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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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Is it luck or good planning that has prompted many pharmaceutical and biotechnology companies to set up manufacturing and research operations in Ireland? In my opinion, the recent Irish pharma and biotech explosion has little to do with luck and everything to do with strategic vision, excellent planning and a well trained, inexpensive workforce.

Currently, 28 out of the 50 top pharmaceutical/biotechnology companies in the world have facilities in Ireland. Some of these companies are Merck, Wyeth, Genzyme, GlaxoSmithKline, Pfizer, Johnson and Johnson, Schering-Plough and Bristol-Myers Squibb. Seven out of 10 of the world’s top selling blockbuster drugs are now manufactured in Irish production facilities. 

Pharmaceutical companies were the first to set up shop in Ireland. However, biotechnology is growing rapidly and biomanufacturing is starting to over shadow traditional small molecule production. Companies including Wyeth, Centocor, Bristol-Myers Squibb, Organon Biosciences (now part of Schering Plough) and Allergan manufacture biologics and biotechnology products in Ireland. In fact, Ireland is home to the world’s largest biomanufacturing facility, Wyeth’s € 1.3 billion Grange Castle near Dublin.

So why pharma and biotech are companies flocking to Ireland? First, the Irish labor force is well trained, everyone speaks English (albeit with an Irish lilt) and wages are still low. Second, Ireland has the lowest corporate taxes in the entire European Union. Further, there are R&D tax credits and financial support for start ups.  For example, there is financial support to purchase consultancy and innovation vouchers worth €10,000, a substantial amount of money for any startup! Finally, and perhaps most importantly, the Irish government had the foresight to create a public/private enterprise known as the National Development Plan (2000-2006) that invested € 2.5 billion to create an Irish R&D infrastructure.

The Irish strategy–“built it and they will come”– has certainly paid off handsomely for Ireland. Another country that has embraced a similar strategy is Singapore–which through a public/private initiative has been building a vibrant life sciences and biotechnology industry since 1999. Both countries now compete for pharma and biotech business. For example, in late 2007, Merck decided to build a € 200 million vaccine facility at Carlow Town in Southeast Ireland. Novartis, on the other hand, opted for Singapore to build a new $180 million pharmaceutical tabletting facility along side of its API production plant.

Unlike Ireland, the American pharmaceutical and biopharmaceutical industries are in trouble and losing their competitive edge. Perhaps the US can learn a thing or two from the Irish to give its bioscience industry a much needed shot-in-the arm.

Until next year….

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

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Germany’s GPC Biotech announced another round of job cuts as it tries to regroup after its failure to win US approval of its experimental prostate cancer drug satraplatin.

The company said that this latest restructuring will sharpen its focus on oncology clinical development efforts and further reduce costs to extend its cash reserves to cover three years of operating expenses. The restructuring is mainly focused on GPC’s early-stage research activities in Munich and will result in 38 job losses. The remaining work force will be 14 in Munich and 49 in Princeton, New Jersey. These latest cuts come after an announcement in November that the firm was slashing its workforce by over 100.

A GPC Biotech spokesperson also announced that the company is discontinuing internal development of the 1D09C3 monoclonal antibody, which is in Phase I clinical trials for relapsed/refractory B-cell lymphomas. However, RGB-286638, a broad-spectrum cell cycle kinase inhibitor, is expected to enter the clinic within the next six months. 

Things are looking pretty dicey at GPC Biotech.

Until next time….

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

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The US Food and Drug Administration said Monday it still had several "outstanding issues" with televancin an antibiotic being developed by Theravance Inc and Astellas Pharma of Tokyo. to treat skin infections.

The agency had canceled an advisory committee meeting scheduled for Wednesday that was set to evaluate the drug, televancin.

In a statement, the agency said that the meeting was being canceled to "allow time for the FDA to review and resolve several outstanding issues." The FDA said it would schedule an advisory committee meeting in the future, if needed.

