Political Intrigue at 3 Big Pharma Companies

The New York times reported today that Britain’s Serious Fraud Office has demanded documents from GlaxoSmithKline, Astra Zeneca and a British affiliate of Eli Lilly & Company in connections with allegations that the companies paid bribes to secure lucrative drug contracts in Iraq while Saddam Hussein was in power. The 3 companies are accused of violating the United Nations’ oil-for-food program that was instituted in post war Iraq in the 1990s.

A report from the fraud office in 2005 accused some 2,200 companies from 40 countries of colluding with the Hussein regime to cheat the UN program out of about $1.8 billion. As I have stated time and time again, drug companies are no different than other companies–profits and stock prices always come before ethics, morality and sometimes the law!

Until next time….

Good Luck and Good Job Hunting!!!!

Can Scientists Be Effective CEOs?

Over the past 30 years or so, the vast majority of chief executives in the drug business have made their way to the top via the sales and marketing departments. Few senior executives have toiled in a research laboratory or for that matter, know the difference between NMR and protein purification. However, things may be changing in the industry. A quick perusal of the CEOs of the top 20 pharmaceutical and biotechnology companies (see below) reveals that 11 of 20 have degrees in engineering (4), medicine (2) and science (5). The remaining 9 have degrees in business and finance (3), sales and marketing (4) or law (2). Several of the scientists (2), engineers (3) and one physician also earned MBA degrees.

 

Conventional wisdom suggests that scientists usually do not make good CEOs (they are not formally trained in business). However, doesn’t the lack of scientific sensibility put non-scientist CEOs at a disadvantage when it comes to making strategic and operational decisions about R &D?  One would think so….!!!!

 

A careful examination of my top 20 list suggests that some of the most successful companies are run by scientist CEOs, e.g. Genentech, Gilead, Novartis and Lilly. Expect to see more scientist CEOs at large biotechnology and pharmaceutical companies in the future–R&D have become way too complex for non-scientist to truly understand its nuances and potential pitfalls. Plus, we scientists know that obtaining a MBA degree is a “piece of cake” as compared with the PhD degree! Hmmm, I wonder what business people think about PhDs?

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FDA Announces A Meeting on Stem Cell Research in 2008

According to the Eye on FDA blog, FDA has announced an upcoming meeting on stem cells.  This excerpt was recently published in the federal register...

"On April 10, 2008, the committee will meet to discuss scientific considerations for safety testing for cellular therapy products derived from human embryonic stem cells. , the committee will meet to discuss updates on the following topics: (1) Research management related to the September 29, 2005, review of research programs of the Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research; (2) 's Somatic Cell Therapy Letter; and (3) recently released FDA guidance documents."

I am not sure what they will talk about given the Bush administration’s intransigence on embryonic stem cell research. Don’t you just love it when Federal agencies waste your tax dollars to hold meetings when there is nothing to talk about? Go figure……

Until next time….

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

Reefer Madness: The Truth About Cannabis

Once again I have to tip my hat to Ed Silverman over at Pharmalot for his intrepid reporting. In today’s blog Ed wrote:

 “A little company in Canada is high on marijuana.  is testing its first product, CAT-310, which it says takes away the so-called “buzz” of marijuana that makes some terminally and chronically ill patients, particularly the elderly, uncomfortable and anxious, The Toronto Star reports. The med is aimed directly at the $4 billion neuropathic pain market that is mainly serviced by various opiates, anti-convulsants and anti-depressants.

The idea is to mimic smoked cannabis through the invention of a new drug delivery technology that can be absorbed on the tongue, like a thin wafer. It doesn’t get digested by the stomach and processed by the liver before reaching the brain, so it’s similar to inhaling cannabis. So far, Cannasat has raised $9 million in seed capital. Get it?”

You just gotta love Ed and those zany Canadians too!!!

Until next time…

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

My Favorite Quote of 2007

"Quite simply, life-saving drugs are irrelevant if they are not affordable"

–Christopher Begley, chairman and chief executive of Hospira Inc., the Lake Forest-based maker of hospital products and specialized medication-delivery devices commenting on the intransigence of FDA to craft legislation that would allow the approval of follow-on biologics aka biogeneric drugs.

For those of you who may have missed it, The Senate Health, Education, Labor and Pensions Committee approved in June the Biologics Price Competition and Innovation Act of 2007, which would allow for biogenerics. The House is expected to take up similar legislation in early 2008 in hearings before the House Energy and Commerce Subcommittee on Health.

Don’t be surprised if this legislation does not see the light of day until well after the 2008 presidential election and only if a democrat is elected.

Until next time….

Good Luck and Good Job Hunting!!!!!

A Second Biosimilar Version of EPO Gets Approved in Europe

As the debate continues to rage in the US about how to regulate biogeneric drugs, the European Medicines Agency (EMEA) has given the go-ahead to Hospira and Stada to sell their copycat version of Johnson & Johnson's anemia drug Procrit.

The European Commission approved Retacrit (epoetin zeta), a biosimilar version of erythropoietin (EPO), to treat anemia associated with chronic renal failure and chemotherapy. EMEA regulators determined that the drug was comparable in efficacy and safety to Procrit.

The EPO market is a large one and more than 250,000 patients in Europe are estimated to be treated with epoetin alfa, which is marketed under various brand names, Procrit (JNJ; US), Eprex (JNJ; Europe) and Epogen (Amgen; US). Worldwide annual sales of EPO drugs are estimated at more than $7 billion, $600 million of which comes from Europe.

The approval for Retacrit comes some three months after Novartis’ generics unit Sandoz got the first go-ahead in Europe to develop its version of epoetin alfa. Sales of Retracrit will begin in Germany in early 2008.

