Earlier this month, the US Senate Finance Committee launched a probe into drugmakers that sell prescription painkillers as well as several patient advocacy groups and physicians due to “an epidemic of accidental deaths and addiction resulting from the increased sale and use of powerful narcotic painkillers." Among those targeted is the
American Geriatric Society, a non-profit that boasts about "improving care for older adults."But the slogan may have a hollow ring after one reads an investigation by The Milwaukee Journal-Sentinel and MedPage Today (see this). The AGS publishes guidelines for physicians nationwide and the 2009 edition, which was the latest such tract, recommended that doctors should consider prescribing opiods for all patients with severe to moderate pain, instead of over-the-counter pain relievers, such as ibuprofen and naproxen, despite growing concerns about addiction and side effects with opioids.
The panel members reportedly relied on research and their experience in revising the guidelines, but acknowledged "existing weak scientific evidence." Moreover, among the 10 panelists who made the recommendations, at least five had financial ties to opioid drugmakers - such as Purdue Pharma, which sells OxyContin - as paid speakers, consultants or advisers when the guidelines were issued. In addition, the panel chair was listed as a paid speaker for one drugmaker the following a year. Among the other drugmakers listed were Pfizer, Endo Pharmaceuticals and Johnson & Johnson (here is the disclosure list, although amounts were not disclosed).
This is big business, after all. Since 2007, top-selling opioids dispensed to people 60 years and older have increased 32 percent, according to an analysis by the Journal-Sentinel and MedPage Today of prescription data from IMS Health, a market research firm. This is double the growth for prescriptions dispensed to those between 40 and 59 years old.
And the investigation notes that groups with industry funding have made "overwhelmingly positive claims" about opioids, such as addiction risks are rare, few patients will need to increase dosages and there is no unsafe maximum dose. These claims can be found in "prescribing guidelines, patient literature, position statements, books and medical education courses." At the same time, serious complications are often ignored - overdosing, increased risk of falls and fractures in older patients and cognitive problems, among other side effects.
These side effects were not included in the 2009 pain guide that was funded by PriCara, which is now part of Johnson & Johnson, and endorsed by the American Geriatrics Society, the investigation found. Instead, the 2009 guide, which you can read here, claimed that opioids allow people with chronic pain to return to work, walk or run, and play sports.
Meanwhile, the guide lists several disadvantages for traditional pain meds such as ibuprofen and naproxen, which are marketed as Advil and Aleve, respectively, but there no disadvantages list for opioid painkillers. But these drugs can cause respiratory suppression, sleep apnea, bowel obstruction, constipation, depression, apathy and increased pain sensitivity, the investigation notes. And the guide used the word "myth" to characterize concerns that patients may need increased doses of opioids over time to control pain.
However, a study published in the Archives of Internal Medicine two years ago collected data on 12,840 Medicare patients with an average age of 80 who had used opioids, traditional anti-inflammatory drugs or non-steroidal anti-inflammatories, such as Celebrex, and found that opioid users were more than four times more likely to suffer a fracture than users of traditional anti-inflammatory drugs. And deaths from any cause were 87 percent more likely among opioid users. Meanwhile, cardiovascular events, including heart attacks, strokes and cardiac death, were 77 percent higher in opioid users than in users of anti-inflammatory drugs (here is the abstract).
In response, AGS president Sharon Brangman offered a statement from its web site to the Journal-Sentinel and MedPage Today: "There is simply no reason to let millions of frail Americans live with horrible pain every day despite having medications that would bring them rapid relief. While we don't advocate casual or improper use of opioids, we do believe that with careful patient selection and monitoring, opioids can be used safely and effectively to treat persistent pain and help avoid its many related costs and complications."
"...Studies have shown that older adults are more likely to experience severe or persistent pain and, as they age, are less able to tolerate severe pain. Collectively, this group is far more likely to suffer from chronic, painful conditions such as arthritis, bone and joint disorders, and cancer than younger adults. Persistent pain or its inadequate treatment can lead to decreased mobility and function, falls, depression, social isolation, poor sleep, and weight loss—let alone unnecessary suffering... Additionally, inadequate pain management often leads to increased emergency room visits and increased re-hospitalization rates."
