Viagra: "The Next Generation"

Pfizer was the first to bring us ED (erectile dysfunction) and now two companies—one large (Johnson and Johnson) and one small (Sciele Pharma)—are daring to boldly go where no MAN has gone before: to conquer PE aka premature ejaculation!

According to a brilliantly-crafted story by Natasha Singer published in this Sunday’s New York Times business section, JnJ developed a pill called Priligy which is intended for men who ejaculate before intercourse or within a few seconds after beginning. Priligy which is intended to help to prolong latency before orgasm is approved and sold in nine countries but hasn’t been approved for sale in the US. On the other hand (so to speak), little known, Atlanta, GA-based Sciele Pharma is planning to seek regulatory approval for a prescription aerosol-based product that is sprayed on the skin (in this case the penis) to prolong latency and forestall ejaculation. While the true incidence of PE is uncertain, the manufacturers of these medications want men (and women) to believe that the condition is more pervasive and prevalent than reported. 

Interestingly, the worldwide sales of Pfizer’s Viagra were approximately $1.93 billion last year. As previously noted on BioJobBlog, Viagra celebrated its 10th anniversary of marketing approval last March. If you do the math, almost $20 billion dollars worth of Viagra prescriptions were written over the past decade. This suggests that many millions of men must suffer from ED worldwide. However, for those of you who may not know, Viagra also works quite well for healthy, sexually active males who don’t suffer from ED. It is generally acknowledged that it is this segment of the male population that is responsible for the annual blockbuster sales of Viagra and related medications. Also, it is important to note that prior to the introduction of Viagra, ED wasn’t a recognized clinical indication (it was known as impotence) and there were very effective treatments for it. And while ED is a legitimate quality-of-life issue, it occurs in only a small percentage of sexually active males; mostly in older men with hypertension, cardiovascular conditions or those who have had their prostates removed.

Viagra, like Botox, Latisse and others, is classified as a so-called “lifestyle” drugs. Generally speaking, lifestyle drugs are developed to improve the quality of life of patients not treat potentially life threatening diseases or conditions. In her article, Ms. Singer takes the pharmaceutical industry to task about the development of  blockbuster lifestyle drugs.

“But creating a blockbuster quality-of-life drug like Viagra involves more than just being innovative or being first. Sometimes it requires a drug maker to create and market a whole new category of disease.

The template goes something like this: Start with a legitimate quality-of-life issue — like fitful sleep or shyness — that does not yet have its own prescription medication and is debilitating to a few people a lot of the time. Next, position the quality-of-life issue as a medical condition with symptoms so common it covers vast numbers of people who had previously not identified themselves as having a health problem, or who thought they were just experiencing an occasional and normal annoyance.

Articles in medical journals with high estimates on the prevalence of the issue help convince doctors and journalists of its scope. F.D.A. approval of the new drug legitimizes the condition as a problem with a medical solution.

While there is no doubt that some men are distressed about their inability to control their orgasms, there is little concrete evidence to suggest that there is an epidemic of premature ejaculation”

Although I have never used Viagra, I have a few “older male friends” who swear by it! And, while I have no doubt that Viagra and the new medications being developed to treat PE may benefit a few men, is it appropriate to elevate premature ejaculation to a bona fide clinical indication and spend billions to develop and market treatments for it? Don’t get me wrong; I am not trying to minimize the emotional distress and discomfort associated with PE. But, the last time I checked, PE didn’t make the top ten lists of the world’s most devastating and debilitating clinical indications or unmet medical needs!

Until next time...

Good Luck and Good Job Hunting!!!!

 

Higher Education: The Next Bubble to Burst?

Amber Johnson of Accredited College Online thought that BioJobBlog readers might be interested in an article that she authored entitled “10 Big Ways that the Recession is Hitting Higher Ed.”  It is an informative piece that might be of interest to high school and undergraduate students and parents who have kids in college.

10 Big Ways the Recession is Hitting Higher Ed

From elementary to college, schools around the nation have felt the recession in many different ways. As the economy sinks, the educational demands rise. Teachers are holding on to dear life for their jobs, students are struggling to pay for college and the states are running out of school funding. But even with all of these economic woes, there are still people eager to teach and happy to learn.

