MedWorm: Pharma Commentators

Xiadafil vip tablets forced off market

PharmaWatchDog — Sat, 26 Jul 2008 11:53:20 +0100

At the request of the U.S. Food and Drug Administration, U.S. Marshals seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc. of Miami, Fla. Although marketed as a dietary supplement to treat erectile dysfunction (ED) and for sexual enhancement, these lots represent an illegally marketed drug containing [...] (Source: PharmaWatchDog)

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Glaxo cuts more jobs at north carolina plant

Pharmalot — Sat, 26 Jul 2008 00:41:26 +0100

The drugmaker is laying off 90 workers, or 10 percent of its headcount, at its manufacturing plant in Zebulon, North Carolina, The Triangle Business Journal reports. The move brings employment at the plant to between 850 and 900, down from 1,350 a year ago. The most recent major layoffs before the current round took place were in February, when 70 jobs were eliminated. Glaxo has been steadily cutting its workforce in the region since October 2007, when the drugmaker announced a cost-cutting program to save $1.4 billion across the globe by 2010. Workers from sales reps to mid-level managers to R&D staffers have been cut from Research Triangle Park, where employment has fallen to an estimated 4,500 workers from 5,000 a year earlier. The Zebulon plant mostly makes the Advair DISKUS, an inhaled form of the top-selling asthma drug. Workers at the site also make the tablet forms of Valtrex, a genital herpes treatment, and Lamictal, used to treat epilepsy and bipolar disorder. But a Glaxo spokesman says additional cuts may be coming. “It’s something that we will continue to evaluate,” she says. “Right now, we just don’t know.” Just the same, Glaxo ceo Andrew Witty showed up on the drugmaker’s new YouTube channel this week to make a pitch why Glaxo is a good place to work. (Source: Pharmalot)

Sanofi-aventis to pay $548m for acambis

Pharmalot — Fri, 25 Jul 2008 18:52:51 +0100

Buying the UK vaccine maker, which is already a partner with Sanofi on several efforts, is a “logical step”, Wayne Pisano, who heads the drugmaker’s vaccine group, Sanofi Pasteur, says in a statement. By purchasing Acambis, Sanofi gains a smallpox vaccine that was contracted by the US government for $425 million. Sanofi is the world’s biggest maker of influenza vaccines and last month announced plans to open a $157 million plant in France, citing projections that demand for immunizations will double by 2016. (Source: Pharmalot)

Grassley vows to pressure nih over grants

Pharmalot — Fri, 25 Jul 2008 17:01:05 +0100

The ranking Republican on the Senate Finance Committee wants the National Institutes of Health to revoke grants to academic scientists who fail to report financial conflicts of interest to their institutions, the Iowa Senator tells The Chronicle of Higher Education. His remarks come after targeting Harvard University, Stanford University and the University of Cincinnati, because some academics underreported their own financial interests in research projects supported by the NIH. Institutions are required by federal regulation to report the existence of those conflicts to the agency. Grassley is seeking info from 20 other institutions about financial conflicts among their scientists, including Brown University’s Martin Keller, and the American Psychiatric Association. Since 1995, an NIH regulation has required scientists to report to their universities any “significant financial interests” they hold in research projects financed by the agency. Those are defined as income or equity interest of $10,000 from a company or 5-percent ownership of its stock. The universities, in turn, are required to tell the NIH whether they were able to manage or eliminate the conflicts in order to avoid bias in the research findings, the paper notes. A January report by the inspector general of the Department of Health and Human Services, the NIH’s parent agency, said the NIH rarely checks up on the universities’ reports. Grassley’s staff found discrepancies when they asked drugmakers to list their payments to researchers and then asked universities to describe financial disclosures by those same scientists, the paper notes. Rather than lean on universities themselves, he expects to use the NIH as the lever to pressure them. “If University X isn’t doing their job, they pull one grant; that’s all they’d have to do, it would send a very clear signal,” he tells the paper. “I don’t know if I want to blame the university, although I don’t see how a university can be blameless…I’ve got oversight over the NIH, and I want them to do their job.” Grassley tells the paper the NIH informed his staff that it believes the agency lacks the legal authority to revoke a grant on those grounds. But the senator disagrees. “If you don’t have the authority to do it, I’ll work to get you the authority to do it,” he says. But the NIH needn’t wait for that. “What university is going to sue the NIH because they pulled a grant because the university wasn’t doing what NIH says they have to do anyway?…That’s like being caught with your hand in the cookie jar.” He also thinks the NIH has failed to ride herd on universities adequately because the agency wishes to maintain “buddy-buddy relationships with universities and with researchers,” ties that “are conflicts of interest in and of themselves.” The agency is working to change the senator’s view. In a letter last week to Mr. Grassley, the NIH’s director, Elias A. Zerhouni, wrote that the agency was working to ensure that its oversight of financial conflicts “is both vigorous and effective.” The NIH will soon formally request public comments about how the existing reporting requirements should be “enhanced.” (Source: Pharmalot)

Drugmaker sponsors journalism group seminar

Pharmalot — Fri, 25 Jul 2008 15:48:40 +0100

We spend an awful lot of time on this site detailing (pun intended) how drugmakers provide various forms of funding to doctors, particularly continuing medical education. The issue is controversial, as you may know, because it speaks to influencing what is supposed to be independent medical judgment. So we are surprised to see that Unity, a minority journalism group, allowed Novo Nordisk to sponsor and organize a seminar at its latest convention in Chicago. The drugmaker hosted a lunch yesterday called “The Diabetes Explosion: A Call to Action for Journalists of Color.” And Novo Nordisk makes and markets diabetes products. What’s wrong with that? Journalists should do their best to remain free of influence. We do not wish to moralize, but Unity should have known better. If its members want to learn about diabetes, the organization should find another way of holding a ‘Lunch n Learn’ seminar that is not organized and run by a company with a vested interest in the subject. The panelists included docs from Harvard, Johns Hopkins and the National Institutes of Health, and some journalists, the WSJ Health blog writes. The promotional material promised attendees would hear from “distinguished experts in diabetes” about the disproportionate effect of type 2 diabetes on people of color and “how journalism can be used to help combat this disease,” according to the blog. A Novo Nordisk spokeswoman tells the blog that 274 journalists showed up, and that the drugmaker selected the speakers and “set the agenda” for what the panelists should talk about, but that the panelists came up with their own presentations. There was no discussion of brand-name drugs, she insists, or any effort to promote Novo Nordisk products, she continues, adding that the lunch was the first time Novo Nordisk sponsored such an event for journalists. May it be the last. We have reached out to a spokeswoman for Unity and will update you with any reply. As the WSJ blog points out, the Association of Health Care Journalists, a group to which we have belonged for several years, does not accept funds from manufacturers of health-care products, including drugs and medical devices. Novo isn’t the only drugmaker making a financial contribution to Unity. Eli Lilly is a bronze sponsor of the event. (Source: Pharmalot)

In australia, pfizer is guilty of discrediting pharma

Pharmalot — Fri, 25 Jul 2008 15:13:22 +0100

Pfizer was handed a record $200,000 fine after its reps wrongly told doctors that a rival drug was dangerous, and the penalty formed part of a record $1.8 million of fines handed down to some of the world’s largest drugmakers, including Glaxo and Roche, by the Medicines Australia trade group, The Age reports. Many of the 37 complaints upheld in the annual report were a result of lavish “educational events” for doctors that drugmakers spent $31 million on in just the last six months of last year, the reports, although the biggest fines were a result of drugmakers making complaints against rivals. Pfizer Australia was fined $200,000, the largest single fine Medicines Australia has given a company, after its reps were found guilty of telling doctors a cholesterol-lowering drug produced by rival AstraZeneca could cause kidney damage. Pfizer was found guilty of a range of breaches of the code including making false and misleading claims and the most serious breach of bringing “discredit to and reduction of confidence in the industry.” A statement by Pfizer Australia yesterday said an investigation had established that while representatives “may have made some statements of the kind alleged by AstraZeneca…no senior manager at Pfizer Australia was aware that the conduct was taking place.” Meanwhile, Roche was fined $110,000 after complaints by Glaxo that it sent media releases promoting unregistered drugs. But Glaxo was itself the subject of complaints by rivals and forced to pay $100,000 in two separate decisions for distributing deceptive promotional material about its products. Glaxo also received $210,000 in fines for two doctors’ conferences at luxury hotels on Sydney’s Darling Harbour. One conference called the “Gold GP diabetes forum” cost $102,970, with almost 90 percent of that spent on hospitality for the 79 doctors attending. Medicines Australia found “less than five hours of actual education was provided” and GSKA guilty of bringing discredit to the industry. Solvay Pharmaceuticals was guilty of bringing discredit to the industry and fined $100,000 for two “educational events,” one of which involved an overnight stay in Western Australia’s wine region and consisted of a $217-a-head dinner and two hours of education. Other such events to attract fines included: ■A two-day conference at the Sofitel on the Gold Coast for 36 registrars that cost almost $70,000 and included only 5½ hours of education, which earned drug company Nycomed a $60,000 fine. ■A two-day physicians’ clinical meeting in Quay West Resort Bunker Bay in WA comprising of five hours and 45 minutes of education, resulting in a $60,000 fine for Servier Laboratories. (Source: Pharmalot)

