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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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As I mentioned in previous posts, things are simply not going Merck’s way. Merck has been battered in the past several months by the Singular flap, precipitous drops in Vytorin and Zetia sales and, most recently, FDA’s rejection of its follow-up Cordaptive anti-cholesterol drug. This has left the drug maker with little choice but to cut an additional 1,200 jobs from its rapidly shrinking US sales force.

The cuts, announced yesterday, are in addition to a companywide reorganization that began in 2005 which resulted in the elimination of approximately 8,100 positions. As of last December, Merck had 59,800 employees worldwide—soon to be 58,600 give or take a few employees!

Until next time….

Good Luck and Good Job Hunting???????

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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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Unraveling the Cholesterol Conundrum

By now, I am sure that everyone is sick of hearing about Zetia, Vytorin, cholesterol levels and heart disease. Whether you like it or not, results from the now infamous Enhance study have certainly caused many scientists and physicians to rethink the relationship between cholesterol levels and heart disease and stroke. Conventional wisdom (and current medical dogma) holds that low LDL cholesterol levels reduce the risk and incidence of heart disease and stroke. This belief is now so widespread and entrenched in that the medical community that FDA now approves drugs to prevent heart disease, as it did with Zetia and Vytorin, solely on the evidence that they lower LDL cholesterol levels. Unfortunately, Enhance study results indicate that lowering LDL cholesterol levels alone are not sufficient to reduce the incidence of heart disease or stroke. 

Zetia, one of the active ingredients of Vytorin, lowers blood LDL cholesterol levels by reducing absorption of cholesterol in the gut (from foods that we eat). In contrast, the other ingredient in Vytorin, Zocor, is a statin that acts to lower LDL cholesterol by interfering with its production in the body. The results of the Enhance study, which showed that Vytorin doesn’t reduce the risk of heart disease or stroke any better than Zocor itself, suggest that the only way to prevent heart disease and stroke (by lowering LDL cholesterol) is through statin use. This assertion is supported by results from clinical trials involving Lipitor and Zocor (both statins), which showed that lowering LDL cholesterol also resulted in a lower incidence of heart disease and stroke. This suggests that statins may act to reduce heart disease and stroke by mechanisms other than their LDL cholesterol-lowering properties. Indeed, statins have also been found to reduce inflammation, keep artery walls flexible and healthy and help to maintain LDL and HDL cholesterol balance in the blood.

There were hints along the way which suggested that the relationship between LDL cholesterol and heart disease and stroke were not as straightforward as it seemed. For example, torcetrapib, a Pfizer drug that lowers LDL and raises HDL cholesterol, was being evaluated in clinical studies that were subsequently halted because it increased the risks of heart attack and stroke rather than prevent them. Another example is estrogen replacement therapy which is known to lower LDL cholesterol levels but failed to reduce the incidence of heart attack and stroke in clinical studies. Nevertheless, it did not take much to convince FDA that lowering LDL cholesterol levels alone was sufficient to prevent or reduce the incidence heart disease a stroke. This notion was strongly substantiated by results from clinical studies with Lipitor and Zocor which showed a strong relationship between lowering LDL cholesterol and reducing the risk and incidence of heart disease and stroke. Unfortunately, it now appears likely that the ability of statin drugs to reduce the incidence of heart disease and stroke is related to other mechanisms besides lowering LDL cholesterol. For an excellent historical review and recap of the cholesterol story, I suggest reading an article is this Sunday’s NY Times by Gary Taubes.

So what are the lessons learned from this story? First, I think that it is unwise to make assumptions about cause and effect relationships until all of the data is carefully analyzed and vetted. Second, it is our obligation as scientists, whether we are company employees or not, to point out inconsistencies or problems with prevailing theories regardless of personal or professional consequences. Finally, and perhaps most importantly, FDA must not allow drug companies to influence or affect the type or amount of data that it requires to approve new drugs.

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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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)

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