FDA Announces Social Media Guidelines–Yawn!

Posted in Social Media

After a very long blogging absence, I decided that it was time for me to begin to write posts on things that continue to pique my interest.  The recent announcement that the US Food and Drug Administration (FDA) has finally released its long awaited guidance on the use of social media in the life sciences industry including pharma, biotech and med. devices.

While words like long awaited have been used to describe this monumental announcement, I think nobody really cares anymore about what the agency thinks about social media!  Put simply, despite some interested starts and stops, social media is not an integral part of the life sciences industry and likely will never be.  In the beginning (about a decade ago) social media transformed a number of industries by introducing transparency and engaging stakeholders to improve their bottom lines. Unfortunately, the modus operandi in the life sciences industry, by virtue of it business model, is opaqueness not transparency. Further, life scientists and life science employees are not the most social individuals and their use of social media for business purposes is almost non-existent. Consequently, social media and the life science industry are not a good fit!!!! Finally, early players in the life science social media space including Novo Nordisk and J&J have already leveraged what they could using social media and have moved on.

In summary, while it may be a banner day at FDA because the agency finally released its social media guidelines, I do not think anybody really cares anymore. The trajectory of social media is on its downward slope and it is no longer fresh or new (except maybe in the minds of pharma/biotech executives).  In fact, social media is no longer new media and is now considered a standard staple of all communication platforms. While many industries benefited from social media it was never a priority for the life sciences industry and industry executives (and US regulators) did everything in their collective power to ensure that social media did not interfere with the secrecy and intentional opaqueness that dominates the industry.

Until next time,

Good luck and Good Job Hunting

Breaking Up Is Hard to Do: Abbott Labs Announces Plans to Split into Two Separate Companies

Posted in BioBusiness

Abbott Laboratories today announced that it will split itself into two companies by spinning off its branded prescription drug business and creating a second company responsible for its medical implants, diagnostic tests and baby formula businesses.

The pharmaceutical company will exclusively sell its branded prescription drugs (including its blockbuster biologic Humira) and will be lead by Abbott’s Richard Gonzalez who currently head the company’s pharmaceutical business. Current Abbott CEO Miles White will lead the diversified medical products company. 

The reason for the split is to allow investors to value each of the companies on their distinct characteristic. Abbott’s decision to split the company is consistent with the prevailing notion that companies that sell both prescription drugs and consumer products don’t perform well. This led Bristol Myers Squibb to sell off its medical devices and consumer products divisions several years ago. Interestingly, prescription pharmaceuticals/consumer products/medical devices were de rigueur in the 1990s and early 2000s. Abbott’s decision leaves companies like Pfizer, Novartis and Johnson & Johnson as examples of the few remaining companies that still house pharmaceuticals, devices and consumer goods under one roof. Don’t be surprised if in the future these companies also decide to spin off or divest themselves of their consumer goods/medical devices divisions.

Finally, while the split may be good for investors, it may not be that great for Abbott employees. Usually, spin offs or divestitures

Until next time..

Good Luck and Good Job Hunting!!!!!!!!!!!!!!


A New Way Forward for FDA?

Posted in BioBusiness

Last week, US Food and Drug Administration (FDA) Commissioner unveiled a “blueprint” that contained immediate and actionable steps that can be taken to spur innovation in the life sciences. The report’s proposals stem from a review of FDA’s current policies and practices, as well as months of meetings with major stakeholders nationwide, including key industry leaders, small biotech, pharmaceutical and medical device company owners, members of the academic community, and patient groups. Entitled “Driving Biomedical Innovation: Initiatives for Improving Products” the report focuses on seven major actions:

  1. rebuilding FDA’s small business outreach services
  2. building the infrastructure to drive and support personalized medicine
  3. creating a rapid drug development pathway for important targeted therapies
  4. harnessing the potential of data mining and information sharing while protecting patient privacy
  5. improving consistency and clarity in the medical device review process
  6. training the next generation of innovators
  7. streamlining and reforming FDA regulations