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Sanofi-aventis reps quash intimidating subpoenas

Pharmalot — Fri, 25 Jul 2008 12:10:53 +0100

A handful of women - three of whom once worked as sales reps for the drugmaker and two who still do - have succeeded in preventing the drugmaker from issuing subpoenas to their new employers, and even prospective employers, a tactic their lawyers accused Sanofi-Aventis of pursing in hopes of intimidating them into withdrawing their sexual discrimination lawsuit. The info sought by drugmaker included resumes, applications, benefit data, payroll records, and references, among other things. In a motion filed in federal court in New York, the reps claim the move by Sanofi-Aventis was a fishing expedition and an invasion of personal rights that is irrelevant to the discrimation claims made and, instead, is designed to harass, embarrass and frighten. The lawsuit was filed last year by Jennifer Storm, who nows work for Takeda Pharmaceuticals; Michelle Popa, who is employed by Baxter Healthcare; Amy Zeoli, who is with Boston Scientific; and two existing Sanofi reps, Nancy Beaney and Karen Bellifemine, both of whom have applied for jobs at Innovex and CV Therapeutics, respectively, according to court documents. Here is their original motion and here is the judge’s order. UPDATE: A Sanofi-Aventis spokesman sends us this statement: “Sanofi-Aventis is an equal opportunity employer and vehemently denies the allegations made. Other than that we will not comment on pending litigation.” (Source: Pharmalot)

Congressional hearing attacks price gouging

Pharmalot — Fri, 25 Jul 2008 11:52:39 +0100

Why has the cost of some drugs skyrocketed? That’s the question the Joint Economic Committee explored at a hearing yesterday in which some specialty pharma companies were skewered for raising prices dramatically after buying meds from larger drugmakers. Among those cited were Ovation Pharmaceuticals, whose ceo, Jeff Aronin, is a PhRMA board member. In her opening remarks, US Senator Amy Klobuchar, a Democrat from Minnesota, indicated she asked the Federal Trade Commission to investigate Ovation for allegedly exploiting a lack of competition to one of its products. Another company cited was Questcor Pharmaceuticals. “When we have pharmaceutical companies like Ovation or Questcor increasing prices to astronomical levels because of the lack of competition in the market, their actions are able to exploit an extremely vulnerable and captive market,” she said. “These staggeringly high prices, in turn, threaten the financial stability of middle class families relying on these drugs.” Alan Goldbloom, ceo of Minnesota Children’s Hospital, testified that Ovation’s Indocin is an example. The drug is used to treat patent ductus arteriosus, or PDA, a condition that can interfere with breathing in newborn and premature babies. Until January 2006, the drug cost about $108 per unit. A few months earlier, though, Ovation bought the med from Merck, gaining exclusive rights, and the price jumped to $1,500 – a 1,278 percent increase. “Indocin is not the only drug Ovation has marked up in such a dramatic fashion,” he continued. “Three other drugs that were purchased from Merck – Cosmegen, Diuril Sodium, and Mustargen have seen price increases of 3,437 percent, 864 percent, and 979 percent, respectively. Cosmegen is an agent used to treat a variety of pediatric cancers, Diuril Sodium is a diuretic used to reduce fluid overload in infants and neonates, and mustargen is used to treat brain tumors and certain lymphomas.” You can read testimony and watch the hearing right here. (Source: Pharmalot)

European regulators to limit antibiotics

Pharmalot — Fri, 25 Jul 2008 11:52:20 +0100

The European Medicines Agency recommends restricting the use of antibiotics based on moxifloxacin because of the potential risk of liver damage, and also wants strengthened warnings. (EMEA statement). The EMEA’s Committee for Medicinal Products for Human Use concluded at a meeting this month that the benefits continue to outweigh its risks, but due to safety concerns, the CHMP says oral antibiotics containing moxifloxacin should only be prescribed for acute bacterial sinusitis, acute exacerbation of chronic bronchitis and community-acquired pneumonia when other antibiotics cannot be used or have failed. The CHMP opinion will now be forwarded to the European Commission to apply to all oral moxifloxacin-containing medicines authorized in the European Union. The move comes shortly after the FDA suggested adding Black Box warnings to several fluoroquinolone antimicrobial drugs used to treat bacterial infections, including Bayer’s Cipro and Avelox, and Johnson & Johnson’s Levaquin, over concerns the meds cause tendonitis and tendon rupture. (Back story). Bayer maintained the review confirmed the positive benefit-risk profile of the drug. “We would welcome an EMEA assessment of other antibiotics used for treatment of these infections in a similar fashion in the interest of patient care,” Kemal Malik, a member of Bayer HealthCare executive committee and chief medical officer, tells Reuters. Avelox had sales of $697.3 million worldwide last year. (Source: Pharmalot)

Up and down the ladder… job changes

Pharmalot — Fri, 25 Jul 2008 11:48:22 +0100

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share with it others. That’s right. Send us your announcements and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going, especially with all the layoffs. Despite the downsizing, there is movement. Here are some of the latest changes. Recognize anyone? Bayer hired Pfizer’s Andreas Fibig as ceo of Bayer Schering Pharma; WuXi PharmaTech hired Richard Soll as vp of medicinal chemistry; Merck named Leslie Brun, ceo of SARR Group, to its board; Innocoll named Anthony Wild to its board; Syntarga named Nitin Damle as an advisor; Isis Pharmaceuticals hired Marty Bedigian as vp and chief medical officer; Bristol-Myers Squibb hired Quentin Roach as senior vp and chief procurement officer; MAP Pharmaceuticals hired Don Kellerman as sr vp, clinical development and medical affairs; CommonHealth promoted Meaghan Onofrey to president of the MBS/Vox research; Caraco Pharmaceuticals named Gurpartap Singh Sachdeva to its board; Safe-BioPharma Assn named Tanya Newton as regulatory affairs and compliance manager; Human Genome Sciences named Dave Southwell, a former Sepracor exec, to its board; Horizon Therapeutics hired Tim Walbert as ceo and president, and named him to the board; Noven Pharmaceuticals hried Joel Lippman as vp of clinical developement and chief medical officer; Silence Therapeutics says ceo Jeffery Vick has resigned and named Iain Ross as his replacement. (Source: Pharmalot)

Pharmalot… pharmalittle… the weekend nears

Pharmalot — Fri, 25 Jul 2008 11:45:43 +0100

We are about to get a head start on the weekend in order to spruce up the Pharmalot corporate campus. We take great pride in our public image, after all. So while we keep busy, please enjoy a few of the items we have found floating about… Bayer Anticoagulant Wins Green Light From EU (Yahoo/Reuters) Genentech Forms Panel To Review Roche Bid (Bloomberg News) FDA Extends Exclusivity For J&J’s Topamax (Associated Press) Glaxo Strikes Stem Cell Deal With Harvard (The Boston Globe) (Source: Pharmalot)

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Medicare part d was a ‘windfall’ for pharma

Pharmalot — Thu, 24 Jul 2008 22:31:02 +0100

Drugmakers received a $3.7 billion “windfall” during the first two years of Medicare’s prescription drug coverage, according to a report from the Democratic staff of the House Oversight and Government Reform Committee. Please look here for the report and here for the testimony. The report focused on so-called dual eligibles, or patients who qualify for prescription drug coverage from both Medicaid, which covers the poor, and Medicare, the health insurance plan for the elderly and disabled. In 2006, six million eligible beneficiaries were shifted from Medicaid to Medicare’s Part D prescription drug coverage, at a cost increase to taxpayers of 30 percent, according to the report. “The drug manufacturers have been paid billions more for the drugs used by the dual eligible beneficiaries than they would have been paid if the dual eligibles had continued to receive their drug coverage through Medicaid,” Henry Waxman, a California Democrat and chairman of the committee, said at a hearing today, according to Reuters. Nine drugs each generated over $100 million more in revenues under the Medicare Part D program than they would have generated had Medicare Part D insurers been able to get the same discounts that Medicaid gets. For these nine drugs, the manufacturers charged the private Medicare Part D insurers 46% more than they charged Medicaid, according to the report. Examples cited: Johnson & Johnson made over $500 million in additional revenues from sales of its Risperdal antipsychotic through Medicare, and Bristol-Myers Squibb made an additional $200 million from its Plavix blood clotter. The Republican committee members released their own report, arguing that reducing costs in Medicare Part D would only increase costs to other payers in the system, such as private employers and unions, Reuters writes. In addition, the Part D program is operating below expected budget projections, said Rep. Tom Davis of Virginia, the committee’s highest ranking Republican. “Repeatedly making economically implausible arguments about the efficiency of government-run drug pricing, or plucking artificial windfalls from thin air, won’t make Part D, a good program, work any better,” Davis said, according to Reuters. Republicans also noted an 85 percent satisfaction rate among seniors with Medicare Part D as another measure of the program’s success. “The success to date of the Medicare prescription drug benefit provides strong evidence that competition among private plans has contributed significantly to lowering both government and beneficiary costs compared to what was originally estimated,” Kerry Weems, acting administrator of the Centers for Medicare and Medicaid Services, told the committee. Many beneficiaries “are experiencing added value through their Part D coverage in the form of effective, safety-promoting medication management programs.” (Source: Pharmalot)

