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Twitter, for all intents and purposes, is arguably the hottest new tool to hit the social media scene since well.....errrrrrr....Facebook (are there really any others?). That said, everyone who is anybody has jumped on the Twitter bandwagon whether or not using Twitter has any positive or negative effects for its users. Nevertheless, insightful social media analysts like Mark Senak, author of the fabulous EyeonFDA blog, frequently attempt to assess the overall effectiveness of social media tools like Twitter on specific industries—in this case, the life sciences industry.

To make sense of the relative effectiveness (influence) of Twitter use by life sciences companies, Mark used a Twitter and Facebook assessment tool known as KLOUT.  KLOUT generates a “score” for individual Twitter feeds based on a combination of 35 different variables. The resultant scores fall into a range from 1-100 with a higher score indicating a wider range of influence. 

Not surprisingly, Mark’s analysis revealed that Twitter feeds sponsored by Roche (Roche News, 52), Novartis (Novartis, 52) and Pfizer (Pfizer News, 51), three of the world’s largest pharmaceutical companies had the most KLOUT. Not far behind were Lilly (Lillypad, 47), Pfizer (PfizerMexico), AstraZeneca (AstraZeneca, 45) and Amgen (Amgen, 44). Other companies that warrant honorable mention include: Genentech (GenentechNews, 40), Bristol-Myers Squibb (BMSNews, 40), Johnson & Johnson (JNJStories, 40) and Vertex Pharmaceuticals (VertexPharma, 39).

Interestingly, many companies sponsor multiple Twitter feeds. For example, Sanofi Aventis AstraZeneca, Bayer, Boehringer Ingelheim and Novartis have five, JNJ has 4 and Roche, Baxter and Amgen have 3. It isn’t clear to me why companies would want to have more than one Twitter feed; doesn’t that dilute corporate messaging? But, then again, what do I know?  I am not a marketing or PR guy!

So, what does this all mean? As far as I can tell—not much! The only conclusion that I can draw from all of this is that Twitter, the most recent successful addition to the social media armamentarium, is no longer new but here to stay!

Until next time...

Good Luck and Good Tweeting!!!!!!!

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The pharmaceutical industry, not unlike all big business during the disastrous Bush Administration, was virtually unregulated. Bush and his cronies managed to accomplish this feat by destabilizing the US Food and Drug Administration (FDA) and essentially hamstringing any regulatory authority that it had. Not surprisingly, many pharmaceutical companies saw an opportunity to increase their bottom lines by engaging in off label marketing of many of their approved drugs—a practice clearly forbidden by the agency. 

Despite the fact that off label marketing is illegal, many big pharma companies knowingly and willfully engaged in the practice. Luckily, the Obama administration has reinvigorated and restored the regulatory powers at the agency and FDA is now aggressively investigating and punishing companies that had promoted off-label use of their products over the last decade.

The New York Times today reported that Novartis joins a growing list of pharmaceutical companies that have settled government investigations into health care fraud in the last few years, including Pfizer, which paid $2.3 billion; Eli Lilly, $1.4 billion; Allergan, $600 million; AstraZeneca, $520 million; Bristol-Myers Squibb, $515 million; and Forest Laboratories, $313 million. Pfizer, Lilly, Allergan and Forest pleaded guilty to crimes in the cases. The company was fined $422 million settle criminal and civil investigations into the marketing of the antiseizure medicine Trileptal and five other drugs. 

According to the article, the five other drugs involved in the civil settlement are Diovan, a hypertension drug that is the company’s top-selling product, at $6 billion last year; Sandostatin, a drug to treat a growth hormone disorder that had worldwide sales of $1.2 billion last year; Exforge, a hypertension drug that sold $671 million; Tekturna, a blood pressure medicine that sold $290 million; and Zelnorm, a medicine for irritable bowel syndrome and constipation that was later withdrawn from the United States market.

It is important to make a distinction between the practices of off-label drug use and off label marketing. As many of you may know, licensed US physicians are allowed to prescribe any FDA-approved drugs if they believe that their use will benefit patients. This is off-label drug use. However, in contrast, it is illegal for companies to actively promote or market approved drugs for therapeutic indications for which they have not received regulatory approval. This is off-label marketing and a strategy that has been used by companies to increase sales of approved products without having to spend money on expensive clinical trials that are required to prove safety and efficacy for a new drug to gain regulatory approval. While this may be a backdoor strategy for companies to boost product sales, it clearly puts patients at risk because the actual safety and efficacy for the indications has not been adequately tested and proven.

Many drug makers have been critical of FDA’s increase scrutiny of drug safety and have argued that it has negatively impacted the regulatory approval rates of new experimental medicines. While this may be troubling to many pharmaceutical executives, the FDA was created to insure that all approved drugs are safe and effective and the risk to Americans who use them is minimal. In other words, the agency is simply doing its job—something it was prevented from doing for the past eight years!