Televancin is a once-daily injectable antibiotic that would be used to treat skin infections, including those caused by resistant bacteria like methicillin-resistant Staphylococcus aureus (MRSA). In October the FDA issued a so-called approvable letter for televancin, suggesting it needed a re-analysis of clinical data and the resolution of manufacturing issues at a third-party manufacturer that was not specifically related to televancin. The FDA said it continues to review televancin's application but didn't give a timetable for completion of the review.

Earlier this month the FDA canceled a Feb. 28 meeting for another antibiotic, ceftobiprole that would also be used to treat skin infections. That drug is being developed by a unit of Johnson and Johnson Co. and Switzerland-based Basilea Pharmaceutica Ltd. The FDA is expected to make a decision on whether to approve ceftobriprole sometime next month.

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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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Due to some technical problems, articles posted after February 4th, 2008 are currently unavailable. So, if you were looking for them, I apologize.  But, the good news is that the IT guys over at Lexblog, the company that built and hosts biojobblog, told me they all should be back by tomorrow AM.

Until next time (that 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 investigated and are no longer controversial issues. All of the aforementioned "issues" have been 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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By law, drug makers are prohibited from marketing or promoting (in any way) their medicines for uses that have not been approved by FDA. But, somewhat paradoxically, physicians who are licensed to practice in the US can prescribe drugs for uses beyond FDA-approved indications, a practice known as off-label use. The agency is no stranger to the issue of off-label drug use and has vigilantly policed the industry over the last decade to prevent the practice. Drug makers including Pfizer, Astra Zeneca, Eli Lilly, Amgen and others have been targeted by federal prosecutors for off-label marketing practices. Click here to see which types of drug are commonly prescribed for off-label use.

However, in something of a policy reversal, FDA officials proposed last Friday new guidelines that would allow pharmaceutical companies to use peer-reviewed medical journal articles to promote drugs for unapproved uses. The proposed guidelines will replace a law that expired in 2006 law. Under the expired law, companies had to submit copies of the articles to FDA for review before sending them to physicians. Under the new proposal, drug companies don’t have to submit articles to the FDA before distributing them to physicians. The agency says it will not punish companies for distributing literature on off-label use if they adhere to certain practices. Articles should not be false or misleading and should come from a peer-reviewed journal that is not influenced by a company. The proposal also says companies should attach a disclaimer to the materials indicating FDA has not reviewed them.

I, along with Congressional Democrats, most notably Henry Waxman (D-CA), am totally baffled by the proposed new guidelines.According to Mr. Waxman, the new guidelines would create a “large loophole” in laws against off-label promotion. “It’s a conflict of interest for the company to be promoting sales when they haven’t been able to establish that a drug is safe and effective through the rigorous FDA process,” he said. Not to mention that a company could save hundreds of millions of dollars by not conducting clinical trials to gain approval for an off-label indication. Risperdal, a Johnson and Johnson medication that is approved to treat serious mental disorders like schizophrenia, bipolar disorder and irritability associated with autism was used off label 66% of the time and brought in $4.2 billion in 2006. If you were the CEO of J & J would you spend any additional monies to win approval for new indications for Risperdal?

I would think that by now the agency would have figured out that drug manufacturer are incapable of policing themselves; there is simply too much money at stake. And, unfortunately, profits will always come before patient safety.  In my opinion, the proposed guidelines are another egregious example of just how much influence the pharmaceutical and biotechnology industries have at FDA. The Bush administration has done everything in its power to destabilize and emasculate the agency. The American public no longer has confidence in FDA and the products that it approves. Something has got to change to restore a sense of wellness in America!

Until next time…

Good Luck and Good Job Hunting!!!!!

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I learned on Wednesday that my dear friend and colleague, Carleen Collins, died suddenly and unexpectedly from cancer. I first met Carleen in 1987 in the Department of Microbiology and Immunology at the University Of Miami School Of Medicine. We had both joined the faculty as Assistant Professors. As fate would have it, we were the only microbiologists in a department of immunologists. Needless to say, both Carleen and I learned more immunology than either of us would care to admit (we both subsequently published immunology-esque papers as Carleen would say).

