Friday, July 31, 2009
Moore's Venetian love story
Michael Moore's documentary on the global financial crisis, "Capitalism: A Love Story", will vie for the top prize at this year's Venice film festival.
The Oscar winner's is one of six U.S. movies in the main competition at the world's oldest film festival, a sign U.S. film-making is back in business after last year's problems, according to organizers.
The Oscar winner's is one of six U.S. movies in the main competition at the world's oldest film festival, a sign U.S. film-making is back in business after last year's problems, according to organizers.
Why is healthcare reform difficult in the US?
Source"They are the villains in this. They have been part of the problem in a major way," Nancy Pelosi said of the insurance industry after her weekly press conference. "It's almost immoral, what they are doing," she said, referring to industry lobbying against a public insurance plan option. "Of course, they've been immoral all along. They are doing everything in their power to stop a public option from happening, and the public has to know about it."
Bifeprunox - RIP
Lundbeck announced the joint decision with its partner Solvay to stop all joint R&D activities for Solvay's compound bifeprunox in development for maintenance treatment of schizophrenia.
The companies made this decision after evaluating the recent results from an interim analysis of pooled data intended for a possible extension of the ongoing clinical phase III trial programme.
The companies made this decision after evaluating the recent results from an interim analysis of pooled data intended for a possible extension of the ongoing clinical phase III trial programme.
Efficacy data did not support pursuing the existing development strategy of stabilisation of non-acute patients with schizophrenia.
Therefore, Lundbeck and Solvay judge that it would be futile to continue the studies.
Thursday, July 30, 2009
Pfizer - Neurontin: Lanier vs Kindler
Pfizer Inc. won’t face a verdict over claims its epilepsy drug Neurontin helped lead a Massachusetts woman to commit suicide, after her family dropped its lawsuit in the midst of trial.
Susan Bulger’s family agreed to dismiss the suit after an anonymous donor offered to put money in a trust for her 10-year- old daughter, Regina, said Mark Lanier, the family’s lawyer. The trial began July 27 and was scheduled to run three weeks in federal court in Boston.
The suit was the first of about 1,200 involving Neurontin. The family claimed Pfizer, the world’s largest drug company, promoted the medication for unapproved uses and didn’t warn it could increase the risk of suicide until forced to do so by the government. Pfizer said Bulger had a history of drug abuse and had made six suicide attempts before taking her life in 2004.
“We are pleased to have been vindicated in this case,” Jeffrey Kindler, chief executive officer of New York-based Pfizer, said in a phone interview on Bloomberg Television today. Neurontin has been “prescribed to treat millions of patients safely and effectively for many, many years and it’s been widely studied for more than two decades,” he said.
The next Neurontin trial is set to start March 29 in Boston federal court, while another case in Tennessee may be tried earlier, Lanier said. The lawsuits claim Pfizer should have warned patients and doctors that Neurontin can increase suicidal thoughts.
Kindler’s comments are “outrageous,” Lanier said. “All Pfizer got today was a six-month stay of execution. We have 1,200 more of these cases to go.”
The anonymous donor was a plaintiffs’ lawyer who wasn’t involved in the case, said Lanier, a friend of the donor’s. “It was the best thing for the family,” said David Egilman, a Brown University medical school professor who serves as the Bulgers’ spokesman.
Susan Bulger’s family agreed to dismiss the suit after an anonymous donor offered to put money in a trust for her 10-year- old daughter, Regina, said Mark Lanier, the family’s lawyer. The trial began July 27 and was scheduled to run three weeks in federal court in Boston.
The suit was the first of about 1,200 involving Neurontin. The family claimed Pfizer, the world’s largest drug company, promoted the medication for unapproved uses and didn’t warn it could increase the risk of suicide until forced to do so by the government. Pfizer said Bulger had a history of drug abuse and had made six suicide attempts before taking her life in 2004.
“We are pleased to have been vindicated in this case,” Jeffrey Kindler, chief executive officer of New York-based Pfizer, said in a phone interview on Bloomberg Television today. Neurontin has been “prescribed to treat millions of patients safely and effectively for many, many years and it’s been widely studied for more than two decades,” he said.
The next Neurontin trial is set to start March 29 in Boston federal court, while another case in Tennessee may be tried earlier, Lanier said. The lawsuits claim Pfizer should have warned patients and doctors that Neurontin can increase suicidal thoughts.
Kindler’s comments are “outrageous,” Lanier said. “All Pfizer got today was a six-month stay of execution. We have 1,200 more of these cases to go.”
The anonymous donor was a plaintiffs’ lawyer who wasn’t involved in the case, said Lanier, a friend of the donor’s. “It was the best thing for the family,” said David Egilman, a Brown University medical school professor who serves as the Bulgers’ spokesman.
Nissen on CME - "it's marketing"
"Companies readily pay hundreds of millions of dollars annually to support 'continuing medical education' for one very simple reason -- it sells their products," said Cleveland Clinic's chair of cardiology, Dr. Steve Nissen. "Industry funded CME is not philanthropy, it is marketing."
Wednesday, July 29, 2009
Medtronic and Mr Polly
By David Armstrong
Did you ever wonder what doctors do to earn big consulting contracts from medical device companies and pharmaceutical concerns?
Records released by Medtronic to Sen. Charles Grassley, a longtime critic of the ties between academics and and health-care companies, provide a rare and detailed glimpse into the daily billings of a consultant — in this case, spine surgeon David Polly of the University of Minnesota.
Polly collected more than $1 million in four years of work for Medtronic, according to the records.
The services he provided were many, but among them, Polly was paid to write articles for medical journals; write a chapter in a book and a book outline; recruit patients for publicity efforts; attend Medtronic national sales meetings; travel to conferences in Japan, Paris and elsewhere; lead training and educational sessions for physicians; and lobby Congress.
Polly also billed for at least two phone calls with Medtronic CEO William Hawkins as well as charging the company $2,000 when Mr. Hawkins visited an operating room. In October, 2003, he billed the company $12,000 for attending a medical meeting of the North American Spine Society, at $4,000 a day.
There are also scores of entries for work billed in five-minute increments, usually to send email or return phone calls. The bill for each five-minute charge? $49.48 a pop.
A lawyer for Polly said the surgeon is also a researcher and consultant, and “works very hard to ensure that he properly tracks and allocates the time spent among these roles and will review any concerns in this area. In every instance, he has conducted himself honorably in advocating for injured veterans.” Medtronic said it’s doing a “comprehensive review” of company procedures aimed at making sure physicians disclose their work for the company and expects to issue new standards in that area.
There is more detail in a WSJ article this morning. Link
Did you ever wonder what doctors do to earn big consulting contracts from medical device companies and pharmaceutical concerns?
Records released by Medtronic to Sen. Charles Grassley, a longtime critic of the ties between academics and and health-care companies, provide a rare and detailed glimpse into the daily billings of a consultant — in this case, spine surgeon David Polly of the University of Minnesota.
Polly collected more than $1 million in four years of work for Medtronic, according to the records.
