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The prescription opioid epidemic in a nutshell
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What about the greater euphoria potential of the short actings?
That was preached for a long time: quicker onset = greater euphoria = greater street value.
That combined with the fact that plain oxycodone (15s and 30s) are by far the most abused in my community per law enforcement. I'm supposed to prescribe that instead of long acting which law enforcement tells me has lower street value now, in my community?
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So do you have no non-cancer patients on opiates? None?
What do I do about the ones that come in on high dose opiates, seem to be suffering, have bad pathology, don't show signs of abuse or diversion, have consistent UDS, consistent Rx reports, no aberrant behaviors?
Tell them, "Get cancer or I'm taking you off your meds, because the 'Thought Leaders' changed their minds"? We have a whole generation of people on opiates for anything and everything, conditioned that you are a cruel quack if you don't prescribe opiates for "Pain".
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well, first, bad is bad... i mean that if something is bad, we need to tell people. i clearly remember the time that my colleagues (not me) would condone smoking. i saw what they eventually had to go through when they changed their tune regarding cigarettes.
what i have done is this - the usual screening/treatment/UDS. discuss if therapy is truly working. discuss how much they are on and how the dose has changed over the years. discuss if they have issues regarding infections, hormonal changes, etc. have brochures, articles, etc about risks of opioid therapy in a binder in each room.
tell them point blank that, for their chronic pain, the option of a dose increase is not possible. that maintaining dose, rotations or holidays are the available options.
then tell them some theoretical advantages of being tapered slowly off their medications, when they are ready to try. tell them point blank that there will probably in the long run be no change in their pain, but there can be significant improvement in pain, mood, functionality.
then wait...
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So do you have no non-cancer patients on opiates? None?
In a nut shell, I have quite a few old folks with CNP on low or moderate dosages. I work in some rural communities where I inherit a few young folks on a variety of dosages and most of them I feel are inappropriate and I'll offer a wean. Most of those to whom I offer a wean leave and never come back. A few are of the lost tribe, stuck in the community, suffering and connected to a PCP who has 'gone to bat for them'. So I will rotate, rid them of the methadone, Soma, benzos, and marijuana, get psych involved, and start the surveillance measures to try and prevent them from becoming a statistic.
What do I do about the ones that come in on high dose opiates, seem to be suffering, have bad pathology, don't show signs of abuse or diversion, have consistent UDS, consistent Rx reports, no aberrant behaviors?
I think these are such rare patients as to be inconsequential. A lot of true believers claim that they've got a statistically impossible # of these in their practices. But I've been in practice in enough places and for enough time to know that there simply is no large cohort of high functioning CNP patients on high dose opioids. This is another Portenoy/Passik/Hurwitz myth.
Tell them, "Get cancer or I'm taking you off your meds, because the 'Thought Leaders' changed their minds"? We have a whole generation of people on opiates for anything and everything, conditioned that you are a cruel quack if you don't prescribe opiates for "Pain".
Stop feeling guilty about not perpetuating the crisis. BTW: our thought leaders haven't changed their minds. Recognition of the epidemic, and the most meaningful responses to it, have come from state/federal epidemiologists and PROP.
In a nut shell, I have quite a few old folks with CNP on low or moderate dosages. I work in some rural communities where I inherit a few young folks on a variety of dosages and most of them I feel are inappropriate and I'll offer a wean. Most of those to whom I offer a wean leave and never come back. A few are of the lost tribe, stuck in the community, suffering and connected to a PCP who has 'gone to bat for them'. So I will rotate, rid them of the methadone, Soma, benzos, and marijuana, get psych involved, and start the surveillance measures to try and prevent them from becoming a statistic.
What do I do about the ones that come in on high dose opiates, seem to be suffering, have bad pathology, don't show signs of abuse or diversion, have consistent UDS, consistent Rx reports, no aberrant behaviors?
I think these are such rare patients as to be inconsequential. A lot of true believers claim that they've got a statistically impossible # of these in their practices. But I've been in practice in enough places and for enough time to know that there simply is no large cohort of high functioning CNP patients on high dose opioids. This is another Portenoy/Passik/Hurwitz myth.
Tell them, "Get cancer or I'm taking you off your meds, because the 'Thought Leaders' changed their minds"? We have a whole generation of people on opiates for anything and everything, conditioned that you are a cruel quack if you don't prescribe opiates for "Pain".
Stop feeling guilty about not perpetuating the crisis. BTW: our thought leaders haven't changed their minds. Recognition of the epidemic, and the most meaningful responses to it, have come from state/federal epidemiologists and PROP.
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Okay. To both of the above, this is exactly what I'm doing, too. It's not easy though, especially trying to build a practice while trying to reverse the tide. It think it's going to take 20 years before we make a dent in this trend, and a lot of education of other doctors that are following the recommendations of 15 years ago that the even the "Thought Leaders" are now abandoning.
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The "thought leaders" are not avocating abandonment of opioid prescribing for chronic non-malignant pain: they are advocating moderation and control in prescribing. Even the Propsters still are advocates of the use of opioids for chronic non-malignant pain since they use them in their own practice. If they advocated eradication of opioids for chronic non-malignant pain yet continued to prescribe them in their own practices, they are guilty of the worst kind of hypocrisy: academic hyperbole. Neither are federal and state officials advocating stopping the prescribing of opioids in chronic non-malignant pain. Neither are attorney generals and the vast majority of pain physicians. There is a far more moderate view that lies far from the extremes exemplified by unmitigated prescribing without medical cause on one hand and total denial of opioids for chronic pain instead preferring to pump people full of steroids for short term pain relief. The expertise of pain physicians does not lie in prescribing gabapentin, lyrica, cymbalta, or celebrex- family docs and nurse practitioners can easily do that. The expertise of pain docs lies in selecting from all the tools available and employing that which is most effective with the least amount of harm. There is nothing we can do for pain patients that does not have associated harm, but the attempt to reduce harm by controlling multiple sedating drug prescribing, and use judicious injections/neuromodulation/neuroablation when indicated is the goal of pain management.
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More extremes in the video. Addiction level of 1%? Probably TRUE based on most of the literature using the DSM4 definitions of chemical dependency. Not habit forming? Absolutely FALSE. Rates of addiction of 20-40% and equating aberrant behavior in and of itself to addiction? FALSE. The rate of aberrant drug behavior is 20-40% and exists because of inadequate monitoring and safeguards by physician practices (who falsely make the assumption the use of opioids are inherently a safe therapy). Did drug companies and doctors overpromote these medications? Absolutely. Do we need changes from past practices? Absolutely
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i have a lot of difficulty accepting the supposed 1% rate of addiction quoted by Fishbain, Fish, Pourtney, etc.
really? only 1% of patients using chronic opioids become addicted, when 12% of all people will become alcoholics, 20% of cocaine users are considered addicted, even somewhere between 6-17% of internet users become addicted to the internet?
what is so unique about opioids that would make opioid addiction so low compared to so many other "temptations"? or are we deceiving ourselves again?
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So do I. The dope peddlers - PROPTsters- are obviating themselves of responsibility. Iatrogenic opioid addiction does not have an ICD-9 code or DSM definition, yet. But, it's much higher than Algos and his PROPTers/dope peddler's acknowlege.
More to come on this issue.
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while i might disagree with algos' positions at times, i would not call him a PROMPTster or anything resembling a dope peddler.
If PROMPT is over here--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------and PROP is here...
.....................................................................I'd say Algos would be here /\, close to where id be /\ ...
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So if we Rx opiates for CNCP we are dope dealers now? F you.
10% opiate addiction in general population.
30% opiate addiction in all patients at pain clinics.
Part of our job is to sort out who may benefit and who is not a candidate for this treatment.
It's called due diligence in opiate prescribing. If you cannot do it adequately, then don't Rx.
I probably have the cohort of high dose (100-200mg MEq) per day who work full time. I bet a lot of others on here do as well. Your attitude is one of hate mongering towards no particular end but to upset the apple cart. Ban opiates? We need regulation, training, education, not a loud mouth talking out of his arse (YOU!)
Simple steps:
All opiates go Schedule 2.
PCP's cannot Rx more than 2 weeks worth or #60 per patient per 6 months.
PMP must go national and all opiates are entered, whether from VAMC, pill mill doling in office, or retail pharmacy. Data must be updated at time of Rx fill, not a week later. Access to PMP is for all who have a DEA registration.
UDS becomes necessary at every visit and is paid by insurance. The private companies must agree to reduce ridiculous charges and the docs profitting from necessary care should not make a mint. Maybe a single contractor per LRMP.
That's a start, not an end to all opiates.
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10% opiate addiction in general population. 30% opiate addiction in all patients at pain clinics.
Ok, closer to the truth. But it depends upon how 'iatrogenic addiction' will eventually be defined. Is it's limited to people with aberrant behavior or does it include unintentional - iatrogenic - overdoses or a life time commitment to opioids maintenance - therapy due to a patient's inability to wean? I would be more inclined to put more emphasis on the iatrogenic definition and less on the patient.
Part of our job is to sort out who may benefit and who is not a candidate for this treatment.
Bingo, this is the key issue. Who, if anyone, with CNP benefits from long-term, highdose, opioid treatment. This is a question that is unanswered in the medical literature. Advocates - like PROMPT and pump practitioners - need to accumulate the 'proof' for their convictions. As it stands today, the theory is being disproven by contradiction (an epidemic of addiction and ODs). For many, if not all of PROMPT/pump tribe, opioids are little more than a component of the business models($). Less opioid means less $.
Divining who with CNP will benefit from long-term, high-dose, opioids isnt an art form that is unique to a gifted practitioner with gray hair at the temple and years of clinical wisdom. Dont try to sell me that crap. None of us are clairvoyant. The ONLY thing we can offer is improvements in the SAFETY of the therapy by instituting heavy surveillance measures. But spotting aberrancy and weaning/stopping therapy while desirable is an entirely different animal that determining which patients with CNP really needs their >100MED in order to lead a productive life, work, support the family, carry on a normal life(Efficacy). Their number is much, much smaller than the last 20yrs of theory would suggest.
Ok, closer to the truth. But it depends upon how 'iatrogenic addiction' will eventually be defined. Is it's limited to people with aberrant behavior or does it include unintentional - iatrogenic - overdoses or a life time commitment to opioids maintenance - therapy due to a patient's inability to wean? I would be more inclined to put more emphasis on the iatrogenic definition and less on the patient.
Part of our job is to sort out who may benefit and who is not a candidate for this treatment.
Bingo, this is the key issue. Who, if anyone, with CNP benefits from long-term, highdose, opioid treatment. This is a question that is unanswered in the medical literature. Advocates - like PROMPT and pump practitioners - need to accumulate the 'proof' for their convictions. As it stands today, the theory is being disproven by contradiction (an epidemic of addiction and ODs). For many, if not all of PROMPT/pump tribe, opioids are little more than a component of the business models($). Less opioid means less $.
Divining who with CNP will benefit from long-term, high-dose, opioids isnt an art form that is unique to a gifted practitioner with gray hair at the temple and years of clinical wisdom. Dont try to sell me that crap. None of us are clairvoyant. The ONLY thing we can offer is improvements in the SAFETY of the therapy by instituting heavy surveillance measures. But spotting aberrancy and weaning/stopping therapy while desirable is an entirely different animal that determining which patients with CNP really needs their >100MED in order to lead a productive life, work, support the family, carry on a normal life(Efficacy). Their number is much, much smaller than the last 20yrs of theory would suggest.