Carleen was a quintessential Californian. She was easy going, extroverted and never had a negative thing to say about anyone. I, in contrast, was a brash, sarcastic New Yorker who couldn’t stop complaining about everything. Despite our seemingly opposite personalities, Carleen and I became fast friends (later I met Ira, her future husband and quickly understood why she and I hit it off so easily). Because Carleen and I were single back then, we used to hang out together after long hours in the lab. Whenever one or more of her sisters came to Miami, we would go to the Clevelander Bar on South Beach to watch the locals. It was always fun to watch the Collins girls “torture” the “boys” at the Clevelander bar.  

Carleen was one of my closest friends in Miami. Whenever things weren’t going well for me either scientifically or personally I would stop by her office or lab and chat (okay so I complained). Not surprisingly, the world always seemed like a brighter place after talking with her. If it wasn’t for Carleen and her smile, I don’t think I would have survived my first three years in the department.

One of my favorite Carleen stories involves Hurricane Andrew. Carleen, who was living on Miami Beach at the time, was forced to evacuate and decided to stay with my wife Alice and me in Kendall (which is inland). As it turned out, Andrew never made it to Miami Beach but Kendall, which was on the northern rim of the hurricane’s eye, was almost completely destroyed. I will never forget the four hours that Carleen, Alice, our dog AJ and I spent together in our tiny, dark, air condition-less bathroom listening to the sounds of Andrew’s devastation. I guess if you go through a natural disaster with someone, you can’t help but become lifelong friends!

I left Miami in 1994 and moved to New Jersey where I still reside. Carleen married Ira, had two children and left Miami for the University of Washington several years later. We would see each other from time to time at meetings but with kids and hectic careers it became harder to stay in touch. Nevertheless, I heard through the science grapevine that things were great and life was good in Seattle.

When Martin Flajnik, a mutual Miami friend and colleague, called me the other day with the bad news, he told me that he spent an evening Carleen and Ira a couple of years ago. He said that during dinner, Carleen told him how wonderful her life was and how much she loved being a mother and scientist. I was happy that she was able to experience that joy and satisfaction with her life before she passed away.

Carleen touched and enriched many lives. She will be sorely missed.

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In my post yesterday about Insmed's advocacy role in the Follow-on Biologics fracas, I inadvertantly mentioned that the results of the economic analysis that they commissioned had yet to be published.  One of my intrepid readers (they do exist!), pointed out that the study was recently finished and available at the Insmed website or here.

Mea Culpa!

Until next time...

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

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Insmed a small, Richmond Va-based biotechnology and manufacturing company has upped the ante in the fight to bring follow-on biologics to America.  After spending some time on Capitol Hill, company executives  found that “people in Washington, as well as payors and patients don’t have an understanding at a reasonable level of the debate that is going on and the issues” surrounding that follow-on biologics debate. To reach as wide an audience as possible and frame the debate on the issues” the company decided to use the Internet to take the initiative to the next level–the Internet.

A key to Insmed’s initiative is an economic study on the potential savings follow-on biologics could provide to patients, payors and healthcare providers. The study is still being conducted and its results will be published on the net when available. The campaign also includes advocacy components that like user-generated content (blogs) and social networking sites. Recently, Insmed posted a video clip on YouTube that feature one of its scientists extolling the virtues and cost-saving advantages of follow-on biologics.

As many of you may know, I have long been an advocate of legislation to allow the approval and sale of follow-on biologics in the US.  Unfortunately, until now, only one side of the debate–from big biotech and BIO–has been heard by the American public. This has largely been due to marketing muscle and deep pockets of big biotech coupled with a lack of unity among follow-on biologics advocates. Web 2.0 with its social networks, blogs and video sites allows people with the smallest voices to be heard. And, sometimes those small voices can turn into  roars!

Kudos to Insmed for having the courage to boldly go where no generics manufacturer has gone before–on YouTube! Yeah baby!!!

Until next time….