The blueprint was issued in response to growing concerns that—despite record investments in biomedical R&D—the drug pipelines at many US life sciences companies has grown exceedingly thin. Not surprisingly, most life sciences companies blame the agency for the thinning pipelines but in reality both side have contributed to the problem. Hamburg’s bold plan seems reasonable. But, it can only be implemented if Congress provides sufficient funding to underwrite the new initiatives proposed in the plan. And, while these funds ought to be allocated, it is not clear whether or not it is likely given the poor economy and the current, unprecedented political divisiveness that exists in Washington these days.

Moreover, Mark Senak, author of the Eye on FDA blog, suggests that FDA can improve its effectiveness by learning how to communicate better with its stakeholders. Mark, a social media advocate provides this compelling insight into FDA’s communication problems and the agency’s inability to grasp that the Internet and social media can help to improve its communication skills:

"The extremely long track record of FDA in attempting to figure out the Internet (first public meeting held in October 1996) and social media (first public meeting held in November, 2009) has yielded no guidance, with little transparency into the process.  It is time for FDA to seek outside communications expertise to help the agency better formulate policy on a timely basis."

While I believe that Commissioner Hamburg’s blueprint for improvement is a good one, it isn’t clear whether she will get the necessary support to implement it.

Until next time…

Good Luck and Good Job Hunting!!!!!!!!


Social Media Update: US Food and Drug Administration To Regulate Mobile Apps?

Posted in Social Media

Mark Senak, author of the highly informative and well written Eye on FDA blog, reported today that a recent article that appeared on the American Medical News website suggests that the US Food and Drug Administration (FDA) may be considering regulating mobile apps that contain medical or clinical components. While the agency has yet to officially publish guidance on the use of social media in the life sciences industry, it now appears that FDA may be turning its attention on the development of mobile apps; one of the fastest growing segments of the social media movement.

The reason why FDA is taking notice of mobile apps is because a handful of app developers have sought and received FDA clearance for their mobile apps that—because of clinical components —are considered to be “medical devices.” As many of you may know, medical devices which include band-aids, surgical instruments, heart monitors, cardiovascular stents and diagnostic kits, all must receive marketing approval by the agency before they can be sold in the US. Although the agency yet to craft any guidance for clinical/medical app development, it makes sense that FDA ought to evaluate and regulate these products to insure that they are medically-effective and safe. 

According to the American Medical News article, the first app developer to receive FDA market clearance was AirStrip Technologies in San Antonio, for its AirStrip OB application. The app, which was approved in 2009, allows physicians to monitor mother and newborn remotely during delivery. In February, the FDA granted clearance to MobiUS, an app developed by Mobisante, a medical device company in Redmond, Wash. The app permits viewing of medical images for diagnostic purposes. Mobile MIM, a remote diagnostic imaging tool developed by Cleveland-based MIM Software, was also granted market clearance that month. A number of pharmaceutical companies, most notably Pfizer, have been extremely active in the mobile clinical app development space.

The reason why it makes sense for FDA to regulate certain clinical/medical apps is because physicians will rely on them to make medical decisions. For example, the AirStrip OB mentioned above will ostensibly allow physicians to remotely monitor a mother and neonate during delivery. Consequently, the app, aka device, must be evaluated by the agency to determine whether or not it can be used safely and effectively by physicians during childbirth. In this case, the app is similar to a heart monitor that is used during childbirth. And, like all other medical devices, the heart monitor required FDA clearance to determine its safety and effectiveness, before it could be used in real-life childbirth situations. To that end, the agency has hinted that it will be much more proactive in monitoring this new class of devices.

I have no doubt that many pharmaceutical companies and medical devices manufacturers will not be pleased when they learn that the agency is going to “stick its nose” into mobile app development. Nevertheless, in my opinion, if a mobile app is going to be used in possible “life or death” situation, then it ought to be regulated by FDA—the agency that is legally responsible for regulating these types of products. That said, Eye on FDA’s Mark Senak raises a number of valid and insightful points about FDA and its possible role in mobile app development.