Until next time,

Good Luck and Good Job Hunting!!!!

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We scientists tend to be a serious bunch who often hard on difficult projects with lofty goals and expectations. However, like most other people, many of us have well developed senses of humor and enjoy a good laugh from time to time.

While working on my recent post on pharma and social media, I came across a post on Wendy Blackburn's blog, epharma Rx, that showcased a clever and well-crafted video created by her agency InTouchSolutions to help pharma companies overcome fears about social media.  I think BioJobBlog readers will enjoy it because it uses scientific principles (presumably understood by life sciences companies employees) to poke fun and educate pharma executives about social media 

Hat tip to Wendy and the InTouchSolutions Team

Until next time...

Good Luck and Good Viewing!!!!!!!

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While studying the pathogenesis of Neisseria gonorrhoeae in Portland, OR in the early 1980s, genital herpes had replace gonorrhea as the scourge of the sexually transmitted disease community. To help to combat the spread of genital herpes, my labmates and I joined the Portland Venereal Disease Action Committee, a grass roots organization that provided public outreach and education about sexually transmitted diseases (STDs). A few years later, the Regan Administration finally admitted to the American public that HIV/AIDS was real and that HIV infections were likely to reach epidemic proportions. While genital herpes can be painful, uncomfortable and often emotionally debilitating, the unprecedented morbidity and mortality of HIV/AIDS almost pushed genital herpes into infectious diseases obscurity. Now that HIV/AIDS is more treatable than ever before, epidemiologists and sexually transmitted diseases experts have begun to reexamine the infection rates and incidence of other STDs (including herpes, gonorrhea, Chlamydia and syphilis) among Americans. To that end, I read today a very troubling article about the infection rates and incidence of genital herpes among sexually active Americans. Here are some of the facts gleaned from a recent CDC report on genital herpes:

1. One in six Americans aged 14 to 49 are infected with genital herpes, making the virus — herpes simplex 2 — one of the most common sexually transmitted diseases in the United States
2. Research shows that people with genital herpes are two to three times as likely to acquire H.I.V. as those without herpes
3. H.I.V.-infected individuals also infected with genital herpes are more likely to transmit H.I.V. to others
4. Infection rates for women are almost twice the rate of men
5. Blacks are three times as likely to be infected as whites
6. Black women have the highest rates of infection, with almost half infected

Looking back, it is understandable why HIV/AIDS took precedent over genital herpes infections. After all, most people usually don’t die from genital herpes. However, the rising infection rates of the disease suggest that the American public needs to be better educated the spread and prevention of genital herpes infections. There is no question that discussions about STDs are embarrassing and often difficult. However, these days, they can be the difference between live and death!

Until next time…

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

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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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Allergan, the maker of Botox and Latisse sued the US Food and Drug Administration (FDA) in federal court yesterday because it believes that regulations banning off label promotion of prescription drugs violates the company’s right to freedom of speech and impedes its ability to provide physicians with information regarding patient safety.

The company contends in a lawsuit filed Thursday that it should be able to educate doctors about the risks and benefits of using treatments for unapproved uses. Botox is approved for several uses by the Food and Drug Administration. In addition to its use as a wrinkle treatment, it is approved for eye muscle disorders and excessive underarm sweating. But physicians often use it for unapproved, or off-label, indications including muscle-spasm conditions.

The impetus for the lawsuit is an FDA requirement that the company provide new risk information education to physicians on Botox as a therapeutic treatment. According to an Allergan spokesperson, "Our reason for seeking action now relates to the fact that we have recently been required by FDA to initiate a REMS (Risk and Mitigation) program for Botox to ensure that physicians are equipped to evaluate the risks and benefits of treatment." In April, health officials warned doctors and patients about potentially deadly risks of using Botox and similar drugs for unapproved uses to treat certain types of muscle spasms. The drugs carried risks of rare botulism symptoms, particularly when given to children to help relax uncontrollable muscle movements.

Allergan estimates that 20% of Botox usage is off-label for unapproved indications. Because of this, the company believes that it is important to “proactively provide comprehensive information to physicians about these off-label uses, such as dosing guidelines, patient selection criteria and proper injection technique to ensure that physicians are equipped to treat patients as safely and successfully as possible. And, “without judicial relief, Allergan is unable to engage in a truthful and relevant information exchange with the medical community for fear of prosecution." 

It sounds to me like the lawsuit is more about increasing the annual sales of Botox for a growing number of unapproved indications rather than ensuring patient safety. These types of lawsuits have becoming increasingly popular because of previous legal precedent that extends an individual’s right to freedom of speech to corporations and other entities. However, more importantly, if Allergan is successful, it could signal the end of the regulations and ban on off label promotion of prescription drugs and devices. Is eliminating a few wrinkles from aging baby boomers (like me) worth all the trouble?

Until next time...

Good Luck and Good Job Hunting (hmm...maybe if I look younger I might be able to find a job?)

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