Good Luck and Good Job Hunting (see you on Web 2.0)!!!!!!!!

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The repercussions of the Exubera debacle are finally being felt at Nektar Therapeutics. The California-based company announced that it is cutting 110 jobs or about 20 percent of its workforce. The company also eliminated 40 open positions, while insisting plans will proceed to find a new marketing partner for Exubera. As many of you know, Pfizer terminated the Exubera deal with Nektar several months ago leaving Nektar holding the proverbial bag!

Until next time….

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

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The Bush administration's proposed 2009 fiscal year budget for the FDA includes not only a 5.7 percent increase but a plan to seek authority to allow the agency to approve abbreviated applications for follow-on biologics.

As part of the budget package, the administration said it is seeking regulatory authority for the FDA to approve follow-on biologics, also called biosimilars or biogenerics, which would be financed through user fees.

The House and the Senate both introduced follow-on biologics legislation in 2007, with the Senate's bill moving the furthest by achieving passage by the Health, Education, Labor and Pensions Committee. Lawmakers have pledged to move the legislation forward in 2008.

Jim Greenwood, CEO of the Biotechnology Industry Organization (BIO), said "BIO strongly believes that the FDA should have a pathway for the approval of follow-on biologics, which protects patient safety and promotes continued innovation," Greenwood added that "The creation of a pathway for follow-on biologics is a top legislative priority for BIO, and we are meeting with members of the House and Senate to encourage them to consider and pass follow-on biologics legislation this session." This is quite a policy turnaround for BIO which over the past 8 years has spent tens of millions or more lobbying against allowing follow-on biologics in the US.

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Cambridge, Mass-based Targanta Therapeutics announced Monday that it had finally submitted a new drug application to the U.S. Food and Drug Administration for its lead product, the antibiotic oritavancin. As mentioned in a previous post Targanta executives had decided to delay the submission of the oritavancin NDA.

Oritavancin is being touted as a viable option for treating antibiotic-resistant bacterial infections. It would compete in the marketplace against drugs including telavancin being developed by Theravance and cubicin, an antibiotic offered by Cubist Pharmaceuticals Inc to treat skin and blood infections.

Targanta has backed up its application with data from 19 clinical trials including two late-stage human clinical trials. More than 2,100 patients took part in the clinical testing of the drug.

I wish Targanta luck–we need new antibiotics!

Until next time…

Good Luck and Good Job Hunting

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US Food and Drug Administration regulators announced on Friday that it will take three months longer than expected to decide whether Entereg, a treatment for post-operative ileus being co-developed by GlaxoSmithKline, will receive marketing approval. The drug was originally supposed to be reviewed for an up-or-down decision on Feb. 10.

Entereg is being co-developed with Pennsylvania-based Adolor Corporation. Post-operative ileus affects patients after bowel surgery. Symptoms include constipation and other gastrointestinal dysfunction.

An FDA advisory panel recommended approval in January but said Adolor needed to come up with a better plan to manage long term use of the drug. FDA regulators are concerned about safety data showing that long term use of Entereg can have adverse cardiovascular effects.

Adolor has submitted a new risk-management plan to the FDA, which will take the extra three months to review it.  GlaxoSmithKline will split the revenue from any U.S. sales of Entereg with Adolor and is responsible for commercialization of the drug outside the country.

Until next time…

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

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Over the past few years, I have heard rumors that artificial sweeteners like saccharine, aspartame and sucralose actually cause people to gain rather than lose weight. I summarily dismissed these stories because they did not make sense to me nor did I think that they had any scientific merit–until today!

Purdue University psychologists Drs. Susan Swithers and Terry Davidson fed rats yoghurt sweetened with glucose (15 calories per teaspoon) or yoghurt containing the artificial sweetener saccharin (0 calories per teaspoon). Rats that were fed the saccharin-sweeten yoghurt subsequently consumed more calories, gained more weight, put on more body fat and were unable to regulate dietary intake of calories as compared with rats that were fed glucose-sweetened yoghurt. The authors surmised that breaking the connection between a sweet sensation and high-calorie food, changes the body’s ability to regulate caloric intake. This could partly explain why obesity has risen with the increasing use of artificial sweeteners in drinks. The study’s findings are consistent with emerging evidence that people who drink more diet drinks are at higher risk for obesity and development of the metabolic syndrome that increases the risk for heart disease and diabetes.