The services he provided were many, but among them, Polly was paid to write articles for medical journals; write a chapter in a book and a book outline; recruit patients for publicity efforts; attend Medtronic national sales meetings; travel to conferences in Japan, Paris and elsewhere; lead training and educational sessions for physicians; and lobby Congress.
Polly also billed for at least two phone calls with Medtronic CEO William Hawkins as well as charging the company $2,000 when Mr. Hawkins visited an operating room. In October, 2003, he billed the company $12,000 for attending a medical meeting of the North American Spine Society, at $4,000 a day.
There are also scores of entries for work billed in five-minute increments, usually to send email or return phone calls. The bill for each five-minute charge? $49.48 a pop.
A lawyer for Polly said the surgeon is also a researcher and consultant, and “works very hard to ensure that he properly tracks and allocates the time spent among these roles and will review any concerns in this area. In every instance, he has conducted himself honorably in advocating for injured veterans.” Medtronic said it’s doing a “comprehensive review” of company procedures aimed at making sure physicians disclose their work for the company and expects to issue new standards in that area.
There is more detail in a WSJ article this morning. Link
JAMA Conference
WHAT: Sixth International Congress on Peer Review and Biomedical Publication
WHEN: September 10 – 12, 2009
WHERE: Vancouver, BC, Canada
New research will be presented about peer review and other processes to evaluate and disseminate medical and scientific research and other information during the conference.
Every four years, editors, publishers and researchers representing the leading medical and scientific institutions and journals from around the world meet with the goal to improve the quality and credibility of biomedical peer review and publication.
Topics Include:
Authorship and Ghost Writing
Conflicts of Interest
Editorial Decisions and Peer Review
Ethical Concerns
Publication Bias
“Spin” on Study Results
Clinical Trial Registration
Quality of Biomedical Publication
Postpublication Concerns
Complete program information available at www.jama-peer.org.
Free Registration for Credentialed Journalists: Register online at www.jamamedia.org on the Events page or onsite.
Special hotel room rates available at the Westin Bayshore Hotel, Vancouver: http://www.ama-assn.org/public/peer/hotel.html.
For More Information: Call JAMA Media Relations at 312-464-JAMA (5262) or email: mediarelations@jama-archives.org.
Alvogen - return of the Viking Boss
Icelandic pharmaceutical entrepreneur Robert Wessman is staging a comeback in the generic drugs business, taking a 30 percent stake and the role of executive chairman at privately held U.S. firm Alvogen Group.
The move comes a year after Wessman stepped down as chief executive officer (CEO) of Actavis, the firm he pieced together into one of the world's biggest copycat drugmakers through a string of more than two dozen acquisitions.
Wessman, once dubbed the "Viking boss" by the Economist, told Reuters he now aims to make Alvogen one of the world's ten biggest generic drug makers by revenues in five years.
More at Reuters
CME: Continuing Medical Education or Commercial Marketing Efforts?
Testimony submitted to the Senate Committee on Aging hearing on
Medical Research and Education: Higher Learning or Higher Earning?
Adriane Fugh-Berman MD
Director, PharmedOut
Department of Physiology and Biophysics
Georgetown University Medical Center
Box 571460
Washington DC 20057-1460
Ajf29@georgetown.edu
http://pharmedout.org/index.htm
Disclosure: Dr. Fugh-Berman has been a paid expert witness on behalf of plaintiffs in litigation regarding pharmaceutical marketing practices.
Continuing medical education (CME) is the pharmaceutical industry’s most important marketing tool. The development of marketing messages for a drug starts seven to ten years before a drug is submitted for FDA approval. Many of the marketing messages that are developed for each product do not mention the drug at all. A ‘pre-launch’ marketing message might emphasize the importance of a specific physiologic process in order to set the stage for acceptance of a drug that affects that mechanism, or might create an unnecessary diagnostic distinction in order to establish a niche for a drug entering a crowded market.
Selling disease
CME can be used to sell drugs by selling diseases. As a marketing article called “Proving the case for investing in CME” states: “The most significant benefits for industry may include creating disease-state awareness and disease state significance.” Another marketing article notes that: “CME activities are most valuable in introducing products early in their life cycles or for promoting mature brands with new indications and new clinical data.”
Industry-funded CME often emphasizes the severity or prevalence of specific conditions in order to prepare, or expand, a market. Manipulating physicians’ understanding of the prevalence or severity of medical conditions can lead to overtreatment and expose patients to the adverse effects of drugs without significant benefit.
The marketing messages embedded in CME lectures, articles, on-line modules, and tests are never advertisements for a specific therapy because physicians will reject speakers or articles that obviously favor a specific drug. One marketing message might emphasize the risks of competing therapies; another the lack of evidence regarding an over-the-counter remedy.
CME is often used to promote unproven uses of a drug. While it is illegal for a drug company to promote off-label use of a drug, CME is not considered promotion and is not regulated by the FDA. Physicians can say whatever they want, so are used as mouthpieces for marketing messages that would be illegal coming from a company rep.
The academic physicians involved in industry-funded CME may protest, quite honestly, that they are expressing their independent opinions. However, these physicians are chosen because what they are saying aligns with a product’s marketing messages, and they are supported only as long as their opinions do so. A physician who expresses doubts about a product’s efficacy, concerns about its risks, or enthusiasm for a competing therapy will be unceremoniously dropped from a company’s speaker’s bureau.
Vetting bias in CME modules
There is little incentive for medical education and communication (MEC) companies or academic medical centers to attempt to ferret out bias in CME modules, because both depend on industry for survival. In 2008, 44% of the $2.4 billion spent on CME came from pharmaceutical manufacturers. Sixty-nine percent of the income from events sponsored by medical education companies is from firms that manufacture FDA-regulated products. Academic medical centers are only a little better; 54% of CME income to medical schools comes from industry.
Although academic CME providers do their best to vet industry-funded modules for bias, such review focuses on the detection of obvious advertising, the use of brand rather than generic names of drugs, and adequate disclosure of conflict of interest. No matter how vigilant they are, CME providers are not trained in recognizing marketing messages and cannot adequately assess industry-funded materials for bias.
As previously noted, marketing begins years before a drug reaches the market. Adequate vetting of CME modules would require knowledge of every drug, biologic, device, and diagnostic test that every company is marketing, developing, or considering. The task becomes even more daunting when mergers, acquisitions, co-marketing agreements and collaborative marketing arrangements (for example, among companies selling drugs in the same class) are taken into account. Similarly, disclosures of financial conflicts of interest are impossible to interpret without knowing every company’s marketing plan for every drug on the market or in the pipeline.
‘Unrestricted’ grants
Unrestricted educational grants to academic medical centers and MECs are no solution. Although the new PhRMA Code of Ethics does not allow sponsors (companies that fund the event) to suggest speakers, sponsors may indicate which topics they are interested in funding. “Unrestricted” grants provided for grand rounds and lunch conferences depend on a sense of obligation rather than a quid pro quo. When lists of recommended speakers are supplied to organizers, it is unstated, but nonetheless understood, that company-paid speakers will be included in the lecture series.
