EyeonFDA Blog: Why FDA Needs to Be Clear About Social Media

Posted in Social Media

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 In late 2009, FDA held another public meeting and promised that draft guidance on the internet and social media would be forthcoming by the end of 2010.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!!!!!!!!


Health Informatics Career Resource List

Posted in BioJobBuzz

As I mentioned in numerous previous posts, health or healthcare informatics is one of the hottest and fasting growing sectors of the US economy. And, not surprisingly, career counselors and job prognostication experts are predicting job shortages unless more Americans are trained for these job opportunities.  To that end, William Hooper of HealthTechTopia sent me a link to a list of 25 online health informatics resource collections

Those of you who are interested or considering pursuing a career in the emerging health informatics field ought to check it out!

 Until next time…

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


Jobseekers: Red Flags for Hiring Managers

Posted in Career Advice

Times are still tough and unemployment remains high. This means that finding a job is a lot harder and will take a lot longer than in previous times. Because of layoffs and reorganizations many jobseekers may have gaps in their resumes or difficult to explain periods of unemployment. Further, it you have a physical disability, health issues, a criminal record or you are older, finding a job becomes even more challenging.                    

With this in mind, an article entitled “Get Hired Despite Red Flags in Your Story” by Susan Adams at Forbes.com provides jobseekers with obvious disabilities, troubled pasts or less than stellar resumes advice on how to present themselves to hiring managers. Much of the advice is obvious but there are other gems in the article that may be useful to some in particularly difficult hiring situations.

Getting Hired Despite Red Flags in Your Story

By Susan Adams

Debra Ann MacDougall advises job seekers with troubled pasts or obvious disabilities on how to present themselves to hiring managers.

When a job-seeker’s challenges are highly visible, like some physical disabilities or a serious weight problem, MacDougall recommends a direct approach. Although the Americans with Disabilities Act prohibits job discrimination based on disability, it’s nevertheless wise to be upfront about a potential employer’s possible concerns.

A client of hers who had lost an arm in a motorcycle accident would routinely answer the ubiquitous first job interview question — tell me about yourself — by saying, "You may have noticed that I have only one arm." Then he’d proceed to explain how he coped, using a specialized computer keyboard on which he could type 85 words a minute. "He had a positive, can-do attitude that inspired other workers," MacDougall says. He landed a job as an administrative assistant at a large company in Los Angeles.

Older job-seekers should also consider potential employers’ concerns, MacDougall says. Hiring managers might worry about an older person’s health, his capacity to learn new systems quickly, his ability to adapt to technology and his energy level. MacDougall had a 59-year-old client who mentioned in interviews that she enjoyed running several times a week and participated in discussion groups on LinkedIn. MacDougall also advised her to get an updated haircut, if she didn’t want to dye her hair, and a fashionable suit. She was hired as a sales manager in Denver.

For job-seekers with less obvious physical challenges, MacDougall recommends what she calls the "make them love you first" approach. For instance, if you have a vision problem that would require you to use a special computer screen or a bad back that makes it impossible to sit through long meetings without getting up, she recommends keeping quiet until you get a job offer. Before accepting, let the employer know about your challenge. "Tell the employer about it, but tell them after they already love you," MacDougall says. She explains that hiring managers are always weighing the benefits and risks of new employees. You want to convince your potential employer that you have a surplus of benefits before revealing your risks.

For more serious challenges like criminal convictions, MacDougall says you should be prepared to talk about what you did and how you’ve changed. She tells the story of a client she calls Chuck who had been jailed on drug charges. Chuck had a moment of clarity and life change when he had to tell his 10-year-old daughter that he would miss her soccer final because he was going to jail. MacDougall recommended that Chuck share that revelation with potential employers and talk openly about how he had remade his life. She also told him to volunteer to take regular drug tests. He is now clean and working, she says.

Job-seekers with criminal records, who are HIV-positive or have alcohol or drug issues do have legal protections, and there are nonprofit organizations that advocate for people who encounter discrimination. The Legal Action Center’s website is a good resource, and the federal government has a site loaded with information about the Americans with Disabilities Act.

Sometimes your serious struggles may be far enough in the past that you don’t need to address them at all with a potential employer. For instance, if you were hospitalized for a mental illness years ago but you’re now healthy and your work performance won’t be affected, you don’t need to discuss it. "The deciding factor is whether the employer will find out about it," MacDougall says. "If it’s not going to affect your ability to do the job, because you’ve stabilized, don’t bring it up." The same applies to drug and alcohol problems, she says.