Senator targets merck over outsourcing

Pharmalot — Thu, 24 Jul 2008 19:58:04 +0100

First, Sherrod Brown goes after Pfizer over its outsourcing and the extent to which it purchases active pharmaceutical ingredients from such countries as China. Now, the Democrat from Ohio, wrote Merck to ask how the drugmaker guarantees the safety of pharmaceutical ingredients and its finished meds. In explaining his reason, Brown cites a January 9 interview with Merck’s Richard Spoor, senior vp of global procurement, who said the drugmaker is “moving in the direction of externally sourcing approximately 35 percent of the overall manufacture of active pharmaceutical ingredients, intermediates, formulated pharmaceuticals, sterile products, vaccines, and packaging by 2010..This would represent a two-fold increase over what we currently source from external manufacturers.” So Brown wants to know the mechanism Merck uses to track the chain of custody for each ingredient in its drugs and biologics; procedures used to ensure every facility in the chain operates in a manner consistent with its quality and safety standards; the percentage of its external sourcing that has been contracted out to US-based companies; the top ten countries to which it outsources by the percentage of business outsourced; and estimated average and median wages paid at companies producing active pharmaceutical ingredients for Merck, according to a letter sent Merck. UPDATE: A Merck spokeswoman sends us this statement: “The company is reviewing the letter from Senator Brown that we received today and we will respond as he has requested. Merck does not purchase, nor do we use, materials from our suppliers who do not meet our rigorous standards.” Previously, Brown asked Pfizer to clarify testimony earlier this year that 17 percent of its active ingredients and drugmaking is outsourced. Brown requested Pfizer report to the Senate HELP Committee how much Pfizer saves each year from outsourcing as well as on the frequency and nature of its outsourcing to countries with less stringent drug oversight standards. Earlier this month, Brown received a response letter from Pfizer on its practice of outsourcing drug manufacturing and ingredient collection to countries with less stringent drug safety standards. Pfizer claimed that outsourcing does not compromise the safety of American consumers and that looser safety standards and lower costs do not motivate company decisions, according to the letter. In an interview with Contract Pharma, Anthony J. Maddaluna, vp of Pfizer Global Manufacturing Strategy and Supply Network Transformation, says that “we’re outsourcing around 16 to 17 percent right now, and our current goal is around 30 percent in the next two to three years.” (Source: Pharmalot)

Bristol-myers will cut even more jobs

Pharmalot — Thu, 24 Jul 2008 18:06:34 +0100

The drugmaker, however, is being coy about specifics. In its earnings release this morning, Jean-Marc Huet, the recently hired senior vp and chief financial officer, reminds us that last year unveiled plans to save $1.5 billion by 2012, but now another $1 billion in cost savings is targeted by 2012. “We have commissioned several internal teams to execute against some already identified projects,” he says in a statement. “We will provide additional information on this second wave of productivity initiatives and its costs by year-end.” According to the most recent Pharmalot layoff tally, which probably needs to be updated a wee bit, Bristol-Myers occupied the No. 7 slot among drugmakers shedding huge numbers of employees with 4,300 jobs being eliminated. Of course, a quick way to cut headcount is to merge, and Huet does have merger and acquisition experience (background). (Source: Pharmalot)

Longing for the good old days of command and control?

On Pharma — Thu, 24 Jul 2008 17:23:57 +0100

Dr. Von Eschenbach is back in the wood shed. This week, Reps Dingell and Stupak sent the FDA a letter (click here to read) demanding responses and more information, and alleging that the Agency might have been aware of GMP compliance issues involving some Ranbaxy products sold in the U.S., but that it failed to [...] (Source: On Pharma)

Making sense of pharma’s recent m&a spike

On Pharma — Thu, 24 Jul 2008 16:36:18 +0100

The past few weeks have seen a dramatic increase in mergers and acquisitions, with the generic drug manufacturer Teva buying Barr and Roche bidding for Genentech. Frost & Sullivan analyst Rhenu Bhuller, pharma industry VP, shared these perspectives. Click here to watch brief video. (Source: On Pharma)

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Antidepressant prescriptions rose in 2005

Pharmalot — Thu, 24 Jul 2008 14:40:45 +0100

The increase amounted to roughly 10 percent, and that occurred in a year in which new and controversial Black Box warnings were added to the labeling on the medications. The data was just released by the Agency for Healthcare Research and Quality, a unit of the US Health and Human Services Department. Those warnings sparked a debate over whether some doctors and patients were being scared away from useful drugs and, therefore, causing an increase in suicides. This contention then prompted an FDA official to say the warnings may have to be revisited if federal data yields such an increase, although the Centers for Disease Control & Prevention has yet to issue more recent numbers. (Back story). The AHRQ found that, in 2002, there were 154.1 million antidepressant prescription purchases in the U.S. civilian non-institutionalized population, and by 2005, that rose to 169.9 million. Psycyhiatrists wrote the largest share of prescriptions, but that fell from 33.6 percent in 2002 to 29.3 percent three years later. The percentages for all other specialties in the top four that prescribed antidepressants remained stable when 2002 was compared with 2005 - general practice, 22.7 percent versus 22.6 percent; family practice, 17.7 percent versus 20.5 percent; and internal medicine 10.8 versus 10.0 percent. Here is the AHRQ report. (Source: Pharmalot)

Personalized vaccines made in tobacco plants

On Pharma — Thu, 24 Jul 2008 14:24:22 +0100

Fierce Vaccines just spotlighted an article from this week’s Scientific American, on a clinical trial of a vacccine for non Hodgkins lymphoma, which was derived by tobacco plants. Researchers produced tumor-fighting antigen within the plants by first extracting the gene coding for the antigen from white blood cells in patients’ tumors, then inserting it into a tobacco [...] (Source: On Pharma)

Meet andrew witty, glaxo’s executive recruiter

Pharmalot — Thu, 24 Jul 2008 13:59:22 +0100

The drugmaker has just launched its own channel on YouTube in a bid to polish its image, explain its purpose in life and, in Witty’s case, lure others to apply for work, even as some jobs are being eliminated (please look here and here). So far, only two videos can be seen, but in one, Witty recounts his start as a management trainee in 1985 and goes on to say Glaxo is looking for people who are curious and like challenge. No doubt, he would like to hear from anyone who knows how to develop spiffy new drugs more quickly. There was no mention, however, of seeking people who can develop rules about disclosing side effect data from clinical trials. Then again, the clip ended prematurely. You can watch here. (Source: Pharmalot)

Sanofi-aventis german unit head resigns

Pharmalot — Thu, 24 Jul 2008 13:29:51 +0100

Heinz-Werner Meier, who runs the drugmaker’s German operations, will leave his post at the end of the year, Financial Times Deutschland reported. Meier, a long-time executive at German drugs and chemicals maker Hoechst, which is now part of Sanofi-Aventis, will also resign from his role as the worldwide head of human resources on September 1. Meier informed staff of his decision in a letter, which was obtained by Financial Times Deutschland, the paper said. Hat tip to Pharmagossip (Source: Pharmalot)

The long wait: amgen’s nplate still not approved

Pharmalot — Thu, 24 Jul 2008 12:55:08 +0100

Kevin Sharer can keep that celebratory press release in his desk drawer a little while longer. The FDA didn’t issue a decision on Amgen’s Nplate yesterday as the biotech had expected, casting yet another gloomy cloud over the ceo’s ability to yank his company out of an ongoing crisis. Amgen wants to market Nplate for a disorder that causes the body to attack its own platelets - the red blood cells that help blood to clot, resulting in bruising and bleeding after minor injuries. This affects about 200,000 people in the US, and Rodman & Renshaw analyst Michael King recently estimated peak annual sales of $500 million. In March, an FDA advisory panel unanimously urged approval of Nplate. “We remain optimistic that a final decision will be made soon, but Amgen cannot speculate on the timing of the FDA’s response,” an Amgen spokeswoman tells Reuters. “Amgen continues to work with the FDA to assist in the completion of the review process.” Just 10 days ago, BusinessWire issued a press release saying the FDA had, indeed, approved Nplate, albeit with certain risk management requirements. The premature release embarassed Amgen, which forced the news service to issue this retraction. (Source: Pharmalot)

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Glaxo aids drug will require genetic testing