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I agree with all of that. If you screen using multiple measures: ORT, SOAPP-R, and others, you will find a good number of addicts that cannot be treated with opiates. These are not iatrogenic, but are folks who are already addicts. There is data to suggest a rate is higher than the Porter and Jick letter to the editor, but still under 5%.
If you continually screen for function and aberrance, you keep weeding out folks from opiate care until you have a polished clinic of high functioning individuals who are benefiting from opiates. And you find folks who after 3 years screw up and need to have opiates weaned/stopped.
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There is a complete disconnect between the opioid overprescribing epidemic and claims that opioids are not indicated for anyone with chronic intractable pain. The fact that there are physicians that overprescribe (the CDC has shown most are primary care docs that will not be visiting this website) does not mean opioids are ineffective or should not be used. The lack of level I evidence to support their use also is not evidence they are not effective: it simply means there is no level I evidence because the studies have not been done. There is some level II and level III evidence, and EBM uses the highest level of medical evidence available. EBM, unlike some of our naive friends, also does not attempt to destroy a valuable therapy due to the lack of level I evidence. Only occupational and environmental medicine docs do that. 
As for PROMPT, I am not a member nor have been to their website. There are actually very few extremist docs on web forums that believe in the extremes of no opioids for chronic benign pain or everyone gets opioids for chronic benign pain. Most pain societies, including ISIS and ASIPP, have a majority of their members prescribing opioids for chronic non-malignant pain. So the positions espoused on this forum are at odds with the rest of medicine, and appear to be the fanciful if not dictatorial recipe of a couple of people that do not represent anyone in medicine other than themselves.
As for PROMPT, I am not a member nor have been to their website. There are actually very few extremist docs on web forums that believe in the extremes of no opioids for chronic benign pain or everyone gets opioids for chronic benign pain. Most pain societies, including ISIS and ASIPP, have a majority of their members prescribing opioids for chronic non-malignant pain. So the positions espoused on this forum are at odds with the rest of medicine, and appear to be the fanciful if not dictatorial recipe of a couple of people that do not represent anyone in medicine other than themselves.
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http://www.jsonline.com/features/he...e-treatment-guidelines-ki7pjr6-184041791.html
Doctors with financial ties to drug companies have heavily influenced treatment guidelines recommending the most lucrative drugs in American medicine, an analysis by the Milwaukee Journal Sentinel and MedPage Today has found.
The guidelines affect how doctors across the country treat patients for everything from diabetes to asthma, chronic pain, depression and high cholesterol.
Issued by leading medical associations and government institutions, treatment guidelines are supposed to be based on rigorous science. But the committees that write them have been dominated by doctors who have worked as paid speakers, consultants or advisers for companies selling the recommended drugs.
Critics say the financial relationships have corrupted medicine, resulting in cases where guidelines make dangerous or ineffective recommendations. Drug companies and some doctors counter that those with conflicts are often top experts in their field.
The Journal Sentinel examined 20 clinical practice guidelines for conditions treated by the 25 top-selling drugs in the United States.
The drugs sit in the medicine cabinets of millions of Americans - Nexium for acid reflux, Lipitor for high cholesterol, Cymbalta for depression and OxyContin for pain. Their collective sales topped $94 billion in 2011, accounting for 30% of drug revenue in the United States.
An analysis of the guideline panels, which involved 293 doctors, found:
Nine guidelines were written by panels where more than 80% of doctors had financial ties to drug companies.
Four panels did not require members to disclose any conflicts of interest. Of the 16 that did, 66% of doctors on the panels had ties to drug companies.
Some guidelines written by conflicted panels recommend drugs that have not been scientifically proven to safely treat conditions, leading to inappropriate or over prescribing. Medical experts have raised such questions about guidelines for anemia, chronic pain and asthma.
Research funded by drug companies was not counted as a conflict in the Journal Sentinel analysis because experts disagree whether research poses as much of a conflict as speaking, consulting and advising.
The findings offer the latest glimpse into how pharmaceutical companies, with billions in sales at stake, exert a powerful but often unrecognized influence over the practice of American medicine.
Past Journal Sentinel reports have revealed articles in medical journals that were ghostwritten by drug company marketers; instructional videos for doctors that made misleading claims about drugs; payments to medical organizations that advocated for more use of drugs; and drug companies paying for continuing medical education courses that, in essence, market their products.
"At the end of the day, the drug companies own medicine," said Eric Campbell, an associate professor at Harvard Medical School who has researched conflicts of interest in treatment guidelines. "We've created a system that allows this."
While it is impossible to measure how drug company payments influence doctors' judgment, the cozy relationships have raised concern among doctors and researchers who contend that conflicts of interest taint the highly influential treatment guidelines.
In March 2011, the Institute of Medicine issued a report that said fewer than 50% of members of a guideline-writing committee should have financial relationships with drug companies. No committee chairman should have a financial conflict of interest, the institute said.
At most, two panels met those requirements in guidelines analyzed by the Journal Sentinel.
Of the 16 panels that disclosed conflicts of interest, at least 10 had chairmen with financial ties to drug companies . Payment amounts were not disclosed in the guidelines, which were issued between 2001 and 2012.
Some medical societies have agreed to adopt the Institute of Medicine's recommendation, but many others complain it is too difficult, costly and contentious among members, said Sheldon Greenfield, chairman of the group that issued the report titled, "Clinical Practice Guidelines We Can Trust."
"By and large, most of the societies have ignored it," said Greenfield, a professor of medicine and executive co-director of the Health Policy Research Institute at University of California, Irvine.
Extensive time, research and expertise are poured into developing most guidelines, a process that can take years. The documents are complicated, dense and extremely technical. At their best, rigorously developed, unbiased guidelines can help synthesize new research and improve the quality of treatment that patients receive.
Even critics who want to minimize or eliminate conflicts acknowledge that guidelines written by doctors with financial ties to drug companies can offer solid, scientifically backed recommendations.
But protecting the integrity of clinical guidelines is essential to the practice of medicine, said Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic.
"If those guidelines are produced in a way that is not completely free of bias, then we are guiding physicians and patients toward therapies based on opinions that may have been influenced by people's financial relationships," Nissen said. "That is a huge problem."
Some doctors and pharmaceutical industry representatives say physicians who consult for drug companies are among the most well-informed experts in their field and should help write guidelines.
Experienced doctors are trained to evaluate and base their decisions on complicated medical and scientific information, without being influenced by their ties with drug companies, said Marjorie Powell, senior assistant general counsel for PhRMA, a trade group that represents drug and biotechnology companies doing research to develop new medicine.
Other doctors and researchers say there are countless experts to call upon who do not have relationships with drug companies.
In fact, doctors are often willing to cut ties with drug companies in order to sit on guideline writing panels, said Daniel Ouellette, vice chairman of the guidelines oversight committee for the American College of Chest Physicians and a senior staff physician at Henry Ford Hospital in Detroit.
Ouellette said he looks at excluding potential bias as part of the scientific process.
"We would rather have our panel be completely non-conflicted," he said.
People with industry ties may be allowed to give insight if their expertise is so unique no one else can provide it, Ouellette said. But they can only add comments and participate in discussions, not vote on or draft guidelines.
First, do no harm?
In some cases, guideline panels have recommended treatments that have not been proven to make a meaningful difference - or that could even harm patients.
Guidelines written by conflicted panels have encouraged prescribing highly addictive narcotic painkillers to treat long-term chronic pain, an area where the safety and effectiveness of the drugs remain unproven.
OxyContin, a popular and addictive opioid, was the 19th best selling drug in the United States last year, with $2.9 billion in sales. In 2009, the American Pain Society and the American Academy of Pain Medicine issued a guideline endorsing opioids to treat chronic pain. The guideline was written by a panel where 14 of 21 members had ties to drug companies.
Also in 2009, the American Geriatrics Society advocated for greater opioid use to treat chronic pain in seniors. That guideline recommended that over-the-counter pain relievers, such as ibuprofen and naproxen, be used rarely and that doctors instead consider opioids for all patients with moderate to severe pain.
Panel members said they relied on research and their own experience in revising the guidelines, acknowledging "existing weak scientific evidence." Half the experts on the panel had financial ties to opioid companies.
Health and regulatory officials have declared misuse of opioids a national epidemic, citing skyrocketing addiction to painkillers and a tripling of fatal overdoses in the past decade. Emergency room departments across the country are adopting policies to discourage doctors from prescribing narcotics to patients with chronic pain and advocates are asking the U.S. Food and Drug Administration to restrict companies' marketing of the drugs.
The asthma drug Advair was the nation's fifth best selling drug in 2011, with $4.6 billion in sales. It is part of a class of drugs recommended in a 2007 guideline from the National Heart, Lung and Blood Institute.
Twelve of the 18 members of the guideline's panel had financial ties to GlaxoSmithKline, which makes Advair. Three other panel members had ties to other companies that market that same of class of drugs, known as beta-agonists. In all, 83% of the panel had conflicts. Beta-agonists have been linked to higher rates of death and severe asthma attacks.
In recent years, medical studies, independent doctors and court records have declared that Advair has been massively overused and inappropriately prescribed.
Expensive anemia treatment
An anemia drug, once Medicare's most expensive, was recommended in guidelines issued in 2006 by the National Kidney Foundation.
The guidelines provided recommendations for treating anemia in chronic kidney disease patients and endorsed a class of drugs including Epogen. The drug helps raise levels of hemoglobin, a protein in red blood cells that carries oxygen. Epogen is marketed by Amgen and had 2011 sales of $2.8 billion.
On almost every level, the drug company was financially linked to the guideline process.
Fifteen of 18 panel members who wrote the guideline for the Kidney Foundation had financial ties to drug companies. Ten of those members, including both co-chairs, had financial relationships directly with Amgen.
Amgen paid $1.7 million in 2004 and 2005 to fund the guidelines for the Kidney Foundation. All told, foundation records show the group received $8.7 million from Amgen in those years.
Ashleigh Koss, a spokeswoman for Amgen, declined to comment.
Concerns about the safety of Epogen and drugs in its class have grown steadily over the past 10 years. Such drugs can increase blood clots and the risk of heart attack, stroke, heart failure and death.
The Kidney Foundation's guideline recommended higher hemoglobin targets than those approved by the FDA, said Daniel Coyne, a kidney disease specialist and professor of medicine at Washington University in St. Louis. Higher targets could require higher doses of Epogen and similar drugs, which could be harmful to patients, he said.
In 2007, Coyne wrote a paper in a kidney disease journal that was highly critical of the guideline and conflicts of interest. At the time, he was an adviser, speaker and consultant for Amgen and other drug companies. He said he no longer does that kind of consulting work.
In 2011, the FDA warned doctors to be more conservative in dosing drugs such as Epogen because data showed higher risk of cardiovascular problems and death in kidney disease patients.
The Kidney Foundation said Coyne's claim that the guideline raised the hemoglobin target is "a fundamental misinterpretation of the guideline." Foundation spokesman Sean Roach said there were subtleties to interpreting the guideline and FDA recommendations.
The foundation said drug companies that provide funding for the guidelines do not influence them and that a separate team of physicians without conflicts gathers evidence for the group writing guidelines.
Managing blood sugar vs. aiding health
In 2006, the American Diabetes Association and the European Association for the Study of Diabetes issued recommendations for managing high blood sugar in people with type 2 diabetes.
The recommendation included use of drugs known as glitazones. At the time, the two most popular glitazones were Avandia and Actos.
Both drugs were approved by the FDA in 1999 on the basis that they improved short-term blood sugar control - not because they reduced heart attacks and strokes.
