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Increasingly, healthcare professionals, patients and consumers are turning to and using their mobile devices for healthcare information. Further, development of mobile software platforms and associated are allowing patients to more regularly directly communicate with their physicians. To help sort out the growing complexity of the mobile healthcare communications industry, the Business Development Institute (BDI) entitled “Mobile Healthcare Communications 2012:Case Studies and Roundtables” will be held on Thursday, January 26, 2012 from 8:00 AM to 1:00 PM at The Graduate Center of the City University of NY (365 5^th Ave, NY, NY 10016).

Registration fee for the event is $195 per attendee. BioJobBlog readers who wish to attend should use promo code BC for a discounted rate of $175.

Speakers and roundtable moderators include:

1. Lance Hill, CEO, Within3
2. Scott Hopkins, Executive Vice President, Anderson Direct Marketing
3. Dr. Katherine Malbon, Assistant Professor of Pediatrics, Division of Adolescent Medicine, Mount Sinai Hospital
4. Talya Miron-Shatz, PhD, Marketing Department, Wharton, University of Pennsylvania 
5. Jenna Mons, Consumer Product Manager for LAP-BAND®, Allergan 
6. John Vieira, Daiichi-Sankyo

Event sponsors include:

BioCrowd, PR Newswire; Within3 ; Anderson Direct Marketing; Cinchcast; Journal of Communication in Healthcare; Manhattan Research; New York University; Society for Healthcare Strategy and Market Development; Pixels & Pills

For event related questions and registration, please contact Maria Feola-Magro at mfeola@bdionline.com or 212.765.8043.

For sponsorship/speaking opportunities, including pricing, please click here or contact Jennifer Brous at jbrous@bdionline.com or 212-765-8358.

For additional information, including registration, please click here to visit the event website.

See you at the conference!

Until next time....

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

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Mark Senak, author of the EyeonFDA blog and a life sciences/healthcare social media enthusiast, wrote a fantastic piece yesterday that provides cogent ideas and insights into the need for FDA to expeditiously craft guidance on the use of social media in the pharmaceutical and healthcare industries.

Here are the facts. First, according to the Pew Internet and American Life Project, social media has fundamentally changed the way in which we interact with one another and ushered in a new era of communication. Unlike the old, so-called “broadcast communication method”—information is continuously streamed from a static source, websites, television, radio etc, to perspective customers and stakeholders—the new paradigm requires that communications must be personal, portable and participatory for effective messaging. Second, the primary source of information sought by most persons who use the Internet is healthcare and medical information. While much of the content is accurate, some is not; which may put persons seeking medical information at great risk. In other words, social media is not just about marketing and medical education; it is also about preserving public health.

The agency has historically been unable to issue guidance on new forms of communication. For example, FDA held its first public meeting in 1996 on Internet use by life sciences and healthcare companies. Sadly, the agency has yet to issue any official guidance on this topic. In late 2009, FDA held another public meeting and promised that draft guidance on the internet and social media would be forthcoming by the end of 2010. Unfortunately the guidance did not materialize in 2010 and it has been delayed twice in 2011. Recently, the agency publicly reaffirmed its commitment to issuing the guidance but without a specific timetable for its release. Consequently, it is anyone’s guess when or if the guidance will be released.

Unlike many, I do not believe that FDA guidance on the Internet and social media is absolutely necessary. However, I will admit that issuance of said guidance will provide drug and healthcare companies with some of the assurances that they need in order to actively use social media to engage patients, physicians and other stakeholders. For this reason alone, FDA ought to issue the guidance (which is never perfect and always a work in progress) and end the social media stalemate that currently exists. Failure to do so may have serious consequences on the public health of many Americans.

Hat tip to Mark!

Until next time...

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

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Recruiting, retaining and managing patients that participate in clinical trials for approval of new medicines and devices have becoming very challenging in the past decade or more. Ironically, the ready availability of experimental new medicines in the US for certain therapeutic areas including oncology, neuroscience and vaccines have forced life sciences companies and CROs to conduct many Phase I and Phase II trials outside of the US. In turn, the globalization of clinical trials has forced many sponsors to increasingly rely on e-based and mobile solutions for patient recruitment, retention and compliance.

