The positions are being eliminated as of Monday as part of a major companywide program announced two months ago to save money in the face of regulatory setbacks and generic competition. At the time, the drugmaker acknowledged plans to cut about 10 percent of its global workforce of 50,000 or so, and that sales reps were high on the list. Wyeth employs roughly 25,000 people in the US.

A Wyeth spokesman tells the Associated Press that reps will be cut from both the pharma and consumer products divisions from around the US. etkus said they will get severance pay and continuing benefits. He would not say how many US sales reps Wyeth employs, although one source say the primary care sales force numbers fewer than 2,000. The drugmaker has been whittling away at its sales teams since 2005, when it cut about 20 percent of its reps and began using more part-timers.

For now, the spokesman says the number of overall jobs to be shed as part of the ongoing reorganization may change. “We’re still evaluating the composition of our global work force,” he told the AP. “Our short-term objective is to achieve a reduction in force of 4 to 6 percent by the middle of the year. We are on track to achieve that.”

Last month, Wyeth won FDA approval to sell its Pristiq antidepressant, but the drugmaker has otherwise run into one setback after another in winning permission to market other drugs. Over the past year, the FDA has bounced a drug, demanded more data or a new patient study. Meanwhile, Wyeth expects generic competition for the Protonix heartburn med, one of its biggest sellers with sales of $1.9 billion.

Otsuka American Pharmaceutical, the US unit of the Japanese drugmaker, agreed to pay more than $4 million to resolve allegations that it marketed the Abilify antipsychotic for off-label uses, according to the US Department of Justice.

The settlement resolves allegations that, from 2002 through 2005, Otsuka knowingly promoted the sale and use of Abilify for pediatric use and to treat dementia-related psychosis, although at the time, the FDA had not approved the drug for use in geriatric patients, teenagers or children. Last November, the FDA did approve Abilify for teenagers.

Otsuka developed Abilify in Japan and then entered an agreement with Bristol-Myers to co-promote the drug in the US. Bristol-Myers paid $515 million last September to settle the same allegations. Meanwhile, the whistleblower, Joseph Piacentile, a physician, will receive about $348,000 as his share of the federal recovery amount from the settlement, and an additional share of the state settlement amount.

The doctor who triggered an international health scare over the safety of the measles, mumps and rubella (MMR) vaccine will take the stand at the General Medical Council in the UK an attempt to save his professional reputation, The Independent reports. Ten years after Andrew Wakefield’s paper linking the MMR vaccine with bowel disease and autism appeared in The Lancet, he will defend the research, which is said to have done more damage than anything published in a scientific journal in living memory, the paper writes.

Scores of parents who are convinced that the vaccine caused autism in their children will demonstrate in his support outside GMC’s headquarters in London, where the case is being heard, as they did when the hearing opened last July. They claim he is the victim of a witch-hunt by the Government and the pharmaceutical industry, who have conspired to cover up the harm the MMR jab has caused.

Along with two of his former colleagues, Simon Murch and John Walker-Smith, the 51-year-old Wakefield is accused of abusing his position as a doctor and of failing to obtain the necessary ethical approval for his research on children, or of going beyond it or of not being qualified to carry out the procedures he undertook. If found guilty of serious professional misconduct, all three doctors face being struck off the medical register. They deny the accusations.

The risk is that the GMC case against Wakefield will reinforce the view that there is a conspiracy by the government, pharma and the medical establishment to promote the MMR vaccine and discredit a doctor whose only sin was to raise questions about its safety. If found guilty, he will become a martyr to the cause – a lone voice struggling to defend the interests of desperate parents and their damaged children. If he is exonerated, it will add fuel to the anti-MMR campaign, The Independent writes.

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The answer will likely be debated for awhile. To some, Lilly was a winner because it agreed to pay only $15 million to a state that spent $40 million over five years on Zyprexa and the med regularly racks up annual sales in the billions of dollars. Others may argue that’s not small change because the deal works out to about $25 a head, based on Alaska’s population of about 600,000. Extend that to other states that have filed suits, or the nation as whole - there are settlement talks with the US Attorney in Philadelphia - the numbers may balloon. One person who takes that position is Patrick Burns of Taxpayers Against Fraud, a non-profit that chases corporate fraud and, yes, is funded by attorneys. Here’s an excerpt from our chat…

Pharmalot: So you think Lilly capitulated. Why is this a bad outcome for the drugmaker?
Burns: Anything short of a complete win for Lilly sets in motion the potential for more cases. There are nine states that have already filed lawsuits against Lilly over Zyprexa and more may now be tempted. More states will show up and ask Lilly to pay up.

