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Saturday, April 30, 2011
BBC NEWS | Panorama | Reputations for sale?
via news.bbc.co.uk
Fiona Godlee is the editor in chief of the British Medical Journal and has written this article about Secrets of the Drugs Trials. Panorama's account of GlaxoSmithKline's successful attempts to market Seroxat for use in children, despite the fact that its own published trial found evidence of serious adverse effects and failed to show benefit, is fascinating but depressingly familiar.
What is even more depressing is that such behaviour is still so widely tolerated within medicine.
There has been no shortage of outcry or official condemnation - including clear statements from the World Association of Medical Editors, the International Committee of Medical Journal Editors, and industry itself through its Good Publication Practice guidelines - that undeclared conflicts of interest and ghost writing are unacceptable.
But, you might reasonably ask, what use are such huffings and puffings in the face of the individual rewards on offer from drug companies.
Let's be clear what is and is not acceptable. There is nothing wrong with getting help from medical writers, provided they and their source of funding are clearly acknowledged.
Nor is there anything wrong with academics or clinicians working with industry, provided they remain personally accountable for everything they say.
What is clearly wrong is writers, academics, or clinicians concealing under their coat tails an army of company spin doctors intent on distorting the scientific record.
Legislation is not going to happen soon - the powerful industry lobby will make sure of that. Regulation is still inadequate.
So what can we do to change the blind-eye culture of medicine? In the interests of patients and professional integrity I suggest intolerance and exposure.
We shouldn't have to rely on investigative journalists to ask the difficult questions.
So at meetings, why not slow hand clap any speaker who does not begin their talk with a sentence or slide declaring their conflicts of interest?
And if journals discover authors who are guests on their own papers, they should report them to their institution, admonish them in the journal and probably retract the paper.
Reputations for sale are reputations at risk. We need to make that risk so high it's not worth taking."
Friday, April 29, 2011
Antitrust: Commission opens investigation against pharmaceutical companies Cephalon and Teva
IP/11/511
Brussels, 28 April 2011
Antitrust: Commission opens investigation against pharmaceutical companies Cephalon and Teva
The European Commission has opened a formal antitrust investigation to assess whether an agreement between US-based pharmaceutical company Cephalon and Israel-based generic drugs firm Teva may have had the object or effect of hindering the entry of generic Modafinil in the European Economic Area. Modafinil is a medicine used for the treatment of certain types of sleeping disorders. The opening of proceedings does not mean that the Commission has conclusive proof of an infringement, only that it will investigate the case as a matter of priority.
The Commission has started an ex officio investigation to assess an agreement between Cephalon, Inc. and Teva Pharmaceutical Industries Ltd. that may have the object or effect of hindering the entry of generic Modafinil products in the markets of the European Economic Area. In particular it is assessed whether the agreement is in breach of the EU Treaty's rules on restrictive business practices (Article 101).
In December 2005 Cephalon and Teva settled patent infringement disputes in the United Kingdom and the United States concerning Modafinil (brand name Provigil®). As part of the settlement agreement Teva undertook not to sell its generic Modafinil products in the EEA markets before October 2012. A series of side deals were included into the settlement agreement, which is also subject to antitrust litigation in the United States initiated by the US antitrust authority FTC.
The opening of proceedings does not mean that the Commission has a definitive finding of an infringement, but indicates that it will investigate the case as a matter of priority.
There is no legal deadline to complete inquiries into anticompetitive conduct. Their duration depends on a number of factors, including the complexity of each case, the extent to which the undertakings concerned co-operate with the Commission and the exercise of the rights of defence.
Background to antitrust investigations
Article 101 of the Treaty on the Functioning of the EU prohibits agreements and concerted practices which may affect trade and prevent or restrict competition. The implementation of this provision is defined in the Antitrust Regulation (Council Regulation No 1/2003) which can be applied by the Commission and by the national competition authorities of EU Member States.
Article 11(6) of the Antitrust Regulation provides that the initiation of proceedings by the Commission relieves the competition authorities of the Member States of their competence to also apply Articles 101 and 102 (ban on abuse of a dominant market position) to the practices concerned. Article 16(1) provides that national courts must avoid giving decisions which would conflict with a decision contemplated by the Commission in proceedings that it has initiated.
The Commission has informed the parties and the competition authorities of the Member States, that it has opened proceedings in this case.
Background on investigation of the pharma sector
In 2008 and 2009 the Commission carried out a broad inquiry of the pharmaceutical sector. Among others, the inquiry pointed to significant risks for European consumers stemming from certain types of patent settlements between originator and generic companies aimed at delaying the arrival into the market of cheaper generic medicines (sometimes also referred to as "pay-for-delay" settlements). The Commission regularly monitors potentially problematic patent settlements. The second such monitoring exercise was launched in January and the results are expected before the summer break (see IP/10/887 and IP/11/40).
The Commission has a number of ongoing individual investigations into suspected anti-competitive practice. In July 2010, the Commission took warmth from the confirmation, by the General Court, of the Commission's decision in the AstraZeneca case, which was its first abuse decision in the pharmaceutical sector. The company had misused the regulatory framework to prevent or, in the very least, delay the market entry of competing generic products, something that has now clearly been ruled as illegal. AstraZeneca has appealed the decision of the General Court.
via europa.eu
Obama Administration punishes reporter for using multimedia : Bronstein at Large
via sfgate.com
White House officials have banished one of the best political reporters in the country from the approved pool of journalists covering presidential visits to the Bay Area for using now-standard multimedia tools to gather the news.
