Other elements of Pfizer's 2010 payments included:
--$34.4 million in speaking fees to about 4,600 professionals to discuss Pfizer products and health topics at events with other professionals.
--$18 million worth of meals, much of which were provided to doctors in their offices by Pfizer sales representatives.
--$8.9 million in professional advising fees to 1,400 doctors.
--$5.8 million in travel expenses.
--$1.7 million in education items.
U.K.-based Glaxo paid $28.5 million to various institutions for their help in conducting research, the company said. The payments were associated with 127 studies involving 595 different lead researchers or principal investigators. Glaxo's total 2010 R&D costs were $6.9 billion.
In addition, Glaxo paid $56.8 million in speaking or advisory fees to 5,331 health-care professionals.
Thursday, March 31, 2011
Pfizer Paid $177 Million, Glaxo Paid $85 Million To US Doctors In 2010 - FoxBusiness.com
Supreme Court Hears Arguments in Generic-Drug Case - NYTimes.com
May the makers of generic drugs, whose products must use the same warning labels as the corresponding brand-name drugs and who cannot alter those labels, also be sued for failing to warn users about the risks posed by their products?
The answer to the question will have enormous financial consequences, said Jay P. Lefkowitz, a lawyer for the drug companies. “This would totally change the way generics do business,” he said of a ruling against his clients.
U.S. jury rejects Glaxo antitrust claims vs Abbott - Yahoo! News
OAKLAND, California (Reuters) – A U.S. jury rejected GlaxoSmithKline's antitrust claims against Abbott Laboratories over allegations of unfair HIV drug pricing, after Britain's biggest drugmaker had asked for hundreds of millions in damages.
Glaxo accused Abbott of improperly hiking the price of one drug, Norvir, to help it preserve sales growth of one of its other HIV blockbusters, Kaletra.
The case had been in trial in an Oakland, California federal court, and the 10-member jury delivered its verdict on Wednesday.
The jury awarded Glaxo $3.4 million on its breach of contract claims. Abbott spokeswoman Adelle Infante said the company was considering an appeal of that finding.
"However, the jury's awarding of $3.4 million dollars in damages, instead of the $571 million that GSK was asking for, confirms our view that GSK's alleged damages were inaccurate and inflated," Infante said in an email.
Wednesday, March 30, 2011
Drug Companies Overestimate Cost Of Developing A New Drug By Merely $1.26 Billion | Techdirt
Drug Companies Overestimate Cost Of Developing A New Drug By Merely $1.26 Billion
from the and-there-you-go dept
It's one of those numbers that comes up every single time we talk about the pharma industry: the claim that it costs $1.3 billion for pharma companies to develop a new drug. In fact, in our recent discussion on the FDA banning drugs that have been on the market for decades, it didn't take someone long to toss out such a number (they used $1.2 billion, but $1.3 billion is the "standard" these days -- just a few years after it was $800 million). Of course, every time people point this number out, I point to the excellent research by Merrill Goozner who did a massively thorough debunking of the $800 million number seven years ago, showing that the true number was closer to $35 million.
And yet, the $800 million number has lived on, boosted by inflation to $1.3 billion.
And it's still bunk. Gerd Leonard points us to some new research that appears to have dug deeper into the question today, and found (once again) that the $1.3 billion claim is total bunk and the real number is more like $55 million -- based on the same data used by the study used to support the $1.3 billion number. In fact, they point out that it appears the pharma industry and those seeking greater protectionism appear to be overestimating the actual cost of drug development by $1.265 billion.
Now, there are some reasonable quibbles with the lower number as well, but there's a growing body of evidence that the real number is a lot closer to the lower one than the higher one. There are certainly some outliers, but the idea that the average cost to develop a new drug is over a billion dollars, and therefore pharma companies need special extra protection is bunk and certainly shouldn't be cited any more.
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Amgen cancer drug fails in late-stage study - Yahoo! Finance
NEW YORK (AP) -- Amgen Inc. and Takeda Pharmaceutical Company Ltd. said Wednesday that their potential cancer treatment motesanib failed to meet its key goal in a late-stage study focusing on lung cancer patients.
The drug candidate failed to improve overall survival rates for patients with non-squamous non-small cell lung cancer. Squamous refers to the type of cells from which the cancer originated. The study involved 1,090 patients receiving combination of the drug candidate and chemotherapy or a combination of chemotherapy and placebo. In 2008, the companies halted the study after early data showed higher mortality rates among patients receiving motesanib than among patients receiving a placebo.
