AstraZeneca Sheds 7,300 Jobs

After announcing its quarterly earnings and a 24 percent increase in 2011 profits, AstraZeneca (AZ) today made public its decision to eliminate another 7,300 jobs. Earlier this week there was speculation that job cuts were likely but the exact numbers were not disclosed. 

The reasons given for the layoffs despite increased annual profits? Government spending cuts for healthcare and stiff generic competition for several of its blockbuster drugs including Seroquel XR (depression), Atacand (hypertension) Crestor (cholesterol-lowering) and Symbicort (asthma); all of which have lost or will be losing patent protection in the near future. According to a company press release generic competition cut revenues by $2.0 billion in 2011 whereas government price interventions cost the company another $1.0 billion. The announced job cuts are expected to save AZ $1.6 billion by 2014—great news for shareholders but not so much for the employees who are losing their jobs!

Most of the cuts will take place in R&D. To that end, the company will close its facility in Montreal and layoff staff at its Soedertaelje site in Sweden. Interestingly, the company plans on focusing more on neuroscience and intends to hire 40 to 50 scientists in its new Innovative Medicine unit which is partly based in Boston, MA and Cambridge in England.

While layoffs at AZ were expected, the size of the current layoff does not bode well for other pharmaceutical employees. It is becoming increasingly clear that big pharma companies are getting out of R&D and focusing their efforts on M&A and licensing deals to fill their thinning pipelines. Also, while shedding R&D and sales jobs in developed markets, big pharma companies are investing heavily in building facilities and hiring thousands of R&D and sales personnel in emerging markets. From my perspective, it appears that big pharma has consciously decided to abandon developed Western markets where sales growth is in the single digits in favor of emerging ones where double digit growth is expected for the next decade.

Until next time...

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

 

Statisticians and "Big Data" Analysts in High Demand

When I was a graduate student back in the dark ages, I took an advanced statistics course and then briefly worked in a laboratory where statistical analysis of data derived from animal models of disease (in this case the guinea pig model of tuberculosis) were essential. After leaving that lab, I developed an appreciation for the power of statistics (when appropriately designed according the laws of parametric statistics) and actually used statistical analyses of in vitro data for my PhD thesis. Unlike me, most of my contemporaries never understood statistics and thought that statistics can be used to manipulate data to confirm any hypothesis put forth by an investigator.

Imagine my surprise when I read in today’s NY Times that statistics are one of the hottest new career opportunities in technology and related industries. This is because billions of bytes of data (aka "big data sets")are generated daily and someone (usually a statistician or a person with knowledge of some arcane statistical analyses) is regarded to tease out trends and interpret the data. Companies like Google, Facebook, as wells as marketers, risk analysts, spies and companies that engage in competitive intelligence are desperately seeking new employees who understand applied statistic, analytics and trend analysis.

According to a recent LinkedIn survey, from 2009 to 2011 the number of new jobs with titles related to analytics grew 53%. Unfortunately, there are not enough trained or qualified persons available to fill these positions at most of these companies. Because of workforce shortages, universities like Stanford, Harvard and North Carolina State (NC State) have created graduate programs to train students in statistics and advanced analytics. 

Ninety per cent of NC State advanced analytic students (a 10 month program created in 2006) annually found jobs. The average graduate’s starting salary for an entry-level job is $73,000. Stanford and Harvard statistics department graduates head to Google, Wall Street and in many instances bioscience companies and start with salaries of over $100,000.

Not surprisingly, competition for entry to these programs is getting fierce. NC State takes only 40 new students per year in its program (185 applicants last year). Moreover, this year, Stanford received over 800 applications for 60 openings in next’ years class; nearly twice the number of applications that it received three years ago.

Like it or not “big data” and analytics are de rigueur and persons with advanced analytics training may be the new rock stars. That said if you like statistics or love to look for trends in large data sets then a career in analytics may be right for you. Now, you have to figure out where to get the training.

Until next time...

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

 

Is There Any Wonder Why Big Pharma Has a PR Problem?

Disposing of unused prescription and over the counter drugs including antibiotics, antidepressants, anticonvulsants and birth control pills by dumping them down the toilet has contaminated the drinking water supply for 41 million Americans. Further, unused prescription drugs stockpiled in medicine cabinets can contribute to drug abuse or overdoses by children, teens and adults. Currently, there are no guidelines or regulations in place to deal with the safe disposal of unused consumer medicines and drugs.

According to a post on today’s Pharmalot blog, a Washington State senator is introducing legislation (for the fourth time) to develop an environmental safe plan to dispose of unused and potentially harmful medications. The plan calls for dropping off unused medicines at local pharmacies; a service that would be underwritten by the pharmaceutical companies who manufacture the drugs. And, wouldn’t you know it, PhRMA, the pharmaceutical industry trade groups is lobbying and fighting against the legislation for the fourth time. In addition to PhRMA, the Consumer Health Products Associations which represents manufacturers of over-the-counter drug and the Washington Biotechnology and Biomedical Association are fighting the proposed legislation. Some municipalities like the City of Puyallup, WA allow persons to dispose of prescription medications including cancer treatments, painkillers, antidepressants and statins in lock boxes in the hallway of the local police department. However, these municipalities are the exception not the norm.

The groups opposing the legislation contend that regulations are unnecessary because contaminating drugs found in drinking water results not from improper disposal practices but through urination and defecation. In fact, they contend that the best way to dispose of unused medicines is in the household trash. But what about leeching of these drugs from landfills into aquifers and other sources of drinking water you ask? And what about dealing with potential drug abuse and sale of illegal prescription drugs? 

Interestingly, I had some minor surgery last week that required some pain medication and as I was rummaging through my medicine cabinet, I found a at least eight bottles of pain medication prescribed for various family members dating back to 1999. I thought about getting rid of the expired pills, but I had no idea about what the best disposal method may be. Consequently, the pill collection is still taking up space in my medicine cabinet. And, with two teenagers in the house, I am starting to get a little anxious! 

That said, it makes perfect sense to me that there ought to be regulations guiding the disposal of drugs in the US. And, because drug manufacturers have made huge profits on their products, I see no reason why drugmakers should not support and help to underwrite programs to safely dispose of unused prescription and over-the-counter medications. Maybe people’s negative impression of big pharma would improve if the powers at be would just suck it up for once and pay to help to solve problems that helped to create!

Until next time...

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

 

Pharma Layoffs Decline As Biotech Layoffs Rise

This past holiday season, as usual, was rife with massive layoffs and downsizing at various big pharma companies. Interestingly, in 2011, most biotechnology companies were able to weather the economic downturn and layoffs were not typical. Sadly, 2012 looks to be a more challenging year for many biotechnology company employees.

In the past week or so, several relatively high profile public biotechnology companies announced layoffs. First, on January 5, XOMA, the long- struggling California-based biotechnology company issued a press release indicating its intention to reorganize to focus it financial resources on its lead product gevokizumab and the company’s unique antibody discovery and development capabilities. The reorganization will result in elimination of 84 positions (34% of its workforce) with 50 jobs being lost immediately and the remainder by the end of the first quarter of this year. The layoffs will save the company $14 million. The same day, Winnipeg-based Cangene Corp, one of Canada’s oldest and largest biotechnology company announced that it would eliminate 120 jobs or 17% of its current workforce.  Finally, today, Human Genome Sciences (HGS) announced at the annual JP Morgan conference in San Francisco announced plans to eliminate 150 jobs across multiple departments.

The HGS announcement was somewhat surprising because the company recently received approval for a pioneering systemic lupus erythematous drug called Benlysta. Apparently, poor Benlysta sales have battered the company’s stock price which resulted in the announced layoffs. HGS reported Benlysta sales of a slightly more than $25 million in the fourth quarter which were must less than analysts had originally predicted.

Although these layoffs may be troubling to some, it is important to note that each of  the three companies have been in existence for 20 years or more and are transitioning from research organizations into companies that are finally commercializing their products. Like it or not, companies with commercial products are held to higher standards and receive much greater scrutiny than start ups and early stage companies. That said, while there may be additional layoffs at some older more established biotechnology companies, it may be a good time to start a company. Word on the street suggests that there is a lot of investment capital out there for new start ups!

Until next time...

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

 

Preparing For and Coping With Annual Performance Reviews

For many corporate employees, the annual performance review process is a bane to their existence. For those of you who may not be familiar with annual reviews, most corporate employees are required to undergo a review process that includes a synopsis of their accomplishments over the past year and new goals for the upcoming one. And, as all corporate employees understand, the quality of an annual review determines the size of the bonus that they can expect to receive and whether or not a salary increase is in order for the upcoming fiscal year. In other words, you never want to get a “less than stellar” annual review because your fiscal well-being depends on it!

Not surprisingly, preparing for the annual review can be nerve-racking and dealing with the results of the review can be equally challenge (especially if the review is a negative one). Although, most of the annual reviews for 2011 have been completed, Eilene Zimmerman who writes the Career Couch for the New Times posted a helpful article that deals with preparing for the dreaded annual review and how best to respond to either a positive or negative one.

I can tell you from personal experience, the annual review is probably one of the silliest and most inane things that was ever invented for corporate employees. That said, it is part and parcel of the corporate workplace game and to excel you need to get good at!

Until next time...