Pharmalot: Yes, but $15 million isn’t a lot of change. Why is that a good number?
Burns: The math is fairly simple. People get confused about geography. It’s a really small state - Alaska only has about 600,000 people. So that works out to, what, $25? Multiply that times the national population and you get a huge number. Because Lilly is negotiating with the federal government. Look at it that way and this isn’t so small.

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The FDA said it is reviewing the issue after receiving reports of mood and behavior changes, suicidal thinking and suicide in patients who took the drug, which is used to treat stuffy nose, sneezing and other allergy symptoms as well as asthma, according to the FDA web site. The agency did not say how many reports it had received.

A definite link to allergy me hasn’t been established, but the agency has asked Merck to evaluate its data for more information on the risk and expects the review to take up to nine months to finish its own review.

The FDA also reviewing reports of behavioral changes in patients taking other similar drugs, including AstraZeneca’s Accolate and Critical Therapeutics’s Zyflo, but hasn’t yet decided whether further investigation is needed. Merck earlier added information about the risk of tremors, depression, anxiousness and suicidal behavior to Singulair’s label.

“We have no indication that anything about the mechanism of Singulair is consistent with these events,” George Philip, Merck’s director of research and product development, tells the Associated Press. “But because suicide is a life-threatening event we thought it was important to provide this information in the product label.”

This must be safety day at the FDA. Yet another alert, and this one is about recent findings from analyses of data collected from a study known as D:A:D, or “The Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) Study.” This is a large observational study of 33,347 HIV-1 infected patients living in North America, Europe and Australia, who are being followed to evaluate short- and long-term adverse effects of HIV drugs.

Data examined through Feb. 1, 2007, showed that the recent use of Glaxo’s Ziagen and Bristol-Myers Squibb’s Videx were associated with an increased risk of heart attack. Patients taking either med had a greater chance of developing a heart attack than those taking other drugs. The risk didn’t appear to increase over time, but remained stable and appeared to be reversible after the meds were stopped, according to the FDA. These drugs, by the way, are nucleoside reverse transcriptase inhibitors, or NRTIs. The analysis looked at relative risk among cumulative use, current use and past use.

Last last year, both Bristol-Myers and Glaxo received the preliminary findings from the D:A:D Study and searched their clinical study databases, and reported that the results are inconclusive, but didn’t show an increased risk. Here are the key findings from the D:A:D Study…

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The agency sent the drugmaker a harsh warning letter concerning its Avinza pill, which is a form of morphine that is specially made to provide long- acting relief of moderate-to-severe chronic pain. King was distributing a 22-page file card that the FDA determined is “false or misleading” because it overstates effectivness and “fails to communicate and minimizes risks.” Avinza, by the way, is a controlled substance and its labeling includes an extensive boxed warning, but King’s file card failed to include “any risk information from the boxed warning,” the FDA wrote. A slight oversight, no doubt.

Tom Abrams, who heads the FDA’s division of marketing, advertising and communications, writes: “We are especially concerned from a public health perspective because the File Card fails to present any information from the extensive Boxed Warning and Warnings sections of the approved product labeling for Avinza or any information about the abuse potential of Avinza, a controlled substance under Schedule II of the Controlled Substances Act.

“These omissions are exacerbated by the fact that the File Card minimizes the little risk information that is presented. In addition, the File Card fails to disclose the limitations to the indicated use of Avinza, thereby implying that Avinza may be used for a much broader range of patients and conditions than are appropriate for the drug. The File Card also makes several unsubstantiated efficacy claims about the outcomes of treatment with Avinza.

“The combination of such broad and unsubstantiated efficacy claims about the benefits of Avinza and the omission of the serious, potentially fatal risks associated with its use, as well as its potential for abuse, is especially egregious and alarming in its potential impact on the public health.”

Why was there a $15 million settlement now in the Zyprexa trial in Alaska? On one hand, the state worried about the upcoming Supreme Court review this fall of a lawsuit against Wyeth and the debate over preemption. This concept turns on whether FDA approval supercedes state law claims challenging safety, efficacy or labeling. Drugmakers and the FDA argue preemption exists by maintaining agency decisions are the final word on safety and effectiveness.

