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The Pharmalot Blog reported today that Schering Plough will eliminate 1,000sales jobs or 20% of its sales force by October. This latest round of layoffs is part of a reorganization plan that was announced last year to cut 10% of it workforce by 2012 (although must of the downsizing will occur by 2010). The reorganization was announced shortly after Schering purchased Organon Biosciences and the “wheels came off” of its Zetia/Vytorin anti-cholesterol medication franchise.

In other news, BioJobBlog heard through the grapevine that Merck has been quietly laying off workers (since Labor Day) in an attempt to reduce its workforce by 20% over the next few years. Many very talented people who have been with Merck for years are looking for new jobs.

Finally, Montvale, NJ-based Memory Pharmaceuticals announced that it was laying off 55 workers or roughly 50% of its workforce. The company, which went public in a much heralded IPO in 2004, focuses on developing treatments for cognitive disorders. Although the company has never been profitable, the person who ran the company for the past three years (first as president, then CEO and finally CFO) earned $876,807 last year. Not surprisingly, he will be leaving the company as part of the downsizing initiative.

The ongoing pharma slowdown coupled with this week’s Wall Street meltdown (many people who work on Wall Street live in New Jersey) should make New Jersey a very challenging and interesting place to live in the coming months.

Hat tip to Ed at Pharmalot.

Until next time….

 

Good Luck and Good Job Hunting (I would avoid NJ)!!!!!!

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Despite an increase in profits, BMS announced today that it will continue with its Productivity Transformation Initiative (PTI) that was instituted last fall. According to the PTI, BMS must save $1.0 billion over the next 2 years. Of course, the only way to accomplish this is by laying off employees whose jobs are not directly related to the process of transforming BMS into a “ next generation biopharma company” (Would somebody please write me and explain what that means)???? I suspect that BMS employees will be receiving “pink slips” after Labor Day.

This has been a devastating week for the NJ-based pharmaceutical industry. First, Teva announced last week that it will buy Montvale NJ-based Barr Pharmaceuticals and then earlier this week Roche issued a press release indicating that it will move its corporate headquarters from Nutley NJ to South San Francisco (Genentech’s headquarters) by 2010. The impending layoffs at BMS coupled with job freezes and downsizing at other NJ pharma companies like Schering Plough and Merck may signal the beginning of the end of New Jersey’s status as the “nation’s medicine chest.”

Until next time….

Good Luck and Good Job Hunting (forget New Jersey)!

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It’s summertime during a recession. What better time is there to give employees an extended vacation by announcing job cuts at the start of summer?  

Generic manufacturer Mylan announced that it is cutting jobs at a pharmaceutical manufacturing plant in central Puerto Rico. According to a company spokesperson, 100 jobs will be eliminated in coming weeks. Mylan had announced in February that it would be eliminating jobs at five locations as part of a companywide restructuring. The Pittsburg, PA-based company is the latest pharmaceutical company to announce cuts in Puerto Rico. The industry has eliminated more than 3,000 jobs here since mid-2006.

In other news, Palo Alto, CA-based Jazz Pharmaceuticals Inc. said Wednesday it plans to cut 8 percent of its work force -- or 33 employees -- primarily in research and development and administrative areas, and delay development of two drugs.

Finally, according to Ed Silverman over at Pharmalot, New Jersey-based Schering Plough has begun the massive layoffs it announced last April. As you may recall, CEO Fred Hassan still reeling from the Vytorin and Zetia flap, assured analysts and shareholders that he can right the ship by laying off about 5,500 employees or 10% of Schering’s workforce. He vowed to “consolidate management; use more shared staff support and services; reduce travel; cut sales and marketing; slash R&D; consolidate product lines, particularly in the animal health unit; and close some of the 60 manufacturing plants.” The previously announced job cuts are in addition to the 400 jobs that were eliminated after Schering Plough acquired Organon Biosciences.

Unfortunately, I guess it is going to be a long, hot, summer for the folks who lost their jobs.

Until next time….

