The following is an email I received soliciting me t sign a petition supporting the "Manhattan Declaratipon". The Declaration's goals are described in the email.
I composed the response at the bottom as I have not seen any comparable reply to thee solicitations. Common sense is the least common thing in the world, it would seem.
JSH
===========================================================================
Subject: Manhattan Declaration
Friends, If this is your religious persuasion, I invite you to go to the website below and sign the "Manhattan Declaration".
From the website:
We are Orthodox, Catholic, and evangelical Christians who have united at this hour to reaffirm fundamental truths about justice and the common good, and to call upon our fellow citizens, believers and non-believers alike, to join us in defending them. These truths are:
1 the sanctity of human life
2 the dignity of marriage as the conjugal union of husband and wife
3 the rights of conscience and religious liberty.
Inasmuch as these truths are foundational to human dignity and the well-being of society, they are inviolable and non-negotiable. Because they are increasingly under assault from powerful forces in our culture, we are compelled today to speak out forcefully in their defense, and to commit ourselves to honoring them fully no matter what pressures are brought upon us and our institutions to abandon or compromise them. We make this commitment not as partisans of any political group but as followers of Jesus Christ, the crucified and risen Lord, who is the Way, the Truth, and the Life.
===========================================================================
I am puzzled why anyone would want to interfere with any other person's right to live life as they wish. For example, the proposition that a gay couple's desire to wed somehow "threatens the institution of marriage" seems completely without any logical basis. If I, a male heterosexual, want to marry a woman, how could two gay people getting married threaten me in any way? How could that threaten the "dignity" of my marriage? My marriage's dignity is something I have to maintain. No one else has anything to do with it. Seems like the objection is just a tabloidism - a catch-phrase to use as a rationalization for trying to interfere with other people's rights. If one is a confident, comfortable, married heterosexual, homosexuality is no threat at all. (If I like vanilla ice cream and you like pistachio, how does that threaten the "dignity" of MY ice-cream?}
The same truth applies to all matters of faith and belief. If one's faith is genuine and solid, one doesn't need 10,000 people agreeing with you. In fact, it doesn't matter if no one else shares your belief. Belief and faith are entirely personal. It is not something proven by counting on a crowd.(As I recall it, when Jesus was on the cross he didn't ask for a show of hands or count the crowd of his supporters. He just called out to his Father.)
So, as far as stem cells, abortion, "matters of faith and belief", all these are personal matters. They are not something to be put up to a vote and the majority rules (and the minority should be punished or jailed.) Personal faiths and beliefs, are personal. They don't require consensus. If a consensus is required, one didn't have a true belief in the first place. It was just insecurity - searching for the reassurance of the crowd mentality.
J.S. Hochman MD
Tuesday, November 24, 2009
Wednesday, November 18, 2009
"A Call to Revolutionize Chronic Pain Care in America"
(But hang up after one ring)
The Mayday Foundation has a long credibility in Pain Management. For over 20 years it has been s significant voice and funding source in approaching pain management policy. The November 4, 2009 publication of the recommendations of a Special Committee, convened by the Foundation to address the continuing suffering of millions of adults and children, is an example of its commitments. The Recommendations provide very useful background information and policy suggestions.
Unarguably the situation for acute and chronic pain patients is currently horrific, and the report clearly documents the situation. Further, pain care should be coordinated, beginning with primary care providers, disparities should be eliminated, unnecessary and ineffective invasive procedures and medication treatments should also be eliminated, and effective, comprehensive treatment should be universally available and implemented.
Further, federal and state agencies, state medical boards, health care payors and providers, medical schools, specialty and subspecialty organizations and all other "stakeholders" should be enlisted in achieving the goals of universal pain care available to all. And specifically the HRSA, HHS, NIH, AHRQ, the Surgeon General, health care providers, insurers and government should work to eliminate disparities in access to pain care related to race, ethnicity, gender, age and socioeconomic status; and federal, state and local agencies should adopt a balanced approach to the regulation of controlled prescription drugs, particularly opioids
Specifically, the report calls for:
· government, health care payers and health care providers should develop and use coordinated health information technology systems to track pain disorders, treatments and outcomes to improve care;
· physicians should be trained to assess and treat pain, and licensing examinations should include assessment of clinical knowledge related to pain care;
· the Health Resources and Services Administration should expand funding for training programs that address pain assessment and management;
· HHS should establish an independent commission to reform the reimbursement practices for chronic pain treatment;
· the NIH should increase funding for pain research;
· the Agency for Healthcare Research and Quality should expand funding to establish a set of best practices that could be used to treat specific types of chronic pain;
· the U.S. surgeon general should create a public education campaign about the risks of untreated and undertreated pain
However, amazingly, what the Committee did not mention was the "War on Doctors' - that horrific campaign that has destroyed the careers (and even the lives) of so many decent,
dedicated and caring physicians, and left thousands upon thousands of chronic pain patients in an abyss of abandonment and professional and regulatory indifference.
Also, conspicuous in its absence, was any mention of the single largest obstacle to adequate pain care - "Opiophobia".
Perhaps the members of the Special Committee believed that their studiously polite diplomacy required that these topics not be mentioned, as education and collegiality would cause them to dissipate before a wave of enlightenment. Perhaps they believed that it was best not "to kick the sleeping dog" - that confrontation would be best avoided in favor of education and the confluence of policy.
We have no way of knowing the Committee's motivations in this regard. However, it is safe to assume that opiophobia will disappear no more quickly than did racism. History makes it abundantly clear that a Chamberlain approach to brutality will accomplish little but self-delusion.
Sad to say, but I predict that collegial policy thumping will have no impact on the destructive mythologies and pharmacological shibboleths that characterize opiophobia. The myths of addiction, tolerance, toxicity, criminality, abuse, diversion are deeply engrained in the professional mindset of opiophobic physicians and the medical Boards upon which they sit. We have already seen in the examples of the "Model Intractable Pain Policy" adopted by the Federation of State Medical Boards in 2003, the "Pain as the Fifth Vital Sign" initiative of the Joint Commission on Accreditation of Health care Organizations in 2001, and the Pain Initiative of the Veterans Administration, that noble pronouncements are completely disconnected from the realities of the day to day priorities and actions of these boards. Everyone already knows the information summarized by the Mayday Committee. It has been part of the Zeitgeist since Dr. Pappagallo's news releases in 1996.
What is needed now is not polite policy but hard-nosed mandates. Whether it is to be federal legislation, state regulations, or a federal lawsuit, the opiophobes must be removed. Politeness and diplomacy will go nowhere (again). So thanks, Mayday, and the "Special Committee". Your intentions are noble. But one of the things that made the Committee "Special" is that there wasn't a single person sitting on it who's life and career is on the line every time they write a schedule II prescription. It's easy to be polite and diplomatic when no one is sticking a gun in your mouth.
I have to agree with Siobhan. Talk, talk, talk.
Joel Simon Hochman MD
Executive Director
The National Foundation for the Treatment of Pain
www.paincare.org
(But hang up after one ring)
The Mayday Foundation has a long credibility in Pain Management. For over 20 years it has been s significant voice and funding source in approaching pain management policy. The November 4, 2009 publication of the recommendations of a Special Committee, convened by the Foundation to address the continuing suffering of millions of adults and children, is an example of its commitments. The Recommendations provide very useful background information and policy suggestions.
Unarguably the situation for acute and chronic pain patients is currently horrific, and the report clearly documents the situation. Further, pain care should be coordinated, beginning with primary care providers, disparities should be eliminated, unnecessary and ineffective invasive procedures and medication treatments should also be eliminated, and effective, comprehensive treatment should be universally available and implemented.
Further, federal and state agencies, state medical boards, health care payors and providers, medical schools, specialty and subspecialty organizations and all other "stakeholders" should be enlisted in achieving the goals of universal pain care available to all. And specifically the HRSA, HHS, NIH, AHRQ, the Surgeon General, health care providers, insurers and government should work to eliminate disparities in access to pain care related to race, ethnicity, gender, age and socioeconomic status; and federal, state and local agencies should adopt a balanced approach to the regulation of controlled prescription drugs, particularly opioids
Specifically, the report calls for:
· government, health care payers and health care providers should develop and use coordinated health information technology systems to track pain disorders, treatments and outcomes to improve care;
· physicians should be trained to assess and treat pain, and licensing examinations should include assessment of clinical knowledge related to pain care;
· the Health Resources and Services Administration should expand funding for training programs that address pain assessment and management;
· HHS should establish an independent commission to reform the reimbursement practices for chronic pain treatment;
· the NIH should increase funding for pain research;
· the Agency for Healthcare Research and Quality should expand funding to establish a set of best practices that could be used to treat specific types of chronic pain;
· the U.S. surgeon general should create a public education campaign about the risks of untreated and undertreated pain
However, amazingly, what the Committee did not mention was the "War on Doctors' - that horrific campaign that has destroyed the careers (and even the lives) of so many decent,
dedicated and caring physicians, and left thousands upon thousands of chronic pain patients in an abyss of abandonment and professional and regulatory indifference.
Also, conspicuous in its absence, was any mention of the single largest obstacle to adequate pain care - "Opiophobia".
Perhaps the members of the Special Committee believed that their studiously polite diplomacy required that these topics not be mentioned, as education and collegiality would cause them to dissipate before a wave of enlightenment. Perhaps they believed that it was best not "to kick the sleeping dog" - that confrontation would be best avoided in favor of education and the confluence of policy.
We have no way of knowing the Committee's motivations in this regard. However, it is safe to assume that opiophobia will disappear no more quickly than did racism. History makes it abundantly clear that a Chamberlain approach to brutality will accomplish little but self-delusion.
Sad to say, but I predict that collegial policy thumping will have no impact on the destructive mythologies and pharmacological shibboleths that characterize opiophobia. The myths of addiction, tolerance, toxicity, criminality, abuse, diversion are deeply engrained in the professional mindset of opiophobic physicians and the medical Boards upon which they sit. We have already seen in the examples of the "Model Intractable Pain Policy" adopted by the Federation of State Medical Boards in 2003, the "Pain as the Fifth Vital Sign" initiative of the Joint Commission on Accreditation of Health care Organizations in 2001, and the Pain Initiative of the Veterans Administration, that noble pronouncements are completely disconnected from the realities of the day to day priorities and actions of these boards. Everyone already knows the information summarized by the Mayday Committee. It has been part of the Zeitgeist since Dr. Pappagallo's news releases in 1996.
What is needed now is not polite policy but hard-nosed mandates. Whether it is to be federal legislation, state regulations, or a federal lawsuit, the opiophobes must be removed. Politeness and diplomacy will go nowhere (again). So thanks, Mayday, and the "Special Committee". Your intentions are noble. But one of the things that made the Committee "Special" is that there wasn't a single person sitting on it who's life and career is on the line every time they write a schedule II prescription. It's easy to be polite and diplomatic when no one is sticking a gun in your mouth.
I have to agree with Siobhan. Talk, talk, talk.
Joel Simon Hochman MD
Executive Director
The National Foundation for the Treatment of Pain
www.paincare.org
Wednesday, November 11, 2009
It's time for the revolution
It's time for the revolution
November 11, 2009
I am really offended now. It is now totally obvious that the Congress and the Insurers:
1. Think we are all too stupid to get what is going on;
2. Don't give a damn if we know what is going on;
3. Are so arrogant in their sense of privilege and power they think they can do whatever they want.
The "Health Care" legislation now before the Congress is an abomination. The insurers have simply hi-jacked the legislative process. The bill from the House simply mandates an additional 35 million subscribers into the existing nightmare of for-profit health "insurance" and gives the insures a half TRILLION dollars a year in additional subsidies to continue screwing the electorate into bankruptcy (60% of all bankruptcies now arise from the unpaid costs of health care!)