If you’ve had a long period of unemployment, MacDougall recommends listing yourself as a consultant on your resume. Include both paid and unpaid experience. Nowadays, she says, employers are increasingly receptive to resumes that include long stints of consulting or freelance work. "They know what the situation is out there," she says.

Until next time…

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

Another Pharma List: Does Size Really Matter?

Posted in BioBusiness

Ed Silverman who runs the outstanding Pharmalot Blog, today posted a 2009 list of the world’s top 20 pharmaceutical companies. The list was compiled by IMS Health and placement was based on revenues generated from 2009 prescription drug sales.  The numbers in parentheses represent the percent change from the previous year.

FYI, the Pfizer-Wyeth and Merck-Schering Plough acquisitions weren’t included whereas the Roche-Genentech acquisition was. Also, it is interesting to note that Teva, the world’s largest generic drug manufacturer came in at number 11and exhibited the greatest increase in sales in 2009. Expect the Israeli drug giant to move into the top ten next year as generic drug sales continue to out pace those of branded products.

  1. Pfizer – $41.7 billion – (0.8)
  2. Novartis – $36.7 billion – 7.0
  3. Sanofi-Aventis – $35.1 billion – (3.3)
  4. GlaxoSmithKline – $34.3 billion – (3.4)
  5. AstraZeneca – $33.2 billion – (7.8)
  6. Roche – $31.3 billion – (8.6)
  7. Johnson & Johnson – $26.9 billion – (6.6)
  8. Merck – $25.0 billion – (4.1)
  9. Eli Lilly – $19.6 billion – (8.3)
  10. Abbott – $19.4 billion – (5.5)
  11. Teva – $15.7 billion – (12.3)
  12. Bayer – $15.4 billion – (3.9)
  13. Wyeth – $14.8 billion – (2.3)
  14. Amgen – $14.8 billion – (3.1)
  15. Boehringer – $14.6 billion – (10.4)
  16. Takeda – $14.4 billion – (2.1)
  17. Bristol-Myers – $14.2 billion – (5.8)
  18. Schering-Plough – $13.1 billion – (4.3)
  19. Daiichi Sankyo – $8.5 billion – (3.1)
  20. Novo Nordisk – $8.2 billion (11.6)

Hat tip to Pharmalot

Until next time…

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


A Eureka Moment…Of Sorts

Posted in Career Advice

Most scientists fantasize about that so-called eureka moment when, after years of hard work, academic challenges and mental anguish, it all makes sense. While I have experienced these moments from time to time during my career as a scientist, it has happened less frequently as a lay person. This morning, while reading a Science Times article on Thomas R. Friedan , former New York City health commissioner and current head of the Centers for Disease Control in Atlanta, GA, I had one of those moments.

After reading the passage:

campaigns to ban trans fats, post calorie counts in chain restaurants, reduce salt in processed food and tax high-calorie sodas. He had a supportive boss in Mayor Michael R. Bloomberg and a receptive populace in New York, but if he were to try anything similar at the C.D.C., tough Congressional hearings could be in his future because conservative lawmakers on Capitol Hill often oppose such measures

it finally dawned on me that conservatives, in general, don’t give a damn or care about human health. Or perhaps, the underlying message may be: “don’t tell me how to eat or take care of myself; it’s my life and I know what is best for my health and me.” Unfortunately, since over half of the American population is obese or overweight and the incidences of diabetes and hypertension among younger and older adults has reached unprecedented epidemic proportion it is becoming increasingly evident that most Americans, regardless of their political affiliations, don’t know how to adequately manage their health.  And, to make matters worse, the inability or unwillingness of these individuals to maintain their health increases the cost and may block access of otherwise healthy Americans to adequate healthcare.

As an American, I strongly believe in individuals’ rights and freedom of expression. However, I also believe that summarily opposing unobtrusive measures to improve human health—based almost exclusively on political philosophy or personal financial gain—is morally bankrupt and overtly un-American!

Until next time…

Good Luck and Good Eating!!!!


Medicare is Offering Bonuses to Digitize Medical Records

Posted in BioJobBuzz

Officials for the Centers for Medicare and Medicaid Services announced on Wednesday that the agency plans on distributing billions in stimulus monies to upgrade the nation’s paper medical records to electronic ones. Under the proposal, doctors and hospitals that keep UPDATED electronic medical records (EMR) of their patients could receive bonus payments for using EMR-based software systems. While the proposal that was floated is not definite, it was posted to the agency’s website and is open for public comment for 60 days before the final guidelines are issued. 