Six of seven panel members had worked as speakers or advisers to drug companies, including three who worked for GlaxoSmithKline, maker of Avandia, and one who worked for Takeda, maker of Actos.
Less than a year after the guideline came out, Avandia was linked to substantially increased risk of heart attacks. In 2010 the drug was banned in Europe and severely restricted in the United States.
Actos has not been shown to increase heart attacks, though the drug has been linked to increased risk of heart failure. U.S. sales for Actos have remained over $3 billion a year in recent years.
David Nathan, chairman of the 2006 diabetes guideline panel, said members did not have data showing Avandia was dangerous and as soon as that information came to light, the panel changed its recommendation.
Nathan, a professor of medicine at Harvard Medical School, was the only panel member who did not work as a speaker or adviser to drug companies. (He has received research grants from drug companies, according to his disclosure in the guideline.)
Nathan said if people with conflicts of interest were eliminated from guideline panels, "we wouldn't be able to put together committees with enough expertise to make them worthwhile."
In an email, Nathan acknowledged that, at the time, there was no rigorous evidence showing that either Avandia or Actos reduced the risk of cardiovascular disease, blindness or kidney damage. He said there is no compelling data that any diabetes drug reduces cardiovascular risk.
Research has shown that improving blood sugar generally lowers the risk of microvascular events such as blindness and kidney damage. It was on that basis that the panel recommended the drugs, he said.
A statement provided by the diabetes association said its policies on guidelines have been evolving and "were radically revised" after the 2011 report by the Institute of Medicine.
"We currently are striving to meet all of the IOM requirements, but recognize that older efforts may not have lived up to that new more rigorous standard," the statement said.
In 2011, the association received $15 million in funding from drug and medical device companies, including $145,325 from GlaxoSmithKline and $638,250 from Takeda, according to its revenue statement. The association would not provide drug company funding amounts from the years before the 2006 guideline.
The guideline panel's recommendation is an example of an ongoing problem in medicine, especially in diabetes care, said John Yudkin, an emeritus professor of medicine at University College London.
Panelists may make recommendations to use certain drugs based on a "surrogate measure," such as improving blood glucose levels, and then assume this also reduces the risk of heart disease, kidney damage or blindness.
But an improvement in a blood measure doesn't always mean a patient is facing less risk of serious health problems. Avandia and Actos never have been proven to reduce kidney damage, amputations, blindness, heart attacks or strokes, Yudkin noted.
Psychiatrists make changes
Increased political scrutiny of drug companies over the past few years has led to more transparency, including the Physician Payment Sunshine Act, which will require drug, device and medical supply companies to disclose any payments made to doctors or teaching hospitals. The first reports are due next spring.
But reformers say that merely disclosing a conflict does not eliminate it.
Four guidelines examined by the Journal Sentinel did not disclose members' conflicts with drug companies. Those guidelines were issued between 2001 and 2005. The American Psychiatric Association issued one of the guidelines in 2004 for treating schizophrenia.
A few years later, the group was embroiled in controversy when it decided to disclose conflicts of interest for a different guideline on depression. That panel included six of seven panel members who had worked as consultants, advisers or speakers for drug companies.
Before the guideline was released in 2010 the association had an independent panel with no drug company ties review the recommendations. No bias was found, said Joel Yager, chairman of the group's steering committee on practice guidelines and a professor of psychiatry at the University of Colorado.
Even so, the American Psychiatric Association no longer allows any doctors with conflicts of interest to sit on its guideline writing panels. It aims to achieve "no possibility of industry bias," Yager said.
"You have to play by the rules," he said.
Doctors with financial ties to drug companies have heavily influenced treatment guidelines recommending the most lucrative drugs in American medicine, an analysis by the Milwaukee Journal Sentinel and MedPage Today has found.
The guidelines affect how doctors across the country treat patients for everything from diabetes to asthma, chronic pain, depression and high cholesterol.
Issued by leading medical associations and government institutions, treatment guidelines are supposed to be based on rigorous science. But the committees that write them have been dominated by doctors who have worked as paid speakers, consultants or advisers for companies selling the recommended drugs.
Critics say the financial relationships have corrupted medicine, resulting in cases where guidelines make dangerous or ineffective recommendations. Drug companies and some doctors counter that those with conflicts are often top experts in their field.
The Journal Sentinel examined 20 clinical practice guidelines for conditions treated by the 25 top-selling drugs in the United States.
The drugs sit in the medicine cabinets of millions of Americans - Nexium for acid reflux, Lipitor for high cholesterol, Cymbalta for depression and OxyContin for pain. Their collective sales topped $94 billion in 2011, accounting for 30% of drug revenue in the United States.
An analysis of the guideline panels, which involved 293 doctors, found:
Nine guidelines were written by panels where more than 80% of doctors had financial ties to drug companies.
Four panels did not require members to disclose any conflicts of interest. Of the 16 that did, 66% of doctors on the panels had ties to drug companies.
Some guidelines written by conflicted panels recommend drugs that have not been scientifically proven to safely treat conditions, leading to inappropriate or over prescribing. Medical experts have raised such questions about guidelines for anemia, chronic pain and asthma.
Research funded by drug companies was not counted as a conflict in the Journal Sentinel analysis because experts disagree whether research poses as much of a conflict as speaking, consulting and advising.
The findings offer the latest glimpse into how pharmaceutical companies, with billions in sales at stake, exert a powerful but often unrecognized influence over the practice of American medicine.
Past Journal Sentinel reports have revealed articles in medical journals that were ghostwritten by drug company marketers; instructional videos for doctors that made misleading claims about drugs; payments to medical organizations that advocated for more use of drugs; and drug companies paying for continuing medical education courses that, in essence, market their products.
"At the end of the day, the drug companies own medicine," said Eric Campbell, an associate professor at Harvard Medical School who has researched conflicts of interest in treatment guidelines. "We've created a system that allows this."
While it is impossible to measure how drug company payments influence doctors' judgment, the cozy relationships have raised concern among doctors and researchers who contend that conflicts of interest taint the highly influential treatment guidelines.
In March 2011, the Institute of Medicine issued a report that said fewer than 50% of members of a guideline-writing committee should have financial relationships with drug companies. No committee chairman should have a financial conflict of interest, the institute said.
At most, two panels met those requirements in guidelines analyzed by the Journal Sentinel.
Of the 16 panels that disclosed conflicts of interest, at least 10 had chairmen with financial ties to drug companies . Payment amounts were not disclosed in the guidelines, which were issued between 2001 and 2012.
Some medical societies have agreed to adopt the Institute of Medicine's recommendation, but many others complain it is too difficult, costly and contentious among members, said Sheldon Greenfield, chairman of the group that issued the report titled, "Clinical Practice Guidelines We Can Trust."
"By and large, most of the societies have ignored it," said Greenfield, a professor of medicine and executive co-director of the Health Policy Research Institute at University of California, Irvine.
Extensive time, research and expertise are poured into developing most guidelines, a process that can take years. The documents are complicated, dense and extremely technical. At their best, rigorously developed, unbiased guidelines can help synthesize new research and improve the quality of treatment that patients receive.
Even critics who want to minimize or eliminate conflicts acknowledge that guidelines written by doctors with financial ties to drug companies can offer solid, scientifically backed recommendations.
But protecting the integrity of clinical guidelines is essential to the practice of medicine, said Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic.
"If those guidelines are produced in a way that is not completely free of bias, then we are guiding physicians and patients toward therapies based on opinions that may have been influenced by people's financial relationships," Nissen said. "That is a huge problem."
Some doctors and pharmaceutical industry representatives say physicians who consult for drug companies are among the most well-informed experts in their field and should help write guidelines.
Experienced doctors are trained to evaluate and base their decisions on complicated medical and scientific information, without being influenced by their ties with drug companies, said Marjorie Powell, senior assistant general counsel for PhRMA, a trade group that represents drug and biotechnology companies doing research to develop new medicine.
Other doctors and researchers say there are countless experts to call upon who do not have relationships with drug companies.
In fact, doctors are often willing to cut ties with drug companies in order to sit on guideline writing panels, said Daniel Ouellette, vice chairman of the guidelines oversight committee for the American College of Chest Physicians and a senior staff physician at Henry Ford Hospital in Detroit.
Ouellette said he looks at excluding potential bias as part of the scientific process.
"We would rather have our panel be completely non-conflicted," he said.
People with industry ties may be allowed to give insight if their expertise is so unique no one else can provide it, Ouellette said. But they can only add comments and participate in discussions, not vote on or draft guidelines.
First, do no harm?
In some cases, guideline panels have recommended treatments that have not been proven to make a meaningful difference - or that could even harm patients.
Guidelines written by conflicted panels have encouraged prescribing highly addictive narcotic painkillers to treat long-term chronic pain, an area where the safety and effectiveness of the drugs remain unproven.
OxyContin, a popular and addictive opioid, was the 19th best selling drug in the United States last year, with $2.9 billion in sales. In 2009, the American Pain Society and the American Academy of Pain Medicine issued a guideline endorsing opioids to treat chronic pain. The guideline was written by a panel where 14 of 21 members had ties to drug companies.
Also in 2009, the American Geriatrics Society advocated for greater opioid use to treat chronic pain in seniors. That guideline recommended that over-the-counter pain relievers, such as ibuprofen and naproxen, be used rarely and that doctors instead consider opioids for all patients with moderate to severe pain.
Panel members said they relied on research and their own experience in revising the guidelines, acknowledging "existing weak scientific evidence." Half the experts on the panel had financial ties to opioid companies.
Health and regulatory officials have declared misuse of opioids a national epidemic, citing skyrocketing addiction to painkillers and a tripling of fatal overdoses in the past decade. Emergency room departments across the country are adopting policies to discourage doctors from prescribing narcotics to patients with chronic pain and advocates are asking the U.S. Food and Drug Administration to restrict companies' marketing of the drugs.
The asthma drug Advair was the nation's fifth best selling drug in 2011, with $4.6 billion in sales. It is part of a class of drugs recommended in a 2007 guideline from the National Heart, Lung and Blood Institute.
Twelve of the 18 members of the guideline's panel had financial ties to GlaxoSmithKline, which makes Advair. Three other panel members had ties to other companies that market that same of class of drugs, known as beta-agonists. In all, 83% of the panel had conflicts. Beta-agonists have been linked to higher rates of death and severe asthma attacks.
In recent years, medical studies, independent doctors and court records have declared that Advair has been massively overused and inappropriately prescribed.
Expensive anemia treatment
An anemia drug, once Medicare's most expensive, was recommended in guidelines issued in 2006 by the National Kidney Foundation.
The guidelines provided recommendations for treating anemia in chronic kidney disease patients and endorsed a class of drugs including Epogen. The drug helps raise levels of hemoglobin, a protein in red blood cells that carries oxygen. Epogen is marketed by Amgen and had 2011 sales of $2.8 billion.
On almost every level, the drug company was financially linked to the guideline process.
Fifteen of 18 panel members who wrote the guideline for the Kidney Foundation had financial ties to drug companies. Ten of those members, including both co-chairs, had financial relationships directly with Amgen.
Amgen paid $1.7 million in 2004 and 2005 to fund the guidelines for the Kidney Foundation. All told, foundation records show the group received $8.7 million from Amgen in those years.
Ashleigh Koss, a spokeswoman for Amgen, declined to comment.
Concerns about the safety of Epogen and drugs in its class have grown steadily over the past 10 years. Such drugs can increase blood clots and the risk of heart attack, stroke, heart failure and death.