I say we have had enough. I am ready to invade Washington DC and picket the Congress. We need to tell Congress that if they want a job they had better get off their asses and give us REAL health care reform.
1. Get private insurers either entirely out of health care or regulate them into providing full coverage to everyone; no exclusion of pre-existing conditions; no prior approvals, denials, delays, deferments, weaseling of any variety; prompt payment of benefits; market level pricing of services, medications and devices; a 15% cap on "overhead" with sane salaries and other corporate expenses.
2. Provide a competitive one payor system that is consumer-oriented and totally responsive to the individual patient (not a sinecure for bureaucrats and a playground for profiteers).
3. Support a revolution in health care which makes physicians responsible for not only medical services but also the financial management of the system. Who is more qualified to understand needs, services, standards of care, measurement of outcome, efficiency, patient and provider needs?
It is time for us all to stand up - patients and providers - and tell them "Hell NO! We are sick of being raped and the party is over!" Get straight, Congress, or go find a real job. If you don't listen to us you are OUT of there, come the next election!!"
J.S. Hochman MD
Executive Director
The National Foundation for the Treatment of Pain
www.paincare.org
Monday, November 9, 2009
Advice ot the Parents of would be Overdose Victoms
DR. HOCHMAN’S GUIDANCE FOR THE PARENTS OF POTENTIAL OVERDOSE VICTIMS
1. Do not pretend that your child will never be involved in drugs
2. Assume that drugs are everywhere and will always be available (“supply-side”
strategies have never succeeded and will NEVER succeed)
3. Make sure that your kids are factually educated about every drug
4. If you misinform them, or give them propaganda, your credibility and
authority with them is over
5. Share your personal experience and knowledge with them. Do not be a
know-it-all (because you don’t)
6. Accept the fact that they may be smarter and more knowledgeable about drugs
than you
7. If you are going to keep medications in your home, keep them absolutely
locked up – NO EXCEPTIONS!
8. Do not expect that they will not try to defeat the security
9. Be informed about the symptoms and signs of intoxication and/or overdose
10. Have an overdose plan. Know what to do, who to call and what to say
11. Do not blame the drugs. Your kid took them; they didn’t take your kid
12. Expect that your kids will experiment. You probably did.
13. Make sure that they know what to expect, and what to do, if they get in
trouble with a drug.
14. Tell them you really love them, will miss them the rest of your life if they
kill themselves and that you would really appreciate it if they don’t
15. Don’t do ANYTHING to convince them it’s too risky to tell you the truth
16. Give every child in your home a copy of my advice to them and discuss it
with them.
1. Do not pretend that your child will never be involved in drugs
2. Assume that drugs are everywhere and will always be available (“supply-side”
strategies have never succeeded and will NEVER succeed)
3. Make sure that your kids are factually educated about every drug
4. If you misinform them, or give them propaganda, your credibility and
authority with them is over
5. Share your personal experience and knowledge with them. Do not be a
know-it-all (because you don’t)
6. Accept the fact that they may be smarter and more knowledgeable about drugs
than you
7. If you are going to keep medications in your home, keep them absolutely
locked up – NO EXCEPTIONS!
8. Do not expect that they will not try to defeat the security
9. Be informed about the symptoms and signs of intoxication and/or overdose
10. Have an overdose plan. Know what to do, who to call and what to say
11. Do not blame the drugs. Your kid took them; they didn’t take your kid
12. Expect that your kids will experiment. You probably did.
13. Make sure that they know what to expect, and what to do, if they get in
trouble with a drug.
14. Tell them you really love them, will miss them the rest of your life if they
kill themselves and that you would really appreciate it if they don’t
15. Don’t do ANYTHING to convince them it’s too risky to tell you the truth
16. Give every child in your home a copy of my advice to them and discuss it
with them.
DR. HOCHMAN’S GUIDANCE FOR WOULD BE OVERDOSE VICTIMS
IF YOU ARE CONSIDERING USING A DRUG:
1. To change your mood
2. To get high
3. Because your friends are doing it
4. In combination with other mind-altering substances, particularly alcohol
5. To cope with stress
6. To escape
7. In a party situation
8. Alone, with potential help unavailable
9. For the first time and you are unfamiliar with it
10. At a dose higher than you are used to (or you don’t know how strong it is)
11. When you have health issues that might affect your breathing or your ability to metabolize the drug
12. And for opiates if you don’t know about Naloxone and it’s not available anyway
The possibility that you may kill yourself is VERY high. Proceed at your own risk and do not blame the drug (you took it, it didn’t take you).
Relax – if you kill yourself, your parents will blame the drug, not you. And they will think about you every day for the rest of their lives.
IF YOU ARE CONSIDERING USING A DRUG:
1. To change your mood
2. To get high
3. Because your friends are doing it
4. In combination with other mind-altering substances, particularly alcohol
5. To cope with stress
6. To escape
7. In a party situation
8. Alone, with potential help unavailable
9. For the first time and you are unfamiliar with it
10. At a dose higher than you are used to (or you don’t know how strong it is)
11. When you have health issues that might affect your breathing or your ability to metabolize the drug
12. And for opiates if you don’t know about Naloxone and it’s not available anyway
The possibility that you may kill yourself is VERY high. Proceed at your own risk and do not blame the drug (you took it, it didn’t take you).
Relax – if you kill yourself, your parents will blame the drug, not you. And they will think about you every day for the rest of their lives.
Wednesday, October 28, 2009
A Teaching Case
Dear Dr. Hochman:
I read your article in the March 2009 issue of Practical Pain management. I learned a new word.
Iatrogenic.... nice.
I used to be a chronic pain patient this is my story:
1. 1996 Hodgkins IIIB. 16 chemos in 12 weeks, 4 weeks of radiation.
2. Severe neuropathy ensued.
3. Oncologist throws me under a bus labelling me "drug-seeking". All I wanted was
relief. His words: "there is no pathological basis for me to treat your pain".
4. Stanford pain clinic took me in as a legitimate patient - all they needed was a look at my
medical records. I was in - in two days!
5. They titrate me up to 100mcg/hr duragesic q48h. Fantastic pain relief with no issues for 4 years.
6. I wanted to see if my nerves had recovered. Not after 4 years.....
7. They did recover after 6 years. Took six months to titrate down from Duragesic +
occassional Actiq for BT pain.
8. Was almost pain-free when I got off opioids - that was in 2002. Took six months to titrate down.
9 Oncologist retires in 2004. Calls me personally, and tells me [with tears] that he broke his hippocratic oath many times - with me being the most egregious.
10. I forgave him on the spot. Life goes on.
I am highly educated - Masters out of UCLA can design chips [integrated circuits]. I sought medicine [took more than prescribed, but told my doctor why, and sought another prescriber, though I knew it was illegal] - when my pain was not treated by my oncologist. Simple.
I rarely share this story with anyone. You seemed the most appropriate.
Sincrely,
B M
-------------------------------------------------
Your case is an excellent teaching case. What stands out as unusual, however, is your recovery from the neuropathic pain. That is very unusual, in my experience. With your permission I would like to cite your case, without identifying you personally. OK?
Dr. Hochman
I read your article in the March 2009 issue of Practical Pain management. I learned a new word.
Iatrogenic.... nice.
I used to be a chronic pain patient this is my story:
1. 1996 Hodgkins IIIB. 16 chemos in 12 weeks, 4 weeks of radiation.
2. Severe neuropathy ensued.
3. Oncologist throws me under a bus labelling me "drug-seeking". All I wanted was
relief. His words: "there is no pathological basis for me to treat your pain".
4. Stanford pain clinic took me in as a legitimate patient - all they needed was a look at my
medical records. I was in - in two days!
5. They titrate me up to 100mcg/hr duragesic q48h. Fantastic pain relief with no issues for 4 years.
6. I wanted to see if my nerves had recovered. Not after 4 years.....
7. They did recover after 6 years. Took six months to titrate down from Duragesic +
occassional Actiq for BT pain.
8. Was almost pain-free when I got off opioids - that was in 2002. Took six months to titrate down.
9 Oncologist retires in 2004. Calls me personally, and tells me [with tears] that he broke his hippocratic oath many times - with me being the most egregious.
10. I forgave him on the spot. Life goes on.
I am highly educated - Masters out of UCLA can design chips [integrated circuits]. I sought medicine [took more than prescribed, but told my doctor why, and sought another prescriber, though I knew it was illegal] - when my pain was not treated by my oncologist. Simple.
I rarely share this story with anyone. You seemed the most appropriate.
Sincrely,
B M
-------------------------------------------------
Your case is an excellent teaching case. What stands out as unusual, however, is your recovery from the neuropathic pain. That is very unusual, in my experience. With your permission I would like to cite your case, without identifying you personally. OK?
Dr. Hochman
Tuesday, October 27, 2009
Thursday, October 22, 2009
Monday, October 19, 2009
Does this help you understand what's going on?
Source:
Open Secrets.org
Title: “Washington Lobbying Grew to $3.2 Billion Last Year, Despite Economy”
Authors: Center for Responsive Politics
Student Researchers: Alan Grady and Leora Johnson
Faculty Evaluator: John Kramer, PhD
Sonoma State University
According to a study by The Center for Responsive Politics, special interests paid Washington lobbyists $3.2 billion in 2008—more than any other year on record. This was a 13.7 percent increase from 2007 (which broke the record by 7.7 percent over 2006).
The Center calculates that interest groups spent $17.4 million on lobbying for every day Congress was in session in 2008, or $32,523 per legislator per day. Center director Sheila Krumholz says, “The federal government is handing out billions of dollars by the day, and that translates into job security for lobbyists who can help companies and industries get a piece of the payout.”
Health interests spent more on Federal lobbying than any other economic sector. Their $478.5 million guaranteed the crown for the third year, with the finance, insurance, real estate sector a runner up, spending $453.5 million. The pharmaceutical/health products industry contributed $230.9 million, raising their last eleven-year total to over $1.6 billion. The second-biggest spender among industries in 2008 was electric utilities, which spent $156.7 million on lobbying, followed by insurance, which spent $153.2 million, and oil and gas, which paid lobbyists $133.2 million. Pro-Israel groups, food processing companies, and the oil and gas industry increased their lobbying expenditures the most (as a percentage) between 2007 and 2008.
Finance, insurance and real estate companies have been competing to get a piece of the $700 billion bailout package Congress approved late last year. The companies that reduced lobbying the most are those that declared bankruptcy or were taken over by the federal government and stopped their lobbying operations all together. “Even though some financial, insurance and real estate interests pulled back last year, they still managed to spend more than $450 million as a sector to lobby policymakers. That can buy a lot of influence, and it’s a fraction of what the financial sector is reaping in return through the government’s bailout program,” Krumholz said.
Business and real estate associations and coalitions were among the organizations that ramped up their lobbying expenditures the most last year. The National Association of Realtors increased spending by 25 percent, from $13.9 million to $17.3 million. The American Bankers Association spent $9.1 million in 2008, a 47 percent increase from 2007. Other industry groups that spent more in 2008 include the Private Equity Council, the Mortgage Bankers Association of America and the Financial Services Roundtable.
The US Chamber of Commerce remained the number one spender on lobbying in 2008, spending nearly $92 million—more than $350,000 every weekday, and a 73 percent increase over 2007—to advocate for its members’ interests. Pro-business associations as a whole increased their lobbying 47 percent between 2007 and 2008.