So, how do the authors explain their seemingly paradoxical findings? Swithers and Davidson postulate that ingestion of sugar-rich (sweet) foods provides a ‘salient orosensory stimulus” that signals that the body is about ingest a lot of calories. This, in turn, induces the body to physiologically-prepare itself for ingestion of a high calorie meal. However, when the false sense of sweetness (provided by the artificial sweetener) is not followed by consumption of large amounts of calories, the system gets “confused”– causing people to eat more or expend less energy to account for the calorie imbalance. Nevertheless, the good news is that people who use artificial sweeteners can still count calories to regulate caloric intake and body weight. Unfortunately, as the authors suggest, counting calories requires a more conscious effort and a lot more work than routinely consuming low-calorie foods.

Although this study was conducted in rats, its findings are consistent with the observations that increased use of artificial sweeteners can contribute to human weight gain. Despite the study’s findings, similar experiments must be conducted in people to substantiate or refute the authors’ hypothesis.

Until next time…

Good Luck and Good Job Hunting (lay off the aspartame and splenda)!!!!!!

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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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Things are not going well these days for Wyeth or the US Food and Drug Administration. In the latest of a series of complaints over FDA's safety review of drugs and industry influence on the agency, a Senate panel found flaws in its scientific objectivity when it reassigned an agency veterinarian over unfounded conflict –of- interest accusations by Wyeth.

The congressional inquiry looked into how the FDA dealt with Wyeth’s accusations against Dr. Victoria Hampshire, an FDA regulator who was helping to review the safety of one of Wyeth’s lucrative veterinary drugs. The case centers on Proheart 6, an injected dog heartworm medication that Wyeth pulled from the market in September 2004 after Hampshire linked the drug to dog deaths. Wyeth later complained about alleged bias by Hampshire. The company claimed that she intend to sell competing drugs through her own Web site. After Wyeth made the allegations, Hampshire was abruptly reassigned to another job within FDA and her case was referred to the U.S. attorney's office for possible criminal prosecution. Federal prosecutors quickly dropped the case, and much to FDA’s chagrin, in 2006, the U.S. Public Health Service named Hampshire veterinarian of the year.

Congressional investigators discovered that FDA referred Hampshire's case to prosecutors on the basis of mistaken allegations about her Web site that could easily have been checked but were not. As it turned out, Hampshire’s did little business at her website and did not sell any products that competed with Proheart 6. In fact, she actually sold Wyeth’s Proheart 6 until the company pulled it from the market. Go figure….

In a letter to HHS Secretary Michael Leavitt and FDA Commissioner Dr. Andrew von Eschenbach, panel Chairman Senator Charles Grassley (R-Iowa) wrote that the panel’s findings suggest “that the scientific process is being compromised internally" at the FDA. Also, he wrote that the case brings into question "the processes that FDA uses in response to industry allegations of wrongdoing by FDA employees."

FYI, a FDA advisory panel narrowly voted to keep Proheart 6 off the market shortly after Hampshire was reassigned in 2004.

Until next time….

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

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For the past 30 years or so, the Unites States government has been looking for any reason what so ever to argue against the legalization of marijuana. This is despite a growing body of evidence that marijuana use provides documented, palliative and therapeutic benefits to people who suffer from serious illness like glaucoma, chronic pain and the side effects of cancer chemotherapy. Although marijuana use for medicinal purposes is illegal at the federal level, some Western States, most notably California, have legalized its use —it can now be purchased by people who have valid prescriptions from specially-designed .

From time to time, papers have appeared in the literatures which suggest that marijuana use has deleterious effects on mental acuity, emotional stability, breathing and sperm production. A  recent report  from New Zealand (which was published in the Journal of the American Medical Association) suggests that chronic marijuana use can increase the likelihood of periodontal disease in young adults.