The organizing board of the CME program may include speakers selected and paid by the sponsor. The desired messages about particular products or diseases may be made clear. Organizers understand that sponsors or exhibitors may withdraw if they don’t like the content. Not every speaker in a lecture series or conference is chosen by industry. Pharmaceutical companies refer to presentations with marketing messages as “message talks,” and sponsored CME programs usually include talks that are not connected with the sponsor’s product. Although these camouflage talks may involve independent speakers, organizers know that they must avoid inviting speakers who might criticize a sponsor’s products or oppose a sponsor’s marketing messages.3
Physicians will never hear about how a targeted disease is overdiagnosed or overtreated at a sponsored event. And rarely will they hear positive recommendations for a competitor’s product, a generic product, or a non-pharmacologic therapy at a sponsored program.
ACCME
The ACCME Standards for Commercial Support to discourage potential conflicts of interest are both weak and ignored. A 2007 annual report by the ACCME, however, showed that 29% of providers failed to comply with Standard 2, which requires that any individuals that control content of a CME activity disclose and resolve conflicts of interest. Twenty-seven percent of the providers did not comply with Standard 3, which includes guidelines to prevent those with commercial interests from dictating the content of a CME activity. And 36% of providers were noncompliant with Standard 6, which requires that all commercial support and financial relationships of authors be disclosed to CME participants before the activity.6
The ACCME does not screen CME activities, and does not encourage audience members to report commercial bas. Although written complaints are accepted, the process is burdensome. Losing accreditation for any reason is rare; according to the annual reports published by the ACCME only one provider lost accreditation in 2005.
Conclusion
If sponsoring CME events did not increase product sales, drug companies would not do it. The large amount of commercial support poured into CME is in itself testimony that industry believes supporting CME is cost-effective. Industry influence on medical discourse limits the discussion to the most profitable therapies, which may not be best for patients. Industry-funded medical education is a contradiction in terms.
###
Acknowledgments: Alicia Bell MS, Margaret Infeld, Clare Murphy, Stephanie Waterhouse, and Nicole Woodard provided background research.
About PharmedOut
PharmedOut, a project based at Georgetown University Medical Center, uses academic research and drug industry insider perspectives to educate prescribers about how covert marketing techniques affect prescribing behavior. PharmedOut was launched through a grant from the Attorney General Consumer and Prescriber Grant Program.
Our latest free, web-based, 3-CME credit educational module is called The Pharmalyzer: Are you prescribing under the influence? Our unique approach draws on academic and marketing materials combined with original interviews with industry insiders to create novel articles, videos, and educational materials. Our goal is to foster evidence-based, cost-effective prescribing and to decrease the adverse public health effects of inappropriate pharmaceutical promotion.
We provide original web-based CME modules and links to more than 150 free, non-industry-funded, web-based continuing medical education (CME) courses – enough for any physician, nurse, or pharmacist to complete annual continuing education requirements. Educational resources include our slideshows, Drug Ad Bingo (a teaching exercise), Fast Facts on Generic Drugs (a factsheet for patients), and seven original videos, featuring industry insiders. Our publications include Off-Label Promotion, On-Target Sales, Following the Script: How Drug Reps Make Friends and Influence Doctors, Do New Drugs Increase Life Expectancy?, Ethical Considerations of Publication Planning in the Pharmaceutical Industry, Prescription Tracking and Public Health, Key Opinion Leaders: Thus Are Our Medical Meetings Managed, and Smoke and Mirrors.
Medical Research and Education: Higher Learning or Higher Earning?
Adriane Fugh-Berman MD
Director, PharmedOut
Department of Physiology and Biophysics
Georgetown University Medical Center
Box 571460
Washington DC 20057-1460
Ajf29@georgetown.edu
http://pharmedout.org/index.htm
Disclosure: Dr. Fugh-Berman has been a paid expert witness on behalf of plaintiffs in litigation regarding pharmaceutical marketing practices.
Continuing medical education (CME) is the pharmaceutical industry’s most important marketing tool. The development of marketing messages for a drug starts seven to ten years before a drug is submitted for FDA approval. Many of the marketing messages that are developed for each product do not mention the drug at all. A ‘pre-launch’ marketing message might emphasize the importance of a specific physiologic process in order to set the stage for acceptance of a drug that affects that mechanism, or might create an unnecessary diagnostic distinction in order to establish a niche for a drug entering a crowded market.
Selling disease
CME can be used to sell drugs by selling diseases. As a marketing article called “Proving the case for investing in CME” states: “The most significant benefits for industry may include creating disease-state awareness and disease state significance.” Another marketing article notes that: “CME activities are most valuable in introducing products early in their life cycles or for promoting mature brands with new indications and new clinical data.”
Industry-funded CME often emphasizes the severity or prevalence of specific conditions in order to prepare, or expand, a market. Manipulating physicians’ understanding of the prevalence or severity of medical conditions can lead to overtreatment and expose patients to the adverse effects of drugs without significant benefit.
The marketing messages embedded in CME lectures, articles, on-line modules, and tests are never advertisements for a specific therapy because physicians will reject speakers or articles that obviously favor a specific drug. One marketing message might emphasize the risks of competing therapies; another the lack of evidence regarding an over-the-counter remedy.
CME is often used to promote unproven uses of a drug. While it is illegal for a drug company to promote off-label use of a drug, CME is not considered promotion and is not regulated by the FDA. Physicians can say whatever they want, so are used as mouthpieces for marketing messages that would be illegal coming from a company rep.
The academic physicians involved in industry-funded CME may protest, quite honestly, that they are expressing their independent opinions. However, these physicians are chosen because what they are saying aligns with a product’s marketing messages, and they are supported only as long as their opinions do so. A physician who expresses doubts about a product’s efficacy, concerns about its risks, or enthusiasm for a competing therapy will be unceremoniously dropped from a company’s speaker’s bureau.
Vetting bias in CME modules
There is little incentive for medical education and communication (MEC) companies or academic medical centers to attempt to ferret out bias in CME modules, because both depend on industry for survival. In 2008, 44% of the $2.4 billion spent on CME came from pharmaceutical manufacturers. Sixty-nine percent of the income from events sponsored by medical education companies is from firms that manufacture FDA-regulated products. Academic medical centers are only a little better; 54% of CME income to medical schools comes from industry.
Although academic CME providers do their best to vet industry-funded modules for bias, such review focuses on the detection of obvious advertising, the use of brand rather than generic names of drugs, and adequate disclosure of conflict of interest. No matter how vigilant they are, CME providers are not trained in recognizing marketing messages and cannot adequately assess industry-funded materials for bias.
As previously noted, marketing begins years before a drug reaches the market. Adequate vetting of CME modules would require knowledge of every drug, biologic, device, and diagnostic test that every company is marketing, developing, or considering. The task becomes even more daunting when mergers, acquisitions, co-marketing agreements and collaborative marketing arrangements (for example, among companies selling drugs in the same class) are taken into account. Similarly, disclosures of financial conflicts of interest are impossible to interpret without knowing every company’s marketing plan for every drug on the market or in the pipeline.