The Chronicle's Carla Marinucci - who, like many contemporary reporters, has a phone with video capabilities on her at all times - pulled out a small video camera last week and shot some protesters interrupting an Obama fundraiser at the St. Regis Hotel.
Read more: http://www.sfgate.com/cgi-bin/blogs/bronstein/detail?entry_id=87978#ixzz1Ktjr...
Ex-drug company boss sues over dismissal - ABC News (Australian Broadcasting Corporation)
The former general manager of Pan Pharmaceuticals is seeking $1 million in damages, claiming he was wrongfully dismissed.
The Pan Pharmaceuticals board terminated John Brennan's contract in 2003, soon after the Therapeutic Goods Administration ordered a massive recall of the company's products because of concerns about their safety.
Doctor Brennan has today sought leave in the New South Wales Supreme Court to sue Pan's liquidator, McGrath Nicol, for $1 million in damages, saying he was wrongfully dismissed.
The deadline for the claim to be made has long passed, but his lawyer says it has taken so long to make the application because of the difficulty of accessing key documents and the court should hear the claim.
The Federal Government recently agreed to pay $67.5 million to shareholders and retailers who lost money when the company collapsed.
via abc.net.au
Bioethics Forum blog - Freedom’s Just Another Word for . . . Restriction?
Freedom’s Just Another Word for . . . Restriction?
Permanent linkWhat tools does a university administration have at its disposal to shut up critics on its own faculty? The University of Minnesota wants to know.
The university’s administration is exploring this question because its own Carl Elliott won’t shut up about the Markingson case. Elliott, a professor in the Center for Bioethics, just keeps talking about what went wrong at his medical school in a 2003 industry-sponsored drug trial in which research subject Dan Markingson killed himself. Since publication of a muckraking article on the subject in Mother Jones, Elliott has criticized the FDA’s response to the case and led a group of faculty in asking the University Trustees to look into the case.
Like many others who continue to follow this story, Elliott is drawn to this case by issues of justice both local and global. Locally, he seeks accountability for what happened to Dan Markingson and to his mother, who tried repeatedly before Dan’s gruesome suicide to convince involved clinicians that study participation went against Dan’s best interests.
But Elliott also sees in this story the impetus for global change that could strengthen protections for patients who become subjects. In this he is hardly alone. Although she has failed to move the University of Minnesota toward any admission of culpability in her son’s death, Dan’s mother, Mary Weiss, took to the state legislature her concerns about the institutional infrastructures that harmed her son. With Elliott’s help, she got the legislature to pass “Dan’s Law,” which prohibits clinician-researchers from recruiting mentally ill patients under a commitment order into psychiatric drug studies.
“The facts of the Markingson case clearly show that something is wrong with the protection of mentally ill research subjects,” said Naomi Scheman in an e-mail message to me this week. Scheman has been following developments both as faculty in philosophy and as president of the University of Minnesota’s AAUP chapter. She elaborated, saying that subjects worth revisiting include “the acceptable risks in clinical trials, especially when there exists a financial reason for the university to support research with minimal scientific value; the role of IRBs in approving clinical trials and exercising oversight over how the research is actually carried out; and the limitations of the guidance of the Common Rule concerning mentally ill research subjects.”
Scheman concluded, “The University of Minnesota has the opportunity to act as a national leader in formulating best practices, and it is highly regrettable that the only administrative responses have been defensive, including the current efforts to mobilize faculty voices against drawing attention to these problems.”
Indeed, the administration at the University of Minnesota seems only interested in focusing its energies on getting Elliott et al to quiet down. So at an April 8 meeting of the faculty’s Academic Freedom and Tenure Committee, the administration asked the committee, “What is the faculty[’s] collective role in addressing factually-incorrect attacks on particular University faculty research activities?” The administration brought Elliott’s activities as the example to talk about. Some involved have since tried to claim that the committee wasn’t working on the Markingson case in particular, but rather on global questions of “civility” and “bullying.” The minutes seem to belie that claim.
In an interview about this with the Chronicle of Higher Education, university counsel Mark Rotenberg opined, “The faculty, as a collective body, should take an interest in attacks on their members that serve to deter or chill controversial research.” Rotenberg seems to be implying that Elliott is guilty of intimidating researchers, but I wrote to Rotenberg to ask whether his own actions might “serve to deter or chill controversial research?” He has not answered.
Rotenberg hasn’t answered another question I put to him. At the April 8 meeting, Tim Mulcahy, vice president for research, tried to compel the committee to act by telling it that “the federal government requires in those cases [where researchers are supposedly wrongly accused] that institutions do all they can to protect the reputation of the accused.” But where, I asked Rotenberg, do regulations require this?
Needless to say, Rotenberg also hasn’t answered my question about what exactly Elliott has gotten wrong about the facts. Notably, the University has not asked Mother Jones to correct anything, nor would its representative answer previous questions from me about what Elliott supposedly got wrong.
By now the administration may have figured out that it played its cards poorly on this. Alarmed by what went on April 8, a number of faculty members attended the subsequent meeting of the Academic Freedom and Tenure Committee on April 22 to object.