Good Luck and Good Job Hunting

 

Boehringer Ingelheim Announces Plans to Bolster Its Manufacturing Capability in China

The German pharmaceutical company Boehringer Ingelheim (BI) today announced that it plans on investing 70 million Euros to expand its manufacturing facility in the Zhangijiang High-Tech Park in Shanghai China. The expansion will continue through 2013 and the number of employees will increase from 240 to 400 at the new facility

BI was one of the first pharmaceutical companies to enter China in 1994 and the planned expansion was proposed to solidify the company’s position in the emerging Chinese market. The expansion will be modular and based on lean manufacturing practices to provide world class manufacturing capability at the site.   The company already sells certain therapeutic products in China including respiratory, cardiovascular, and CNS. Expansion of the existing manufacturing facility is intended to allow BI to expand into other therapeutic areas that include diabetes, oncology and stroke prevention.

Late last week Merck announced plans to build a new R&D facility in Beijing. Other companies have also announced plans to increase their presence in the Chinese market. I think it may be the time for American student to begin to consider Mandarin as their foreign language in primary and second school education programs.

Until next time...

Good Luck and Good Job Hunting!!!!!

 

A Commentary: Pharma's Ongoing PR Problem

Not a day goes by without some report about pharma’s ongoing problems with illegal drug promotions, class action suits against blockbuster medications or civil or criminal settlements with state and federal governments. A quick perusal of articles posted to the Pharmalot Blog in November alone revealed no fewer than eight big pharma companies including Lilly, Merck, GlaxoSmithKline, Bayer, Pfizer, Novartis and Amgen that were involved in some sort of legal action regarding inappropriate marketing claims or failure to disclose potential side effects of blockbuster drugs. To make matters worse, a larger than usual number of pharma companies have experienced manufacturing problems that have resulted in drug recalls or shortages. This list includes companies such as Genzyme, Baxter, Johnson & Johnson, GlaxoSmithKline and most recently Boehringer Ingelheim. While chronic legal and manufacturing problems are extremely troubling (some assert it is just the cost of doing “business”), I believe that the amount of money spent lobbying Congress for legislation favorable to the industry is even more egregious.

According to a recent post on Knowledge Ecology International, the pharma industry has so far spent $115,571,832 on lobbying in 2011 (this number is sure to go higher by the end of this fiscal year). Interestingly, the biggest year for pharmaceutical industry lobbying was in 2009—a year after the Affordable Health Care Bill was passed—with totals in excess of $186,000,000. Just think about how many jobs could have been saved if companies reinvested the money into R&D rather than greasing the palms of lobbyists to induce Congress to pass laws to continue to get favorable tax rates, improve ROI and bolster the stock prices of those companies! To wit, Newt Gingrich, a Republican Presidential candidate and Former Speaker of the House has been accused of lobbying former congressional colleagues to vote for a Medicare drug subsidy while he was a paid consultant to AstraZeneca. Gingrich vehemently denies these allegations; probably because he realizes that most Americans don’t like big pharma and may vote against him if the claims are proven to be true and he wins the Republican presidential nomination.

Not withstanding the legal issues and unnecessary lobbying, what is really hurting the pharmaceutical industry is its lack of communication and transparency with patients and its unfailing practice of putting profits before healthcare. While every big pharma company I know always talks about fulfilling unmet medical needs, meeting those needs always comes at great costs (literally) to patients. Sadly, many patients can no longer afford the costs of potentially lifesaving medicines and treatments. Unless pharma begins to change the way it presents itself to the American public, it will continue to suffer the lost of confidence and trust of the American people. And, if the industry is unable to regain the public’s trust, its inability  will ultimately result in legislation that allows the US government to control drug prices: something that exists in most other countries in the world and big pharma has been desperately trying to prevent for the past 50 years!

Until next time...

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

 

The Impact of Consolidation on Pharmaceutical R&D

Over the past 10 years or so there has been an enormous amount of consolidation in the life science industry. While this activity has been very good for shareholders, it has had a devastating effort on pharmaceutical R&D says John  LaMattina PhD, a chemist, blogger, author and former President of Pfizer Global R&D.

In his article “The Impact of Merger on Pharmaceutical R&D," LaMattina asserts:

“Mergers and acquisitions of pharmaceutical companies over the past 15 years have had a major consequence on the internal research and development productivity of these organizations. Industry consolidation has eliminated a high degree of competition and resulted in the downsizing of internal research efforts. The execution of these mergers has caused a loss of momentum in the development pipelines of these companies along with loss of scientific talent.”

In addition, he believes that M&A and outsourcing of R&D operations has resulted in the loss of scientific talent required for innovation and development of novel new medicines. “Sadly, this loss of innovation comes at a time when we are trying to find treatments for challenging and difficult-to-treat diseases like Alzheimers and many cancers” says LaMattina.

While most life sciences executives believe that consolidation is good for business, LaMattina, along with John Lechleiter, the outspoken CEO of Eli Lilly& Co (who is also a PhD-trained chemist) believe that continued consolidation in the industry will have devastating consequences. “We are still very much opposed to a large-scale combination. We don’t think size is necessarily supportive of innovation.” says Lechleiter. 

LaMattina added “Downsizing R&D hinders the ability of companies to develop new drugs because they lack the scientific expertise required to make critical decision as a drug candidate makes it way through the pipeline.”

Unfortunately, most current pharmaceutical and life sciences executives don’t think like LaMattina. Since 2001, over 300,000 pharmaceutical employees, mostly R&D scientists and sales representatives have lost their jobs.

Until next time...

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

 

Merck Announces More Layoffs

After a relatively quiet summer, big pharma companies are beginning to ramp up layoffs once again. Novartis recently announced that more job cuts were likely and last week I got wind of Merck’s impending reorganization and layoffs from a colleague whose partner works for the company. Today, Merck formally announced that it had sent e-mails to employees about the new round of layoffs. Last July, Merck said that it planned to cut 12 percent to 13 percent of its workforce of about 100,000 by 2015 as it adjusts to market conditions and its 2009 acquisition of Schering Plough.

The layoffs will be part of the company’s restructuring of “select HQ functions and field groups within the U.S. Market: Marketing & Customer Solutions; Managed Markets & Policy; Strategy & Commercial Model Innovation; and the Neuropsychiatric and Women's Healthcare specialty sales teams,"

While it is not clear how many workers will be layed off during the next round of downsizing, industry insiders are speculating that about 5,200 of the total cuts could be U.S. jobs, with from 3,000 to 4,000 in New Jersey and Pennsylvania. A Merck spokesman would not comment on the state-by-state plans. The cuts through October won't be the end of the process, though.

In August, the company offered buyout packages to some employees, but it is unlikely that buyouts and voluntary retirements alone would meet the numbers that Merck executive expect to make. Interestingly, Merck spokespersons said that the company will continue to add new employees but cut jobs elsewhere. I suspect that most of the cuts will come in R&D and sales as they have in the past.

Until next time...

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

 

Pharma and Social Media: Lilly Launches A YouTube Channel

Mark Senak, author of the outstanding EyeonFDA blog, tweeted today, that Eli Lilly & Co had launched a YouTube Channel. According to a post on the company’s blog Lilly Pad, its new channel dubbed the “Lilly Health Channel” will “videos on health and wellness, employee and community outreach efforts, health innovation, Lilly programs and other non-product-branded initiatives.”

While the announcement of a launch of another pharma-sponsored YouTube channel is no longer new or novel, Eli Lilly has been trying to transform itself into a modern, social media and crowdsourcing-focused pharmaceutical company. For example, Lilly is one of only a handful of big pharma companies that sponsors its own corporate blog. Moreover, the company is a leader in using so-called crowdsourcing to discover and develop potential new drugs. It has spun off at least two ventures that utilize a crowdsourcing approach to new drug discovery. Finally, unlike most other big pharma CEOs, its chief executive John Lechleiter has been outspoken about the lack of innovation and available workforce talent in the US life sciences industry. 

Is Lilly truly the pharmaceutical company of the future? That remains to be seen! 

Until next time... 

Good Luck and Good Viewing!!!!

 

New Thoughts on Pharmacovigilance, Adverse Event Reporting and Social Media

About a year ago, I suggested that real time social media platforms like Twitter could be invaluable tools for adverse event (AE) reporting and related pharmacovigilance activities. However the mere mentioned of the dreaded AE causes many marketing, legal and regulatory affairs professionals at major pharmaceutical companies to break out into a cold sweat. 

As Mark Senak aptly pointed out in a recent post on his blog EyeonFDA,

“...the reporting of adverse events using social media has long been the bogeyman feared by the legal and regulatory departments of drug manufacturers in the US.”

Further, Mark rightly asserts:

“....the adverse event issue may have proven a red herring.  That is perhaps evidenced by the now large number of Twitter feeds that are active representing pharmaceutical manufacturing companies and even their products; the growing, though not as quickly and not with as much success, presence of YouTube channels; the large number of Facebook pages and even an uptick in the number of corporate sponsored blogs – now at five by my count.  If the adverse event reporting issue really were an issue, this presence would be shrinking, not growing.”

So, what is the “real reason” why drug manufacturers refuse to embrace social media like almost every other industry that I can think of? True, FDA has not yet issued its long awaited guidance on the use of social and digital media in the life science industry. But, the lack of guidance has not prevented pharma and biotech companies from innovating in the past. I suspect that one of the reasons why many companies refuse to adopt social media is the requisite transparency and interactivity that are typically associated with its use. And, perhaps more importantly is the perceived loss of control over product messaging that companies with approved drugs on the market have enjoyed for the past 50 years or more.

Whatever the reasons are, I still contend that social media platforms are ideal tools for AE reporting and pharmacovigilance activities. Hopefully, drug makers will come to realize this with or without FDA guidance on the topic.

Until next time...

Good Luck and Good Tweeting!

 

Are US Immigration Laws Really Hurting Life Science Innovation?

