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Forbes Magazine released its annual list of America’s most livable cities. The list is created based on quality of life measures in cities with populations of 500,000 or greater. The cities on the list indicate where unemployment is low, income growth is high and living the good life is affordable. 

Number one on the list was Portland, ME because it is safe and apparently has several outstanding microbreweries. Bethesda, MD (what about traffic), and Des Moines IA (what?) round out the top three, followed by Bridgeport/Stamford, CT ($$$) and Tulsa, OK (no way)! The remaining five on the top list included Oklahoma City OK (where the waving wheat....), Cambridge, MA (Harvard and MIT, what’s not to like), Baltimore, MD (Camden Yards rocks), Worchester, MA (why?) and Pittsburgh, PA (nice family town). My favorite place to live, Madison, Wisconsin was relegated to 13^th place on this year’s list (sigh).

Until next time...

Good Job Hunting and Good Living!!!!!!!!!!

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I just returned from a weekend of teaching regulatory affairs to biotechnology students at Georgetown University where I tried to convince them that the US Food and Drug Administration (FDA) is fundamentally sound despite its near demise during the Bush administration. Even before the Bush-induced wreckage, the agency was chronically understaffed, under funded and had serious leadership and morale problems. This, coupled with two nationwide Salmonella outbreaks in the past year, several highly publicized drug recalls, and steadily declining drug approval rates has prompted its critics to propose that FDA be split into two separate agencies—one that oversees the drug industry and another that would have responsibility for cosmetic and food safety. For those of you who may not know, FDA became responsible for oversight and regulation of the food and drug industries, in addition to the drugs, after passage of the Food, Drug and Cosmetic Act in 1938.

Drug industry advocates and longtime FDA critics contend that the agency as it exists today can no longer effectively oversee and insure the safety of American food and drug supplies. Critics argue that the history of FDA suggests that the agency focuses on medical products and only focuses on food safety when a crisis comes up. And when they occur, FDA is so distracted that it interferes with the drug review/approval process. While this is what FDA critics want you to believe, it is simply not the case. Despite its recent problems, the FDA has historically done an outstanding job when it comes to drug and food safety—when it is funded and staffed to appropriate levels.

Unbeknownst to the American public, food borne illnesses are very common and Americans are only alerted when the outbreaks reach a certain size. While the recent Salmonella outbreaks were larger in scope and breadth than past outbreaks, they were not extraordinary. However, they were extremely media worthy at the time that they were reported on. You may recall that at the time of the outbreaks, the American economy was beginning to fail and there was an inordinate amount of China, Mexico and free trade bashing going on in the US. Unfortunately, the news media decided to exploit the outbreaks to make a case that Americans ought to reduce their reliance on imported foods—a practice that was beginning to cut into the revenues of the US agriculture and food industries. Ironically, the Salmonella outbreaks might have been prevented if the production facilities (owned by American companies) were compliant with FDA mandated quality control and assurance regulations which were designed to insure food safety.

Drug industry advocates who argue that FDA ought to be split into two separate agencies have financial interests rather than safety concerns in mind.  As an investment banker or VC will tell you, slow, new drug approval rates can have serious financial consequences for the companies that are developing them—it can literally cost a company millions of dollars a day for every day the drug is kept off the market.  Interestingly, when FDA increased its drug approval rates in the late 1990s and early 2000s, there weren’t many industry insiders advocating a break up of the agency. Only recently, as FDA has become more risk adverse which in turn, has caused the new drug approval rates to slow again have critics begun to call for massive organizational changes at FDA.

Like I told my biotech students over the weekend, the only mechanism by which FDA can insure food and drug safety is by conducting regular inspections of drug and food manufacturing facilities. Unfortunately, FDA hasn’t been able to keep up with its mandatory inspections schedule because the agency has been under funded and poorly staffed for over a decade. Several FDA inspectors, who I talked with suggested that routine inspections of manufacturing facilities takes place every three to five years rather than every two years as required by FDA regulations. While in theory this shouldn’t affect a company’s ability to remain compliant with FDA regulations, in reality it does. Put simply, pharmaceutical and food companies, like most other for profit industries are incapable of policing themselves in the absence of regulatory oversight.