Good Luck and Try to Hold On To Your Job (if you have one)

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It looks as though Enzon Pharmaceuticals, the first company to successfully commercialize protein PEGylation, finally buckled under the pressure exerted by Carl Icahn, one of its major shareholders.  As I mentioned in a previous post, Carl recently started buying large blocks of Enzon stock to gain a controlling interest in the company to maximize shareholder value. To accommodate Icahn’s "vision" and demands, Jeff Buchalter, Enzon’s Chairman and CEO has decided to spin out a new biotechnology company.  According to an Enzon press release, the new company (to be named later) will get Enzon’s core technology (PEGylation) and its entire preclinical pipeline (i.e.; their RNA antagonist oncology portfolio). Enzon will also invest $150m in the new venture.

So, what does Enzon get out of the deal? It retains ownership of a small, aging manufacturing facility and a portfolio of nominally-performing specialty pharma drugs. I think comments made by Eben Tessari, a financial analyst who follows Enzon, sums up of the essence of the proposed spin out.  He writes: “Maybe I’m way off here but it seems to me in analyzing this deal that the new company gets all the goodies while Enzon is left with a manufacturing plant and a stable of marginal drugs (zero out of four therapies have over $50m a year in revenue). Now, I don’t mean to imply that I think Enzon is a bad company - hell, they’ve managed to make more profit this quarter than any pharma company I’ve ever worked for - I’m just saying they are selling their future based on the advice of a man notorious for breaking up companies and wringing every last dime out of a shakeup.”

Not surprisingly, Jeff Buchalter, the brains behind the deal, thinks it will provide Enzon shareholders with the value that they demand. “By separating these unique businesses into two focused companies, the opportunities for both the specialty pharmaceutical business and the biotechnology business could be substantially enhanced and greater value could be created than under the current structure. Operating separately will allow each company to benefit from greater strategic and managerial focus and appeal to their own unique shareholders. The separation will enable the two businesses to compete more effectively in their respective markets and optimize their business goals, research initiatives and capital requirements. We look forward to creating this opportunity for the shareholders,” said Buchalter.

Jeff, who learned how to turn around failing companies from his former boss Fred Hassan (turn around specialist and current CEO of Schering Plough) ought to know a little something about value. According to SEC filings, last year Jeff made $773,558 (base salary) with $1,162,500 in bonuses for a total cash compensation of about $2 million. In addition, Jeff received just over $3.1 million in equity bringing his total 2007 compensation package to approximately $5.2 million —almost 3 times the amount received by any other Enzon executive.  Not that there is anything wrong with that!!!!!!!!!!!!

Until next time….

Good Luck and Good Job Hunting (try Enzon’s spin out, they are flush with cash)!!!!!!

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It seems like nothing is going right for Merck these days. On Monday, the US Food and Drug Administration (FDA) issued a “not approvable”–aka a rejection letter–for Merck’s new cholesterol drug called Cordaptive or MK-0524A. The highly-touted drug, which Merck executives hoped would replace Merck’s blockbuster cholesterol drug, Zocor (which lost patent protection a couple of years ago), can both lower LDL (bad) and raise HDL (good) cholesterol. Although experts believe that these properties should benefit people with high cholesterol, the results from recent clinical trials suggest that drugs that raise LDL and lower HDL cholesterol may have safety problems.

Cordaptive consists of an extended-release form of niacin (a B vitamin) and another agent that inhibits a niacin side effect called flushing — redness, burning and tingling of the face. Niacin has been used to control cholesterol for decades. Abbott Laboratories already sells an extended-release form of niacin called Niaspan.

Despite positive results from recent clinical trials and pending approval by the European Union, the agency rejected Merck’s NDA. Regulators also rejected Cordaptive as a brand name. It is likely that FDA is scrutinizing and proceeding cautiously with new cholesterol medications because of the recent flap over Zetia and Vytorin (which are co-marketed and sold by Merck and Schering Plough). As you may recall, both companies have been accused of trying to protect sales of the two drugs by delaying results of a study that showed Vytorin worked no better than Zocor, which is much cheaper.  Merck’s stock price dropped about 5% yesterday after the company announced that it received a not approvable letter from FDA.

Although MK-0524A may ultimately reach the US market, I wouldn’t count on it anytime soon. Merck has seriously tarnished its reputation with FDA because of the Vioxx, Vytorin and Singular controversies. The old adage, “You reap what you sow” is particularly apt in this instance. Look for more “asset reallocation” moves in Rahway.