According to agency spokespersons, healthcare professionals (HCPs) who use EMR for 80 per cent of their medical instructions could receive bonus payments. This means that HCPs would have to provide patients with printouts of their medical history and use computers for potential drug-drug interactions. Further, hospitals would be required to complete 10 per cent of medical orders electronically. Separately, the agency laid out technology standards that EMR software should meet to qualify for the program.

Although technology standards for government-based EMR systems have now been delineated, similar standards for private sector EMR keeping systems have yet to be clearly enunciated by the government. Many hospitals and HCP organizations hastily threw together EMR plans to qualify for stimulus monies that were disbursed early last year. Unfortunately, at present, there is still no general consensus on the software platforms and middleware programs that will need to be developed so that different EMR systems can communicate with one another! Consequently, the national drive to digitize paper medical records is occurring in a haphazard and piecemeal fashion. To realize improved efficiencies and cost savings, I contend that general guidelines ought to be issued before too much private sector work goes on. Allowing the private sector to dictate technology standards may not be in the best interest of a national EMR effort. Nevertheless, as I mentioned an earlier post this week, healthcare informatics is one of the fasted growing industries in the US!

Until next time…

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


Healthcare Informatics Staffing Shortages Predicted For 2010

Posted in BioJobBuzz

Healthcare informatics (HCI) is one of the fastest growing professions in the US. This is because the Obama administration has allocated billions of stimulus dollars to create electronic healthcare records (EHR) in an attempt to reduce healthcare costs. 

To qualify for EHR stimulus monies organizations must develop a plan and then take steps to implement it! Not surprisingly, because of the short ramp up phase for EHR, the number of available jobs far outstrips the numbers of qualified and skilled employees to fill them. The acute shortage of qualified HCI employees resulted in a cover story in the December 2009 issue of Health Informatics entitled “Got People?” It is a great read and provides insights into the types of employees that HCI companies are looking to hire.  The EHR Initiative will likely create over 500,000 new jobs in the next few years. For those of you, who may be interested in pursuing a career in HCI, check out this list of the top 100 HCI companies to work for.

Finally, a group of bioinformatics and genomics PhD students and postdoctoral fellows approached me to help them find sponsors for a Health Informatics Career Development symposium that they are trying to develop for the 2010 Intelligent Systems for Molecular Biology (ISMB) conference that will be held in Boston, MA from July 9-13, 2010.  

If you are interested in sponsoring the HCI symposium please contact me.

Until next time…

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


The Future: DNA Identify Theft?

Posted in BioBusiness

Advances made in DNA sequencing technology and genomic analysis has lowered the cost of sequencing a genome from millions of dollars a decade ago to less than $500 today. And, because of this, there are a growing number of companies that are willing to quickly and cheaply sequence and analyze your DNA. While this may be medically beneficial and appealing to some, it may not be for everyone. Moreover, and perhaps more importantly, who will control access to and insure the privacy of your genetic information if you choose to have your genome sequenced and analyzed. 

Alan McHughen, PhD, a molecular biologist and Professor of Botany and Plant Sciences at the University of California-Riverside, who has previously written about privacy and access to personal genomic data, wrote an article for BioJobBlog that explores the ramifications and possibility of DNA identity theft in the future. Also, he has written a book ‘Pandora’s Picnic Basket; The Potential and Hazards of Genetically Modified Foods’ to refute the myths and explore the genuine risks of genetic modification technology

Genetic Privacy

By Alan McHughen

For just $399 (plus shipping and handling), the scientists at 23and me.com will scan your complete genome. The DNA analysis reports on 118 different medical and health dispositions, your maternal and paternal ethnic ancestry, and a curious bunch of genetic trivia concerning your persona (is your earwax sticky or flaky?). All you do is pay the money and spit into a collection tube; they extract your DNA from the spit and look for half a million single nucleotide polymorphisms (SNPs) scattered throughout your genome, including many in or near genes associated with particular traits. Other companies offer similar services. For example, Decodeme.com charges $985, but catalogs twice as many SNPs, and you collect your DNA with a cheek swab.

Alternatively, if you don’t need the complete genome scan but are curious about specific medical conditions or family lineage, you can get less expensive gene tests from an increasing number of companies willing to take your money and DNA sample in exchange for the genetic information their scientists reveal. If heart disease runs in your family, you may either relieve or exacerbate your anxieties by shelling out $200 to have a cardio scan for relevant genetic predispositions. Or, for as little as $99, a man can have his Y chromosome probed to confirm his place in the family patrilineage, and possibly connect to ancient and famous princes or pirates.