Novo Nordisk, Eli Lilly, Grünenthal and Napp named in advertisements for breaches of the UK ABPI Code of Practice
For promoting Victoza prior to the receipt of its marketing authorization on a number of occasions, making claims and comparisons that were misleading, disguising promotional material and failing to provide information which reflected available evidence, Novo Nordisk was ruled in breach of the following clauses of the Code:
Clause 2 - Bringing discredit upon and reducing confidence in the
pharmaceutical industry.
Clause 3.1 - Promoting a medicine prior to the grant of its marketing
authorization.
Clause 7.2 - Making misleading claims.
Clause 7.3 - Using misleading comparisons.
Clause 7.9 - Failing to provide information about side-effects and reflect
available evidence.
Clause 9.1 - Failing to maintain high standards.
Clause 12.1 - Disguising promotional material.
For failing to comply with an undertaking not to use material previously ruled in breach of the Code and for providing inaccurate information in that undertaking, Novo Nordisk was ruled in breach of the following clauses of the Code:
Clause 2 - Bringing discredit upon and reducing confidence in the
pharmaceutical industry.
Clause 9.1 - Failing to maintain high standards.
Clause 25 - Failing to comply with an undertaking.
For promoting a medicine before the grant of the marketing authorization, Lilly was ruled in breach of the following clauses of the Code:
Clause 2 - Bringing discredit upon or reducing confidence in the
pharmaceutical industry.
Clause 3.1 - Promoting a medicine prior to the grant of the marketing
authorization.
Clause 7.2 - Making misleading claims.
Clause 9.1 - Failing to maintain high standards.
For promoting an unlicensed indication for Versatis in the poster session of a meeting of the British Pain Society, Grünenthal was ruled in breach of the following clauses of the Code:
Clause 2 - Reducing confidence in the pharmaceutical industry.
Clause 3.2 - Promoting a medicine for an unlicensed indication.
Clause 9.1 - Failing to maintain high standards.
For making cost comparisons for Versatis which were incorrect and misleading and failing to declare that a named author on a poster was one of its employees, Grünenthal was ruled in breach of the following clauses of the Code:
Clause 2 - Reducing confidence in the pharmaceutical industry.
Clause 7.2 - Making inaccurate and misleading cost comparisons.
Clause 9.1 - Failing to maintain high standards.
For providing business class air travel to delegates it had sponsored to attend an international congress and failing to certify overseas travel arrangements, Napp was ruled in breach of the following clauses of the Code:
Clause 2 - Bringing discredit upon or reducing confidence in the
pharmaceutical industry.
Clause 9.1 - Failing to maintain high standards.
Clause 14.2 - Failing to certify overseas travel.
Clause 19.1 - Providing excessive hospitality in the form of business class
air travel.
UK's NICE Doesn't Back Use Of Bristol-Myers Squibb's Orencia - FoxBusiness.com
LONDON -(Dow Jones)- The U.K.'s health-care costs regulator said Wednesday it isn't recommending Bristol-Myers Squibb Co.'s (BMY) drug Orencia, also known as abatacept, for use in the state-funded National Health Service for treating adults with moderate to severe active rheumatoid arthritis who haven't responded to conventional non-biological anti-rheumatic drugs, largely due to cost considerations.
Explaining its draft decision, the National Institute for Health and Clinical Excellence, or NICE, said it already recommends a number of disease-modifying anti-rheumatic drugs, or Dmards, for second-line use for patients with moderate to severe active rheumatoid arthritis. These include adalimumab, etanercept, infliximab and certolizumab pegol.
Tuesday, March 29, 2011
FDA chemist, son charged with insider trading - Courant.com
WASHINGTON (Reuters) - A U.S. Food and Drug Administration chemist and his son were arrested and charged on Tuesday with using sensitive inside information from the agency to profit on drug approval decisions, U.S. authorities said.Cheng Yi Liang and his son Andrew reaped more than $2.27 million involving five pharmaceutical companies between November 2007 and March 2011, including $1 million off the FDA's approval of Vanda Pharmaceutical's drug Fanapt, the Justice Department said.
Roche will not be for sale, vice chairman tells newspaper | Reuters
) will not be up for sale in future and one investor's exit from the group's controlling shareholder pact does not mean the family is running away from the Swiss drugmaker, one of the pool's members was quoted saying.(Reuters) - Roche (ROG.VX
The family group, which has controlled Roche Holding AG for decades, now holds 45.01 percent, down from 50.01 percent after Maja Oeri decided to exercise her shareholder rights independently, leaving an agreement that has existed since 1948.