When are American pharmaceutical and biotechnology executives going to wake up and realize that they will lose millions in revenue to biosimilar competition?  I think the old adage; “If you can’t beat ‘em, join ‘em” is apt when talking about the biogenerics industry.

Until next time…

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

A Presidential Debate About Science.....Cool!

On Tuesday, ScienceDebate2008, an amalgamation of politically-minded scientists, challenged Democratic and Republican candidates to hold at least one debate focusing on the environment, medicine and health and science policy.

Despite my advancing age, I am still a “revolutionary” at heart….I kinda miss the marches, energy and vision of the “60s!  Maybe if we come together as a lobbying group we scientists can use politics to effectuate changes in science and healthcare policies—stranger things have happened!

Until Next Time….

Good Luck and Good Job Hunting!!!!!

Wyeth May Be This Year's "Biggest Loser"

Just days after hiring its Chairman and former CEO Bob Essner as a highly paid consultant, Wyeth learned on Monday that that Teva Pharmaceutical Industries could sell a generic version of its blockbuster heartburn medication Protonix ($2.8 billion in annual US sales) and the US Food and Drug Administration delayed approval of its new osteoporosis medication Viviant for the second time. The agency failed to approve Viviant because of lingering safety concerns that it might cause blood clots and strokes.

It is widely known that Wyeth has struggled to introduce new products to replace sales it will lose when its top-seller Effexor loses patent protection in 2010. The loss of Protonix, which has annual sales of  over $1.8 billion, could be a devastating blow to Wyeth. The company’s stock price fell $1.41or 3 percent to $45.45 on Monday after Wall Street learned Protonix’s fate.

During Essner’s six year tenure as CEO, he oversaw a diet-pill scandal that cost the company $12 billion in liability claims and has had no fewer than four (4) product approvals delayed by FDA. In addition to Vivant (delayed twice), Wyeth’s bifeprunox for schizophrenia and Pristiq for depression and menopausal hot flashes were delayed pending requests for additional data. Torisel, its kidney cancer drug, was delayed before it won approval last April.

It is still not clear to me, why Wyeth hired Essner as a consultant given his less-than-stellar record of product approval. Maybe Bernie Poussot, Wyeth’s newly appointed CEO, can pick up the pieces. I certainly hope so, because earlier this month Wyeth’s Board of Directors elected to raise the annual base salary of its CEO to $1.5 million, despite laying off thousands of employees this past year.

When is big pharma going to learn that raising a CEO’s salary does not necessarily translate into better earnings or a higher stock price? In my opinion, companies would be better off by raising the salaries (and retaining) motivated and talented employees—after all, aren’t these the folks who actually do the work? But then again, what do I know—I have never been a highly-paid CEO of a Fortune 500 company!

Until next time…

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

Contracting Has Been Very Good to Me!

For those of you who are interested, I wrote an article about contract work in the pharmaceutical and biotechnology industry that appeared in Science Careers about a week ago.

As many of you may know, I am a contractor so I can "walk the walk and talk the talk".  That said, for those of you looking for employment try contracting on for size.  You may like it!  Borrowing from Garrett Morris a fomer '70s Saturday Night Live alum "Contracting has been berry  berry good to me"!

Until Next Time....

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

Pharma Winter Wonderland

I am sure that most of you have heard by now that it takes about $1.0 billion to shepherd a new drug from discovery through commercialization. It is a nice round number but methinks that “something is rotten in pharma land”. The massive pharma layoffs in 2007 were justified because of nearing patent expiry, encroachment by generic manufacturers, over zealous FDA scrutiny and failing stock prices. To that end, how do you explain this little tidbit about Wyeth that my colleague Ed Silverman at Pharmalot reported on late last week? 

As you may know, about three months ago Wyeth’s CEO Bob Essner announced his pending retirement as from the struggling drug maker. It turns out, that Bob will remain chairman through December 31, 2008 and will receive the same $1.73 million in 2008 that he received this year as company CEO.As Ed reported “Bob will also be entitled to a bonus based on his 2008 salary that is “consistent with (his) position,” although his duties are not defined—nor his title. Presumably, Bob is now a consultant.” I along with Ed will look forward to hearing his ideas and what he will be doing for Wyeth over the next 12 months. Maybe he and Bernie Poussot, Wyeth’s new CEO (who will be making a measly $1.5 million this year) can have lunch from time to time to discuss strategy.

Maybe this is why it takes a billion to commercialize a new drug?

Until Next Time

Good Luck and Good Job Hunting (try Wyeth, they apparently have money to burn)

Genentech Resolves Its Avastin-Lucentis-Macular Degeneration Controversy

The New York Times reported today that Genentech resolved a dispute with ophthalmologists that will allow its cancer drug Avastin to continue to be used to treat macular degeneration. As you may recall, the dispute began in October when the Company announced that it would change the distribution of Avastin which would have made it difficult to use the drug. Many ophthalmologists felt that the policy change was an attempt to force them to used Genentech’s newly approved macular degeneration drug Lucentis which has the same mechanism of action but is much more expensive than Avastin. Although Avastin is not approved to treat macular degeneration, many ophthalmologists use it as an off-label alternative to the more costly Lucentis.

According to the agreement, Genentech will sell Avastin directly to ophthalmologists rather than to compounding pharmacies as it previously had (Avastin which was meant as a cancer treatment must be divided into tiny portions for use in the eye under sterile conditions). Physicians who purchase Avastin will have to send it to compounding pharmacies at their own expense to prepare it for patient use. However, the American Academy of Ophthalmology and the American Society of Retina Specialists cautioned that some states might have regulations that would make it difficult to use the new arrangement.