Until next time…

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

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There has been some confusion surrounding the reporting of results from the Enhance Trial. As you know, the results from this study showed that the cholesterol-lowering drug Vytorin—a combination of Zetia and Zocor (a statin) —was no better than a generic version of Zocor by itself at controlling atherosclerosis.

In the Enhance clinical trial, 720 patients were treated with Vytorin or a generic version of Zocor and the amount of plaque that accumulated in the arteries of both groups was assessed by blood vessel imaging. Because Vytorin lowers LDL-cholesterol more than Zocor alone, both Schering –Plough and Merck (the companies that sponsored the trial) expected the patients who took Vytorin to have less growth of plaque in their arteries than those who took generic Zocor alone. As we all now know, this was not the case. In fact, there are some data which suggests that Vytorin treatment may actually enhance or promote plaque deposition and growth.

Since arterial plaque is closely associated with heart attack and stroke, the results from the Enhance trial led some to suggest that Vytorin doesn’t work any better than Zocor at preventing heart attack or stroke. While this may prove to be the case, there are currently no data to substantiate or refute this assertion. Those data will be generated in planned outcome trials that will measure the incidence of heart attack and stroke in patients taking Vytorin or Zocor. Merck and Schering-Plough began enrolling patients for these studies in 2006 and don’t expect any results before 2012. This may be too little, too late.

Merck and Schering have come under fire for not releasing the results from the Enhance trial in a timely fashion. A Congressional committee investigating the Vytorin controversy alleges that Merck and Schering Plough executives knew about the results of the Enhance studies at least two years before they released the data. The companies repeatedly delayed releasing the results of the trial, however, saying publicly that many of the images of the arteries were unclear and might need to be re-examined. Both companies have also have been criticized for delaying the initiation of the planned outcomes trials.

Shares of Merck and Schering-Plough plummeted yesterday following Sunday’s announcement at the American College of Cardiology meeting in Chicago.

Until next time….

Good Luck and Good Job Hunting (avoid NJ)!!!!!!!!!

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

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

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

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

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

Until next time….

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

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Oh, what a difference a couple of years or results from a pivotal clinical trial can have on a company’s financial outlook. As you may recall in 2005, Merck was in a shambles after the Vioxx scandal broke. Its CEO was ousted, its stock was trading at less than $35 per share and employee morale was at an all time low. After two short years, Richard Clark, a life-long Merck employee, was able to turn the company around. Merck’s stock reached a high of almost $61 last December and many of its employees were dancing in the streets of Rahway because their stock options were now worth more than the paper that they were printed on. But, like many things in life, all good things must come to an end.

Since December Merck’s stock price has plummeted to $40 and appears to be headed downward. What sparked the retreat was the release of results from the now infamous ENHANCE clinical trial which showed that Vytorin, which is co-marketed by Merck and Schering Plough, offered no greater benefit than a cheaper, generic version of Zocor (one of the two active ingredients of Vytorin) to reduce the risk of heart attack and stroke. The fallout from this revelation has been intense and dramatic. Both Merck and Schering Plough are being investigated by Congress for marketing violations and the financial maneuvers’ of several senior executives from both companies are under intense scrutiny. 

Many industry analysts believe that Merck may be on the ropes again and are afraid that the company may slip back into the morass it found itself in after the Vioxx debacle.

I have always held Merck in high regard–no fewer than 15 people who I went to graduate school have worked at Merck at one time or another. Further, the Merck name used to be synonymous with “second to none” science and outstanding pharmaceutical products. Sadly, over the past decade Merck’s leadership has consistently placed profits before good science causing the American public to lose confidence in one of its flagship pharmaceutical companies. Maybe Dick Clark, who was around during Merck’s glory days, can restore Merck’s reputation by insisting that from now on, good science will always come before corporate profits. Time will tell….

Until next time….

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

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Merck and Schering Plough have taken out two-page ads in several major newspapers defending their cholesterol drugs Zetia and Vytorin whose efficacy has been seriously questioned following release of data from a clinical study called ENHANCE late last week. The new ad campaign takes direct aim at the fallout from ENHANCE which showed that neither Zetia nor Vytorin (Zetia plus Zocor) is more effective in preventing heart attack or stroke than a cheaper generic version of Zocor alone.