A report in Bloomberg News today suggested that Eli Lilly & Co. Chief Executive Officer John Lechleiter, PhD told a technology conference today that unfavorable US permanent resident (green card) laws are to blame for declining US innovation in the life sciences. With this in mind, Lechleiter plans on calling for US immigration officials to issue more green cards and adopt a shorter and simpler process for highly skilled foreign nationals to gain permanent residence in the US. According to Dr. Lechleiter, one of only a handful of big pharma CEO who is also a PhD-trained scientist, current green card regulations are so-called job killers and force many talented foreign nationals to return to their native countries to work with firms that directly compete with American life sciences companies. Unlike most of his peers, Lechleiter has been very outspoken about the lack of US life sciences innovation.

While Lechleiter comments may have been appropriate five or more years ago, they are no longer germane to America’s waning innovation in the life sciences. There is little doubt that many bright and talented foreign nationals were denied permanent residency during the Bush era (2000 to 2008) because of stringent immigration policies and limits on the numbers of green cards allotted for persons from certain parts of the world; mainly China, India and the Middle East. This, in turn, forced many life scientists—many of whom desperately wanted permanent residency in the US—to return to their home countries to look for work and gainful employment.

As Lechleiter rightly asserts, these scientists found work with companies that began to directly compete with US life sciences. This phenomenon, coupled with the rapid assent of the middle class in many of these nations, made it possible to begin to conduct Western style research at a much lower costs in these countries. To that end, by 2007, most big pharma companies—many of whom had dwindling pipelines and monstrous overhead costs—realized that it would be more cost effective to outsource or move R&D to countries with emerging pharmaceutical and biotechnology markets and a well trained R&D workforce. And, for the past four years downsizing and outsourcing of R&D are exactly what have been taking place at many American big pharma and biotechnology companies.

In my opinion, the larger question that must be addressed, as far as US innovation in the life sciences is concerned is: why are so few Americans willing to pursue scientific careers? To wit, the main reason why so many foreign life scientists were educated and trained in the US over the past 20 years was because there weren’t enough American students to fill the incoming roster at most American graduate training programs. Put simply, America’s growing lack of innovation in the life sciences over the past decade can be directly attributed to far fewer Americans pursuing scientific careers and an increased reliance on foreign nationals—who were unable to stay in the US—to innovate! While changing US immigration laws may allow some foreign nationals to more easily remain in the US, there simply aren’t enough life sciences jobs left in the US to make it worth their while! In fact, the likelihood of them finding life sciences jobs in their home countries is now greater than it is in the US. In my opinion, the only way to restore American innovation in the life sciences is to convince American students that pursuing scientific careers is worthwhile and that the requisite training for industry jobs is available to them.

Interestingly, after leading with changes to US immigration laws, Lechleiter also suggested that America’s innovation problem could be solved by lowering US corporate tax rates and American companies should not be forced to pay taxes on oversea earnings. Also, he asserted that the US Food and Drug Administration (FDA) should stop putting off decisions or erring on the side of avoiding risk when considering new drug applications. 

This begs the questions, how do lower taxes, no overseas taxes and expedited drug approvals help to spur American innovation when most life sciences R&D is conducted outside of the US?

Until next time...

Good Luck and Good Innovating!!!!!!!!

 

More Evidence That Big Pharma's Investment in R&D Will Continue to Wane

There is no longer any doubt that big pharma companies are beginning to reduce their emphasis on internal R&D activities. Instead the companies will increasingly rely on outsourcing, partnerships, closer collaborations with academia, public private partnerships and M&A to keep their drug development pipelines full

Therefore it was not surprising when Merck’s new CEO, Kenneth Frazier recently mentioned in a conference call to financial analysts and investors that its multi-billion spending on new drug R & D will likely decline as a percentage of overall sales in the coming years. Merck is one of the largest pharmaceutical companies in the world

According to an article on Nasdaq.com, in 2010, Merck spent $11 billion on R&D, or 24% of total sales. Adjusted to exclude certain acquisition-related and other costs, R&D spending was $8.1 billion. Merck has predicted 2011 adjusted R&D spending would be $8.1 billion to $8.5 billion for 2011.

Frazier, the first African American CEO of a major pharmaceutical company, came under pressure earlier this year after he decided to not substantially cut R&D as many of Merck’s rivals, most notably Pfizer, did. He noted that cuts in R&D spending would have jeopardized Merck’s long term product development pipeline.

While rumors persist that Merck may be seeking to jettison its non-pharmaceutical consumer health and animal health businesses, Frazier insisted that the two units are complementary to its core pharmaceutical and vaccine focus and are not for sale. That said, if I was a Merck employee in either of those divisions, I would be updating my resume just about now.

Until next time...

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

 

Vaccines: The New Blockbusters?

Not too long ago, the mere mention of the word “vaccine” caused most big pharma executives to break out into a cold sweat. Once derided as low margin products and potential market busters—once most populations are immunized the incidence of disease declines and the market begins to falter—vaccines, primarily pediatric ones, have made a huge comeback over the last five years. 

One of the main reasons for the resurgence of the vaccine industry, was passage of US legislation that better-defined the legal obligations of vaccine makers and inclusion in the legislation of provisions that cap the size of awards made to persons claiming injury after vaccination. Another factor that contributed to the growing popularity of vaccines was emergence of the middle class in vast and concomitant improves in the healthcare systems of emerging markets that include South America, Asia and Africa. Unlike the mature vaccine markets in the US, Europe and Japan (because of low birthrates), the Asian, Latin American and African markets are poised for explosive growth over the next two decades.

In a recent article entitled “Vaccines-The Sustainable Blockbuster Business” Frost and Sullivan’s Senior Healthcare Analyst Barath Shankar Subramanian provides some interesting and insightful factoids about the vaccine industry. They are:

Pediatric vaccines are leading adult vaccines and represent the fastest growing segment of the global vaccine market

Europe is the world’s leading vaccine producer with over 90% of total production

The top five vaccine manufacturers (all big pharma companies) produce more than four-fifths of global vaccine revenues while other manufacturers (approximately 40) account for only one-fifth.

The North American market accounts for over 50 percent of the total spend on vaccines

North America and Europe supply only 14 percent of the world’s vaccine demand; the rest is met by suppliers in developing markets

Government investment, not-for-profit spending and industry alliances/ partnerships, in addition to private R&D spending, are helping to drive the current resurgence of the global vaccine industry

At present, there no fewer than 80 new candidates in late stage clinical development. Further, almost 40 per cent of the new vaccine candidates are for indications that currently have no vaccines on the market.  Finally, improvements in vaccine delivery are helping to drive the improved uptake of vaccines. For example, aerosols, transdermal skin patches, oral drops and even pills—all designed to eliminate needles and improve patient compliance and overcome cold chain supply issues are currently being developed.

From a business perspective—as far as sustainable markets go—the pediatric segment of the vaccine market is a clear winner. Currently, the leading global causes of vaccine-preventable, deaths for children under five include: pneumococcal disease, rotavirus, measles, Hemophilus influenzae b (Hib) infections, pertussis and tetanus. To that end, it is likely that governments in emerging markets will continue to add existing and new vaccines to government-mandated immunization programs. This is almost certain to propel the vaccine market to new heights over the next 10 years or more.

Until next time...

Good Luck and Good Job Hunting (think biologics!)

 

Antibiotic Revenues and Antibacterial Drug Discovery Research Are Declining

The loss of patent protection and a decline in revenues for a number of blockbuster brand name antibiotics has caused many big pharmaceutical companies to exit the antibacterial drug discovery market. The three remaining big pharma companies still actively engaged in antibacterial research are GlaxoSmithKline, AstraZeneca and Novartis (all European owned companies).

A new report by UK-based Datamonitor entitled “Forecast Insight: Antibacterials” predicts that antibiotic sales revenues will decline from $19.6 billion in 2009 to about $16.4 billion in 2019. Not surprisingly, the report blames the projected decline on generic competition and the lack of new antibiotic launches over the past 10 years.

At present, the top seven antibiotic markets in the world include the US, Japan, France, Germany, Italy, Spain and the UK. According to Datamonitor’s analyses, total sales in these markets have fallen by about 1.6 percent annually since 2005 and will continue to decline by almost 2.0 percent a year through 2019. In 2009, three antibiotics had sales of about or more than $1.0 billion; Johnson & Johnson’s Levaquin (market leader), and Pfizer’s Zosyn, and Zyvox. Interestingly, Pfizer recently decided to shut down its US-based antibacterial drug discovery program and move it to China and Johnson & Johnson recently announced that it was getting out of the antibiotic discovery business

Big pharma’s decision to abandon antibiotic research could not have come at a worse time. The incidence of antibiotic resistance among both Gram positive and Gram negative bacteria is rising at unprecedented rates. And while safe and effective treatments for Gram positive infections including MRSA (methicillin-resistant Staphylococcus aureus) still exist, the number of treatment options to treat Gram negative infections caused by Acinetobacter spp, Pseudomonas aeruginosa and enteric bacteria is severely limited. The recent description and rapid spread of a beta-lactamase enzyme called NDM-1 that inactivates the antibiotic carbapenem—the last safe and effective antibiotic to universally treat infections caused by Gram negative bacteria —is extremely troubling and worrisome.

While much of the focus over the last decade was on MRSA, infections caused by untreatable, multiple drug resistant Gram negative bacteria will pose the greatest public health threat over the next 10 years. Unfortunately, it is much harder to develop new antibiotic treatments for Gram negative infections as compared with ones caused by Gram positive bacteria. Further, at present, most of the companies that remain in the antibiotic space continue to focus on new treatment for MRSA and related bacteria. Consequently, new treatments for Gram negative infections may be more than a decade away!

