Life Science Compliance Update

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 04, 2017

JAMA Harps on PAOs

Pill_bottles_cash

JAMA Internal Medicine recently published an article, “Patient Advocacy Organizations, Industry Funding, and Conflicts of Interest.” The article focused on the nature of industry funding of patient advocacy organizations (PAOs) in the United States.

As the basis for the article, a survey was conducted from September 1, 2013, to June 30, 2014, of a nationally representative random sample of 439 PAO leaders, representing 5.6% of 7865 PAOs identified in the United States. Survey questions addressed the nature of their activities, their financial relationships with industry, and the perceived effectiveness of their conflict of interest policies.

Of the 439 surveys mailed to PAO leaders, 289 (65.8%) were returned with at least 80% of the questions answered. The PAOs varied widely in terms of size, funding, activities, and disease focus. The median total revenue among responding organizations was $299 140 (interquartile range, $70 000-$1 200 000). A total of 165 of 245 PAOs (67.3%) reported receiving industry funding, with 19 of 160 PAOs (11.9%) receiving more than half of their funding from industry. Among the subset of PAOs that received industry funding, the median amount was $50 000 (interquartile range, $15 000-$200 000); the median proportion of industry support derived from the pharmaceutical, device, and/or biotechnology sectors was 45% (interquartile range, 0%-100%). A total of 220 of 269 respondents (81.8%) indicated that conflicts of interest are very or moderately relevant to PAOs, and 94 of 171 (55.0%) believed that their organizations’ conflict of interest policies were very good. A total of 22 of 285 PAO leaders (7.7%) perceived pressure to conform their positions to the interests of corporate donors.

The study found that roughly two-thirds of a national sample of patient advocacy organizations (most of which were not for profit), reported receiving funding from for-profit companies. Twelve percent received the majority of their funding from industry; a median proportion of just under fifty percent of industry funding was derived from the pharmaceutical, device, and/or biotechnology sectors.

The authors of the study felt as though patient advocacy organizations engage in wide-ranging health activities. Although most PAOs receive modest funding from industry, a minority receive substantial industry support, raising added concerns about independence. Many respondents report a need to improve their conflict of interest policies to help maintain public trust.

Conclusion

As noted above, the article found that most advocacy organizations receive money from industry. Therefore, the authors of the study concluded that increased transparency and robust conflict of interest policies and practices are needed to help the non-profit organizations maintain their independence.

However, as we have noted time and time again, conflict of interest policies and practices (along with transparency efforts) are not always the answer, and are not usually required to help non-profit (or even for-profit) organizations maintain their independence.

Additionally, the sample size for the study was only 5.6% of the 7865 PAOs identified in the United States. This is such a small sample size, and any results assumed from such a small sample size, nationally representative or not, should not be taken as an impetus for change. Transparency is confusing to the general population, who typically care about getting the healthcare they need, when they need it. Patience assistance organizations play a large role in helping those who need healthcare and other related items get what they need – they should not be targeted as the new “bad guy.”

March 29, 2017

Chicago Releases Draft Rules on Industry Representative Licensure

Regulation-art

In a city where crime rates are sky-high and illegal drugs are easily picked up on the street, on November 16, 2016, the City of Chicago passed an ordinance that, effective July 1, 2017, requires pharmaceutical sales representatives to become licensed before they can promote prescription drugs to health care providers within city limits. 

Mayor Rahm Emanuel states that the new licensing requirement is part of a larger series of efforts by the city to combat heroin and opioid addiction. However, the law will impose significant new burdens on any pharmaceutical manufacturer with sales representatives who call on health care providers in Chicago.

The draft rules for this ordinance were released on March 17, 2017.

These recently-released draft rules provide additional detail regarding the licensure requirements as well as other associated education and disclosure requirements with which pharmaceutical representatives will be expected to comply beginning in July of this year.

To obtain their initial licensure as a pharmaceutical representative, applicants must complete an online course, for which proof of completion must be submitted. The cost of the initial license will run each representative $750. Then, to maintain the license, representatives must complete a minimum of five hours of continuing professional education every year thereafter. 

Approved providers for continuing professional education can be found on the city’s website. Making this burden even more onerous, continuing education provided by pharmaceutical manufacturers to their employees will not be accepted as fulfilling the requirement, unless the manufacturer previously applied for, and received, approval. A licensed representative who does not meet these continuing education requirements may face substantial penalties, including suspension or revocation of the license, inclusion in a public list of representatives whose licenses have been revoked, and/or a fine between $1,000 and $3,000 per day of violation.

In addition to the professional education requirement, pharmaceutical representatives will also be required to track and report certain sales information on an annual basis or upon request by the Commissioner of Public Health. This information must include: a list of the health care professionals who were contacted, the location and duration of each contact, the pharmaceuticals that were promoted, and whether product samples or any other compensation was offered in exchange for the contact.

For applicants who receive initial licensure, the time period for the data that must be collected and reported shall cover an 11-month period, starting on the first day of licensure and exactly ending one month before its expiration. For representatives with a renewed license, the data shall cover a 12-month period that will begin one month before the license renewal and will end one more before its expiration.  If the Commissioner of Public Health requests the information at any other time, the request will designate the time period the submission must cover, and it will be due within 30 days of the request.

A pharmaceutical representative who is found to have violated any provision of the Ordinance or these rules will be subject to suspension or revocation of licensure and/or a fine of $1,000 to $3,000 per day of violation. Inexplicably, once a license is revoked, it cannot be reinstated for a period of two years from the date of revocation.

These new requirements will place a significant burden on pharmaceutical manufacturers and their sales representatives who work in Chicago. Late last year, in an attempt to prevent the ordinance from going into effect, a coalition of sixteen pharmaceutical companies, along with organizations such as the Illinois Chamber of Commerce, the Illinois Manufacturer’s Association, the Epilepsy Foundation of Greater Chicago, and the Pharmaceutical Research and Manufacturers of America, wrote a letter to the City Council of Chicago expressing its concerns. The group noted, “[t]hese proposed reporting requirements are unnecessary and duplicating, creating an unnecessary tax on one of the most important sectors of our economy.”

The public is invited to submit any comments it may have on the proposed rules by April 2, 2017. readers are encouraged to send in comments, especially those local to the Chicago area to submit their comments about these regulations. The pharmaceutical industry is one of the most regulated industries in the country as it is.  The FDA requires reps to distribute REMS information on drugs that their company provides.  It is not clear how tracking the office visits and amount of time spent with healthcare providers by pharmaceutical reps is in the public interest.

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