With record spending on lobbying, some industries face serious cut backs and have put the brakes on spending, but have not discontinued the practice. Automotive companies decreased the amount they paid lobbyists by 7.6 percent, from $70.9 million to $65.5 million. This is a big change from prior years; auto manufacturers and dealers increased lobbying spending by 21 percent between 2006 and 2007. Between 2007 and 2008 the Alliance of Automobile Manufacturers, which testified before Congress with Detroit’s Big Three last year, decreased its reported lobbying by 43 percent, from $12.8 million to $7.3 million. Of the Big Three, only one company, Ford, increased its efforts, though not by much: it went from $7.1 million to $7.7 million, an 8 percent increase.
Among Washington lobbing firms, Patton Boggs reported the highest revenues from registered lobbying for the fifth year in a row: 41.9 million dollars, an increase over 2006 of more than 20 percent. The firm’s most lucrative clients included private equity firm Cerberus Capital Management, confection and pet food maker Mars, communication provider Verizon, pharmaceutical manufacturers Bristol-Myers Squibb and Roche, and the American Association for Justice (formerly the Association of Trial Lawyers of America).
Update by Lindsay Renick Mayer
It seems like this should be a classified ad: “Laid off and looking for work? The lobbying industry wants you!” Since we posted this story on OpenSecrets.org in January, the lobbying industry has only continued to grow, even as industries across the board have continued to shrink, forcing hundreds of thousands of Americans out of work. This growth could be attributed in part to the economy itself—many executives are looking for some help from the government to keep their businesses afloat. Others are simply taking advantage of the opportunities that a spate of government handouts has presented. But as long as there’s a federal government calling the shots, lobbyists will be paid more and more each year to hold their clients’ fire to lawmakers’ feet.
Year after year we see increases in lobbying expenditures—in fact, 100 percent over the last decade—and the flurry of activity during the first three months of 2009 indicates that the trend won’t come to an end any time soon. Based on records from the Senate Office of Public Records, the nonpartisan Center for Responsive Politics found that from January through March, lobbying increased slightly compared to the same period of time last year, by at least $2.4 million. Unions, organizations and companies spent at least $799.7 million so far this year on sending influence peddlers to Capitol Hill, compared to $797.2 million during the same time in 2008. That might seem like a small increase compared to the billions spent each year on this activity, but in a time of economic turmoil, that’s a hefty revenue stream for a single industry.
That said, the industries that have made the most headlines for the help they’ve asked for or received from the federal government actually decreased the amount they spent on lobbying in the first three months of 2009 compared to 2008. Recipients of cash from the federal government’s Troubled Asset Relief Program (TARP) handed out less money to lobbyists than they had in any quarter of 2008, in part, perhaps, because they faced new rules restricting their lobbying contact with officials in connection with the bailout program. CRP found that TARP recipients have spent $13.9 million on lobbying so far this year, compared to $20.2 million in January through March of last year and $17.8 million in the last three months of 2008. With the government doling out billions of dollars, these sums pale in comparison to the benefit the companies are reaping.
To read more about how lobbying and influence peddling are shaping legislation, keep up with CRP’s blog at http://www.opensecrets.org/news/.
Open Secrets.org
Title: “Washington Lobbying Grew to $3.2 Billion Last Year, Despite Economy”
Authors: Center for Responsive Politics
Student Researchers: Alan Grady and Leora Johnson
Faculty Evaluator: John Kramer, PhD
Sonoma State University
According to a study by The Center for Responsive Politics, special interests paid Washington lobbyists $3.2 billion in 2008—more than any other year on record. This was a 13.7 percent increase from 2007 (which broke the record by 7.7 percent over 2006).
The Center calculates that interest groups spent $17.4 million on lobbying for every day Congress was in session in 2008, or $32,523 per legislator per day. Center director Sheila Krumholz says, “The federal government is handing out billions of dollars by the day, and that translates into job security for lobbyists who can help companies and industries get a piece of the payout.”
Health interests spent more on Federal lobbying than any other economic sector. Their $478.5 million guaranteed the crown for the third year, with the finance, insurance, real estate sector a runner up, spending $453.5 million. The pharmaceutical/health products industry contributed $230.9 million, raising their last eleven-year total to over $1.6 billion. The second-biggest spender among industries in 2008 was electric utilities, which spent $156.7 million on lobbying, followed by insurance, which spent $153.2 million, and oil and gas, which paid lobbyists $133.2 million. Pro-Israel groups, food processing companies, and the oil and gas industry increased their lobbying expenditures the most (as a percentage) between 2007 and 2008.
Finance, insurance and real estate companies have been competing to get a piece of the $700 billion bailout package Congress approved late last year. The companies that reduced lobbying the most are those that declared bankruptcy or were taken over by the federal government and stopped their lobbying operations all together. “Even though some financial, insurance and real estate interests pulled back last year, they still managed to spend more than $450 million as a sector to lobby policymakers. That can buy a lot of influence, and it’s a fraction of what the financial sector is reaping in return through the government’s bailout program,” Krumholz said.
Business and real estate associations and coalitions were among the organizations that ramped up their lobbying expenditures the most last year. The National Association of Realtors increased spending by 25 percent, from $13.9 million to $17.3 million. The American Bankers Association spent $9.1 million in 2008, a 47 percent increase from 2007. Other industry groups that spent more in 2008 include the Private Equity Council, the Mortgage Bankers Association of America and the Financial Services Roundtable.
The US Chamber of Commerce remained the number one spender on lobbying in 2008, spending nearly $92 million—more than $350,000 every weekday, and a 73 percent increase over 2007—to advocate for its members’ interests. Pro-business associations as a whole increased their lobbying 47 percent between 2007 and 2008.
With record spending on lobbying, some industries face serious cut backs and have put the brakes on spending, but have not discontinued the practice. Automotive companies decreased the amount they paid lobbyists by 7.6 percent, from $70.9 million to $65.5 million. This is a big change from prior years; auto manufacturers and dealers increased lobbying spending by 21 percent between 2006 and 2007. Between 2007 and 2008 the Alliance of Automobile Manufacturers, which testified before Congress with Detroit’s Big Three last year, decreased its reported lobbying by 43 percent, from $12.8 million to $7.3 million. Of the Big Three, only one company, Ford, increased its efforts, though not by much: it went from $7.1 million to $7.7 million, an 8 percent increase.
Among Washington lobbing firms, Patton Boggs reported the highest revenues from registered lobbying for the fifth year in a row: 41.9 million dollars, an increase over 2006 of more than 20 percent. The firm’s most lucrative clients included private equity firm Cerberus Capital Management, confection and pet food maker Mars, communication provider Verizon, pharmaceutical manufacturers Bristol-Myers Squibb and Roche, and the American Association for Justice (formerly the Association of Trial Lawyers of America).
Update by Lindsay Renick Mayer
It seems like this should be a classified ad: “Laid off and looking for work? The lobbying industry wants you!” Since we posted this story on OpenSecrets.org in January, the lobbying industry has only continued to grow, even as industries across the board have continued to shrink, forcing hundreds of thousands of Americans out of work. This growth could be attributed in part to the economy itself—many executives are looking for some help from the government to keep their businesses afloat. Others are simply taking advantage of the opportunities that a spate of government handouts has presented. But as long as there’s a federal government calling the shots, lobbyists will be paid more and more each year to hold their clients’ fire to lawmakers’ feet.
Year after year we see increases in lobbying expenditures—in fact, 100 percent over the last decade—and the flurry of activity during the first three months of 2009 indicates that the trend won’t come to an end any time soon. Based on records from the Senate Office of Public Records, the nonpartisan Center for Responsive Politics found that from January through March, lobbying increased slightly compared to the same period of time last year, by at least $2.4 million. Unions, organizations and companies spent at least $799.7 million so far this year on sending influence peddlers to Capitol Hill, compared to $797.2 million during the same time in 2008. That might seem like a small increase compared to the billions spent each year on this activity, but in a time of economic turmoil, that’s a hefty revenue stream for a single industry.
That said, the industries that have made the most headlines for the help they’ve asked for or received from the federal government actually decreased the amount they spent on lobbying in the first three months of 2009 compared to 2008. Recipients of cash from the federal government’s Troubled Asset Relief Program (TARP) handed out less money to lobbyists than they had in any quarter of 2008, in part, perhaps, because they faced new rules restricting their lobbying contact with officials in connection with the bailout program. CRP found that TARP recipients have spent $13.9 million on lobbying so far this year, compared to $20.2 million in January through March of last year and $17.8 million in the last three months of 2008. With the government doling out billions of dollars, these sums pale in comparison to the benefit the companies are reaping.
To read more about how lobbying and influence peddling are shaping legislation, keep up with CRP’s blog at http://www.opensecrets.org/news/.
Tuesday, October 13, 2009
Advertising
I have elected to allow Google to place advertising on my blog. Why? Because it generates income. If I can get the traffic up significantly we can use the revenue to fund the Foundation and its legal projects, one of which I am about to launch.
So, as far as the ads are concerned, caveat emptor. I have not vetted anything advertised on this blog. So, if you see an ad that promises to cure your fibromyalgia, increase the length of your penis or extend your orgasm, etc., I take no responsibility.
So, as far as the ads are concerned, caveat emptor. I have not vetted anything advertised on this blog. So, if you see an ad that promises to cure your fibromyalgia, increase the length of your penis or extend your orgasm, etc., I take no responsibility.
Saturday, October 10, 2009
Opiophobia – The War Heats Up
After moving back to Houston following 25 years in Santa Fe, from 1998 to 2006 I practiced effective pain management in peace. I succeeded in helping over 2,000 patients regain the quality of their life. In strict conformance with the standard of care that became formalized recently in the Guidelines of the American Pain Society, published in February of this year, my patients improved their functionality, contained their pain and made often remarkable progress in their physical condition and psychological status. They did this all with no complications, adverse effects, overdoses, any symptom of abuse addiction or diversion. They were universally grateful, secure and committed to their contract of treatment.
Sadly, after all those tranquil years, in 2006 I got my first notice from the Texas Medical Board of a review of my pain management cases. From that date to April of 2009, they reviewed 19 cases. In every instance, to their total frustration, they could find no reviewer to fault my pain management. In September of 2009 they subpoenaed another 9 cases. Yesterday, on October 9, 2009, I attended an “Informal Settlement Conference” with two representatives of the Texas Medical Board, to review those cases.
This time they found two anonymous interventionalist anesthesiologists to allege that my prescription of pain medications involved “massive” and “excessive” doses; that I didn’t perform complete physical examinations on each visit and that my telephone follow-up visits used the wrong billing code (I don’t bill for my services as I accept no insurance assignments).
I responded by providing detailed evidence demonstrating that these allegations were completely baseless, and that the opinions of the Board’s “reviewers” were clearly the product of anachronistic opiophobia, and a complete lack of experience with the treatment of intractable pain. I also presented statements from all nine patients involved in this “investigation”, detailing the complete effectiveness of my care in saving their lives, restoring the quality of their life, and describing their complete satisfaction with my care - and the absence of any complications, adverse effects, abuse, diversion, overdose or the induction or worsening of any addictive disorder. They ignored it all, and it appears didn’t even bother to read the patients’ outcome letters. They knew what “outcome” they were looking for.
So sadly, the “Informal Settlement Conference” was a sham. The “settlement” they offered included 20 hours of Continuing Medical Education in Pain Management (their way), quarterly supervision of my cases for five years by a physician of their choice, submission to supervision of my billing by an external authority and a $10,000 administrative fine. They produced this offer (which is much more complicated than this brief summary) just twelve minutes after concluding their “review” and “deliberations”. It obviously had been prepared before the “conference” – it would have taken them more than twelve minutes just to write it.