“Related to a possible guidance for apps, there are a lot of questions that need to be answered when considering its development – when is an app a medical app?  When does it require regulation?  Who will pay for the oversight – will there be App Developers User Fee Act (ADUFA?) and if so, what will that do to the price and to access.  Will insurance companies have to cover apps?  And what will the process for approval be – something like a 510(k)?”

Finally, I think that the app developers who proactively approached FDA for guidance abut the clinical apps that they were developing “got it right.” This will get the agency “thinking” about clinical/mobile apps and how they ought to be approved and regulated in the future. In turn, this will provide future app developers with a clear regulatory framework that will guide the development of cost effective, safe and efficacious mobile clinical apps.

Until next time…

Good Luck and Good Job Hunting!!!!!!!


Pharmaceutical Direct-to-Consumer (DTC) Advertising Goes Mobile

Posted in BioBusiness

While big pharma continues to struggle with the use of social media to promote its products, direct-to-consumer advertising (DTC), the method of choice for American pharmaceutical advertising is alive, well and robust. Therefore, it should come as no surprise that big pharma is reallocating some its traditional DTC advertising dollars to deliver drug ads to mobile devices which are growing in popularity. 

According to a recent article posted on PharmaLive, drug companies are mainly using mobile devices —in addition to delivering ads—to “help educate patients and motivate them to seek, accept, and adhere to therapy.” In other words, to more effectively promote their products to improve sales and corporate profits. Regardless of the motive, medical communication agencies have recognized the trend and have responded by launching mobile divisions and initiatives at their firms. Some agencies are now generating close to 50% of their revenues from mobile initiatives and campaigns. Further, many pharmaceutical companies have finally realized that corporate websites can be more than simple placeholders on the Internet. To that end, the PharmaLive post notes that pharmaceutical brand websites are evolving into a robust resource structured to be easily searchable and maintained. Maybe a better understanding and use of social media is next up for drug makers.

Pfizer remains the leading spender and purveyor of DTC advertising despite a 15% overall decrease in 2010 as compared with 2009. PharmLive reports that the company allocated $903.8 million to brands such as Lipitor, Pristiq, Viagra, Chantix, and Lyrica. Of these brands, Pristiq saw the highest increase of DTC advertising in 2010, up 17% to $122.2 million compared to 2009.

As mobile media continues to grow, don’t be surprised if someone develops a TIVO-like fast forward app to skip all of the DTC ads on your iPhone or android devices.

Until next time..

Good Luck and Good Job Hunting!!!!!


FDA Inspections: Insights into Responding to FDA Inspectional Observations

Posted in BioBusiness

US Food and Drug Administration (FDA) inspections of drug and devices manufacturing facilities are typically anxiety ridden exercises that can strike fear into even the most seasoned quality and regulatory affairs professionals. And, most manufacturing facilities do not escape these inspections unscathed and are routinely cited, in many cases, for minor infractions.

For those of you who may not be familiar with FDA inspections, manufacturing facilities that produce approved drugs and devices must be inspected every two years for insure regulatory compliance with Current Good Manufacturing Practices (CGMPs). During the inspection, FDA inspectors document “significant objectionable conditions, relating to products and/or processes or other violations of the Food Drug and Cosmetic Act” that they observe. These are known in the industry as Form FDA 483 Inspectional Observations or simply 483. Companies that receive 483s must correct the so-called objections conditions to remain CGMP compliant.

While receiving 483s during an inspection may be routine, it can be overwhelming to inexperienced companies and their representatives. With this in mind, I found a great blog post by Bruce McDuffee, Global Marketing Manager, Veriteq that provides insights on interacting with the agency to manage 483s. He offers the following advice:

“One thing that you should be clear about is that this is not a ‘warning letter’; it is an offer to help you resolve issues and improve your quality system. The FDA may or may not issue a warning letter next if you have not addressed the conditions of the 483 to its satisfaction. Receiving a 483 does not necessarily mean you are out of compliance.

