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A post at the Pharmalot blog said that the US FDA and the Centers for Disease Control issued a statement today indicating, that after reviewing side effect reports, Merck’s anti-HPV (cervical cancer) vaccine Gardasil is safe and effective, and its benefits continue to outweigh its risks.

According to the statement, the joint agency review determined that 94 percent of  all side effects reported after Gardasil vaccination were not serious. The most commonly reported adverse events fainting, pain at the injection site, headache, nausea and fever. Fainting is common after injections and vaccinations, especially in adolescents, the agencies noted.

Although there have been 20 reported deaths following vaccination, there was no common pattern or tend that would suggest they were caused by the vaccine itself. The statement went on to say that in cases where autopsy, death certificate and medical records were available, the cause of death was explained by factors other than the vaccine.

The statement was likely issued in response to highly publicized and widely circulated adverse events reports issued by the ultraconservative Judicial Watch which is morally opposed to HPV vaccination. It is extremely unfortunate that a small but vocal group of conservative Christians are willing to risk the health of their daughters because they are morally opposed to premarital sex and birth control. 

Until next time….

Good Luck and Good Job Hunting!!!

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Like my kids frequently say when I mutter something obvious…”Like..DUH.! According to an article in today’s New York Times, “American medical care may be the most expensive in the world, but that does not mean it is worth every penny. A study to be released Thursday highlights the stark contrast between what the United States spends on its health system and the quality of care it delivers, especially when compared with many other industrialized nations.” No surprises here—the US spends more per capital on healthcare than all other industrialized nations but a greater percentage of the US population is without adequate healthcare.

One of the things that irritate me the most is that many Americans still believe that US healthcare is second to none. True, Americans have greater access to experimental and new cutting-edge treatments than others in the world, but when it comes to preventing or prophylatically delaying the onset of chronic diseases like diabetes, high blood pressure, obesity etc, the American healthcare system is grossly deficient.  

Healthcare insiders and third party payors have known that the system has been failing for past 20 years. Unfortunately, the healthcare and drug maker company lobbies have effectively blocked and prevented any changes to correct the glaring deficiencies of the American healthcare system. Anytime, anybody utters the phrase “nationalized healthcare” a collective shudder is exhibited by most Americans. The truth is that Medicare, a government-run healthcare insurer, is responsible for covering almost 60% of all medicals claims that are filed annually in the US. This means that healthcare benefits supplied to a majority of Americans are under the auspices of a nationalized healthcare program. Why not go all the way and cover the medical costs of all Americans?????

Politicians can no longer deny that it’s time for a change—the health of America depends on it!

Until next time…

Good Luck and Good Job Hunting

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In an attempt to assuage the jitters and financial concerns of investors who own stock in pharmaceutical, biotechnology and medical device companies, the US Food and Drug Administration announced yesterday that it will be change the format of the letter received by companies whose products are not ready for approval.

In the old days (at least until yesterday), when the agency determined that drugs were not suitable for sale, it would send companies a so-called non-approval letter. This letter was designed to inform drug and device makers that their products had issues that needed to be resolved before the agency will approve them. Apparently, (at least according to drug and device manufacturers), receipt of non-approval letters by companies signaled to investors that the product in question would never, under any circumstances, be approved by FDA. This urban legend was born because most companies that receive non-approvable letters decide against investing more time and money into products that FDA has deemed “unapprovable” i.e. there isn’t enough of a financial inducement or upside to continue further development.

Now, when new products are not up to snuff, companies will receive something called a “complete response letter.” According to the agency, the new letters will describe what is missing from a new drug or device application and, when, appropriate, offer advice on how to fix or address the problem(s). However, because contents of FDA letters are not released to the public, investors may now be less informed about the prospects of a new drug than in the past when the agency was able to send “approvable” or “non-approval” letters to companies.  “While this new plan may provide more detailed information to a company regarding issues that need to be addressed, investors will likely be kept in the dark on the true status of a drug’s approvability” said a pharmaceutical analyst after learning about the format changes. He went on to say “Investors will no longer know whether a drug is truly dead in the eyes of FDA.”

In my opinion, this is another example of FDA cow towing to the whims and wishes of industry. Whether you call it, a “non-approvable” or “complete response letter”, it still means the same thing—the drug or device is not ready for prime time! I don’t think that the change in semantics will do anything to assuage concerns of jittery investors. What it WILL do is force investors to rely solely on the honesty of the management teams that receives these letters—Oy!

I think that FDA ought to stick to the business of evaluating the safety and efficacy of drugs and be less concerned with the political and economic needs of the drug and device industries. Finally, it would be prudent for FDA to allow appropriately trained professionals to provide psychotherapy to all of the frightened and jittery investors out there!!

Until next time…

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

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Just when you thought the obvious couldn’t be anymore obvious to US lawmakers, the Congressional Budget Office (CBO) today released a long-awaited assessment of the cost of a biogenerics bill and found that the legislation, if enacted, would reduce total expenditures on biologics in the US by $25 billion over the next decade—duh!!!  

According to a post over at Pharmalot, “The report comes as a growing group of drugmakers, insurers and employers agitate over the high cost of biologics, which may only be rectified if Congress passes legislation that would give the FDA guidance on creating a so-called pathway to approve biogenerics, or follow-on biologics. Two House bills have been proposed that are similar to the Senate bill reviewed by the CBO, although the looming summer recess and election-year politics suggest passage may not occur this year.”

Unfortunately, as I suggested in a previous post, the bills currently under consideration are flawed and would give unwarranted patent exclusivity to innovator companies if enacted. Nevertheless, as Kathleen Jaeger, head of the GPHA (a generic manufacturing trade group) aptly stated “We are still reviewing the analysis, but we are pleased that CBO agrees that significant savings will be achieved by bringing biogeneric medicines to consumers and that even greater savings will result from removing harmful barriers to access, including brand evergreening and unprecedented market exclusivity provisions. With Americans growing increasingly concerned about health care costs, we should be increasing access to affordable medicines while fostering competition in the pharmaceutical marketplace. “

By the time that a US approval pathway for biogenerics is divined, European and Asian biogeneric manufacturers will already control the market and the “new” (what took you so long) American legislation will provide little financial incentive for US companies to enter the biogenerics market space.