When I asked her about why she went to the April 22 meeting, Karen-Sue Taussig, a medical anthropologist, replied: “I was worried the committee might be being used to intimidate a member of the faculty who was critical of the University. It seemed to me that there was a logical inconsistency in the University counsel's position: he did not provide any evidence that any individual faculty member felt chilled by Carl's work, yet his bringing up the issue clearly posed the threat of chilling Carl's speech. . . . In short, I was concerned about the possibility of an Orwellian attempt to invoke academic freedom in order to chill academic freedom.”
Philosopher and historian of science Ken Waters, who also attended the second meeting, was just as concerned. “The University's general council planted a false question, the implicature of which [the committee] seemed to be uncritically accepting (that Carl was advancing factually incorrect claims),” he wrote to me in an e-mail. “And in planting the question, the counsel was trying to turn the tables and squelch my colleagues' academic freedom by somehow suggesting that they were impinging upon the academic freedom of others.”
Waters told me that he spoke to the committee from his own disciplinary background: “I have examined the history of genetics, much of which took place here at the University of Minnesota. We have a lot of research in genetics of which we should be proud. But we also have a lot of which we should be ashamed, namely eugenics. And the faculty involved in eugenics here were exonerated time and time again. Does that mean that debate about genetics should have stopped? No, of course not. Academic debate is what universities are about."
Bioethics has not traditionally been a field featured in cases involving questions of academic freedom, presumably because bioethicists have rarely done what Elliott has done: criticize their own schools. But as Hilde Lindemann, former ASBH president, wrote to me in an e-mail: “The very least we bioethicists can do is call out serious wrongdoing when it's right under our noses. I am only sorry that some of those in authority at Carl's university don't understand this.”
Colleagues may recall that, in 2009, Lindemann led the ASBH board in defending Ezekiel Emanuel and Robert Pearlman against false representations of them in the national press. Who ever expected that bioethicists like Elliott might need the same kind of protection much closer to home?
Alice Dreger is a professor of clinical medical humanities and bioethics at Northwestern University Feinberg School of Medicine. She has collaborated with Carl Elliott on various occasions and was on the faculty of the University of Minnesota in 1995-96.
Shareholders Give Thumbs Up to J&J Executive Pay - NYTimes.com
At Johnson & Johnson’s annual meeting on Thursday, shareholders voted, on an advisory basis, to approve the compensation package being awarded to the company’s chief executive.
Some investors had expressed unhappiness with the $30-million-plus being awarded to William C. Weldon, Johnson & Johnson’s chief executive, after a challenging year for the health care giant.
As we reported in an article on Wednesday, Mr. Weldon’s pay and performance have been criticized in light of the company’s struggles to resolve the manufacturing issues at its McNeil Consumer Healthcare unit.
If you’re interested in finding out more about what happened at the meeting, you can check out the company’s blog, which offers results of all the shareholder votes and some of the highlights of the meeting.
The Death of Pharmaceutical Rep Detailing?
We know, for example, that ten years ago, there were about 40% more detailing representatives than there are now. The doctor-to-rep ratio has gone from 6-to-1 to 10-to-1. At the same time, as we are seeing doctors decreasing access, there is quite a bit of evidence that when a doctor sees a rep, it is for less time – in our surveys, we see a little more than half of the consummated discussions last four minutes or less.
Jury orders Allergan to pay $212 mln in Botox case | Reuters
(Reuters) - A Virginia U.S. District Court jury has ordered Allergan Inc (AGN.N) to pay $212 million to a man who claimed that injections of wrinkle-smoothing Botox left him with brain damage.
The jurors awarded 67-year-old Douglas Ray Jr $12 million in compensatory damages and $200 million in punitive damages, the company said on Thursday.
Ray said he was injured after getting Botox injections to relieve a hand tremor and writer's cramp, according to a report in the Richmond Times-Dispatch.
Allergan said in a statement that there was no evidence that the company failed to provide adequate information about the potential risks of the drug. It also said there was no proof that Botox caused his symptoms.
The company said it is evaluating the basis for an appeal, noting that Virginia state law caps punitive damages at $350,000.
Allergan agreed last year to plead guilty and pay $600 million to resolve a federal probe involving marketing Botox for unapproved non-cosmetic uses.
The Justice Department accused the company of paying kickbacks to doctors to prescribe Botox for unapproved uses -- such as treating headaches, pain and juvenile cerebral palsy -- and teaching doctors how to bill for such "off-label" uses. (Reporting by Deena Beasley; editing by Carol Bishopric)
via reuters.com
Thursday, April 28, 2011
Wendell Potter: Health Execs Getting Richer As Some Americans Beg for Help to Pay for Care
On Monday, I wrote about the good fortune of UnitedHealth Group, one of the big seven for-profit health insurance companies, and its CEO, Stephen J. Hemsley. Last week, UnitedHealth pleased Wall Street so much with its report of earnings during the first three months of this year that investors clamored to buy the company's stock.
By the time the New York Stock Exchange closed last Thursday, shares of UnitedHealth's stock had shot up more than 8 percent and reached their highest value in more than three years. The company's shareholders, including Hemsley, now the highest paid CEO in America, were suddenly much wealthier.
Owners of health insurance company stock continued to get richer this week. On Tuesday, Humana Inc. announced that its first quarter earnings would be so much better than Wall Street expected that it was raising its full-year profit outlook and instituting a dividend. The company's stock price jumped 5.5 percent after disclosing that fabulous news.
The good news, at least for shareholders, just keeps on coming. This morning, Aetna announced that it, too, had exceeded Wall Street's expectations during the first quarter -- by an astonishing 54 cents a share. Yesterday, WellPoint Inc., which operates more than a dozen Blue Cross plans across the country, announced that its earnings topped expectations by 48 cents per share.