The Advance Learning Institute’s conference entitled “Patient Recruitment, Compliance And Retention For Clinical Trials: Integrating The Latest Technologies With Traditional Tools To Maximize Patient Engagement” that will be held in Manhattan on October 24-26, 2011 will provide attendees with insights into the best practices to maximize patient engaged in clinical trials. Presentations will be given by a variety of pharmaceutical companies, CROs and academic institutions including Pfizer, Merck Research Laboratories, Shire Pharmaceuticals, Celgene Corporation, Quintiles, Omniscience Mobile, Albert Einstein College of Medicine and the Michael J. Fox Foundation for Parkinson’s Research. A complete agenda for the conference can be found here.

Those of you who mention BioJobBlog or BioCrowd when registering for the conference will receive a $200 registration discount.

See you at the meeting!!!!!!!

Until next time...

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

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Over the past few months, a number of celebrities have agreed to help pharmaceutical and biotechnology companies pitch their products in direct-to-consumer advertising campaigns. Perhaps this is related to the economic downturn and these actors are having trouble finding high paying gigs to support their lifestyles. Alternatively, their motives may be altruistic or they or one of their loved ones may suffer from a life-altering or threatening illness.

The latest addition to the celebrity pitchperson parade is the soap opera diva Susan Lucci. After her husband Helmut Huber was unexpectedly diagnosed a decade ago with atrial fibrillation—a type of irregular heartbeat that increase the risk of stroke five-fold, Lucci yesterday announced that she and her husband would partner with Boehringer Ingelheim the National Stroke Association and StopAfib.org to launch a new education campaign to raise awareness of atrial fibrillation. Financial terms of the relationship were not disclosed.

In other news, Amgen and Pfizer yesterday announced the joint launch of "Psophisticated Style:  A Guide to Everyday Style and Psoriasis™," an online resource, providing a wealth of style advice specifically for people with psoriasis.

The new online presence will be hosted by B-list celebrity Tim Gunn, mentor to the designers on TV's "Project Runway" and chief creative officer of Liz Claiborne, Inc. and dermatologist Susan C. Taylor, M.D., the style guide includes five videos, which illustrate various style issues for individuals with psoriasis. Practical and insightful highlights from each video are also available and can be printed.  The new website is well designed and has a decidedly web 2.0 look and feel to it. And, you can even follow Psophisticated Style on Facebook and share the site with your friends!

According to a press release Addressing Psoriasis™ was developed to inspire people with plaque psoriasis to actively manage their condition, be more confident and not allow the condition to inhibit their everyday style. 

Despite the slow uptake, Pharma’s attitude on the use of social media is beginning to shift. Last week, Eli Lilly &Co announced the launch of Lilly Pad a blog and twitter feed designed to provide information and helpful tips to patients with diabetes. Yesterday at the Business Development Institute’s HealthCare Social Communications Leadership Forum in Manhattan, Todd Siesky , Public Relations Manager, Roche Diabetes Care described an innovative and creative initiative (started two years ago) to establish a network of influential bloggers in the diabetes space. The bloggers are not paid and do not benefit financially from their interactions with the company. Roche interacts with the blogging network on a quarterly basis and has held two summits to bring the bloggers together to brainstorm and interact with one another (Roche covers airfare and hotel accommodations).

Also, Ted Phelan, Senior Regional Scientific Manager Medical Affairs at Astra Zeneca gave an illuminating talk about his company’s efforts to build a physician community in the gastrointestinal therapeutic space. Ted’s take away from his impromptu presentation (the originally scheduled Astra Zeneca representative couldn’t attend) was you won’t be successful unless you understand the needs of community members (he is married to a physician).

For those of you who may not closely follow the pharmaceutical social media space, building Facebook fan pages and creating a Twitter feed are no longer de rigueur. Instead, the next big thing is building company-sponsored, unbranded, online patient and physician communities around different therapeutic indications! Move over Patients Like Me, there may be some new kids on the block in the very near future!