Until next time…

Good Luck and Good Job Hunting!!!!

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Last year was a banner year for the pharmaceutical lobby (the largest in Washington DC). It spent over $168 million to inform Congress about issues that its members thought were in the best interest of the pharmaceutical and biotechnology industries. So what were the main issues that occupied a majority of the lobby’s time?

• blocking the importation of inexpensive drugs from other countries
• protecting pharmaceutical patents both within the United States and abroad
• ensuring greater market access for pharmaceutical companies in international free trade agreements

You are probably wondering which company was the top spender—it was Amgen! As you may recall, Amgen’s EPO franchise was under intense medical, regulatory and congressional scrutiny because of safety issue that resulted from over prescription. In my limited understanding of how things work in Washington, I have been told by lobbyist friends of mine that there is no better way to solve nagging problems than by paying influence peddlers to make them go away.  That said, Amgen’s lobbying costs paled in comparison with the $23 million spent by Pharmaceutical Research and Manufacturers of America a pharmaceutical industry trade group.  You Go PhRMA!!!!

A quick perusal of the top lobbying list reveals that all major US pharmaceutical companies invested heavily to influence members of Congress to allow them to preserve their stranglehold on the American healthcare system. Not surprisingly, all of the major foreign pharmaceutical manufacturers were also on list.  Much to my surprise, Teva, the Israeli generic manufacturing giant made the list this year—so it goes!

I guess altruism is out and avarice is still in! Hat tip to Pharmalot.

Until next time….

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No doubt that many of you already know that DTC advertising is an effective way for pharmaceutical companies to “push” their drugs. However, when I saw the amount of money that was spent on DTC in 2007 I was shocked! In 2007 alone, drug companies spent $5,375,117,382 on advertising. Yes, that's $5.375 billion dollars (think of how many research grants could have been funded or how much money could have been spent on universal healthcare!).  The aggregate ROI for 25 pharma companies examined was impressive–totaling about $32 billion or roughly 7-fold!

A table published by Consumer Reports AdWatch highlights 25 of the biggest spenders along with their sales, giving an indication of how much their ad spending has paid off —or not! The drugs that received the biggest bang for the buck are bolded. Despite the conflict of interest and false advertising DTC flap over Lipitor, it still managed to have the third best return among the 25 products analyzed.

Drug	Approved for1	DTC advertising 20072	Retail sales 20073	Sales per ad dollar spent
Lunesta	Insomnia	$294,180,616	$712,740,000	$2.42
Ambien CR	Insomnia	$204,065,972	$876,028,000	$4.29
Cymbalta	Anxiety, depression, diabetic neuropathy pain	$183,336,687	$1,732,827,000	$9.45
Lipitor	High cholesterol	$180,866,960	$6,165,531,000	$34.09
Plavix	Stroke risk reduction	$174,942,656	$3,082,712,000	$17.62
Rozerem	Insomnia	$171,466,210	$116,658,000	$0.68
Cialis	Erectile dysfunction	$151,649,663	$453,233,000	$2.99
Vytorin	High cholesterol	$140,715,035	$1,938,882,000	$13.78
Nasonex	Seasonal allergies	$131,220,183	$892,534,000	$6.80
Advair Diskus	Asthma	$121,197,100	$3,390,766,000	$27.98
Boniva	Osteoporosis	$112,958,755	$404,109,000	$3.58
Zetia	High cholesterol	$110,357,144	$1,405,066,000	$12.73
Requip	Restless Legs Syndrome, Parkinson's disease	$106,271,994	$407,665,000	$3.84
Abilify	Bipolar disorder and schizophrenia	$105,768,412	$1,781,562,000	$16.84
Flomax	Enlarged prostate	$100,969,013	$1,002,163,000	$9.93
Nexium	Heartburn and GERD	$96,960,417	$4,355,901,000	$44.92
Valtrex	Herpes and shingles	$88,409,332	$1,395,313,000	$15.78
Spiriva	Chronic obstructive pulmonary disease	$84,002,514	$868,226,000	$10.34
Yaz	Contraceptive pill	$83,566,746	$254,592,000	$3.05
Viagra	Erectile dysfunction	$83,064,378	$824,946,000	$9.93
Lyrica	Fibromyalgia and neuropathic pain	$70,663,685	$1,000,069,000	$14.15
Chantix	Smoking cessation	$63,979,755	$764,723,000	$11.95
Singulair	Asthma and seasonal allergies	$63,289,786	$2,863,326,000	$45.24
Celebrex	Pain from conditions like osteoarthritis	$55,230,236	$1,416,084,000	$25.64
Zyrtec	Seasonal allergies	$38,476,595	$1,302,807,000	$33.86

¹Consumer Reports Consumer Drug Reference, 2008.
²Data compiled by Nielsen Media research, March 2008.
³Data provided by Drug Topics and Verispan, March 2008.

No wonder why everybody wants to work for a pharmaceutical company–despite the downsizing there is still substantial money to be made!

Until next time….

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

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As many of you may recall, Merck tried unsuccessfully last year to lobby state and federal officials to pass legislation that would require mandatory vaccination of girls aged 9-26 with Gardasil, its anti-HPV, cervical cancer vaccine. Merck came under fire for its efforts (which seemed ethically disingenuous to many). Consequently, the company’s image took a hit and its stock price started to tumble. Although Merck stopped its lobbying campaign (mostly because of bad press and a flagging stock price), Gardasil ads continued to run and went largely unnoticed.