When I was handling financial communications at CIGNA, I knew investors would be pleased if the company exceeded their expectations by even a penny a share. During my nearly two decades in the industry, I never saw insurers blow past what they had been expected to earn by such wide margins. Health insurers' shareholders must be pinching themselves today to make sure they're not dreaming.
To make this kind of money, insurance companies have to spend far less paying their policyholders' medical claims than anyone thought possible.
They've been able to do that so far this year, despite the new health care reform law, by shifting many policyholders into plans that force them to spend more from their own pockets before coverage kicks in. Insurance firms also fatten their bottom lines by denying more claims.
What are the real-world consequences? Let me share portions of just three e-mails I received this week to give you a hint. I wish I could say that such e-mails are rare.
The first came from a man who actually sells policies for one of the above-mentioned firms on a part-time basis. He decided to write me after visiting a family that was on the verge of bankruptcy because of what they have to pay for insurance coverage and out-of-pocket expenses.
He told me that the head of the family was a small business owner who was still working well into his late 60's because it was the only way he was able to provide insurance for himself, his wife and a daughter suffering from mental illness. He was paying $28,800 in annual premiums and had just been notified that he would have to pay 25 percent more when the current term of his policy expired.
Even though he was paying more than $2,000 a month for coverage, it was far from adequate. It did not cover his daughter's three-times-a-week visits to her mental health doctors, which meant that he had to pay an additional $300 per visit out of his own pocket. On top of that, he had to pay $1,000 every month for her prescriptions.
"It truly disgusted me, and I had no idea what I could do to help them," he wrote.
The irony is that the part-time insurance salesman who sent the email was uninsured. He couldn't afford coverage himself.
The second e-mail came from Molly Poole, a woman I had met in March in Lancaster, Pa. She was writing to tell about a new website -- www.LetScottLive.com -- that she created to help raise money for her husband's care. While Stephen Hemsley and a handful of other insurance company executives are becoming billionaires, Molly and Scott Poole, who has Lou Gehrig's disease, are now effectively beggars. They wrote asking me to help spread the word about their plight and to assist in their efforts to raise money.
Here's what Molly wrote:
In short, we have been terrorized since spring 2009 with a variety of insurance company games. First we were told (by Highmark Blue Cross) that we were about to hit Scott's million-dollar lifetime cap 'in the next month or so.' That was wrong, but that didn't stop them from calling every few months to give us another 'you're hitting your cap soon' scare and giving a vague date a few months out. They were always wrong in the end, but that did nothing for the panic level at the time.Molly wrote that Scott had been transferred to COBRA on Nov. 7, 2010, after losing his job. As that coverage was about to expire, the Pooles applied for an extension. A case manager for their insurer said it would be a waste of time to apply for the extension because Scott was rapidly approaching the lifetime coverage limit. After weeks of battle, the Pooles finally got the extension, but only for a short while.
"We only have coverage through May 7," Molly, wrote, "so that's why we've created a website to try to raise funds. We need to come up with approximately $400,000 a year to cover nursing and other medical costs. God forbid a hospital stay. What savings we have left are what's running the house. We start tapping them, we lose the house."
Molly ended her e-mail with this: "The illness itself has been a walk in the park compared to the insurance hassles. Can you imagine something that makes dealing with Lou Gehrig's disease a breeze compared with what they are putting you through?"
The third e-mail I got was from Stan Brock, the saint who founded Remote Area Medical (RAM) to provide care to people in isolated villages in less developed countries. Stan started his mission by flying doctors to nearly inaccessible places along the Amazon River in South America.
Today, most of RAM's "expeditions" are in the United States, and increasingly they are to locations that are not at all remote. I went to a RAM expedition in Wise County, Va., a few years ago. The experience changed my life and contributed to my decision to quit my job and start speaking out about the abuses of the U.S. health insurance industry.
Stan wrote to tell me about RAM's most recent two expeditions in California.
The crowds for the pair of expeditions "were similar to those you saw in Wise County, VA. We could have seen more patients had we been allowed to bring in volunteers from out of state," he wrote.
I am convinced that if federal laws were changed so that doctors could cross state lines to provide free care, that RAM-type operations would begin to spring up nationwide and make a significant difference for health care for the underserved at no cost to the government or taxpayer. We really need an economics expert to make those sort of projections on a nationwide basis with volunteer clinics going on weekly in every state; not just by RAM but by numerous other charitable organizations and civic groups.These three emails are just the most recent I've received out of many over the past several months.
I will continue to share some of them with you -- and fill you in on how incredibly rich a few executives and shareholders are becoming while Americans are being reduced to begging for help to pay for health care or waiting for one of Stan Brock's expeditions.
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Follow Wendell Potter on Twitter: www.twitter.com/wendellpotter
Ken Robinson on reforming education: ADHD is a "fictitious epidemic." - Boing Boing
via boingboing.net
Ken Robinson's presentation about reforming education is beautifully enhanced with RSA Animate's incredible illustrations.
He believes ADHD is a "fictitious epidemic."
Duane Reade To Pay US $369,744 To Settle Pharmacy Charges - FoxBusiness.com
New York-area drugstore chain Duane Reade Inc. will pay $369,744 to settle charges in a whistle-blower lawsuit that alleged a store-marketing program illegally paid doctors to prescribe more prescription drugs.