A month before, in September, they subpoenaed all my prescriptive records from a pharmacy I use often, and the records of 14 more of my cases – all decent, deserving and successful pain patients whose suffering has been conquered simply by adequate titration of their medications to effectiveness – are being “reviewed”. It appears that they have now located “reviewers” who will do their opiophobic bidding (unlike their frustrations in 2006 and 2007).
I don’t think this will end until an end is enforced upon then. I am turning now to the courts, to restore law into pain management in Texas (I helped write the rules for pain treatment in Texas – now the Texas Medical Board will have to be legally compelled to follow them).
As is detailed in my Brief History of Experience with the Texas Medical Board, Texas, once the leader in the nation in enlightened pain care, has regressed to the dark ages under right-wing politics (thanks George Bush and co-conspirators).
In March of 2006 I gave testimony to the Texas legislature about the problems of pain management under this Medical Board.
http://www.txppr.org/newsletter.cfm?NewsletterID=35&CategoryID=0
I re-iterated my opinions before the “Sunset” Commission of the Texas Legislature in November of 2008. Earlier this year – 2009 - I was actively involved in the unsuccessful effort to get important revisions in the Texas Medical Practices Act. (We’ll be back in the next session of the legislature.)
I also have been very outspoken about pain management on my blog http://jfshmd.blogspot.com/, on the web site of the National Foundation for the Treatment of Pain http://www.paincare.org/about/intro_message.php and in the professional literature, and on the LISTserve of “The Project on Pain and Chemical Dependency”. Further, I founded the Pain Practice Liability Association (www.pplaonline.com) - an organization to bring physicians together to defend themselves against Opiophobia, State Medical Boards, the DEA and other persecutors of pain management.
Given all of this, my current issues with the Board cannot be just a coincidence. I know, also, that several insurance companies have filed complaints about my pain care – growing out of the cost to them of pain medication. Other players are also involved, still hidden behind the “anonymity” practices of the Texas Medical Board.
Further, I am by nature a libertarian, constitutionalist and rational thinker. This doesn’t sit well with bigots, racists, religious crack-pots, greedy corporations and their minions. (I have written often that Opiophobia can only be understood through the psychodynamics of racism.)
So, I am harvesting what I have sown. Although I am now an old warrior, I am not ready to retire from battle. New Mexico was just the first skirmish. There is too much to do and so much that can be accomplished.
I believe that Mr. Obama’s election was a turning point in the history of America. The Nobel Prize just given him is a testament to that. The dark forces that have corrupted our national ideals are vicious and desperate. They sense the sands of time sifting out from under them. So they are in a frenzy of last efforts. The Texas Medical Board is a relic of Medievalism, and it too shall pass. I need only to persevere as I try to be a midwife to its delivery into enlightenment.
There is no guarantee that I will succeed. But regardless of the outcome, I will know that I did the right thing. I’m not the kind of person who can sit passively and watch the trains go by to Auschwitz.
JSH
October 10, 2009
Sadly, after all those tranquil years, in 2006 I got my first notice from the Texas Medical Board of a review of my pain management cases. From that date to April of 2009, they reviewed 19 cases. In every instance, to their total frustration, they could find no reviewer to fault my pain management. In September of 2009 they subpoenaed another 9 cases. Yesterday, on October 9, 2009, I attended an “Informal Settlement Conference” with two representatives of the Texas Medical Board, to review those cases.
This time they found two anonymous interventionalist anesthesiologists to allege that my prescription of pain medications involved “massive” and “excessive” doses; that I didn’t perform complete physical examinations on each visit and that my telephone follow-up visits used the wrong billing code (I don’t bill for my services as I accept no insurance assignments).
I responded by providing detailed evidence demonstrating that these allegations were completely baseless, and that the opinions of the Board’s “reviewers” were clearly the product of anachronistic opiophobia, and a complete lack of experience with the treatment of intractable pain. I also presented statements from all nine patients involved in this “investigation”, detailing the complete effectiveness of my care in saving their lives, restoring the quality of their life, and describing their complete satisfaction with my care - and the absence of any complications, adverse effects, abuse, diversion, overdose or the induction or worsening of any addictive disorder. They ignored it all, and it appears didn’t even bother to read the patients’ outcome letters. They knew what “outcome” they were looking for.
So sadly, the “Informal Settlement Conference” was a sham. The “settlement” they offered included 20 hours of Continuing Medical Education in Pain Management (their way), quarterly supervision of my cases for five years by a physician of their choice, submission to supervision of my billing by an external authority and a $10,000 administrative fine. They produced this offer (which is much more complicated than this brief summary) just twelve minutes after concluding their “review” and “deliberations”. It obviously had been prepared before the “conference” – it would have taken them more than twelve minutes just to write it.
A month before, in September, they subpoenaed all my prescriptive records from a pharmacy I use often, and the records of 14 more of my cases – all decent, deserving and successful pain patients whose suffering has been conquered simply by adequate titration of their medications to effectiveness – are being “reviewed”. It appears that they have now located “reviewers” who will do their opiophobic bidding (unlike their frustrations in 2006 and 2007).
I don’t think this will end until an end is enforced upon then. I am turning now to the courts, to restore law into pain management in Texas (I helped write the rules for pain treatment in Texas – now the Texas Medical Board will have to be legally compelled to follow them).
As is detailed in my Brief History of Experience with the Texas Medical Board, Texas, once the leader in the nation in enlightened pain care, has regressed to the dark ages under right-wing politics (thanks George Bush and co-conspirators).
In March of 2006 I gave testimony to the Texas legislature about the problems of pain management under this Medical Board.
http://www.txppr.org/newsletter.cfm?NewsletterID=35&CategoryID=0
I re-iterated my opinions before the “Sunset” Commission of the Texas Legislature in November of 2008. Earlier this year – 2009 - I was actively involved in the unsuccessful effort to get important revisions in the Texas Medical Practices Act. (We’ll be back in the next session of the legislature.)
I also have been very outspoken about pain management on my blog http://jfshmd.blogspot.com/, on the web site of the National Foundation for the Treatment of Pain http://www.paincare.org/about/intro_message.php and in the professional literature, and on the LISTserve of “The Project on Pain and Chemical Dependency”. Further, I founded the Pain Practice Liability Association (www.pplaonline.com) - an organization to bring physicians together to defend themselves against Opiophobia, State Medical Boards, the DEA and other persecutors of pain management.
Given all of this, my current issues with the Board cannot be just a coincidence. I know, also, that several insurance companies have filed complaints about my pain care – growing out of the cost to them of pain medication. Other players are also involved, still hidden behind the “anonymity” practices of the Texas Medical Board.
Further, I am by nature a libertarian, constitutionalist and rational thinker. This doesn’t sit well with bigots, racists, religious crack-pots, greedy corporations and their minions. (I have written often that Opiophobia can only be understood through the psychodynamics of racism.)
So, I am harvesting what I have sown. Although I am now an old warrior, I am not ready to retire from battle. New Mexico was just the first skirmish. There is too much to do and so much that can be accomplished.
I believe that Mr. Obama’s election was a turning point in the history of America. The Nobel Prize just given him is a testament to that. The dark forces that have corrupted our national ideals are vicious and desperate. They sense the sands of time sifting out from under them. So they are in a frenzy of last efforts. The Texas Medical Board is a relic of Medievalism, and it too shall pass. I need only to persevere as I try to be a midwife to its delivery into enlightenment.
There is no guarantee that I will succeed. But regardless of the outcome, I will know that I did the right thing. I’m not the kind of person who can sit passively and watch the trains go by to Auschwitz.
JSH
October 10, 2009
Friday, October 9, 2009
Chronic fatigue - a pattern in medicine?
From today's Wall Street Journal
By AMY DOCKSER MARCUS
Researchers have linked an infectious virus known to cause cancer in animals to chronic-fatigue syndrome, a major discovery for sufferers of the condition and one that concerned scientists for its potential public-health implications.
An estimated 17 million people world-wide suffer from chronic-fatigue syndrome, and the Centers for Disease Control and Prevention puts the U.S. figure at between one million and four million. CFS is characterized by debilitating fatigue and chronic pain, but there are no specific treatments, and the diagnosis is often made by ruling out other diseases. Thus there is disagreement in the medical community as to whether CFS is a distinct disease. A study showing a strong viral association with CFS could change that equation.
[Researchers] Michael Hillerby, Whittemore Peterson Institute.
Researchers Judy Mikovits and Vincent Lombardi work in the lab at Whittemore Peterson Institute.
But the significance of the finding, published Thursday in Science, extends far beyond the community of people living with CFS. Researchers are just as concerned about the finding that nearly 4% of healthy people used as controls in the study were also infected with the virus, called XMRV. If larger studies confirm these numbers, it could mean that as many as 10 million people in the U.S. and hundreds of millions of people around the world are infected with a virus that is already strongly associated with at least two diseases.
The study was done by researchers at the Whittemore Peterson Institute for Neuro-Immune Disease in Reno, Nev., the National Cancer Institute and the Cleveland Clinic.
In September, researchers at the University of Utah and Columbia University Medical Center found XMRV in 27% of the prostate-cancer samples they examined. That study also showed that 6% of the benign prostate samples had XMRV. The chronic-fatigue study is the first to find live XMRV virus in humans.
Neither study conclusively shows that XMRV causes chronic-fatigue syndrome or prostate cancer. But the National Cancer Institute was sufficiently concerned to convene a closed-door workshop in July to discuss the public-health implications of XMRV infection. "NCI is responding like it did in the early days of HIV," says Stuart Le Grice, head of the Center of Excellence in HIV/AIDS and cancer virology at NCI and one of the organizers of the July workshop.
Like HIV, XMRV is a retrovirus, meaning once someone is infected, the virus permanently remains in the body; either a person's immune system keeps it under control or drugs are needed to treat it. The virus creates an underlying immune deficiency, which might make people vulnerable to a range of diseases, said Judy Mikovits of the Whittemore Peterson Institute and one of the lead authors on the paper.
So far, XMRV, known fully as xenotropic murine leukemia virus-related virus, doesn't appear to replicate as quickly as HIV does. Scientists also don't know how XMRV is transmitted, but the infection was found in patients' blood samples, raising the possibility that it could be transmitted through blood or bodily fluids.
Dr. Le Grice of the NCI said the highest priority now was to quickly develop a validated blood test or other assay that could be used in doctors' offices to determine who has XMRV. At the workshop, participants also raised the issue of protecting the nation's blood supply. Dr. Le Grice said there isn't enough evidence yet to suggest that people with XMRV shouldn't be blood donors but that determining how XMRV is transmitted was a critical issue. "A large effort is under way to answer all these questions," he said. "I do not want this to be cause for panic."
Although Thursday's scientific paper doesn't demonstrate conclusively that XMRV is a cause of CFS, additional unpublished data make it a very strong possibility. Dr. Mikovits said that using additional tests, the scientists determined that more than 95% of the patients in the study are either infected with live virus or are making antibodies that show their immune systems mounted an attack against XMRV and now had the virus under control. "Just like you cannot have AIDS without HIV, I believe you won't be able to find a case of chronic-fatigue syndrome without XMRV," Dr. Mikovits said.