I guess Genentech wanted to spread some “good cheer” before the holidays.

Until next time….

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

Not So Fast: Plaintiff Lawyers Seek to Alter Merck's Vioxx Settlement

Several lawyers representing people who sued Merck over Vioxx asked the federal judge overseeing the $4.85 billion Vioxx settlement for the freedom to keep some of their clients outside of the settlement while allowing others to accept it. Currently, it is an all or nothing deal—if the lawyers want any clients to receive money from the settlement they must recommend the deal to all of their clients. This was a crucial part of the settlement offered by Merck. A Merck lawyer said that the company will oppose the motion and that the settlement had been carefully devised to be fair to plaintiffs and the company. For the deal to take effect, 85% of all plaintiffs must agree to all terms of the settlement.

The emergency motion may have been prompted by the recent firestorm surrounding Merck’s cholesterol-lowering drug Zetia. Maybe the lawyers think that renewed questions about Merck’s ongoing reluctance to release pertinent safety information about its products may induce juries to render positive verdicts in certain jury trials involving patients who took Vioxx continuously for more than a year. That said, about 18 Vioxx cases have been tried and the plaintiffs have lost most of them. Nevertheless, as the old adage goes: “It never hurts to ask.”

Merck is certainly in the hot seat today and right before the holidays too!!!!!!!  

Until next time…

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

Once Again Merck Chooses Sales Over Patient Safety

There is a storm brewing around Zetia, Merck and Schering Plough’s blockbuster cholesterol-lowering drug. However, let me preface this post by reminding everyone that all drugs have side effects and if a drug’s benefits outweigh its risks then it will likely be prescribed to patients. That said, new evidence has been uncovered which shows that Merck, and  Schering Plough, conducted  at least 8 clinical trials from 2000 to 2003– to evaluate Zetia’s risk to the liver when taken with other cholesterol-lowering drugs (statins) – but chose to not publish the results of those studies. This is what we know about Zetia:

  • Zetia has annual sales of over $ 5 billion
  • Despite no evidence that Zetia’s cholesterol-lowering ability actually reduces the incidence of heart attack or stroke in patients who take the medication, it was approved by the US FDA in 2002. A 10,000 patient Zetia clinical study called ENHANCE is currently underway to determine whether the drug’s ability to lower cholesterol really translates into a reduction in heart attacks and strokes
  • Millions of people who take Zetia also take statins such as Zocor, Lipitor, Pavachol, Crestor and Mevacor to lower cholesterol (Vytorin, Merck’ new cholesterol-lowering drug contains Zetia and Zocor in a single pill)
  • From 2000 to 2003 Merck and Schering Plough conducted 8 long-term safety studies of Zetia in combination with a variety of statins but only published the results from 3 of the 8 studies. Also, the unpublished studies were not listed on industry websites where companies are supposed to register by law the results of all ongoing clinical trials after 2002 (because some of these trials were initiated before 2002 the law does not apply to them)
  • FDA supposedly reviewed the results of the unpublished studies and approved Zetia use with statins anyway
  • Prior to its approval in 2002, at least one internal FDA reviewer recommended that Zetia not be approved for use with statins because the combination caused liver disease in animals. Also, since 2006 a number of case reports have been published in medical journals that suggest the combination of Zetia and statins has caused severe liver damage in some patients
  • In the US, Zetia’s product label only contains mild warnings about the drug’s potential to cause liver damage. However, since 2005, product labels in Canada and Australia have carried strong warnings about Zetia’s potential to cause hepatitis, pancreatitis and depression—warnings that have seemingly been ignored in the US
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Oops, Pfizer Does it Again!

Pfizer Inc. said Tuesday it will buy privately-held biotechnology company CovX in a move to augment its own internal pipeline of biotechnology products. CovX’s expertise lies in developing long-acting, peptide-based biotherapeutic drugs.

La Jolla, Calif.-based CovX has already generated one early-stage diabetes candidate and two early-stage cancer treatment candidates, Pfizer said. It will operate as part of Pfizer's Biotherapeutic and Bioinnovation Center in California.

According to Pfizer CEO Jeffry Kindler, “The acquisition of CovX is a further step in Pfizer's strategy to acquire and identify new product candidates that we can put into development, leveraging both Pfizer's expertise and that of world-class scientists charged with discovering and bringing in new compounds.” The truth is: that Pfizer hasn’t seen a deal that it could not resist!

A Pfizer spokesperson said CovX scientists will remain with the company. That is exactly what Pfizer told Warner Lambert and Pharmacia employees after those companies were purchased.
If I was working at CovX I would be updating my resume–just in case

Some Good News for Employees After J&J Sells A Manufacturing Facility

A Johnson & Johnson Co. plant in Bedford MA that manufactures medical devices was sold for $45 million in cash to an Indiana-based provider of orthopedic products used in arthroscopy, dental and other medical professions.

The plant’s 200 workers will keep their jobs, and additional jobs could be added in the future depending on customer demand, said Fred L. Hite, senior vice-president and chief financial officer of Symmetry Medical Inc.

Symmetry, a public company listed on the New York Stock exchange, purchased the 82,000 square-foot facility from DePuy Orthopaedics, Inc., which is owned by Johnson & Johnson. Both Symmetry and DePuy are headquartered in Warsaw, Ind., known to some as the orthopedic capital of the country.

According to a release from Symmetry, DePuy is required to make minimum purchases from the New Bedford plant for four years following the acquisition, which is expected to be completed within 60 days.