This move could leave Roche vulnerable to being taken over and some speculated last week that Novartis, which owns a third of the voting rights in Roche, may rekindle its interest in the group after making a play for its cross-town rival in 2004.
But Andre Hoffmann, spokesman for the family group and also vice chairman of Roche, said the shareholders would continue to protect Roche's independence.
"Roche will also not be up for sale in the future. From our point of view a fusion of Roche and Novartis makes even less sense than it did five or 10 years ago," Hoffmann was quoted saying in an interview with Swiss newspaper SonntagsZeitung on Sunday.
"The two groups have strategically positioned themselves quite differently. Novartis has additional pillars with eye medicine and generics. Roche is concentrating on personalized medicine with innovative pharma and diagnostics. That doesn't go together," Hoffmann said.
European Medicines Agency closes PIM project
The European Medicines Agency (EMA) announced the closure of the PIM project today. The PIM, or the Product Information Management, project was established to increase the efficiency of the management and exchange of product information (summary of product characteristics, package leaflet and labelling) through the structuring of the information and its exchange by electronic means.
Dr Des Spence explains why the UK needs a Sunshine Act - BMJ
Notes
Footnotes
- bmj.com Observations: Data sharing: let the sunshine in (BMJ2010;340:c1896, doi:10.1136/bmj.c1896); News: US drug manufacturers will have to disclose payments to doctors (BMJ 2010;340:c1648, doi:10.1136/bmj.c1648); News: Drug industry weakens US bill about disclosure of gifts (BMJ 2008;336:1268, doi:10.1136/bmj.39598.476250.DB)
Monday, March 28, 2011
Could Abbott benefit from a break up?
Abbott Labs has three main business divisions (prescription drugs, nutritionals, and medical device) that are largely unrelated. During Abbott's last conference call, Jami Rubin, a drug analyst at Goldman Sachs argued that Abbott's stock is currently undervalued and could surge by 30% or more should management decide in favor of a company's breakup. The break-up theme was then re-examined in an issue of Barron's, published on February 12th, 2011. Management does not seem to favor the break-up strategy at this junction.
Curbs on generic dispensing "cost US $7.7 billion a year" - PharmaTimes
Prescriptions which stipulate that a brand-name drug must be dispensed rather than a generic could be costing US patients around $1.2 billion a year, while the costs to the government could be as high as $7.7 billion, according to new research.
Patients are less likely to fill a prescription designated "dispense as written" - meaning that the drug dispensed must be the named brand drug and not a generic - even if the patient themselves has requested the designation, according to researchers at Harvard Medical School.
Their study looked at 5.6 million prescriptions written for more than 2 million patients over a one-month period, and found that nearly 5% were designated "dispense as written," with over 2.7% of the requirements being made by doctors and 2% at the request of patients. But nearly 12% of the patient-requested "dispense as written" prescriptions were never filled, compared to about 8% for prescriptions for chronic-disease medicine which did not stipulate a brand, say Dr William Shrank and his team, reporting their findings in the American Journal of Medicine.
The study also found that patients paid an average of $44.50 for their prescriptions for brand-name drugs for which a generic alternative was available, compared with around $18 for a generic prescription.
By substituting the generic alternative for each multi-source brand that was filled for each "dispense as written"-designated prescription, patients in the study could have reduced their charges by more than $1.7 million and their health plans could have reduced their costs by over $10.6 million during the one-month study period, the researchers estimate.
Moreover, for the 3.6 billion-plus prescriptions filed in the US every year - and assuming a similar rate of "dispense as written" requests nationwide for both uninsured patients and those covered by state, federal and commercial health plans - eliminating "dispense as written" opportunities could reduce patient charges by as much as $1.2 billion annually and cut health system costs by up to $7.7 billion, they add.
"Physicians and patients should be aware that 'dispense as written' designations not only increase costs to the patient but also adversely affect rates that patients purchase those prescriptions," say the authors, who note that requests for such designations are more likely to be made by specialists, older physicians and patients aged 55-74, groups which, they suggest, "may represent targets for educational outreach."
Such educational efforts should focus on initiation of chronic medications, because patients disproportionately fail to purchase these prescriptions when either physicians or patients make the request, they add.
The researchers conclude that, while "advocates of 'dispense as written' may argue that providing physicians and patients with greater discretion offers greater choice, opportunities for communication and adherence to therapy, our results indicate that 'dispense as written' requests are associated with excess costs and that patients are less likely to fill [such] prescriptions."
Moreover, they note: "it is interesting to observe that physicians request 'dispense as written' frequently for single-source branded products, medications for which no generics could be automatically substituted. Physicians with a strong preference for branded medications may not be aware of whether a generic is available and may request the branded agent as a preventive measure. Alternatively, physicians may request the branded medication to ensure that pharmacists do not substitute a different medication in the class."