At the July workshop, Dr. Mikovits also presented preliminary data showing that 20 patients of the 101 in the study have lymphoma, a rare form of cancer. The link between XMRV and lymphoma is still being investigated, but it raised the possibility that XMRV may be associated with other cancers in addition to prostate cancer. NCI's Dr. Le Grice said studies will be launched to determine whether XMRV is associated with other diseases. At the Whittemore Peterson Institute, Dr. Mikovits said they also found XMRV in people with autism, atypical multiple sclerosis and fibromyalgia.
The Science study was based on blood samples from a national repository at the Whittemore Peterson Institute collected from doctors in cities where outbreaks of chronic-fatigue syndrome occurred during the 1980s and '90s. One of the key questions that the NCI's Dr. Le Grice says must now be answered is whether XMRV shows up in large numbers of CFS patients all over the country.
Robert Silverman, a professor at the Cleveland Clinic Lerner Research Institute who is one of the co-authors of the study and one of the discoverers of the XMRV virus, said he believes the virus began in mice and then spread to humans, and that "in most cases, people's immune systems are probably able to control the virus." Researchers are already starting to test antiretroviral therapies developed for AIDS to see if they are effective against XMRV.
The work on XMRV in chronic-fatigue patients initially was funded by Annette and Harvey Whittemore and the University of Nevada, Reno. The Whittemores set up the institute in 2006 after watching their daughter Andrea suffer from chronic-fatigue syndrome for most of her life. They spent millions of their own money to pay for administrative services, office space, lab equipment and research operations. They were frustrated by the lack of government funding for scientific research into the disease.
At their home in Reno, Andrea Whittemore-Goad, 31 years old, used oxygen before speaking about the devastating toll CFS has taken on her.
Ms. Whittemore-Goad says she was a regular school girl, playing sports and involved in school activities, until the age of 10, when she became ill with a monolike virus that she couldn't shake. She said doctors first told her parents that the illness was psychological, that she had school phobia and was under stress from her parents. "We kept searching for an answer," says Ms. Whittemore-Goad, who says lymph nodes in her groin were so painful that her brothers and sisters used to have to carry her upstairs. She was diagnosed at age 12 with chronic-fatigue syndrome.
Over the years, doctors have treated her symptoms, like intense headaches and severe pain, but the illness persists. She has had her gallbladder, spleen, and appendix removed because they became infected. She tried an experimental drug that she says gave her relief for years, but she then started experiencing side effects and had to stop taking it. Recently the illness has become worse; she began suffering seizures and can no longer drive.
Sitting on the couch next to her husband, whom she married six months ago, Ms. Whittemore-Goad says the news that she is infected with XMRV "made everything that has happened to me make sense." Brian Goad, her husband, said he felt relieved knowing "now we can find a way to treat and hopefully cure it." For both of them, the discovery of the virus is life-changing. There are more than 10 families in the group where family members also tested positive for XMRV. Members of the Whittemore family are now being tested.
Write to Amy Dockser Marcus at amy.marcus@wsj.com
--------------------------------------------------------------
I think I have detected a pattern in my profession. For far too many physicians, when they encounter something they don't know about they tend to:
1. deny its existence
2. blame it on a psychiatric disorder
3. demonize the patient
There is nothing dumber than a really dumb, really smart, person.
JSH
By AMY DOCKSER MARCUS
Researchers have linked an infectious virus known to cause cancer in animals to chronic-fatigue syndrome, a major discovery for sufferers of the condition and one that concerned scientists for its potential public-health implications.
An estimated 17 million people world-wide suffer from chronic-fatigue syndrome, and the Centers for Disease Control and Prevention puts the U.S. figure at between one million and four million. CFS is characterized by debilitating fatigue and chronic pain, but there are no specific treatments, and the diagnosis is often made by ruling out other diseases. Thus there is disagreement in the medical community as to whether CFS is a distinct disease. A study showing a strong viral association with CFS could change that equation.
[Researchers] Michael Hillerby, Whittemore Peterson Institute.
Researchers Judy Mikovits and Vincent Lombardi work in the lab at Whittemore Peterson Institute.
But the significance of the finding, published Thursday in Science, extends far beyond the community of people living with CFS. Researchers are just as concerned about the finding that nearly 4% of healthy people used as controls in the study were also infected with the virus, called XMRV. If larger studies confirm these numbers, it could mean that as many as 10 million people in the U.S. and hundreds of millions of people around the world are infected with a virus that is already strongly associated with at least two diseases.
The study was done by researchers at the Whittemore Peterson Institute for Neuro-Immune Disease in Reno, Nev., the National Cancer Institute and the Cleveland Clinic.
In September, researchers at the University of Utah and Columbia University Medical Center found XMRV in 27% of the prostate-cancer samples they examined. That study also showed that 6% of the benign prostate samples had XMRV. The chronic-fatigue study is the first to find live XMRV virus in humans.
Neither study conclusively shows that XMRV causes chronic-fatigue syndrome or prostate cancer. But the National Cancer Institute was sufficiently concerned to convene a closed-door workshop in July to discuss the public-health implications of XMRV infection. "NCI is responding like it did in the early days of HIV," says Stuart Le Grice, head of the Center of Excellence in HIV/AIDS and cancer virology at NCI and one of the organizers of the July workshop.
Like HIV, XMRV is a retrovirus, meaning once someone is infected, the virus permanently remains in the body; either a person's immune system keeps it under control or drugs are needed to treat it. The virus creates an underlying immune deficiency, which might make people vulnerable to a range of diseases, said Judy Mikovits of the Whittemore Peterson Institute and one of the lead authors on the paper.
So far, XMRV, known fully as xenotropic murine leukemia virus-related virus, doesn't appear to replicate as quickly as HIV does. Scientists also don't know how XMRV is transmitted, but the infection was found in patients' blood samples, raising the possibility that it could be transmitted through blood or bodily fluids.
Dr. Le Grice of the NCI said the highest priority now was to quickly develop a validated blood test or other assay that could be used in doctors' offices to determine who has XMRV. At the workshop, participants also raised the issue of protecting the nation's blood supply. Dr. Le Grice said there isn't enough evidence yet to suggest that people with XMRV shouldn't be blood donors but that determining how XMRV is transmitted was a critical issue. "A large effort is under way to answer all these questions," he said. "I do not want this to be cause for panic."
Although Thursday's scientific paper doesn't demonstrate conclusively that XMRV is a cause of CFS, additional unpublished data make it a very strong possibility. Dr. Mikovits said that using additional tests, the scientists determined that more than 95% of the patients in the study are either infected with live virus or are making antibodies that show their immune systems mounted an attack against XMRV and now had the virus under control. "Just like you cannot have AIDS without HIV, I believe you won't be able to find a case of chronic-fatigue syndrome without XMRV," Dr. Mikovits said.
At the July workshop, Dr. Mikovits also presented preliminary data showing that 20 patients of the 101 in the study have lymphoma, a rare form of cancer. The link between XMRV and lymphoma is still being investigated, but it raised the possibility that XMRV may be associated with other cancers in addition to prostate cancer. NCI's Dr. Le Grice said studies will be launched to determine whether XMRV is associated with other diseases. At the Whittemore Peterson Institute, Dr. Mikovits said they also found XMRV in people with autism, atypical multiple sclerosis and fibromyalgia.
The Science study was based on blood samples from a national repository at the Whittemore Peterson Institute collected from doctors in cities where outbreaks of chronic-fatigue syndrome occurred during the 1980s and '90s. One of the key questions that the NCI's Dr. Le Grice says must now be answered is whether XMRV shows up in large numbers of CFS patients all over the country.
Robert Silverman, a professor at the Cleveland Clinic Lerner Research Institute who is one of the co-authors of the study and one of the discoverers of the XMRV virus, said he believes the virus began in mice and then spread to humans, and that "in most cases, people's immune systems are probably able to control the virus." Researchers are already starting to test antiretroviral therapies developed for AIDS to see if they are effective against XMRV.
The work on XMRV in chronic-fatigue patients initially was funded by Annette and Harvey Whittemore and the University of Nevada, Reno. The Whittemores set up the institute in 2006 after watching their daughter Andrea suffer from chronic-fatigue syndrome for most of her life. They spent millions of their own money to pay for administrative services, office space, lab equipment and research operations. They were frustrated by the lack of government funding for scientific research into the disease.
At their home in Reno, Andrea Whittemore-Goad, 31 years old, used oxygen before speaking about the devastating toll CFS has taken on her.
Ms. Whittemore-Goad says she was a regular school girl, playing sports and involved in school activities, until the age of 10, when she became ill with a monolike virus that she couldn't shake. She said doctors first told her parents that the illness was psychological, that she had school phobia and was under stress from her parents. "We kept searching for an answer," says Ms. Whittemore-Goad, who says lymph nodes in her groin were so painful that her brothers and sisters used to have to carry her upstairs. She was diagnosed at age 12 with chronic-fatigue syndrome.
Over the years, doctors have treated her symptoms, like intense headaches and severe pain, but the illness persists. She has had her gallbladder, spleen, and appendix removed because they became infected. She tried an experimental drug that she says gave her relief for years, but she then started experiencing side effects and had to stop taking it. Recently the illness has become worse; she began suffering seizures and can no longer drive.
Sitting on the couch next to her husband, whom she married six months ago, Ms. Whittemore-Goad says the news that she is infected with XMRV "made everything that has happened to me make sense." Brian Goad, her husband, said he felt relieved knowing "now we can find a way to treat and hopefully cure it." For both of them, the discovery of the virus is life-changing. There are more than 10 families in the group where family members also tested positive for XMRV. Members of the Whittemore family are now being tested.
Write to Amy Dockser Marcus at amy.marcus@wsj.com
--------------------------------------------------------------
I think I have detected a pattern in my profession. For far too many physicians, when they encounter something they don't know about they tend to:
1. deny its existence
2. blame it on a psychiatric disorder
3. demonize the patient
There is nothing dumber than a really dumb, really smart, person.
JSH
Thursday, October 1, 2009
Letter to the Editor of the NY Times
October 1, 2009
To the Editor
NY Times
Re: Swiss Medical System
The essential point which is not considered in this article is the “overhead” cost of medical health insurance. What is the percentage of “overhead” that the Swiss permit their insurance companies to charge? How does this compare to the “overhead” which American Insurers divert from the total expenditures for health care in the United States? Of that approximately 6% difference between the percentage of the GNP spent on health care in the U.S. and in Switzerland, how much of this difference is derived from insurance company “overhead”? One must wonder if the Swiss permit the CEOs of their insurance companies to pay themselves $100,000,000 per year, or to purchase $55,000,000 corporate jets and spend $400,000 for a week end jaunt to Aruba.
Further, granting insurance companies in the U.S. additional power to control the practice of medicine through “prior authorizations”, “reviews of service”, demands for the demonstration of “medical necessity”, “green letters”, etc., would simply be giving an A-47 to the coyotes already “guarding” the hen house. In the U.S. insurance companies could care less about patient well-being and effective/efficient health care. Proof of this is their refusal to pay for preventative and “life-style” prophylactic medical care. As Michael Moore made abundantly clear in “Sicko”, they care only about making money, and restricting health care is how they do it. There is absolutely no regulation and/or competition in the health care insurance industry. So the suggestion that what the U.S. needs is more powerful insurance companies is outrageous. Do your homework before you jump into the dialogue.
J.S. Hochman MD
Executive Director
The National Foundation for the Treatment of Pain
To the Editor
NY Times
Re: Swiss Medical System
The essential point which is not considered in this article is the “overhead” cost of medical health insurance. What is the percentage of “overhead” that the Swiss permit their insurance companies to charge? How does this compare to the “overhead” which American Insurers divert from the total expenditures for health care in the United States? Of that approximately 6% difference between the percentage of the GNP spent on health care in the U.S. and in Switzerland, how much of this difference is derived from insurance company “overhead”? One must wonder if the Swiss permit the CEOs of their insurance companies to pay themselves $100,000,000 per year, or to purchase $55,000,000 corporate jets and spend $400,000 for a week end jaunt to Aruba.