I ‘m not certain that the agency needs to be split into two separate agencies to continue to insure the safety of the American drug and food supplies. What I know is the agency needs more funding and much larger numbers of trained inspectors to be successful. In my opinion, the safety of the American food and drug supplies can only be guaranteed if the companies regulated by FDA make a commitment to quality manufacturing and play by the rules.

Until next time...

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

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Mention the word “scientist” to most people and they will likely conjure up an image of a socially-inept, nerdy individual who cannot talk to “normal everyday folks” because they are either “too smart” or out of touch with the “real world.” I have been fighting that stereotype for as long as I can remember. I believe that, along the way, I have convinced a few people otherwise and hope that they have learned that “one size does not fit for all scientists”—or any other professional group for that matter. The public perception of scientists was improving until George W Bush, an inveterate anti-science and anti-intellectual advocate became President in 2001. I hope that America’s attitude toward science (and scientists) will change over the next four years as President Obama tries to “restore science to its rightful place.” Nevertheless, I felt compelled to write this post after reading a New York Times review of a television drama called “Breaking Bad” (AMC, Sundays, 10 EDT) which, in my opinion, reinforces the negative stereotypes of scientists held by many members of the lay public.

Breaking Bad centers on a former Caltech chemistry genius named Walt, who failed to live up to the legend of his graduate school days. At 50, he is teaching high school chemistry in Albuquerque, NM. Although he contributed to work of a Nobel-winning team, the teaching job in New Mexico is inexplicably the best that he can get. To make matters worse, his best friend at Cal Tech has amassed a fortune (based largely on Walt’s graduate school work) and is married to Walt’s beautiful ex-wife. Walt learns  after attending a lavish party thrown by his friend, that most of his graduate school classmates (unlike him) are famous world class scientists who live in big homes and make enough money to purchase guitars that previously belonged to Eric Clapton. On top of his devastating psychic and emotional pain, Walt is also suffering from stage 3A lung cancer—even though he never smoked! To save his life, Walt partners with one of his former high school students in the crystal methamphetamine business. Walt’s chemical genius allows him to synthesize the meth from scratch—unlike his scientifically-challenged competitors who must extract the starting materials from over the counter cold remedies—earning him the reputation as one of the best meth ‘cookers” in the US. Walt uses the drug money to pay for his chemotherapy to stay alive and care for 15 year old son with cerebral palsy.  

While the show sounds intriguing, and by all accounts is well acted and provides a glimpse into the lives of people struggling with chronic illness and unrealized career aspirations, it sends the wrong messages to the American public about scientists, their motivations and their lives. First, it portrays Walt’s classmates as wealthy, elitist dilettantes who live lavish lives and don’t think twice about flaunting their status and power as world class scientists. Aside from Craig Venter and several other high profile scientists who are sometimes featured on 60 Minutes, I don’t think that there are many scientists who enjoy the luxurious and opulent lifestyles depicted in Breaking Bad. To the contrary, I suspect that the vast majority of us are struggling, like others, to make ends meet to put food on the table. And, perhaps more importantly, I don’t think that money, fame and fortune induced most of us to become scientists in the first place. Portraying scientists as ego-maniacal, thoughtless, self-absorbed dilettantes sends the wrong message to an American public that is already suspicious and distrustful of science.