Until Next Time.....

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

Pfizer Throws a "Lay Off" Party in Ann Arbor

According to an article in the Ann Arbor News, hundreds of Pfizer employees and their guests gathered at Eastern Michigan University's Convocation Center late last week for a good-bye party sponsored by the company.

The party included a live band parodying popular songs with Pfizer-themed material, with the participation of site director David Canter, and a retrospective video documenting change at the Ann Arbor site since it was built in the late 1950s.

Nobody was crying in their beer or anything like that," said a seven-year employee. "There was good food, nice music ... people were there just to have a nice time with their colleagues. ... It's hard to be bitter when you had such great people to work with." Gee, with such loyal employees, you wonder why Pfizer shut down the facility?

I guess business is business–at least Pfizer Ann Arbor ex-employees know that the company appreciated them a lot and that there are no hard feelings.

Until next time…

Good Luck and Good Job Hunting (I hear Ann Arbor is nice)

Glaxo Falters Again

GlaxoSmithKline announced today that the U.S. Food and Drug Administration wants more information on its cervical-cancer vaccine called Cervarix before clearing it for sale, giving Merck & Co. more time before a rival comes to market. As you may know, Merck was first to market with its highly touted (and somewhat controversial) cervical cancer vaccine called Gardasil. Both vaccines protect against infections with certain human papilloma virus (HPV) strains that cause over 99.9% of all cases of cervical cancer. Gardasil targets four strains of HPV - including two causing cancer and two causing genital warts, while Cervarix targets only the two cancer strains.

According to Ed Silverman at Pharmalot, “the FDA has issued a so-called ‘complete response letter’ for its Cervarix vaccine. Although it’s not clear, though, whether the agency wants additional trials, leaving open the possibility that the unexpected delay in approval can last anywhere from just six months to up to two years.”

As you may recall, Merck was actively lobbying state and federal legislators earlier this year to make Gardasil vaccination mandatory for girls aged 12 and older. I find it interesting that the agency is questioning Cervarix’s approvability given Merck previous and extremely vigorous lobbying campaign for mandatory vaccination with Gardasil.  “executives shouldn’t blame their problems on FDA being slow to green light new medicines”. Thank you for the insight Mr. Clark!
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The Axe Falls Quickly at Novartis

My friends over at the WSJ Health Blog alerted me to the 2,500 jobs that were cut today by the Swiss drug maker Novartis. Daniel Vasella, Novartis’ CEO foreshowed the event in a recent interview with the Wall Street Journal that was published only 2 days or so ago. Hmmmmmmmm……….how clever!

The layoff represents about 2.5% of the Company’s workforce – a mere drop-in-bucket compared to recent layoffs at BMS, GSK and others. However, I would not want to tell that to the Novartis employees who lost their jobs today.

Analysts think that Novartis’ workforce is still too large. Novartis also plans on cutting over 1,250 US sales jobs. Look for additional right-sizing in 2008.

Until next time….

Good Luck and Good Job Hunting (not in NJ)

Boston Scientific Sells Two Business Units As Part of Its Restructuring Plan

The New York Times reported today that medical device maker Boston Scientific Corporation had agree to sell its fluid management and venous access businesses for $425 million to the private equity firm Avista-Capital Partners.

This is part of the restructuring plan that the Company announced several months ago.

Until next time…

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

It Had to Happen Sooner or Later!

Until yesterday, I had never been admitted to a hospital via emergency services. I ended up in a hospital \emergency room because earlier in the week I had this sharp pain in my lower right abdomen and it bothered me enough to seek professional help. After a visit to my doctor and a CAT scan at my local hospital, I was asked to walk my films around the corner to the emergency room where I would be met by a surgeon because I had a perforated appendix–my worst fears had come true. Now, here is where it got interesting from a medical and microbiological standpoint.

Based on my recollections from childhood (how many of you know kids who had their appendixes removed?) I thought I was definitely headed to surgery for an emergency appendectomy. But hold on– much to my surprise, there are actually 3 different flavors of appendicitis. The most common form is when the appendix is inflamed and the organ remains intact and can be easily removed by routine surgical methods. The second most common form, which many of you may have heard of, is when the appendix ruptures. When this occurs, the floridly-inflamed and enlarged organ actually bursts and releases the bacteria that cause the organ to enlarge into the peritoneal (stomach) cavity. In this case, there in no option but surgery which can be messy and serious because there is always a concern that the released bacterial will cause an infection of the stomach cavity called peritonitis. Peritonitis can be fatal if not treated with appropriate antibiotic therapy. Finally, the least common and most difficult to diagnose form is called the “perforated appendix.” This is when a small lesion occurs in inflamed and enlarge appendix and small amounts of bacteria escape into the peritoneal cavity (the infectious disease resident who looked at my CAT scan films said it looked like a small bomb exploded—lucky me). Now, when this happens there are two treatment options that the patient must choose between—surgery or intravenous antibiotics for 5 days in the hospital. Surprisingly, my surgeon recommended the IV antibiotics option. After thinking it through, the IV antibiotics option made medical sense. Because only a small number of bacteria were released into the peritoneal cavity 5 days of IV antibiotics ought to prevent peritonitis from occurring. Further, antibiotic treatment will suppress bacterial growth in the appendix and allow it to return to normal. Once appendix is sufficiently healed and no longer inflamed it can be safely removed in an outpatient surgical setting (once you have had one bout of appendicitis, the likelihood of recurrence is high)

Although this experience has certainly not been a pleasant one, it has been extremely educational. But, more importantly, it restored my faith in the medical profession–which has come under a lot of fire recently and reminded how committed and dedicated most healthcare professionals are when it comes to patient health and well being.