Finally, like MRSA, most infections caused by multiple drug resistant Gram negative bacteria are nosocomial in nature (although the incidence of community acquired infections is also on the rise). This means that the most likely place to become infected with these bacteria is institutionalized healthcare settings including hospitals and nursing homes.

In the past, we have relied on pharmaceutical and biotechnology companies to discover new antibiotic treatments. The decision of many of these companies to leave the antibacterial space for purely financial reasons is unfortunate and regrettable. However, the growing incidence of antibiotic resistance among both Gram positive and Gram negative bacteria suggests that new antibiotics are necessary and that alternate approaches to new antibiotic drug discovery must be implemented. Whether this is through public/private partnerships or strictly through government programs is irrelevant. The bottom line is that we need new antibiotics; and if they are not discovered soon, many patients will die from previously treatable bacterial infections!

Until next time...

Good Luck and Good Job Hunting (start an antibiotic drug discovery company)

 

Alternate Career Options for Life Scientists: Persons Able to Manipulate "Big" Data Sets Will Be In High Demand Says New Report!

An article in today’s NY Times entitled “New Ways to Exploit Raw Data May Bring Surge of Innovation, a Study Says” suggests that persons with quantitative skills and a firm grasp of the scientific method will be in high demand in the near future. This is because there is a current data surge coming from “sophisticated tracking of shipments, sales, suppliers and customers, as well e-mail, Web traffic and social network comments.” And, the quantity of business data has been estimated to double every 1.2 years!

According to the report “Big Data: The Next Frontier for Innovation, Competition and Productivity” put together by the McKinsey Global Institute, harvesting, managing, mining and analyzing “big new data sets” can lead to a new wave of innovation, accelerated productivity and economic growth. And, the place where this may be felt first is the US healthcare system. The report asserts that better management of big data sets can lead to as much as $300 billion in savings. Also, American retail companies could possibly increase their operating profit margins by as much as 60 percent. However, one of the major hurdles to this paradigm shift is a talent and skills gap. The US alone will likely need 140,000 to 190,000 with expertise in statistical methods and data-analysis skills. McKinsey also notes that an additional 1.5 million data-literate manages will be required. Accordingly, “Every manager will really have to understand something about statistics and experimental design going forward,” noted one of the report’s authors.

As far as jobs for scientists in the healthcare realm are concerned, the report suggests that

“....the biggest slice of the $300 billion gain is expected to come from more effectively using data to inform treatment decisions. The tools include clinical decision support to assist doctors, and comparative effectiveness research to make more informed decisions on drug therapy.” That said, life scientists with backgrounds in statistical analyses, bioinformatics, genomics, public health, epidemiology and quantitative analysis will be ideal candidates for these new job opportunities."

While these types of jobs (mainly health informatics) are certain to available in the future, it isn’t clear how soon. This is because the big-data trend has just begun and, according to economists, it may take years to recognize its financial advantages and benefits. In any event, it is something for life scientists who may be considering alternate career options, to think about. To that end, if you begin to train for these opportunities now, you may find yourself in the right place at the right time in the not-to-distant future.

Until next time....

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

 

Looking Back: The Largest Big Pharma Drug Settlements in the Past Two Years

Big pharma continues to lament the increased scrutiny being imposed on it by the US Food and Drug Administration (FDA). Like it or not, the agency’s directive is to insure that the drugs that it approves are safe and effective for the American public. And, for the most part, the agency does its job and frequently catches companies that attempt to break the rules.

To that end, an article that appeared in FiercePharma last October noted that eleven big pharma companies had paid a total of over $6.0 billion in fines to the US government over the last two years or so. The biggest losers include Eli Lilly paid over $1.4 billion in fines because of alleged illegal marketing of its anti-psychotic drug Zyprexa and Pfizer which paid $2.3 billion for marketing missteps with three drugs including Bextra (pain), Geodon (schizophrenia) , Lyrica (neuropathic pain) and Zyvox (antibiotic). 

More recently, GlaxoSmithKline agreed to pay $750 million fine in a whistle blower lawsuit that alleged that the company had sold "adulterated products" manufactured in a Cidra Puerto Rico production facility. Also, the company announced last February that it intends to pay $3.4 billion to settle lawsuits alleging the improper promotion and sale of several of its products including the blockbuster diabetes drug Avandia and Paxil (depression).

The article also included a timeline of some of the other major settlements that have recently taken place (seen below)

Novartis
With: U.S. Attorney's office for the Eastern District of Pennsylvania
When: Sept. 30, 2010
Infraction: Novartis agreed to a $422.5 million settlement with the Eastern District of Pennsylvania for its off-label promotion of Trileptal and other allegations against Diovan, Exforge, Sandostatin, Tekturna and Zelnorm.

Forest Labs
With: Dept. of Justice
When: Sept. 15, 2010
Infraction: After marketing Levothroid, an unapproved thyroid drug, Forest Labs received its penalty, to the tune of $313 million. The settlement also covered Forest's off-label use of Celexa for children's use.

Allergan
With: Dept. of Justice
When: Sept. 1, 2010
Infractions: Allergan's $600 million Department of Justice settlement was broken into two parts: $375 million in fines and $225 million in civil penalties, all of which stemmed from its off-label use of Botox for headaches, pain management and cerebral palsy.

Elan
With: U.S. Attorney's Office in Massachusetts
When: July 15, 2010
Infraction: The Irish drugmakers received its $203.5 million fine for its marketing tactics of Zonegran, an epilepsy drug. Also, the company's U.S. branch pled guilty to a misdemeanor and the company will enter into a corporate integrity agreement with the HHS Inspector General.

Johnson & Johnson
With: Department of Justice
When: April 29, 2010
Infraction: Though J&J's more infamous woes stem from its phantom recalls, two of the troubled drug maker’s subsidiaries received a $81 million penalty for off-label promotions of Topamax, an epilepsy drug.

AstraZeneca
With: U.S. Attorney's office in Philadelphia
When: April 27, 2010
Infraction: In the same week as the J&J settlement, AstraZeneca was hit with a $520 million penalty for its antipsychotic, Seroquel. The company misled doctors and patients about the drug's safety.

Despite concerted efforts by the US Food and Drug Agency to limit off-label promotion of prescription drugs, most pharma companies continue to see how far they can push the envelope before the agency catches up with them. Given the current budget woes facing FDA, don’t be surprised if the frequency of off label promotion and misrepresentation of prescriptions drugs continue to rise.

Until next time...

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

 

Is Latin American The Next Big Market?

While India and China have been getting much of the attention and press over the past few years, Latin America is quietly become a market to watch for the life sciences industry.  According to industry analysts,the Brazilian pharmaceutical market has been growing at a rate of about 12 percent per year and is expected to be the world's fifth-largest pharmaceutical market by 2015.

A number of companies have been doing deal in Latin America mainly in Mexico and Brazil. Late last week, Amgen announced that it had purchased the privately-held Brazilian company Bergamo for about $215 million. As part of the transaction Amgen had reacquired marketing rights in the country to several Amgen products. Also, Amgen also agreed with Hypermarcas, a maker of personal hygiene products, to reacquire Brazilian rights to several products, including its Vectibix cancer drug.

Bergamo, which had $80 million in revenue last year, supplies medicines to the Brazilian hospital sector and has capabilities in oncology. Amgen, which is acting more and more like a pharmaceutical company rather than a biotechnology company, has clearly signaled its intention to take advantage of opportunities in emerging markets in BRIC (Brazil, China, India and China) counties.

Amgen has been struggling of late and its drug development pipeline, like many of its pharmaceutical rivals, has grown thin over the past decade.  Don't be surprised if Amgen is the next biotechnology company to be purchased by a big pharma company.  Merck's intention to enter into the biosimilar and biomanufacturing sectors suggest that Merck may be a likely suitor to gain control of the EPO and Neupogen franchises as well as Amgen's stake in the Enbrel market.

Until next time...

Good Luck and Good Job Hunting (try Brazil)

 

The Job Cuts Keep On Coming at Big Pharma Companies

The French drug maker Sanofi-Aventis continues to reorganize and slash jobs in anticipation of its acquisition of Genzyme. Today the company disclosed that it would shed another 700 jobs from its European operations. The job cuts come amid the company’s reorganization of its units in Austria, Germany, Switzerland, Portugal Spain, Holland, the Czech Republic and the United Kingdom (basically the entire EU).  The goal is to consolidate and reorganize the 30 European subsidiaries into only 10.

In other news, the Japanese drug maker Eisai announced that it plans on cutting 600 jobs or 20 percent of its US workforce. This announcement comes only one week after the company disclosed that it would trim 900 jobs in the next five years from European and Japanese operations. Impending generic competition for Eisai blockbuster treatment for Alzheimer’s disease, Aricept, is largely responsible for the layoffs. Like most other big pharmaceutical companies there aren’t enough drugs in development pipelines to offset the loss of revenue from generic encroachment on blockbuster brands.

Until next time...

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

 

What's Up With FDA Inspections Anyway?

BioJobBlog readers who understand Current Good Manufacturing Practices (CGMP) for pharmaceuticals and biologics know that the US Food and Drug administration is mandated to review approved drug manufacturing facilities once every two years. While this is the mandated inspection schedule, most industry insiders know that manufacturing plant inspections now take place once every three or more years. This has resulted because of an increased reliance by US drug makers on foreign manufacturing facilities to produce licensed pharmaceuticals and biologics, a lack of regulatory oversight by the agency during the Bush administrations and funding shortfalls that have resulted in a shortage of FDA inspectors.

Congress recently took the agency to task about a lack of oversight for food and drugs manufactured in foreign countries. In September, the Government Accountability offices reported that FDA inspects foreign drug facilities on average once every nine years as compared with every 30 months or more with US plants. To correct this, FDA announced that it aims to increase reliance on third party inspectors in other countries to maintain better oversight of ex-US manufacturing plants. In other words, it is less costly to train and work with inspectors already in foreign countries rather than send US inspectors overseas.