Pharmalot — Thu, 24 Jul 2008 12:36:20 +0100

The FDA will issue an advisory today for doctors to use a genetic test to screen patients before prescribing the widely used Ziagen medication, because patients with a particular variation in an immune system gene are at a far higher risk of a severe allergic reaction to the drug, The New York Times reports. The recommendation for the test will be included in a Black Box warning. A small percentage of Ziagen patients suffer so-called hypersensitivity reactions, either when they start the drug or when they resume using it after some interval, the Times writes, adding that symptoms can include fever, rash, nausea and breathing difficulties. Ziagen, by the way, is also a component of two combination pills, Trizivir and Epzicom. The association between the variant in the immune system gene and risk of the reactions was first reported several years ago. But the agency says a randomized clinical trial had since definitively proved the value of the genetic prescreening. The study, published in The New England Journal of Medicine in February, found that prescreening reduced the incidence of suspected hypersensitivity reactions to 3.4 percent, from 7.8 percent. Based on that data it was estimated that 61 percent of people with the genetic variant would suffer a hypersensitivity reaction, in contrast to only 4 percent without the variant, the paper writes. Ziagen was in the news recently over a different health issue - an increased risk of heart attacks. (Source: Pharmalot)

Fda relaxes gmp rules for early-stage trials

Pharmalot — Thu, 24 Jul 2008 12:23:17 +0100

The impetus would be the different requirements for scaling up for clinical trials and commercial manufacturing, according to in-PharmaTechnologist, which adds that the FDA’s new regulatory guidance removes the requirement that candidate drugs are produced using a fully validated manufacturing process. The ruling, which goes into effect on September 15 and will apply to most candidate biologics, small molecules and vaccines, also removes some of the stock rotation requirements and labelling regs that are applied to drugs produced on a commercial scale, the trade reports, according to in-Pharma. Drugmakers must still comply with statutory current GMP guidelines and submit detailed info about production processes as part of an IND, or investigational new drug application, but the new guidance frees companies of some rules that are seen as relevant to commercial scale production, in-Pharma adds. An agency spokesman tells in-Pharma that the: “FDA’s position is that the US GMP regulations were written primarily to address commercial manufacturing and do not consider the differences between early clinical supply manufacture and commercial manufacture.” “The move could encourage innovation in the drug discovery sector as it considerably lowers the cost of moving candidates from the laboratory to the clinic,” in-Pharma speculates, and then adds that the change may provide drug developers with “considerable leeway in dealing with the variability that is common when production is scaled to create clinical trial inventories.” The FDA first proposed making candidate drugs exempt from Phase I GMP requirements in 2006 only to withdraw its ruling later that year following several adverse comments from industry players. The new exemption does not apply to investigational drugs that are also in Phase II or III examination, or those that are already commercially available but are being assessed at Phase I for alternate indications. US Health and Human Services Deputy Secretary Tevi Troy said: “We are tailoring the cGMP requirements to make them appropriate to the earliest stages of drug development. This approach will ensure that these investigational products can be developed as efficiently as possible with the highest level of patient protection.” (Source: Pharmalot)

Pharmalot… pharmalittle… morning edition

Pharmalot — Thu, 24 Jul 2008 12:10:04 +0100

A rainy day here in the nation’s medicine chest. We are spending our morning waiting for a long overdue check-up of the official Pharmalot limo to wrap up. We hope the start of your day is more pleasant. So grab a cup of stimulation or a bottle of water, if you prefer, and catch up with these… Waiting On Wyeth’s Alzheimer’s Drug (Bloomberg News) Bristol-Myers Profit Jumps; More Cuts Planned (press release) Lilly’s Profit Rise Is Helped By Taxes (Yahoo/Reuters) Genetic Test May Predict Statin Risk (Bloomberg News) Medco Health Profit Beats Estimates (Yahoo/Reuters) ImClone Profit Falls On Higher Costs (Yahoo/Reuters) (Source: Pharmalot)

Ohno! lean science fiction? new novel focuses on lean and iso 9001

On Pharma — Wed, 23 Jul 2008 22:27:34 +0100

Looking for a book to take to the beach this summer? How about a novel about ISO 9001? Well, if it’s not a riveting page-turner, at least it could be a safer alternative to Ambien or other pharmaceutical sleep aids. Instead of sleep-walking, binging on candy or driving in your sleep, you’d intone Toyota precepts and chapter [...] (Source: On Pharma)

And the next pharma plant to close will be…

Pharmalot — Wed, 23 Jul 2008 21:42:44 +0100

When we talk about shrinkage, we usually toss out the number of jobs being cut. But another way to look at consolidation is to track all the plants closing. Since January 2007, a total of 77 industry sites employing more than 14,000 people were either closed or have been put on notice, according to Industrial Info Resources, a research firm. Among the 26 that are still scheduled to be shuttered is an AstraZeneca facility in Ontario; a pair of Biovail plants in Puerto Rico; a Bristol-Myers Squibb facility in Puerto Rico, and a Barr Pharmaceuticals plant in New Jersey. “Some of the plants targeted for closure will undoubtedly be reopened by others. With companies eager to shed the buildings, and often the equipment inside, some good deals come on the market…Others, like Pfizer in Michigan, are donating buildings and equipment to local colleges, universities and economic development boards to bolster education and, ironically, new job creation for emerging companies,” according to IIR. “For a few million dollars in renovations, the plants and research sites can often be reopened in just a matter of weeks. Yet, in other cases, some of these sites are tainted by the very factors that targeted them for closure. Aging facilities and equipment coupled with stringent FDA regulations place a particular burden on reopening the doors anytime soon.” (Source: Pharmalot)

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Alabama schedules bristol-myers fraud suit

Pharmalot — Wed, 23 Jul 2008 20:29:12 +0100

An Alabama judge has scheduled a trial for October in the state’s drug pricing lawsuit against Bristol-Myers Squibb, which is one of more than 70 drugmakers being sued for allegedly overcharging the state’s Medicaid program, the Associated Press reports. So far, Alabama has won all three cases. Earlier this month, a jury decided Glaxo and Novartis defrauded the state and ordered them to pay more than $114 million in damages. In the first trial in February, AstraZeneca was ordered to pay the state $215 million, although that was later reduced to $160 million. After the latest victory, Jere Beasley, an attorney representing Alabama, told the remaining drugmakers they had 30 days to reach a settlement. The AP reports the state is currently talking to about 20 drugmakers about a settlement, but Beasley wouldn’t disclose names. Meanwhile, Montgomery County Circuit Judge Charles Price delayed the start of trials for Abbott Labs and Novartis’ Sandoz unit, but did not set dates. (Source: Pharmalot)

Which are the top ten biopharma companies?

Pharmalot — Wed, 23 Jul 2008 19:06:15 +0100

Depends who you ask. But Contract Pharma magazine decided that a biopharma company is one that makes more than 40 percent of its drug revenues by selling biologic products, including biotherapeutics, vaccines and other proteins. As the mag’s editor, Gil Roth, says: No royalty-based companies allowed! (That means you, ImClone). This can be limiting, though. Gil could only find nine companies that would qualify for his Top 10 list. So to round it off, he threw in Elan, since it co-markets Tysabri with Biogen Idec. Good editors think creatively. 1 - Amgen - $14.3 billion 2 - Genentech - $9.4 billion 3 - Novo Nordisk - $7.7 billion 4 - Merck Serono - $6.1 billion 5 - Baxter BioScience - $4.6 billion 6 - Biogen Idec - $3.1 billion 7 - Genzyme - $2.8 billion 8 - CSL - $2.3 billion 9 - Allergan - $1.2 billion 10 - Elan - $446 million Based on 2007 biopharma revenues only. If you want to read about each company, please look here. (Source: Pharmalot)

Doctor blogs reveal patient info & endorse products

Pharmalot — Wed, 23 Jul 2008 16:17:43 +0100

For all the complaints about not having enough time to see patients or keep up with the latest innovations, some docs do manage to blog an awful lot. And that may be causing a problem - some authors may be unwittingly revealing confidential patient info, according to a new study in the Journal of General Internal Medicine. The study, which was funded by the Robert Wood Johnson Foundation, examined 271 blogs and found that, while overt violations were rare, 45 blogs, or 16.6 percent, included sufficient info for patients to identify their doctors or themselves. Individual patients were described in 114, or 42.1 percent of the blogs. Patients were portrayed positively in 43 blogs, or 15.9 percent, and negatively in 48 blogs, or 17.7 percent. And three blogs showed recognizable photographic patient images. Here is the study. They cite an example in which the anonymous blogger “Flea” revealed details of a patient’s death after a malpractice case was brought against him. The lawyer for the plaintiffs recognized the description of the case, and shortly thereafter, the case was settled out of court and the author removed his blog from the Internet. (You can read about that here). “The blogging community has made an effort to set standards for medical bloggers, but unfortunately, professional organizations and medical educators haven’t come out with rules for handling the new medium,” lead author Tara Lagu of the University of Pennsylvania tells Pharmalot. “Medical blogs are a great opportunity to learn about the health care system, but they need to know some bloggers have unprofessional conduct, although that doesn’t represent the medical profession as a whole. The issue is the risk of losing patient trust. We want to maintain that.” Another interesting finding - healthcare products were promoted, either by images or descriptions, in 31, or 11.4 percent of the blogs. The products included prescription drugs, medical devices and nutritional supplements. She notes that a recent poll found 29 percent of bloggers have been approached by a public relations professional to endorse a product, and of those, 52 percent had written a post endorsing the products on their blogs. Meanwhile, the study found there were no disclosures indicating author conflicts of interest info. “I don’t know if its public relations firms or companies directly contacting bloggers, but there are promotions and we looked for conflict of interest statements and didn’t find any. And that’s the most disturbing thing for us,” Lagu contines. “By standards of the profession, you should have to disclose conflicts when giving a talk or writing a paper. When you have an ad on the side of your blog, people know it’s an ad. But when you write in the text about a product, people don’t know. But what about simply mentioning or reviewing a product? “Sometimes, it sounded very much like an endorsement. Other cases, it was difficult to know. And that’s part of our point. If there was mention in the text that was going on and on about the merits of the product, it could almost sound like a pitch. So we would count that.” (Source: Pharmalot)