Prescribing Advice for GPs » MeReC Bulletin – medicines used for IBD
The National Prescribing Centre (NPC) has published a MeReC Bulletin (PDF) that answer some common questions around medicines used for inflammatory bowel disease (IBD).
AstraZeneca pays its back taxes | Reuters
The settlement of matters dating back more than a decade will see the Anglo-Swedish drugmaker pay a net amount of $1.1 billion to resolve all U.S. transfer pricing issues -- less than the amount it had set aside in provisions.
One fourth of family medicine residencies "pharma free," says survey - Medical Marketing and Media
Most US family medicine resident programs have limits on drug industry interaction with doctors, and a quarter shun doctor-company contacts altogether, said a survey by Georgetown University Medical Center and the American Medical Student Association.The survey, begun in 2008, went out to directors or coordinators of all 460 accredited family medicine residency programs and drew responses from nearly two-thirds (62.2%). Around half said that they refused drug samples (52.1%) and industry gifts or food (48.6%). Sixty-eight percent said they did not allow industry-sponsored residency activities, and 44.1% denied industry access to students and residents at the family medicine center. Seventy-five residencies, 26.2% of those responding, were designated as “pharma-free.”
By comparison, in 1992, 90% of family medicine residencies allowed industry support, said Georgetown's Dr. Adriane Fugh-Berman, MD, who is also director of drug industry watchdog PharmedOut.
Industry-physician contacts have come in for withering criticism in recent years, particularly from academic medicine, and these results, though served up by a pair of institutions prominent among conflict-of-interest hawks, suggest that the criticism is having an impact.
“Family medicine is leading the way in closing the door on pharma” said Dr. Fugh-Berman in a statement. “Our survey allows for comments, so we know that some residency programs report recent changes in plans or practices to limit industry interaction. Although some faculty and some residents are opposed to these limits, it's clear that industry influence on family medicine residencies is waning.”
Sunday, March 27, 2011
Martin Sheen Testifies for James Marshall in Suit Seeking $11M from Maker of Acne Drug Accutane - News - ABA Journal
Actor Martin Sheen testified via a video hookup from California today in a New Jersey trial in which actor James Marshall is seeking $11 million from the maker of the acne drug Accutane.
Marshall, 44, who played the role of Louden Downey in the movie A Few Good Men had great career promise before he had his colon removed in 1995 on an emergency basis, Sheen told the Atlantic City jury. Marshall blames manufacturer Roche Holding AG for the surgery that led to his becoming, he says, a “prisoner in my home” who must go to the bathroom up to 20 times daily, reports Bloomberg.
Roche unit Hoffman-LaRoche Inc. based in Nutley, N.J., actually makes the drug.
Sheen, 70, told the jury he was a close friend of Marshall's father who has known the actor since birth and directed him in several productions. Marshall's personalilty changed drastically and he looked wasted after the ulcerative colitis and surgery for which Accutane allegedly was responsible.
Actor Brian Dennehy gave similar testimony several weeks ago.
The drug manufacturer says there is no conclusive proof of a connection between Marshall's travails and the acne medicine. However, it took Accutane off the market in 2009 after juries began awarding substantial damages in other cases alleging bowel damage from the drug.
Medical Marijuana Sales Grow to Rival Viagra’s: New Report – TIME Healthland
The report, released by See Change LLC, a Colorado company that provides investment advice to businesses (See Change is selling an in-depth version of the report for $1,150), shows that medical marijuana sales have already reached $1.7 billion in states where it is legal — compared with annual Viagra sales of $1.9 billion. (More on Time.com: The 'Gateway' Myth that Will Not Die)
In a conference call with reporters this week, report editor Ted Rose noted that 1 in 4 Americans lives in a state in which medical marijuana is legal, and that nearly 25 million people in those states have medical problems for which the drug can be prescribed. Rose projects that medical marijuana sales will reach $8.9 billion in five years.
Read more: http://healthland.time.com/2011/03/24/medical-marijuana-sales-rival-viagras-n...
Friday, March 25, 2011
The Placebo Journal starts to save the planet!
- FUNNY MEDICAL STORY OF THE DAY
- PLACEBO JOURNAL FANS on FACEBOOK
- PLACEBO JOURNAL BLOG
- PLACEBO TELEVISION
- MEDICAL SPEAKER SITE
U.S. multinationals have more than $1 trillion in profits stashed in overseas subsidiaries.
