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Wednesday, 10 April 2013 12:36

Prescription drug industry needs to be reined in

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op frWhat’s deadlier than a crazed maniac in a kindergarten class with a loaded assault weapon?

In the most horrifying massacre in the history of the United States, a few days before Christmas, 20-year-old Adam Lanza walked into a classroom of 5- and 6-year-old children, opened fire and killed them all plus six teachers and staff including the highly respected principal and then himself.

 

What could be more horrifying that that? Fifty to 70 deaths per day from doctor prescribed medications. While the whole country focuses on the Sandy Hook tragedy for weeks, months and possibly years, reviewing questions of how to prevent this from happening again, twice that many people are dying per day from societally accepted, doctor-prescribed medications and nobody’s doing anything about it!

The Centers for Disease Control, the National Institute of Health and the National Institute of Mental Health are calling deaths from drug overdoses the “modern epidemic,” and indeed it is. If anything else caused this much death and destruction of otherwise healthy lives — a plane crash, a school massacre — the whole country would be up in arms within 24 hours to stop it.

 

How did we get here?

Under the guise of trying to help patients with chronic, non-cancer pain (“benign pain” or pain from a condition that won’t kill the patient), Drs. Russell K. Portenoy and Katherine M. Foley published an article in 1986 purporting to support the use of opioid (narcotic) pain medication. Drs. Foley and Portenoy were at Sloan Kettering cancer center in New York City and had managed countless patients with terminal illnesses but had acquired a number of patients referred by doctors for chronic management because of their skills with opioid medication management.

They published an observational report describing 38 patients followed over various periods of time but about four to seven years on various opioid medications. In this report, they state that of 38 patients, 14 had inadequate pain relief and “few substantial gains in employment or social function could be attributed to the institution of opioid therapy.”

I should point out that rejected from inclusion in this study were patients on workman’s compensation and patients with back pain. 

I should also point out that in the intervening quarter century there has not been a shred of objective, scientific long-term evidence that opioids actually help people with chronic pain. There have been plenty of short-term studies funded by drug companies, but they are on the order of four to 12 weeks. These studies compare a potent opioid such as slow release morphine, slow release oxycodone, hydromorphone to a placebo! Accepting this kind of data as a scientific study to actually help patients seems a joke to me in view of the decades-long (possibly centuries) history of knowing these drugs are dangerous, addictive and cause personality changes.

The ravages of addiction to opioids were well known by the time Freud was trying to treat morphine addiction with cocaine and failed (the patient wound up addicted to both) in the late 1890s. There were plenty of published reports and certainly it was well known before then that these medications are powerful, dangerous and lethal.

Indeed the very few long-term studies (Eriksen, et. al. Pain, 2006) show that long-term treatment of patients with opioid actually makes them worse as far as a) pain symptom reporting, b) return to work, c) functionality and d) personal life.

 

Pharmaceutical profits

What has happened? Again, how did we get to the point that most primary care and other doctors in the United States believe that the treatment for patients who complain of pain is to put the patient on opioid medications, sometimes even as a first line treatment?

Drug company profits and drive for aggrandization, that’s how.

The Wall Street Journal, in the very same issue (Dec. 15, 2012) that reports on the front page about the Sandy Hook massacre, also had on its front page an article about Dr. Portenoy. In it he says, “I gave innumerable lectures in the late 1980s and 90s about addiction that weren’t true,” that this had contributed to the soaring rates of addiction and overdose deaths.

Because of drug company funding of talks, lectures, symposia, medical school grants and generous funds from pharmaceutical companies, Dr. Portenoy and his like-minded colleagues have had lucrative and illustrious careers. Dr. Portenoy is chairman of the Beth Israel Hospital (a Harvard institution) Pain Medicine department. Numerous other doctors have had similar careers and support directly and indirectly from the companies that make narcotic pain medications.

How have the drug companies fared with this investment? In exchange for investing millions over the decades in “medical education groups,” sponsoring lecturers like Dr. Portenoy, generously donating money to medical schools to “research and teach” about “pain medicine” they have generated many tens of billions of dollars in profits. For instance, my understanding is that Perdue Pharma went from making a profit of $2 billion a year to $8 billion a year when it was able to get FDA approval to approve OxyContin for treatment of chronic pain instead of just terminal cancer pain.

In my opinion, the drug companies are well-meaning but misguided, and eventually the rewarded doctors have become the modern day drug pushers, the goal seeming to be to develop a large population of addicted patients in the United States who will “require” their expensive medications for the rest of their lives.

The cost? How about up to 24,000 drug overdose deaths per year, and again with no evidence that long-term treatment really helps people.

 

The Lazarus Project

What are “we” doing to help with this? The Lazarus Project seeks (so far with increasing success) to get reversal agents such as Narcan into the hands of doctors, patients and significant others to reduce the death rate from these medications. Congress has initiated a study of the connection between for-profit drug companies and “support” for research and other academic activities.

What else are we doing? Is anybody telling doctors that maybe trying to treat chronic pain with opioids is a bad idea? No. Why? Because there’s no money in it, and because the drug companies have run such effective campaigns to get entire medical communities to believe that pain equals give prescription for opioids that a doctor is sometimes considered a bit “off” if he or she still thinks “pain medication is addicting.”

However, think for a minute: if Adam Lanza, who murdered 26 innocent people were apprehended instead of killing himself, what would have happened to him? Would he have received the death penalty?

Now think of people who have contributed to the deaths of perhaps 250,000 or more patients over the decades by deliberately pushing opioid treatment with knowledge of how dangerous these drugs are to make money or for status? What should we think of them? Should they be chairpeople of the best academic departments in the country? Should they be CEOs of pharmaceutical companies that personally make salaries of millions of dollars?

Think for yourself. Think on behalf of your patients — are you doing them a favor, are you treating their disease if you have a patient with chronic pain for whom you initiate opioid therapy?

I believe that doctors need to come to the realization that chronic pain is like any medical disease: sometimes you can cure it with treatment, sometimes you can palliate it, reduce it, increase the patient’s functionality but sometimes it eludes treatment. There are many examples of patients who experienced chronic pain from trauma or other issues who were started on opioid medication, and over a period of time, years perhaps, developed the usual problems. These patients, when they stopped taking the medication either through self withdrawal or perhaps through a program, reported feeling better and being more functional even though they continued to experience chronic pain.

There is no substitute for hard science, for blinded, controlled studies comparing a dangerous medication like opioid to the otherwise best available treatment, not a sugar pill. And these studies should be funded by truly independent grant entities such as the NIH, not drug companies! If this happens, possibly there may be a role for long-term opioid medication; however, these studies may also show that ultimately the patients actually are not better.

Editor’s note: After The Smoky Mountain News cover story last week on prescription drug overdose deaths, Dr. Allan Zacher of Lake Junaluska submitted this guest column. Zacher operates Interventional Pain Services of WNC and lectures frequently on this topic. He is board certified in the field of “pain medicine” by the American Board of Anesthesiology. Last week’s SMN cover story can be found at  http://smokymountainnews.com/news/item/10047.

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