In a post last week on the Pharmalot Blog, Ed Silverman reported that Bloomberg News reviews almost 10,000 inspections at US manufacturing plants from 2000 until September 30, 2010. While the Bloomberg report did not provide details on the frequency and nature of violations uncovered at the inspections, the results of the reports were eye-opening. According to Ed:

“The FDA makes 0.9 visits, on average, to each facility each year, compared with 0.6 visits annually when George W. Bush was in the White House. Looked at another way, the agency NOW visits each of the 2,567 plants registered in the US almost once a year.”

Further he noted:

“Some of the biggest drugmakers do not have a good track record when it comes time for FDA inspectors to visit their plants. Overall, the FDA found violations at 54 percent of plants inspected last year, up 20 percent from a decade low in 2007, according to data obtained from the agency by Bloomberg News. And 80 drugmakers failed more than half of their inspections.”

So, which companies had the poorest inspection track records? Ed noted

“Abbott Labs failed 59 percent of 111 inspections; Pfizer flunked 57 percent of 202 inspections; Merck bombed out on 52 percent of 134 visits and Johnson & Johnson failed 48 percent of 161 inspections. By contrast, [generic drug manufacturer] Mylan passed 79 percent of 56 inspections!”

Republicans are threatening to slash FDA funding for US inspections mainly because the agency is focusing more on overseas manufacturers and suppliers. In response to the funding cut threats, the Obama Administration proposed that drug manufacturers whose production plants fail inspections would be required to pay fines of roughly $49,000. At present, there are no mandatory fines levied against drug makers that fail FDA inspection (the agency can and does impose fines if companies that fail inspections refuse or are reluctant to fix the problems that were uncovered).

I find it interesting that despite the numerous drug recalls and problems with drug safety of approved drugs over the past few years that the Republicans, could in good conscience, threaten to cut FDA funding to increase the frequency of inspections to bring them in line with the mandated once every two years rather than once every 2.5 to 3.0 years that has been the norm for the last decade.

Until next time....

Good Luck and Good Job Hunting!!!!!

 

More Downsizing and Outsourcing at Big Pharma Companies

The Japanese drug maker Eisai, Co announced that it will cut at least 900 jobs over the next five years to improve operating margins to offset the impending lost of patent protection for Aricept its blockbuster Alzheimer’s  disease treatment. The company did not specify where the cuts would take place.

In other news, based Eli Lilly & Co announced plans to outsource its R&D bioanalytical functions to Advion Biosciences a contract research organization that is building new laboratories Lilly’s home town of Indianapolis, Indiana. Ithaca NY-based Advion is building a 22,000 sq ft facility that will focus on ADME and toxicology experiments that are required for new molecules to enter human clinical testing.

Advion offers a range of Good Laboratory Practice-compliant and discovery bioanalytical services, including liquid chromatography-tandem mass spectrometry (LC/MS/MS) for determining small-molecule drugs, macromolecule therapies and biomarkers; immunoassay services; ADME (absorption, distribution, metabolism, and excretion) screening; cytochrome P450 inhibition and induction study support; metabolism profiling; metabolite identification; sample management; and sample storage.

According to a press release:

 “Lilly will transition its own drug discovery bioanalytical capabilities to Advion and will offer employees affected by the move the opportunity to join Advion. The new laboratory is expected to be fully operational by the end of May 2011.”

This is another example of big pharmaceutical companies exiting the R&D space. Because of the rampant downsizing and outsourcing of R&D functions to CROs, now could be one of the better times in years to start a biotech company. Big pharma is relying on starts up companies and academic laboratories to be the major source of new molecules that they develop. That said, the age of big “in-house” drug discovery operations at big pharmaceutical companies is drawing to an end. 

Until next time...

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

 

Study Finds Pharma Wrongdoing on the Rise

In a first-of-its-kind study, researchers at the Public Citizen’s Health Research Group tracked the civil and criminal financial penalties levied against the pharmaceutical industry for wrongdoing over the past 20 years. 

The main findings of the study revealed:

  1. Of the 165 settlements comprising $19.8 billion in penalties during this 20-year interval, 73 percent of the settlements (121) and 75 percent of the penalties ($14.8 billion) have occurred in just the past five years (2006-2010).
  2. Four companies (GlaxoSmithKline, Pfizer, Eli Lilly, and Schering-Plough) accounted for more than half (53 percent or $10.5 billion) of all financial penalties imposed over the past two decades. These leading violators were among the world’s largest pharmaceutical companies.
  3. The practice of illegal off-label promotion of pharmaceuticals has been responsible for the largest amount of financial penalties levied by the federal government over the past 20 years. This practice can be prosecuted as a criminal offense because of the potential for serious adverse health effects in patients from such activities.
  4. Deliberately overcharging state health programs, mainly Medicaid fraud, has been the most common violation against state governments and is responsible for the largest amount of financial penalties levied by these governments. This type of violation is also the main factor in the considerable increase in state settlements with pharmaceutical companies over time.
  5. Former pharmaceutical company employees and other “whistleblowers” have been instrumental in bringing to light the most egregious violations and have been responsible for initiating the largest number of federal settlements over the past 10 years. From 1991 through 2000, qui tam (whistleblower) cases made up only 9 percent of payouts to the government, but from 2001 through 2010, they comprised 67 percent of total payouts.

The companies, their missteps and the fines imposed are shown below:

The authors conclude:

"Over the past two decades, especially during the past 10 years, there has been a marked increase in both the number of government settlements with pharmaceutical companies and the size of the accompanying financial penalties. Given the relatively small size of current financial penalties when compared to the perpetrating companies’ profits, both increased financial penalties and appropriate criminal prosecution of company leadership may provide a more effective deterrent to unlawful behavior by the pharmaceutical industry."

Interestingly, about a month ago officials at the US Food and Drug Administration signaled that were willing to prosecute company executives to the fullest extent possible (including criminal prosecution) to reduce the incidence of fraud, off-label marketing and manufacturing violations that have become commonplace in the pharmaceutical industry in the past five years.

Until next time....

Good Luck and Good Job Hunting!!!!

WikiLeaks, Pharma Manufacturing and US National Security

Ed Silverman, author of the fabulous Pharmalot Blog, showed his investigative reporting bona fides by revealing today that there may be a direct link between pharma manufacturing facilities, US national security and the brouhaha over WikiLeaks.

Ed uncovered a cable dated Feb. 18, 2009 from the US Secretary of State to all overseas diplomats that stated pharma facilities are vital to US national security and that “losing these facilities could critically impact the public health, economic security, and/or national and homeland security of the United States.”

The cable stressed that these facilities produce insulin, a variety of vaccines that protect against potentially devastating infectious agents and other medications and a vital part of the US National Infrastructure Protection Program. According to Ed’s post, the facilities mentioned in the cable are located all over the world and included companies such as Baxter, GlaxoSmithKline, Novo Nordisk, Sanofi-Aventis, Genzyme, Novartis, IDT Biologika, Vetter Pharma, Roche, CSL Behring and Grifols. Interestingly, only two of the companies mentioned, Baxter and Genzyme, are US-owned companies. Go figure!!!!!!!

Until next time...

Good Luck and Be Alert (you never know who may be watching)

 

Pharmaceutical Job Cuts Exceed 50,000 in 2010

Despite signs earlier this summer that job cuts at pharmaceutical companies were beginning to slow, it appears that the number of jobs lost in 2010 may come close to the roughly 61,000 pharmaceutical jobs that were eliminated in 2009. This is based on quarterly Job-Cut Announcement Report published by the outplacement firm Challenger, Gray and Christmas. 

In past month or so, two big pharma companies, Roche and Novartis, announced that there will be major corporate reorganizations and deep job cuts to reduce spending, increase profits and bolster flagging stock prices. 

While things appear to be improving in other parts of the economy, the life sciences industry has been devastated by massive job layoffs in the past three years. Although pharma executives publicly blame the downsizing on the recession, massive R&D units, thinning pipelines and a failure to obtain a sufficient ROI on the huge sums of money poured into new drug development over the past decade are the real reason for the blood letting. Unfortunately, the US job market for life scientists won’t be improving anytime soon; mainly because it is more cost effective for companies to perform R&D and clinical testing in the emerging markets of China, India, Brazil and Russia (BRIC).

The ability of life sciences companies to successfully perform these activities outside of the US is in large part due to the lack of interest by American students in science careers and misguided immigration policies that prevented talented US-trained foreign nationals from remaining in the US after completing their training. This allowed many foreign countries to achieve a critical mass of US-trained life scientists and provide Western life sciences companies with a highly trained and well equipped scientific workforce.

With the holidays approaching, now may be a good time for those of you who work or considering careers in the life sciences industry to re-evaluate or consider alternate career options for life scientists.

Until next time...

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

 

Despite Assertions to the Contrary Novartis Lays Off 1,400 Sales Reps

Despite public assertions made by Novartis a mere eight days ago that it would not be eliminating thousands of jobs, the company today announced that it was eliminating 1,400 sales reps. Roughly 1,150 jobs will be cut from its primary care division—which is being consolidated into three units from four in the US—and another 250 from psychiatric and neuroscience. No jobs will be eliminated from Novartis’ headquarters in Hanover, NJ. While the job cuts announced today were not in the thousands (almost) it isn’t clear whether or not more are to come.