Pssst…. i heard about this drug and…

Pharmalot — Wed, 23 Jul 2008 14:22:31 +0100

For all the money spent on consumer advertising, word of mouth may work just as well. Of course, a consumer may have heard about a drug from an ad, but a survey suggests that the buzz spreads from there. Seventy-four percent of word-of-mouth exchanges about a prescription med takes place in person, and 69 percent of that info is deemed credible, according to the Kay Feller Group research firm, which queried 13,750 people between June 2006 and July 2007. Interestingly, when a family member shares, the info is given more prominence, even when considering a physician or other healthcare professional - 28 percent versus 17 percent. And effectiveness is the leading topic discussed - 37 percent chat about whether a drug does the job, compared with 28 percent reviewing the illness, 17 percent discussing side effects and 13 percent talking about cost. Here are some slides… (Source: Pharmalot)

Up in smoke: pfizer’s chantix sales go poof

Pharmalot — Wed, 23 Jul 2008 12:21:45 +0100

The smoking-cessation drug isn’t ringing the register, thanks to months of bad publicity and regulatory warnings, although this should hardly come as a surprise. In its earnings report, Pfizer notes that Chantix revenues in the second-quarter were $207 million, an increase of just 3 percent compared with the same period a year earlier. In the US, specifically, Chantix revenues fell 35 percent to $109 million, although international sales rose 197 percent to $98 million. To compensate, Pfizer vows to continue educational and promotional efforts focused on the Chantix “risk-benefit proposition” and the health consequences of smoking. Meanwhile, overseas marketing is expanding. Known as Champix overseas, the drug was just launched in Japan and will soon debut in Russia, Turkey, China and six other countries over the next year. (Source: Pharmalot)

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Glaxo’s witty tries to be clever

Pharmalot — Wed, 23 Jul 2008 11:53:08 +0100

The ceo is trying to take the drugmaker in new directions with a pair of initiatives involving branded generics and a plan to create a start-up atmosphere for Glaxo scientists. In the first move, Glaxo has signed a deal with South Africa’s Aspen Pharmacare to market low-cost branded, but unpatended drugs and register the meds in markets where these have not been approved. Aspen, meanwhile, will continue to sell the drugs in sub-Saharan Africa and elsewhere. The profit-sharing arrangement is part of a drive to expand in emerging markets. Here is the press release. Another effort involves splitting researchers into small teams that will compete for $1 billion in annual funding from a panel called the Drug Discovery Investment Board that will include a venture capitalist and a biotech ceo. Instead of annual budget requests, the teams will apply as if they were start-ups seeking three years of support, with applications assessed by the board. “This will be analogous to a university spin-out going to a venture capitalist, and having to answer the questions of whether their strategy stacks up with the market place and is the team the right one to deliver,” Glaxo ceo Andrew Witty tells The Financial Times after discussing his new priorities with investors. (Source: Pharmalot)

Roche helps catch tour de france cheater

Pharmalot — Wed, 23 Jul 2008 11:36:49 +0100

Ricardo Ricco, who upset some big names in biking during this year’s tour, was caught doping after the drugmaker planted a traceable molecule in the banned stamina-building drug he had taken, according to the World Anti-Doping Agency. And so the 24-year-old was kicked off after testing positive for EPO, or erythropoietin. Roche included a molecule in the third generation of EPO, called Continuous Erythropoiesis Receptor Activator (CARA), that acted as a flag in drug tests showing when an athlete was using the substance, John Fahey, WADA’s chief, tells the Australian Broadcasting Corporation. Until this year’s Tour, the CARA EPO, which is released into the body more slowly than its predecessors, had been thought to be virtually undetectable by drug testers, ABC reports. But Fahey says cooperation with drugmakers is the way to fight drug cheats. “There’s more and more of this occurring,” Fahey tells ABC. “The more cooperation the scientists can have with the drug companies in the detection of performance-enhancing drugs the greater the likelihood is they will be detected when tests are undertaken.” Ricco is one of three riders to test positive for EPO at this year’s tour, tarring the race once again with a drugs controversy. He denied using the substance, which was developed to boost oxygen levels in the blood of people with anemia who also have kidney disease. It has been banned in sports as it gives athletes an unfair advantage over their rivals. (Source: Pharmalot)

Merck’s gardasil gets clean bill of health

Pharmalot — Tue, 22 Jul 2008 20:57:56 +0100

In response to ongoing reports of adverse events associated with the HPV vaccine, the FDA and the Centers for Disease Control reviewed side effect reports and today issued a statement indicating Gardasil continues to be safe and effective, and its benefits continue to outweigh its risks. The joint agency review found 94 percent of side effects reported after vaccination were not serious, and these reports included syncope (fainting), pain at the injection site, headache, nausea and fever. Fainting is common after injections and vaccinations, especially in adolescents, the agencies noted. There were also 20 deaths reported, but no common pattern that would suggest these were caused by the vaccine. In cases where autopsy, death certificate and medical records were available, the cause of death was explained by factors other than the vaccine, according to the statement. Guillain-Barre Syndrome, a rare neurological disorder causing muscle weakness, was also reported, but the agencies say there is no evidence Gardasil increased the rate of GBS above what is expected in the population. “While we continue to carefully analyze all reports of GBS submitted to VAERS, the data do not currently suggest an association between Gardasil and GBS,” the agencies stated. Judicial Watch, which bills itself as a conservative public interest group that “advocates high standards of ethics and morality in our nation’s public life,” twice last year released FDA side effect reports showing an increase in adverse events attributed to Merck’s HPV vaccine. Gardasil has been controversial from the start over concerns by some conservative groups that the vaccine, which is marketed as a prevention against cervical cancer, will be construed by teenagers as a green light for premarital sex. It was approved for use in girls and women 9 through 26 years of age. (Source: Pharmalot)

Glaxo hires former fda chief counsel dan troy

Pharmalot — Tue, 22 Jul 2008 20:19:24 +0100

The preemption prince is joining the big drugmaker as senior vice president and general counsel on September 2. This is a coup for Glaxo, because Troy is widely known - some might say notorious - for being supportive of the pharmaceutical industry (see here). During his tenure as FDA chief counsel, Troy instructed agency staff to issue fewer warning letters in the belief that the missives were being ignored, which critics say led to less effective enforcement of advertising violations. He also laid the groundwork for the current legal battle over preemption, which says FDA approval supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue preemption exists by maintaining agency actions are the final word on safety and effectiveness. A case goes before the US Supreme Court this fall and the ruling could determine whether patients can sue a drugmaker through state law when a product has already been approved by the FDA. Coincidentally, a US District Court Judge in Indiana last week reversed his prior opinion in which he had dismissed a Paxil suicide case based on preemption. This also comes as a Justice Department investigation of Glaxo’s handling of its Paxil antidepressant is widening. You may recall the drugmaker last month confirmed that a previously disclosed Justice Department investigation of marketing practices, which was based in Colorado, now includes the US Attorney’s office in Boston and is being coordinated by the agency in Washington. This followed a demand by Chuck Grassley, the ranking Republican on the Senate Finance Committee, for an FDA investigation. More recently, the same committee began probing Martin Keller, a Brown University psychiatrist, for his role in studying Glaxo’s Paxil antidepressant. The committee, according to sources familiar with the investigation, sent a letter last month. Currently, Troy is a partner at the Sidley Austin law firm in Washington, DC, where he represents drugmakers and trade groups on issues concerning the FDA and government regulations. “Dan shares our vision that it is critical in today’s healthcare environment that we deliver differentiated products of real value to patients and payors. His wealth of experience in the regulatory legislative area will be of enormous benefit to us, and ultimately to patients,” says Glaxo ceo Andrew Witty, in a statement. (Source: Pharmalot)

