Life Science Compliance Update

April 20, 2017

FDA Public Workshop on Opioid Training

FDA-pills

The Food and Drug Administration (FDA) has announced a public workshop to obtain input on issues and challenges associated with federal efforts to train prescribers on pain management and the safe use of opioids.

The workshop has three major goals. First, participants will be asked to discuss the role that health care provider training plays, within the broader context of ongoing activities, to improve pain management and the safe use of opioids. Second, participants will be asked to comment on how best to provide health care providers, who prescribe or are directly involved in the management or support of patients with pain, appropriate training in pain management and the safe use of opioids. As a part of this discussion, current training efforts by States, hospitals and health care systems, Federal Agencies, professional associations and other groups will be considered in order to strategize how best to facilitate training for these health care providers. Finally, participants will also be asked about issues and challenges associated with possible changes to Federal efforts to educate health care providers on pain management and the safe use of opioids.

The public meeting, “Training Health Care Providers on Pain Management and Safe Use of Opioid Analgesics – Exploring the Path Forward,” is scheduled for May 9th and 10th, 2017, from 8:30 am to 5:00 pm on the 9th and 8:30 am – 4:30 pm on the 10th. The event will be hosted at the Sheraton in Silver Spring, Maryland.

Seating for this event is limited and the FDA may limit the number of participants from each organization. If you are interested in attending, either in person or via webcast, you can register here. Registration closes for the event on May 1, 2017.

During online registration, you may indicate if you wish to provide a statement during the Open Public Comment Period. The FDA will do what it can to accommodate requests to make public comments based on time allocated for public comment. Individuals and organizations with common interests are urged to consolidate or coordinate their comments, and request time for a joint presentation. Following the close of registration date, the FDA will determine the amount of time allotted to each commenter and the approximate time each oral comment is scheduled to begin; commenters should arrive ahead of their scheduled time in case the agenda moves ahead of schedule so as to be sure not to forfeit their speaking time. All requests to make oral comments must be received by the close of registration on May 1, 2017. No commercial or promotional material will be permitted to be presented or distributed at the public workshop.

If time and space permit, the FDA will allow for onsite registration on the day of the workshop, starting at 7:30 am.

Comments can be submitted either electronically or written by July 10, 2017.  

April 19, 2017

New Documentary on Difficulties Faced by Patients With Chronic Pain

Webster-feature

Dr. Lynn Webster of Utah recently produced a documentary about pain treatment. The documentary, “The Painful Truth,” can be found online and on public television stations across the country and provides insight into the difficulties patients run into when trying to find effective treatment for chronic pain.

The patients featured in “The Painful Truth” include some who are fearful of losing access to opioid treatment, as well as those who say some doctors have refused to treat them and pharmacies have balked at filling their prescriptions. The apprehension among some pain patients that they won’t be able to get opioids has been reported in several media outlets, including STAT.

Webster acknowledged that several of the patients in his documentary are “miserable” even while taking opioids, and the documentary makes the point that better treatments are desperately needed. For now, however, he said opioid medications are often the best of several flawed options.

“With all of the focus on opioid addiction, we are forgetting many people with pain who have benefited,” he said. “It’s the only thing that keeps them from suicide.”

Critical Article from STAT

I was a fan of the author David Armstrong when he wrote for Wall Street Journal. However, his recent article on Lynn Webster’s documentary starts out with guilt by association. Roughly a year ago, Lynn called me and asked for advice on how to promote this documentary. At that time, he was passionate about the way pain management patients and their physicians are being unfairly shunned by society. 

Armstrong notes that Dr. Webster and several of the experts he quotes in the program have long-standing financial relationships with pain medicine makers. When asked why these relationships are not disclosed to viewers, Webster told STAT that he did not receive any drug industry funding for the documentary. He said it was funded entirely by himself and his wife.

“I am cognizant of that issue, but I think I dealt with it as carefully as I could,” he said in an interview. If viewers want to know whether any of the individual doctors associated with the documentary have financial relationships with pharmaceutical makers, Webster said they can search for that information on the web.

Dr. Webster Paid for the Documentary Himself

I encourage the media to call Lynn and hear why he did this documentary and paid for it out of his own pocket.  Yes, Lynn worked for industry but that is by no means his primary motivation to do this documentary. Go spend some time in a pain clinic and meet some patients who are truly in pain, this is by no means a binary issue.

“There are dozens of important stories about people with opioid addiction almost daily but rarely is there a story about people in pain,” Webster said in an email to STAT.

Does the Media Own Some Part of the Opioid Crisis?

It hit me recently that the Media needs to take some responsibility for the Opioid crisis, in 2004 when the Cox 2 inhibitors were slammed as “unsafe” there was no thought to what other alternative therapies that were available to alleviate pain.  Had the media or the medical community for that matter, paid just a little attention and thought, the best Cox 2 inhibitors would have been hugely successful and companies would have reaped the benefit, but the opioid crisis might never have happened.