The ad offsets the most important line in boldface: "All of us at Merck and Schering-Plough proudly stand behind the established efficacy and safety profiles of ZETIA and VYTORIN." And then it's "signed" by Robert J. Spiegel MD, Chief Medical Officer of Schering and Merck’s VP of External Medical and Scientific Affairs, Richard Murray MD. However, this advertising blitz may be too little, too late. Consumer and physician confidence in Merck and Schering Plough have fallen precipitously after the ENHANCE data were released last week.

According to various sources, the companies reportedly spent more than $100 million on a highly visible, slick marketing campaign to promote Vytorin and Zetia last year. Who doesn’t recognize the ubiquitous commercials with the folksy violin music and the "colorful" relatives dressed to look like food to accentuate the point that cholesterol levels are related to family history (genetics) and the foods that one consume. They have taken a new tact with today’s ads which showcase a matter-of-fact advertising approach. We'll see if it the new, less flamboyant advertising campaign can staunch the hemorrhaging that it taking place today at both companies.

Until next time…

Good Luck and Good Job Hunting!!!!!

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I want to thank for his intrepid reporting on the Vytorin scandal and keeping BioJobBlog abreast of all late-breaking news and rumors that are flying about. 

In today’s post Ed reports that  “…..the House Energy and Commerce Committee wants to know more about the so-called independent panel formed to review the Vytorin trial data, the study’s Data Safety Monitoring Board, stock sales by Schering-Plough execs and the amount of money spent on Vytorin by the Centers for Medicare and Medicaid Services (CMS), given the Enhance trial results showed the drug wasn’t more effective than cheap generic versions of Zocor, which is part of the Vytorin combo therapy.

The congressmen leading the probe - John Dingell and Bart Stupak, both Democrats from Michigan - sent separate letters today seeking all sorts of info from CMS and Schering-Plough. Already, they’re looking at whether Merck and Schering-Plough concealed or manipulated clinical trial data, given that the release of the Vytorin data was delayed nearly two years and the primary endpoint was briefly changed without the consent of the lead investigator. The probe is also focusing on the heavy advertising for Vytorin.

The Vytorin scandal coupled with the Vioxx debacle has done little to instill any consumer confidence in the pharmaceutical industry or the US Food and Drug Administration. Industry’s growing involvement in the drug regulatory approval process coupled with the Bush Administration’s intentional destabilization of FDA has resulted in the recent approval of drugs with dubious therapeutic efficacy and questionable safety profiles. 

Pharma has made it abundantly clear that profits are more important than patients’ health or safety. It is time for the Congress and the American people to stuff the corporate genie and its unbridled avarice back in the bottle!

Until next time….

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

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Fred Hassan joined Schering Plough as its CEO five years ago. At that time, Mr. Hassan inherited a company that was being investigated by FDA for regulatory compliance violations and the SEC was investigating it former CEO for investing and accounting irregularities. Since his arrival at the company, Mr. Hassan increased sales of key products, filled an empty product pipeline and returned profitability to a company that posted losses in 2003 and 2004.  

Much of his success can be attributed to Zetia and Vytorin, cholesterol-lowering drugs Schering Plough sells jointly with Merck & Co. Zetia lowers blood cholesterol levels by preventing absorption of dietary cholesterol from the gut. Vytorin is a combination product that contains Zetia and Merck’s statin drug called Zocor. Statins help to reduce blood cholesterol by inhibiting its production in the liver. Sales of both drugs have doubled to $5 billion a year since 2005. But that rich revenue stream is at risk following this week's disclosure that results from a large scale clinical trial called ENHANCE (which was initiated in 2002) showed that Vytorin did not reduce the incidence of atherosclerosis or lower the risk of heart attacks or strokes.

Schering and Merck said Monday that results of the now-controversial ENHANCE study showed that Vytorin failed to slow progression of heart disease more effectively than simvastatin generic form of Zocor that is sold at a far lower price. After learning about the results of the study, Dr. Steven E. Nissen, chairman of cardiovascular medicine at the Cleveland Clinic  quipped "Here we are, six years after this drug was marketed and promoted with a massive marketing campaign and has become a $5 billion drug" without evidence that it works as well as a statin. Now, "the first trial we have, is reported much too late and doesn't show really any evidence of benefit."