Until next time (I ought to be out by Sunday)….

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

Biogen/Idec Throws in the Towel

The Wall Street Journal reported late Wednesday that after weeks of exploring a possible sale to a larger pharmaceutical concern, Biogen Idec Inc. reported it had received no serious offers, prompting a 27% drop in the company's stock price.

In after-hours trading, Biogen's stock plunged $20.38 to $55.50, erasing $6 billion in market value. Before the announcement, the shares ended regular trading on the Nasdaq Stock Market at $75.88, up 49 cents according to the journal. Within a few minutes of the announcement, Biogen lost nine months of gains fueled mainly by buyout rumors. Acquisition candidates may have been dissuaded by Biogen's high stock price and market valuation -- its market value had grown to $25 billion after the company announced its intention to sell a couple of months ago.

In a previous post, I suggested that it would be unlikely that Biogen Idec would be able to induce a pharmaceutical suitor to take the “bait”. There simply was “too much hair” on the deal to warrant serious consideration by pharmaceutical suitors.

This will likely to be a serious and damaging blow to the Company. I am not sure what the future holds for Biogen Idec but I suspect it is not a bright one—whatever the outcome. Don’t be surprised if words like reorganization, strategic reallocation of resources or creative staffing solutions begin to appear in the media.  The company needs to sweeten the deal in order to get a real bite!

Until next time…

Good Luck and Good Job Hunting (try Biogen/Idec, all of the”smart” people are dusting off their resumes)!!!!!

More Pharma Job Cuts and Restructuring

According to Ed Silverman at Pharmalot the newly-formed executive steering committee at Sanofi-Aventis sent a letter to its R &D employees it will take care of implementing “strategic moves,” apportioning resources, overseeing overall management.

A Sanofi spokesman said “is a condensed structure, designed to facilitate quick decision making.” Yeah right–look for some corporate right sizing, allocation of strategic resources and job cuts at the French drug maker.

On another note, West Pharmaceutical Services, a Lionville, PA-based Company announced that it would shed 250 jobs or 13% of its work force as part of a restructuring program. A company spokesperson said it will reduce spending throughout the segment by consolidating two tool production operations into one facility, in Scottsdale, Ariz., and by reductions and consolidations at other production, engineering and administrative operations in North America.

Until next time….

Good Luck and Good Job Hunting!

Why is the US Congress Doing FDA's Job?

The US Food and Drug Administration (FDA), like other federal agencies during the Bush administration, has been hobbled by a lack of leadership and an agency-wide feeling of ennui. What do you expect from a federal agency that didn't did not have a Director for 5 out of 8 years since 2001? At present, the agency is in disarray, grossly ineffective and under siege.

Over the past 5 years or so, numerous product recalls and safety issues with newly-approved drugs have caused many medical professionals and the American public to lose faith in FDA. This is clearly evident by a willingness of the US Congress to step in and assume many of the regulatory activities and legal responsibilities granted to the agency in the Food, Drug and Cosmetic Act of 1938. For example, the New York Times reported today  that a Congressional committee is investigating Merck and Schering-Plough for their handling of a critical clinical trial of Zetia, their blockbuster cholesterol-lowering drug. The House Committee on Energy and Commerce demanded more information about delays in the trial, which was completed in April 2006 but whose results have not yet been released. Independent scientists have viewed the results of this study as crucial because it is the first trial that would answer whether Zetia’s ability to lower cholesterol has real biological benefits for patients. The results might also help answer nagging questions about Zetia’s safety.  I ask: "Why are their still nagging safety questions about a blockbuster drug that has been on the market since 2002? "

FDA’s mission is to insure that all approved drugs and medical devices are safe and effective for Americans. Overall, from a historical perspective, I think that the agency has accomplished its mission and done an outstanding job. It is only recently that things have begun to become undone and spin out of control. I believe that the time has come for FDA to “step up to the plate”  to right itself and get back on track. Personally, I would rather have medical and regulatory experts rather than politicians reviewing medical and scientific data to determine whether a drug is safe and efficacious. FDA may be broken but the damage is not irreversible. With a little determination, hard work and competent leadership the agency ought to be able to regain its former reputation as a preeminent regulatory agency.

Until next time….

Good Luck and Good Job Hunting (they are looking for a few good men and women)

Strike 2 for GlaxoSmithKline's Avandia

The New York Times reported today that an independent study that analyzed thousands of older people with diabetes found that those treated with the widely used drug Avandia had significantly elevated risks of heart attack and death.

According to the Times article, the finding, published on Tuesday, in this month’s Journal of the American Medical Association (JAMA), could rekindle the debate about whether Avandia, a controversial treatment for Type 2 Diabetes, should remain on the market. Earlier studies drew similar links between Avandia and cardiac risks.

The new study concludes that Avandia users had a 60 percent increased risk of heart failure, a 40 percent increased risk of heart attacks and a 30 percent increased risk of death compared with patients taking other oral diabetes medicines.

Sales of the drug, formerly a $3.4 billion product globally, have declined sharply since June 2007 when an article appears in the  questioning the drug's safety.

Not good news for GSK. The big question now is whether the company ought to cut its losses and take Avandia off the market or continue to squeeze as much money out of the product until lawsuits begin to accumulate.

Until next time…

Good Luck and Good Job Hunting (not at GSK)!!!!!!!!!!!