Further, granting insurance companies in the U.S. additional power to control the practice of medicine through “prior authorizations”, “reviews of service”, demands for the demonstration of “medical necessity”, “green letters”, etc., would simply be giving an A-47 to the coyotes already “guarding” the hen house. In the U.S. insurance companies could care less about patient well-being and effective/efficient health care. Proof of this is their refusal to pay for preventative and “life-style” prophylactic medical care. As Michael Moore made abundantly clear in “Sicko”, they care only about making money, and restricting health care is how they do it. There is absolutely no regulation and/or competition in the health care insurance industry. So the suggestion that what the U.S. needs is more powerful insurance companies is outrageous. Do your homework before you jump into the dialogue.
J.S. Hochman MD
Executive Director
The National Foundation for the Treatment of Pain
Monday, August 24, 2009
The Roll of Ballantyne and Mao in the Worldwide Tragedy of Opiophobia
Opiophobia is a Worldwide Tragedy
“The majority of (Australian) pain physicians support opioid medication use. The case against its use is largely dependent on a single flawed article (see Ballantyne et al below).
Despite the fact that the majority of pain physicians support the use of opioid medication, some practitioners and some governments have tried to limit its use. This decision is not based on any clinical or relevant research evidence. This decision has been based on prejudice and ignorance of proper opioid (treatment). At the base of this conduct is “opiophobia”.
The majority of reputable pain organizations, including the International Association for the study of pain (IASP) the largest pain organization representative group, and the International Association for Pain and Chemical Dependence ( IAPCD) support opioid medication, and recognize that in a some specific cases large doses of opioid medication are the preferred course of action.
Although there is debate about absolute or arbitrary limits on use of opioids, many conclusions proposed in the case against pain management are flawed (see Hochman below).
1. there is no evidence to support the claim that an upper limit of dosage should be mandated. (From a treatment perspective there is no evidence to show that there is ceiling dose, and as the dose increases, the analgesic benefit will also improve).
2. there is no evidence that these medications impair cognitive and personal function, indeed they frequently improve both.
3. addiction is uncommon.
4. the rationale to opioid use is purely relief of symptoms and improvement of function.
In South Australia there has been a major bureaucratic effort to obstruct and prevent treatment of chronic pain. This has been achieved by numerous measures: -
• improper denial of pain relief to patients.
• inappropriate action against practitioners administering to these patients.
• Treatment decisions made by administrators lacking the appropriate technical skills. (Not one patient has been examined by them).”
– Ian Buttfield MD,
Australia
“HYPERALGESIA”, “OPIOPHOBIA”. AND BALLANTYNE AND MAO: AN ANALYSIS
January 14, 2009
The treatment of Intractable Pain remains a peculiarly unresolved controversy in American medicine. Although, in theory, it is generally accepted that pain must be treated, particularly in cancer patients, the treatment of pain unrelated to malignancy remains a stubborn issue.
Some legal experts assumed that as a consequence of tort actions (Bergman v Chin) physicians would be forced to treat pain effectively in compliance with the community standard of care. In this civil lawsuit in San Francisco, California, a jury found Dr. Chin to be negligent in failing to
adequately treat and relieve the suffering of his cancer patient, Mr. Bergman, and awarded his family $2.5 million (reduced subsequently by the court to $1.5 million).
In fact, the Bergman v Chin case had little impact on the medical community. There has been no subsequent case of its sort. Further, in the entire United States, there has been only a single instance of a physician being disciplined by a State Medical Board for inadequately treating pain. In contrast, “unnecessary prescription of opioids” continues to be one of the most common causes of action taken against physicians daring to treat chronic pain unrelated to cancer.
Indeed, the case against pain management has been intensified.
• Insurance companies, clearly responding to the expense of pain medications, have attempted to deter pain treatment through filing state Medical Board complaints against doctors for “unnecessary prescribing”.
• Insurers have also utilized the device of “peer-reviews” to discourage prescribing (described by some observers as “sham reviews”)
• Physicians (typically “interventionalists”) have been hired by insurers to opine that the prescriptions of opioids were “outside the standard of care”.
o They falsely claim that only interventions conform to the standard of care; that the prescribing of opioids is “unnecessary”, “excessive”, “dangerous”, or “addicting”.
o They recommend detoxification, denying or ignoring the medical necessity for on-going treatment of intractable pain. (Interestingly, when these “peer-reviews” are appealed to independent reviewers, affirmation of opioid treatment has been virtually universal.)
An additional strategy in the campaign to save “opiophobia” from extinction has been a movement to establish arbitrary limits on opioid usage, reaching a recent zenith in the drafting of an arbitrary daily limit of 120 mg of morphine, or its equivalent, in the State of Washington (resulting in a federal lawsuit.)
The opioid limitation campaign has largely depended on a single article, by Ballantyne and Mao, published in the New England Journal of Medicine in 2003 (purportedly the product of peer review.) There is no other “peer-reviewed” article in the medical literature promoting absolute or arbitrary limits on the use of opioids. The article has been frequently cited by anti-opioid activists.
Given the central position of this article in the struggle around pain management, this author decided to revisit the original publication, to examine its content, assumptions and conclusions. The findings were enlightening.
BALLANTYNE AND MAO
Turning to the article, Ballantyne and Mao stated that:
1. Experts on pain recommend that pain patients not be denied opioids.
2. Despite this many physicians remain uncertain about prescribing opioids and do not prescribe.
3. Some physicians (a minority) argue that opioids are only marginally useful in the treatment of chronic pain, have a minimal effect on improving functioning, and may even worsen the outcome.
4. Key organizations strongly support the use of opioids to treat chronic pain and have published consensus statements to guide. Ballantyne and Mao reviewed the common elements in these guidelines, including regular assessment of the achievement of goals, careful monitoring for signs of opioid abuse (including toxicological screening in some cases), the use of adjunctive treatments whenever possible, and a willingness to end opioid treatment if the goals are not met, and full documentation.
Ballantyne and Mao then discussed clinical studies, noting that:
1. Most of the literature on opioid therapy consists of reports of surveys and uncontrolled case series and that patients with chronic pain not associated with a terminal disease can achieve satisfactory analgesia by using a stable (non-escalating) dose of opioids, with a minimal risk of addiction, in up to six years of treatment.
2. In most cases, doses are in a moderate range (up to 195 mg of morphine or morphine equivalent per day.
3. In other reports, higher doses were used (up to 2 g/day)
4. Some studies have also assessed functioning on the basis of patients’ own reports, with most patients reporting improvement.
5. Studies have shown that cognitive function, including the ability to drive and operate machinery, is preserved in patients taking stable, moderate doses of opioids for chronic pain.
6. However they then asserted that cognitive function may be impaired for up to seven days after an increase in the dose, “though the effect of high doses of opioids on cognitive function is unknown. “
7. Several controlled studies involving the use of single doses or short intravenous infusions of opioids confirm the responsiveness of various pain syndromes, including neuropathic pain.
8. Neuropathic pain has traditionally been considered opioid-resistant. However, recent clinical studies have shown opioids to be effective, provided an adequate dose can be reached without excess side effects.
9. Controlled studies have assessed the usefulness of long-term oral opioid therapy for chronic pain, and show significant analgesic efficacy of opioids in the treatment of chronic pain, including neuropathic pain,
10. The evidence of their effect on functioning is mixed, with a few studies reporting that pain relief was achieved without functional improvement.
11. Pain relief is the expected end point of opioid therapy, but there is no consensus on whether pain relief without other benefits is a reasonable outcome
12. A fundamental principle of pain management is that the dose of an opioid should be increased until maximal analgesia is achieved with minimal side effects.
However, despite their recognition of all these findings, Ballantyne and Mao then directed their focus on their view that dosage of opioids must be limited. They stated:
1. Clinical experience suggests that many physicians take a much more liberal approach to dose increases. Some patients with chronic pain receive doses as high as 1 g or more of morphine (or a morphine equivalent) per day, which may be five or more times the doses validated by the literature
2. Anecdotal evidence suggests that patients receiving opioid doses of this magnitude rarely report satisfactory analgesia or improved function.
3. Although the clinical trials carried out to date have not examined the efficacy and safety of prolonged, high-dose opioid therapy, evidence is rapidly accumulating that, in the treatment of patients with chronic pain, opioid doses should be limited in order to maintain both efficacy and safety.
4. Opioid Tolerance is an adaptive process at the cellular level
a. Several mechanisms are linked to the desensitization of opioid receptors
b. In patients receiving prolonged opioid therapy, increased expression of the endogenous opioid dynorphin has been noted in the spinal cord dorsal horn associated with enhanced pain sensitivity.
c. Although the exact mechanisms of NMDA-receptor–mediated opioid tolerance have not yet been elucidated, this line of research has provided insights into several issues related to prolonged opioid therapy.
d. Long-term use of opioids may also be associated with the development of abnormal sensitivity to pain
e. Preclinical and clinical studies suggest that opioid-induced abnormal pain sensitivity has much in common with the cellular mechanisms of neuropathic pain.
f. Animal models have also shown that NMDA-receptor–mediated cellular mechanisms mediate irreversible neurotoxic changes.
g. Repeated administration of opioids not only results in the development of tolerance (a desensitization process) but also leads to a pro-nociceptive (sensitization) process.
h. Together, desensitization and sensitization arising during prolonged opioid therapy may contribute to an apparent decrease in analgesia.
i. Prolonged opioid therapy can lead to cellular and intracellular changes,
j. Such changes may contribute to pharmacologic opioid tolerance, increased sensitivity to pain, or both and the need for dose escalation.
k. Prolonged opioid treatment may also result in hormonal changes and may alter immune function.
l. These effects may be exacerbated by dose escalation in some circumstances.
m. Thus, the need for dose escalation during opioid therapy — that is, the development of “apparent” opioid tolerance — may be the result of pharmacologic opioid tolerance, opioid-induced abnormal pain sensitivity, or disease progression.
n. Exogenous opioids may affect immunity through their neuroendocrine effects, or through direct effects on the immune system.
o. On the basis of studies in animals, prolonged exposure to opioids appears to be more likely to suppress immune function than short-term exposure, and abrupt withdrawal of opioids may also induce immune suppression.
p. Different opioids appear to act differently on the immune system. For example, methadone may be less immunosuppressive than morphine.
q. Studies of immune function in patients receiving long-term opioid therapy for chronic pain are notably lacking, but the direct evidence that opioids impair immune function has aroused concern, particularly in the case of susceptible persons. (However, pain itself can impair immune function)
r. The greatest concern is likely to pertain to patients receiving high doses of opioids who do not obtain satisfactory pain relief.
s. Apparent opioid tolerance does not equal pharmacologic opioid tolerance; and prolonged, high-dose opioid therapy may have serious adverse con-sequences.
5. Clinical tolerance is related to pharmacologic tolerance
a. Pharmacologic tolerance to opioids has defined cellular mechanisms.
b. Tolerance is the need for increasing doses to maintain the same level of analgesia.
c. There is evidence that opioids can induce abnormal pain sensitivity or hyperalgesia,
d. Although sophisticated testing can identify hyperalgesia (to distinguish it from pharmacologic tolerance), it may not distinguish the hyperalgesia due to opioid treatment from the hyperalgesia due to worsening neuropathic pain.
e. In every day clinical practice (without testing), it is impossible to distinguish between pharmacologic tolerance and abnormal pain sensitivity.
f. Whether opioid-induced abnormal pain sensitivity is related to the dose, the particular opioid, the route of administration, the duration of use, or other factors remains unclear.
g. Abnormal pain sensitivity may, at least in part, explain the failure to relieve pain in some patients, despite increases in the opioid dose. Thus, in some instances, treating increasing pain with in-creasing doses of opioids may be futile.