Because GlaxoSmithKline may be close to launching Cervarix^Tm—its cervical cancer vaccine—  the company recently decided that it was time to ramp up its Gardasil advertising efforts. Starting this past Saturday and continuing through June 26, Gardasil ads will be gracing the screens of a theater  near you. The ads will be shown with films like “Sex and the City” (hmmm, clever wouldn’t you say?), “Get Smart” (who doesn’t remember Barbara Feldon), “The Happening” (what woman doesn’t love a scary movie), “You Don’t Mess with the Zohan” (Adam Sandler is hot) and several others. I want to thank Ed Silverman over at Pharmalot for the heads up on this story!  I don't know about you, but I think that showing commercials at the movies, especially those hawking pharmaceutical products, is just plain wrong!!!!!!!!

This isn’t the first appearance of Gardasil ads at the cinema—I recall seeing an ad for Gardasil the last time I went to the movies (I don’t remember the movie but I clearly can recall the ad!). According to a Merck spokeswoman (aren’t pharmaceutical companies clever?), “We purchased advertised space that is relevant for our older female target audiences; specifically for the summer movies that are relevant to those aged 19 through 26.” 

As Ed so eloquently stated in his Pharmalot post: “Of course, plenty of teenagers will be seeing some of these flicks, too. Zohan and Get Smart are rated PG-13. And Sex and The Happening are rated R, but the restrictions only apply for kids under 17– some of whom will, no doubt, see them anyway.  In any event, Gardasil is unlikely to be available as a value pack that includes soda and popcorn. But we (Pharmalot) are curious to know whether the Gardasil beach towel is about to make a comeback.”

 Until next time….

Good Luck and Good Movie Watching!!!!!!!!!!

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The newest culprit in the direct-to-consumer (DTC) television ad cat and mouse game between pharmaceutical manufacturers and US regulators is Cordis, a medical device subsidiary of Johnson & Johnson. The ad in question deals with promotion of the use of a cardiac stent called Cypher that is manufactured by the company. The television ad is the first ever to market a medical device. Nevertheless, according to an article published in this week’s New England Journal of Medicine, the ad overstates the benefits of the stent without mentioning possible adverse effects that can include heart attack and stroke.

The current brouhaha is nothing new in the ongoing battle between drug manufacturer (and now, medical device companies) and regulators over DTC advertising. As some of you may know, the US is one of a few industrialized countries in the world that allows DTC advertising.  Further, DTC ads don’t require FDA review or approval before they are aired or printed–although in some instances, companies do request FDA review. 

Because of growing problems with DTC ads (especially television spots), there is mounting pressure on FDA to limit consumer medical advertising or, at the very least, increase regulatory oversight of it. To that end, on Friday, an FDA advisory panel will convene to discuss whether television ads for prescription medications ought to include a statement encouraging consumers to report any adverse side effects via a toll free number to the agency. At present, this type of disclaimer is only required for DTC print ads.

For those of you who don’t know, FDA has (by law) a post marketing surveillance network in place to allow consumers to report any side effects (big or small) that they may experience after taking prescription or over the counter medications. Further, companies are required by FDA regulations to immediately report any and all side effects associated with their products.

Of interest, in a hearing last week on drug advertising (being conducted by the House Energy and Commerce Committee), several drug company representatives in attendance were asked whether or not they would support a toll free number on television ads to encourage viewers to report adverse side effects. Surprisingly (perhaps not) they could or would not directly answer the question. According to John D. Dingell, chair of the committee and advocate of greater regulatory oversight of DTC advertising, “Some ads appear to be misleading and others appear to be downright deceptive.” Imagine that!

What is particularly disturbing about the DTC controversy is that government officials and legislators are frequently incredulous when they learn about DTC advertising abuses. As I have stated time and time again, there are larges sums of money at stake here. This coupled, with little or no regulation, and mounting pressures to keep company stock price shares high, is a sure recipe for disaster (as we have begun to witness over the past 5 years or more). In my opinion, there is only a single solution to the problem–craft more stringent regulations and greater FDA oversight for DTC advertising. Asking drug and medical devices companies to regulate themselves in any area is tantamount to allowing a fox to live in a hen house—the pickings are easy and only the fox gets fat!

Until next time….

Good Luck and Good Job Hunting!!!!!

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I learned late last evening that Ron Mardigian, founder and manager of Bio-Rad’s Biotechnology Explorer Program, died suddenly and unexpectedly in his sleep last December. Not surprisingly, I learned of his passing in a publication from Bio-Link, an NSF-funded organization committed to biotechnology training at the high school and community college levels.

Ron and I first met (via the telephone) in1996 when he was putting the finishing touches on the first of a series of education kits that would ultimately become Bio-Rad’s Biotechnology Explorer Program. At the time, I was working at Rutgers to create variants of the Green Fluorescent Protein (GFP) that could be used for educational purposes. Like me, Ron immediately realized that GFP could be used as a powerful education tool to showcase the principles of molecular biology and biotechnology. After talking on the phone for hours at a time, Ron and I finally met in 1997 at an International GFP meeting in New Jersey at which he was conducting a series of teacher training workshops. Imagine my surprise when I saw, for the first time, this striking, long-haired, cool-looking dude of indeterminate age who purportedly worked for the Bio-Rad Corporation! I knew that this was the beginning of a long and enduring friendship. 

Ron was one of those special people who have an amazing energy about them. His unrelenting drive, passion and commitment to education (and life for that matter) were always palpable. When Ron was “in the house”, nothing was impossible and no problem was insurmountable. At work, Ron was a consummate professional who was available 24/7. I can’t remember an instance when Ron failed to quickly return a phone call or e-mail query. But, when Ron was on vacation, everybody who knew him understood that it was “his time” and that they shouldn’t bother him. He was an avid windsurfer, cyclist and intrepid explorer who could not resist an adventure. Ron’s annual three week sojourns to Hawaii, Northern California and places unknown are now legendary.