As we have noted previously, opioid prescribing has led to what is described as an epidemic in prescription painkiller abuse. A 2010 report from the US Centers for Disease Control and Prevention noted that the rise in overdose deaths in the US paralleled a 300 percent increase since 1999 in the sale of prescription painkillers. The drugs were involved in 14,800 overdose deaths in 2008, more than cocaine and heroin combined (here is the report).
The prescribing trend has also been blamed for a rise in crime. Last week, for instance, the district attorney in Suffolk County, New York, which comprises part of Long Island, released a recent grand jury report about the killing of four people last June by a pair who robbed a pharmacy in search of opioid pain meds. And the report, in part, blamed the "profit motive" of drugmakers for the larger problem (read the report here).
As Andrew Kolodny, who chairs the psychiatry department at Maimonides Medical Center in New York and heads Physicians for Responsible Opioid Prescribing, recently told us: "I can’t think of a better example of what’s wrong with industry influence on medical practice than the opioid analgesic epidemic. I honestly believe that the epidemic of opioid overdose deaths and addiction that we’re dealing with today could have been avoided if we had strict firewalls in place 15 years ago to limit industry influence on medical education and our professional societies" (here is the complete interview).
Thanks to the Milwaukee Journal-Sentinel and MedPage Today for the use of the chart
17 Comments
The attitudes exemplified by PROP caused my family a great deal of needless suffering some years back. I hope that when you revisit this issue you will include an interview with a qualified pain specialist having more mainstream views.
Simplistic solutions won't solve the problems, they just shift the suffering from one group to another.
There are positions being taken that opiates are to be used only for those in end stage cancer. This is inane response. Opiates serve multiple purposes in medicine. They alleviate suffering. They also speed healing by reducing the aggravating effects of pain.
Thanks for the note and I appreciate the point you make about the use of the medications. I agree with you that there is a role for prescription painkillers. The post, which is largely based on the Journal-Sentinel and MedPage Today coverage, does not mean to suggest these drugs cannot or should not be used for those who would benefit. Nor was there was an attempt to advocate such a position.
Obviously, this is a polarizing topic that appears to lend itself to extremes. But the issue that is being raised is questionable promotion that has led to widespread use and, consequently, tied to addiction, harm and crime. As noted, this has prompted the CDC to say there is an epidemic of abuse. The recent allegations made by the Senate Finance Committee suggest that extensive usage, and the acceptance of these medicines as being unquestionably appropriate for many people, is due to questionable marketing that has also encompassed some physicians. Meanwhile, the advocacy groups have, as the story noted, emphasized the positive while downplaying the negative. Some may see this is as an issue of balance.
In other words, there would appear to be an effort to bring the promotion and usage back toward some middle ground. This is what the story about the American Geriatric Society attempted to illustrate. And as I understand it, that is where the Physicians for Responsible Opioid Prescribing has directed its efforts. You obviously disagree and that's fine. Publicly, at least, the group has been on record as being in favor of moderating use, not banning or severely restrcting the medicines, as far as I understand it.
I'm not sure if this helps, but I appreciate having the discussion.
Regards ed
I must say that I think Pharmalot gave Kolodny a free ride. It happens to be a FACT, which Kolodny and his fans don't realize, that opiates and NSAIDs are totally different classes of drugs with different spectra of action. Unfortunately your articles on opiates DID advocate the PROP position, not least because you failed to present the views of an expert on the other side of the issue.
In fact you did not, as you claim, present evidence of questionable sales practices by opiate manufacturers. Purdue and three of its execs got hit with severe fines in Virginia, and the FDA made them "retool" their long-acting OxyContin, so that now it is no more vulnerable to tampering than an ordinary oxycodone tablet.
May I suggest that it's generally bad medicine to give politicians an uncritical forum to meddle in medicine? I think that justice was done in the Purdue case, and that we should entrust the FDA - not the Senate FINANCE Commiittee or PROP - with the job of determining the efficacy and safety of the medicines on our pharmacy shelves.
Thank you for your comments,
Bob
Meanwhile, three cheers and a hat tip for/to the Milwaukee JS for some excellent medical reporting in recent years.
Now I go drool.
p.s. my math problem to post was unusually challenging this time. Probably a mental status exam of some kind.