Second, Walt’ colleagues view him as a “failed scientist” who, despite his brilliance, has been humiliated and reduced to teaching chemistry (at a low wage) to high school students. Listen to an exchange between Walt and his oncologist “I am an extremely overqualified high school chemistry teacher. When I can work I make $43,700 per year. I have watched all of my colleagues and friends surpass me in every way imaginable....” Unfortunately, Walt’s view of himself—as a lowly, underpaid high school chemistry teacher —is consistent with the attitudes of many academicians who feel that teaching is far less important or valuable than laboratory research. In my previous life as a medical school faculty member, it wasn’t uncommon to see a prominent researcher cringe or shake his/her head in disbelief at the mere mention of a teaching career by a graduate student or postdoctoral fellow. I contend that we ought to encourage (and not dissuade) some of our best and brightest students to pursue teaching instead of research careers. Further, academic researchers must begin to recognize that PhDs who choose to pursue careers in teaching are not less competent or failed scientists—they are simply individuals who want to teach! Given the 20-year long decline in American science and technology preparedness, the scientific community can no longer afford to continue to exclusively promote research over careers in teaching and education.

Finally, the American public has long been suspicious and distrustful of science. In support of this, scientists are often portrayed in literature, movies and in the news as dark, and sometimes mad people who, when left unchecked, will unleash scientific “horrors” on the world.  I am old enough to remember the public fears about the secret bio-warfare programs in the Soviet Union and US during the cold war and more recently, the rumor that was circulating after the HIV/AIDS epidemic was disclosed, that the virus was created by the US government. The brouhaha that erupted over genetic engineering in the 1980s and continued suspicions surrounded genetically modified foods and human cloning are other examples of the public’s distrust of science. Sadly, the decision of the Breaking Bad’s creators to turn Walt, whose chemistry brilliance is unrivaled, into a crystal meth cooker perpetuates the myth about “evil misguided scientists” who are willing to jeopardize the safety of others for their own motives or self gain. The creators of Breaking Bad want us to believe that Walt is justified in turning to the dark side because his power hungry, egomaniacal, scientific colleagues have derailed his career and forced him to become an overqualified, underpaid chemistry teacher. In other words, he had no choice but to use his scientific talents to survive, and perhaps, more importantly, prove to his colleagues (and himself) that he truly is a gifted chemist and not a failed scientist.

Admittedly, while the plot line of Breaking Bad is a little over the top, it tends to reinforce the public’s negative perceptions of scientists and does little to assuage suspicions about the dark underside of modern science.  Like most other people, we scientists are human and have made our share of mistakes. Nevertheless, I think that we  must challenge ourselves to make an effort to educate the American public about who we are and what scientists do on a day to day basis.  If we fail to meet this challenge, I think that President Obama will continue to struggle to “restore science to its rightful place in America.”

Until next time...

Good Luck and Good Job Hunting (try public education-schools are hiring!)

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For the past decade or so, I have worked as a career counselor at national scientific meetings where I present seminars about resume writing, interviewing techniques and other career related issues. About two years ago, I started to hear about the fierce competition for H-1 and J-1 visas that foreign students must obtain to remain in the US to continue their studies and research. Many of the foreign students that I talked with sounded more like immigration lawyers than graduate students or postdocs—I was amazed at how well informed they were about visa availability and the changes and loopholes in US immigration law that can be exploited to obtain visas.

Since that time, it has become increasingly apparent that the visa problems experienced by most foreign students are beginning to wreak havoc on US science and engineering. Curiously, nobody at the US State Department seems to know why these visa problems exist. According to an article in today’s NY Times, a State Department official claims that visa delays can be attributed to “unfortunate staffing shortages.” Many of the students (and some immigration lawyers) that I talked with believe that it is annual visa limits and quotas not staffing issues that make it so difficult to obtain them.

It is no secret that American middle and high school students are no longer interested in pursuing careers in science and engineering. Because of this, American universities have come to rely on foreign students to fill open slots in graduate and postdoctoral sciences and engineering programs. With this in mind, it should come as no surprise that, over the past decade or more, foreign talent has been largely responsible for much of the technical and scientific innovation in the US.  Finally, and perhaps most importantly, American universities can no longer assume that the US is the first choice or destination for many foreign undergraduate, graduate and postdoctoral students—teaching and research at many foreign universities have vastly improved in recent years and can now compete with the best research institutions in the US.  In the past, it was largely assumed that when given a choice foreign student would choice a US university over all others. Together these findings beg the question: “If foreign students and postdocs are largely responsible for maintaining America’s competitive edge in science and technology, why would the US government make it so difficult to recruit the world’s best and brightest?”