Ron once told me how he convinced the President of Bio-Rad to allow him to start the Biotechnology Explorer Program. As the story goes, Ron, who had worked at Bio-Rad for several years in a technical capacity, was at a crossroad in his career. As he put it, “he needed to clear his head” and the best way for Ron to do that was a road trip. After a three week jaunt to the Baja and Mexico, Ron came up with an idea to leverage his knowledge of molecular biology into a series of self-contained kits to teach biotechnology to high school teachers and students. The fact that he was able to convince a multinational, laboratory reagent and equipment manufacturer to take a risk on education is a testimonial to Ron’s charisma, passion and skills as an inveterate salesperson. Nobody I know was ever able to say no to Ron–including me! 

Unfortunately, the last time I spoke with Ron was about a year ago. He told me that things were going well and that life was full and rich. I regret the fact that I didn’t have an opportunity to speak to him before he passed away.

Bio-Rad’s Biotechnology Explorer Program has been wildly successful during its first 10 years of existence. I’m sure that nobody but Ron expected this. Like any parent, I suspect that he experienced nothing but pleasure and joy watching his baby mature into adolescence. Unfortunately, he will not be here to shepherd his child into adulthood. I hope Bio-Rad will keep Ron’s memory alive by continuing to support and promote the Biotechnology Explorer program.

Farewell “bro”–thank you for allowing me to accompany you on a part of your journey!

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I was reading the paper this morning and I happened upon an article about the uproar over Miley Cyrus aka Hannah Montana posing in a topless photo for Vanity Fair magazine (as it turns out she is not topless, but wrapped in a silk sheet in a very, alluring, adult-like pose). For those of you who care, the photo was taken by Annie Liebowitz, photographer extraordinaire. According to 15 year old Miley, it was a cool, artsy photo that she didn’t have a problem with– although she is now publicly stating that she is “embarrassed” by it!  So, why are parents everywhere in America going ballistic over the photo?

As you may know, Hannah Montana is a Disney creation. And, for some reason, Disney has come to represent “good, clean American family values and fun”.  If this is true, it begs the question: Why would Hannah Montana, who has been canonized as a wholesome, innocent, and drug-free All American teenage girl, pose in a sexually alluring photograph? I think the answer to the question is obvious—money! Miley’s handlers; agents (and parents?) probably understand that she likely has made as many million as she can playing Hannah Montana, the all American girl.  They must have decided that it was time for Miley to grow up, become a sex icon and continue to sell as much merchandise and movie tickets as possible. After all, this tactic has worked for many other young female stars (and has also helped to sell tens of millions of dollars of inappropriate attire to girls aged 8-16), so why should Hannah Montana not be allowed to cash in on the opportunity? Isn’t becoming rich what the American dream is all about?

What I find disingenuous about the whole incident is that Disney is publicly outraged over the photo! I guess they have a right to be; Miley recently signed a new, multimillion, seven year deal with the company.  If, contrary to popular opinion, her image is actually tarnished by the photograph, she may be worth less than less Disney expected and the company may not be able to recover its ROI on the Hannah Montana franchise. What I find even more astonishing is that many Americans truly believe that Disney represents (and is synonymous with) American family values.  I hesitate to tell these folks that Disney is like any other multinational, publicly-traded company —primary goal is to make as much money as possible to provide profits to its stakeholders. Morals and ethics have little to with what actually makes Disney or any other corporation tick! In my opinion, American values ought to be taught to children by their parents, relatives and friends; not publicly traded corporations.

After seeing the photograph, my wife and I had very mixed feelings about the entire Miley Cyrus incident.  So, we asked our nine (9) year old daughter, who is a big fan of Hannah Montana, what she thought about the photo. After viewing the photo, she said that “she thought that it was wrong for Miley Cyrus to have her picture taken that way because she is only 15”. My wife then asked: “How old she thought that someone should be before posing in a picture like that”, my daughter shrugged and said, “I don’t know, 25”?  I must admit, that I was very surprised and pleased with her answer! For the record, my wife and I have never taken our daughter or two sons (ages, 14 and 12) to Disney—so I say “Rock on Hannah Montana”.

Until next time….

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

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The Boston Globe reported the other day that regulators at the US Food and Drug Administration (FDA) rejected a request by Framingham, MA-based Genzyme to continue to market and sell its Pompe Disease drug, Myozyme, which is being manufactured at a newly built production facility in Allston, MA. Myozyme is a recombinant version of alglucosidase alfa that is used to treat Pompe Disease, a rare enzyme storage disease. Genzyme is seeking to transfer Myozyme manufacturing operations from its Framingham production site to the larger Allston facility to meet increased market demand for the drug. Pompe Disease affects an estimated 5,000 to 10,000 patients worldwide.

According to Genzyme, FDA rejected the manufacturing transfer request because of slight differences that were detected in the carbohydrate array of Myozyme manufactured at the Allston site as compared with similar material produced in Framingham. Because of these slight but detectable carbohydrate variations, FDA is insisting that Genzyme conduct new clinical studies (safety and efficacy) with Allston-manufactured material before it will allow the company to sell it in the US. Company officials claim that they have data from approximately 900 patients who are currently taking the new version of the drug and will share this information with the agency. Interestingly, over 40 countries have already approved the new version of Myozyme manufactured at the Allston facility.

Personally, I think it is perfectly reasonable for FDA to request additional clinical studies to insure that the Allston version of Myozyme is as safe as the original. For those of you who don’t know, Myozyme was originally approved as an orphan drug. Typically, this means that only a small number of human safety and efficacy trials were conducted to gain initial approval for a product. Therefore, I think that Genzyme should only be required to conduct safety trials (not efficacy studies) before the Allston material is allowed to be sold in the US.  That said, the safety data that Genzyme has already collected from the 900 patients using the Allston-manufactured drug may obviate the need for any safety studies at all!

