Monday, August 31, 2009
Isn't Brilinta ...... brilliant!?
AstraZeneca presented previously announced Phase III data at the European Society of Cardiology Congress showing that experimental antiplatelet agent Brilinta (ticagrelor) significantly reduced cardiovascular events in patients with acute coronary syndromes (ACS), compared with sanofi-aventis and Bristol-Myers Squibb's Plavix (clopidogrel). Cardiologist Douglas Weaver, a past president of the American College of Cardiology, remarked that Brilinta "will become the new standard of care." Full story
Pharma Giles writes ,,,
Billy Brilliant talks about PharmRMA highlights for August…
“Isn’t everything brilliant nowadays? Take patent protection for pharmaceuticals, for example. Companies get a patent on a new drug and that means that no-one else can make it, not even if they can make it cheaper. That’s brilliant.
So companies can charge what they like and make loads of money and all of the company executives can get paid millions. That’s what capitalism is all about, innit? Brilliant.
Some of the money even gets used to discover new medicines, so the companies can get more patents and make even more money. That’s brilliant, that is.
Except that pharmaceutical companies have forgotten how to discover medicines any more because they’ve fired all of their scientists to cut costs and make even more money. But that’s brilliant as well. Except for the scientists, of course...
And now the government is passing new laws to stop people importing equivalent drugs that are cheaper than our patented ones. This means that our pharmaceutical companies won’t have to cut costs to compete with imports and can go on making huge profits. Bloody brilliant.
And what about health care reform? Isn’t that brilliant? We pretend to make an $80 billion commitment to health care reform, and in exchange, pharmaceutical companies don’t have to cut their prices and can go on charging what they like for medicines. Brilliant.
And what about that paper published in the August 25th edition of Health Affairs, ‘Global Drug Discovery: Europe Is Ahead,’ eh? That’s brilliant, innit? At least for Europe, anyway.
But what about us, eh? We’re brilliant as well. Last year, America’s pharmaceutical research and biotechnology companies continued to lead the world in research of new medicines, investing a record $65.2 billion in R&D. Brilliant.
OK, we didn’t discover anything, but we did spend loads of money trying. And that’s brilliant, innit? Brilliant. Everything’s BRILLIANT.”
Is it me or are the well-funded ranks of pharmapologists sounding more and more like the Fast Show…?
Ghostwriting - the FT comments
Ghost-writing, which conceals underlying authorship, influence and financial support, is wrong. All those involved in an article should be cited; those without any significant input should not be mentioned as authors at all.
Sunday, August 30, 2009
RIP Simon Dee
Sammy Davis Jr leads Max Harris' 'Dee Time' orchestra in an utterly-unrehearsed version of the then-new Bacharach/David number 'This Guy's In Love With You'. The band is sight-reading, Sammy's winging it, and the result is magic.
Saturday, August 29, 2009
Compass - Big Phama is killing the golden goose!
The UK's NHS risks bankruptcy from a soaring drugs bill which is outstripping Britain's GDP growth, according to a report published today.
The report, by the pressure group Compass, calls for regulation of the pharmaceutical industry to curb prices. The coalition of academics, campaigners and union leaders also warns that the billions spent by big pharma on seminars and conferences gives companies undue influence over doctors.
The report highlights several concerns:
• The drugs bill, which has gone up by £7.5bn since 1991, at a rate faster than GDP growth.
• Lack of innovation. The number of new drugs to treat conditions for which there are no effective remedies has been declining. Between 1993 and 2003 fewer than half the drugs licensed offered a potential improvement on those doctors already use – 152 out of 321.
• The £1.65bn spent annually by pharmaceutical companies on "continuing medical education" – such as conferences and seminars – for doctors, 300 times the Department of Health's contribution of £4.95m.
The report warns that the industry is in trouble because of a lack of innovation, declining productivity and governments' increasing reluctance to pay the high costs of drugs.
The pharmaceutical industry risks becoming the next big economic disaster after the banks, the report says, but it is too important to public health to be allowed to fail.
"The argument in this report is that the pharmaceutical industry must be more effectively regulated, so that all stakeholders – the public as well as the private investors – get a better deal. Like housing, transport, gas, electricity and now financial services, some things are too important to be left to the whims of the market," said Zoe Gannon, research fellow at Compass and the report's co-author.
"We have learnt from the banking crisis that some things are too important to let fail – the pharmaceutical industry is one of them. The report shows that unless we take action now we are not going to get the lifesaving drugs we need in the future," said co-author Jon Cruddas, the Labour MP for Dagenham.