Job Cuts and Restructuring at Novartis

Ed Silverman at Pharmalot alerted me to this tidbit. Daniel Vasella, CEO of the Swiss drug maker Novartis AG, mentioned in an interview with The Wall Street Journal that he is planning a companywide restructuring aimed at reducing “layers of management and bureaucracy—following through on reorganization comments he made several months ago.

Novartis, plans to disclose more about its restructuring plans by mid-month and elaborate further in February, adding that the restructuring will involve some job cuts, but Vasella declined to say how many. In an October briefing for analysts, Novartis executives said there would be 240 jobs cut in US headquarter functions Hanover, NJ) and 510 sales reps and 510 contracted rep positions eliminated, for savings of $230 million.

Novartis is one of several big drugmakers to cutback - AstraZeneca, Pfizer, Bristol-Myers Squibb, Glaxo and Johnson & Johnson have all announced layoffs in the past year. And Merck and Wyeth continue to trim selectively as part of ongoing savings programs.

According to the Journal, the changes at Novartis will follow recent management changes and comes after a tough year for Novartis. The drugmaker, faced generic competition on some of its

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Guess What Isn't On the Projected Growth List!

If you are contemplating a career move, check out the new list from the Bureau of Labor Statistics that projects the fastest-growing  jobs from 2006 to 2016.

Forecast percentage growth from 2006 to 2016

Network/data analysts (53%)

Personal and home care aids (51%)

Home health aides (49%)

Software engineers (45%)

Veterinary technicians (41%)

Personal finance advisors (41%)

Theatrical makeup artists (40%)

Medical assistants (35%)

Veterinarians (35%)

Substance abuse and behavorial disorder counselors (34%)

A quick perusal of the list reveals that most of the jobs are service-oriented with perhaps the exception of software engineers and maybe veterinarians. We Americans do love our pets and who doesn’t like a good Broadways show or Hollywood film. Of course, it goes without saying that we have a need for many more personal finance advisors and, given all the stress associated with becoming rich, who can argue against an increased need for substance abuse and behavioral disorder counselors?  After looking at the list, do you think we should begin to worry a little about America’s loss of competitiveness in science and technology? 

 

Until next time….

 

Good Luck and Good Job Hunting (if there are any left by 2016)!!!!!!!

Uh Oh, Here We Go Again--US Falls Further Behind in Science Education

The US has fallen further behind in science education. According to a report in my local paper, “A recent test of 15-year-old students from around the world showed that U.S. students ranked 29th out of 57 countries when it comes to science literacy. Worse yet, the U.S. ranked below the international average score, according to the Organization for Economic Cooperation and Development. The international study, conducted every three years by the Programme for International Student Assessment, tested 400,000 15-year-olds on literacy in science, math and reading last year. This most recent study placed a special emphasis on science because, as the report stated, solving scientific problems in today's society is "more important than ever."

The students from Finland scored the highest in the study, followed by students from Hong Kong/China, Canada and Estonia. The poor performance by the United States should not be taken simply as more bad news. Instead, it should be used as a rallying point for educators and politicians to begin to develop and implement strategies to improve science and math education.

If the current trends are not reversed, American students may have difficulty competing in science with international students, the result of which will mean fewer jobs for Americans in science-related fields in the coming years and a long- term negative impact on the American economy.”

This is nothing new. Others and I have been talking about the lack of science preparedness in the US for the past decade. Unfortunately, when it comes to education nobody really pays attention except to pass numbskull educational initiatives like “No Child Left Behind.” Sure, why not spend hundreds of million on standardized testing so that we can assess the effectiveness of primary and secondary education in the US. And then, let’s pat ourselves on the back when test results indicate that students are passing the tests at higher rates each year. I am sure that the rest of the world is quite impressed!

Until next time…

Good Luck and Good Job Hunting (if we can compete)!!!!!!


Amgen Shares Take a Nose Dive

Shares of Amgen had their steepest decline in seven months on Friday after the company reported that it may have to revise the safety information for its largest product Aranesp. Amgen shares fell $3.05 or 5.3 percent to $52.10 in regular trading.

FDA has been scrutinizing prescribing information for all EPO-like drugs including Aranesp, Procrit, Epogen and others for the past eight months.  An FDA advisory panel will meet before the end of March 2008 to continue its review of prescribing information for this class of drugs.

Now may be a good time to buy some Amgen stock--the Company may be down but not out!!!

Until next time....

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

Merck's Quiet Buying and Deal-Making Spree

Let me say from the outset that I have always been a big Merck fan (not withstanding the Vioxx scandal). Many people who I went to graduate school with in the late 1970s at the University Of Wisconsin Department of Bacteriology wound up getting jobs at Merck (more than 15 at last count). It goes without saying that there is a world of difference between Madison (“yeah, baby”) and Rahway NJ but, nevertheless, there has been a long standing relationship between UW and Merck dating back to the 1960s– I guess good science begets good science! That said, Merck showed the world with the Vioxx debacle that even one the best and most respected pharmaceutical companies is fallible and can make mistakes when it loses sight of what earned it its reputation in the first place–good science and better drugs.

Merck is well on its way to recovery and it desperately wants to regain its former reputation as an innovative pharmaceutical company. Rather than attempt to accomplish this through internal organic growth, Merck has embarked on a global search to find innovation and then, either make a deal or simply buy it! Since 2004, Merck has done about 140 deals. Merck’ has continued this torrid pace and inked 53 or so deals in 2006 with various biotech and specialty pharmaceutical companies. The company plans to extend this deal-making spree into 2008 (as long as it continues to settle Vioxx court cases and its stock price remains high). Here is something of a “highlight film” of the acquisitions and deals that Merck closed in 2006.