There is no doubt that the US government, in a post-September 11^th world ought to carefully scrutinize foreign students before they are issued visas to study or work in the US. But, why has it become increasingly difficult for foreign students to renew their visas to continue to study or work in the US? Interestingly, visa availability and renewal problems are not only restricted to foreign nationals from likely places like China, India, the Middle East or Russia.  Many students and postdocs from Australia, Europe and elsewhere are also experiencing major delays and difficulty obtaining student or work visas.

While the visa issues facing foreign students may not seem like a big one to most Americans (most of who are not involved in science and engineering), its effects on American science and engineering are beginning to become apparent. For example, conference organizers are reluctant to hold international meetings in the US because they fear that many students and scientists will not be able to attend because of limited visa availability. Further, many talented foreign nationals, who want to remain and work in the US, are frequently forced to return to their home countries (to find employment) because they are unable to renew or extend their US visas. There is no question that America has grown increasingly dependent upon foreign students to conduct research in science and engineering.  I contend, that without these students, America’s competitiveness in science and engineering will continue to wane as it has over the past 20 years.  I believe that America has two choices to prevent this from happening. First, we can somehow convince larger numbers of American high school students to pursue careers in science and engineering. Second, the US government can improve and simply the visa process so that talented foreign students can continue to study and do research in the US. Nevertheless, something must be done soon—the future competitiveness of American science and engineering depends on it!

Until next time...

Good Luck and Good Visa Hunting!!!!!!

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I watched the Obama inauguration today and like many other Americans I was moved to tears during his speech. A new day is truly dawning in America!  The one line that resonated the most for me is when he said he was going to restore American science to its rightful place.  My colleague Vincent Racaniello also heard that line and he offer this take on what the implications that one statement may have for American science over the next 4 years.

The Audacity of Hope

I just heard President Obama, in his inaugural address, say the words “We will restore science to its rightful place”. What does he mean by this?

In “The Audacity of Hope”, the book President Obama wrote in 2006 to set forth his thoughts on “reclaiming the American dream”, he suggests that we will need to invest in education, science and technology, and energy independence to make America more competitive. With respect to science, he has specific plans:

…fifteen years ago, 20 t0 30 percent of all research proposals received significant federal support. That level is now closer to 10 percent. For scientists and researchers, this means more time spent raising money and less time spent on research. It also means that each year, more and more promising avenues of research are cut off - especially the high-risk research that may ultimately yield the biggest rewards.

…our declining support for basic research has a direct impact on the number of young people going into math, science, and engineering - which helps explain why China is graduating eight times more engineers as the United States every year.

If we want an innovation economy, one that generates more Googles each year, then we have to invest in our future innovators - by doubling federal funding of basic research over the next five years, training one hundred thousand more engineers and scientists over the next four years, or providing new research grants to the most outstanding early-career researchers in the country. The total price tag for maintaining our scientific and technological edge comes out to approximately $42 billion over five years - real money, to be sure, but just 15 percent of the most recent federal highway bill.

In less than a page, Obama crystallizes today’s problems with science. I could not have said it better myself. And his solution is concrete and reachable.

His words were written in 2006, well before our current financial crisis. But I am convinced that President Obama knows that supporting science and technology is one of the keys to the future of this country. I know he will find ways to follow through with his promises.

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Takeda Pharmaceutical Co., Japan’s largest pharmaceutical manufacturer, announced that it has agreed to buy Cambridge MA-based Millennium Pharmaceuticals for $8.8 billion. Millennium, founded in 1993 by high profile MIT researchers and once heralded as one the most innovative American biotechnology companies, never lived up to analyst’s expectations. That said, the company did develop and win regulatory approval for an anti-cancer drug, Velcade, which is expected to garner additional approval for wider use in oncology later this year.