The Kidney Foundation's guideline recommended higher hemoglobin targets than those approved by the FDA, said Daniel Coyne, a kidney disease specialist and professor of medicine at Washington University in St. Louis. Higher targets could require higher doses of Epogen and similar drugs, which could be harmful to patients, he said.
In 2007, Coyne wrote a paper in a kidney disease journal that was highly critical of the guideline and conflicts of interest. At the time, he was an adviser, speaker and consultant for Amgen and other drug companies. He said he no longer does that kind of consulting work.
In 2011, the FDA warned doctors to be more conservative in dosing drugs such as Epogen because data showed higher risk of cardiovascular problems and death in kidney disease patients.
The Kidney Foundation said Coyne's claim that the guideline raised the hemoglobin target is "a fundamental misinterpretation of the guideline." Foundation spokesman Sean Roach said there were subtleties to interpreting the guideline and FDA recommendations.
The foundation said drug companies that provide funding for the guidelines do not influence them and that a separate team of physicians without conflicts gathers evidence for the group writing guidelines.
Managing blood sugar vs. aiding health
In 2006, the American Diabetes Association and the European Association for the Study of Diabetes issued recommendations for managing high blood sugar in people with type 2 diabetes.
The recommendation included use of drugs known as glitazones. At the time, the two most popular glitazones were Avandia and Actos.
Both drugs were approved by the FDA in 1999 on the basis that they improved short-term blood sugar control - not because they reduced heart attacks and strokes.
Six of seven panel members had worked as speakers or advisers to drug companies, including three who worked for GlaxoSmithKline, maker of Avandia, and one who worked for Takeda, maker of Actos.
Less than a year after the guideline came out, Avandia was linked to substantially increased risk of heart attacks. In 2010 the drug was banned in Europe and severely restricted in the United States.
Actos has not been shown to increase heart attacks, though the drug has been linked to increased risk of heart failure. U.S. sales for Actos have remained over $3 billion a year in recent years.
David Nathan, chairman of the 2006 diabetes guideline panel, said members did not have data showing Avandia was dangerous and as soon as that information came to light, the panel changed its recommendation.
Nathan, a professor of medicine at Harvard Medical School, was the only panel member who did not work as a speaker or adviser to drug companies. (He has received research grants from drug companies, according to his disclosure in the guideline.)
Nathan said if people with conflicts of interest were eliminated from guideline panels, "we wouldn't be able to put together committees with enough expertise to make them worthwhile."
In an email, Nathan acknowledged that, at the time, there was no rigorous evidence showing that either Avandia or Actos reduced the risk of cardiovascular disease, blindness or kidney damage. He said there is no compelling data that any diabetes drug reduces cardiovascular risk.
Research has shown that improving blood sugar generally lowers the risk of microvascular events such as blindness and kidney damage. It was on that basis that the panel recommended the drugs, he said.
A statement provided by the diabetes association said its policies on guidelines have been evolving and "were radically revised" after the 2011 report by the Institute of Medicine.
"We currently are striving to meet all of the IOM requirements, but recognize that older efforts may not have lived up to that new more rigorous standard," the statement said.
In 2011, the association received $15 million in funding from drug and medical device companies, including $145,325 from GlaxoSmithKline and $638,250 from Takeda, according to its revenue statement. The association would not provide drug company funding amounts from the years before the 2006 guideline.
The guideline panel's recommendation is an example of an ongoing problem in medicine, especially in diabetes care, said John Yudkin, an emeritus professor of medicine at University College London.
Panelists may make recommendations to use certain drugs based on a "surrogate measure," such as improving blood glucose levels, and then assume this also reduces the risk of heart disease, kidney damage or blindness.
But an improvement in a blood measure doesn't always mean a patient is facing less risk of serious health problems. Avandia and Actos never have been proven to reduce kidney damage, amputations, blindness, heart attacks or strokes, Yudkin noted.
Psychiatrists make changes
Increased political scrutiny of drug companies over the past few years has led to more transparency, including the Physician Payment Sunshine Act, which will require drug, device and medical supply companies to disclose any payments made to doctors or teaching hospitals. The first reports are due next spring.
But reformers say that merely disclosing a conflict does not eliminate it.
Four guidelines examined by the Journal Sentinel did not disclose members' conflicts with drug companies. Those guidelines were issued between 2001 and 2005. The American Psychiatric Association issued one of the guidelines in 2004 for treating schizophrenia.
A few years later, the group was embroiled in controversy when it decided to disclose conflicts of interest for a different guideline on depression. That panel included six of seven panel members who had worked as consultants, advisers or speakers for drug companies.
Before the guideline was released in 2010 the association had an independent panel with no drug company ties review the recommendations. No bias was found, said Joel Yager, chairman of the group's steering committee on practice guidelines and a professor of psychiatry at the University of Colorado.
Even so, the American Psychiatric Association no longer allows any doctors with conflicts of interest to sit on its guideline writing panels. It aims to achieve "no possibility of industry bias," Yager said.
"You have to play by the rules," he said.
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http://www.inthefaceofpain.com/advocacy-101/barriers-to-pain-management/
Paid shills: http://www.inthefaceofpain.com/voices-of-hope/advocate-perspectives
Barriers to Pain Management
"The evidence that physicians and nurses do not treat pain adequately began to appear in the medical literature nearly 30 years ago. In the following decades, the accumulated data showed that many types of pain – acute pain, cancer pain, and chronic nonmalignant pain – were being undertreated. The reasons offered for undertreatment, usually characterized as ‘barriers' to effective pain relief, were remarkably consistent across the literature. Despite numerous calls to educate health care professionals about pain management, only the rhetoric has expanded.
Unfortunately, many barriers prevent effective pain assessment and treatment. Some barriers exist for a reason. Health care professionals are concerned about their patients, patients are concerned about their health, and the health care system struggles with providing effective health care at a cost that can be sustained. However, over time, each of these groups has contributed to building barriers to proper pain management and making them appear insurmountable. This is where advocacy can help make a difference.
As an advocate, YOU are a part of the solution in helping to overcome these barriers. By developing your key messages and consistently communicating these to audiences such as your community, the media, legislative bodies, and your own peers, YOU are a part of the team that raises awareness of pain management issues and breaks down the barriers to effective pain care.
Health Care Professional Barriers
•Inadequate knowledge of pain mechanisms
•Inadequate knowledge of pain assessment
•Inadequate knowledge of the appropriate use of pain medications
•Fear of producing addiction
•Concern about analgesic side effects
•Inadequate knowledge about how to treat side effects of analgesic medications
•Concern about the development of tolerance to medication
•Inability to differentiate between tolerance, physical dependence, and addiction
•Fear of regulatory scrutiny
•Time and reimbursement pressures that prohibit effective pain assessment and management
Patient Barriers
•Reluctance to report pain
•Reluctance to take pain medications as prescribed
•Concerns about addiction
•Belief that pain is inevitable and not treatable
•Lack of access to pain management professionals
•Inability to effectively manage the side effects of pain medications
•Fear of masking new symptoms
•Cost of pain medications and/or other treatment modalities
•Lack of comprehensive insurance coverage for pain management
System Barriers
•Failure to make pain management a high priority
•Lack of a systematic and collaborative approach to pain assessment and management
•Absence of accountability for pain management
•Lack of organized pain management teams
•Inadequate reimbursement for pain management
•Regulations and/or legislation that restricts access to needed treatment such as the prescribing and dispensing of controlled substances
Paid shills: http://www.inthefaceofpain.com/voices-of-hope/advocate-perspectives
Barriers to Pain Management
"The evidence that physicians and nurses do not treat pain adequately began to appear in the medical literature nearly 30 years ago. In the following decades, the accumulated data showed that many types of pain – acute pain, cancer pain, and chronic nonmalignant pain – were being undertreated. The reasons offered for undertreatment, usually characterized as ‘barriers' to effective pain relief, were remarkably consistent across the literature. Despite numerous calls to educate health care professionals about pain management, only the rhetoric has expanded.
Unfortunately, many barriers prevent effective pain assessment and treatment. Some barriers exist for a reason. Health care professionals are concerned about their patients, patients are concerned about their health, and the health care system struggles with providing effective health care at a cost that can be sustained. However, over time, each of these groups has contributed to building barriers to proper pain management and making them appear insurmountable. This is where advocacy can help make a difference.
As an advocate, YOU are a part of the solution in helping to overcome these barriers. By developing your key messages and consistently communicating these to audiences such as your community, the media, legislative bodies, and your own peers, YOU are a part of the team that raises awareness of pain management issues and breaks down the barriers to effective pain care.
Health Care Professional Barriers
•Inadequate knowledge of pain mechanisms
•Inadequate knowledge of pain assessment
•Inadequate knowledge of the appropriate use of pain medications
•Fear of producing addiction
•Concern about analgesic side effects
•Inadequate knowledge about how to treat side effects of analgesic medications
•Concern about the development of tolerance to medication
•Inability to differentiate between tolerance, physical dependence, and addiction
•Fear of regulatory scrutiny
•Time and reimbursement pressures that prohibit effective pain assessment and management
Patient Barriers
•Reluctance to report pain
•Reluctance to take pain medications as prescribed
•Concerns about addiction
•Belief that pain is inevitable and not treatable
•Lack of access to pain management professionals
•Inability to effectively manage the side effects of pain medications
•Fear of masking new symptoms
•Cost of pain medications and/or other treatment modalities
•Lack of comprehensive insurance coverage for pain management
System Barriers
•Failure to make pain management a high priority
•Lack of a systematic and collaborative approach to pain assessment and management
•Absence of accountability for pain management
•Lack of organized pain management teams
•Inadequate reimbursement for pain management
•Regulations and/or legislation that restricts access to needed treatment such as the prescribing and dispensing of controlled substances
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i know people talk about fish and fishbain and pourtnoy..
but lynn webster seems to have become much more active and atm more dangerous, especially since he almost regularly appears on sites like medscape advertising "safe" opioid use, including advocating BTP treatment.
btw, this site is sponsored by Purdue.
but lynn webster seems to have become much more active and atm more dangerous, especially since he almost regularly appears on sites like medscape advertising "safe" opioid use, including advocating BTP treatment.
btw, this site is sponsored by Purdue.
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We need to move away from safety and toward efficacy. This will shut the pushers down.
High dose opioids for CNP helps the pocket books of the physician prescribing and drug companies, but fu*ks society.
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Unless you are a cash only practice ($200/visit, i.e. pill mill), doing interventional procedures helps the pocket book much more. An hour doing procedures will yield significantly more than an hour seeing chronic pain patients in clinic.
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i think this was discussed earlier in this or some other thread, where some were postulating that patients were being "enticed" to come for the injections with the bargain of getting prescriptions for opioids in exchange.
so get benefit of charging for the injection, and patient gets his/her script....
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http://www.latimes.com/news/local/la-me-prescription-reforms-20121229,0,5224601.story
Medical board appeals to public to combat prescription overdoses
The Medical Board of California asks the public to report deaths in which doctors might have overprescribed drugs.
By Scott Glover and Lisa Girion, Los Angeles Times
December 29, 2012, 5:00 a.m.
In an appeal for the public's help in stemming the epidemic of prescription drug deaths, the Medical Board of California is asking people whose relatives died of overdoses to contact the board if they believe excessive prescribing or other physician misconduct contributed to the deaths.
Linda K. Whitney, the board's executive director, urged those with information about improper treatment to contact the board without delay. By law, the agency has seven years from the time of the alleged misconduct to take disciplinary action against a physician.
"The sooner we get the information, the sooner we can move forward," she said in an interview.
