important "ask" from an important member of Congress. But ultimately how we feel about lobbying depends on our opinion on a political issue. Those who claim that the "Israel Lobby" has "too much influence" based on campaign contributions do so because they have a problem with American support for Israel. Those who claim that "Big Pharma" has "too much influence" similarly are likely to support price controls, drug importation, more FDA regulation.
So let's be honest. If you attack the Israel Lobby, you are not a Zionist.
If you attack Big Pharma's lobbying effort, you do not believe free markets are the best way to make new drugs available.
In or out. Simple as that.
But the industry doesn't come close to many others in trying to push their point in a political system that frankly requires money to move messages around. Case in point, Phrma the trade group is way down the list when it comes to spending on lobbying comparrd to many DC trade groups according to CPI.
Using CPI data (1998-2004), pharma (and I don't know if they count biotech in that mix) is about even when it comes to lobbying compared to the aggregated spending of other health care interests that have been under less scrutiny and attack. Both have spent about $650 million on lobbying during that time. Add insurance companies (life and health) and the whole health care financing and delivery system has spent twice as much on lobbying as drug companies and it trade group. Electric utilities alone spent $500 million. Add in all energy related lobbying and you are close to a $ 1 billion. Banking, financing, credit concerns spend as much as pharma. So do defense and aerospace companies.
And so do all manner of government, government officials, public unions,city, county, state, sewer authorities, foreign, you name it.
Lobbying has a Jack Abrahamoff taint to it. And granted there are there are plenty of folks who set up shop and sell themselves and justify a large monthly retainer because they are able to get that all important "ask" from an important member of Congress. But ultimately how we feel about lobbying depends on our opinion on a political issue. Those who claim that the "Israel Lobby" has "too much influence" based on campaign contributions do so because they have a problem with American support for Israel. Those who claim that "Big Pharma" has "too much influence" similarly are likely to support price controls, drug importation, more FDA regulation.
So let's be honest. If you attack the Israel Lobby, you are not a Zionist.
If you attack Big Pharma's lobbying effort, you do not believe free markets are the best way to make new drugs available.
In or out. Simple as that.