6. High dose opioid, prolonged, therapy opioids may have adverse consequences, including:
a. opioid tolerance with the need for dose escalation, and opioid-induced abnormal pain sensitivity.
b. hormonal effects that result in reduced fertility, libido, and drive.
c. immunosuppression, especially in susceptible persons. (“We do not yet know to what extent these effects are clinically relevant. However, prolonged use of high doses of opioids is likely to be more toxic than short-term use of low doses, so hormonal effects are most likely to occur in patients with chronic pain who receive high-dose opioid therapy”).
d. Paradoxically, opioid treatment may actually increase the burden of care, because the management of opioid therapy in patients with complex problems is time-consuming and difficult.
7. The concept of a ceiling dose of opioids in the treatment of chronic pain is growing, yet it is difficult to define a dose that could be recommended as a ceiling. Daily doses above 180 mg of morphine or a morphine equivalent have not been validated in clinical trials involving patients with chronic pain and might be considered excessive. However, ceiling doses probably vary among patients, given the known differences in patients’ responses to opioids. More important than the dose itself, however, may be the need for frequent dose escalation beyond the time when establishing a stable dose during the dose-adjustment phase (e.g., up to eight weeks) would be reasonable. The goal of these strategies is to maintain opioid efficacy while avoiding an adverse outcome.
8. Whereas it was previously thought that unlimited dose escalation was at least safe, evidence now suggests that prolonged, high-dose opioid therapy may be neither safe nor effective. It is therefore important that physicians make every effort to control indiscriminate prescribing, even when they are under pressure by patients to increase the dose of opioids.
------------------------------------------------------------------------------------------------------------
ANALYSIS
Drs. Ballantyne and Mao created a document which is now used, uncritically, by both individual practitioners and governmental authorities, as a basis for attempting to set arbitrary and absolute limits on the dosage of opioids in managing intractable pain. However, a careful reading of their article reveals it to be largely conjectural, though subtly so.
Initially they establish that the treatment of intractable pain is supported by the contemporary standard of medical practice. They then review the accepted approach to pain management through careful titration. Having established this foundation, they then proceed to attempt to construct their case against opioids.
Their case is based upon:
1. The allegation that opioids may impair cognitive and personal function
2. The allegation that opioids may impair the immune system
3. The allegation that opioids may cause serious hormonal problems
4. The allegation that high dose opioids may induce tolerance
5. The allegation that opioids are ineffective
6. The allegation that high dose opioids may induce allodynia and other pain hypersensitivities
Careful reading reveals that none of these allegations are supported by the medical and scientific literature they cite. Nowhere do they state that they do. Instead, every allegation is qualified with the statement that this hypothetical adverse consequence of high and/or long-term opioid usage may be so. Evidence that “suggests” something does not prove it. Hypotheses are not conclusions. They remain hypotheses until proven. None of these allegations have any basis in proof. Indeed, the vast body of clinical evidence, to date, disproves the allegations, with the single exception noted below.
Their clear objective was to construct an argument against opioids, under the rubric of a review of the medical literature.
“Whereas it was previously thought that unlimited dose escalation was at least safe, evidence now suggests that prolonged, high-dose opioid therapy may be neither safe nor effective. It is therefore important that physicians make every effort to control indiscriminate prescribing, even when they are under pressure by patients to increase the dose of opioids.”
We know of no publication, article or practitioner who has ever called for the indiscriminate prescription of opioids. This is simply a straw man. But, most importantly, the hypotheses of adverse consequences, initially qualified by “may”, “can” and “could”, are suddenly reified, and a leap is made to an ideological absolutism. “Opioids are over-prescribed, high doses are dangerous and must be limited – as they are neither safe nor effective.” No evidence is offered to support any of these claims, and they are, in fact, scientifically indefensible.
The Ballantyne and Mao article in fact does not establish that substantial evidence exists that high dose opioid therapy is neither safe nor effective. In fact, there is no such evidence. Indeed, all clinical evidence points to the opposite conclusion.
Specifically, extensive clinical experience demonstrates that, in the treatment of chronic pain:
1. opioids do not impair cognitive and personal function
1. opioids do not impair the immune system (except in a limited number of instances of suppressed testosterone levels in males)
2. opioids do not cause serious hormonal problems, otherwise
3. high dose opioids do not induce tolerance (in intractable pain patients)
4. opioids are effective in controlling pain and dramatically improving the quality of life of pain patients
5. high dose opioids do not induce hypothetical allodynia or other pain hypersensitivities to any significant extent
6. Opioid overdoses are universally the outcome of addictive misuse or unauthorized polypharmacy frequently including alcohol, and are statistically insignificant among pain patients, when the medication is used as prescribed
CONCLUSIONS
While it is judicious to exercise caution and continuing evaluation of the effects of the long term treatment of pain with opioids, the speculation that one MAY (the word is used at least 26 times in the Ballantyne and Mao article) encounter adverse long-term effects is not a defensible basis for assuming that they do.
What Ballantyne and Mao fail to respect is that their speculations are not supported by any substantial or factual evidence. Indeed, the contrary is true. All actual evidence and every clinical report concludes the opposite. To date, none of the allegations they presented has gained any substantial or reproducible evidence to support them. The sole exception, known for decades, is that continued therapy with opioids may induce suppression of serum testosterone levels in males, which is easily rectified with exogenous testosterone supplementation. Sadly, the Ballantyne and Mao speculations have achieved the status of “Urban Myth”, with many physicians uncritically quoting the hypothesis of hyperalgesia as an accepted fact. In fact, “Hyperalgesia” is a hypothetical theory proposed by a minority group of physicians who seek to explain why their inadequate dosing of pain results in treatment failure. There is not a single citation in the medical literature of a peer-reviewed article, based upon scientifically defensible evidence, supporting this hypothesized theory.
Caution is laudable in the practice of medicine. Ideology, masquerading as a scientifically objective review of the literature, is not.
Joel Simon Hochman MD
Executive Director
The National Foundation for the Treatment of Pain
www.paincare.org
3150 words
“The majority of (Australian) pain physicians support opioid medication use. The case against its use is largely dependent on a single flawed article (see Ballantyne et al below).
Despite the fact that the majority of pain physicians support the use of opioid medication, some practitioners and some governments have tried to limit its use. This decision is not based on any clinical or relevant research evidence. This decision has been based on prejudice and ignorance of proper opioid (treatment). At the base of this conduct is “opiophobia”.
The majority of reputable pain organizations, including the International Association for the study of pain (IASP) the largest pain organization representative group, and the International Association for Pain and Chemical Dependence ( IAPCD) support opioid medication, and recognize that in a some specific cases large doses of opioid medication are the preferred course of action.
Although there is debate about absolute or arbitrary limits on use of opioids, many conclusions proposed in the case against pain management are flawed (see Hochman below).
1. there is no evidence to support the claim that an upper limit of dosage should be mandated. (From a treatment perspective there is no evidence to show that there is ceiling dose, and as the dose increases, the analgesic benefit will also improve).
2. there is no evidence that these medications impair cognitive and personal function, indeed they frequently improve both.
3. addiction is uncommon.
4. the rationale to opioid use is purely relief of symptoms and improvement of function.
In South Australia there has been a major bureaucratic effort to obstruct and prevent treatment of chronic pain. This has been achieved by numerous measures: -
• improper denial of pain relief to patients.
• inappropriate action against practitioners administering to these patients.
• Treatment decisions made by administrators lacking the appropriate technical skills. (Not one patient has been examined by them).”
– Ian Buttfield MD,
Australia
“HYPERALGESIA”, “OPIOPHOBIA”. AND BALLANTYNE AND MAO: AN ANALYSIS
January 14, 2009
The treatment of Intractable Pain remains a peculiarly unresolved controversy in American medicine. Although, in theory, it is generally accepted that pain must be treated, particularly in cancer patients, the treatment of pain unrelated to malignancy remains a stubborn issue.
Some legal experts assumed that as a consequence of tort actions (Bergman v Chin) physicians would be forced to treat pain effectively in compliance with the community standard of care. In this civil lawsuit in San Francisco, California, a jury found Dr. Chin to be negligent in failing to
adequately treat and relieve the suffering of his cancer patient, Mr. Bergman, and awarded his family $2.5 million (reduced subsequently by the court to $1.5 million).
In fact, the Bergman v Chin case had little impact on the medical community. There has been no subsequent case of its sort. Further, in the entire United States, there has been only a single instance of a physician being disciplined by a State Medical Board for inadequately treating pain. In contrast, “unnecessary prescription of opioids” continues to be one of the most common causes of action taken against physicians daring to treat chronic pain unrelated to cancer.
Indeed, the case against pain management has been intensified.
• Insurance companies, clearly responding to the expense of pain medications, have attempted to deter pain treatment through filing state Medical Board complaints against doctors for “unnecessary prescribing”.
• Insurers have also utilized the device of “peer-reviews” to discourage prescribing (described by some observers as “sham reviews”)
• Physicians (typically “interventionalists”) have been hired by insurers to opine that the prescriptions of opioids were “outside the standard of care”.
o They falsely claim that only interventions conform to the standard of care; that the prescribing of opioids is “unnecessary”, “excessive”, “dangerous”, or “addicting”.
o They recommend detoxification, denying or ignoring the medical necessity for on-going treatment of intractable pain. (Interestingly, when these “peer-reviews” are appealed to independent reviewers, affirmation of opioid treatment has been virtually universal.)
An additional strategy in the campaign to save “opiophobia” from extinction has been a movement to establish arbitrary limits on opioid usage, reaching a recent zenith in the drafting of an arbitrary daily limit of 120 mg of morphine, or its equivalent, in the State of Washington (resulting in a federal lawsuit.)
The opioid limitation campaign has largely depended on a single article, by Ballantyne and Mao, published in the New England Journal of Medicine in 2003 (purportedly the product of peer review.) There is no other “peer-reviewed” article in the medical literature promoting absolute or arbitrary limits on the use of opioids. The article has been frequently cited by anti-opioid activists.
Given the central position of this article in the struggle around pain management, this author decided to revisit the original publication, to examine its content, assumptions and conclusions. The findings were enlightening.
BALLANTYNE AND MAO
Turning to the article, Ballantyne and Mao stated that:
1. Experts on pain recommend that pain patients not be denied opioids.
2. Despite this many physicians remain uncertain about prescribing opioids and do not prescribe.
3. Some physicians (a minority) argue that opioids are only marginally useful in the treatment of chronic pain, have a minimal effect on improving functioning, and may even worsen the outcome.
4. Key organizations strongly support the use of opioids to treat chronic pain and have published consensus statements to guide. Ballantyne and Mao reviewed the common elements in these guidelines, including regular assessment of the achievement of goals, careful monitoring for signs of opioid abuse (including toxicological screening in some cases), the use of adjunctive treatments whenever possible, and a willingness to end opioid treatment if the goals are not met, and full documentation.
Ballantyne and Mao then discussed clinical studies, noting that:
1. Most of the literature on opioid therapy consists of reports of surveys and uncontrolled case series and that patients with chronic pain not associated with a terminal disease can achieve satisfactory analgesia by using a stable (non-escalating) dose of opioids, with a minimal risk of addiction, in up to six years of treatment.