If FDA forces Genzyme to conduct new efficacy and safety studies, then it wouldn’t be unreasonable for Genzyme to ask the agency to issue a second license for the “new” Myozyme. After all, it appears that FDA is treating the Myozyme manufactured at the two Genzyme –run production facilities as distinct and unrelated drug products. And, according to the provisions of the Orphan Drug Act, newly approved orphan products are entitled to receive seven years of market exclusivity from the their date of approval. Therefore, if FDA issues a new license for the Allston material, Genzyme ought to receive an additional seven years of market exclusivity for Myozyme!

As one Genzyme official noted, FDA’s decision regarding Myozyme sends “a very loud and clear message and sets a very high bar.” It suggests that FDA regulators will be reluctant to approve any generic versions of biologics or biotechnology drugs without clinical studies that prove that the new drugs are as safe and efficacious as the originals

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I just returned from my career development sojourn at this year’s FASEB meeting in San Diego, CA. Not surprisingly, all of my sessions were well attended. In fact, attendance at many of the presentations was standing room only. Again, this was not terribly surprising because the job market for graduate students and postdoctoral fellows for the last 5 years has been dismal. However, in contrast with past years, there was a noticeable and palpable difference in the attitudes of many of the students and postdocs who attended the sessions. In previous years, many career development participants seemed resigned to the possibility of a “jobless future”. However, this year there was a small but vocal group of participants who openly expressed their anger and resentment at the possibility of not finding a job after completing their training. I think that many graduate students and postdoctoral fellows have begun to realize that they are being exploited by a fundamentally flawed academic system and that they are “not going to take it anymore.”

Academia has always resembled a medieval, feudal system. Principal Investigators (PIs) are the kings because they hold all the power, money and authority and rule with impunity. Postdoctoral fellows are the lords or vassals who behave somewhat autonomously but have sworn oaths of allegiance and fealty to their kings. Research associates (technicians) are the indentured servants who rely on the king and his vassals for sustenance and protection. Finally, graduate students are the slaves whose lives and well being solely depend upon unquestioned obedience to their Kings. As we all know, feudal systems broke down when kings could no longer maintain control over their slaves and indentured servants. This culminated in rebellions and revolutions, the eventual demise of monarchies and ultimately gave rise to modern republics and democracies.

Although I am not necessarily advocating revolution (okay, so maybe I am), it is time that drastic and systemic changes be made to academia as we know it.  First, there needs to be a limit or moratorium on the number of students that are annually accepted into graduate programs. There are simply not enough academic, industrial or government jobs to justify the number of PhDs and postdoctoral fellows that are trained each year. Second, tenure should be abolished at all research universities and medical schools and be replaced with 5 year renewable contracts. This will force PIs, whose primary job is to do research (not teach), to remain competitive and productive. Further, it will reduce the likelihood that ego-centric PIs will be able to accumulate enough wealth and power to establish the “fiefdoms” that are prevalent in academia today. Third, PIs must increase their reliance on technicians (rather than postdoctoral fellows) to achieve their research objectives and goals. Allowing postdocs to work 5 or more years in the same laboratory because it is cheaper to hire them than technicians is, in my opinion, ethically and morally bankrupt. Finally, and perhaps most importantly, it is vital that PIs actually become mentors and play active roles in advising and shaping the careers of their students and postdoctoral fellows. Given the paucity and competitiveness of academic positions, it is disingenuous for PIs to promote academic careers for every person who passes through or works in their laboratories. As a former medical school tenure track Assistant Professor, I didn’t find it too difficult to identify which students and postdocs were “cut out” for academic careers. Further, it is incumbent upon PIs to take the time to

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Metals like copper and silver have long been known to possess antibacterial properties. I learned this as an undergraduate microbiology major circa 1972. That said, I didn’t know whether to laugh or cry when I read an article in today’s NY Times entitled "Regulators Stamp Copper as a Germ Killer". According to the article, the Copper Development Association (CDA), a NY-based trade group for copper companies, announced that federal regulators at the US Environmental Protection Agency (EPA) approved its application to market copper, bronze and brass-containing products as antibacterials that are effective enough to protect against bacterial infection. Apparently, what made this newsworthy is that this is the first time that EPA has allowed health claims to be attached to a solid antimicrobial material (rather than an aerosol or liquid disinfectant). For those of you who may not know, EPA (not FDA) regulates antimicrobial agents like disinfectants and air fresheners that are not directly applied to the human body.

Not surprisingly, there are many consumer products already on the market which are impregnated with silver and some other antimicrobial substances that claim to reduce the risk of infection.  Some of the more creative and pricey ones include silver-coated computer keyboards and mice manufactured by Iogear. However, none of the companies that manufacture these products can legally claim that the impregnated metals in them kill bacteria or provide a health benefit because they never thought to submit data to  EPA regulators to substantiate these claims. This is marked contrast with the CDA which smartly and painstakingly performed “clinical studies” for the past 4 years with copper and its alloys (mostly door knobs) to gain regulatory approval to claim that these metals have bona fide antibacterial properties. According to a CDA spokesperson, additional “clinical trials are underway to test how copper bed rails, arm rests and other hospital fixtures can reduce the numbers of bacteria in hospitals.”

Don’t get me wrong–you gotta love the creativity of the CDA for developing an innovative business strategy to help maintain the price of copper and bolster the sales of copper-based products. As you may know, the advent of fiber optics and silicon chips has been steadily pushing the price of copper down for the past few years–something that the CDA is keenly aware of.  Unfortunately, in contrast with CDA’s new vision, I believe that the only way to effectively reduce the high bacterial loads in our hospitals is through vigorous enforcement of hospital sanitation and hygiene programs, regular screening of hospital personnel and routine environmental monitoring.  Based on over 30 of experience with food borne and nosocomial bacterial diseases, I firmly believe that improperly sterilized equipment and instruments and people who are either unsuspecting carriers or fail to maintain good sanitation and hygiene practices are the main causes of bacterial contamination and transmission in hospital settings. I don’t think that inanimate metal objects (which have long been known to have inherent antimicrobial properties) contribute to the high levels of bacteria that are commonly found in today’s hospitals. Nor do I think that replacing existing hospital fixtures with copper, brass or bronze ones will do much to reduce bacteria levels in most hospitals.  Nice try CDA–but no cigar this time (at least not from me)!