Viagra may help depressed women have orgasms

Pharmalot — Tue, 22 Jul 2008 19:37:03 +0100

Maybe this will give Pfizer stock a lift, too. Women with sexual dysfunction caused by the use of antidepressants experienced a drop in adverse sexual effects by taking Viagra, according to a small study of 98 patients in the Journal of the American Medical Association. As the Pfizer-funded study notes, antidepressants can disturb sexual functioning, which is estimated to occur in 30 percent to 70 percent of men and women treated for major depression with antidepressants. And this causes many people to stop taking the meds. In other words, if Pfizer’s Zoloft relieves your depression, but sidelines your libido, then just pop a different Pfizer pill. The researchers found that 73 percent of women taking placebo, compared with 28 percent taking Viagra reported no improvement with treatment. While 72 percent of the women taking Viagra reported improvement on an overall scale, only 27 percent of those on placebo reported improvement. The average age, by the way, was 37, and this was a randomized, controlled, eight-week trial. Here is the abstract. “For women on antidepressants with orgasm problems, this may provide some wonderful relief,” Stan Althof, director of the Center for Marital and Sexual Health of South Florida in West Palm Beach, who was not involved in the study, tells the Associated Press. “But it will not improve their desire or arousal.” A Pfizer spokeswoman tells the Associated Press there are no plans to pursue FDA approval for using Viagra to treat female sexual dysfunction, and internal research on Viagra for women ended in 2004. While Viagra was found to be safe, the results were inconclusive, she adds. Psychologist Leonore Tiefer of New York University School of Medicine tells the AP that industry-funded research has oversimplified women’s sexual experience. She noted the new study found more side effects than benefits. Althof calls it “worrisome” that 43 percent of the women on Viagra experienced headaches, compared to 27 percent of women on placebo. Indigestion and reddening of skin (flushing) also were reported more often by the women taking Viagra. “We’re not talking about a lifestyle issue. We’re talking about a medical necessity issue,” George Nurnberg of the University of New Mexico School of Medicie in Albuquerque, tells the AP> And he adds that Pfizer had no influence on the design, findings or manuscript. He and several of the other authors disclosed financial ties to Pfizer and other drugmakers. (Source: Pharmalot)

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Nottingham university goes 'kerplunk'!

Scientific Misconduct Blog — Tue, 22 Jul 2008 17:29:00 +0100

I have posted previously about the embarrassment that has emanated from Nottingham University over recent weeks. The Nottingham saga related to a student who had in his possession a printout of terrorist material. The student was studying terrorism. The material was printed (and freely accessible) from a US government website.Why discuss this on a scientific integrity blog?It reflects the same system malfunction which leads lawyers and Vice Chancellors to make unprincipled anti-academic comments about the most basic safeguards of academia in science. Do I, as an academic, have the right to see, discuss, and properly assess data (mis)represented in my name by a commercial company? Are doctors prescribing drugs allowed to see and discuss the most fundamental aspects of science underlying that prescribing decision? Does an academic studying terrorism have the right to assess and to see (and even to possess) the information he is studying? What exactly are the roles and obligations of a University and of academic leadership?Now we have this from the Times Higher Education Supplement (17 July 2008):Researchers have no 'right' to study terrorist materials, By Melanie Newman"Academics have no "right" to research terrorist materials and they risk being prosecuted for doing so, the vice-chancellor of the University of Nottingham has told his staff."...Mr Sabir's personal tutor Bettina Renz, a lecturer in international security, and his MA supervisor, Rod Thornton, a terrorism specialist and former soldier, have both said they told police that Mr Sabir's possession of the document was legitimate given his research interests....[Despite this, the University in a new letter] "warned Mr Sabir that he risked re-arrest if found with the manual again" and added: "The university authorities have now made clear that possession of this material is not required for the purpose of your course of study nor do they consider it legitimate for you to possess it for research purposes."..."Since his release without charge, Mr Sabir has been accepted to study for a PhD in radical Islam at Nottingham under Dr Thornton's supervision. His doctorate application proposes an analysis of Islamic terrorists' military and political strategy "based on primary documents, including reports published by think-tanks and research centres and documentation published or released by Islamist groups (strategic and political statements, military manuals, group manifestos and charters)"...."Mr Sabir insisted to Times Higher Education that he had downloaded his version of the al-Qaeda manual from a US government website and that it was still freely available on the internet"...."He said he was now unclear what he could and could not legitimately research for his PhD, given the police and the university's warning"...."Vanessa Pupavac, lecturer in international relations at Nottingham, said: "The university suggests it is illegitimate to study the operational or the tactical as opposed to the political or strategic dimension of al-Qaeda." Scholars were interested in both dimensions, she argued."...Oliver Blunt QC, of the Anti-Terrorism team at Furnival Chambers in London, said that academics do have a "right" to "access" terrorist materials, whether for research or otherwise, as long as they do not "possess" them. (!) He said: "Once the researcher knowingly downloads or saves the materials that he is accessing, then he is in 'possession' of terrorist materials.On the internet, what exactly is the difference between "reading", "downloading" and "possessing"?The Vice Chancellor at Nottingham is quoted as follows"There is no 'right' to access and research terrorist materials. Those who do so run the risk of being investigated and prosecuted on terrorism charges. Equally, there is no 'prohibition' on accessing terrorist materials for the purpose of research. Those who do so are likely to be able to offer a defence to charges (although they may be held in custody for some time while the matter is investigated). This is the law and applies to all universities." --- Colin Campbell, Vice-Chancellor of Nottingham University (THE, 17 July 2008)The following from Professor Scott Lucas (University of Birmigham), an open letter to the Vice Chancellor at NottinghamThe problem was never the type-set pages of Mein Kampf; rather, it was in the use of those pages to justify bigotry, racism, war, genocide. The problem was never Marx’s Das Kapital or Mao’s Little Red Book or Adam Smith’s The Wealth of Nations or the Koran or the Bible. It was, still is, and always will be the manipulation of those texts to justify the taking of lives. Vice-Chancellor, do you think that --- through your denial of texts to us --- that you make us safer? Do you think that, by denying us our ability to think, consider, criticise that you shelter us from harm? Do you think that you protect us from ourselves, prevent us from becoming extremists? If you do, you are reducing your staff, your students, your administrators, your trustees to no more than children incapable of judgement? You go in one step from being a proud university to a fortress of ignorance.“There is no 'prohibition' on accessing terrorist materials for the purpose of research. Those who do so are likely to be able to offer a defence to charges.” Thus we are allowed freedom of thought under the caution that we are guilty before being proven innocent. Perhaps you know, Vice Chancellor, of other societies in other times who have also maintained their standard. Perhaps you know where scholars, students, citizens have been advised that they may read their books and then, as those books are burned, explain why they have not committed a crime. Read onWhat has become of us, and why do the leadership of other universities remain silent?There are cogent comments from Edward Reid-Smith on the THES articleThe situation seems to be that a small elite group is able to access and possess certain materials without being themselves "corrupted" or to be charged as terrorists .... Their decision is that others accessing and possessing the same materials will be "corrupted" or liable to be charged as "terrorists" whether or not they actually are terrorists. The 99.9% of the population not privileged will not be allowed to possess the material, and legislation will ensure that they are terrorised into not seeking knowledge about what "terrorists" actually think and do.....The passing of legislation which leaves any community uncertain of exactly what is allowed and what is banned, presents an excellent tool for oligarchic dictatorship at whim. One may question whether non-specific legislation is the result of ineptitude, or because there is some strange pleasure to be gained from putting the populace in fear (i.e. terrorising?) seeking information.Upper echelons of the university (businessmen) have decided that they know what constitutes "legitimate research material".Certainly there are real and serious dangers in this world of ours. People who feel they have the right to blow other random individuals apart (or to act as apologists for others who do) are a part of that problem. Dealing with those dangers involves proper discussion as to what they are. That is what Universities are for.A few other links about this story here, here, here. U-Tube video of Rizwaan Sabir here.Earlier|Later|Main Page (Source: Scientific Misconduct Blog)

Merck stock sinks like a rock

Pharmalot — Tue, 22 Jul 2008 17:19:11 +0100

So how do you lose confidence on Wall Street? You can start by acknowledging sluggish sales of key products and withholding earnings guidance for the rest of the year, which is exactly what Merck ceo Dick Clark did yesterday (see the release). So far, Merck shares are down nearly 10 percent today to less than $32, a price not seen in roughly two years. Just months after basking in the warm glow of a $4.85 billion Vioxx settlement - which inspired some investors to hail Merck’s revival - the drugmaker is suffering from difficult sales of two key products - the Singulair asthma med, which has been tied to troubling side effects, and the Gardasil HPV vaccine, which isn’t catching on as planned. And let’s not forget the ongoing woes over Vytorin and Zetia. And so brokerages are issuing warnings. Herman Saftlas at Standard & Poor’s dropped the stock to sell from hold and lowered the target price by $16, to $29. Sanford Bernstein’s Tim Anderson cut his target by $10 to $36, although kept an “outperform” rating. Deutsche Bank’s Barbara Ryan cut her price target by 13 percent to $44.25 but kept a “buy” rating based on the low valuation and high dividend support at 4.6 percent. Credit Suisse’s Catherine Arnold dropped her price from $46 to $40. (Source: Pharmalot)

Who will run the genentech-roche show?