‘Unrestricted’ grants
Unrestricted educational grants to academic medical centers and MECs are no solution. Although the new PhRMA Code of Ethics does not allow sponsors (companies that fund the event) to suggest speakers, sponsors may indicate which topics they are interested in funding. “Unrestricted” grants provided for grand rounds and lunch conferences depend on a sense of obligation rather than a quid pro quo. When lists of recommended speakers are supplied to organizers, it is unstated, but nonetheless understood, that company-paid speakers will be included in the lecture series.
The organizing board of the CME program may include speakers selected and paid by the sponsor. The desired messages about particular products or diseases may be made clear. Organizers understand that sponsors or exhibitors may withdraw if they don’t like the content. Not every speaker in a lecture series or conference is chosen by industry. Pharmaceutical companies refer to presentations with marketing messages as “message talks,” and sponsored CME programs usually include talks that are not connected with the sponsor’s product. Although these camouflage talks may involve independent speakers, organizers know that they must avoid inviting speakers who might criticize a sponsor’s products or oppose a sponsor’s marketing messages.3
Physicians will never hear about how a targeted disease is overdiagnosed or overtreated at a sponsored event. And rarely will they hear positive recommendations for a competitor’s product, a generic product, or a non-pharmacologic therapy at a sponsored program.
ACCME
The ACCME Standards for Commercial Support to discourage potential conflicts of interest are both weak and ignored. A 2007 annual report by the ACCME, however, showed that 29% of providers failed to comply with Standard 2, which requires that any individuals that control content of a CME activity disclose and resolve conflicts of interest. Twenty-seven percent of the providers did not comply with Standard 3, which includes guidelines to prevent those with commercial interests from dictating the content of a CME activity. And 36% of providers were noncompliant with Standard 6, which requires that all commercial support and financial relationships of authors be disclosed to CME participants before the activity.6
The ACCME does not screen CME activities, and does not encourage audience members to report commercial bas. Although written complaints are accepted, the process is burdensome. Losing accreditation for any reason is rare; according to the annual reports published by the ACCME only one provider lost accreditation in 2005.
Conclusion
If sponsoring CME events did not increase product sales, drug companies would not do it. The large amount of commercial support poured into CME is in itself testimony that industry believes supporting CME is cost-effective. Industry influence on medical discourse limits the discussion to the most profitable therapies, which may not be best for patients. Industry-funded medical education is a contradiction in terms.
###
Acknowledgments: Alicia Bell MS, Margaret Infeld, Clare Murphy, Stephanie Waterhouse, and Nicole Woodard provided background research.
About PharmedOut
PharmedOut, a project based at Georgetown University Medical Center, uses academic research and drug industry insider perspectives to educate prescribers about how covert marketing techniques affect prescribing behavior. PharmedOut was launched through a grant from the Attorney General Consumer and Prescriber Grant Program.
Our latest free, web-based, 3-CME credit educational module is called The Pharmalyzer: Are you prescribing under the influence? Our unique approach draws on academic and marketing materials combined with original interviews with industry insiders to create novel articles, videos, and educational materials. Our goal is to foster evidence-based, cost-effective prescribing and to decrease the adverse public health effects of inappropriate pharmaceutical promotion.
We provide original web-based CME modules and links to more than 150 free, non-industry-funded, web-based continuing medical education (CME) courses – enough for any physician, nurse, or pharmacist to complete annual continuing education requirements. Educational resources include our slideshows, Drug Ad Bingo (a teaching exercise), Fast Facts on Generic Drugs (a factsheet for patients), and seven original videos, featuring industry insiders. Our publications include Off-Label Promotion, On-Target Sales, Following the Script: How Drug Reps Make Friends and Influence Doctors, Do New Drugs Increase Life Expectancy?, Ethical Considerations of Publication Planning in the Pharmaceutical Industry, Prescription Tracking and Public Health, Key Opinion Leaders: Thus Are Our Medical Meetings Managed, and Smoke and Mirrors.
Clinical Knowledge Summaries Update
Clinical Knowledge Summaries (CKS) has been updated for a second time in July 2009. CKS may have change their publishing schedule. Updates are available for the following clinical areas:
- Antiplatelet treatment
- Chronic kidney disease – not diabetic
- Hypertension – not diabetic
- Immunisations – seasonal influenza
- Insomnia
- Otitis media – acute
- Palliative cancer care – malignant ulcer
- Sleep disorders – shift work and jet lag
Hat tip: http://www.prescriber.org.uk/
DSM IV vs DSM V - the truth about psychiatric diagnoses
IV = “a naked land grab by a profession threatened with marginalization by biomedical research.’’
V = “a wholesale imperial medicalization of normality that will trivialize mental disorder and lead to a deluge of unneeded medication treatment - a bonanza for the pharmaceutical industry but at a huge cost to the new false positive ‘patients’ caught in the excessively wide DSM-V net.’’
More
V = “a wholesale imperial medicalization of normality that will trivialize mental disorder and lead to a deluge of unneeded medication treatment - a bonanza for the pharmaceutical industry but at a huge cost to the new false positive ‘patients’ caught in the excessively wide DSM-V net.’’
More
Tuesday, July 28, 2009
'Capitalism: A Love Story' to be released Oct. 2
Michael Moore's opting to spoof romantic conventions in titling his upcoming documentary "Capitalism: A Love Story," which addresses the causes of the global economic meltdown.
"It will be the perfect date movie," Moore said in an announcement Wednesday. "It's got it all -- lust, passion, romance and 14,000 jobs being eliminated every day. It's a forbidden love, one that dare not speak its name. Heck, let's just say it: It's capitalism."
Moore and Overture Films had announced previously that the film would be released domestically on Oct. 2 -- a year and a day after the U.S. Senate voted to approve a $700 billion bailout of Wall Street. Paramount Vantage will handle international distribution.
The film is described as focusing on "the disastrous impact that corporate dominance and out-of-control profit motives have on the lives of Americans and citizens of the world."
Pic is Moore's first since "Sicko" in 2007. He's made three of the top six highest-grossing documentaries -- "Fahrenheit 9/11," "Sicko" and "Bowling for Columbine."
Overture and Par announced the project a year ago, during the Cannes Film Festival, but were vague as to the project's theme beyond noting that it was coming from the same filmmaker who had delivered "Fahrenheit 9/11." As the project took shape, Moore decided to focus on the financial crisis and issued an appeal in February for people working on Wall Street or in the financial industry to come forward and share what they knew.
"Be a hero and help me expose the biggest swindle in American history," Moore said at the time.
Overture CEO Chris McGurk and chief operating officer Danny Rosett previously worked with Moore on the release of "Bowling for Columbine" at MGM/United Artists.
By Dave McNary / Variety
Alizyme - bone picking
It will be interesting to see who picks up the pieces left over from Alizyme going into administration on Friday.
The Granta Park-based biotech company looked earlier this month as if it had a knight in shining armour riding in to save the day, but serial biotech entrepreneur and investor Alan Goodman (pic) has been forced to throw in the towel.
He took over briefly as chairman in a last ditch effort to save the business, which had already warned it would not last without more funds by the end of next month.