C’mon, gum disease….are you kidding me? Don’t get me wrong, untreated periodontal disease is a serous medical issue. That said,  I suspect that more people are likely to develop periodontal disease from poor dental hygiene and a lack of dental insurance than from smoking a joint from time to time. The fact that the American Medical Association is subliminally try to turn marijuana-induced periodontal disease into an American public health crisis signals to me that government officials are running out of credible arguments to prevent the legalization of marijuana in this country.

Growing up in the 60s, I am very familiar with the consequences and negative outcomes of drug misuse and abuse. While I don’t advocate the use of marijuana and other psychotropic drugs for recreational use, I do believe that patients with serious medical illnesses ought to have legal access to drugs that are safe and offer therapeutic benefits. Further, I think that many drugs that are currently illegal in America ought to be legalized. In my opinion, the legalization of drugs in America will help to reduce crime, allow monies currently allocated to combat illegal drug trafficking to be used for struggling social programs and to demystify the use of illegal drugs American children and young adults. Ironically, illegal drug use by  American children and young adults has been declining over the last few years whereas abuse of  legal, prescription drugs has been skyrocketing out of control. Maybe it is time for America to re-think its drug polices and craft new ones that do a better job of safeguarding America’s youth.

Until next time….happy trails to you! And as always…..

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

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A federal judge ruled that Amgen Inc. must defend itself against charges that it misled investors about safety concerns with its flagship anemia drug, Aranesp.

A US district court judge dismissed charges against five of nine Amgen officers and directors but left plaintiffs 30 days to amend their complaint in order to include those defendants. The investors, led by Connecticut Retirement Plans and Trust Funds, assert that positive statements made by company officials regarding the safety of Amgen's two anemia drugs, Aranesp and Epogen, were knowingly at odds with clinical studies that had raised concerns.

The plaintiffs assert, according to court filings, that they unknowingly purchased artificially inflated shares, between April 2004 and May 2007. In one instance, during its fourth-quarter 2006 conference call, Amgen announced results of a clinical trial that tested Aranesp in 939 patients with anemia from cancer. The Food and Drug Administration, according to court filings, described the study as "demonstrat(ing) significantly shorter survival rate in cancer patients receiving (anemia drugs) as compared with those (sic) receiving transfusion support."

Describing the results of the study during the conference call, Roger Perlmutter, a defendant and executive vice president of research and development, said, "We did not see a statistically significant adverse affect of Aranesp on overall mortality in this patient population, and so we conclude that the risk/benefit ratio for Aranesp in these extremely ill patients with anemia secondary to malignancy is, at best, neutral and perhaps negative."

Sounds misleading to me! It is unfortunate that companies compromise their scientific integrity and corporate reputation simply to boost their stock price in the short term. I think companies are slowly learning that if they are dishonest or disingenuous with the American public that the public will soon lose confidence in them and their products. This, in turn, will lead to a decrease in sales and ironically a reduction in company stock price. As the old adage goes “Honesty is always the best policy!”

Until next time….

Good luck and Good Job Hunting!!!!!!!!!!!!

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Astra Zeneca and Sanofi-Aventis announced job cuts today that will take place in the UK and Germany.

AstraZeneca says it plans to cut more than 300 jobs at its research and development hub at Alderley Park near Wilmslow England, 60 more than unions had feared.

The company, one of the biggest employers in Cheshire, said last week that it was examining its global R&D structure, prompting trade unions to claim that 244 jobs were likely to go at Alderley Park - its largest site for research - which employs more than 3,500. The majority of those affected at Alderley Park work on R&D into respiratory conditions, while there will be a smaller number of job losses from the cardio-vascular team.

Sanofi Aventis plans to eliminate 380 sales and marketing jobs in Germany, one-fifth of the total, because of difficult market conditions, a company spokesperson said. Sanofi Aventis currently employs 1,900 sales and marketing personnel in Germany. The company has 10,000 employees in the country.