In responding to a 483, your objectives should include these three things; establish credibility, demonstrate acknowledgement and understanding of the observations and the associated requirements and show commitment to corrective actions."

Bruce recommends that you take the following actions when dealing with 483s:

  1. Get your response in on time or even early if possible. The FDA wants to see the response within 15 days, so plan your review and internal processes accordingly.
  2. In the first paragraph, demonstrate your understanding of and desire to comply with FDA regulations.
  3. Respond individually to each item addressed on the form. Give a corrective action and time-frame for implementing.
  4. Prioritize by first addressing the conditions that will most likely affect product quality.
  5. Outline how and when each deficiency will be corrected.
  6. Avoid talking about whose fault the issue is or how it came to be. For example, keep a positive tone and indicate how the quality system will be improved.
  7. Include any reference documents, such as purchase agreements for a new monitoring system or employment agreement for a new quality manager.
  8. Keep in mind that there is a formal process available for you to dispute the findings.
  9. Be proactive in addressing the conditions. For example, address why the deficiencies were not detected internally and what will be done to correct this condition.
  10. Seek clarification with the inspector when you receive the 483 on the spot. Be sure you understand each objectionable condition before the inspector leaves the site. It may behoove you and your firm to seek out an industry expert if the matters seem complex or if the issues are not able to be resolved by your own personnel.”

While CGMP and regulatory compliance may seem like arcane concepts, they are vitally important and must be clearly understood by companies that are manufacturing FDA-approved drugs and devices. Failure to comply can result in penalties, monetary fines and revocation of a license to manufacture a drug or device.

Until next time….

Good Luck and Good Job Hunting (try regulatory affairs or quality assurance and control)


Some Medical Devices Companies Jump on the FDA-Bashing Band Wagon

Posted in BioBusiness

Many life sciences company executives will tell you that getting US Food and Drug Administration (FDA) approval for their products has gotten tougher than it has been in the past 10 years or so. This shouldn’t come as a surprise to most BioJobBlog readers because there was almost know regulation of pharmaceutical, biotechnology and medical devices products during the eight years that Bush was in power. Seemingly, many life sciences companies have forgotten that FDA’s mission is to provide the American public with SAFE and efficacious drugs and devices; not to quickly approve products to bolster a company’s stock share price. That said, some medical devices companies, like their pharmaceutical and biotechnology cousins, have begun to complain about the FDA regulatory process for medical devices.

Historically, the regulatory challenges for getting medical devices approved have always been much lower than those for garnering approval of prescription drugs, vaccines and other biological products. Since 2000, the regulations guiding regulatory approval for medical devices had grown extremely lax.  For example, there has recently been a spate of recalls for certain previously-approved devices including cardiovascular stents, implantable cardiac devices and hip replacements.

The Obama administration is attempting to restore the rigor of the approval process and some medical devices companies are extremely unhappy about it. This renewed effort has forced some devices companies to eschew the lucrative US devices market entirely in favor of European and Asian markets; mainly because they were unable to garner FDA approval for their devices. Interestingly, the companies that are complaining the loudest are start ups rather than established medical devices companies. Their main complaints are the ever-increasing size of the clinical trials and length of time it takes to win regulatory approval for their products. Not surprisingly, these complaints are mostly driven by financial pressures at the start ups. Because of the recession, many of the venture capitalists who backed these companies have less money to invest and demand quicker and higher returns on their investments. Consequently, many of the star tups are under capitalized and simply don’t have the financial resources to stay in business and wait for FDA approval. While I understand their business pressures and urgency, winning FDA approval is suppose to be about safety and efficacy not about ROI. Maybe start up devices companies experiencing these difficulties ought to retool or reinvent their business plans!