Velcade, which is used to treat relapsed multiple myeloma after other drugs fail generated more than $800 million last year. Millennium anticipates U.S. approval by June to promote Velcade as an initial therapy to treat these disorders. Millennium markets Velcade in the US and shares revenue with Johnson & Johnson which markets Velcade in 85 other countries. Analysts predict that the Takeda acquisition will help to propel Velcade to blockbuster status.

The Takeda-Millennium deal follows Eisai Co.’s (another Japanese company) agreement in December to buy the U.S.'s MGI Pharma Inc. for $3.9 billion as Japanese companies, aided by a weak dollar against the yen, seek growth abroad. Japanese companies have been hampered by government-ordered price cuts, weak pipelines and a lack of new products  As one financial analyst put it ``There's no doubt the weak dollar against the yen is making U.S. biotech very attractive right now to potential Japanese buyers,''

Takeda’s best seller is the diabetes drug Actos which is slated to lose patent protection in the near future. Acquisition of Millennium provides Takeda with an entrée into the oncology and cardiovascular markets both of which are poised for expansive growth in the next five years. Analysts also believe that the Millennium acquisition will boost Takeda’s drug discovery and development flow. Millennium is conducting human trials with experimental drugs for cancer, heart disease, gastrointestinal disorders and rheumatoid arthritis.

The ongoing acquisition of American biotechnology companies by Japanese pharmaceutical companies reminds me of  the Japanese foray into the US real estate market in the early 1990s. Only time will tell whether the Japanese will be able to hang on to their acquisitions this go around (they weren’t the last time).  Earlier this week, Switzerland's Novartis AG agreed to buy 77 percent of eye-care company Alcon Inc. in a two-step transaction totaling $39 billion. Does anybody else see a troubling trend developing here as a result of the recession that we are in or heading into?

Don’t be surprised to see some “asset reallocation” and downsizing at Millennium. The Japanese are well recognized for increasing efficiency and work output with smaller numbers of employees.

Until next time….

Good Luck and Good Job Hunting (not in Cambridge MA)!!!!!!!!

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An editorial published in this week’s New England Journal of Medicine and recommendations from an expert panel at an American College of Cardiology meeting being held in Chicago urged that the cholesterol-lowering medications Zetia and Vytorin should be used only as the last resort to treat patients with elevated LDL-cholesterol. Instead, the panel recommended that doctors and patients should use statins, older and sometimes cheaper medications, which have been clinically proven to lower cholesterol and reduce the risk of heart attack and stroke. The panel's recommendations were announced to the almost 30,000 physicians who were attending the conference.

As you may recall, Zetia and Vytorin, which reduce cholesterol levels by inhibiting its absorption from the intestinal tract, didn’t reduce the incidence of heart attack or stroke in patients taking the medications (in the Enhance clinical trial) even though LDL-cholesterol levels were lowered. Further, there is some emerging evidence which suggests that Zetia and Vytorin may actually speed rather than slow the development of plaque in arteries. Merck and Schering are conducting larger clinical studies (initiated in 2006) to measure effects of Zetia and Vytorin on heart disease and stroke. The results from these trials are not expected until 2012

Zetia and Vytorin are among the top selling drugs in the world with combined sales of $5 billion in 2007. Approximately 5 million people, including about 4.0 million Americans take the medications which were heavily advertised to US consumers. Many cardiologists believe that heavy marketing of the drugs has resulted in their over use. The fallout from the Enhance clinical trial controversy has already depressed the sales of both Zetia and Vytorin. A greater reduction in sales is anticipated as more doctors and patients digest the implication of the Enhance trial results.

The flap over the utility of Zetia and Vytorin will likely take a heavy toll on Schering Plough’s revenue stream. Analysts say that sales of Zetia and Vytorin produce almost 70% of Schering’s profits. The controversy will have less of a direct effect on Merck which co-markets Vytorin with Schering. However, Merck is still reeling from reports last week linking its popular asthma medication Singulair to suicide. 

Things are not looking too good in pharma land these days.

Until next time….

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

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