Until next time...

Good Luck and Good Tweeting!!!!!

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I want to state at the onset of this post that I am an ardent supporter of online patient communities because I believe that the exchange of information between people who suffer from the same or similar medical conditions is vital to their health and well being. Further, I believe that social media will force physicians, the medical community and the US healthcare system to become more transparent, open and interactive. That being said, in this past Sunday’s New York Times, Natasha Singer wrote an extremely revealing article about some possible, unforeseen “side effects” associated with membership in online patient communities.

The reason why these online communities exist is for patients to commiserate with one another and exchange personal stories and medical information. While personal stories may be emotionally satisfying for patients, it is their medical information and demographic data that is extremely valuable to drug makers. To that end, many online patient communities inform their members that they reserve the right to share information and data for research purposes. And many of them do!

To be clear, I am not suggesting that the people who create or manage online patient communities have avaricious, nefarious or otherwise unsavory ulterior motives for the medical and patient demographic data that they collect. However, these communities need to generate revenue in order to stay in business and drug makers are willing to pay for access to it.

According to Singer, the popular PatientsLikeMe community admits that it sells health and medical data gathered from member profiles (but with certain identifying information removed) to pharmaceutical companies and others for scientific and marketing research purposes. Further, a large number of unbranded “disease awareness” pages have recently begun to appear on Facebook and YouTube. In her article, Singer contends that “drug companies may pay people to moderate patient forums [in the community] or give testimonials but might not prominently display that fact to participants. Other sites collect consumer health data to help drug makers’ aim at specific kinds of consumers, using psychological cues.” At a medical communications meeting that I attended several years ago, a MySpace sales rep freely admitted to me that it allow pharmaceutical companies to mine profile data in order to develop targeted marketing campaigns. Is Facebook next?

Finally, while the Health Insurance Portability and Accountability Act of 1996 (HIPAA) restricts the way health care providers use and disseminate patients’ information, consumer health websites and online patient communities aren’t subject to its privacy provisions. In other words, there are no regulations guiding the privacy and use of medical information and data collected using social media tools! Essentially, this means that the persons who run online patient communities can do pretty much whatever they like with the medical and personal information that they collect!

As I stated at the beginning of the post, I am a social media enthusiast who subscribes to the notion that if used correctly, social media can help to better inform and improve the lives of people suffering from various disease. That said, I also believe that people who choose to participate in online communities MUST be fully informed about the potential uses of the personal information and data that they contribute. Until the Food and Drug Administration provides some regulatory guidance on the use social media to collect and disseminate medical information patients will be at the mercy of the entities that run online patient communities. Let’s hope that they see fit to “do the right thing.”

Until next time...

Good Luck and Be Careful What You Say Out There!!!!!!!!!

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I came of age in the freewheeling 1960s and early 70s when the counterculture revolution was in full swing and people were regularly experimenting with marijuana and psychedelic drugs aka hallucinogens.

As a veteran of that era, I am well acquainted with these drugs and can personally tell you that they are not for everyone. However, the pharmacological active ingredients of marijuana (tetrahydrocannabinol) and the naturally-occurring hallucinogens found in peyote (mescaline) and magic mushrooms (psilocybin) have long been known to possess inherent therapeutic value. Unfortunately, because these drugs are associated with a particularly tumultuous period in American history, research into their use as therapeutic agents has long been stymied by the federal agencies that fund basic research in the US. 

Despite these formidable obstacles, a small number of intrepid researchers have managed to demonstrate that these long-vilified and illegal drugs can be used in some cases to treat cancer patients suffering from difficult-to-treat depression and other forms of mental illness. To that end, there was a fascinating article in yesterday’s New York Times that described a Johns Hopkins clinical study that showed that psilocybin can be used to manage untreatable depression in a small number of cancer patients.