To be clear, FDA approval rates for medical devices are down; 19 premarket approvals (PMA) were granted in 2010 as compared with 48 in 2000. Also, the average time to win 510(k) clearance (less stringent than PMA and used for most devices) rose to 116 days in 2008 from 97 days in 2002. There is no question that winning regulatory approval for new medical devices may seem to be getting tougher than in the recent past. But, if that helps to improve efficacy and patient safety than I don’t necessarily think that it is such a bad thing. And as Stephen Oesterle, MD senior vice president for medicine and technology at Medtronic (one of the world’s largest medical devices companies) aptly said in a recent NY Times article “The FDA is asking for larger trials, more thoughtful trials, all in the interest of the American public.”

Until next time…

Good Luck and Good Job Hunting!!!!


FDA Begins Reining In Genetic Testing Companies: It's About Time!

Posted in BioBusiness

The US Food and Drug Administration (FDA) announced on Friday that it will begin monitoring and investigating the services offered by consumer-focused, personal genomic testing companies. In warning letters to five companies, the agency notified company executives that their tests are considered medical devices and therefore must be federally approved as safe and effective. None of the companies have submitted their products for approval, according to the FDA. Further, the agency contends that personal genomic tests as medical devices must be “analytically and clinically accurate so that individuals are not misled by incorrect test results or unsupported clinical interpretations." Previously, the agency hadn’t definitively classified the tests as medical devices. However, the agency has become increasingly concerned that results from the tests may ultimately be used for diagnostics and prognostic purposes by various entities including insurance companies and employers.

The companies that received letters on Friday included California-based 23 and Me (backed by Google Health), Navigenics and Illumina and Knome of Cambridge, Mass.; and deCode Genetics of Lake Barrington, Ill. The FDA sent a similar letter in May to Pathway Genomics of San Diego, after Pathway announced it intended to sell its tests through Walgreens drugstores. Many industry insiders believe that the proposed Pathway Genomic-Walgreens was the proverbial “straw that broke the camel’s back” which prematurely forced the agency to take regulatory action.

The letters deal with specific tests marketed by: 23andMe Inc., deCODE Genetics, Illumina, Navigenics and Knome Inc. FDA asks each of the companies to contact the agency to make arrangements for submitting their tests for review. 23andMe and Navigenics and DeCode Genetics, sell tests that scan a person’s DNA, looking at genetic variations that can suggest whether a person is at a higher or lower risk of getting certain diseases like cancer or diabetes. Illumina sells DNA chips that are used by some companies to do the DNA scans whereas Knome offers consumers a complete sequence of their DNA, which can be used to glean disease risk information. While 23 and Me is pushing back, deCode Genetics CEO stated that the company will work with the agency to legitimize its tests as part of “standard medical care.” Knome, whose whole genomic sequencing platform will ultimately supplant the services offered by 23 and Me, Navigenics and Pathway Genomics, has also expressed a willingness to work with the agency.

Despite the existence of theGenetic Information Nondiscrimination Act (GINA) enacted in May 2008—which ostensibly would shield patients from potential “genetic discrimination”—many privacy and medical information advocates fear that loopholes will allow insurance companies and prospective employers to abuse the results from personal genomic analyses. To that end, GINA does not cover life, individual disability insurance, or long-term care insurance, and the potential for genetic discrimination still exists in these areas. For example, a person at genetic risk for developing Alzheimer’s could be denied long-term healthcare insurance because Alzheimer’s patients have been known to live for long periods of time, and their care is costly.

Another legitimate concern raised by some people is ownership of the results of personal genomic analyses. Surprisingly, at present, it isn’t clear who owns or ultimately controls a person’s genetic information data after it is generated. For example, it is likely (but not certain) that a consumer who purchases whole genome sequencing services from a personal genomics company owns and controls his/her sequence data. Ownership and control of the information isn’t likely to be straightforward or easily defined until rules and regulations are crafted to clarify how genomic information is owned, stored, and accessed by individuals and third parties.

