Life Science Compliance Update

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36 posts from July 2010

July 30, 2010

Massachusetts Code of Conduct Hurts Primary Care Physicians

Last night, I read an interesting account by a local Massachusetts physician Kate Atkinson, MD on the effect the Massachusetts Pharmaceutical and Device Code of Conduct i.e. the “gift ban” is having on primary care physicians in Massachusetts.   This was originally published on Kevin MD.

 Six years ago, I organized a group of female healthcare practitioners for a women’s medical journal club. A multidisciplinary team of doctors and NPs from primary care and sub-specialties regularly attended monthly dinners. Invited speakers presented on a variety of topics and over the course of a meeting we exchanged insights while challenging each other on how best to manage our challenging patients.

Our group grew close enough to provide some much needed emotional support – something, any physician can use but more so for women providers who try to juggle work and family issues. Ultimately, we became more skilled at our craft, helping patients, while building strong working relationships with colleagues from across the community. To the surprise of some, these meetings would not have been possible without industry support. The cost of dinner and a babysitter priced many of us out once we lost that support and our group has dwindled sadly since the ban.

This is the so-called ‘wining and dining’ that is slowly being eliminated by heavy-handed conflict of interest policies being promulgated by academic medical centers (AMC) and by misguided “gift bans” being enacted by state legislatures. AMC’s purport that severing industry ties will ensure a more “pure” clinical environment (Note: no claim is made about improving patient care). And legislators have been convinced that inhibiting interactions between pharmaceutical companies and physicians will control spiraling health care costs, a myth deftly debunked by Drs. Tom Lee and James Mongan in Chaos and Organization in Health Care (neither of whom could be considered industry shills).

Although their stated goals differ, the consequences of such policies and laws are the same: Productive interactions supported by those marketing products as well as those discovering and developing products, are quickly becoming extinct.

With the rapid advances in medicine and skyrocketing health care costs, there could not be a worse time for “bans” that choke off opportunities for clinicians to gather new scientific information (even pharmaceutical marketing material must pass FDA review for scientific content and balance) and exchange real-world clinical information. Primary care, considered the bedrock of a strong health care system, is already in dire condition and cannot afford to have partially informed clinicians. Cost-effective care truly depends on access to information, whether the source is biased towards new therapies (industry) or biased towards cheap therapies (insurers and academic detailers), clinicians need all of the available information.

Primary care already suffers from low reimbursement rates relative to the value of care provided, high medical school debt-to-income ratios, and excessive insurer paperwork burdens that diminish valuable time with patients. It is no surprise that few physicians-in-training are choosing primary care and many current practitioners are choosing early retirement or are simply abandoning medicine altogether.

I can attest that running a small primary care practice is a Herculean feat and additional barriers to my success, like bans, do little to “bend the curve” of primary care decline. Like many of the other clinicians that attend our meetings, I run my own practice, and see ~100 patients per week. I also have four school-aged children. And as much as our meetings allowed us to learn about the latest products or get new information on older products, they were also about interacting with fellow colleagues. They provided a forum for mutual education and support. They also fostered detailed case discussions, sharing of medical pearls on clinical management and even tips on how to better interact with male colleagues.

We averaged 15-20 providers at each of our dinners and often hosted medical students and residents, modeling interdisciplinary work in a small town setting. (And I would challenge almost any small town to demonstrate such an vital educational group with such staying power over the years.) We also invited a highly selective group of clinicians to lecture on topics that we otherwise may not have found the time to learn by simply wading through the medical literature. In fact, in one six-month span we heard on topics including hormone-therapy, EMRs, ophthalmology, osteoporosis, alternative medicine and pain management topics. We even had a sex therapist talk which was most illuminating to many of us. In exchange for hosting our Journal Club the pharmaceutical representative used to be entitled to one talk to our group each year and we had say over who the speaker was and the topic.

Since our State enacted its “gift ban,” we have been unable to find a sponsor for our meetings. The medical society outright declined our request because our meetings were not considered sufficiently inclusive (i.e., females only). Post-“ban” we have limped along paying our own way but the truth is medical practice is demanding and chaotic for us all, and possibly even more so for women with families – the logistics alone have stymied us. We are not close to an academic teaching hospital and even our community hospital is a 40-minute drive for me and many of my colleagues. Therefore, there are no other resources of this quality and nature in our community. And if we tried to host the meetings in our homes our family members would pose a distraction. A once staunchly loyal group of 15-20 now often sees 5-6 women attending.

We limped along this past year despite immediately losing all of our NP’s and more recently losing most of our primary care doctors as well. (Sad but true that the cost of a dinner was prohibitive.) It has been painful to watch such a dynamic and supportive group dwindle over the past year. We had something truly special. In the past many people wanted to join our group – even male doctors – and we frequently received unsolicited requests from individuals interested in presenting to the group.

When the “gift ban” was passed, it seemed as if the vote was influenced exclusively by those with access to the big teaching hospitals (which ironically, according to a recent report by the Massachusetts Attorney General, we now know they are the real cost-drivers in the state)–they even wrote it so that their grand rounds could still be subsidized by pharmaceutical companies– and that there was little understanding of what we, the practitioners beyond the Boston “medical Mecca” needed. The ‘country doctors’ were not even consulted.

Many recognize that it is hard to practice primary care. And most recognize that it is particularly hard to practice in our State. What few appreciate is that it is even harder to practice in a rural area of our State, where access to resources is more limited. We had a solution that made us both better clinicians and better equipped to survive another day as clinicians for our patients – two things our nation and Massachusetts desperately need – yet politics prevailed and took this solution from our community and its patients.