Comments from Tom Fogarty, MD

We reached out to Tom Fogarty, Founder of the Fogarty Institute and inventor of the catheter, who stated,

Opioid addiction is a serious and worldwide problem that is ever increasing.  The reasons are multi-factorial, unfortunately a minority of physicians are responsible for this.  A doctor’s sole purpose is to relieve pain and suffering and the vast majority adhere to that doctrine. The minority who knowingly do not, should be investigated and corrected.  Continued excessive use of opioid prescriptions (easily documented) should be followed by fines and some other forms of punishment imposed upon the responsible physician.  Chronic addiction to opioids and other drugs should be handled by specialists in the field of pain management.  Dr. Lynn Webster and others should be looked to for resolution of these problems.  The majority should not be punished, that is our patients, by inappropriate laws or recommendations.

Viewpoints Should Not Be Discounted Because of Past Work History

It always bothers me when I see someone’s viewpoints discounted simply because they have worked for industry in the past. The author is capable of doing better work.

Further, Aaron Pruitt, director of content at MontanaPBS, said he was “not aware” of any financial connections between Webster and companies that make opioid pain relievers. “If there is some evidence of that, I have seen nothing,” he said. After being directed to public disclosures of those relationships, Pruitt wrote in an email, “As far as I can tell, he has been working with companies to find safer, less addictive treatments for patients.”

In a pitch to television stations offered the documentary, the distributors write that “NETA and MontanaPBS have carefully reviewed The Painful Truth, and the credentials of Dr. Webster. We have found Dr. Webster to be one of the country’s experts on pain treatment, a past president of the American Academy of Pain Medicine, and an advocate for the safe prescription of opioids.”

Disclosure: the company I own, Rockpointe, receives grants from pharmaceutical and device manufacturers for accredited educational programs.

April 13, 2017

McCaskill Opens Investigation into Opioid Manufacturers

Claire McCaskill

Senator Claire McCaskill, Ranking Member of the Senate’s Homeland Security and Governmental Affairs Committee, has launched a wide-ranging investigation into the business practices of the manufacturers of America’s top five prescription opioid products (based on 2015 sales). The investigation is slated to explore whether pharmaceutical manufacturers have contributed to the opioid epidemic with which America is currently dealing.

Senator McCaskill sent letters to Purdue, Janssen (parent company: Johnson & Johnson), Insys, Mylan, and Depomed, asking for information related to the sale, marketing, and education strategies these companies have used to promote opioids. She is asking for information, including:

  • Documents showing any internal estimates of the risk of misuse, abuse, addiction, overdose, diversion or death arising from the use of any opioid product or any estimates of these risks produced by third-party contractors or vendors;
  • Any reports generated within the last five years summarizing or concerning compliance audits of sales and marketing policies;
  • Marketing and business plans, including plans for direct-to-consumer and physician marketing, developed during the last five years;
  • Quotas for sales representatives dedicated to opioid products concerning the recruitment of physicians for speaker programs during the last five years;
  • Contributions to a variety of third party advocacy organizations; and
  • Any reports issued to government agencies during the last five years in accordance with corporate integrity agreements or other settlement agreements.

McCaskill Has Long Been Involved in the Epidemic

This is not McCaskill’s first effort in attempting to uncover what has contributed to this epidemic. Earlier this year, she requested the Department of Justice Office of the Inspector General open an investigation into the role of drug distributors in the opioid epidemic. She's also been involved in investigating Medicare Part D's role in preventing abuse of prescription narcotics.

“I hear it everywhere I go — drug overdose deaths, the vast majority of them related to prescription opioids or heroin, are single-handedly destroying families and communities across Missouri and the country,” McCaskill said in a statement.

“The vast majority of the employees, executives, sales representatives, scientists and doctors involved with this industry are good people and responsible actors, but some are not,” McCaskill said. “This investigation is about finding out whether the same practices that led to this epidemic still continue today, and if decisions are being made that harm the public health.”

Manufacturer Response

John Puskar, the spokesman for Purdue Pharma (manufacturer of OxyContin), said in an email that the “the opioid crisis is among our nation’s top health challenges, which is why our company has dedicated itself for years to being part of the solution. OxyContin accounts for only 2% of the opioid analgesic prescription market nationally, but we are an industry leader in the development of abuse-deterrent technology and advocating for the use of prescription drug monitoring programs. We are reviewing Senator McCaskill’s letter and will respond accordingly.”

Jessica Castles Smith, the spokeswoman for Janssen (owned by Johnson & Johnson), said in an email that the company would address McCaskill’s request. She said the company believes it has “acted appropriately, responsibly and in the best interests of patients regarding our opioid pain medications, which are FDA-approved and carry FDA-mandated warnings about the known risks of the medications on every product label.”

Christopher Keenan, the spokesman for Depomed, said the company has received McCaskill’s letter and “will cooperate accordingly.”

Nina Devlin, the spokeswoman for Mylan, called on McCaskill to include more opioid suppliers and said the company was only the 17th biggest opioid supplier in 2016, noting that, “[d]espite being a small player in this area, we are committed to helping find solutions to the issue of opioid abuse and misuse.”

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