These genetic information services, with prices now well into recreational and hobby budget range, provide the most personal, private — and unchangeable— information possible about you. The sinister side of this fascinating field is all too often overlooked—it can reveal your most intimate genetic details to strangers and nosy neighbors. While the various testing labs assure confidentiality, there is little to no control over personal genetic information. In the US, anything you discard is salvageable by anyone else, and your trash can become another’s treasure if it carries blood, saliva, hair, semen or any other DNA-laden bodily secretions.

While we worry about identity theft, personal financial or other private information, our uniquely personal information is up for grabs. The Genetic Information Nondiscrimination Act (GINA) of 2008 offers some protection, but it is limited to employment and medical insurance issues. GINA does not protect your genetic information from being abused by life insurers. Or nosey neighbors. 

Genetic privacy raises a whole spectrum of social, ethical, legal and medical issues. Suppose your neighbor salvages your trash and has your DNA analyzed. This local gossip then shares the juicy news that you have a “higher than average predisposition” to, say, alcoholism. Soon, everyone in the community shuns you as a latent alcoholic, and you have no idea why. The community knows more about your genetic makeup than you do. And, because they don’t know how to interpret statistical language such as “a higher than average predisposition”, those conditions may easily be exaggerated into probabilities, if not certainties.

If people have a right to know their own genetic information, they have the obverse right to NOT know. People can choose to remain ignorant about their genetic makeup. Consider, for example, Huntington’s disease (HD). This death sentence is one of the few health conditions almost due to genetics, and the DNA assay has been available for years. Curiously, most people at risk, i.e., those with HD in their direct lineage, choose NOT to take the test; they prefer not to know until (or if) symptoms appear. What happens when the local busybody lets the cat out of the bag on HD? Word will get around and the at-risk person will inevitably find out, if only by the ‘different’ treatment by neighbors, thus obliterating the exercise of their right to remain ignorant. Whether the test result is positive or negative on HD is immaterial at this point, the rights will have been violated. The DNA test for HD is currently more elaborate than the simple SNP analysis, but because SNPs associated with HD are being reported, it’s only a matter of time before they come generally available.

Perhaps you’ve suspected the woman down the street had a child from an adulterous one night stand a few years ago, and the cuckold husband remains a doting, if clueless, dad. Now, with just $89 (including overnight FedEx delivery!) and a little misdemeanor creativity, well within the standard ethical bounds of busybodies, you can satisfy your suspicions with a surreptitious and discrete paternity test. And, to provoke some real excitement in your sleepy small town, show the results to the husband.

A few minutes of thought and discussion generates many other issues and examples of the precarious security of personal genetic information and identity, and the potentially dire consequences of genetic information getting out. Society is yet to discuss the privacy issues surrounding genetic identity as vigorously as we have with personal financial or medical records. It’s getting late. Do you know where your DNA is?


Upcoming Conference on Social Media and Digital Health

Posted in Social Media

For the first time in history, more people are searching the Internet for health information than asking doctors. Web 2.0 and social media tools are allowing people to discover new ways to connect, learn and engage one other in search of healthcare and drug information.

e-Patient Connections 2009 which will be held in Philadelphia, PA on  October 26 and 27 will feature a number of leading authorities on social media and digital health  Some of the featured speakers include Wired Magazine’s Thomas Goetz, Jay
Bernhardt of the CDC, and Lee Aase of the Mayo Clinic. The conference also offers case studies, 1:1 coaching sessions with industry experts and the latest products from digital health companies.

BioJobBlog readers can use the discount code kru500 to save $500 off the current price.

See you there!


Managing Emotional Fallout After Losing a Job

Posted in Career Advice

Losing a job is a BIG deal whether you were layed off, fired or right-sized out of it. Not only do you have to worry about health insurance, bills and paying rent or making a mortgage payment, you must also deal with a myriad of self esteem and emotional issues that frequently arise after losing a job. While there are many articles and books that describe how to functionally conduct a job search after being layed off, there are only a handful that discuss how to cope with the stress and negative emotions that frequently accompany job loss.

Many people who lose their jobs frequently experience emotions like anger, desperation, hopelessness and even depression. These feelings must be acknowledged and then addressed and managed because they not particularly useful when looking for a new job. Further, when left unattended, these feelings can exact both a financial and an emotional toll on the unemployed.

In this Sunday’s New York Times, Phyllis Korkki, who writes “The Search” column describes how to manage the negative emotions and financial problems commonly associated with losing a job. She also provides tips on how to minimize “the pain” and accentuate the positive after experiencing a job loss.

Until next time…

Good Luck and Good Job Hunting!!!!

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