The results from the study suggest that psilocybin, when administered using rigorous protocols and safeguards, can help to alleviate many of the symptoms of severe depression experienced by cancer patients undergoing chemotherapy. The researchers also contend that the use of hallucinogens can be transformative and may help to identify an endogenous neural pathway that may be responsible for so-called religious epiphanies.

Researchers from around the world are gathering this week in California for the largest conference on psychedelic science held in the United States in four decades. Attendees are expected to discuss studies of psilocybin and other psychoactive hallucinogens to treat depression in cancer patients, obsessive-compulsive disorder, end-of-life anxiety, post-traumatic stress disorder and addiction to drugs or alcohol.

Because reactions to hallucinogens can vary among individuals (primarily depending on the setting and external environment), researchers have developed stringent guidelines to set up a comfortable environment with expert monitors in the room to deal with adverse reactions. Also, they have established standard protocols so that the drugs’ effects can be assessed more accurately by scanning the brains of people who have taken hallucinogens. This is in marked contrast with the recreational use of hallucinogens which generally take place in a variety of sometimes difficult to control social settings; which may be responsible for some of the highly publicized “bad trips” experienced by hallucinogen users.

While there is no question that hallucinogens are very powerful psychoactive drugs—and their misuse can have serious cognitive and emotional consequences—it has never made sense to me why their use as potential therapeutic agents had been so discouraged. Ironically, marijuana and other illegal and so-called “dangerous illegal drugs” may actually be safer and more beneficial than some similar FDA-approved including certain antidepressants.

To be clear, I am not advocating the use of illegal drugs. However, in my experience, there is no obvious correlation between the legality of drugs and their potential therapeutic benefits. For example, both cigarettes and alcohol are legal drugs whereas marijuana (in many places) is not. A quick perusal of the number of people who are maimed or die each year from smoking pot as compared with those who die from lung cancer or are injured or killed by drunk drivers tends to emphasize this assertion. The bottom line: don’t throw any potential drug candidates on the pharmaceutical junk heap until they have been thoroughly researched and vetted as prospective therapeutic agents!

Until next time…

Good Luck and Good Job Hunting!!!!! (Right on man)

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At long last, marijuana for medical use is legal in New Jersey. As one of his more courageous acts while in office, outgoing Governor John Corzine signed the act into law late yesterday making New Jersey the fourteenth state to legalize medical pot. Four more states and the District of Columbia are expected to follow suit by year's end.

Many things are driving this sea change. The federal government last year announced that it would no longer prosecute medical marijuana smokers in states where it is legal, while the National Institutes of Health has begun funding research on medicinal use in a reversal of a long-standing policy.

Gallup Polls show a solid majority of Americans sympathetic to therapeutic marijuana use.

Unlike California's medical marijuana law which allows the use, possession, and cultivation of marijuana by anyone who possess a "written or oral recommendation" from their physician that he or she "would benefit from medical marijuana," New Jersey's version requires patient identification cards and state-monitored dispensaries -- easing fears that medical use will fuel illegal sales and teenage substance abuse.

While cannabis preparations have been used to relieve nausea and pain since ancient times, research involving medical uses of marijuana was under funded and in many instances discouraged according to an article in today’s New York Times. But over the last 15 years, research on the body's cannabinoid receptors has begun to decipher the chemistry and biology of the positive effects of cannabinoids especially in the areas of glaucoma and chemotherapy induced nausea and vomiting experienced by patients being treated for cancer. More recently, clinical trials have shown that these benefits outweigh the concerns about addiction, heart and respiratory diseases, cancers, and psychoses -- at least, with short-term use.

Marinol, a synthetic cannabinoid pill, is approved by the Food and Drug Administration for treating AIDS-related wasting and chemotherapy-related nausea. But many patients say choking down a slow-acting pill simply doesn't provide the convenient and immediate relief of inhaling marijuana smoke. A new drug, Sativex, made by GW Pharmaceuticals, may renew the debate. A cannabinoid-based oral spray, Sativex is approved in Canada for treating pain in multiple sclerosis and advanced cancer. The company is now completing the clinical testing needed for approval in Europe and the United States.