2. In most cases, doses are in a moderate range (up to 195 mg of morphine or morphine equivalent per day.
3. In other reports, higher doses were used (up to 2 g/day)
4. Some studies have also assessed functioning on the basis of patients’ own reports, with most patients reporting improvement.
5. Studies have shown that cognitive function, including the ability to drive and operate machinery, is preserved in patients taking stable, moderate doses of opioids for chronic pain.
6. However they then asserted that cognitive function may be impaired for up to seven days after an increase in the dose, “though the effect of high doses of opioids on cognitive function is unknown. “
7. Several controlled studies involving the use of single doses or short intravenous infusions of opioids confirm the responsiveness of various pain syndromes, including neuropathic pain.
8. Neuropathic pain has traditionally been considered opioid-resistant. However, recent clinical studies have shown opioids to be effective, provided an adequate dose can be reached without excess side effects.
9. Controlled studies have assessed the usefulness of long-term oral opioid therapy for chronic pain, and show significant analgesic efficacy of opioids in the treatment of chronic pain, including neuropathic pain,
10. The evidence of their effect on functioning is mixed, with a few studies reporting that pain relief was achieved without functional improvement.
11. Pain relief is the expected end point of opioid therapy, but there is no consensus on whether pain relief without other benefits is a reasonable outcome
12. A fundamental principle of pain management is that the dose of an opioid should be increased until maximal analgesia is achieved with minimal side effects.
However, despite their recognition of all these findings, Ballantyne and Mao then directed their focus on their view that dosage of opioids must be limited. They stated:
1. Clinical experience suggests that many physicians take a much more liberal approach to dose increases. Some patients with chronic pain receive doses as high as 1 g or more of morphine (or a morphine equivalent) per day, which may be five or more times the doses validated by the literature
2. Anecdotal evidence suggests that patients receiving opioid doses of this magnitude rarely report satisfactory analgesia or improved function.
3. Although the clinical trials carried out to date have not examined the efficacy and safety of prolonged, high-dose opioid therapy, evidence is rapidly accumulating that, in the treatment of patients with chronic pain, opioid doses should be limited in order to maintain both efficacy and safety.
4. Opioid Tolerance is an adaptive process at the cellular level
a. Several mechanisms are linked to the desensitization of opioid receptors
b. In patients receiving prolonged opioid therapy, increased expression of the endogenous opioid dynorphin has been noted in the spinal cord dorsal horn associated with enhanced pain sensitivity.
c. Although the exact mechanisms of NMDA-receptor–mediated opioid tolerance have not yet been elucidated, this line of research has provided insights into several issues related to prolonged opioid therapy.
d. Long-term use of opioids may also be associated with the development of abnormal sensitivity to pain
e. Preclinical and clinical studies suggest that opioid-induced abnormal pain sensitivity has much in common with the cellular mechanisms of neuropathic pain.
f. Animal models have also shown that NMDA-receptor–mediated cellular mechanisms mediate irreversible neurotoxic changes.
g. Repeated administration of opioids not only results in the development of tolerance (a desensitization process) but also leads to a pro-nociceptive (sensitization) process.
h. Together, desensitization and sensitization arising during prolonged opioid therapy may contribute to an apparent decrease in analgesia.
i. Prolonged opioid therapy can lead to cellular and intracellular changes,
j. Such changes may contribute to pharmacologic opioid tolerance, increased sensitivity to pain, or both and the need for dose escalation.
k. Prolonged opioid treatment may also result in hormonal changes and may alter immune function.
l. These effects may be exacerbated by dose escalation in some circumstances.
m. Thus, the need for dose escalation during opioid therapy — that is, the development of “apparent” opioid tolerance — may be the result of pharmacologic opioid tolerance, opioid-induced abnormal pain sensitivity, or disease progression.
n. Exogenous opioids may affect immunity through their neuroendocrine effects, or through direct effects on the immune system.
o. On the basis of studies in animals, prolonged exposure to opioids appears to be more likely to suppress immune function than short-term exposure, and abrupt withdrawal of opioids may also induce immune suppression.
p. Different opioids appear to act differently on the immune system. For example, methadone may be less immunosuppressive than morphine.
q. Studies of immune function in patients receiving long-term opioid therapy for chronic pain are notably lacking, but the direct evidence that opioids impair immune function has aroused concern, particularly in the case of susceptible persons. (However, pain itself can impair immune function)
r. The greatest concern is likely to pertain to patients receiving high doses of opioids who do not obtain satisfactory pain relief.
s. Apparent opioid tolerance does not equal pharmacologic opioid tolerance; and prolonged, high-dose opioid therapy may have serious adverse con-sequences.
5. Clinical tolerance is related to pharmacologic tolerance
a. Pharmacologic tolerance to opioids has defined cellular mechanisms.
b. Tolerance is the need for increasing doses to maintain the same level of analgesia.
c. There is evidence that opioids can induce abnormal pain sensitivity or hyperalgesia,
d. Although sophisticated testing can identify hyperalgesia (to distinguish it from pharmacologic tolerance), it may not distinguish the hyperalgesia due to opioid treatment from the hyperalgesia due to worsening neuropathic pain.
e. In every day clinical practice (without testing), it is impossible to distinguish between pharmacologic tolerance and abnormal pain sensitivity.
f. Whether opioid-induced abnormal pain sensitivity is related to the dose, the particular opioid, the route of administration, the duration of use, or other factors remains unclear.
g. Abnormal pain sensitivity may, at least in part, explain the failure to relieve pain in some patients, despite increases in the opioid dose. Thus, in some instances, treating increasing pain with in-creasing doses of opioids may be futile.
6. High dose opioid, prolonged, therapy opioids may have adverse consequences, including:
a. opioid tolerance with the need for dose escalation, and opioid-induced abnormal pain sensitivity.
b. hormonal effects that result in reduced fertility, libido, and drive.
c. immunosuppression, especially in susceptible persons. (“We do not yet know to what extent these effects are clinically relevant. However, prolonged use of high doses of opioids is likely to be more toxic than short-term use of low doses, so hormonal effects are most likely to occur in patients with chronic pain who receive high-dose opioid therapy”).
d. Paradoxically, opioid treatment may actually increase the burden of care, because the management of opioid therapy in patients with complex problems is time-consuming and difficult.
7. The concept of a ceiling dose of opioids in the treatment of chronic pain is growing, yet it is difficult to define a dose that could be recommended as a ceiling. Daily doses above 180 mg of morphine or a morphine equivalent have not been validated in clinical trials involving patients with chronic pain and might be considered excessive. However, ceiling doses probably vary among patients, given the known differences in patients’ responses to opioids. More important than the dose itself, however, may be the need for frequent dose escalation beyond the time when establishing a stable dose during the dose-adjustment phase (e.g., up to eight weeks) would be reasonable. The goal of these strategies is to maintain opioid efficacy while avoiding an adverse outcome.
8. Whereas it was previously thought that unlimited dose escalation was at least safe, evidence now suggests that prolonged, high-dose opioid therapy may be neither safe nor effective. It is therefore important that physicians make every effort to control indiscriminate prescribing, even when they are under pressure by patients to increase the dose of opioids.
------------------------------------------------------------------------------------------------------------
ANALYSIS
Drs. Ballantyne and Mao created a document which is now used, uncritically, by both individual practitioners and governmental authorities, as a basis for attempting to set arbitrary and absolute limits on the dosage of opioids in managing intractable pain. However, a careful reading of their article reveals it to be largely conjectural, though subtly so.
Initially they establish that the treatment of intractable pain is supported by the contemporary standard of medical practice. They then review the accepted approach to pain management through careful titration. Having established this foundation, they then proceed to attempt to construct their case against opioids.
Their case is based upon:
1. The allegation that opioids may impair cognitive and personal function
2. The allegation that opioids may impair the immune system
3. The allegation that opioids may cause serious hormonal problems
4. The allegation that high dose opioids may induce tolerance
5. The allegation that opioids are ineffective
6. The allegation that high dose opioids may induce allodynia and other pain hypersensitivities
Careful reading reveals that none of these allegations are supported by the medical and scientific literature they cite. Nowhere do they state that they do. Instead, every allegation is qualified with the statement that this hypothetical adverse consequence of high and/or long-term opioid usage may be so. Evidence that “suggests” something does not prove it. Hypotheses are not conclusions. They remain hypotheses until proven. None of these allegations have any basis in proof. Indeed, the vast body of clinical evidence, to date, disproves the allegations, with the single exception noted below.
Their clear objective was to construct an argument against opioids, under the rubric of a review of the medical literature.
“Whereas it was previously thought that unlimited dose escalation was at least safe, evidence now suggests that prolonged, high-dose opioid therapy may be neither safe nor effective. It is therefore important that physicians make every effort to control indiscriminate prescribing, even when they are under pressure by patients to increase the dose of opioids.”
We know of no publication, article or practitioner who has ever called for the indiscriminate prescription of opioids. This is simply a straw man. But, most importantly, the hypotheses of adverse consequences, initially qualified by “may”, “can” and “could”, are suddenly reified, and a leap is made to an ideological absolutism. “Opioids are over-prescribed, high doses are dangerous and must be limited – as they are neither safe nor effective.” No evidence is offered to support any of these claims, and they are, in fact, scientifically indefensible.
The Ballantyne and Mao article in fact does not establish that substantial evidence exists that high dose opioid therapy is neither safe nor effective. In fact, there is no such evidence. Indeed, all clinical evidence points to the opposite conclusion.
Specifically, extensive clinical experience demonstrates that, in the treatment of chronic pain:
1. opioids do not impair cognitive and personal function
1. opioids do not impair the immune system (except in a limited number of instances of suppressed testosterone levels in males)
2. opioids do not cause serious hormonal problems, otherwise
3. high dose opioids do not induce tolerance (in intractable pain patients)
4. opioids are effective in controlling pain and dramatically improving the quality of life of pain patients
5. high dose opioids do not induce hypothetical allodynia or other pain hypersensitivities to any significant extent
6. Opioid overdoses are universally the outcome of addictive misuse or unauthorized polypharmacy frequently including alcohol, and are statistically insignificant among pain patients, when the medication is used as prescribed
CONCLUSIONS
While it is judicious to exercise caution and continuing evaluation of the effects of the long term treatment of pain with opioids, the speculation that one MAY (the word is used at least 26 times in the Ballantyne and Mao article) encounter adverse long-term effects is not a defensible basis for assuming that they do.
What Ballantyne and Mao fail to respect is that their speculations are not supported by any substantial or factual evidence. Indeed, the contrary is true. All actual evidence and every clinical report concludes the opposite. To date, none of the allegations they presented has gained any substantial or reproducible evidence to support them. The sole exception, known for decades, is that continued therapy with opioids may induce suppression of serum testosterone levels in males, which is easily rectified with exogenous testosterone supplementation. Sadly, the Ballantyne and Mao speculations have achieved the status of “Urban Myth”, with many physicians uncritically quoting the hypothesis of hyperalgesia as an accepted fact. In fact, “Hyperalgesia” is a hypothetical theory proposed by a minority group of physicians who seek to explain why their inadequate dosing of pain results in treatment failure. There is not a single citation in the medical literature of a peer-reviewed article, based upon scientifically defensible evidence, supporting this hypothesized theory.
Caution is laudable in the practice of medicine. Ideology, masquerading as a scientifically objective review of the literature, is not.
Joel Simon Hochman MD
Executive Director
The National Foundation for the Treatment of Pain
www.paincare.org
3150 words
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