At one time Alizyme was seen as a big rising star in the biotech firmament and over the biotech years more than £100m has gone into the company, only 15 months ago a further £10m was raised via a share placing.
Mr Goodman told the News earlier this month as he stepped into the chair:
"I love a challenge. I am looking to do my magic."
But even his magic wand couldn't knock away a surprise hit at the end of last week when US firm Prometheus Labs decided to file a complaint against Alizyme for breach of contract.
Mr Goodman pooh-poohs any breach and says he was in negotiations with Prometheus before the surprise complaint, which, he says, immediately made it impossible to raise more funds for Alizyme.
"It's like getting married and having filed for divorce two days beforehand," he said, referring to the complaint filing, which was actually logged on July 21.
"It would have cost £5m to defend and the company doesn't have £5m," he added. "It was a bolt from the blue.
Mr Goodman agreed that the door was now open to pick up Alizyme's assets cheaply and without any encumbrances such as breach of contract complaints.
"But there's a whole lot more pain to come and the sensible thing to do would have been to negotiate. I thought I could do it, but didn't manage to pull it off."
There are 10 people working for the company, which was founded in 1996 by Andrew Porter, a biotech financial analyst, and Tim McCarthy, who was chief financial officer, and until Mr Goodman took over as chairman and ceo earlier this month, chief executive.
In happier times the company was a winner in the London Stock Exchange TechMark Awards. Drugs have been under development to treat obesity and irritable bowel syndrome.
Pfizer - Trovan: $75 million settlement
NIGERIA - Kano State government will on Thursday formally sign a historic agreement with Pfizer, the multi-national drug producers, over the contentious drug trial associated with a cerebro-spinal meningitis outbreak in the state in 1996.
The final out-of-court settlement in a multi-billion-dollar lawsuit over the trial of meningitis drug, Trovan, is coming after years of bitter lawsuits between both parties, their lawyers said yesterday.
"We have settled and we are signing an agreement on Thursday, Kano State government has finally reached a $75 million settlement agreement with Pfizer Pharmaceutical Company, over the 1996 trovan test in the state. said Aliyu Umar, counsel for Kano State government.
The final agreement between the pharmaceutical giant and the Kano state government is based on an out-of-court settlement agreed by both parties over the three-year drug test in the state.
The state governor, Alhaji Ibrahim Shekarau had disclosed during an interview with the British Broadcasting Corporation, BBC Network Africa, earlier in the year that he was in London along with leader of the Trovan test victims' chairman, the State Attorney-General and the State Commissioner for Health to finalise agreement and work out modalities with Pfizer executives on how the money would be shared.
Shekarau who explained why the full payment might take up to 2011, said there were certain things that could not come in one fell swoop.
The governor had said then that the victims would receive $35 million; the state government would get $30million, while $10 million would go to the lawyers , stressing that they agreed to out-of-court settlement because of the protracted dimension the legal tussle had taken.
According to him, "The logic behind our amicable settlement out-of-court was that the case may take yet another 10 years before coming to an end," he said. He noted that the settlement was due as it would alleviate the suffering of the victims and the parents of the dead victims.
Shekarau said a committee of trustees involving various stakeholders had been set up to verify the victims and the veracity of their impairment to ensure that justice is done in the sharing of the compensation.
Kano State had instituted a series of lawsuits against Pfizer seeking damages over allegations that the study resulted in brain damage, paralysis or slurred speech in many children.
Eleven children died during the test, which was performed during an outbreak of the disease, but the governments and Pfizer disagreed about whether the deaths were caused by the tests or by meningitis .
The final out-of-court settlement in a multi-billion-dollar lawsuit over the trial of meningitis drug, Trovan, is coming after years of bitter lawsuits between both parties, their lawyers said yesterday.
"We have settled and we are signing an agreement on Thursday, Kano State government has finally reached a $75 million settlement agreement with Pfizer Pharmaceutical Company, over the 1996 trovan test in the state. said Aliyu Umar, counsel for Kano State government.
The final agreement between the pharmaceutical giant and the Kano state government is based on an out-of-court settlement agreed by both parties over the three-year drug test in the state.
The state governor, Alhaji Ibrahim Shekarau had disclosed during an interview with the British Broadcasting Corporation, BBC Network Africa, earlier in the year that he was in London along with leader of the Trovan test victims' chairman, the State Attorney-General and the State Commissioner for Health to finalise agreement and work out modalities with Pfizer executives on how the money would be shared.
Shekarau who explained why the full payment might take up to 2011, said there were certain things that could not come in one fell swoop.
The governor had said then that the victims would receive $35 million; the state government would get $30million, while $10 million would go to the lawyers , stressing that they agreed to out-of-court settlement because of the protracted dimension the legal tussle had taken.
According to him, "The logic behind our amicable settlement out-of-court was that the case may take yet another 10 years before coming to an end," he said. He noted that the settlement was due as it would alleviate the suffering of the victims and the parents of the dead victims.
Shekarau said a committee of trustees involving various stakeholders had been set up to verify the victims and the veracity of their impairment to ensure that justice is done in the sharing of the compensation.
Kano State had instituted a series of lawsuits against Pfizer seeking damages over allegations that the study resulted in brain damage, paralysis or slurred speech in many children.
Eleven children died during the test, which was performed during an outbreak of the disease, but the governments and Pfizer disagreed about whether the deaths were caused by the tests or by meningitis .
Monday, July 27, 2009
Kiddies BNF
The British National Formulary for Children 2009 has been updated, published and made available online.
Hard copies can be ordered from the publishers however many NHS staff will already have received a free hard copy through usual channels and can also access the online version at http://www.bnfc.nhs.uk.
Hat tip: http://www.prescriber.org.uk/
Kids on drugs! A tenfold increase in atypical antipsychotics
Medical research out of the University of British Columbia suggests the number of children taking medications known as atypical antipsychotics has increased tenfold over the past decade, CBC News has learned.
The drugs — a class of medicines used to treat psychosis and other mental and emotional conditions — can have potentially serious side-effects, and are linked to increases in stroke and sudden death in adults.
Health Canada has not approved atypical antipsychotics for children.
"None of the atypical antipsychotics approved in Canada [Risperidone, Quetiapine, Olanzapine, Clozapine, Paliperidone, Ziprasidone] are indicated for use in children," Philippe Laroche, a Health Canada spokesman, told CBC News in an email on Thursday.
Colin Dormuth is an epidemiologist who reviewed all prescriptions involving atypical antipsychotics and written for children in B.C. over the last decade.
He says he found a tenfold increase in prescriptions of atypical antipsychotics for children 14 and under. Also called neuroleptics or second-generation antipsychotics, they include risperidone (Risperdal), quetiapine (Seroquel) and olanzapine (Zyprexa).
Dormuth was surprised at the young age of some of the children on the powerful medications, he told CBC.
The drugs — a class of medicines used to treat psychosis and other mental and emotional conditions — can have potentially serious side-effects, and are linked to increases in stroke and sudden death in adults.
Health Canada has not approved atypical antipsychotics for children.