Pharmalot — Tue, 22 Jul 2008 16:38:08 +0100

The surprise bid by the big drugmaker caught a good many people off guard, including Genentech ceo Art Levinson, who is expected to meet with Roche chairman Franz Humer this evening to talk about integrating the two companies and who will play what role in making that happen. Roche, you may recall, already owns 56 percent of Genentech and plans to shift many operations to California. Genentech, of course, has a different culture than Roche. One is a biotech, albeit a large one, that works to preserve an entrepreneurial mindset. The other is a lumbering drugmaker that favors traditional top-down edicts. So imagine Levinson’s surprise when he received a phone call Sunday night from Humer about the offer, as The Wall Street Journal reports. There is always fallout from a deal, but retaining Genentech managers and scientists is important to Roche’s success if something more than a product portfolio is to be gotten. “We will do everything to preserve the unique and science-driven culture of Genentech, something which made Genentech so successful and something we want to build on,” Severin Schwan, Roche’s ceo, tells the paper. But what of Roche execs? At a meeting late yesterday with hundreds of Roche managers in Nutley, New Jersey, Pascal Soriot, who runs oversees the global pharma commercial business, tried to soothe the troops, by saying there will be job opportunities. However, George Abercrombie, who heads the US pharma business (pictured right), repeatedly emphasized that consolidation is coming and, interestingly, was mute about his own future, sources say. A Roche spokesman declined to discuss George’s role, saying such decisions are premature. “There will be a selection process down the line,” he tells us. (Source: Pharmalot)

For fda’s andy, the dog days of summer

Pharmalot — Tue, 22 Jul 2008 15:21:02 +0100

The FDA commish is being berated this week in full-page ads in The Washington Post by animal activists, who are frustrated and impatient that the agency has failed to respond to their entreaties to eliminate animal testing used to determine toxicity in drugs. And so PETA, the People for the Ethical Treament of Animals, have placed a cute little beagle alongside von Eschenbach’s hound dog mug in hopes of stirring widespread passion among the public. The ad reads: “Because the FDA guidelines are antiquated, dogs are still forced to ingest, inhale, or be injected with drugs. Those who don’t die outright can suffer for months or even years while their organs fail and they become riddled with cancer and other diseases. Thanks to the FDA, dogs are also purposely infected with diseases but not provided with medicine or pain relief.” UPDATE: An FDA spokeswoman sends us this statement: “FDA supports efforts to reduce the number of animals used in product safety testing, and replacement with laboratory tests where possible. We also require companies to meet Good Laboratory Practices so that animals used in product testing are treated in a humane and compassionate manner. “At the present time, there are some necessary animal-based tests for which a suitable laboratory test has not yet been developed. However, FDA, the industry, and scientific organizations continue to seek replacement test methods and we are optimistic that as science continues to advance, we can make further progress in this area.” (Source: Pharmalot)

The blame game: zyprexa judge blasts the fda

Pharmalot — Tue, 22 Jul 2008 11:56:16 +0100

During a hearing last week on the sprawling litigation over Lilly’s antipsychotic, US District Court Judge Jack Weinstein decided to have his own day in court. In a few short minutes, he let loose a stinging rebuke of the FDA’s role in allowing Zyprexa on the market, despite persistent allegations that such side effects as diabetes and obesity were hidden, causing the government and insurers to overpay. “Compared to its peer agencies in other parts of the world, the FDA has arguably failed consumers and physicians by over relying on pharmaceutical companies to provide supporting research for new drug applications; by allowing them, through lax enforcement, to conduct off-label marketing; by acquiescing to industry pressure on drug labels; by not requiring doctors-the main line of defense against misusing prescriptions-to be adequately informed; and by leaving information dispersal and control largely to industry-influenced medical journals and non-governmental associations. The result of such claimed governmental failures arguably causes overuse and overpricing of pharmaceuticals, resulting in mass litigations such as this one for Zyprexa.” And he had some words for others who ensured the drug was widely used. The mountains of document “could suggest to jurors inadequate controls of the pharmacological research, distribution, delivery, use and payment systems in the US: failure of the federal and state protective agencies upon which users of pharmaceuticals primarily depend to protect against overpricing and misuse, and, in particular, the FDA’s lack of adequate research and control over marketing; failure of third-party payers, pharmacy benefit managers, and their consultants to exercise control over drug pricing and use; failure of what should be impartial and timely research by governmental and non-governmental organizations; inadequate steps by governmental and non-governmental organizations to promptly publicize efficacy and dangers; and, to some extent, failure of prescribing doctors and other medical personnel to limit appropriately usage and costs.” But Lilly was not exempt, in his view. “Lilly’s alleged lack of transparency, failure to warn, and deceptive or illegal marketing practices are but some of the factors that a juror could find led to this litigation.” And he went so far as to say there is “some merit” to the allegation that “Lilly exaggerated the utility of the drug, both on and off-label, and de-emphasized its dangers, in order to support an excessive price. Evidence of defendant’s alleged failure to disclose its products’ side effects, its violation of obligations of transparency, and its deliberate encouragement of off-label use, permits-but just barely-a jury finding of liability under RICO.” There’s more if you want to look here. (Source: Pharmalot)

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Phrma: reps don’t influence prescribing habits

Pharmalot — Tue, 22 Jul 2008 11:53:16 +0100

Only 11 percent of docs say that info provided by sales reps greatly affects their prescribing decisions, and only 24 percent report that the info is very useful in staying informed about drugs, according to a new survey of 501 office and hospital-based docs by PhRMA, the industry trade group. Moreover, only 8 percent do any prescribing based on info received solely from sales reps, and just 29 percent say they are very satisfied with info reps deliver. At the same time, 30 percent docs want to get drug info from reps, and more than half like the info on drug interactions and the free samples. So where do docs like to get their info? 69 percent say CME is very useful and 67 percent like peer-reviewed journals. And 92 percent trust their own clinical experience when prescribing. Docs also weigh a patient’s situation, clinical guidelines, journals and formulary coverage ahead of reps. In touting the results, PhRMA ceo Billy Tauzin says the “survey shows that doctors rely on a wide variety of information to make important prescribing decisions…” Here is the full statement with a link to charts. Of course, there are other ways to intepret the findings. PhRMA may now argue the drumbeat of complaints that reps have outsized influence on prescribing is inaccurate. And drugmakers may use the data to further eliminate still more reps. In some circles, this is called a win-win - unless, you’re a rep. (Source: Pharmalot)

Pharmalot… pharmalittle… morning edition

Pharmalot — Tue, 22 Jul 2008 11:06:01 +0100

Who said the summer is a slow season? Yesterday brought us the news that doctors may have yet another reason to wonder about Vytorin. And many Roche employees in New Jersey must now consider finding new jobs or, in some cases, moving to California to work for Genentech. What will today bring? We can only stay tuned. Hope this helps you get started… Ranbaxy Says UK Court Quashes Fraud Prosecution (Bloomberg News) FDA Employees Should Be Stationed Overseas Next Year (Bloomberg News) Merck Withholds Forecasts After Vytorin Study (Yahoo/Reuters) J&J’s Topamax Raised Birth Defect In Epilepsy Study (Bloomberg News) Amylin Pharmaceuticals Posts Wider Loss (Yahoo/Reuters) (Source: Pharmalot)

Fred hassan sidesteps vytorin cancer risk

Pharmalot — Mon, 21 Jul 2008 23:03:42 +0100

What cancer scare? That was the deft touch the Schering-Plough ceo had when asked on a teleconference call today with Wall Street analysts about the news that the so-called SEAS trial found an unexpectedly higher rate of cancer in Vytorin patients than those given a placebo. Instead of mentioning the ‘C’ word, Fred focused on a secondary endpoint - a statistically significant 22 percent reduction in non-fatal heart attacks and coronary artery bypass surgery. Never mind that SEAS failed to meet the main goal of improving cardiovascular outcomes for patients with aortic stenosis, which is an irregular thickening of the main valve to the aorta. “What I took away is that this study confirmed the results from other cholesterol lowering agents that reducing LDL does not reduce the rate of progression of aortic valve disease,” he told analysts. “Vytorin had positive outcome data, reducing the risk of coronary artery disease in these patients.” But what about cancer? “I’ll leave the interpretation of the science to the independent scientists.” Chuck Grassley, however, is having none of it. He sent yet another round of letters to Fred and his counterpart at Merck, Dick Clark, who have a joint venture to market Vytorin, because the drugmakers have yet to fully respond to earlier inquiries. The SEAS “study itself may make the situation uncertain or even more confusing. But one thing is clear and that is that the drug maker hasn’t been responsive to Congress and ought to be given the public safety and public expenditures involved with Vytorin.” (Source: Pharmalot)

No place like u.s. for manufacturers?