The unidentified whistle-blower pointed to the Duane Reade Kiosk Program, which allowed customers to enter prescription information electronically at their doctors' offices before they picked them up at their local Duane Reade store. The government said Duane Reade failed to charge a market rate for renting kiosk space at the doctors' offices and instead paid practitioners higher "rents" for prescribing more medications.
A spokesman for Duane Reade owner Walgreen Co. (WAG) declined to comment immediately on the settlement.
The agreement is the latest in a series of deals the government has struck with health-care companies accused of overcharging.
Cardinal Health Inc. (CAH) last week agreed to pay the federal government $8 million after two independent pharmacy operators in Ohio said the company paid them kickbacks to buy its drugs. A spokeswoman for Cardinal denied wrongdoing and said the company settled the charges but decided to settle to avoid further litigation.
CVS Caremark Corp. (CVS) pharmacies in New Jersey and New York in January settled allegations of billing federal health-care programs for prescriptions filled by an excluded pharmacist. The company agreed to pay the U.S. $969,230 to resolve the civil and administrative claims.
via foxbusiness.com
Wednesday, April 27, 2011
Dramatic Price Increases in Brand Name Drugs Spur Shareholders to Action
Investors from the Interfaith Center on Corporate Responsibility (ICCR) say new policies are needed to reign in drug costs
NEW YORK, April 27, 2011 /PRNewswire-USNewswire/ -- As the skyrocketing costs of brand name drugs leave millions of Americans skipping doses or abandoning their prescriptions, investors representing 14 faith and health care organizations are petitioning the nation's top pharmaceutical companies to re-examine pricing for commonly used drugs like Lipitor, Plavix and Celebrex in an effort to make them more affordable.
The group is citing several benchmarking reports including one from the General Accountability Office this past February that found branded drugs consistently outpacing generics relative to inflation (6.3% vs. 3.8%). ICCR members are asking management for pricing that hews closer to the consumer price index, a strategy they believe is a more accurate reflection of value and a more sustainable policy over the long term.
The Centers for Medicare and Medicaid Services projects that U.S. prescription drug spending will grow 93% during 2008-2018, exceeding all major categories of health expenditures. AARP reports that the branded prescriptions most widely used by Medicare patients increased 9.7%, far exceeding the cost for other consumer goods in the last 12 months: prices for generics during the same time period fell. A November 2010 report from Deloitte Consulting concluded that the issue will intensify, and that current pricing practices are not sustainable.
"The evidence from all the studies is clear," said Ed Gerardo, director, Community Commitment and Social Investments of Bon Secours Health System, Inc. "Measures must be taken to control costs and bring transparency into the drug pricing equation."
Resolutions are on the ballots at the nation's top pharmaceutical companies including Johnson and Johnson, Abbott, Bristol-Myers Squibb and Pfizer, requesting that management utilize a combination of approaches to keep drug prices at reasonable levels.
ICCR members have been in dialogue with pharmaceutical companies for decades on issues of access and affordability.
Cathy Rowan, consultant to Trinity Health, said, "Many of us represent health care systems with missions to enhance the health of the communities they serve. We would like to see the pharmaceutical companies in which we invest have access to medicines at the heart of their business strategies."
"This isn't about charity or foregoing a profit," said Laura Berry, Executive Director of ICCR. "Our members expect that the companies they invest in espouse policies, pricing and otherwise, that promote both justice and sustainability while enhancing shareholder value. The absence of clear and reasonable pricing policies is neither just for consumers nor sustainable as a business practice."
Barbara Aires, coordinator, Corporate Responsibility, the Sisters of Charity of St Elizabeth, said, "It's hard to justify these increases in this economy. More and more, people have to choose between buying groceries and picking up their prescriptions and when people can't afford to take their medicines they get sick, straining an already fragile health care system. Our company needs a rational pricing policy that keeps branded products affordable and accessible to consumers yet will remain competitive to generics when patents expire."
Contact:
Susana McDermott
Director of Communications, ICCR
212-870-2938
smcdermott@iccr.orgAbout the Interfaith Center on Corporate Responsibility (www.iccr.org):
Currently celebrating its 40th year, ICCR is the pioneer coalition of active shareholders who view the management of their investments as a catalyst for change. Its 300 member organizations with over $100 billion in AUM have an enduring record of corporate engagement that has demonstrated influence on policies promoting justice and sustainability in the world.
SOURCE Interfaith Center on Corporate Responsibility
Back to topRELATED LINKS
http://www.iccr.org
via prnewswire.com
Prescribing Advice for GPs » NICE Guidance – April 2011
The National Institute of Health and Clinical Excellence has published new guidance for the month of |pril 2011. This month there are two clinical guidelines that impact upon primary care.
The lung cancer (QRG) and ovarian cancer (QRG) clinical guidelines both provide investigation guidance and referral criteria to aid early diagnosis.
AstraZeneca Launches Live Click-to-Chat Feature on CRESTOR and NEXIUM Consumer Websites - News Press Release | PharmiWeb.com
AstraZeneca (NYSE:AZN) announced today the launch of “click-to-chat” on CRESTOR.com and PurplePill.com. The new “click-to-chat” technology gives consumers an option to contact a live AstraZeneca customer service representative with just a click of a button. Click-to-chat is a live, online chat option, similar to instant messaging, and can be accessed at the “Contact Us” page of the CRESTOR® (rosuvastatin calcium) and NEXIUM® (esomeprazole magnesium) websites.