Whitney also said board investigators would review autopsies and other records on specific overdose deaths described in recent articles in the Los Angeles Times.
She said the board, which licenses and oversees California physicians, was acting in response to reports in The Times that documented the connection between doctors' prescribing practices and fatal overdoses involving OxyContin, Vicodin and other narcotic painkillers.
Whitney said members of the public can report concerns about excessive prescribing by calling 1-800-633-2322 or filling out and mailing a complaint form, which can be downloaded from the agency's website, http://www.mbc.ca.gov.
A revolution in treatment of chronic pain has caused a huge increase in prescriptions for pain and anxiety medications. There has been an accompanying sharp rise in prescription drug deaths over the last decade.
In response, authorities have focused on how addicts and drug dealers obtain such drugs illegally, such as by stealing from pharmacies or relatives' medicine cabinets. The Times articles reported that many fatal overdoses stem from drugs prescribed for the deceased by a doctor.
In nearly half of the prescription drug deaths in four Southern California counties from 2006 through 2011, medications prescribed by doctors caused or contributed to the death, according to an analysis of coroners' records.
Seventy-one doctors, a tiny fraction of all practicing physicians in the four counties, were associated with a disproportionate number of deaths, The Times found.
Sixteen patients of a Huntington Beach pain specialist died of overdoses from 2006 through 2011 after taking medications he prescribed. A San Diego County doctor lost 15 patients to overdoses, a Westminster physician 14, coroners' records show.
All three doctors have clean records with the medical board, and there is no evidence that board officials knew about the deaths.
That medical regulators could be unaware of clusters of fatal overdoses underscores gaps in the state's system of physician oversight.
Drugs fatalities are documented in great detail in county coroners' files, which in many cases list medications found at the scene of death, along with the name of the prescribing doctor. But medical board investigators do not review those files to look for patterns of reckless prescribing or other inappropriate treatment.
Whitney said the board would like to receive reports from county coroners on all prescription overdose deaths. State Sen. Curren Price, (D-Los Angeles), responding to the Times coverage, has promised to introduce a bill that would require such reports.
A fatal overdose does not necessarily mean a doctor did anything wrong, Whitney said. Board investigators must review patient records to determine whether physician misconduct contributed to a death, she said.
Public participation will aid such investigations, she said, because investigators can gain access to a physician's patient files more readily if a family member has granted consent.
In addition, family members may be able to contribute information about overdose deaths that is not in coroners' files. Tips from relatives could also be valuable in calling attention to previously overlooked cases, Whitney said.
Julianne D'Angelo Fellmeth, a public interest lawyer who has monitored the medical board for the state Legislature, called Whitney's announcement a "good first step," adding: "They need this information."
But Fellmeth said the board may be hindered in its investigative efforts by the effects of years of budget cuts.
The agency has fewer investigators than it did in 2001 and investigates about 40% fewer misconduct cases per year, according to board data. Over the same period, the number of licensed physicians in California has risen to more than 102,000.
"They should be actively seeking to restore the number of investigators' positions that they had before and increase those to keep up with the increase in the physician population," Fellmeth said. "It's not acceptable to have the ranks of medical investigators decrease in the face of this kind of misconduct and abuse."
From the time the board receives a complaint, it takes nearly a year on average for an investigation to be completed. In some cases, doctors under investigation for excessive prescribing have lost several patients to drug overdoses by the time the board took disciplinary action.
[email protected]
[email protected]
Medical board appeals to public to combat prescription overdoses
The Medical Board of California asks the public to report deaths in which doctors might have overprescribed drugs.
By Scott Glover and Lisa Girion, Los Angeles Times
December 29, 2012, 5:00 a.m.
In an appeal for the public's help in stemming the epidemic of prescription drug deaths, the Medical Board of California is asking people whose relatives died of overdoses to contact the board if they believe excessive prescribing or other physician misconduct contributed to the deaths.
Linda K. Whitney, the board's executive director, urged those with information about improper treatment to contact the board without delay. By law, the agency has seven years from the time of the alleged misconduct to take disciplinary action against a physician.
"The sooner we get the information, the sooner we can move forward," she said in an interview.
Whitney also said board investigators would review autopsies and other records on specific overdose deaths described in recent articles in the Los Angeles Times.
She said the board, which licenses and oversees California physicians, was acting in response to reports in The Times that documented the connection between doctors' prescribing practices and fatal overdoses involving OxyContin, Vicodin and other narcotic painkillers.
Whitney said members of the public can report concerns about excessive prescribing by calling 1-800-633-2322 or filling out and mailing a complaint form, which can be downloaded from the agency's website, http://www.mbc.ca.gov.
A revolution in treatment of chronic pain has caused a huge increase in prescriptions for pain and anxiety medications. There has been an accompanying sharp rise in prescription drug deaths over the last decade.
In response, authorities have focused on how addicts and drug dealers obtain such drugs illegally, such as by stealing from pharmacies or relatives' medicine cabinets. The Times articles reported that many fatal overdoses stem from drugs prescribed for the deceased by a doctor.
In nearly half of the prescription drug deaths in four Southern California counties from 2006 through 2011, medications prescribed by doctors caused or contributed to the death, according to an analysis of coroners' records.
Seventy-one doctors, a tiny fraction of all practicing physicians in the four counties, were associated with a disproportionate number of deaths, The Times found.
Sixteen patients of a Huntington Beach pain specialist died of overdoses from 2006 through 2011 after taking medications he prescribed. A San Diego County doctor lost 15 patients to overdoses, a Westminster physician 14, coroners' records show.
All three doctors have clean records with the medical board, and there is no evidence that board officials knew about the deaths.
That medical regulators could be unaware of clusters of fatal overdoses underscores gaps in the state's system of physician oversight.
Drugs fatalities are documented in great detail in county coroners' files, which in many cases list medications found at the scene of death, along with the name of the prescribing doctor. But medical board investigators do not review those files to look for patterns of reckless prescribing or other inappropriate treatment.
Whitney said the board would like to receive reports from county coroners on all prescription overdose deaths. State Sen. Curren Price, (D-Los Angeles), responding to the Times coverage, has promised to introduce a bill that would require such reports.
A fatal overdose does not necessarily mean a doctor did anything wrong, Whitney said. Board investigators must review patient records to determine whether physician misconduct contributed to a death, she said.
Public participation will aid such investigations, she said, because investigators can gain access to a physician's patient files more readily if a family member has granted consent.
In addition, family members may be able to contribute information about overdose deaths that is not in coroners' files. Tips from relatives could also be valuable in calling attention to previously overlooked cases, Whitney said.
Julianne D'Angelo Fellmeth, a public interest lawyer who has monitored the medical board for the state Legislature, called Whitney's announcement a "good first step," adding: "They need this information."
But Fellmeth said the board may be hindered in its investigative efforts by the effects of years of budget cuts.
The agency has fewer investigators than it did in 2001 and investigates about 40% fewer misconduct cases per year, according to board data. Over the same period, the number of licensed physicians in California has risen to more than 102,000.
"They should be actively seeking to restore the number of investigators' positions that they had before and increase those to keep up with the increase in the physician population," Fellmeth said. "It's not acceptable to have the ranks of medical investigators decrease in the face of this kind of misconduct and abuse."
From the time the board receives a complaint, it takes nearly a year on average for an investigation to be completed. In some cases, doctors under investigation for excessive prescribing have lost several patients to drug overdoses by the time the board took disciplinary action.
[email protected]
[email protected]
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The California medical board has been roasted in the press recently due to their inaction in several prominent cases in which their more immediate intervention would have saved lives. This is the pendulum swinging the other direction as a CYA move.
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http://www.washingtonpost.com/busin...4205a6-4bc3-11e2-b709-667035ff9029_story.html
Rising painkiller addiction shows damage from drugmakers' role in shaping medical opinion
By Peter Whoriskey, Published: December 30
Portsmouth, Ohio — Over much of the past decade, the official word on OxyContin was that it rarely posed problems of addiction for patients.
The label on the drug, which was approved by the FDA, said the risks of addiction were "reported to be small."
The New England Journal of Medicine, the nation's premier medical publication, informed readers that studies indicated that such painkillers pose "a minimal risk of addiction."
Another important journal study, which the manufacturer of OxyContin reprinted 10,000 times, indicated that in a trial of arthritis patients, only a handful showed withdrawal symptoms.
Those reassuring claims, which became part of a scientific consensus, have been quietly dropped or called into question in recent years, as many in the medical profession rediscovered the destructive power of opiates. But the damage arising from those misconceptions may have been vast.
The nation is confronting an ongoing epidemic of addiction to prescription painkillers — more widespread than cocaine or heroin — that has left nearly 2 million in its grip, according to federal statistics.
"It turns out that the doctors didn't know what they were talking about," said Barbara Howard, whose daughter Leslie, a home-care nurse, died of an overdose in 2009 in this small Appalachian town devastated by the epidemic. She had developed a habit after knee surgery. She left behind a 9-year-old son.
"Leslie trusted the doctors. We thought the doctors knew what was best. But they didn't. We — and lots of the other victims — had no warning."
Conflicts of interest
A closer look at the opioid painkiller binge — retail prescriptions have roughly tripled in the past 20 years — shows that the rising sales and addictions were catalyzed by a massive effort by pharmaceutical companies to shape medical opinion and practice.
Opioids are a class of powerful drugs, often used for pain, that includes morphine, heroin and brand names such as OxyContin, Vicodin and Percocet.
For years, doctors had been cautious about prescribing opioids to anyone except patients with cancer or in acute pain.
But drug manufacturers and some pain specialists helped create a body of scientific research assuaging the long-standing worries about opioids and pushed to expand the use of the drugs in people with chronic pain — bad backs, arthritis, sore knees.
Their studies reported minimal risks of addiction and dependence. These, in turn, were accepted by the FDA and the nation's medical journals. State medical boards made their rules for prescribing opioids more liberal. Academic and industry articles dismissed the old fears as "opiophobia."
These reports reached doctors through marketing efforts and told them that there were few risks in using opioids to treat chronic pain.
But according to a Washington Post examination of key scientific papers, a court document and FDA records, many of those claims were developed in studies supported by Purdue Pharma, the maker of OxyContin, or other drug manufacturers. In addition, the conclusions they reached were sometimes unsupported by the data, and when the FDA was struggling to come up with an opioid policy, it turned to a panel populated by doctors who had financial relationships with Purdue and other drugmakers.
●A review of 16 key clinical trials on the subject shows that five were funded by Purdue and an OxyContin distributor, two were co-authored by Purdue employees, and two were sponsored by other drug companies making different opioids. None of the 16studies showed clear warnings about the addiction dangers or the physical dependence generated by the drugs. The low rate of addiction reported in these studies is at odds with more recent findings indicating that diagnoses of addiction are common in opioid patients.
●Internal company documents indicate that one of the key published studies sponsored by Purdue — the one reprinted 10,000 times — omitted suspected cases of withdrawal symptoms. The published paper offered assurance that only two of more than 100 OxyContin patients had withdrawal symptoms; the internal documents showed that at least 11 exhibited possible signs of withdrawal, and some experts say it is likely that at the doses given, most of the patients would have experienced withdrawal.
●To refine its policy on opioids, the FDA convened a key meeting in 2002 and invited 10 outside experts for advice. Five of them reported having served as speakers or investigators for Purdue. Three others reported working as speakers for or as advisers and consultants to other pharmaceutical companies.
One of those FDA advisers, Russell Portenoy, who was then the chair of the Department of Pain Medicine and Palliative Care at the Beth Israel Medical Center in New York, has since expressed regret for his evangelism on behalf of opioids.