While I don’t endorse or use illegal drugs (any more), there is no question that medical marijuana helps patients deal with chronic and, in some instances, severely debilitating conditions that impact the overall quality of their lives. I have long contended that just because a substance is deemed illegal it doesn’t negate potential medically-beneficial properties. An example of legal drugs that don’t have any therapeutic benefits and cause much more morbidity and mortality than marijuana are cigarettes and alcohol. Need I say more?

All I gotta say is that we have come a long way since I saw the film Refer Madness while growing up and coming of age in the late 60s. For those of you who haven’t seen the film it is funny whether you are straight or high! object width="445" height="364">

I guess the nation—well NJ anyway—is finally going to pot!

Until next time...

Good Luck and Good Toking (only for medicinal purposes of course)!!!!!!!!!!!

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The generic drug industry didn’t exist until the passage of the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments). This piece of legislation, better known in the pharmaceutical industry as the Hatch-Waxman Act, was proposed and adopted by the US Congress because of the escalating costs of brand name drugs manufactured by large pharmaceutical companies (sound familiar?). The act provided the US Food and Drug Administration (FDA) with a regulatory pathway to approve and bring to market “generic” versions of branded drugs that lost patent protection. During the debate over the amendment, and for many years thereafter, branded pharmaceutical manufacturers tried to stifle the growth of the generic drug industry by suggesting that generic versions of their branded medications were unreliable and unsafe. This tactic was partly responsible for the stinted growth of the generic pharmaceutical industry until the mid 1990s when the price of branded pharmaceutical drugs began to skyrocket and insurance companies began to realize that something had to be done to manage rising drug reimbursement costs. To that end, insurers and third party payors began requiring patients to use generics (when available) instead of branded products to cap rising prescription drug costs. Because of this, the generic industry has grown by leaps and bound over the past decade and now threatens the stability of the branded pharmaceutical industry! 

Unfortunately, while increased generic drug use may be good for generic drug manufacturers and insurance companies, it isn’t always in the best interests of patients who use prescription medications. For example, there are a growing number of stories and complaints from patients who were forced to switch from a brand name drug to a generic one and had side effects, or found that their symptoms returned or may have been worse than before. In fact, this happened to my mother who was switched from a brand name pain reliever that worked to a generic version that no longer controlled her symptoms and induced some untoward side effects. Scientifically, there ought to be little difference in the efficacy, safety or tolerability profiles of a branded drug and its generic equivalent. This is because both medications contain the same active pharmaceutical ingredient. However, differences in the formulation of the branded and generic versions of the drugs may be responsible for reduced efficacy or safety and tolerability issues.

While clinical studies conducted by the insurance industry suggest there are no safety or tolerability differences between brand name and generic drugs and the American Medical Association’s assertion that, as a whole, generic drugs do work as well as branded drug, there is some evidence to suggest that some generic drugs may not be interchangeable or substitutable for certain branded medications. This appears to be the case for certain drugs that are used to treat neurological conditions and mental health diseases like seizures, depression and bipolar disease. Lesley Alderman, in an article she wrote in today’s New York Time business sections provides excellent examples of this.   

The problems with some generic drugs may arise as a result of the approval process for this class of drugs. According to provisions outlined in the Hatch Waxman Act which stipulate that a generic version must have the same active ingredient, strength and dosage form as the brand name drug or reference product. The generic version must also be demonstrated to be “bioequivalent” to the brand name drug. This means that the generic product must be shown to reach blood levels (drug concentration) that are very similar to the brand name product. This is usually determined by administering the generic and brand name drugs to a relatively small number (24 to 36) of healthy human volunteers. Generally speaking, once bioequivalence is established it paves the way for regulatory approval of the product. Typically, once approved, many generics receive what is known as an AB rating. Generics that are AB-rated can freely be substituted (by a licensed pharmacist) for a brand name product even though the physician may have written the prescription for the branded product.