Glycofi-New Hampshire, ($400 million); Merck acquired this innovative company founded by my colleague Tillman Gerngross (very smart guy) that developed a novel and unique humanized yeast platform to manufacture biopharmaceuticals.
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Another Feather in Fred's Hat

Schering-Plough Corporation was honored by Scrip World Pharmaceutical News last night with three top pharmaceutical industry awards: Large Pharma Company of the Year, Management Team of the Year, and Executive of the Year for Fred Hassan, Schering-Plough chairman and CEO.

I have to tip my hat to Mr. Hassan. He inherited a failing and dysfunctional company from former CEO  about 5 years ago. He certainly has turned things around at Schering Plough. So much so, that the company may soon regain its former reputation as a top-tier pharma company. Fred also turned things around after he arrived at Pharmacia (which was subsequently acquired by Pfizer).

I know several people who have worked with Fred as part of his executive team. They have nothing but positive and superlatives things to say about him. Mr. Hassan is truly one of the best CEOs in the pharmaceutical and biotechnology industries.

Until next time….

Good Luck and Good Job Hunting (try Schering Plough)!!!


Patent Expiry: Coming Soon to a Pharmaceutical Company Near You!

The Wall Street Journal Online published an insightful article today on the future of the pharmaceutical industry.  The article did not contain anything that we didn’t already know–pharma is in deep doo-doo. Starting in 2010, the pharmaceutical industry faces one of the biggest waves of patent expirations ever, affecting dozens of top-selling drugs.

The WSJ was kind enough to put together a great table showing the drugs that will be losing patent protection in the near future, their manufacturers, the clinical indications for which the drugs were approved and the size of the current market for each product.

Don’t you just love the resources that high impact newspapers have at their disposal? Check it out…..

Until next time….

Good Luck and Good Job Hunting (if you can find one)!!!!!!

As Expected: Thumbs Down for Genentech's Avastin

The NY Times reported today that a federal advisory committee voted that Genentech’s drug Avastin should not be approved as a treatment for metastatic breast cancer.

By a 5-4 vote, the committee decided that Avastin’s ability to delay the worsening of cancer did not outweigh the drug’s toxic side effects, especially since women getting Avastin did not live significantly longer in the end. Although the committee recommended against approval for Avastin, FDA has the final word. That said, FDA usually follows the recommendations of its external advisory panels.

FDA’s staff reviewers had been critical of the drug in an analysis released on Monday. Nevertheless, many Wall Street analysts thought the committee, made up mainly of cancer experts and physicians, would vote in favor of approval.

Analysts were expecting an approval in breast cancer to add $1 billion or more to annual sales of Avastin. Genentech’s stock price has been steadily declining for the last two years because its once explosive growth appears to be slowing.

Avastin is already one of the world’s best-selling cancer drugs, with United States sales alone of $1.7 billion in the first nine months of 2007.

Until next time....

Good Luck and Good Job Hunting

Bristol-Myers Squibb Sheds 4,300 Jobs and Closes Several Manufacturing Facilities

According to posts by my colleague Ed Silverman over at Pharmalot, BMS announced today that it would cut 4,300 employees or approximately 10% of its workforce by 2010 in an effort to control costs and keep its stock afloat. The company also announced that it was selling its Medical Imaging business and would considering selling its Convatec (medical devices) and Mead Johnson (consumer products) divisions to a buyer(s) for the right price. In addition, the drug maker announced plans to close plants in Puerto Rico and Panama. The Park Avenue headquarters in New York will also shrink as fewer floors will be occupied. Finally, BMS wants to reduce the number of brands in its portfolio by 60 percent between 2007 and 2011 and reduce the number of manufacturing plants by more than half by the end of 2010. These moves are expected to save the company approximately $1.5 billion.

BMS has long been considered a takeover target. However, with Plavix losing patent protection in a few years and Erbitux losing ground in the anti-cancer market there may not be enough left for an acquisition or merger. Only time will tell.

What a mess ex-CEO Peter Dolan created for the company. So it goes….

Until next time…

Good Luck and Good Job Hunting (not in New Jersey)!!!!

The Nose Knows-Antibiotic Treatment May Not Help Sinus Infections

Sinus infections are diagnosed in about 31 million Americans each year and are among the most common reasons for doctor visits. The infections affect the air spaces (sinuses) around the nose and in the lower forehead. Inflammation and excess mucous can cause nose congestion, headaches and eye and face pain. Causes include bacteria, viruses, fungal infections and allergies.

A study published in the December issue of the Journal of the American Medical Association (JAMA) showed that patients with sinus infections treated with antibiotics did not get better more quickly than those treated with placebo, And, that most sinus infections would resolve themselves over time without treatment. The lack of effectiveness of antibiotic treatment could be explained by the inability of many antibiotics to reach the site of infection in the sinuses. Also, it is important to point out, that antibiotic treatment is ONLY EFFECTIVE when treating bacterial infections; not those caused by viruses or fungi. To that end, infectious disease experts issued guidelines in 2001 advising against using antibiotics for most sinus infections in otherwise healthy people, blaming overuse for contributing to the growing problem of antibiotic resistance.

Critics of the study questioned whether all the patients in the study had true bacterial sinus infections. Although patients were recruited to the study by family doctors, the results were based on patients' self-reported symptoms rather than medical exams that confirmed actual cases of sinus infections. So it goes….

BTW, recent studies suggest that yellowish or greenish mucous doesn't always mean the infections are bacterial–another urban legend bites the dust.

Until next time….

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

Oops....Merck Fails to Meet Wall Street Expectations

The New York Times reports today that Merck’s profit forecasts for this year and next fell a penny short of Wall Street expectations sending its shares lower. Ah, what a difference a penny can make!