During the trial, the judge remarked that, without lawsuits like the one Alaska brought against Lilly over Zyprexa marketing, claims that drugs cause health problems “might well go unaddressed.” His comment underscored the possibility that seeing the trial to completion may not be such a smart move. “We had this issue with the Supreme Court deciding pre-emption this fall that could have completely unwound any victory we might have had,” Ed Sniffen, Alaska’s senior assistant attorney general, told The New York Times.

Meanwhile, only three of 12 jurors were leaning toward Lilly and the rest were for the state. Lilly may have detected the mood, given that jury consultants are regularly hired to watch trials. Remember, this trial was seen as a test case because nine other states have sued Lilly and more may follow. Few jurors supported the drugmaker, but most probably would have gone the state’s way after talking it out, according to Dennis Jump, who sided with Lilly. “I guess in the end, Lilly…pushed a line and they probably at points pushed it too far,” Jump tells The Anchorage Daily News.

He thought the benefits of Zyprexa for conditions like schizophrenia outweighed the risks, but not for depression, a market that Lilly hoped to reach. But while each side relied heavily on expert witnesses and studies that essentially canceled each other out, he tells the paper. “Where’s the army of Alaskan doctors who are mad and said Lilly’s people came into our office and bald-faced lied to me?”

But Jennifer Mitchell, another juror, tells the News she was disappointed she didn’t get to hear all of Lilly’s evidence. “But that said the State of Alaska had a really strong case.” “A definite cover-up,” is how another juror, Misty Steed, describes Lilly’s tactics. Lilly was trying to minimize the risks and it tortured the data from studies, she tells the paper. “I was concerned about what this is doing not only to Alaska, but also the nation.

And how about that $15 million? Was that a good deal?

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And Andy blames it on too many responsibilities and not enough funding. In a speech yesterday, von Eschenbach worries that the FDA “may fail in its mission to protect and promote the health of every American. Peril exists. (The agency must be) stronger, bigger and better” to continue as “the world’s gold standard as a regulatory agency,” according to Bloomberg News. Nonetheless, Andy continued, the FDA is focused on “how to manage and get out of this crisis.” And yet, he proclaimed, “the prognosis is excellent.”

You may recall that an outside panel last year issued a report saying Americans are in danger because the FDA lacks the funding to keep pace with science. The agency’s budget is more than $2 billion annually and The White House proposed increasing the FDA’s budget by 5.7 percent to $2.4 billion for fiscal 2009. The agency has insisted Andy sought more money, but never said how much. The panel believes the FDA budget will need to increase to $3.7 billion by 2013, and recommended increasing funding by $375 million to $460 million each year.

But Democratic lawmakers continue to criticize Andy for failing to press publicly for more funding. “Time and again, we have asked Commissioner von Eschenbach to tell us what he needs, but he has refused,” Congressman Bart Stupak, who chairs the House Energy and Commerce investigations subcommittee, wrote Bloomberg in an e-mail. “We have asked whether he is satisfied with the administration’s most recent budget proposal, but he wouldn’t comment.”

However, Stupak, a Michigan Democrat who has called for Andy to resign, did note that when Congress gave the FDA a $10 million funding increase, “he doled it out in bonuses to the agency’s political appointee top brass.”

Cost cutting may still be in vogue, but the rest of the management team wants a CFO who functions more like a business partner, someone who participates in shaping strategy and provides insight into overall business indicators. A new survey finds that 74 percent of the CFO’s managerial peers expressed such sentiment, while only 41 percent prefer the equivalent of a scorekeeper - the CFO who monitors the financials.

In other words, traditional activities are still important, but in a toughening business, other pharma execs want more than conventional bean counting. They want a CFO who can handle mergers and acquisitions. Bristol-Myers Squibb, for instance, recently hired a new CFO and the announcement emphasized one thing - acquisition experience.

Just the same, the survey, which was conducted by Ernsty & Young, also found that 92 percent say cost reduction is a key issue, with 25 percent saying cost reduction has been a focus for more than two years and 35% saying it has been a focus “for as long as I can recall.” And 56 percent felt it was the CFO who must lead cost cutting plans. However, 58 percent cited both competitive pressures and profitability, while only 33 percent cited the need to provide better investor returns as a motivator.

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