He was "trying to create a narrative so that the primary care audience would . . . feel more comfortable about opioids," Portenoy said in a 2010 interview with Andrew Kolodny, the chief of a group seeking to rein in drug use, Physicians for Responsible Opioid Prescribing. "Because the primary goal was to destigmatize [opioids], we often left evidence behind. . . .
"To the extent that some of the adverse outcomes now are as bad as they have become in terms of endemic occurrences of addiction and unintentional overdose deaths, it's quite scary to think about how the growth in that prescribing driven by people like me led in part to that occurring."
Through a spokesman, Portenoy declined to comment for this report, but he has said that he continues to believe that many patients with chronic pain can benefit from opioids, though the estimates of how many patients may become addicted are larger than previously thought.
At the time of the 2002 FDA meeting, Portenoy reported being a speaker for Purdue Pharma. He also reported involvements on contracts and grants with Parke-Davis, Boehringer Ingelheim, Elan, Ortho Biotech, Endo, Ametek, Medtronic, Purdue Pharma, Pfizer, Janssen, Abbott, Curatech, Ortho-McNeil and Searle.
James Heins, a spokesman for Purdue, said that "it is implausible that our marketing caused an upsurge in overall prescriptions of opioids or in the incidence of abuse" because the company commands only a small portion of the painkiller market.
Moreover, he said, the notion that the risk of addiction was small was "not based on studies funded by Purdue but rather on the larger body of medical literature and clinical experience."
Even today, he said, it is difficult to say exactly how many people who are prescribed opioids become addicted.
‘Absolutely devastating'
In few places are the effects of the opioid epidemic clearer than in Portsmouth, a town near Ohio's borders with West Virginia and Kentucky. About 10 percent of babies are born addicted to opioids. At one point, nine "pill mills" operated out of this region of 80,000 people. About 20 people a year die of drug overdoses. Last year, for every resident, more than 100 doses of opioids were prescribed and dispensed.
Ask someone here whether the risks of opioid addiction are minimal, and some snort or roll their eyes.
"Around here, we call it ‘pharmageddon,' " said Lisa Roberts, the public health nurse for the town, whose primary job is to reduce the fatalities associated with drug use. "This has been absolutely devastating to Appalachia. From what we've seen, the risks of addiction were tremendous."
For decades, many doctors had been wary of prescribing opioids except for use by cancer patients and the terminally ill.
In 1992, for example, a survey of state medical board members, most of them physicians, found that only 12 percent described prescribing opioids for an extended period for chronic pain as a "lawful and generally acceptable medical practice."
Advocates for opioid prescription, backed in part by drugmakers, set about seeking to change those attitudes. More than 20 states changed their rules. And in December 1995, these marketing efforts surged as Purdue Pharma introduced OxyContin, a controlled-release form of the opioid oxycodone.
From 1996 to 2000, the company doubled its sales force from 300 to 671, according to a 2003 report by what was then the General Accounting Office. The amount of sales bonuses Purdue Pharma offered tied to OxyContin grew from $1 million a year to $40 million a year. It sponsored pain-related Web sites, advertised in medical journals and paid influential doctors such as Portenoy to talk to other physicians.
As the number of overdoses and reports of addicts rose in the early 2000s, key questions arose. How were the addicts becoming addicted? Was it by going to the doctor with a legitimate pain and getting a legitimate prescription? Or was it just people seeking a high and buying the prescription drugs off the street?
If it was only the latter, limiting prescriptions might have little direct effect on the problem and could penalize pain sufferers.
But it was both. Although many addicts started on opioids just to get high, experts say, a good portion arrived at their habits after coming into contact with opioids after a doctor's visit for a legitimate pain. That's how Leslie Cooper came to the drug, and it is reportedly the way some celebrities became addicted: Rush Limbaugh, Matthew Perry, Cindy McCain.
Other trials have reported that significant numbers of pain patients are addicted. In one review out of Yale School of Medicine, investigators found that diagnoses of addiction are "common" in patients given opioids for back pain, with as many as 24 percent engaging in "aberrant" or peculiar ways of taking the pills.
Early on, officials at the Drug Enforcement Administration perceived the danger to patients.
"The company's aggressive methods, calculated fueling of demand and the grasp for major market share very much exacerbated OxyContin's widespread abuse and diversion," a November 2003 memo from the agency said. "The claim in Purdue's ‘educational' video for physicians that opioid analgesics cause addiction in less than one percent of patients is not only unsubstantiated but also dangerous because it misleads prescribers."
But amid the marketing blitz, concerns about addiction in patients appear to have faded from the medical profession.
The FDA, which must approve drug labels, allowed Purdue to say on its label: "The development of addiction to opioid analgesics in properly managed patients with pain has been reported to be rare."
The agency warned that drug abusers and addicts might try to obtain the drugs, but it indicated that the risks seemed minor for patients: "We do not know how often patients with continuing (chronic) pain become addicted to narcotics, but the risk has been reported to be small."
The agency, however, would later change its mind.
By 2008, the claims that the risks of addiction in patients were small were removed from the OxyContin label, after "extensive negotiations" with Purdue, an FDA spokeswoman said.
"The labeling information, including language regarding addiction, has evolved over time as data has become available,"Morgan Liscinsky said.
The FDA did not say what evidence led the agency to allow the previous claims or what new findings led it to ask for the removal of those claims.
Early on, however, the agency relied on industry experts for advice. In the 2002 FDA meeting, for example, eight of the 10 invited experts had connectionswith pharmaceutical companies. Of those, five had served as speakers, consultants or investigators for Purdue, including Portenoy and Kathy Foley, a neuro-oncologist at Memorial Sloan Kettering Cancer Center. Together, Portenoy and Foley had published a key study on opioids in 1986 that found that only two of 38 patients seemed to abuse the drugs and that both had histories of substance abuse.
"Their past work with industry should not preclude them from sharing their expertise with government agencies or their peers in the medical community," Heins, the Purdue spokesman, said.
The FDA and doctors also could turn to a spate of other trials that seemed to suggest there was little reason to worry that chronic pain patients could get addicted to opioids.
Take, for example, a 2003 report in the New England Journal of Medicine, which reviewed the conclusions from several studies.
"The general finding is that patients with chronic pain . . . can achieve satisfactory analgesia . . . with a minimal risk of addiction," it said, while questioning the use of high doses.
What may be most striking about the paper, though, is that its lead author has become one of the top critics of opioid prescribing habits. But Jane Ballantyne, a pain specialist at the University of Washington, said that at the time there were very few clinical trials that showed any sign of an addiction risk.
"There were very few studies then that suggested that any more than 8 percent of people on prescription opioids exhibited addiction-type behaviors," Ballantyne said. Now, she said, the understanding is that the number may be as high as 50 percent.
How did all these studies — co-authored by doctors with university affiliations and published in academic journals — lead to conclusions that now are in dispute?
One reason, according to critics, is that most of the studies were conducted by drug companies.
"A pharmaceutical company that has a vested interest in promoting their product should not be seen as a reliable source of safety information," said Orman Hall, director of the Ohio Department of Alcohol and Drug Addiction Services. "Some of those estimates are ludicrous."
Consider the 16 clinical trial reports that Ballantyne highlighted and used in her article, which reflect the medical literature at the time. Her summary did not discuss sponsors of the studies. But of those 16, six were sponsored by Purdue Pharma or co-authored by its employees, one was sponsored by Mundipharma, which distributed OxyContin and other opioids, and two were sponsored by another drug company or co-authored by drug company employees.
In the trials, patients were given an opioid for pain, but in most, there were no systematic checks for withdrawal symptoms or addiction. Instead, in most of the trials, regardless of whether they were sponsored by drug companies, the investigators generally found that the benefits of pain relief outweighed the risks of side effects such as constipation and dry mouth.
If investigators were looking for signs of addiction, they weren't looking hard.
"In the absence of rigorous evaluation and surveillance, it's hard to know whether the low levels of addictive behavior reported in those studies are accurate," said David A. Fiellin, a professor of medicine at Yale with an expertise in addiction.
Fiellin noted that the design of a study can dramatically change the results and that entrusting the design to scientists with conflicts of interest could introduce bias. What patients are admitted to the trial? How are side effects measured? How large are the doses?
"All of those are scientific decisions that should be made by people without any regard for how the findings will affect the company's bottom line," Fiellin said, adding that the government could play a larger role in funding.
Data discrepancy
In one of the studies sponsored by Purdue that Ballantyne covered, and that played a large role in the marketing of OxyContin, there appear to have been significant discrepancies between the data that were gathered and those that were published.
A March 2000 issue of the Archives of Internal Medicine published a study that followed 106 arthritis patients treated with OxyContin for several months.
Six times during the trial, researchers intentionally stopped the doses.
Remarkably, according to doctors who study addiction and dependence, there were no reports of withdrawal during those respites.
Two patients had withdrawal problems, but one was at the end of the study, and the other had simply run out of the medication.
"Withdrawal syndrome was not reported as an adverse event for any patient during the scheduled respites," the authors reported.
The trial also showed that the drug was effective and was embraced by the Purdue marketing team, which ordered 10,000 reprints to distribute to its sales staff, with instructions to highlight the finding on withdrawal.
But according to company documents disclosed in a court case, the paper left out several cases of withdrawal.
Inside Purdue, supervisors and employees reviewed a more complex set of data, according to a document signed by company attorneys and prosecutors, which accompanied a 2007 settlement in which federal prosecutors charged Purdue with misbranding the drug.
The document has not previously been linked to the Archives article.
"Multiple" patients, a company review said, "directly stated or implied that an adverse experience was due to possible withdrawal symptoms."
Eleven study patients "reported adverse experience due to possible withdrawal symptoms during these periods," according to the court document.
How did this discrepancy arise?
One of the authors of the Archives article, Roy Fleischmann, a clinical professor of medicine at the University of Texas Southwestern Medical Center at Dallas, said the authors were given the data by Purdue.
"We reported on the data which was provided to us," he wrote.
He said the discrepancy may have arisen because some of the side effects — such as insomnia, nausea and anxiety — were not characterized by Purdue "as withdrawal symptoms, although, in retrospect, they probably were," he said in an e-mail.
Doctors who have treated OxyContin addicts, and some former addicts, moreover, say that considering the doses given to the patients in the trial and its duration, even the internal document undercounted patients reporting withdrawal symptoms. They say the majority of patients were likely to have suffered withdrawal symptoms when the drug was cut off.
At the doses given in the trial, most patients are "pretty consistently" going to have withdrawal symptoms, said Phillip Prior, a board-certified addictionologist in the Portsmouth area who has treated thousands of patients addicted to opioids.
He said the lower estimates are "flawed conclusions from a very flawed study."
"I've never seen anyone come off of them and not get withdrawal," said Billie Taylor, 42, a former addict who works at a treatment center in Portsmouth. "I would have quit a lot earlier if it had not been for the withdrawal. You feel like you want to die. Even if you take them at prescribed levels, you get withdrawal."
"You could say these marketing tactics are merely concerning," Prior said. "But I think of them as satanic. What the data are telling us is that these drugs are ruining people's lives."
© The Washington Post Company
Rising painkiller addiction shows damage from drugmakers' role in shaping medical opinion
By Peter Whoriskey, Published: December 30
Portsmouth, Ohio — Over much of the past decade, the official word on OxyContin was that it rarely posed problems of addiction for patients.
The label on the drug, which was approved by the FDA, said the risks of addiction were "reported to be small."