"None of the atypical antipsychotics approved in Canada [Risperidone, Quetiapine, Olanzapine, Clozapine, Paliperidone, Ziprasidone] are indicated for use in children," Philippe Laroche, a Health Canada spokesman, told CBC News in an email on Thursday.
Colin Dormuth is an epidemiologist who reviewed all prescriptions involving atypical antipsychotics and written for children in B.C. over the last decade.
He says he found a tenfold increase in prescriptions of atypical antipsychotics for children 14 and under. Also called neuroleptics or second-generation antipsychotics, they include risperidone (Risperdal), quetiapine (Seroquel) and olanzapine (Zyprexa).
Dormuth was surprised at the young age of some of the children on the powerful medications, he told CBC.
Could Big Pharma pool assets rather than merge?
Shona the Canadian
What's wrong with this ad!?
There's more:
Insider's view: Healthcare in Canada and the UK may not be perfect - but it's GOOD!
Neither Obama nor congressional Democrats are advocating a Canadian-style system. And Canadian health officials said that patients with life-threatening conditions aren’t subject to waiting periods. The New York-based Commonwealth Fund, a non- profit, non-partisan research group, found 8 percent of Canadians waited that long, and only for elective operations.
I'm glad Shona got what she needed by travelling to the US - I wonder how much she had to pay? Maybe doing the ads is helping her pay off her bills!
Pfizer 's riser on the up!
Viagra prescriptions in the UK are on the RISE with more than 1.18 million men getting the little blue pill from GPs in the past year.
The figure is UP six per cent on the previous year with a total of 1.98 million men prescribed Viagra and rival brands, costing the NHS £35m a year.
The figure is UP six per cent on the previous year with a total of 1.98 million men prescribed Viagra and rival brands, costing the NHS £35m a year.
Sunday, July 26, 2009
Wyeth - Premarin/Prempro: pass me my reading glasses
A federal judge has ordered the unsealing of thousands of pages of documents pertaining to the ghostwriting practices of Wyeth Pharmaceuticals, which is being sued over hormone replacement drugs.
U.S. District Judge Bill Wilson ordered the papers unsealed Friday at the request of a medical journal and The New York Times. Plaintiffs attorneys presented the papers earlier at trial to show Wyeth routinely hired medical-writing firms to ghostwrite articles that appeared in seemingly objective medical journals but included only the name of a scientific researcher as the author.
The ruling came in a case that involves about 8,000 lawsuits that have been combined before Wilson. The lawsuits focus on whether Wyeth hormone therapy drugs Prempro and Premarin, used to treat symptoms of menopause, have caused breast cancer in some women.
The New Jersey drugmaker already had turned over the documents, which it says concern about 40 articles in medical journals and other publications, to Sen. Charles Grassley, R-Iowa. Grassley sought them last year without a subpoena as part of a congressional investigation into drug-industry influence on doctors.
U.S. District Judge Bill Wilson ordered the papers unsealed Friday at the request of a medical journal and The New York Times. Plaintiffs attorneys presented the papers earlier at trial to show Wyeth routinely hired medical-writing firms to ghostwrite articles that appeared in seemingly objective medical journals but included only the name of a scientific researcher as the author.
The ruling came in a case that involves about 8,000 lawsuits that have been combined before Wilson. The lawsuits focus on whether Wyeth hormone therapy drugs Prempro and Premarin, used to treat symptoms of menopause, have caused breast cancer in some women.
The New Jersey drugmaker already had turned over the documents, which it says concern about 40 articles in medical journals and other publications, to Sen. Charles Grassley, R-Iowa. Grassley sought them last year without a subpoena as part of a congressional investigation into drug-industry influence on doctors.
Saturday, July 25, 2009
IMS to decimate
IMS Health has reported a 19% drop in Q2 profit to $62.9m from $77.7m a year earlier.
Accordingly, the firm is planning to shed a total of 850 staff, or 11% of its global workforce; 500 jobs in Europe and 170 positions will be made redundant in the US.
Friday, July 24, 2009
ShMerck offer info
Merck & Co. and Schering-Plough Corp. say they are offering to disclose new information about their planned tie-up to settle a class action lawsuit by shareholders.
The New Jersey-based companies proposed a settlement in which they would disclose more information about the proposed $41.1 billion combination, the opinions of financial adviser JPMorgan on the fairness of the deal, and other details.
No damages would be paid, and Merck says the settlement is not an admission of wrongdoing or liability.
It says the plaintiffs will be able to request that Merck pay their fees and costs. Schering-Plough says if the court approves the settlement, it will resolve all claims that were brought or could be brought by shareholders.
The New Jersey-based companies proposed a settlement in which they would disclose more information about the proposed $41.1 billion combination, the opinions of financial adviser JPMorgan on the fairness of the deal, and other details.
No damages would be paid, and Merck says the settlement is not an admission of wrongdoing or liability.
It says the plaintiffs will be able to request that Merck pay their fees and costs. Schering-Plough says if the court approves the settlement, it will resolve all claims that were brought or could be brought by shareholders.
Pharma Giles writes .....
PhoniPharm “prepared for swine flu vaccine demand” says CEO.
CEO and Chairman of Phoni, Johnny B. Sinister, rejected allegations that the pharmaceutical industry was unprepared to meet the demand for vaccines arising from the current swine flu pandemic.
“It’s ridiculous to suggest that companies such as Phoni aren’t ready to meet the global demand for swine flu vaccinations,” Sinister said earlier today, “and indeed, we’ve been actively preparing for such a pandemic for the past three years.”
“This is precisely why we’ve been closing vaccine research centres and bulk manufacturing facilities in the West, and transferring the business to cheaper and less-regulated third world and Far Eastern companies,” Sinister told reporters today. “We are now fully prepared to make as much money as possible out of any pandemic, including the current one.”
Sinister acknowledged that there had been some technical challenges related to delivering swine flu vaccines in the quantities requested by European countries, especially the UK.
“We’ve been struggling with yields on the swine flu process,” he said. “This is because some of the Far Eastern dictatorships where we make the vaccines are now insisting that we supply their own populations with the vaccines before we export any to the UK. This is significantly affecting the yield of money we can screw out of the UK government’s desperate attempts to try and convince a sceptical public that they actually have some control over the pandemic, or indeed over anything,” Sinister explained.
Swine flu is believed to be a variant of a disease until recently only found in CEOs and other senior financial advisors. GSF1 or “Greedy Swine Flu” was characterised by symptoms of itchy palms, an uncontrollable craving for wealth and power, sweating and shortness of breath in the presence of financial regulators and an inability to think beyond the next big bonus payout.
Governments around the world have poured hundreds of billions of dollars into alleviating the effects of GSF, but the disease now appears to have crossed the species barrier. Large numbers of ordinary people have now become affected, with symptoms ranging from depression and desperation, through to outright poverty and loss of the will to live.