While companies like 23 and Me and their ilk aren’t pleased that FDA has finally classified their tests as medical devices, they had to know that regulatory oversight of the personal genomic testing business was inevitable. This is because the results from personal genomic tests have been and will continue to be used by various and sundry entities a diagnostic and prognostic tools.

It is obvious to almost everyone in the life sciences industry that there are huge sums of money to be made in the personal genomic testing space. Consequently, the last thing that personal genomics company executives wanted was regulatory oversight by FDA (it tends to interfere with business and profit margins). However, we all have experienced first hand what happens when companies are allowed to operate in the absence regulatory oversight.

Hat tip to FDA for finally taking a stand on this important issue!

Until next time…

Good Luck and Good Job Hunting!!!!!!!!


What Do You Think: Should FDA Have a Facebook Fan Page?

Posted in Social Media

Mark Senak, social media enthusiast and author of the EyeonFDA blog, raised the question on his blog today as to whether or not the US Food and Drug Administration (FDA) ought to have a fan page on Facebook: the ever expanding, ubiquitous social media platform. He aptly points out that FDA has already created a channel on YouTube and has a twitter account. So, why not a fan page on Facebook, he asked.

While Mark and I agree on most things, I am not convinced that having an FDA fan page on Facebook would make a difference in the way in which FDA communicates with the American public. FDA is already behind on the social media curve and, as the FDA public hearings held late last year suggest, the agency is struggling with formulating regulatory guidelines for its use by drug and devices manufacturers. Might not creating a FDA fan page on Facebook be the proverbial straw that broke the camel’s (agency) back? 

Perhaps I am overreacting to the whole Facebook phenomenon and grossly under estimating the agency’s capabilities. But I simply don’t get Facebook!  At best, it is overwhelming, difficult to navigate and seemingly cluttered mindless chatter and people engaging in Mafia wars. There is no question that a fan page would increase FDA’s exposure and its “hipness quotient” but to what end? The agency already has trouble maintaining and managing its existing web assets (have you ever tried finding information at FDA.gov?). Adding a new website would simply mean more work for overworked and underpaid government employee who seemingly play by different rules than the outside world.

Don’t get me wrong. I am an avid social media enthusiast who believes that persons who engage in social media must be “all in” to be effective. Having said that, I believe that the agency would be better served if it works to improve the navigability and accessibility to information on its existing web assets. There is no question that building an agency fan page on Facebook may convince Americans that FDA gets “the whole social media thing.” But if the fan page doesn’t provide Americans with relevant and useful scientific, medical and regulatory information, then adding a FDA fan page to Facebook will do little more than increasing the heft of an already bloated social media platform whose utility and effectiveness is already beginning to wane.

In my experience, building a website or fan page is the easy part; continuing to populate the pages and sites with useful, meaningful and temporally-relevant content is the difficult part!

Hat tip to Mark for starting the conversation!

Until next time…

Good Luck and Good Job Hunting!!!!!


Nagging Concerns Persist About Continuing Medical Education

Posted in Career Advice

As part of their licensure requirements, all physicians and other healthcare providers (HCPs) in the US must participate in continuing medical education (CME). CME requirements are established on a state-by-state basis HCPs who fail to meet annual quotas face reprimand, censure and possibly loss of their medical licenses. As you may imagine, CME is a big business and, not surprisingly, there is no dearth of CME content developers and providers. Unfortunately, CME course development costs are high and, despite state mandated licensure requirements, no one seems to want to sponsor or underwrite the CME development programs except drug and devices companies. Obviously, this creates the potential for monumental conflicts of interest mainly because physicians and other HCPs are drug and device company primary customers.