According to a post on today’s Pharmalot blog:

"Novartis had attempted to dampen speculation that a huge bloodletting was imminent after Roche disclosed plans to axe 4,800 jobs worldwide (back story) and, in fact, Joe Jiminez, the CEO, had written on his internal blog that news reports about big layoffs were inaccurate. Technically, the Novartis reduction is not in the thousands, but the number is still large and, essentially, confirms concerns that have been expressed over the past month at CafePharma, the online forum where reps dish the dirt (look here)."

Don’t you just love the holidays?

Until next time...

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

 

Bayer to Cut 4,500 Jobs

The German drug maker Bayer today announced that it plans to eliminate 4,500 jobs by 2012. Of the 4,500 positions to be cut, roughly 1,700 will be eliminated in Germany. Interestingly, during the same period, Bayer plans on creating 2,500 new jobs in “emerging markets;” yet another sign that big pharma is betting on translating the explosive growth of these markets into large profits.

While pharma’s interest in emerging markets may be good for the workers who live in these regions, it has been disastrous for scientists and sales personnel in developed markets like the US and Europe. To date, almost 200,000 pharmaceutical and biotechnology employees have lost their jobs since 2007.

Until next time...

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

 

Despite Large Profits Big Pharma Continues to Shed Employees

The fiscal year at most life sciences companies is drawing to a close, new budgets are being crafted and the holiday season is almost upon us. In years past, this time of year typically meant that it was bonus time for most pharma workers. Sadly, over the past three years bonus time has been replaced by layoff time. And, unfortunately the upcoming holiday season may not be joyous for many Pfizer and Roche employees.

Yesterday, Pfizer indicated that it may lay off up to 11,700 more employees than the 19,500 it had announced in connection with the buyout last year of Wyeth Pharmaceuticals. While Pfizer confirmed that it would be reducing its worldwide work force by more than the originally expected 19,500 the exact number remains a mystery. However, a quarterly report filed Friday with the U.S. Securities and Exchange Commission stated that Pfizer has estimated termination costs for 46,600 employees, while only 33,400 workers had actually been laid off as of Oct. 3. This appears to suggest that the company plans to reduce its work force by 11,700 more than originally announced, given that Pfizer is only 1,500 positions away from fulfilling its job-elimination pledge related to the Wyeth merger.

The additional job cuts—if they are realized—would amount to about 10 percent of Pfizer’s worldwide work force. If a reduction of that magnitude were applied to Pfizer drug-research sites in Groton and New London, which currently employ nearly 5,000 workers, about 500 jobs would be lost. The company in January 2009 announced that cuts would total 15 percent of the combined Pfizer and Wyeth work force. At the time, the combined work force numbered about 130,000; the latest official figure places that number at 111,500.

In other news, Roche today announced plans to cut 4,800 jobs, or 6 percent of its worldwide workforce of 82,000. Today’s announcement confirms the news leak three months ago (reported by the Pharmalot Blog) which suggested that job cuts would be likely during the fall.

According to today’s press release, technical operations activities will be reorganized in California, Mannheim, Germany and various other sites, resulting in the elimination of 750 jobs. The company also intends to sell sites in Florence, South Carolina and Boulder, Colorado; shedding an additional 600 jobs. About 1,200 jobs will be cut in the North American commercial operations, mainly in Roche’s primary-care business, while 700 positions will be lost in commercial operations in Europe.

R&D will also be affected. The company will discontinue activities in research and early development in RNA interference in Kulmbach, Germany, Nutley, New Jersey, and Madison, Wisconsin. Also, there are plans to reorganize other operations at these sites which will eliminate another 600 jobs.

Until next time...

Good Luck and Good Job Hunting (are there any left?)!!!!

 

Move over China and India: Big Pharma Is Eyeing Brazil

Most major pharmaceutical companies left Brazil about 30 years ago. However, much has changed in the country over the past 30 years and most western pharmaceutical companies are rushing back into Brazil to expand their operations and make acquisitions. At the same time, many Brazilian drug makers are beginning to consolidate and spread abroad.

The exodus of multinational drug companies in the 1980s was prompted by high inflation, tough government-mandated price controls and the lack of strong intellectual property and patent laws. Over the past 20 years Brazil has become a leader in agricultural technologies and made substantial investments into biotechnology. Along with these gains, patent rules and regulatory rules for pharmaceuticals and generics have become much stricter; making Brazil much more attractive to most major pharmaceutical manufacturers as growth of established markets continues to slow and need to increase sales in developing markets is critical. At present, Brazil is the eight largest eighth-largest drug markets in the world by sales. Much of this growth has been spurred by the rapid growth of the middle class (remarkably without reimbursement from state or private health insurance).

Some of the drug makers that have already invested in Brazil include Novo Nordisk, Sanofi-Aventis, Pfizer and Astra Zeneca. Novo Nordisk was an early entrant with its purchase in 2001 of Biobrás, a large insulin production plant outside São Paulo. Last year, Sanofi-Aventis acquired Medley, growing its portfolio of over-the-counter and branded products to complement its own offerings. Last month, Pfizer bought 40 per cent of Teuto, another generics business; other US, European and Japanese companies are continuing to study the Brazilian market closely.

While many western companies have gained a foothold in Brazil through M &A activity, others are attempting to develop their own internal presence.  Astra Zeneca, for example, is preparing for a launch of a series of both branded and generic products in the country.

In addition to the growing interest of multinational companies, some of Brazil’s domestic drug makers have been active. For example, Aché, a family-owned group and one of Brazil’s largest branded generics producers, has made smaller domestic acquisitions, and was considering buying Medley. The company has also begun forging alliances across Latin America, while its rival Eurofarma earlier this year bought Laboratorios Gautier in Uruguay, as the groups seek economies of scale in manufacturing and sales across the region. Even Farmaguinhos, the state-owned Brazilian drug company, has been collaborating with the African nation Mozambique.

Although the Brazilian government has made sizeable investments into research units such as the Butantan Institute in São Paulo and Oswaldo Cruz in Rio de Janeiro, the Brazilian drug industry is still in its infancy. The question is whether or not domestic drug makers will be able to meet demand before they are acquired by foreign companies interested in making inroads into Brazil’s burgeon drug market.

Until next time….

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

 

Big Pharma Merger-Mania Continues at a Brisk Pace

I am certain that many of you may have noticed that the size of the life sciences industry is shrinking at an unprecedented rate. Big pharma companies flush with cash, near- empty pipelines and impending patent cliffs have embarked on a buying spree that is likely to continue for next years (or at least until the economy shows clear signs of resuscitation). Pfizer’s impending acquisition of King Pharmaceuticals is just another transaction in a long list of M&A deals that have occurred over the past three years.                             

According to an article in today’s NY Times, roughly $42.2 billion worth of pharma deals have been transacted so far this year. That number is close to the $45.8 billion in M&A transactions announced by the same time last year (excluding Pfizer’s acquisition of Wyeth and Merck’s purchase of Schering Plough). Unfortunately, these mega-merger deals almost always result in massive layoffs in the industry.

While blockbuster mergers may not be good for pharmaceutical employees, the behind the scenes players—investment bankers, brokers, advisers and consultants—make out extremely well. For example, according to an article in Pharmaceutical Technology Europe, over a three month period in 2009 pharmaceutical company merger and acquisition activities generated $500 million in advisory fees for investment bankers. Clearly, mergers and acquisitions are in the best interest of company executives and the investment bankers not pharmaceutical employees.

There is no question that the recession and the down economy are driving much of the M&A activity in the life sciences sector. And, industry consolation is to be expected during challenging economic times. However, while M&A may be in the best interest of pharma company shareholders in the short term, I don’t think it will help to insure American competitiveness and innovation in the life sciences over the long term. 

Until next time...

Good Luck and Good Job Hunting

Roche Publicly Affirms Its Commitment to Social Media

Mark Senak, a pharmaceutical social media advocate and the author of the EyeonFDA blog, today reported that the Swiss pharmaceutical giant Roche published on its website a document entitled Social Media Principles. The document outlines Roche’s rules and regulations guiding the company’s use and commitment to social media.

In an accompanying statement, Roche officially affirmed the role of social media as part of its Communication Policy.

Roche actively uses Social Media to communicate with its stakeholders. As committed in our Communication Policy we want to be a transparent company and thus welcome this new form of communication.

Further, while the company recognizes the use and benefits of social media, it acknowledged the regulatory risks associated with the new medium

Roche recognizes the ubiquity and benefits of social media and welcomes its use - however, we also acknowledge that certain risks are associated with these new channels. We have therefore developed this guideline to help our employees use these new platforms in a responsible way.

Finally and perhaps most importantly, Roche appointed Sabine Kostevc as Head of
Corporate Internet and Social Media. 

Contact

Sabine Kostevc

Head of Corporate Internet and Social Media

She may be the first communication executive to hold an official title that has the phrase ‘social media” associated it. Surprisingly, this may be the biggest development of all; mainly because once one pharmaceutical company does something new, they all similar to follow!

Roche’s willingness to publicly commit to the use of social media is a bold and calculated move by a company that recognizes its power and the major role it will likely play in the future of the pharmaceutical industry. Further, it suggests that Roche, unlike most of its competitors, it willing to take a proactive role in helping to shape the social media regulatory guidelines being developed by the US Food and Drug Administration. Finally, Roche executives realize that increased transparency and open communications with its stakeholder may help to improve the public image of big pharma companies and perhaps rekindle the innovation that has been sorely lacking in the industry.

The bottom line: Rather than remaining part of the problem, Roche has boldly proclaimed that it wants to be part of the solution!

Hat tip to Mark and Roche!

Until next time...

Good Luck and Good Tweeting err Facebooking err Blogging!!!!!!!!!!!