Kate Atkinson is a family physician in Massachusetts


FDA: Warning Letters May Double in 2010


A recent article in MM&M highlighted how warning letters (found here) sent by the Food and Drug Administration’s (FDA) Division of Drug Marketing, Advertising, and Communications (DDMAC) could double in 2010.

In fact, it was noted that “FDA letter-writers have already been prolific in 2010 on themes of risk omission, inflated efficacy claims, and unfair balance presentation as seen in promotional materials targeting physicians and consumers.” In fact, DDMAC has already sent out 40 enforcement letters – 30 Untitled Letters and 10 Warning Letters – in 2010, compared with a total of 41 enforcement letters – 28 Untitled Letters and 13 Warning Letters – in all of 2009, according to Karen Mahoney, an FDA spokesperson. The 2010 number thus far is also substantially greater than the 21 enforcement letters DDMAC sent in 2008, 11 of which were Warning Letters.

According to Ayse Yeaton, an FDA spokesperson, “the increase in the number of regulatory letters are the result of DDMAC putting more resources into enforcement, and the FDA Enforcement Initiative announced by Commissioner [Margaret] Hamburg” last August. What has also led to the increase in letters according to Yeaton is that “the agency has also streamlined its review process for regulatory letters,” making it more efficient for DDMAC to stop more misleading promotion.”

MM&M explained how “typically, Warning Letters are more severe than Untitled Letters, although both types usually ask that recipients immediately cease the dissemination of violative promotional materials.” In addition, since 2005, Warning Letters have also requested “corrective” messaging from advertisers, or “a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed,” to be sent to any “audience(s) that received the violative promotional materials.”

In response to the increase of letters, Arnold Friede, an FDA legal expert and former attorney at Pfizer, said “People [in the pharmaceutical industry] aren't paying attention to these letters. He further added that we are “seeing repeated instances of the same kinds of violations,” such as non-disclosure of risk information and unsubstantiated efficacy claims.

Since companies are making the same mistake, Friede asked “how far up against the wall industry will push the FDA before [increasingly severe] actions are taken.” He equated the problems to the fact that companies are either “not paying attention, or they're not absorbing the lessons in the letters.”

Perhaps there is a need for more education between companies and the FDA/DDMAC to help clarify the expectations and regulations regarding marketing and advertisements.

It is important that companies take these letters very seriously as we reported last year State Attorney Generals are well aware of these letters and using them as a basis for state actions.

Before companies find themselves facing significant administrative burdens that keep their products off the market and patients uninformed, there needs to be a better dialogue about these problems, not just one way letters.   


July 29, 2010

Decrease in Commercial Support of CME Correlates with Increase in Medication Errors

Medical Errors Slide 

While the percentage of commercial support for continuing medical education (CME) has continued to drastically drop over the past few years (29% decrease from 2007 to 2009), recent data, which show an epidemic of medication errors in hospitals, make this decrease even more troublesome.

At a time when 30 million more patients will flood our hospitals, do we really need to reduce the amount of funding that goes to educate our doctors and health care providers? With an increase of 277% in medication errors this past year, according to a recent two-year investigation of Nevada hospitals by the Las Vegas Sun, doesn’t it seem obvious that the more resources we take away from educating our physicians about the proper use of medications, the less they will have to learn about how to treat us? The evidence speaks for itself already, unfortunately.

What is more disturbing about this data is that “Nevada hospitals aren’t unusual.” In fact, “there’s evidence that facilities across the country continue to hide their safety lapses.” Critics of commercial support are content on banning such funding to save costs and money. But how can that be possible if physicians who are not kept up to date on treatments “inflict unnecessary pain and suffering on patients, while also driving up the cost of healthcare, which harms other patients by limiting their access to care?”

What made the Nevada hospitals a specific target was that hospital billing records for 2.9 million inpatient visits that have been submitted to the state over the past decade showed 1,363 occurrences, in which patients are harmed or threatened with harm, but Nevada hospitals reported only 402 events for those years.

“In other words, there was a big discrepancy between what the hospitals reported to the state and what their billing records revealed about medical errors they actually treated.” The article also lists specific occurrences and uses a table to show the types of events reported.

As a result of this data, “the state now plans to audit hospital medical records in order to find out what’s really going on.” This practice could also spread because “many other states collect hospital billing records, just as Nevada does.” If similar evidence is found of errors in hospitals, it will make a strong argument for physicians needing more education to reduce such problems and with less commercial support for CME, finding resources to provide such programs will be difficult.

A few years ago, the Joint Commission, which accredits hospitals, began requiring them to report “unexpected outcomes” — another term for sentinel events. A hospital survey done soon afterward revealed that a majority of hospitals disclosed medical errors at least some of the time. Through the Joint Commission’s database, evidence showed that the number of sentinel events that all accredited U.S. hospitals had reported in 2008 and 2009 for certain kinds were continuing to increase: e.g., 126 wrong-site surgeries were reported in the first nine months of 2009, up 34 percent from the same period a year earlier. Medication errors nearly tripled from 2008 to 2009.

Data such as this reveal a need for more education of health care providers and hospitals to prevent and detect such errors. If commercial funding of CME continues to drop at the current pace, who knows how many errors physicians and hospitals will be making.

Accordingly, In light of the fact that many hospitals accept commercial funding for CME, it would be extremely harmful to patients to prohibit such events or for staff to be prohibited from attending these events.

That’s why it would be in the best interest of patients, physicians and staffs at hospitals to have the ability to give continuing education programs supported by industry on medications that will help resolve medication errors and other issues that are obviously becoming an increasingly serious problem. And since hospital funds may be tied up paying out claims for such errors, commercial funding seems to be the best and most appropriate source for effectively reducing these gaps in care.


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