Thanks again for writing in. The allegations of inappropriate marketing to which I referred in my last note had to do with the relationships between manufacturers and patient advocacy groups, as well as physicians. This allegedly constitutes a form of promotion (which can be different than a specific sales practice), and the American Geriatric Society, its guidelines and the ties between its experts and various drugmakers was the example used as an illustration.
I understand your point about seeking an expert to discuss the benefits of using opioids to treat pain. Again, however, the post did not advocate that the drugs should not be used for that purpose or that some patients may not find a benefit. If that was not clear, then I apologize for the lack of clarity. The post attempted to point out that opioids may not be appropriate for all pain patients and that the messages disseminated by the ASG - whose guidelines were developed by physicians with ties to various drugmakers - were skewed in favor of the medications, without providing comparable information about risks and when use may be inappropriate. That's a different issue.
As to Physicians for Responsible Opioid Prescribing, my understanding is that the group advises that opioid therapy should be considered only after other approaches, including NSAIDs, have failed, but that is not the same thing as recommending an NSAID instead of an opioid in any and all situations, regardless of other considerations. If I misunderstood you, please let me know.
In any event, I happy to search for another qualified individual to interview on the subject of pain medication - someone not affiliated with Physicians for Responsible Opioid Prescribing - for the purposes of running a Q&A as I did with Kolodny earlier this month. This may take some time to gel, but I will put it on my list. The Kolodny quote I used in the post today, by the way, came from that earlier Q&A which, for the record, I had noted.
Again, thanks for the discussion. I enjoy the give and take.
Regards ed
She suffered being stoned (a completely new experience for her since she's old world and had a half glass of wine once a year, at most), in excruciating pain, and frightened about her mental capacity because no one was listening to her for 1.5 days until I finally was able to fly in to see her. Unfortunately, no one knew her medical history - she's in that class of people for whom opioids do not work.
Once they gave her other medication, and the opiods cleared, she did well. But that incident sunk in deep - created a terror of another hospitalization, probably due, in part, to opioid side effects (hallucinations).
It should be a standard prior history question and family/friends should know about prior experiences with pain medications. Stuff doesn't work for me, either. Learned that after major dental work and taking one too many pills in a time period because of the lack of efficacy - never want to repeat that experience! Motrin was exponentially better. Since it's about 30% of the USA population that does not respond, it should be a no-brainer for advancing personalized medicine based on identifying the genotype.
PROP believes, as does the CDC, that overprescribing of opioids is fueling an epidemic of addiction and overdose deaths. We believe that physicians need to prescribe opioids more cautiously. For this to happen, they need accurate information about risks and benefits. The problem is most education on this topic is industry-sponsored and it minimizes risks/exaggerates benefits.
As John Fauber's story illustrates... Patients are being harmed because of drug company influence on medical education.
The rapid growth in deaths from drug overdose began in the 1970's, long before the introduction of Oxycontin and other prescription drugs the current "epidemic" is blamed on. It was cocaine, then heroin, then crack cocaine, then methamphetamine, and in each case we were told that if spent enough money and accepted enough limits on our civil rights, the government would shut down what were were told was a supply-driven problem. But after 40 years of this, the deaths keep climbing, the street price of heroin is at an all time low, and the death rate continues to increase as the socioeconomic problems that are the true drivers of the epidemic continue to fester.
Here is what I think will happen if you are successful in limiting the access of those with severe chronic pain to prescription pain drugs. First and foremost, a lot of pain will be inadequately treated. The death rate from drug overdose will continue its climb, as abusers shift to other readily available drugs of abuse, such as heroin. And given that we now know that even non-selective COX inhibitors are associated with an increased risk of CV events, the number of treatment-related deaths among patients who use their prescription drugs responsibly will remain mostly unchanged or possibly climb.
Drug abuse is not a supply-driven problem. And even if it were, the efforts of the last 40 years have shown that controlling supply in the face of high demand is not feasible.
If your doctor has not had subspecialty training in pain management, then ignore the diploma on the wall that says "Diplomate, American Board of Psychiatry and Neurology", unless you also see a plaque that says "Subspecialty Certification in Pain Management". If you don't see the latter keep walking down the hall.
I'll put Dr. Kolodny's opinion on pain treatment on the shelf right next to Jenny McCarthy's opinion on vaccines.