 

New Directions: Pfizer Creates an Orphan Drug Division

Pfizer today announced plans to set up a Rare Diseases Research Unit that will target the more-than-6000 global orphan diseases. For those of you who may not know, orphan diseases are classified by the US Food and Drug Administration as those that afflict 200,000 persons or less.

According to a press release, Pfizer’s new division will “pursue treatments across all therapeutic areas and modalities and will serve as the focal point for the company’s existing research on rare diseases”. It also intends to “work closely with patient advocacy groups, like the National Organization for Rare Diseases, as it develops and advances the unit’s research strategy. It will be lead by Edward Mascioli, most recently the head of Dapis Capital, a private equity firm. Previously he was vice president of clinical affairs at Peptimmune and senior medical director at Paraxel.

Pfizer’s decision to enter the orphan drug market signals that no markets are too small for big pharmaceutical companies to consider in an era where blockbuster drugs are few and far between. Nevertheless, it is noteworthy that orphan drugs (which are generally biologics) offer drug maker several perks including: seven years of market exclusivity, tax breaks and credits, reduced clinical trials costs and expedited regulatory review. More importantly, perhaps, orphan drugs are highly priced and can yield impressive returns even though they are used to treat small patient populations. For example, several of Genzyme’s drugs such as Myozyme and Cerezyme—both designated as orphan drugs—have already reached over $1.0 billion in annual sales. 

While sales of orphan drugs may never reach those of Plavix, Lipitor, Epogen and other multibillion dollar blockbusters, garnering US regulatory approval for four or more (which cost much less than $1.5 billion to develop) will likely provide a substantial ROI to companies that develop them. Also, developing drugs that improve the quality of life for patients with no other treatment options will undoubtedly go a long way to improve tarnished reputation of the pharmaceutical industry.

Until next time...

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

 

Why Layoffs Won't Help Big Pharma

For the past three years, I assiduously have attempted to track all of the major layoffs announced by big pharma and biotechnology companies. Quite honestly, it has been hard to stay on top of these almost weekly announcements. To date, over 200,000 life sciences employees have lost their jobs. And, I don’t think that job layoffs will abate for a year or more.

While pharma layoffs make sense in the short term—most notably to insure that stock share prices remain as inflated as possible—they are not going to solve pharma’s lack of innovation and the rising attrition rates for new molecular entities. On paper, outsourcing R&D make perfect fiscal and scientific sense. After all, there are literal thousands of US-trained scientists all over the world these days; mainly in China, India and Eastern Europe and it is much more cost effective to do research in these regions. However, in my opinion, outsourcing R&D, like layoffs, is a short term strategy that will likely backfire and not deliver the anticipated ROI. For example, many US technology companies that outsourced sizable portions of their operations in the early 2000 are now beginning to bring them back to the US as Asian labor costs continue to rise and product quality declines. This begs the question: what should big pharma companies do to regain their edge to bring new medicines to market?

Allan Haberman, of Haberman Associates, wrote a compelling post several months ago on his blog the Biopharmconsortium Blog where he offers some insights and strategies that may help big pharma out of its current lack of innovation and new product development.  Until that happens, I will continue to track pharma and biotech company layoffs as they are announced.

Until next time....

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

 

Big Pharma is Betting on Emerging Markets to Lift Profits

It is no secret that growth of the pharmaceutical industry has slowed to single digits in the past five years or more. In fact, many experts don’t expect there to be double digit growth in this sector for a long time. Instead, future robust growth of the pharmaceutical industry is expected to take place in emerging markets including India, China, Brazil, South Africa and others. This is because the economies of these countries are booming and the middle class in these nations continues to rapidly grow. 

While branded prescriptions drugs once dominated Western markets, it is likely that generics or branded generic products will be the major players in emerging markets. Because of this, big pharma companies such as GlaxoSmithKline, Daiichi Sankyo and most recently Abbott Laboratories have either purchased or crafted large marketing deals with smaller regional drug manufacturers.

Daiichi Sankyo paid $4.0 billion in 2008 for a major share of India’s Ranbaxy Laboratories and GlaxoSmithKline earlier this year acquired exclusive rights to over 100 products produced by Dr. Reddy’s Laboratories, another Indian drug maker with a broad reach in emerging markets.

Today, Abbott Laboratories announced that it would purchase the healthcare business of Piramal Healthcare Ltd, one of India’s largest purveyors of branded generics for $3.72 billion. When the deal closes, Abbott will inherit the rights to about 350 brands and trademarks and a manufacturing plant in northern India. Also, Piramal agreed to a six year non-compete agreement for branded generics. The remaining parts of Piramal include a custom manufacturing business, over-the-counter products, vitamins, diagnostic devices and Piramal Life Sciences a drug discovery company.

The company, which has India’s largest sales force, would become a subsidiary of Abbott Laboratories and employ about 7,500 workers. Last week, Abbott said it would license at least 24 products from Zydus Cadila to sell in emerging markets. Analysts estimate that emerging markets account for 20 percent of Abbott’s business. The Piramal and Zydus Cadila deals suggest that Abbott maybe the company to reckon with in emerging markets in India and elsewhere.

 Until next time...

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

 

The Pharmaceutical Industry's New Math

Those of us a certain age have all heard of the so-called new math—which by all accounts wasn’t much different than old math—that was suppose to revolutionize the way math was taught at the primary and secondary education levels. While new math may not have not have much different or better than old math from an academic perspective, pharmaceutical companies will have to reckon with the new math associated with the pricing of brand name prescription drugs if they want to remain competitive in the future.

According to statistics offered in a recent New York Times article on Teva Pharmaceuticals, the world’s largest generic drug manufacturer, generics now account for 75 per cent of the prescriptions filled in the United States. This figure is up 47 percent from a decade ago. Further, a recent study from IMS, the research firm that tracks prescription drug use, generic drugs saved the American healthcare system $734 billion between 1999 and 2008. These numbers, coupled with a paltry 25 per cent market share, suggest that brand name pharmaceutical companies must rethink the low volume, large margin pricing strategy that has guided big pharma for the past 50 years. 

As one Teva executive candidly put it, “If you are used to the fat margins of big pharma, it is hard to compete in the rough and tumble of price-cutting generics.” 

The push for wider adoption and use of generic pharmaceuticals and biologics (as compared with brand name drugs) suggests that there will likely be more belt-tightening at big pharma companies in the not-so-distant future.

Until next time..

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

 

Another Pharma List: Does Size Really Matter?

Ed Silverman who runs the outstanding Pharmalot Blog, today posted a 2009 list of the world’s top 20 pharmaceutical companies. The list was compiled by IMS Health and placement was based on revenues generated from 2009 prescription drug sales.  The numbers in parentheses represent the percent change from the previous year.

FYI, the Pfizer-Wyeth and Merck-Schering Plough acquisitions weren’t included whereas the Roche-Genentech acquisition was. Also, it is interesting to note that Teva, the world’s largest generic drug manufacturer came in at number 11and exhibited the greatest increase in sales in 2009. Expect the Israeli drug giant to move into the top ten next year as generic drug sales continue to out pace those of branded products.

  1. Pfizer - $41.7 billion - (0.8)
  2. Novartis - $36.7 billion - 7.0
  3. Sanofi-Aventis - $35.1 billion - (3.3)
  4. GlaxoSmithKline - $34.3 billion - (3.4)
  5. AstraZeneca - $33.2 billion - (7.8)
  6. Roche - $31.3 billion - (8.6)
  7. Johnson & Johnson - $26.9 billion - (6.6)
  8. Merck - $25.0 billion - (4.1)
  9. Eli Lilly - $19.6 billion - (8.3)
  10. Abbott - $19.4 billion - (5.5)
  11. Teva - $15.7 billion - (12.3)
  12. Bayer - $15.4 billion - (3.9)
  13. Wyeth - $14.8 billion - (2.3)
  14. Amgen - $14.8 billion - (3.1)
  15. Boehringer - $14.6 billion - (10.4)
  16. Takeda - $14.4 billion - (2.1)
  17. Bristol-Myers - $14.2 billion - (5.8)
  18. Schering-Plough - $13.1 billion - (4.3)
  19. Daiichi Sankyo - $8.5 billion - (3.1)
  20. Novo Nordisk - $8.2 billion (11.6)

Hat tip to Pharmalot

Until next time…

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

 

Branded Generics: Something Old, Something New?

Earlier this week, an article appeared in the NY Times Business section heralding the entry of several large pharmaceutical companies into the branded generics industry. For those of you who may not know, generic drugs are lower cost versions of brand name prescription drugs that have lost patent protection. Generic prescription drugs are usually much cheaper than their brand name counterparts but generally deliver the same therapeutic effects as the branded product. In most cases, so-called “commodity generic drugs” are not branded and sold to consumers by their chemical names. A good example of a commodity generic drug is the anti-depressant sertraline HCl; which Pfizer sells under the brand name Zoloft. Pfizer still manufactures and sells Zoloft but Zoloft lost patent protection several years ago and a generic version of the active ingredient, sertraline HCl, is now available to consumers. Because sertraline HCl is much cheaper than Zoloft, pharmacists almost always substitute prescriptions for Zoloft with sertraline HCl. This is perfectly acceptable because sertraline HCl was approved by the US Food and Drug administration with an AB rating which means that sertraline HCl is biologically equivalent to Zoloft.

Unlike commoditized (no-name) generics, branded generics are off-patent prescription drugs that are sold to consumers—as the name implies—under a brand name. Typically, because these products are “branded” and actively marketed by manufacturers they are sold at higher prices than equivalent no-name generics. This is because consumers are generally willing to pay more for drugs that are manufactured by well known and trusted companies as compared with no-name generics which are usually produced by lesser known or unidentified manufacturers.