The company’s stock price has risen, trading in recent days near its 52-week high of $60.49 after it announced less than one month ago it would pay $4.85 billion to settle tens of thousands of lawsuits stemming from its painkiller Vioxx, which it withdrew from the market in 2004.

Merck said that while it expected higher sales of its cervical cancer-fighting vaccine Gardasil, its diabetes treatment Januvia and its allergy treatment Singulair next year, generic competition would drive down sales of another top seller, Fosamax, an osteoporosis treatment.

Aside from Vioxx debacle, Merck has been on somewhat of a roll for the past three years. It was able to bolster its stock price during this time by instituting a cost-cutting plan that included draconian-like job cuts in 2005. Merck, which has already cut about 6,000 jobs under the plan, said yesterday that it would reach its target of eliminating 7,000 positions by the end of 2008.

This coupled with the recent layoffs at Bristol-Myers Squibb, Novartis, Johnson and Johnson suggest that now is not a good time to be looking for pharmaceutical or biotechnology jobs in New Jersey.

Until next time….

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

"A Spoonful of HONEY(?) Makes the Medicine Go Down...."

Forget about the medicine….just take the honey. A study published in the December issue of Archives and Pediatrics and Adolescent Medicine found that a teaspoon of honey before bed seems to calm children’s cough and makes them sleep better.

For the study, researchers recruited 105 children with upper respiratory infections from a clinic in Pennsylvania. Parents were given a paper bag with a dosing device inside. Some were empty. Some contained an age-appropriate dose of honey-flavored cough medicine containing the cough suppressant dextromethorphan. And some contained a similar dose of honey.

The parents were asked about their children's sleep and cough symptoms, once before the bedtime treatment and once after. They rated the symptoms on a seven-point scale.
All of the children got better, but honey consistently scored best in parents' rating of their children's cough symptoms. “Honey may work by coating and soothing an irritated throat” the study authors said. For those of you who don’t know, honey is an amazing substance that is very nutritious and possesses anti-bacterial properties (I took a bee keeping course as an undergraduate at Cornell—bees are way cool).

This is good news for parents because federal health advisers have recently warned that over-the-counter cough and cold medicines should not be used in children under 6 and several pharmaceutical companies are taking some products for young children off the market. However, honey SHOULD NOT be given to children under age 1 because of a rare but serious risk of infant botulism.

So grandma was right after all…

Until next time…

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

A Chink in Genentech's Armor

All good things must come to an end. Yesterday, FDA regulatory reviewers suggested that Avastin, Genentech’s anti-cancer drug, may not be an effective treatment for breast cancer. FDA reviewers determined that Avastin did not help women with breast cancer live significantly longer, and it caused serious side effects, including a few deaths.

An advisory committee to the F.D.A. will meet tomorrow to discuss whether Avastin, already a blockbuster drug for colon and lung cancer, will win an additional approval for breast cancer. The drug had $1.7 billion in United States sales in the first nine months of 2007.

It is unlikely that the advisory panel (composed of practicing physicians, other healthcare professionals and community advocates) will recommend approval of Avastin given the analysis provided by agency reviewers. That said, stranger things have happened at FDA over the past 9 years or so! My sources at FDA tell me that agency reviewers recommended against approval for Vioxx (Merck’s Cox-2 inhibitor that was subsequently withdrawn from the market) but the recommendation was not heeded by agency administrators.

The analysis by the agency’s staff appeared to dim the prospects that Avastin would win an approval as a treatment for breast cancer. Genentech’s stock fell $2.75, or 3.6 percent, yesterday, closing at $73.50.

Until next time....

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

Are Biotech Drugs ALWAYS Better?

The buzz and promise of biotechnology is the likely cause of the buying frenzy that big pharma has been on lately. Word on the street is that biotechnology products are innovative, have a higher return on investment (ROI) and are generally perceived to be “better” than conventional small molecule drugs. I agree that biotechnology products are certainly innovative and the gargantuan ROIs are titillating. But, are biotechnology products always safer and more efficacious than extant small molecule drugs? According to a recent study–maybe not!

A study conducted at the Agency for Healthcare Research and Quality in the UK evaluated the effectiveness of 11 different drugs to treat rheumatoid arthritis (RA). They analyzed the results of clinical trials that enrolled at least 100 subjects that were conducted between 1980 and 2007. After analyzing 101 studies (50% of which were conducted by or on behalf of drug companies) they were unable to detect a significant difference in efficacy or safety of small molecule and biotechnology medications that are used to treat RA. The drugs that were analyzed included conventional corticosteroids, synthetic disease modifying anti-rheumatic drugs (DMARDS) such as hydroxychloroquine, leflunomide, methotrexate and sulfasalazine and a variety of biotechnology products including Orencia® (abatacept, Bristol Myers Squibb) Humira® (adalimumab, Abbott Laboratories) Kineret® (anakinra, Amgen), Enbrel® (etanercept), Remicade® (infliximab, Johnson & Johnson) and Rituxan® (rituximab, Genentech).

As is the case with all medications, there are substantial patient-to-patient variations in efficacy and side effect profiles and one drug may work better for patient than another– whether it is a protein-based biotechnology product or a small molecule drug. Generally speaking, biotechnology drugs focus on novel targets and may have unique mechanisms of action. That said it is not prudent to assume that new biotechnology drugs are inherently better than pre-existing small molecule treatments. The jury should remain out on any drug, biotechnology or otherwise, Phase IV clinical trials and exhaustive post marketing data are collected, analyzed and evaluated.

Until next time….