Follow the Money and the “Experts” It Buys
Because of the fear of addicting patients, physicians seldom prescribed opiates until the mid-1980s and early 1990s. At that time “medical experts” and “thought leaders” led by the neurologist and pain specialist Russell Portenoy, MD, proclaimed that the risks of addiction to opioids were minimal and that not treating pain was cruel and even amounted to medical negligence. Pain was to be considered the fifth vital sign.1 To this day in most American hospitals nurses on their daily rounds ask patients to rate their pain on a scale of one to ten and then may administer a narcotic accordingly.
Portenoy once had an impeccable reputation. He wrote numerous articles and book chapters on pain and has won many accolades and awards. He was known as the “King of Pain.” He was the Chairman of Pain Medicine and Palliative Care at Beth Israel Hospital in New York. Portenoy and other “thought leaders” had been so influential in promoting the safety of opioids that regulatory agencies such as the Joint Commission which accredits hospitals and the Federation of State Medical Boards wrote guidelines and rules for the treatment of pain. In many cases hospital lawyers warned physicians that their patients could sue them if they did not treat their pain adequately.2
Portnenoy and his acolytes wrote articles and gave lectures to physicians about the safety of narcotics they repeatedly cited a study by Porter and Jick in The New England Journal of Medicine that stated that only 1% of patients treated with narcotics became addicted. Time magazine described the Porter and Jick article a “landmark” study.3 The problem was that Porter and Jick’s so-called ‘landmark study’ was incredibly not a controlled study at all. It consisted of a short 101-word one paragraph letter to the editor. The lead author Hershel Jick, MD, has repeatedly stated that his letter to the editor has been misinterpreted. It was based solely on hospitalized patients and did not apply to patients after they left the hospital.4
Recently and belatedly, Portenoy has backtracked and admitted he was wrong about the addictive properties of opioids. He stated: “I gave innumerable lectures in the late 1980s and ‘90s about addiction that weren’t true.”5 Incredibly the much discredited Portenoy remains the chairman of the pain clinic and palliative care clinic at Beth Israel Medical Center.
Based on false statements about the addicting properties of opioids and the assertions that leaving pain untreated might constitute malpractice the genie was out of the bottle. As of 2011, 75% of the world’s opioid prescriptions were in the United States which comprises 5% of the world’s population. Opioids are the most common cause of preventable death in America today - a horrifying and shameful statistic!6 It is estimated that 50% of opioid overdoses resulting in death are from physicians’ prescriptions. From 1999 to 2014 opioid prescriptions quadrupled and there were more than 165,000 deaths related to opioid overdose.7 (See Figure 1.)
Figure 1.
But statistics on death do not tell the whole story. Thousands of lives have been destroyed by opioid addiction and a like number of families have been devastated and disrupted never to see their loved ones return to a normal productive life. In his book “Dreamland: The True Tale of America’s Opiate Epidemic” investigative reporter Sam Quinones documents the prescription drug problem in America. He writes that drug addiction crosses all social strata affecting white middle class families from all walks of life including families of doctors, lawyers, judges, business people, politicians, and police.8
‘Follow the Money’
In attempting to understand the role physicians and researchers with financial conflicts played in creating the drug problem it is essential to follow the money. Dr. Portenoy and his pain center have received millions of dollars of funding from many pharmaceutical companies including Purdue Pharma, the manufacturer of oxycontin, as well numerous other well known drug manufacturers such as Mallinckrodt, Wyeth, Baxter, and Pfizer. Portenoy has admitted to having financial relationships with more than a dozen companies most of which produce opioid pain killers. Portenoy defends himself with the statement: “My viewpoint is that I can have these relationships [and] they would benefit my research mission and to some extent they can benefit my own pocketbook, without producing in me any tendency to engage in undue influence or misinformation.”9 [Editor’s note: emphasis added]
When drug companies fund research published in prestigious medical journals or give money to physician or PhD speakers at medical meetings or at upscale restaurants, practicing physicians should be very skeptical and hyper-critical of their findings and recommendations. The conflicts of interest are real and their conclusions are frequently suspect.
The American Medical Association has addressed this problem as have academic medical centers and scholarly medical journals. Their solution is currently that simply disclosing conflicts of interest is sufficient. It is left up to physicians and researchers to determine whether the research is valid. In the case of opioid prescribing this “buyer-beware” strategy has been a disaster. Busy doctors are in no position to evaluate shoddy research.