The cuts will be made through a voluntary departure plan and retirements, the spokesperson said, citing difficulties in obtaining reimbursements, competition from generic drugs, and falling prices as reasons for the cuts.

The spokesman declined to comment on German press reports which said Sanofi Aventis's sales in Germany fell 8 per cent last year.

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Last December, the US Food and Drug Administration (FDA) asked GlaxoSmithKline for additional information related to its cervical cancer vaccine Cervarix. The company has yet to reply to unspecified queries in the FDA's "complete response letter" that it received last December.

Many analysts believe Cervarix is now unlikely to be launched until 2009 at the earliest. GSK won European regulatory approval last July for the vaccine and had originally anticipated a US launch by the start of this year. However, FDA requested clarification after GSK's submission last April based on interim clinical data that the submitted from its most comprehensive five-year clinical trial for the vaccine. Financial analysts believe that FDA concerns may center on GSK's proprietary AS04 adjuvant that is used  in Cervarix to improve the effectiveness of the vaccine.

The delay has been a serious blow to GSK’s efforts to generate fresh product sales and catch up with Gardasil, the rival HPV vaccine developed by Merck & Co, which is available in the US and Europe.

I wonder whether the delay at FDA is really based on legitimate regulatory and scientific concerns. As you may recall, Merck launched a flat-out, take-no-prisoners lobbying campaign to get State and Federal legislators to mandate that all girls 10-21 years old be vaccinated with Gardasil. While Merck abruptly abandoned its lobbying efforts last fall after it came under fire from various legislative and regulatory sources, I can’t help but wonder whether Merck achieved its intended objectives anyway—to keep Cervarix out of the US market as long as possible so that Merck can capture a majority share of the lucrative American cervical cancer market.

Until next time….

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

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Two companies, Theravance and Targanta, have developed two new glycopeptide antibiotics, similar to vancomycin that the US Food and Drug Administration (FDA) will consider for approval. This is very welcome news because antibiotic treatment options continue to diminish as bacterial antibiotic resistance continues to skyrocket. Unfortunately, like vancomycin, both antibiotics must be administered intravenously to treat infections.

Theravance filed a new drug application(NDA) with FDA for telavancin, a bactericidal, once-daily injectable antibiotic proposed to treat complicated skin and skin structure infections (cSSSI) caused by Gram-positive bacteria, including resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA). The company received an approvable letter from FDA for telavancin but was asked for additional information to determine whether the agency will approve the drug. Theravance received notice in December from FDA that the agency's Anti-Infective Drugs Advisory Committee will meet on February 27 to review the new information and make a recommendation on telavancin’s approvability.

Targanta expects to file a NDA for its antibiotic, oritivancin, in the first quarter of 2008. Oritavancin is a semi-synthetic glycopeptide antibiotic with potent bactericidal (killing) activity against a broad spectrum of gram-positive bacteria. Two Phase 3 studies for the treatment of complicated skin and skin structure infection (cSSSI) have been completed. The antibiotic was originally discovered in the mid 90s by Eli Lilly research laboratories. In 2001, Lilly licensed oritivancin to Intermune who subsequently finished the phase III studies, but delayed filing the NDA in 2004 because of adverse side effects including injection site phlebitis. In 2005, Intermune divested itself of oritavancin and sold the worldwide ownership rights to Targanta.

The company apparently delayed submitting its NDA for oritivancin to FDA (even though the data were available for a couple of years) because the agency has been described as fickle when it comes to antibiotic approvals. Apparently, Targanta executives wanted to see how telavancin fared with FDA before it filed its application. Nevertheless, approval of the ortivancin NDA is strongly contingent upon information describing the benefits of oritavancin over vancomycin.

While neither antibiotic is groundbreaking for the treatment of infections caused by Gram positive pathogens, they both offer certain benefits over vancomycin.  Further, the addition of these new antibiotics to our current antibacterial armamentarium is timely given the growing incidence of vancomycin-resistant bacterial isolates.

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