Pfizer staff to learn their fate in May
Hundreds of Pfizer staff will learn their fate at the doomed Sandwich plant in May.
The pharmaceuticals giant has confirmed a "significant number" of staff have been informed their jobs are at risk.
But they won't know their fate until the end of a 90-day consultation process, which is completed on May 1.
In February, the pharmaceutical giant announced plans to close its research and development plant in Sandwich with the loss of 2,400 jobs.
The shock decision is part of a global programme of changes which it says will accelerate Pfizer's long-term research and development strategy.
But the news came as a huge blow to employees of the company, which has had a presence in the area for more than 50 years.
The pull-out is expected to have a huge impact on the East Kent and wider Kent economy.
A statement on the redundancies said: "Colleagues will receive notice of redundancy at different times dependent upon factors, including critical business needs.
"We can confirm that the earliest a colleague could be served notice of redundancy is May."
But bosses said they had no immediate plans to close any of the Sandwich buildings.
Pfizer intends to fully quit the site before the end of 2012.
Thursday, March 24, 2011
Glaxo lawyer says Abbott used HIV drug as weapon | Reuters
OAKLAND, Calif., March 24 (Reuters) - Abbott Laboratories (ABT.N) improperly hiked the price of one drug to help it preserve sales growth of one of its other HIV blockbusters, an attorney for GlaxoSmithKline told a jury.
Closing arguments began on Thursday in a case in which Abbott is accused by GlaxoSmithKline of anti-competitive behavior regarding the drugs Norvir and Kaletra.
Norvir plays a key role in AIDS-fighting cocktails because it can boost the effectiveness of other drugs. Glaxo accuses Abbott of raising Norvir's price by 400 percent in 2003, as part of an effort to harm competitors whose drugs were dependent on being used in combination with Norvir.
The case has been in trial for the past few weeks in an Oakland, California federal court. On Thursday, Glaxo attorney Brian Hennigan said that if more patients used Norvir, then fewer would use Kaletra, leading to the Norvir price hike.
"Norvir was just being used in the background as a weapon to protect Kaletra," Hennigan said.
Hennigan asked the jury to award damages of $571.6 million, representing lost sales for Glaxo.
Annual sales of Kaletra hit $538 million in 2007, up from $382 million in 2003, despite side effects associated with the drug like diarrhea, Hennigan said.
Several retailers -- including CVS Caremark (CVS.N), Walgreen (WAG.N) and Safeway (SWY.N) -- had been in trial alongside Glaxo, but settled their claims mid-trial. [ID:nN23284111] Terms of that settlement were not disclosed.
Abbott's closing argument was slated to begin later on Thursday.
The case in U.S. District Court, Northern District of California is Smithkline Beecham Corporation, doing business as GlaxoSmithKline, v. Abbott Laboratories, 07-5702. (Reporting by Dan Levine; Editing by Richard Chang)
Backlash builds over KV's 'outlandish' price for prenatal drug
No one dreamt it would be $1,500 a dose," said Dr. Alan Fleischman, the organization's medical director. "We're outraged.
EU Clinical Trials Register
Staggered release of clinical trial information from 22 March 2011
Historical data (information entered into the EudraCT database between 1 May 2004 and the release of version 8.0 of the EudraCT database on 10th March 2011) will be gradually published online from 22 March 2011.
Display of Trial Status
On the summary view there is a field "Trial Status:". Data is not currently displaying in this field, for trials where the status is Ongoing or Not Authorised. The data is available and can be viewed for each clinical trial, by clicking on the country code of interest to you. We will soon update the system so the information also appears on the summary view.
Former Pfizer chairman exits board - delawareonline.com
It's definitely a changing of the guard," said Les Funtleyder, a fund manager at Miller Tabak & Co., which owns Pfizer shares. "The acquisition strategy he pursued was very successful, but it stopped being successful. Companies need to be able to adapt, and the strategy that works in one era may not work in another.
Spartanburg jury says Johnson & Johnson, maker of drug Risperdal, deceptive | GoUpstate.com
You want verdicts to speak the truth, and I believe it was a truthful verdict.
Wednesday, March 23, 2011
Ex-Glaxo Lawyer Lauren Stevens Wins Dismissal of U.S. False-Statements Indictment - Bloomberg
Prosecutors said in court that if Judge Titus threw out the indictment, they would seek another one. Stevens was scheduled to go to trial on April 5.
“The department will not have any comment,” said Patrick Jasperse, the Justice Department attorney prosecuting the case. Titus dismissed the indictment without prejudice, meaning prosecutors can seek a new indictment.