As reported in the Wall Street Journal “The impact of the finding was amplified by a long delay in releasing the results, and the revelation in November that the researchers considered altering the study's primary goals -- widely considered a violation of scientific protocol. The developments exposed the companies to suspicions -- which they have denied -- that they had postponed announcing the results because they were unfavorable. Also, the results of the Enhance trial were announced at a press conference rather than published in a peer reviewed scientific journal.”

“The missteps are likely to dent the companies' finances and reputation. Congress is investigating whether the companies improperly deferred publicizing the results, and yesterday lawmakers expressed concern about Vytorin ads. In addition, prominent medical professionals have questioned the drug's benefits.”

The fallout from ENHANCE is having other negative effects and possible long term consequences at Schering Plough. Yesterday, for example, widely circulated reports questioned the timing of stock trades made by the president of Schering's pharmaceutical division, Carrie Cox, in April and May 2007 that totaled about $28 million. Also, yesterday, leaders of the House Energy and Commerce Committee widened their investigation of the Enhance trial disclosure to include Ms. Cox’s stock sale and the high-profile Vytorin "food and family" ad campaign (the ones where people are dressed to resemble the food that they can eat while taking Vytorin).

Investor unrest is focused less on Merck than on Schering, whose bottom line relies much more on the drugs than Merck's does. Analysts estimate that Vytorin and Zetia account for more than half of Schering's earnings. Other analysts estimate the figure is closer to 60% for 2007, compared with about 15% in 2007 for Merck.

The big question that still remains is: If Vytorin has no greater benefit than a statin, why did FDA approve it? The drug was approved by the Food and Drug Administration based on its ability to reduce low density lipoprotein cholesterol (LDL). As is the case with many drugs the agency didn't demand proof that using the drug actually reduced the risk of heart attacks or stroke. Instead, they relied solely on surrogate markers like LDL cholesterol levels.

The Enhance results are now part of a larger debate over what kind of evidence the FDA should require before approving a drug. Drug manufacturers argue that studies that answer questions about heart attacks, strokes and mortality can take many years, thousands of patients, cost millions of dollars and would lead to prolonged delays getting a drug to market. Consequently, drug companies should be allowed to use surrogate markers to prove drug efficacy. Using this logic, it appears perfectly reasonable for drug manufacturers to bring expensive, new drugs to market (to increase profits and bolster their stock prices) despite the fact that they offer no greater health benefits than cheaper generic versions of similar drugs! According to FDA regulations, drugs will be approved only when available evidence indicates that they are SAFE and EFFICACIOUS —not one or the other!

Until next time…

Good Luck and Good Job Hunting (I would avoid New Jersey for now)!!!!!!!!!

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There are currently two injectable products on the market that are used to treat chronic Hepatitis C infections. Both products, PEG-INTRON (Schering Plough) and Pegasys (Roche) are PEGylated versions of the cytokine interferon-alpha that are used in combination with ribavarin (an orally-delivered small molecule drug) to treat patients infected with Hepatitis C virus.  

PEG-INTRON (peginterferon alpha-2b) was co-developed by Schering Plough and Enzon in the early 1990s and brought to market in 2000. Pegasys (peginterferon alpha-2a) , which use a different chemistry to attach PEG to interferon-alpha, was approved in early 2002 and quickly supplanted PEG-INTRON as a treatment of choice for Hepatitis C infections. Pegasys also gained approval in 2005 to treat chronic Hepatitis B infections.

The knock on PEG-INTRON was that it appeared to lose potency in liquid form (a claim that has always been denied by Schering and Enzon). Nevertheless, PEG-INTRON was supplied to patients as a sterile powder which had to be reconstituted prior to injection. In contrast, Pegasys was supplied in liquid form in pre-filled self injection pens to infected patients. This was possible because the PEG chemistry used to create Pegasys was found to be extremely stable (as compared with PEG-Intron?) in liquid form. Although there appeared to be no real differences in efficacy between PEG-INTRON and Pegasys to treat Hepatitis C infections, patients tended to prefer Pegasys over PEG-INTRON because it was easier and more convenient to use.