On Pharma — Mon, 21 Jul 2008 21:17:06 +0100

If it hasn’t quite sunk in how much the struggling economy in the U.S. is changing the mindset of industry, heed the words of Dr Heinrich Hiesinger, CEO of Siemens’ Industry Sector. His firm, at least at present, views the U.S. as a “low cost” production country, ripe as a base for exportation. Siemens has [...] (Source: On Pharma)

Docs: we’ll see a rep any old time of day

Pharmalot — Mon, 21 Jul 2008 20:11:35 +0100

Hard to believe? But a new survey says 76 percent of doctors will see a sales rep from a drug or device maker any time or any day. And only one quarter require the rep to make an appointment (patients should be so lucky, yes?). Scheduled visits are especially popular among docs in North Dakota and Wisconsin, but much less so in Idaho and Delaware. There is another way to view the situation: 17 percent of docs refuse to see sales reps at any time. And specialtists, such as pathologists, are much more likely to restrict access than general practitioners, according to SK&A Information Services, a health care market research firm that combed its database and rang 230,000 medical practices representing 640,000 docs nationwide. Some other findings: 14 percent of group practices have a general policy to restrict access to physicians at all their office locations, and 20 percent of physicians restrict access at all their office locations. The survey also found major Metropolitan Statistical Areas may not follow regional trends. In the San Francisco area, for example, access 27 percent more restrictive than the regional average. And when a medical practice is owned by a hospital, reps can expect to jump more hurdles trying to reach physicians. The survey found 30 percent of practices owned by hospitals have “no see” policies and 40 percent require an appointment. Look here for the complete figures. (Source: Pharmalot)

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Vytorin trial misses goal & shows cancer risk

Pharmalot — Mon, 21 Jul 2008 17:56:14 +0100

The so-called SEAS trial of 1,873 patients unexpectedly suggests an increase in cancer among those on the controversial cholesterol drug - 39 on Vytorin compared with 23 on placebo, according to researchers who presented their findings today. Want to watch the replay? Then click here. This was a “disturbing finding,” says Terje Pedersen of Ulleval University Hospital in Oslo, Norway, the lead researcher, although he stressed the trial involved a small number of patients and the findings could have been due to chance. In other words, it may not be conclusive. Here is the official release. In fact, the investigators say two larger, ongoing Vytorin trials - the SHARP and IMPROVE-IT trials with more than 20,000 patients combined - so far haven’t shown such a risk. “There is no good, no credible evidence, when you look at these studies, of an increased risk of cancer,” says Richard Peto, professor of medical statistics and epidemiology and co-director of the clinical trials service unit, University of Oxford. “This is a rather bizarre hypothesis…What matters is that we have drugs that seriously lower cholesterol…” Peto continued, noting that he compared data from all three trials. “Again, they do not confirm the hypothesis that treatment increases the overall risk of getting cancer. The SEAS, SHARP and IMPROVE-IT trials do not provide any credible evidence of developing cancer.” The Data Monitoring Committee unanimously supports Peto’s conclusion. The results, by the way, have been provided to regulators, according to Peto. Beyond this sobering news, the cholesterol med failed to meet the main goal of improving cardiovascular outcomes for patients with aortic stenosis, which is an irregular thickening of the main valve to the aorta. No significant difference was seen between the patients who received Vytorin and those who received a placebo. However, the drug did meet a secondary goal - there was a statistically significant 22 percent reduction in non-fatal heart attacks and coronary artery bypass surgery. And Vytorin patients also had much lower LDL than patients on placebo. The trial was designed to determine whether aggressive cholesterol lowering can lessen the need for surgical replacement of aortic valves, reduce cardiac death and reduce cardiovascular events, including heart attacks. In an investor note this afternoon, Wachovia Capital Markets analyst Larry Biegelsen writes: “Although the increase in cancer risk may have been due to chance and this outcome has not been seen with other ongoing Vytorin trials, we think the media and competition will likely highlight this risk which could put additional downward pressure on Zetia and Vytorin prescriptions.” “As scary as this sounds, the truth of the matter is that it is likely a red herring,” writes Sanford Bernstein analyst Tim Anderson in his own investor note. “There is no plausible mechanism by which Vytorin should cause this, and analyses of other, larger ongoing trials (i.e. SHARP and IMPROVE-IT) shows no link.” He adds that Merck and Schering-Plough can now claim to have “at least semblance of outcomes data, although he concedes how much comes from Zocor versus Zetia is unclear. (Source: Pharmalot)

Watch the vytorin update right here, right now

Pharmalot — Mon, 21 Jul 2008 17:28:59 +0100

The connection was a bit spotty at first, but you can tune in by going to this link… It was supposed to start at 1 pm EST, but of course, was delayed. So you haven’t missed much. Why bother? You can see for yourself what the researchers say about the SEAS trial, which examined patients with aortic stenosis who were given Vytorin. The anticipation over the results caused Merck and Schering-Plough to delay reporting their second-quarter earnings until later today, which helped sour the mood on Wall Street. (Source: Pharmalot)

Where are those medicare part d discounts?

Pharmalot — Mon, 21 Jul 2008 17:25:00 +0100

That’s the question the Committee on Oversight and Government Reform will try to answer this Thursday at a 10 am EST hearing in the Rayburn House Office Building in Washington, DC. As the committee notes, the Medicare Part D program provides prescription drug coverage to almost 30 million enrollees, and will cost federal taxpayers almost $1 trillion in the next decade. Since Part D began in January 2006, there have been questions whether private insurers who run the program are effectively negotiating with drugmakers for low prices. The hearing will examine whether insurers that receive government subsidies to provide the Part D benefit are able to effectively obtain discounts. Here is the witness list… Kerry Weems - Acting Administrator, Center for Medicare and Medicaid Services; Steve Schondelmeyer- Dep of Pharmaceutical Care and Health Systems, University of Minnesota; Gerard Anderson - Director, Center for Hospital Finance and Management, Bloomberg School of Public Health, Johns Hopkins University; Fona Scott Morton - economics professor, Yale School of Management, Yale University; Mark Merritt - ceo, Pharmaceutical Care Management Association; Rick Smith, senior vp of policy, PhRMA; Paul Precht, director of policy and communications, Medicare Rights Center (Source: Pharmalot)

Bias in the lab? really? mark lindner explains…

Pharmalot — Mon, 21 Jul 2008 15:56:52 +0100

As drugmakers race to discover and develop new drugs, a nagging question may linger – was the proper criteria used to move that compound from the pre-clinical to the clinical phase or was there some bias involved? Mark Lindner, a PhD in pre-clinical behavioral pharmacology and consultant who was previously a principal scientist at Bristol-Myers Squibb, says the need for better controls at the pre-clinical phase would lead to better choices and, ultimately, save big pharma big money. He published a paper about this issue a year ago (here it is) and we recently spoke with him about the problem, which he believes is industrywide… Pharmalot: How big a problem is the bias you desribe? Lindner: You can look at the literature to see. The FDA requires clinical trials to have special controls – double-blinded, randomized, placebo-controll trials - to prevent bias. But it’s not required in pre-clinical, so people just don’t do it. I’m not suggesting pre-clinicals are sloppy or aren’t well designed. People do use control groups and careful measurements, but the extra controls to prevent bias are not used as a standard precaution. Pharmalot: What kind of bias are we talking about? Lindner: There are a lot of different ways, but it’s important to emphasize that I’m not talking about fraud or willful deceit. I’m talking about things that affect the decision-making process and judgement outside your usual awareness. But the assessment of a compound’s therapeutic potential are made by drug discovery teams, which are responsible for advancing the compound into the clinic. And they’re being asked to justify a way to advance that compound. So they’re very motivated, because they’re expected to be an advocate. As an example, take a compound for treating Alzheimer’s. The best way to test it is with test A. But if it doesn’t pass, then you go to test B. You can keep going down the list to less clinically relevant tests until you get the result you want it to show. And that’s commonplace in industry. In order to drive your program, you need a way to distinguish your compound. So you have to use something that shows an effect. Pharmalot: Sounds like there’s a lot of waste. Lindner: The job of pre-clinical groups is to advance compounds. But it’s diffcult for more senior executives to decide what to take into the clinic. It’s hard to distinguish when everything is presented as a strong candidate, because every team puts together a data package that’s as strong as they can make it. It becomes more of a promotional package. Pharmalot: But each group focuses on a very few compounds out of many, right? Lindner: Yes, they may look at thousands, but ultimately, only choose one, two or three. Look, this system evolved for certain reasons. And they were good reasons. The effort makes sense if people are focused on completing an objective and making sure people are motivated. But there are reasons to be reworked. Pharmalot: What’s the practical effect? Lindner: This is all about why things look efficacious in the models, but not necessarily in the clinic…There’s so much attention now on why the industry is struggling – you hear a lot about the need for innovation. But I’d argue one of the most important elements of the whole process that has been neglected is the human element. People just don’t think like computers. That’s why you get bias. You need to address the role that scientists play in the process. Pharmalot: And so the solution would be what? Lindner: You need to have more controls in the pre-clinical phase. Otherwise, you’ll continue to have those issues. I think that’s the change that needs to happen. It’d be difficult, but it’s inevitable that some companies will realize these issues need to be addressed, because they cost a lot of money. I’m hoping people in charge of success rates will be open to the issue. (Source: Pharmalot)