Purdue Pharma has paid over $600 million in fines for misrepresentation of the addictive properties of oxycontin and three of their chief executives were criminally charged.10 But does that restore the lost or ruined lives of the tens of thousands of victims and their families? And what has happened to Portenoy and the other “experts” and “thought leaders” who falsely promoted the safety of opioids? What has happened to the Joint Commission and the Federation of State Medical Boards and hospital lawyers all of whom played ‘follow the leader’ and climbed on the opioid bandwagon and advised doctors they had better treat pain with opioids or possibly face sanctions or malpractice claims? The answer is a resounding nothing.
Physicians believed the false message of Portenoy and the other industry compensated “thought leaders” on the safety and the non-addictive properties of opioids. And now these physicians are being blamed for their role in causing the opioid epidemic-deservedly so in my opinion.
New studies show that opioids are not effective in most non-cancer chronic conditions causing pain. Such studies were available in the past but were ignored. The Centers for Disease Control and Prevention (CDC) has issued new guidelines against opioid prescriptions for chronic pain.11 It is well recognized that patients receiving opioids long term can develop both tolerance and hyperalgesia or increased sensitivity to pain.12
The industry financed and physician led-physician driven opioid disaster proves, like no other example, that the policy of simple disclosure of conflicts of interest do not work. Probably nothing will be done about the problems of conflicts of interest. There is simply too much money at stake in our commercialized health care system for those who profit from these conflicts of interest: drug companies, academic medical centers, hospitals, researchers, medical education programs, and finally some physicians.
The commercialization of Medicine is the result of a little known 1972 unanimous Supreme Court decision known as Goldfarb. This decision ruled that Medicine (and Law) were no longer to be considered learned professions but were to be considered “ordinary purveyors of commerce.”13 Right after the Goldfarb decision the Federal Trade Commission sued the American Medical Association successfully and removed one of its most important Principles of Medical Ethics which was a restatement of the Hippocratic Oath.14 Both of these Supreme Court decisions were intended to lower health care costs. Ironically they did not lower costs. Health care costs have increased dramatically since their enactment.15
When the practice of Medicine loses its ethical foundation and operates by the rules of the market place rather than ethical standards one can expect that disasters like the money driven-physician caused opioid epidemic to occur again. Physicians should be very skeptical and extremely careful in analyzing research by physicians and researchers compensated by pharmaceutical companies. They ought to avoid attending lectures given by physicians with blatant conflicts of interest. If these ethical bright lines had been honored with regard to opioid prescribing a great American tragedy might have been prevented.
Biography
Arthur H. Gale, MD, MSMA member since 1976, is a Missouri Medicine Contributing Editor. He practice Internal Medicine in St. Louis.
Contact: agalemd@yahoo.com
References
- 1.Catan Thomas, Perez Evan. A Pain-Drug Champion Has Second Thoughts. The Wall Street Journal. 2012 Dec 17; [Google Scholar]
- 2.ibid
- 3.ibid
- 4.Quinones Sam. Dreamland, The True Tale of America’s Opiate Epidemic. 2015. [Google Scholar]
- 5.Catan Thomas, Perez Evan. ibid. [Google Scholar]
- 6.Gupta Sanjay. CNN. May 12, 2016. Doctors Must Lead Us Out of Our Opioid Abuse Epidemic. [Google Scholar]
- 7.Centers for Disease Control and Prevention. Mar 12, 2016. [Google Scholar]
- 8.Quinones Sam. ibid. [Google Scholar]
- 9.Catan Thomas, Perez Evan. ibid. [Google Scholar]
- 10.Catan Thomas, Perez Evan. ibid. [Google Scholar]
- 11.Zalkind Susan. The Guardian. Mar 17, 2016. CDC Issues Guidelines Against Opioid Prescriptions to Treat Chronic Pain. [Google Scholar]
- 12.Melville Nancy A. Opioid Tolerance or Hyperalgesia? Key Symptoms Offer Clues, Medscape. 2013 Sep 16; [Google Scholar]
- 13.Goldfarb v. Virginia State Bar (421 U.S. 773 [1975])
- 14.American Medical Association v. FTC. (421 U.S. 676 [1975])
- 15.The Commonwealth Fund. A Comparison of Hospital Administrative Costs in Eight Nations: U.S. Costs Exceed All Others by Far. Sep, 2014. [DOI] [PubMed] [Google Scholar]