Schering Plough has been struggling for the past 5 years or so to recapture the market share that it lost following Pegasys’ introduction in late 2002. To that end, in 2003 the company received FDA approval for a pre-filled injection pen to administer PEG-INTRON. Further, to dispel any rumors regarding PEG-Intron’s efficacy relative to Pegasys, Schering decided to conduct two large head-to-head clinical studies that compared PEG-Intron or Pegasys in combination with ribavarin as treatments for Hepatitis C patients. Today, Schering-Plough announced the results of the first of these two large scale clinical studies called IDEAL. The results from the IDEAL study showed that PEG-Intron was just as effective as Pegasys for treating patients with Hepatitis C. Further, it appeared that fewer patients taking PEG-INTRON relapsed after treatment.

It is not clear whether Schering will win the war but the company certainly appears to have won this most recent skirmish!

Until next time…

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

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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

So what do Merck and Schering Plough have to say about the results of the unpublished safety trials? According to the New York Times, Dr. Robert J. Spiegel, Schering Plough’s Chief Medical Officer said “The companies had not considered the studies scientifically significant enough to publish their findings. Some may eventually be published.” Similar statements were made by Merck executives about Vioxx’s safety after they pulled it from the market! Not surprisingly, most of the safety studies that were published by Merck and Schering Plough generally played down the liver problems associated with Zetia and statin combination therapy.

Although many physicians still think that Zetia is safe, I believe that the failure of Merck and Schering Plough to promptly and openly disclose all research about the drug may be leaving the American public with a misleadingly favorable view of Zetia’s safety and efficacy (sort of like Vioxx). For the past 8 years or so, FDA has been slow in issuing safety warnings and demanding label changes for many widely used drugs like Merck’s pain killer Vioxx, GSK’s diabetes medication Avandia and Lilly’s anti psychotic drug Zyprexa that have turned out to carry serious safety risks. I think that it is time for FDA to “step up to the plate” and do its job—provide Americans with SAFE and efficacious medicines. Also, I hope that pharmaceutical companies are beginning to realize that they must be more forthcoming about the safety of their products if they want Americans to use them. Finally, and perhaps most importantly, drug company profits should never come at the expense of patient safety—NEVER!

Until next time….

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

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Pfizer said on Tuesday it will eliminate another 40 workers from factories in Puerto Rico. Pfizer closed a plant in Arecibo, Puerto Rico in 2005 and last year announced 210 layoffs in the U.S. Caribbean island territory

As pointed out by Ed Silverman over at Pharmalot, Puerto Rico has long been a manufacturing hub for US pharmaceutical companies. Over the past 30 years, pharmaceutical manufacturing has accounted for a quarter of the island’s gross domestic product and currently employs about 20,000 Puerto Rican citizens.

Over the past few years, companies like Watson Pharmaceuticals (generics), GlaxoSmithKline, Teva (generics), Bristol Myers Squibb and Schering Plough have either closed or will close manufacturing facilities on the Island. These closings were somewhat surprising because the Puerto Rican workforce is one of the best pharmaceutical manufacturing workforces in the world. That said, US pharmaceutical companies are looking elsewhere to produce their drugs because of rising wages, changing tax structures and the high cost of electricity (supplied by oil-fired power plants) on the island. Further, over the past decade, there have been ongoing compliance and quality assurance problems at many of the shuttered manufacturing facilities. Officials from these companies explained that it was less costly to shut down and move operations elsewhere rather than modernize the plants and bring them into regulatory compliance.

Despite these recent facility closings, the island’s pharmaceutical manufacturing industry still produces 13 of 20 best selling drugs in the US. However that number will likely continue to dwindle over the next few years. Many companies that have closed or are considering closing production facilities are moving operations to Asian destinations like Singapore, China, Thailand (and even Vietnam) where there are trained workforces, lower wages and cost structures and many people speak English.

Unlike most pharmaceutical companies, Amgen, Abbot and Lilly recently built or relocated biomanufacturing operations to Puerto Rico. Because of a trained workforce and Puerto Rico’s ongoing familiarity with FDA regulatory requirements, I suspect that other biotechnology and specialty pharmaceutical companies will consider establishing biomanufacturing facilities in Puerto Rico– pharma’s loss may well be biotech’s gain!!!!

Until next time….

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

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