Lord Karzi, who is still this month’s UK Health Minister, strongly defended the government’s pandemic strategy. “Our programme of empty promises, meaningless reassurances and useless or impractical advice is in full swing,” Lord Karzi said earlier today, “and I’m delighted to say that the UK media is supporting these efforts. Its hysterical doom-laden coverage is distracting everyone from remembering what a clueless and dishonest bunch of clowns the current administration really are, which is just what we want…”
In the real world, some are questioning whether the promises of “H1N1 vaccines for all” can be fulfilled…
Thursday, July 23, 2009
MeReC Extra - read all about it!
The UK's National Prescribing Centre has published MeReC Extra 40 (PDF) which covers the results of recent studies into the benefits of prostate cancer screening, the effect of rosuvastatin on venous thromboembolism (VTE) and the efficacy of clopidogrel in preventing major vascular events in patients with atrial fibrillation.
BMS buy Medarex
Bristol-Myers Squibb announced that it will acquire Medarex in a deal valued at approximately $2.4 billion.
Wednesday, July 22, 2009
P&G close to sale?
The Wall Street Journal reported that Procter & Gamble is in discussions with potential buyers of its prescription-drug business, which could attract bids of approximately $3 billion, according to sources familiar with the matter.
Pharma Giles writes .......
Phoni told the WSJ that it did not know about a study published last week in Nature that claims the life expectancy of mice was increased 9 - 14 percent if they took Heapamunee, a drug Phoni markets to suppress the immune system so that organ transplants won’t be rejected.
A Phoni spokesman called it an “interesting preclinical study” and said that the company had only just become aware of the findings.
“Phoni have only just acquired Heapamunee as a result of our hostile takeover of Whyus,” said Phoni’s President of Global Marketing, Rich Pillager, “and so we’re still working out just what assets we need to strip out of the company before we shut it down. However, following the Nature study, our marketing team is already up to speed on the case,”
“We’re already getting the CME packs together on the back of the Nature report,” Pillager says. “After all, we made hundreds of millions of dollars out of illegally selling another merged-in product, the human growth hormone Gotnohopein, to anti-aging quacks before we got caught. Sure, we got fined $30m, but we were still way in profit on the scam, and so we hope to cash in on Heapamunee while the window of opportunity is still open.”
Pillager is also excited about the prospect of product co-marketing.
“A recent study into long-term users of our pain-killer Viletoxx found no-one who appeared to be over the age of sixty,” he said. “We’re hoping that a combination therapy with Heapamunee, combined with carefully-worded advertising, will enable us to put a positive spin on that finding and allow us to offset the life-shortening effects of one drug with the apparent life-extending effects of another.”
“Failing any of that, at least our Animal Health business should be able to cash in on Heapamunee sales to owners of pet mice,” Pillager notes. “At least, until we sell that division off…”
The study published last week in Nature has also aroused interest from other quarters.
“It’s time to break out of our denial about aging,” said Aubrey de Nutcase, a British fringe medical practitioner and loony, who has attracted widespread derision for his suggestions on how to forestall death.
“Dying is unequivocally the major cause of death in the industrialized world and a perfectly legitimate target of medical intervention,” foamed de Nutcase. “We have reason to believe that avoiding the medical condition known as death will be a major step forward in living longer, and I welcome further research into this concept. And into flying saucers as well...”
A completely unrelated story from the real world may be found here....
Tuesday, July 21, 2009
Jim Edwards is on fire
While the rest of us are laying back for summer Jim is coming up with the goods:
This is funny!
And this is a scoop!
This is funny!
And this is a scoop!
Merck figures - it's all about the cuts
Merck, set to buy rival Schering-Plough Corp., said profit dropped less than analysts expected on savings from job cuts, boosting the shares in before-market trading.
Second-quarter net income fell 12 percent to $1.59 billion, or 74 cents a share, Whitehouse Station, New Jersey-based Merck said today in a statement on Business Wire. Excluding items, the company said it earned 83 cents a share, exceeding the 77-cent estimate of 12 analysts surveyed by Bloomberg.
Revenue dropped 2 percent to $5.9 billion, the company said. Chief Executive Officer Richard T. Clark aims to reverse the sales decline partly by spending about $44 billion to buy Schering-Plough for its experimental treatments. Clark also is in the process of firing more than 7,000 workers to reduce costs. Merck is looking to spur sales of its vaccines, which suffered in previous quarters from manufacturing interruptions and weakness in Gardasil demand.
More
Second-quarter net income fell 12 percent to $1.59 billion, or 74 cents a share, Whitehouse Station, New Jersey-based Merck said today in a statement on Business Wire. Excluding items, the company said it earned 83 cents a share, exceeding the 77-cent estimate of 12 analysts surveyed by Bloomberg.
Revenue dropped 2 percent to $5.9 billion, the company said. Chief Executive Officer Richard T. Clark aims to reverse the sales decline partly by spending about $44 billion to buy Schering-Plough for its experimental treatments. Clark also is in the process of firing more than 7,000 workers to reduce costs. Merck is looking to spur sales of its vaccines, which suffered in previous quarters from manufacturing interruptions and weakness in Gardasil demand.
More
Philippino pharma prices pared
The Philippines’ government has accepted the price cuts offered by drugmakers for 14 of the country’s 21 most commonly-prescribed medicines, and will reduce the prices of the other seven by Executive Order (EO).
President Gloria Macapagal-Arroyo will sign the EO tomorrow (July 22) and the prices of all 21 drugs will be halved by August 15, say government officials.
Thirteen companies submitted voluntary price reductions, but only just over half of them fully complied with the government’s demand for price cuts of 50% or more.
For seven of the products, they offered reductions averaging 30%-35%, which the government has dismissed, and these medicines will now be subject to Maximum Retail Prices (MRP).
More
President Gloria Macapagal-Arroyo will sign the EO tomorrow (July 22) and the prices of all 21 drugs will be halved by August 15, say government officials.
Thirteen companies submitted voluntary price reductions, but only just over half of them fully complied with the government’s demand for price cuts of 50% or more.
For seven of the products, they offered reductions averaging 30%-35%, which the government has dismissed, and these medicines will now be subject to Maximum Retail Prices (MRP).
More
Monday, July 20, 2009
Alzheimer's cause - Big Pharma's billion dollar bet
“Drug companies are betting billions that beta amyloid is a cause of Alzheimer’s, and I desperately hope they are right,” Paul Rosenberg, assistant professor of psychiatry at Johns Hopkins University School of Medicine, said in a telephone interview. “My optimism is somewhat tempered because I’m not sure our hypothesis is really solid.”
More at Bloomberg
More at Bloomberg
Pfired Wyeth OK
EU antitrust regulators cleared Pfizer's proposed $68-billion merger with Wyeth on the condition that Pfizer carry through with its commitments to divest certain animal health assets in the EU. Officials noted that the companies' activities with regard to human health are largely complementary. Full story
Saturday, July 18, 2009
Bayer's billion dollar ad consolidation
Bayer is looking to consolidate its estimated $1 billion global advertising account, in what will be one of the biggest account reviews and consolidations in advertising history.
The review is part of a global creative sourcing initiative by Bayer, the Leverkusen, Germany-based chemical and pharmaceutical company, "to determine whether there are ways to improve the effectiveness and efficiency" in creative services and media buying, says the company.