Until next time….

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

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There was an alarming article in today’s New Times which reported that greater numbers of parents are rejecting vaccination for their children. You may ask, “How is this possible. Aren’t childhood vaccinations mandatory?  Well, yes and no. As it turns out, 20 states including California, Texas and Ohio allow some kind of personal belief exemption from otherwise mandatory childhood vaccinations. And, more and more parents are opting out every year. In 1991, less than 1% of children in states with personal belief exemptions went without vaccinations. By 2004, the most recent year for which data are available, the percentages swelled to over 2.5 %. Frighteningly, according to a 2006 article in the Journal of the American Medical Association, exemption rates of 15% to 18% has been found in certain areas of Oregon, Washington and California.

So, what is responsible for this startling increase? Unfortunately, misinformation on the Internet promulgated by American news media outlets has caused some parents to question the safety of many childhood vaccines including those for measles, mumps, rubella, and diphtheria and whooping cough. Although parents who opt to not vaccinate their children believe that they are protecting them from serious vaccine-induced side effects, they are, in reality, increasing the risk that their children and others may contract these diseases. Surprisingly, many parents who choose not to vaccinate their children are aware hat they may be placing other children at risk. For instance, in the NY Times article, one mother chose not to vaccinate her child said, “I cannot deny that my child can put someone else at risk” 

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After an exhaustive nationwide search, FDA Commissioner Andrew von Eschenbach decided yesterday that Janet Woodcock, a career FDA staffer, was the best choice to lead the agency’s struggling Center for Drug Evaluation (CDER). For Dr. Woodcock who has been the acting head of CDER since September, this will be the second time that she was tapped to lead the center. She was previously appointed to the top CDER job in 1994 by then FDA Commissioner David Kessler (the last time FDA had any real leadership).

The inside skinny on the appointment is that she beat out Jesse Goodman for the position, another career FDA employee  who is currently the head of the agency’s Center For Biologics Evaluation and Research (CBER).  What surprises me the most about Woodcock's appointment is that after a nationwide search to find a new leader for CDER, von Eschenbach’s final choice was between two career FDA bureaucrats!  Why bring in an outsider with fresh new ideas when the best available talent in the land already works for you?

Don’t expect anything to change at the agency.  Dr. Woodcock tows the party line and is loyal to von Eschenbach (who by the way is a personal friend of the Bush family). It is no secret that FDA is broken and desperately needs to be fixed. Choosing a person to lead CDER (for the second time) who has been at FDA for almost her entire career, signals  that Commissioner von Eschenbach is neither ready nor willing to implement the systemic changes that are so drastically needed at the agency.  Maybe something will change at FDA when someone other than George W. Bush is in the White House?

Until next time….

Good Luck and Good Job Hunting!!!!!

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We all know (or should know) that eating dirty or yellow snow is a big “no-no”. Those of us who are parents (and live in regions where there are regular snowfalls) teach our children this lesson as quickly as possible. That said, should parents worry when their children eat new or freshly falling snow because it contains air-borne bacteria? 

Last week, a group of scientists at Louisiana State University reported in Science magazine that there may be a relationship between ice-nucleating, air-borne bacteria and global rainfall patterns. For those of you who don’t know, the formation of ice in clouds is required for snow and most rainfall. Although dust and soot particles serve as ice nucleation particles, bacterial ice nuclei are capable of catalyzing freezing more quickly at much warmer temperatures and their presence in the atmosphere may affect the processes that trigger precipitation. Results from the Science study suggested that bacteria like Pseudomonas syringae, which have long been know to serve as nucleators and induce ice formation, are widely distributed in the atmosphere and likely play critical roles in influencing the amount of rain that falls at various locations in the world–pretty cool new stuff for those of us interested in global warming and climate change in general. Therefore, it surprised me when I saw that lay newspaper reporters chose to “cherry pick” data from the paper to suggest to Americans that even freshly fallen snow contains large numbers of bacteria and that, perhaps, parents should be careful when they allow their children to eat snow!

As a card-carrying microbiologist and seasoned science educator, I want to assure all of you that eating freshly fallen snow will not cause disease in you or your children. The types of bacteria found in the atmosphere, and ultimately in snow, are not human pathogens and don’t cause disease. Thankfully, in a story entitled “Study: Driven snow isn’t all that Pure” that appeared in my local paper (The Trenton Times)– a member of the American Academy of Pediatrics Committee on Environmental Health was quoted as saying ; “We eat stuff that’s covered with bacteria all the time, and for the most part, it is killed in the stomach.” Another pediatrician, who is a member of the academy’s committee on infectious diseases, reinforced the claim that snow munching was not harmful and said “Children practically bathe in bacterial when they go to the playground and they won’t get anything from snow that they would not get from dirt.”  

Although most of the stories about bacteria and snow munching that appeared in the lay media were “fluff pieces”, they did alarm some parents! As one mother said in the Trenton Times article: “When I heard bacteria, at first, I went “eeeewwww”. But as long as the kids eat snow as it’s falling, I think it is okay. I tell them not to eat it if it’s on the ground.” What was particularly troubling about her remark was her initial negative reaction to the mere mention of the word bacteria. Unfortunately, most Americans have little understanding about bacteria and the negative impressions that they have formed are based on the sensationalistic and often scientifically inaccurate pieces about “dangerous” bacteria and fungi (mold) that often appear in print media and on television.