While I don’t profess to be an expert on CME rules and regulation, I know that the rules and regulations that guide CME content development have become increasingly restrictive over the past few years. In the past, drug and devices manufacturers were able to identify relevant product-related topics within certain therapeutic areas, engage a CME provider to create a curriculum and then offer a product-focused program to physicians. Today, drug companies aren’t allowed to create CME program built around specific products. Instead, CME developers compete for grant monies from drug and device manufacturers and are asked to create CME around relevant issues in certain therapeutic areas. Of course, most of the companies that award the grants have products in those therapeutic areas; but i digress. Companies that award the grants cannot participate or influence the content that appears in the CME programs. Of course this is impossible!

For example, several years ago I was working at an agency that received a “grant” from a client that was developing a new treatment for a virus-associated metabolic syndrome. While we weren’t allowed to highlight or suggest specific treatment options we did receive in direct and subliminal guidance (through various company channels) regarding messaging around content development. To that end, while the company wasn’t directly involved in content development, its medical affairs and marketing departments were “aware” of the content that we were developing. While this was appropriate and well within regulatory guidelines, it is not difficult to see that potential conflicts of interest and bias may have existed in this instance.

Over the last year or so, questionable medical writing practices and conflict of interest concerns about CME course development have come under intense scrutiny in the US Congress. Consequently, there have been ongoing and repeated calls to prohibit industry participation in CME content development. While this may be a great idea, if drug companies no longer are allowed underwrite or sponsor CME course development, there isn’t likely to be any CME in the future. And, if there is no CME, physicians and other HCPs won’t be able meet state-mandated CME requirements to maintain their licenses to practice? What a conundrum!

One solution to the problem is to require state governments, the American Medical Association, university medical schools, hospitals and other organizations (insurance companies?) to underwrite CME development costs! After all, these are the entities that require CME for HCPs to retain their licenses. While this is a perfectly logical solution to a vexing problem, don’t expect any of them to step up to the plate anytime soon. The bottom line: drug companies support and underwrite CME because they recognize that it is a viable marketing vehicle—albeit a subtle one—that is certain to improve product awareness and ultimately sales. For example, if Pfizer sponsors a CME program on erectile dysfunction at a high end resort in some exotic locale and, its logo or mention of a grant to develop the curriculum is acknowledged, it is not unreasonable to assume that physicians attending the course may possibly choose to prescribe Viagra over a competitor’s product. To make matters worse, CME sponsors often time help to defer costs of hotel accommodations, provide support for meals, and even sponsor receptions for physicians who attend CME training programs.

I suspect that some of you may be wondering why I am ranting and raving about CME today. Well, there was an article in today’s New York Times about Stanford Medical School receiving an unrestricted, three-year $3.0 million grant from Pfizer to develop unspecified new CME curricula for physicians. Philip Pizzo, MD, dean of Stanford’s medical school lauds this as the beginning of a new age in CME and suggests that Pfizer will have no say on how the grant monies will be spent. 

Dr. Pizzo contends that the “no-strings-attached” provisions of the grant will insure that the new curricula will be devoid of drug industry influence that has permeated CME courses in the past. Stanford plans to set up “unbiased programs” of postgraduate education on the Stanford campus rather than the industry-selected topics of the past that have been presented to rooms full of doctors at hotels and resorts.” While the new grant sounds promising, I wonder whether or not Stanford is going to disclose the amount of research funding it annually receives from Pfizer. Further, will faculty members who receive or previously have received research monies from Pfizer be prohibited from contributing to content development?  The point I want to make is that, despite Stanford’s good intentions and assertions to the contrary, there is no way to insure that there will be no bias or conflicts of interest in the new curriculum that is developed. 

Finally, I don’t think that there is any question that CME is essential to insure that Americans receive the latest and best possible medical treatments that are available. However, to insure farness and no bias, drug makers and device manufacturers should not be allowed to underwrite or participate in CME content development. This activity should be in the purview of not-for-profit entities (that don’t receive drug industry money) and state government agencies. Like it or not, we live in a quid pro quo society and drug and devices companies (like all “for profit” companies) don’t make investments unless there is an anticipated or guaranteed return on the investment!

Until next time…

Good Luck and Good Job Hunting!!!!!!!!

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