The New England Journal of Medicine, the nation's premier medical publication, informed readers that studies indicated that such painkillers pose "a minimal risk of addiction."
Another important journal study, which the manufacturer of OxyContin reprinted 10,000 times, indicated that in a trial of arthritis patients, only a handful showed withdrawal symptoms.
Those reassuring claims, which became part of a scientific consensus, have been quietly dropped or called into question in recent years, as many in the medical profession rediscovered the destructive power of opiates. But the damage arising from those misconceptions may have been vast.
The nation is confronting an ongoing epidemic of addiction to prescription painkillers — more widespread than cocaine or heroin — that has left nearly 2 million in its grip, according to federal statistics.
"It turns out that the doctors didn't know what they were talking about," said Barbara Howard, whose daughter Leslie, a home-care nurse, died of an overdose in 2009 in this small Appalachian town devastated by the epidemic. She had developed a habit after knee surgery. She left behind a 9-year-old son.
"Leslie trusted the doctors. We thought the doctors knew what was best. But they didn't. We — and lots of the other victims — had no warning."
Conflicts of interest
A closer look at the opioid painkiller binge — retail prescriptions have roughly tripled in the past 20 years — shows that the rising sales and addictions were catalyzed by a massive effort by pharmaceutical companies to shape medical opinion and practice.
Opioids are a class of powerful drugs, often used for pain, that includes morphine, heroin and brand names such as OxyContin, Vicodin and Percocet.
For years, doctors had been cautious about prescribing opioids to anyone except patients with cancer or in acute pain.
But drug manufacturers and some pain specialists helped create a body of scientific research assuaging the long-standing worries about opioids and pushed to expand the use of the drugs in people with chronic pain — bad backs, arthritis, sore knees.
Their studies reported minimal risks of addiction and dependence. These, in turn, were accepted by the FDA and the nation's medical journals. State medical boards made their rules for prescribing opioids more liberal. Academic and industry articles dismissed the old fears as "opiophobia."
These reports reached doctors through marketing efforts and told them that there were few risks in using opioids to treat chronic pain.
But according to a Washington Post examination of key scientific papers, a court document and FDA records, many of those claims were developed in studies supported by Purdue Pharma, the maker of OxyContin, or other drug manufacturers. In addition, the conclusions they reached were sometimes unsupported by the data, and when the FDA was struggling to come up with an opioid policy, it turned to a panel populated by doctors who had financial relationships with Purdue and other drugmakers.
●A review of 16 key clinical trials on the subject shows that five were funded by Purdue and an OxyContin distributor, two were co-authored by Purdue employees, and two were sponsored by other drug companies making different opioids. None of the 16studies showed clear warnings about the addiction dangers or the physical dependence generated by the drugs. The low rate of addiction reported in these studies is at odds with more recent findings indicating that diagnoses of addiction are common in opioid patients.
●Internal company documents indicate that one of the key published studies sponsored by Purdue — the one reprinted 10,000 times — omitted suspected cases of withdrawal symptoms. The published paper offered assurance that only two of more than 100 OxyContin patients had withdrawal symptoms; the internal documents showed that at least 11 exhibited possible signs of withdrawal, and some experts say it is likely that at the doses given, most of the patients would have experienced withdrawal.
●To refine its policy on opioids, the FDA convened a key meeting in 2002 and invited 10 outside experts for advice. Five of them reported having served as speakers or investigators for Purdue. Three others reported working as speakers for or as advisers and consultants to other pharmaceutical companies.
One of those FDA advisers, Russell Portenoy, who was then the chair of the Department of Pain Medicine and Palliative Care at the Beth Israel Medical Center in New York, has since expressed regret for his evangelism on behalf of opioids.
He was "trying to create a narrative so that the primary care audience would . . . feel more comfortable about opioids," Portenoy said in a 2010 interview with Andrew Kolodny, the chief of a group seeking to rein in drug use, Physicians for Responsible Opioid Prescribing. "Because the primary goal was to destigmatize [opioids], we often left evidence behind. . . .
"To the extent that some of the adverse outcomes now are as bad as they have become in terms of endemic occurrences of addiction and unintentional overdose deaths, it's quite scary to think about how the growth in that prescribing driven by people like me led in part to that occurring."
Through a spokesman, Portenoy declined to comment for this report, but he has said that he continues to believe that many patients with chronic pain can benefit from opioids, though the estimates of how many patients may become addicted are larger than previously thought.
At the time of the 2002 FDA meeting, Portenoy reported being a speaker for Purdue Pharma. He also reported involvements on contracts and grants with Parke-Davis, Boehringer Ingelheim, Elan, Ortho Biotech, Endo, Ametek, Medtronic, Purdue Pharma, Pfizer, Janssen, Abbott, Curatech, Ortho-McNeil and Searle.
James Heins, a spokesman for Purdue, said that "it is implausible that our marketing caused an upsurge in overall prescriptions of opioids or in the incidence of abuse" because the company commands only a small portion of the painkiller market.
Moreover, he said, the notion that the risk of addiction was small was "not based on studies funded by Purdue but rather on the larger body of medical literature and clinical experience."
Even today, he said, it is difficult to say exactly how many people who are prescribed opioids become addicted.
‘Absolutely devastating'
In few places are the effects of the opioid epidemic clearer than in Portsmouth, a town near Ohio's borders with West Virginia and Kentucky. About 10 percent of babies are born addicted to opioids. At one point, nine "pill mills" operated out of this region of 80,000 people. About 20 people a year die of drug overdoses. Last year, for every resident, more than 100 doses of opioids were prescribed and dispensed.
Ask someone here whether the risks of opioid addiction are minimal, and some snort or roll their eyes.
"Around here, we call it ‘pharmageddon,' " said Lisa Roberts, the public health nurse for the town, whose primary job is to reduce the fatalities associated with drug use. "This has been absolutely devastating to Appalachia. From what we've seen, the risks of addiction were tremendous."
For decades, many doctors had been wary of prescribing opioids except for use by cancer patients and the terminally ill.
In 1992, for example, a survey of state medical board members, most of them physicians, found that only 12 percent described prescribing opioids for an extended period for chronic pain as a "lawful and generally acceptable medical practice."
Advocates for opioid prescription, backed in part by drugmakers, set about seeking to change those attitudes. More than 20 states changed their rules. And in December 1995, these marketing efforts surged as Purdue Pharma introduced OxyContin, a controlled-release form of the opioid oxycodone.
From 1996 to 2000, the company doubled its sales force from 300 to 671, according to a 2003 report by what was then the General Accounting Office. The amount of sales bonuses Purdue Pharma offered tied to OxyContin grew from $1 million a year to $40 million a year. It sponsored pain-related Web sites, advertised in medical journals and paid influential doctors such as Portenoy to talk to other physicians.
As the number of overdoses and reports of addicts rose in the early 2000s, key questions arose. How were the addicts becoming addicted? Was it by going to the doctor with a legitimate pain and getting a legitimate prescription? Or was it just people seeking a high and buying the prescription drugs off the street?
If it was only the latter, limiting prescriptions might have little direct effect on the problem and could penalize pain sufferers.
But it was both. Although many addicts started on opioids just to get high, experts say, a good portion arrived at their habits after coming into contact with opioids after a doctor's visit for a legitimate pain. That's how Leslie Cooper came to the drug, and it is reportedly the way some celebrities became addicted: Rush Limbaugh, Matthew Perry, Cindy McCain.
Other trials have reported that significant numbers of pain patients are addicted. In one review out of Yale School of Medicine, investigators found that diagnoses of addiction are "common" in patients given opioids for back pain, with as many as 24 percent engaging in "aberrant" or peculiar ways of taking the pills.
Early on, officials at the Drug Enforcement Administration perceived the danger to patients.
"The company's aggressive methods, calculated fueling of demand and the grasp for major market share very much exacerbated OxyContin's widespread abuse and diversion," a November 2003 memo from the agency said. "The claim in Purdue's ‘educational' video for physicians that opioid analgesics cause addiction in less than one percent of patients is not only unsubstantiated but also dangerous because it misleads prescribers."
But amid the marketing blitz, concerns about addiction in patients appear to have faded from the medical profession.
The FDA, which must approve drug labels, allowed Purdue to say on its label: "The development of addiction to opioid analgesics in properly managed patients with pain has been reported to be rare."
The agency warned that drug abusers and addicts might try to obtain the drugs, but it indicated that the risks seemed minor for patients: "We do not know how often patients with continuing (chronic) pain become addicted to narcotics, but the risk has been reported to be small."
The agency, however, would later change its mind.
By 2008, the claims that the risks of addiction in patients were small were removed from the OxyContin label, after "extensive negotiations" with Purdue, an FDA spokeswoman said.
"The labeling information, including language regarding addiction, has evolved over time as data has become available,"Morgan Liscinsky said.
The FDA did not say what evidence led the agency to allow the previous claims or what new findings led it to ask for the removal of those claims.
Early on, however, the agency relied on industry experts for advice. In the 2002 FDA meeting, for example, eight of the 10 invited experts had connectionswith pharmaceutical companies. Of those, five had served as speakers, consultants or investigators for Purdue, including Portenoy and Kathy Foley, a neuro-oncologist at Memorial Sloan Kettering Cancer Center. Together, Portenoy and Foley had published a key study on opioids in 1986 that found that only two of 38 patients seemed to abuse the drugs and that both had histories of substance abuse.
"Their past work with industry should not preclude them from sharing their expertise with government agencies or their peers in the medical community," Heins, the Purdue spokesman, said.
The FDA and doctors also could turn to a spate of other trials that seemed to suggest there was little reason to worry that chronic pain patients could get addicted to opioids.
Take, for example, a 2003 report in the New England Journal of Medicine, which reviewed the conclusions from several studies.
"The general finding is that patients with chronic pain . . . can achieve satisfactory analgesia . . . with a minimal risk of addiction," it said, while questioning the use of high doses.
What may be most striking about the paper, though, is that its lead author has become one of the top critics of opioid prescribing habits. But Jane Ballantyne, a pain specialist at the University of Washington, said that at the time there were very few clinical trials that showed any sign of an addiction risk.
"There were very few studies then that suggested that any more than 8 percent of people on prescription opioids exhibited addiction-type behaviors," Ballantyne said. Now, she said, the understanding is that the number may be as high as 50 percent.
How did all these studies — co-authored by doctors with university affiliations and published in academic journals — lead to conclusions that now are in dispute?
One reason, according to critics, is that most of the studies were conducted by drug companies.
"A pharmaceutical company that has a vested interest in promoting their product should not be seen as a reliable source of safety information," said Orman Hall, director of the Ohio Department of Alcohol and Drug Addiction Services. "Some of those estimates are ludicrous."
Consider the 16 clinical trial reports that Ballantyne highlighted and used in her article, which reflect the medical literature at the time. Her summary did not discuss sponsors of the studies. But of those 16, six were sponsored by Purdue Pharma or co-authored by its employees, one was sponsored by Mundipharma, which distributed OxyContin and other opioids, and two were sponsored by another drug company or co-authored by drug company employees.
In the trials, patients were given an opioid for pain, but in most, there were no systematic checks for withdrawal symptoms or addiction. Instead, in most of the trials, regardless of whether they were sponsored by drug companies, the investigators generally found that the benefits of pain relief outweighed the risks of side effects such as constipation and dry mouth.
If investigators were looking for signs of addiction, they weren't looking hard.
"In the absence of rigorous evaluation and surveillance, it's hard to know whether the low levels of addictive behavior reported in those studies are accurate," said David A. Fiellin, a professor of medicine at Yale with an expertise in addiction.