“AstraZeneca understands that our consumers want flexibility, especially when it comes to health information,” said Donna Holder, senior director, AstraZeneca Information Center. “This new resource enables consumers to have easier access to the information they seek through the convenience of a real-time, online channel.”
Patients can contact the AstraZeneca Information Center by telephone at 1-800-236-9933, Monday through Friday from 8 a.m. to 6 p.m. ET, excluding holidays, or by submitting an e-mail request form. In addition, CRESTOR and NEXIUM brand websites launched “Call Me Now” in October 2010. Call Me Now offers visitors the option to receive a personal phone call from an Information Center representative to help answer their questions about CRESTOR or NEXIUM without having to go through telephone prompts, wait on the line or listen to a recorded operator.
“AstraZeneca is one of the first pharmaceutical companies to use this technology, making it a very forward-thinking company in the pharmaceutical industry,” said Don Keane, vice president of marketing and product strategy for Angel, a leading provider of customer interaction solutions such as Interactive Voice Response (IVR) and chat technologies. “Click-to-chat enables consumers to engage in a live-chat session and interact directly with AstraZeneca representatives, adding another communications channel for great customer service.”
via pharmiweb.com
GlaxoSmithKline Q1 profit jumps despite sales fall - Yahoo! News
LONDON (AFP) – British drugmaker GlaxoSmithKline said on Wednesday that net profit rose 14 percent to £1.525 billion (1.72 billion euros, $2.5 billion) in the first quarter, despite a slump in product sales.
Savings from a major cost-cutting programme and asset disposals helped to offset a 10-percent drop in sales to £6.585 billion in the three months to March 31, compared with the first quarter of 2010, GSK said in a statement.
GSK was rocked in September when the EU medicines regulator decided to pull its former diabetes product Avandia off the shelves over fears that it increased the risk of heart attack and strokes.
Regulators also restricted its availability in the United States.
Meanwhile sales of GSK's herpes treatment Valtrex have been hit by generic competition.
"Reported (first quarter) sales were down 10 percent, reflecting a £1 billion reduction in sales of pandemic products, Avandia and Valtrex versus a year ago," chief executive Andrew Witty said in Wednesday's results statement.
"This impact is set to decline going forward and we expect underlying sales growth to translate into sustainable reported growth in 2012."
Shrugging off the sales slump, Witty said that the first quarter was "positive on many fronts, with good progress made in delivery of our strategy to improve long-term financial performance".
via news.yahoo.com
Johnson & Johnson purchase of medical device maker is its biggest ever - NorthJersey.com
GENEVA - Health products giant Johnson & Johnson said Wednesday it will buy U.S.-Swiss medical device maker Synthes Inc. for $21.3 billion, greatly increasing its share of the market for surgical trauma equipment and orthopedic implants.
J&J's largest ever deal will see the New Jersey-based company offer 159 Swiss francs in cash and stock for each Synthes share. That is a 22 percent premium on the April 14 share price, the day before reports first claimed Synthes was considering a takeover.
Synthes is based in West Chester, Pennsylvania, but has its global headquarters in Solothurn, Switzerland. Last year it had global sales of $3.69 billion, including $2.15 billion in North America.
"Orthopedics is a large and growing $37 billion global market and represents an important growth driver for Johnson & Johnson," CEO Bill Weldon said in a statement.
J&J said Synthes would complement its own DePuy orthopedics portfolio to address what it called "significant market trends."
via northjersey.com
Tuesday, April 26, 2011
Possible billions sought in drug marketing suit | The Post and Courier, Charleston SC - News, Sports, Entertainment
COLUMBIA -- It's now up to a Spartanburg County judge to decide how much a Johnson & Johnson subsidiary should pay South Carolina for deceptive marketing of an antipsychotic drug. If the judge agrees with attorneys for the state, that number could be in the billions of dollars.
Last month, a jury ruled that Janssen Pharmaceutica, Inc. -- a subsidiary of the New Brunswick, N.J.-based drug manufacturer -- had violated the South Carolina Unfair Trade Practices Act by sending misleading letters to about 7,200 doctors in South Carolina downplaying the links between diabetes and its schizophrenia drug Risperdal.
The blockbuster antipsychotic lost patent protection in 2008. Johnson & Johnson said last month that Risperdal Consta, the long-acting version of the drug, generated $1.5 billion in sales last year.
The company also made tens of thousands of drug marketing-related phone calls that minimized Risperdal's link to diabetes, improperly claimed the drug was safer than other competing medications, and enclosed misleading information inside drug packages, the jury found.
In the Nov. 10, 2003, letter, a Janssen official said research showed Risperdal was not associated with an increased risk of diabetes when compared to other drugs or patients receiving no treatment at all.
"Evidence also suggests that RISPERDAL is associated with a lower risk of diabetes than some other studied atypical antipsychotics," Janssen vice president Ramy Mahmoud wrote.
The company also argues that, if South Carolina had truly feared for patients' safety, the state would have requested an injunction stopping any prescriptions from being filled, noting that an expert for the state testified that there were no facts to support any risk of death in the elderly as a result of taking the drug.
"There is no evidence in the record that Risperdal has actually caused any South Carolina patients to experience adverse effects related to the alleged risks," Janssen attorneys wrote in a brief filed April 15. "This case is novel: there was no precedent -- not a single authority -- that so much as suggested that an FDA-approved package insert could be the subject of a state law deceptive trade practices claim."