More
The review is part of a global creative sourcing initiative by Bayer, the Leverkusen, Germany-based chemical and pharmaceutical company, "to determine whether there are ways to improve the effectiveness and efficiency" in creative services and media buying, says the company.
More
What's Corey Goodman upto after life at Pfizer?
He's not Frank Sinatra, but a lot more people these days are calling neuroscientist and entrepreneur Corey Goodman "chairman of the board."
Goodman, who joined Pfizer in 2007 to help build a network of biotech research centers and left soon after the Wyeth acquistion was announced, was last week elected chairman of the Limerick BioPharma Inc. board. The previous week, Goodman became chairman of startup iPierian Inc., which aims to turn the latest advance in stem-cell research into laboratory tools for drug discovery.
Two months after leaving his high-profile gig at Pfizer, Goodman is a whirlwind of activity. In addition to chairing the two startups, he's part of a sub rosa investment and advisory firm called VenBio, and he's involved in a green-tech startup based around the PhyloChip, invented at the Lawrence Berkeley National Laboratory and commercialized by Bay Area biotech chipmaker Affymetrix Corp. The PhyloChip performs rapid identification of microbes in real-world environments.
Goodman's work at Pfizer helped piece acquisitions such as Rinat and CovX together with internal scientists like the regenerative medicine and stem-cell group. Goodman abruptly left in May, a few months after Pfizer said it would swallow Wyeth and promoted a top Wyeth scientist to run its biologics research.
When asked about Pfizer's recent announcement that it would abandon its half-built San Francisco biotech HQ, just a short walk from Goodman's office, Goodman shook his head, began to speak and said he'd rather not go on the record.
But in a long interview this week at his San Francisco office, he did go on the record about his departure from Pfizer, the broken model of drug development and new financing models that need to emerge.
Stay tuned; the full interview is coming soon in The Deal magazine.
Alex Lash
Goodman, who joined Pfizer in 2007 to help build a network of biotech research centers and left soon after the Wyeth acquistion was announced, was last week elected chairman of the Limerick BioPharma Inc. board. The previous week, Goodman became chairman of startup iPierian Inc., which aims to turn the latest advance in stem-cell research into laboratory tools for drug discovery.
Two months after leaving his high-profile gig at Pfizer, Goodman is a whirlwind of activity. In addition to chairing the two startups, he's part of a sub rosa investment and advisory firm called VenBio, and he's involved in a green-tech startup based around the PhyloChip, invented at the Lawrence Berkeley National Laboratory and commercialized by Bay Area biotech chipmaker Affymetrix Corp. The PhyloChip performs rapid identification of microbes in real-world environments.
Goodman's work at Pfizer helped piece acquisitions such as Rinat and CovX together with internal scientists like the regenerative medicine and stem-cell group. Goodman abruptly left in May, a few months after Pfizer said it would swallow Wyeth and promoted a top Wyeth scientist to run its biologics research.
When asked about Pfizer's recent announcement that it would abandon its half-built San Francisco biotech HQ, just a short walk from Goodman's office, Goodman shook his head, began to speak and said he'd rather not go on the record.
But in a long interview this week at his San Francisco office, he did go on the record about his departure from Pfizer, the broken model of drug development and new financing models that need to emerge.
Stay tuned; the full interview is coming soon in The Deal magazine.
Alex Lash
Friday, July 17, 2009
Introducing Justinian Lane's blog
He writes:
I've been publishing a ton of documents from Fentanyl, Reglan, and phospho-soda lawsuits. Some of the Fentanyl documents had been under seal until very recently, and as far as I know, no one else has published them anywhere. Some of them are depos from company execs, and they make for a very interesting read.
http://www.dangerousdrugs.us/
Also
http://www.dangerousdrugs.us/
Also
Thursday, July 16, 2009
Michael Moore's 'Sicko' on US TV Tonight
Thursday, July 16th, 2009
The Movie Channel, this evening, will be airing the Oscar-nominated documentary, "Sicko," Michael Moore's film about a villain known as the health insurance industry. With the debate raging in Washington, D.C. -- Republicans trying to scuttle it, the President trying to hang on to his public option, and nearly a hundred members of Congress pushing for a single-payer system -- showing "Sicko" tonight is very timely. Mike lays out all the facts and the arguments as to why the private insurance companies are never going to side with what's best for the American people.
"Sicko" airs on The Movie Channel tonight at 8:00 PM. It's also scheduled to air on The Movie Channel on July 27th at 4:05 PM and on TMC Xtra on August 2nd at 10:45 PM and August 5th at 2:15 AM and 7:30 AM. Click here for showtimes.
There are people around the country who are holding "Sicko" viewing parties this weekend in their homes. Check out this call to revisit "Sicko" on the Daily Kos this week.
We are in a critical time regarding which direction the health care debate is going to go. Make your voice heard. And be armed with the facts. Watch "Sicko" again!
The 8000% price premium to Lucentis over Avastin
The Healthcare Channel previously exposed a 1000% price increase on a generic drug made by Actavis and how it was a case example for healthcare reform.
The United States spends approximately $300 Billion or more annually on prescription drugs. Branded drugs have high prices that translate into 85% gross profit margins in many cases. The pricing for drugs is established by the pharmaceutical companies with little control from Medicare or private insurance. Moreover, drug companies raise prices 10% or more annually, far exceeding inflation.
The various healthcare reform bills in the House and Senate have all met with resistance due to their trillion-dollar estimated costs. As a result, congress is now exploring ways to fund the bill resorting to once taboo methods, such as allowing The HHS to negotiate drug prices. Being a large purchaser of drugs, The HHS or Medicare would be able to demand steep price cuts. The drug industry is adamantly opposed to this option.
How much fat could be trimmed from drug expenditures by cutting prices? In addition to our Actavis example, an expensive eye medication sold by Roche, Lucentis, is another example of a huge price premium on a drug, 8000% in this case, compared to alternative treatments.
The HCC interviewed Philip Rosenfeld, MD, PhD, Professor of ophthalmology at the University of Miami, to discuss how he innovated an alternative therapy to Lucentis that he estimates has saved $6 Billion in drug costs globally since 2005.
The drug industry argues that high prices on drugs in the United States are necessary because of the cost involved in developing drugs and the high failure rate in clinical trials. The HCC estimates that drug prices could be trimmed by as much as 50% and the companies would still be profitable. Using Wall Street sell-side models, the average gross profit margin (revenue minus the cost of manufacturing the drug) exceeds 80%. After deducting the clinical development costs, marketing costs, and research costs, the companies still post operating profit margins of 40%. If an industry-wide 10% cut in drug prices were instituted, more than $30 Billion would be saved in the U.S. alone. This is based on global drug revenues of more than $700 Billion (source IMS) and half of that derived from the U.S. markets.
Senate committees are considering drug price cuts as an option to fund healthcare reform, according to the Pink Sheet and our own sources. At this point, it is unlikely that any measure would survive to the final bill. However, the situation is very dynamic.
The Dr. Rosenfeld interview can be viewed here.
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