In my opinion, America’s negative attitude and poor understanding of science is a consequence of ongoing, misguided science reporting that has plagued this country for years. Although the American lay news media is mostly responsible for this, scientists are also complicit because of their unwillingness or inability to publicly speak out on important scientific issues and problems.

I believe that scientists are obliged to do everything in their powers to ensure that lay science reporting is fair and balanced and that the correct scientific messages reach the American public. Our failure to act will surely jeopardize the future of American science–something that we Americans can ill afford. Enough said–have a plate of snow on me!

Until next time….

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

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For the past year or more, the US media has been vociferously bashing tainted imported Chinese goods any time it can. The tainted products have ranged from toys to dog food and most recently to Baxter’s heparin which has been associated with illnesses and deaths in this country.  

I suspect that this recent spate of China bashing has more to do with political and future economic issues than the safety and well being of the American public. Nevertheless, according to US Food and Drug Administration Current Good Manufacturing Practices (CGMP) regulations, companies that hold the licenses to manufacture pharmaceutical and biotechnology products assume full responsibility for the quality and safety of their products. To accomplish this, companies are required to test all raw materials, excipients and APIs (regardless of their source) before they are assembled to make a finish pharmaceutical or biotechnology product. The results of these tests must be carefully analyzed and compared with the product quality specifications established by the company and approved by FDA. If the test results for product ingredients are outside of the normal range of established specifications, then the company is obliged to reject the materials and not used them to manufacture product. To that end, there was clearly, something was wrong with quality testing at the Baxter heparin manufacturing facility because the adulterated heparin API should have been detected long, before it was used to manufacture the final product. Although the Chinese heparin may have adulterated, the onus was on Baxter (the company that holds the product license) and not the Chinese government to insure its final product met quality standards and was safe for public use.

Outsourcing is a fact of life in almost every sector of the American economy. Pharmaceutical and biotechnology companies import the materials they use in their products from all over the world. It is FDA’s job to insure that American companies remain CGMP compliant so that they produce safe and effective medications. To blame America’s regulatory shortcomings on foreign manufacturers and their governments is dangerous and naïve-not to mention chauvinistic.

Until next time…

Good Luck and Good Job Hunting (try Shanghai)!!!!!!!!!!

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I am old enough to remember when the artificial heart was invented and used to extend the life of Barney Clark, a dentist in Seattle, WA. It was a phenomenal accomplishment back in the day. So, it seemed appropriate to me that Robert Jarvik, the guy who invented the artificial heart, appeared in Pfizer’s Lipitor ads as a spokesperson to promote heart health. However, a Congressional committee examining consumer drug advertising has questioned whether the Lipitor ads may have misrepresented Dr. Jarvik and his credentials to promote the drug.

Although Dr. Jarvik has a medical degree, he is not a cardiologist nor is he licensed to practice medicine! Further, one television ads depicts Dr. Jarvik as an accomplished rower but the ad used a body double for him and, as it turns out, he does not even row! To make matters worse, a former colleague of Jarvik contends that he is not the actual inventor of the artificial heart. He suggested that the distinction belongs to Jarvik’s mentor Willem J. Kolff and his associate Tetsuzo Akutsu at the University of Utah. Go figure! Despite the firestorm, Pfizer continues to air the television ad ( I saw it just a few days ago).

Pfizer has spent more than $258 million advertising Lipitor (a cholesterol-lowering statin) since January 2006, most of it on the Jarvik campaign in an attempt to protect Lipitor from generic competition. Lipitor is the world’s best selling drug and generated $12.7 billion in revenues in 2007. While Lipitor has patent protection until 2010, some patients have already switched to a generic version of a competing cholesterol drug Zocor. According to published reports Pfizer agreed to pay Jarvik about $1.35 million under a two-year contract that expires next month. I think it is safe to assume that Jarvik will not appear in any future Lipitor ads.

As many of you may know, drug companies FDA is not required to review direct-to-consumer ads before they are aired to the American public. While some companies request FDA review of their promotional materials before they are used in advertising campaigns, the vast majority of companies do not. Unfortunately, because of this regulatory loophole, direct-to-consumer advertising has turned into something of a cat and mouse game–there are only consequences and penalties if you get caught misrepresenting or not fully disclosing information about your products.

In my opinion, Pfizer’s misrepresentation of Jarvik’s credentials (and Jarvik’s complicity) is unethical and unconscionable. More importantly, it demonstrates how easily and willing companies are to “bend the truth” to preserve blockbuster drug franchises that generate billions of dollars in annual revenues. I think that what Pfizer did was wrong and shameful. The company should be fined and sanctioned for the Lipitor campaign. That said, it is likely that the size of the fine levied by FDA will pale in comparison to Lipitor revenues generated by the Jarvik campaign. I believe that it is time for Congress and FDA close the loopholes in current direct-to-consumer advertising regulations–the safety and health of the American public depends on it!

Until next time….

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

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 A report on the state of the Massachusetts biotechnology industry suggests that global competition and shortages of trained workers might cause the state to loss its reputation as one of the world’s top life sciences cluster. The report points out that there simply aren’t enough trained workers to meet the growing demand from Massachusetts-based biotechnology companies-both because of a lack of adequate training programs and lack of interest from students.  

To help to remedy the situation, the study recommended that more job training programs ought to be created at two- and four-year state colleges and that Massachusetts should do more to encourage students to pursue careers in the life sciences. As usual, the report recommended that math and science education should be improved at the K-12 levels. Other suggestions included setting up a “summer bio camp” and launching an unpaid bioscience internship program.

Unfortunately, this report, which was prepared by Boston-based Mass Insight Corp and McKinsey & Co and was likely very expensive, is almost identical to other studies published over the past decade about ongoing workforce shortages in the life sciences industry. Like its predecessors, it contains the same tired and unimaginative recommendations that others have proposed to solve bioscience labor shortages. To learn more about some creative solutions to avert life sciences workforce shortages click here.