Saying that the drug manufacturer acted in good faith, attorneys for Johnson & Johnson also argue that it sent the "Dear Doctor" letter without being asked to do so by the U.S. Food and Drug Administration and that drug regulators never expressed any concern over the package insert.
But the FDA did voice worries about the 2003 communications, issuing a warning letter in 2004 in which it called the company's argument "false or misleading" because of its claims that Risperdal is safer than other drugs and failed to include information about minimizing diabetes-related ailments.
Violations of this South Carolina law carry potential penalties of up to $5,000 apiece. In a court exhibit, attorneys for the state argued that they see the number of violations as potentially including every single prescription, sample box or "Dear Doctor" letter written since the mid-1990s -- numbers that reach into the millions when totaled up.
Considering the 620,000 Risperdal prescriptions written for people on Medicaid and the state health plan alone, that could mean more than $3.1 billion -- without even taking into account any of the sample boxes or "Dear Doctor" letters the state also argued were in violation of the law.
Janssen spokesman Greg Panico said the company was disappointed in the South Carolina jury's verdict but did not know if it would appeal, the action Janssen has taken against a Louisiana verdict ordering the company to pay nearly $258 million for misrepresenting Risperdal's links to diabetes.
Monday, April 25, 2011
What do others say about AstraZeneca's Nexium?
"You should be embarrassed if you prescribe Nexium because it increases costs with no medical benefits.. The fact is Nexium is Prilosec .it is the same drug. It is a mirror compound." -Thomas Sully, Center for Medicare & Medicaid Services (CMS) Director, addressing the American Medical Association.
"Nexium is a game that is being played on the people who pay for drugs." -CMS Director Thomas Sully
"When optimal doses are used, Prilosec and generic omeprazole appear to be as effective as Nexium or any other PPI." - Managed Healthcare Executive April 1, 2004"Nexium offers no innovation; the drug owes its existence entirely to AstraZeneca's need to retain the company's considerable share of the $8.3 billion PPI market." - HealthFacts
"Nexium.is virtually identical and.a generic is available for a price about 10 times less." - Los Angeles Times, February 15, 2004
AstraZeneca’s $6B Stomach Ache: Nexium Causes Bone Fractures | BNET
AstraZeneca (AZN) has allegedly known since 2006 that Nexium, its top-selling drug, puts users at an increased risk of bone fractures but failed to warn patients of that until 2010.
via bnet.com
Battle Over Pitching Drugs to Doctors Goes to Supreme Court - NYTimes.com
Before pharmaceutical company marketers call on a doctor, they do their homework. These salespeople typically pore over electronic profiles bought from data brokers, dossiers that detail the brands and amounts of drugs a particular doctor has prescribed. It is a marketing practice that some health care professionals have come to hate.
“It’s very powerful data and it’s easy to understand why drug companies want it,” said Dr. Norman S. Ward, a family physician in Burlington, Vt. “If they know the prescribing patterns of physicians, it could be very powerful information in trying to sway their behavior — like, why are you prescribing a lot of my competitor’s drug and not mine?”
Marketing to doctors using prescription records bearing their names is an increasingly contentious practice, with three states, Maine, New Hampshire and Vermont, in the vanguard of enacting laws to limit the uses of a doctor’s prescription records for marketing.
On Tuesday, the Supreme Court will hear arguments in a case, Sorrell v. IMS Health, that tests whether Vermont’s prescription confidentiality law violates the free speech protections of the First Amendment.
via nytimes.com
Sunday, April 24, 2011
More med schools are going 'pharma free' | Philadelphia Inquirer
More than a quarter of all medical residencies are now "pharma free," up from one in ten 20 years ago, says a study published by Academic Medicine, the journal of the American Association of Medical Colleges, in May's issue. These programs refuse free drug samples, block drug-company direct gifts and meals, forbid industry-sponsored parties and events, and kept drug salespeople off the premises.
The American Medical Students Association, which rates med schools' drug-company conflict-of-interest policies, gives Penn an A grade for banning drug-company gifts and visits. Jefferson, Penn State, and Temple get B grades because their ban on free samples isn't as complete. Drexel and the University of Medicine and Dentistry of New Jersey's Stratford campus get C grades, and Philadelphia Osteopathic gets a D, for being more accommodating to pharmaceutical marketers. See the ratings at www.amsascorecard.org
via philly.com
AstraZeneca to demolish three buildings | The News Journal
Jewell said AstraZeneca employees have been notified of the demolition plans, and site work will not be complete there until 2013. The company has not determined what it will do with the open space, but demolition will begin sometime later this year.
Ryan's Medicare Plan Would Be a Windfall for Insurance Companies
April 21st, 2011 9:51 PMRyan's Medicare Plan Would Be a Windfall for Insurance Companies
Rep. Paul Ryan's plan to privatize Medicare would accelerate a trend started several years ago by corporate CEOs and their political allies to shift ever-increasing amounts of risk from Big Business and the government to workers and retirees.
If enacted, the Ryan plan would represent a windfall of unprecedented proportions for insurance corporations and other businesses.
For millions of average Americans, many of whom already are finding it impossible to save for retirement, it would represent financial calamity. The nation's middle class would pay dearly for Ryan's proposed shredding of the social safety net that Medicare currently provides.
Ryan, chairman of the House Budget Committee, wants to dismantle the Medicare program and replace it with a system of vouchers. Starting in 2022, the government would give the average 65-year-old Medicare beneficiary $8,000 a year to buy coverage from a private insurer. That's the amount health care analysts estimate will be what the Medicare program will spend on every 65-year-old in 2022 if the government doesn't turn it over to private insurance companies.