  1. Budget Cuts. Since the beginning of the fiscal year, the U.S. has suffered a 5 percent drop (about $4 billion) from the amount of money state governments apportioned for higher education, according to a U.S. News & World Report article. This is directly affecting universities across the country, who’ve seen larger class sizes, less professors and counselors, as well as canceled courses, which experts say could "threaten the quality of education."
  2. Spike in Tuition. College tuition has been an inevitable hurdle for many students and families for years, but in this recession, it stings that much more. Since 1982, college tuition and fees have increased 439 percent, which is about three times higher than the increase in family incomes, according to an ABC news report. In some cases, tuition increases are the school’s response to more financial aid requests, but these scholarships may not be enough to cover soaring prices.
  3. Decline in Aid. Many states are cutting college financial aid programs when students need it most. An increase in unemployment and financial losses has caused 620,000 more students to apply for federal aid in the first quarter compared to last year. An Associated Press article reports that without financial assistance, students may be forced to drop out, transfer or be laden with debt.
  4. Decline in Endowments. A major factor in these educational downturns is the decline in college endowments. Big and small donors simply aren’t giving back right now, which has caused hiring freezes, cutbacks on financial aid and halted construction projects, according to a Wall Street Journal article.
  5. Graduate in Three Years.Graduating in three years is a surefire way to slash college costs. American colleges are now starting to offer three-year college degrees, which is the normal time frame for many British and Canadian students. It’s an upcoming trend, according to CBS MoneyWatch, that could make "elite education" more affordable.
  6. More Kids Are Going Public. According to a CBS News report, private school enrollments have declined as many students make the switch from private to public schools. While some continue to pay top dollar for private school tuition payments, others have had to transfer to less prestigious schools to save money.
  7. Arts Programs Suffer. With devastating budget cuts on the agenda, college art departments are the first area to be altered. According to a New York Times article, students can expect to see fewer teachers, programs and courses in the arts when they return to campus in the fall. While some colleges are phasing out programs altogether, others, like Louisiana State University, are holding off on new computers, production technology and traveling for conferences to lessen their demand for funding.
  8. Growth and Decline of Majors. For college students, choosing the right major during the recession may secure a stable career in the future. Certain industries, such as journalism, entertainment and finance should be avoided, according to a report by College Finance 101, because they have seen the most turmoil during the recession.
  9. Higher Community College Enrollment. With the recession at its peak, many college students have opted for the more affordable institutions — community colleges, according to The Chronicle of Higher Education. However, this influx of students has caused some community colleges to turn them away, claiming there’s not enough room, teachers and accommodations at these campuses.
  10. Distance Learning is More Desirable. A big thing hitting the economy is online education. Whether people have lost a job, are fearful of losing one or want a degree, online colleges have open seats. A CNN report, titled "Riding out the recession in a virtual classroom," touches on the idea of investing in education during troubled times to have a back-up plan and find the right career path for you.

 

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The Pharmalot Blog Is No More!

Today is a sad day in the pharmaceutical and biotechnology blogging world. Pharmalot, a two year old, pioneering blog created by the intrepid Ed Silverman and the Star Ledger News has decided to call it quits. Unfortunately, the Star Ledger is in dire financial straits and it could no longer provide Ed with the support he needed to continue to run the Pharmalot blog. Please read Ed’s last blog post for the full story.

Pharmalot was a well crafted and informative blog. I frequently (more times then I care to admit) used Pharmalot as source material for many of my posts at BioJobBlog. I am not sure how I will fill the void left by Pharmalot’s untimely  demise!

I first met Ed about 8 years ago when he did a story about a biopharmaceutical company that I founded (along with Abe Abuchowski) called Prolong Pharmaceuticals.  His coverage was outstanding and I am pleased to report that Prolong is still in business today. Ed and I reconnected a little over a year ago at a panel discussion about scientific integrity and journalism. Ed shared the podium with the WSJ Health Blog, the New York Times, Advanstar Publications and several well known authors who write about pharma and biotech. I was truly impressed with his understanding of the pharmaceutical industry (he is a journalist not a scientist) and his commitment to telling people the truth regardless of the consequences. I took his message to heart and have attempted to apply the same philosophy to my posts at BioJobBlog.

I want to personally thank Ed for his unwavering commitment to journalistic integrity and his help in ferreting out the truth. I wish him the best for whatever the future may hold for him—he will be sorely missed.

Until next time…


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

Pfizer's Viagra Turns 10 Today!

Has it really been 10 years since the launch of Viagra, the first drug that was approved to treat erectile dysfunction (ED)?  Why it seems like just yesterday. For those of you who don’t know, Pfizer was originally developing Viagra as a treatment for cardiovascular disease (it increases blood flow). However, members of the Viagra clinical development teams quickly observed Viagra’s unmistakable erectogenic potential and understood the impact that it would have on male sexual function for years to come.

Before Viagra’s launch in 1998, impotence, (the term previously used to describe what is now known as ED) was rarely discussed or mentioned by anyone, including many physicians. Now, with the advent of Viagra, Levitra and Cialis ED has become a part of the American lexicon.  So-called tough guys like Bob Dole to NFL players are no longer ashamed to mention that they suffer from ED now that they can take a pill to overcome the condition. All kidding aside, Viagra has helped many men with conditions ranging from diabetes, atherosclerosis to prostrate cancer. But, there is one question that I have. “Are there really that many men who suffer with ED to account for the roughly $6.0 billion per year that is spent on Viagra and related medications? 

Anyway, Happy Birthday Viagra! Maybe the little blue guy’s birthday can get a “rise” out of Pfizer’s stock today–sssshhhhhhh, let’s not put too much pressure on Viagra, it may interfere with its performance!

Until next time....

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