Despite what the experts and pundits would have you believe, the etiology of the workforce shortages in the life sciences industry is easy to decipher. Put simply, most universities and colleges don’t believe that job training or career development should be part of their academic initiatives or educational missions. Likewise, companies don’t feel that education or training should fall within their purview–according to industry executives, college and professional school graduates ought to be sufficiently prepared to enter the workforce after they complete their education.

Because neither academia nor industry wants to assume responsibility (financial or otherwise) to prepare or train students for careers in the life sciences, it should come as no surprise that there are workforce shortages in this industry. Although a number of federally-funded biotraining programs were initiated in the late 1990s, these programs were poorly promoted and are incapable of sustaining themselves without government support. Paradoxically, there are many more innovative, industry-focused biotechnology and bioscience training programs at the high school level as compared with the undergraduate and graduate levels. I suspect that many professors in undergraduate and graduate life sciences departments are more concerned about their own research programs than about the careers of their students. Go figure………!!!!!

There will continue to be workforce shortages in the biotechnology, pharmaceutical and medical devices industry until either academia, industry or both claims ownership of bioscience training and career development.  I think that it time for academicians and industry professionals alike to put their heads together to solve this serious and ongoing problem. Failure to do so will result in the loss of America’s global dominance in the life sciences industry.

Until next time…

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

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Despite what the American public has been led to believe, the scientific, regulatory and safety issues related to biogenerics aka follow-on biologics, biosimilars, or subsequent entry biologics have been clearly are no longer controversial issues. They have been identified, analyzed and carefully vetted. This allowed EMEA, the European Medicines Agency in 2006 to craft a comprehensive regulatory approval pathway for biosimilars. For those of you who may not know, several biosimilar products are currently are the market and sold in all European Union member states. This begs the question–what is taking the US so long?

From the beginning, big pharma and big biotech have unequivocally and steadfastly opposed any legislation that would allow biogenerics to be approved and sold in the US. The trade groups BIO and PhRMA have literally spent millions of dollars lobbying members of Congress to oppose any legislation that would allow approval of biogenerics in the US. Now, in a sudden and unprecedented about face, big biotech and pharma have thrown their collective weight behind proposed biogenerics legislation that will be introduced in the near future by Representative Anna Eshoo (D-CA).

As far as I can tell, the primary reason for this sea change is the market exclusivity that may be afforded to innovator companies by the legislation. A quick perusal of the bill reveals that innovator companies will be granted 12-year market exclusivity for a product after its initial licensure. Further, under certain circumstances, this period of market exclusivity for an innovator product may be extended to 14.5 years. Also, reference product sponsors (innovator companies), as well as interested third parties (most notably universities) that own patents on the reference product may sue a biogeneric applicant for patent infringement. Under certain circumstances, such litigation could delay or prevent approval of the biogeneric product.

So what does the proposed legislation mean for biogeneric manufacturers seeking regulatory approval for their products in the US?  Unfortunately, it means that a biogeneric product application may not be approved or made effective until 12 to14 years after the original date of licensure of the innovator (reference) product. It also opens the door for patent litigation against biogeneric manufacturers to hinder or delay approval of their products. In my opinion, the proposed legislation is extremely one-sided and biased toward innovator companies. More importantly, it seems to me that the real intent of the legislation is to discourage (rather than encourage) biogeneric manufacturers from seeking US approval for their products, i.e. there are no real financial incentives or inducements for these manufacturers to seek approval because of the excessively-long market exclusivity period for innovator products.

On the surface, the proposed legislation would appear to be a long sought victory for biogeneric advocates and the American public which would benefit from less costly versions of potentially life-saving biotechnology drugs. That said, it seems to me that the proposed legislation is nothing more than a disingenuous attempt by big biotech and pharma to placate biogeneric advocates and the American public. In reality, the legislation provides innovators companies with a legally-binding regulatory approval pathway that will allow them to maintain or extend their monopolistic stranglehold on blockbuster biotechnology products. I think that the US Congress can do better when it comes to biogeneric legislation–the American public not only deserves it but demands it!

Until next time…

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

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Unlike many other countries with national healthcare systems, US healthcare and prescription drug costs are primarily shouldered by employers. As healthcare costs continue to rise, many American employers are calling for the US government to assume more of the costs through nationalized healthcare. The opposite situation is unfolding in the rest of the world, where overburdened nationalized healthcare systems are forcing employers to pay for workers supplemental health care costs.

A recent survey conducted by Watson Wyatt found that in countries like India, China and Russia healthcare is the number 1 benefit desired by a majority of workers. Globally, companies are projecting large year-to-year increases in medical and healthcare costs. In many places, medical and healthcare costs are rising faster than inflation.

Contrary, to popular belief, it appears that the US is not the only country struggling with skyrocketing healthcare and prescription drug costs. The graph below shows the expected increases in national healthcare costs from 2007 to 2008 (source Watson Wyatt).

  

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The US Food and Drug Administration announced late last week that it intends to post inspectors in embassies and consulates throughout the developing world to improve the quality of the food and medicines that flow into the US. FDA Commissioner Andrew C. von Eschenbach (Bush’s latest appointee to head the agency), said that he wants to have “boots-on-the-ground in developing nations like India and China and regions like Central and South America and the Middle East.” At present, less than 1% of the food imported into the US is inspected each year

As many of you know, FDA inspectors are required to visit both domestic and foreign manufacturing facilities that produce food, cosmetics and medicines that are sold in the US. By law, these inspections must take place every 3 years. Unfortunately, due to budget shortfalls and inspector shortages, routine inspections at domestic facilities are now taking place every 4 to 5 years– it is unclear how frequently inspections occur at foreign manufacturing facilities.  Based on von Eschenbach’s call for more foreign-based inspectors, the answer is likely “not frequently enough.”

The obvious solution to this problem is to increase the agency’s budget to hire and train new inspector