While that might sound fair on the surface, it would actually be a very bad deal for people who turn 65 that year, compared to those who turn 65 in 2021. That's because commercial insurance plans are much more expensive, and operate far less efficiently, than the current Medicare program.
The amount of money commercial plans actually spend to pay medical claims has been declining rapidly over the past several years while the amount they spend on administrative activities such as marketing and underwriting -- and to pay executives and reward shareholders -- has been increasing. That's why Congress included a provision in last year's health care reform law to require insurance firms to spend no more than 20 percent of their policyholders' premiums on overhead. By contrast, the current Medicare program spends just 3 percent of its budget on administration.
The nonpartisan Congressional Budget Office says the $8,000 voucher won't be nearly enough for seniors to buy comparable coverage from private insurers and pay the additional out-of-pocket costs that those insurers would require them to pay. The amount the average 65-year-old would have to shell out to buy private insurance in 2022, according to the CBO, will actually be $20,510. Seniors would have to pay the difference -- $12,510. If Medicare is not privatized, the difference would be $6,150.
Here's why this would be a dream-come-true for the insurance industry: The more health plan enrollees have to pay out of their own pockets, the less insurers have to pay for medical care. The money that insurers avoid paying out in claims goes straight to their bottom line -- and into shareholders' pockets.
Insurers have been shifting more and more of the cost of care to their policyholders over the past several years by enticing -- or pushing -- them into plans with ever increasing deductibles. This trend is part of what Yale professor Jacob S. Hacker called "the personal responsibility crusade" -- making people more responsible for the management and financing of the major economic risks they face -- in his 2006 book, The Great Risk Shift.
This crusade has been led by Republicans and insurance company executives who have been saying for years that the best way to control medical costs is for Americans to have more "skin in the game." That's an expression that former Aetna CEO Jack Rowe used often before he retired in 2005, the year he made $22.2 million. It was also a sound bite favored by the CEO I used to work for, CIGNA's Ed Hanway, before he retired in 2009. Hanway's total compensation that year was almost $111 million.
The problem is, most Americans have far less skin to put in the game than CEOs like Rowe and Hanway or even Rep. Ryan, who makes $174,000 as a member of Congress. The median household income in the United States was just $49,777 in 2009, which was down $335 from 2008.
That decline, by the way, was the continuation of another trend that began as the Clinton era was ending and the George W. Bush era was beginning. Median household income in the United States peaked in 1999 at $52,388 (adjusted for inflation). It fell more than $2,000 during the eight years of the Bush administration.
During that time, health costs rose dramatically. According to the Kaiser Family Foundation, the average annual health insurance premium for family coverage increased from $5,791 in 1999 to $13,770 in 2010. The average amount that workers contributed out of their own pockets for family coverage increased from $1,543 to $3,997.
With household incomes declining, Americans have had far less money to put into retirement. According to a recent survey conducted by Opinion Research Corp. for America Saves and the American Savings Education Council, less than half of current workers are saving enough to have a "desirable standard of living in retirement."
If workers are having this much difficulty saving for retirement, where in the world will they find the money to pay what Rep. Ryan would make them pay for Medicare coverage when they turn 65?
Ryan's "blueprint" is one that will take America back to the pre-1965 days when senior citizens were losing their homes and their farms to pay for medical care. They were becoming destitute -- and dying much earlier than they are today -- because insurers would not sell them coverage because they were too much of a risk to insure, and there was no safety net for them.
That's exactly the same place future senior citizens would find themselves if Ryan's plan to privatize Medicare ever becomes public policy.
via michaelmoore.com
Top TED
| 1) Jill Bolte Taylor My Stroke of Insight 2008 When the neuroscientist picks up a human brain with a spinal cord attached, the audience gasps. When she's done talking about her stroke, they're crying. Watch the Video >> | 6) Dan Pink Surprising Science of Motivation 2009 The science proves that intrinsic motivation works better than extrinsic rewards, but your boss doesn't understand. Pink explains how to tell her. Watch the Video >> |
| 2) Patti Maes and Pranav Mistry Sixth Sense Demo 2009 The MIT Media Lab researchers debut a spooky Minority Report -- style wearable interface. Watch the Video >> | 7) Hans Rosling The Best Stats You've Ever Seen 2006 The Swedish professor dances through a spectacular animation of world development. Watch the Video >> |
| 3) Ken Robinson Schools Kill Creativity 2006 This highly influential talk spawned a viral 2010 follow-up and made the creativity expert a star; Robinson says he now "gets stopped in airports." Watch the Video >> | 8) Benjamin Zander On Music and Passion 2008 TED hosts performances as well as talks. This blends the two, with Zander at the grand piano. Watch the Video >> |
| 4) Tony Robbins Why We Do What We Do 2006 Robbins high-fives Al Gore in this video. "One of the best TED moments of all time," says TED video chief June Cohen. Watch the Video >> | 9) Barry Schwartz The Paradox of Choice 2006 In a baggy T-shirt, with glasses sliding down his nose, Schwartz gives a profound, witty discourse on why more freedom doesn't equal more happiness. Watch the Video >> |
| 5) Elizabeth Gilbert Nurturing Creativity 2009 The best-selling author bares her struggle to repeat the success of Eat, Pray, Love. Watch the Video >> |
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