Branded generics are not a new or novel concept. They were previously championed by a number of generics manufacturers, most notably Barr Laboratories, which was recently purchased by the Israeli generics giant TEVA. In the past, when pharma embraced the blockbuster drug business model, drug manufacturers built in revenues— that eventually would be lost through patent expiry—into the price of their top selling drugs. This allows drug companies to maximize ROI early in a drug’s life cycle years before patent expiry Studies have shown that branded prescription drugs can lose as much as 90% of their original value two years after the introduction of generic equivalents. Consequently, because of drastically diminishing financial returns after patent expiry, it didn’t make economic sense to continue to promote and support a brand that was facing generic competition. Put simply, the company made its money on the drug and it is time to move on. 

However, the emergence in recent years of an affluent middle class in developing markets like China, India, Brazil, Eastern Europe and elsewhere is causing branded pharmaceutical companies to reconsider their generics strategy. In these markets, many people frequently pay out of pocket for their medicines but cannot afford to pay for the expensive brand name drugs. Also, in some emerging markets, where the threat of low quality or counterfeit prescription drugs may be high, consumers who can afford to purchase medicines are willing to pay more for drugs manufactured by well known and respected companies. Finally, IMS Health estimates that close to $89 billion in US drug sales alone will be lost to generic competition over the next five years or so.

In the absence of any new blockbuster drugs on the horizon, many big pharma companies have been scrambling to acquire or enter into relationship with established regional generic manufacturers. For example, GlaxoSmithKline recently bought a stake in Aspen a South African generics manufacturer and entered into an agreement with India-based Dr. Reddy’s laboratory to sell generic products in Asia and other emerging markets. Likewise, in the last year, Pfizer created an off-patent generics division (products are sold under Greenstone label which is a wholly owned subsidiary of Pfizer) and signed agreements with three Indian companies to sell their products in the US and other markets. These deals added about 200 products to Pfizer’s new generics portfolio. Further, Pfizer recently announced that the Greenstone brand has become the world’s seventh largest generics seller. In addition, Pfizer is expected to make a formal bid to purchase the financially-troubled German generics manufacturer Ratiopharm; one of Germany’s largest purveyor of generic drugs.

Not to be outdone by the competition, the French drug maker Sanofi-Aventis recently purchased Brazil-based Medley, a dominant player in the South American branded generics industry and Laboratorios Kendrik, a Mexican generics producer. Last year, the company also purchased Zentiva, a leading Czech generic manufacturer signally the company’s intention to move into financially-lucrative Eastern European markets.

Watson, one of the largest American generics manufacturers (which primarily operates in the US) recently purchased Arrow, a generic producer that operates in 20 different countries. Finally, Novartis, recognizing a business opportunity before most of its competitors, entered the generic market in 2003 following creation of Sandoz, a division of Novartis that manufactures and sells small molecule generic drugs and branded biosimilar products. Recently, Novartis purchased the German branded generics manufacturer Hexal, making it the world’s second largest generic drug manufacturer after Teva.

The entry of pharmaceutical companies into the generics business is allowing these companies to pursue a two-tiered business strategy in certain markets which is designed to preserve the long term value of their branded franchises. For example, companies can continue to sell their expensive name-brand drugs to the wealthy (or those that can afford them) and concurrently sell the more moderately priced branded generics which includes and over the counter products to the broader market. 

While some may lament the end of the blockbuster drug era, rising healthcare costs and generic competition is forcing big pharma to continue to explore novel and innovative strategies to reinvent itself.

Until next time...

Good Luck and Good Job Hunting (try the generic industry; business is booming)

 

Rare Disease Day: FDA to Offer Orphan Drug Development Workshop

A rare or orphan disease is defined in the US as one that affects fewer than 200,000 at any given time. It is estimated that there are 6000 to 8000 rare diseases in the world today. Because the number of patients afflicted with orphan diseases is so small, drug companies have historically been reluctant to invest money to discover and develop new treatments for them. The dearth of treatments for rare diseases induced Congress to pass the Orphan Drug Act in 1983 which provided market exclusivity, tax breaks and incentives and regulatory help for companies to development new drugs for orphan disease indications.

While many current blockbuster drugs including recombinant human insulin, growth hormone and erythropoietin originally garnered regulatory approval after receiving orphan status in the late 1980s, most big pharma and biotechnology companies (except Genzyme) largely abandoned orphan drug development until recently. The renewed interest in orphan drug development has been primarily driven by the demise of big pharma’s blockbuster business model that began in the early 2000s. The search for new, non-blockbuster drugs and fresh markets is what induced Pfizer, the world’s largest pharmaceutical company, to recently inked a multimillion dollar deal with Protalix Biotherapeutics, a small biopharmaceutical company developing a new treatment for Gaucher disease—an orphan indication.

Because of renewed interest and the ever increasing need for new orphan drugs, the FDA’s Office of Orphan Products Development is offering an Orphan Drug Designation Workshop that will provide a unique opportunity for all potential drug sponsors—including biotechnology companies, pharmaceutical firms and academic institutions—to learn about the application process for orphan drug designation.

The National Organization for Rare Disorders (NORD) is a co-sponsor of the workshops, which will take place on February 25-26 at Keck Graduate Institute and August 3-4 at the University of Minnesota.

Participants are encouraged to bring specific product proposals for at least one candidate orphan drug that holds promise for the treatment of a rare disease. A significant portion of the workshop will be dedicated to preparing applications, including one-on-one guidance sessions with FDA staff members. FDA will keep product and disease information confidential.

Final applications can be submitted to the FDA at the close of each workshop. For information or to register:

FDA Workshop Brochure
Registration for the February Workshop

Finally, February 28th is Rare Disease Day. The event is sponsored by the EURODIS a European advocacy group that promotes awareness and research for rare diseases. NORD and Discovery Health are also sponsoring the day.

Until next time....

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

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Pharmaceutical Industry Consolidation: A Historical Timeline that Traces Big Pharma's M &A Activity

The old baseball adage which says that  “you can’t tell the players apart without a program” is particularly apt when it comes to tracing the M &A activity that led to the creation of some today's largest pharmaceutical companies.

I used to be able to keep track of all of the moving parts  of most of these mergers but advancing age and unprecedented M&A activity in the pharma industry prevents me from successfully doing this any longer. To that end, about a week ago, the New York Times published a pretty cool and informative chart that historically traces the corporate mergers that lead to creation of Pfizer, Novartis, GlaxoSmithKline, Sanofi-Aventis and others.

Check it out!!!!!

Until next time...

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

 

A Modest Proposal

How many of you read the printed ingredients and nutrition fact boxes found on packaged foods to help you decide which of two similar products you ought to buy? What if the same concept was applied to direct-to-consumer (DTC) prescription drug ads? Do you think that it would be easier to determine which of two similar medications may be best for you? Well, researchers at Dartmouth Medical School think so! And, they are urging the US Food and Drug administration to adopt a similar concept for all DTC advertising.

Based on results from two randomized, clinical studies, the Dartmouth team proposed that numerical tables that quantify the benefits of a drug (compared with placebo) and also the odds of developing certain side effects should be included on DTC advertisements including television, print and web-based ads. In those studies, patients were shown drug ads that did and did not include a fact box. Participants looked at ads (with and without fact boxes) for two similar prescription heartburn medications and two widely prescribed cardiovascular drugs. The trial using the heartburn medications was designed to evaluate consumer decision-making about drugs that are used to treat symptoms whereas the cardiovascular medications trial was used to evaluate decision-making about the use of preventative medications that reduce the risk of future events, e.g., heartache or stroke.

Overall, the researchers said, the addition of facts boxes to prescription drug ads allowed consumers to make better decisions about the choices of drugs for their symptoms and were better informed about the benefits of drugs that could be used for prevention. For example, when asked which drug they would choose for heartburn 68 percent of those who had seen ads with facts boxes picked what the researchers referred to as "the superior drug," as compared with 31 percent of those who had seen ads without facts boxes. Also, about 80 percent of the facts-box group, as compared with 38 percent from the non-fact-box group, knew that both drugs had similar side effects. After looking at cardiovascular drug ads with or without fact-boxes, 72 percent of those who saw ads with facts boxes correctly described the risk reduction associated with both drugs whereas only 9% of non-fact-box participants were able to do this.

DTC advertising is big business—last year the pharmaceutical industry spent approximately $4.8 billion on television and print ads alone. While DTC advertising is known to influence prescription drug sales, it is also somewhat controversial suggested Dr. David L. Katz, director of the Prevention Research Center at Yale University School of Medicine "Direct-to-consumer drug advertising is controversial in medical circles, largely out of concern that drug companies will talk patients into preferences not in their best interest, "But I often encounter the opposite problem in my patients. After hearing the litany of potential side effects of a drug, they absolutely refuse to take it," Katz said. Nevertheless, he and the Dartmouth researchers agree that better-informed patients make better drug choices.

Drs. Woloshin and Schwartz, leaders of the Dartmouth team, are scheduled to present their findings tomorrow to an FDA advisory panel on “risk communication.” The panel is tasked with examining how best to provide consumers with data about prescription drugs using printed matter. 

Adding fact-boxes to print, television or web-based ads won’t substantially increase the cost of creating and producing them. Also, rather than hurt prescription drug sales—what most pharmaceutical companies are worried about—the new approach may be good for the industry. According to Robert Ehrlich, who heads DTC Perspectives, a company that specializes in pharmaceutical marketing, “If there is high benefit and low risk, doctors will prescribe more of the drugs. If there is low benefit and high risks than the drug should probably not be on the market,” said Ehrlich.

Stay tuned for updates.

Until next time...

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