Fiellin noted that the design of a study can dramatically change the results and that entrusting the design to scientists with conflicts of interest could introduce bias. What patients are admitted to the trial? How are side effects measured? How large are the doses?
"All of those are scientific decisions that should be made by people without any regard for how the findings will affect the company's bottom line," Fiellin said, adding that the government could play a larger role in funding.
Data discrepancy
In one of the studies sponsored by Purdue that Ballantyne covered, and that played a large role in the marketing of OxyContin, there appear to have been significant discrepancies between the data that were gathered and those that were published.
A March 2000 issue of the Archives of Internal Medicine published a study that followed 106 arthritis patients treated with OxyContin for several months.
Six times during the trial, researchers intentionally stopped the doses.
Remarkably, according to doctors who study addiction and dependence, there were no reports of withdrawal during those respites.
Two patients had withdrawal problems, but one was at the end of the study, and the other had simply run out of the medication.
"Withdrawal syndrome was not reported as an adverse event for any patient during the scheduled respites," the authors reported.
The trial also showed that the drug was effective and was embraced by the Purdue marketing team, which ordered 10,000 reprints to distribute to its sales staff, with instructions to highlight the finding on withdrawal.
But according to company documents disclosed in a court case, the paper left out several cases of withdrawal.
Inside Purdue, supervisors and employees reviewed a more complex set of data, according to a document signed by company attorneys and prosecutors, which accompanied a 2007 settlement in which federal prosecutors charged Purdue with misbranding the drug.
The document has not previously been linked to the Archives article.
"Multiple" patients, a company review said, "directly stated or implied that an adverse experience was due to possible withdrawal symptoms."
Eleven study patients "reported adverse experience due to possible withdrawal symptoms during these periods," according to the court document.
How did this discrepancy arise?
One of the authors of the Archives article, Roy Fleischmann, a clinical professor of medicine at the University of Texas Southwestern Medical Center at Dallas, said the authors were given the data by Purdue.
"We reported on the data which was provided to us," he wrote.
He said the discrepancy may have arisen because some of the side effects — such as insomnia, nausea and anxiety — were not characterized by Purdue "as withdrawal symptoms, although, in retrospect, they probably were," he said in an e-mail.
Doctors who have treated OxyContin addicts, and some former addicts, moreover, say that considering the doses given to the patients in the trial and its duration, even the internal document undercounted patients reporting withdrawal symptoms. They say the majority of patients were likely to have suffered withdrawal symptoms when the drug was cut off.
At the doses given in the trial, most patients are "pretty consistently" going to have withdrawal symptoms, said Phillip Prior, a board-certified addictionologist in the Portsmouth area who has treated thousands of patients addicted to opioids.
He said the lower estimates are "flawed conclusions from a very flawed study."
"I've never seen anyone come off of them and not get withdrawal," said Billie Taylor, 42, a former addict who works at a treatment center in Portsmouth. "I would have quit a lot earlier if it had not been for the withdrawal. You feel like you want to die. Even if you take them at prescribed levels, you get withdrawal."
"You could say these marketing tactics are merely concerning," Prior said. "But I think of them as satanic. What the data are telling us is that these drugs are ruining people's lives."
© The Washington Post Company
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How bout you legalize and sell any drugs that have a positive benefit (dont see crack having one) not sure about meth but ampetamines do.
Teach people how to control THEMSELVES instead of trying to control them.
ALLOW THEM TO COME TO DOCTORS WHEN THERE IS A PROBLEM INSTEAD OF TREATING THEM LIKE A CRIMINAL!!!
and maybe not as many will become addicts.
The pain pill problem isnt about the pills its about our society in general, more restrictions wont stop it, people will turn from their legit needed meds to heroin dont fool yourselfs thats what big daddy US Government want so they can profit from the CIA flying in heroin...and before you call me a quack its been documented look it up.
When people start abusing their pills, send them to treatment, but keep them on their pills (atleast give them 1 more chance if they screw up tell them if you want to be on these you need to under go so and so therapy ect... then we will try again and if your responsible fine)
Drug test every week and pill count once a week. it cant be that damn hard, my doctor pill counts 1 time every 3-4 months and has never drug tested me, hes fcking lazy and yeah i take more than i should because my dose doesnt help and when i try to talk to him he asks me ******ed questions about why i have this pain, YOUR THE FCKING DOCTOR U TELL ME im coming to you for help!!
Teach people how to control THEMSELVES instead of trying to control them.
ALLOW THEM TO COME TO DOCTORS WHEN THERE IS A PROBLEM INSTEAD OF TREATING THEM LIKE A CRIMINAL!!!
and maybe not as many will become addicts.
The pain pill problem isnt about the pills its about our society in general, more restrictions wont stop it, people will turn from their legit needed meds to heroin dont fool yourselfs thats what big daddy US Government want so they can profit from the CIA flying in heroin...and before you call me a quack its been documented look it up.
When people start abusing their pills, send them to treatment, but keep them on their pills (atleast give them 1 more chance if they screw up tell them if you want to be on these you need to under go so and so therapy ect... then we will try again and if your responsible fine)
Drug test every week and pill count once a week. it cant be that damn hard, my doctor pill counts 1 time every 3-4 months and has never drug tested me, hes fcking lazy and yeah i take more than i should because my dose doesnt help and when i try to talk to him he asks me ******ed questions about why i have this pain, YOUR THE FCKING DOCTOR U TELL ME im coming to you for help!!
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More than PROP or threat of criminal prosecution or threat of physical harm, it is the attitude of posters like this that will ultimately make me stop prescribing opioids for everyone.
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1/3rd of patients referred for addiction treatment obtained their opioid introduction secondary to pain treatment...
Many thanks to Andrea Furlan and Andrew Kalodny for both the reference, and confirmation that their practice findings are similar.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3129653/
J Subst Abuse Treat. 2010 Dec;39(4):378-83. doi: 10.1016/j.jsat.2010.06.012. Epub 2010 Aug 19.
Physician introduction to opioids for pain among patients with opioid dependence and depressive symptoms.
Tsui JI, Herman DS, Kettavong M, Alford D, Anderson BJ, Stein MD.
Source
Boston University School of Medicine/Boston Medical Center, Boston, MA 02118, USA. [email protected]
Abstract
This study determined the frequency of reporting being introduced to opioids by a physician among opioid-dependent patients. Cross-sectional analyses were performed using baseline data from a cohort of opioid addicts seeking treatment with buprenorphine. The primary outcome was a response to the question: "Who introduced you to opiates?" Covariates included sociodemographics, depression, pain, and current and prior substance use. Of 140 participants, 29% reported that they had been introduced to opioids by a physician. Of those who were introduced to opioids by a physician, all indicated that they had initially used opioids for pain, versus only 11% of those who did not report being introduced to opioids by a physician (p < .01). There was no difference in current pain (78% vs. 85%, p = .29); however, participants who were introduced to opioids by a physician were more likely to have chronic pain (63% vs. 43%, p = .04). A substantial proportion of individuals with opioid dependence seeking treatment may have been introduced to opioids by a physician.
Many thanks to Andrea Furlan and Andrew Kalodny for both the reference, and confirmation that their practice findings are similar.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3129653/
J Subst Abuse Treat. 2010 Dec;39(4):378-83. doi: 10.1016/j.jsat.2010.06.012. Epub 2010 Aug 19.
Physician introduction to opioids for pain among patients with opioid dependence and depressive symptoms.
Tsui JI, Herman DS, Kettavong M, Alford D, Anderson BJ, Stein MD.
Source
Boston University School of Medicine/Boston Medical Center, Boston, MA 02118, USA. [email protected]
Abstract
This study determined the frequency of reporting being introduced to opioids by a physician among opioid-dependent patients. Cross-sectional analyses were performed using baseline data from a cohort of opioid addicts seeking treatment with buprenorphine. The primary outcome was a response to the question: "Who introduced you to opiates?" Covariates included sociodemographics, depression, pain, and current and prior substance use. Of 140 participants, 29% reported that they had been introduced to opioids by a physician. Of those who were introduced to opioids by a physician, all indicated that they had initially used opioids for pain, versus only 11% of those who did not report being introduced to opioids by a physician (p < .01). There was no difference in current pain (78% vs. 85%, p = .29); however, participants who were introduced to opioids by a physician were more likely to have chronic pain (63% vs. 43%, p = .04). A substantial proportion of individuals with opioid dependence seeking treatment may have been introduced to opioids by a physician.
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Of 140 participants, 99 reported that they had NOT been introduced to opioids by a physician. So 71% were receiving their meds illegally.
exactly so what;s the point of this study. the majority were already addicted to opioids from the street
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Source?
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Dumbest thing ever posted in this forum. Please read it out loud and tell me again.
They went to the addpsych not because they were an addict. They Wen. because they heard wonderful things about heroin chic. Try the veal.
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Let's be intellectually honest here. If we are going to deride the "addiction is rare, occurs <1%" anecdote that became gospel, we should not take the number 30% as gospel, either, just because a different well-known-guy said it.
I'm on your side here, and I agree with a lot of PROPs points, but we need to do better than "new anecdote trumps old anecdote."
I'm on your side here, and I agree with a lot of PROPs points, but we need to do better than "new anecdote trumps old anecdote."
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I am not suggesting that 30% of patients with CNP become addicts because of their prescribed opioid exposure. I am saying that 30-33% of patients seen in addiction medicine clinics are referred/self-referred from pain clinics. 1 in 3 patients.
It's hard to defend the 'pro-opioid' approach for CNP any more. It hasn't panned out for the betterment of patients or society.
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If you are saying "zero opioids" unless you have cancer, surgery or a broken bone within the past 4 weeks, I don't think that we'll get their in our lifetimes. However, if you are suggesting we raise the bar much, much higher for chronic long term opiates and monitor way, way, more closely, then I totally agree. That we should eliminate "pain = automatic opiate increase". Agree. Maybe the default for "stable" patient should be pushing the dose down, not a default of always same or higher (never decrease) dose. They are medications that can be incredibly dangerous, if conditions are not 100% ideal. I would echo Drusso's comment given above and quoted below:
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1+
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how many of you have patients who are
1) Under age 65
2) No terminal cancer or cancer in remission
3) minimal pathology
4) on high dose opioids
5) functioning at a high level (ie: working).
1) Under age 65
2) No terminal cancer or cancer in remission
3) minimal pathology
4) on high dose opioids
5) functioning at a high level (ie: working).
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http://www.samhsa.gov/data/2k12/NSDUH115/sr115-nonmedical-use-pain-relievers.htm
States with Rates between 5.33 and 6.37
Oregon 6.37%
Colorado 6.00%
Washington 5.75%
Idaho 5.73%
Indiana 5.68%
Arizona 5.66%
Nevada 5.62%
Delaware 5.61%
Arkansas 5.55%
New Mexico 5.45%
States with Rates between 5.33 and 6.37
Oregon 6.37%
Colorado 6.00%
Washington 5.75%
Idaho 5.73%
Indiana 5.68%
Arizona 5.66%
Nevada 5.62%
Delaware 5.61%
Arkansas 5.55%
New Mexico 5.45%
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If we can assume the rate of addiction is 10-13% in the general population, excluding tobacco and alcohol, then we can assume roughly half of addicts abuse opiates. I would have thought the number would be higher, with the decline in cocaine, THC, and meth abuse always being reported.
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Why isn't Florida higher on that list? Weird.
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Is this a trick question?
I had a <65 yr old patient with a normal L spine MRI today, insist Roxi 30 is the ONLY thing that could possibly help.
I said no opiates.
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