In the past, patients were usually given a choice between a generic and a brand name drug —a decision that was largely based on the percentage of the cost of drug that would be covered by insurance. These days, patients no longer have a choice and are generally forced to use generic drugs rather than brand name products based on formulary lists compiled by insurance companies. While I am not practically or philosophically opposed to using generic drugs, there is a growing body of evidence which suggests that not all patients respond the same way to branded and for that matter generic drugs. Therefore, I contend that allowances ought to be made for these differences and patients who don’t respond to (or experience side effects) after taking generics shouldn't’t be denied access to the branded product that, in most cases, was originally prescribed by that patient’s physician. It is one thing to cut costs; it is another to increase a patients suffering or anxiety. If you are concerned about switching from a branded medication to a generic, please read this for some helpful tips and guidance.

Until next time...

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

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I suspect that a majority of BioJobBlog readers have at one time or another been prescribed a drug to treat a particular medical condition or ailment. Like most of you, I assumed that my prescription information and history was private and that only healthcare professionals were privy to it. However, after reading an article in this Sunday’s NY Times, I learned how wrong I was! Much to my dismay,  I learned that prescription information including the name and dosage of a drug, the name and address of the physician who prescribed as well as a patient’s address and social security number is a commodity that is regularly bought and sold usually with a patients’ knowledge or permission. And apparently, this practice is perfectly legal as long as patient’s names are removed or encrypted before the information is sold, typically to drug manufacturers.

Unfortunately, privacy experts and information technology specialists contend that it isn’t difficult to match names, addresses, and social security numbers to reconstruct information that had supposedly been rendered anonymous. To make matters worse, until very recently, federal patient privacy and data security rules were loosely enforced and frequently abused by medical marketers, advertisers, drug manufacturers and retail pharmacies. Finally, re-identifying a patient’s prescription drug information and history provides drug makers with a powerful tool to target and market drugs to specific patient populations.

Tracking prescriptions and mining prescription data is not new—it has been big business for many decades. The major players in the drug mining business are companies like IMS Health, Verispan and CVS Caremark. Also, large discount pharmacy retailers like Walgreens and Target engage in this practice and they all sell their prescription information data to interested parties. Prescription drug data-mining companies say that their services are valuable and warranted because gathering and analyzing information from tens of thousands of patients helps drug manufacturers to identify trends and potential safety and tolerability issues with prescription drugs. Nevertheless, despite assertions that prescription drug data are anonymous when it is sold, class action and private lawsuits alleging this not to be the case have been filed against some of the major players including Walgreens, IMS Health and CVS Caremark. While this is troubling, loopholes in the current prescription drug data mining regulations allow pharmacy companies like Walgreens and others to accept money from drug manufacturers to mail advice and reminders to customers to take their medications without first obtaining their permission. The loopholes also allow drug makers to send customers’ promotional information and materials about drugs other than the ones that they are already taking.

Under the Obama Administration’s $19 billion healthcare stimulus package, selling prescription drug data to drug makers will still be allowed (only if patient’s names are removed). Also, subsidized marketing by drug makers will be allowed to continue but companies will no longer be able to promote drugs other than those the customer already buys. While the new legislation allows data mining and the sale of prescription drug information to continue, its primary goal is to tighten and insure patient privacy so that personal prescription drug history and information can no longer be used to exploit the buying habits and behaviors of individual American consumers.

Until next time...

Good Luck and Good Job Hunting!!!!

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We were able to entice Berci Mesko —a Hungarian medical student who writes at ScienceRoll and is founder of Webicina —to chat with us about the transection of Web 2.0, science and medicine.

Berci, who only sleeps four hours each night, is a medical section editor at Wikipedia, runs courses in Second Life (and real life at his medical school) and can frequently be found on Twitter enlightening his followers on topics ranging from personalized RSS feeds for physicians to the latest breakthroughs in medical genetics. While this ought to be enough for most people, Berci told us that he always wanted to be a scientist and— to realize this dream— will be entering a PhD program next fall. He is a very bright, energetic and engaging fellow whose understanding of the relationships between physicians and patients are insightful and instructive.

Have a listen and also check out BioCrowd!

Until next time…

Good Luck and Good Listening!!!

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