MoreSimon says
"Television as a medium, in terms of being literate and telling stories, has short-changed itself since its inception.
"That is because of advertising."
Sanofi Aventis - KC blues
Sanofi-Aventis is closing its Kansas City manufacturing plant after failing to find a satisfactory buyer for the operation, which employs 370 people.
The decision to shutter the 33-year-old plant, which manufactures solid-dose oral medications including Allegra, marks the end of an era. It was the last to have been operated by Marion Laboratories, the pharmaceutical empire established by Ewing Kauffman.
Aventis, later Sanofi-Aventis, has owned it since 2000.
The decision to shutter the 33-year-old plant, which manufactures solid-dose oral medications including Allegra, marks the end of an era. It was the last to have been operated by Marion Laboratories, the pharmaceutical empire established by Ewing Kauffman.
Aventis, later Sanofi-Aventis, has owned it since 2000.
Big Pharma's "Gold-in Rule": Do whatever is necessary to bring in the maximum gold, without getting caught.
Insider thinks it might even be worse - even when Big Pharma get caught they just buy their way out of the problem and put it down to "the cost of doing business"!
Amoral!
Friday, August 28, 2009
Risky business
PLoS Medicine has published the results of study that aimed to assess the effect of presenting statistics to patients in different ways when making decisions about taking statin medication to reduce cardiovascular risk.
Hat tip: Matt
PharmaTimes' GOD (Great Oxford Debate)
The pharmaceutical industry faces an ethical dilemma when it conducts trials on its own drugs, Dr Jeffrey Drazen Editor in Chief of the New England Journal of Medicine and Dr Fiona Godlee, Editor in Chief of British Journal of Medicine, will argue in the world famous debating chamber at Oxford Union next month alongside Guardian Bad Science columnist Ben Goldacre.
Clinical trials are central to the success of the industry, providing the bedrock of evidence for a medicine’s use. Typically, these studies are conducted and paid for by pharma: in other words, the medicines developed by industry are tested by the industry.
But is this a conflict of interest? Is it acceptable for industry to pay for and run clinical trials of its own medicines – either for the purposes of registration or subsequent use?
Arguing in industry’s favour at the PharmaTimes’ Great Oxford Debate will be Robert Ruffolo, former R&D President of Research at Wyeth, Scott Gottlieb, former FDA senior official and a frequent Wall Street Journal columnist, and Vincent Lawton, ex-Managing Director of MSD and President of the Association of the British Pharmaceutical Industry.
“The motion – There is an unacceptable conflict of interest when pharma conducts trials on its own drugs – hits at the heart of the way new medicines are evaluated and how the pharmaceutical industry interacts with researchers, regulators, journals and clinicians,” comments Dr Godlee.
Prof Trevor Jones CBE, who will introduce the debate, calls it a very timely and especially relevant topic to debate in the current climate of expansion of international clinical trial size and requirements. "It will be of particular interest to hear from the expert speakers how the needs of the pharmaceutical industry, regulators, academic researchers, publishers of learned journals and not least, the public, can accommodated", he notes.
Can any scientific endeavour be run without experimental bias? Have your say by joining us on September 23 at the Oxford Union. For more details and to register your attendance go to www.pharmatimes.com/god
Clinical trials are central to the success of the industry, providing the bedrock of evidence for a medicine’s use. Typically, these studies are conducted and paid for by pharma: in other words, the medicines developed by industry are tested by the industry.
But is this a conflict of interest? Is it acceptable for industry to pay for and run clinical trials of its own medicines – either for the purposes of registration or subsequent use?
Arguing in industry’s favour at the PharmaTimes’ Great Oxford Debate will be Robert Ruffolo, former R&D President of Research at Wyeth, Scott Gottlieb, former FDA senior official and a frequent Wall Street Journal columnist, and Vincent Lawton, ex-Managing Director of MSD and President of the Association of the British Pharmaceutical Industry.
“The motion – There is an unacceptable conflict of interest when pharma conducts trials on its own drugs – hits at the heart of the way new medicines are evaluated and how the pharmaceutical industry interacts with researchers, regulators, journals and clinicians,” comments Dr Godlee.
Prof Trevor Jones CBE, who will introduce the debate, calls it a very timely and especially relevant topic to debate in the current climate of expansion of international clinical trial size and requirements. "It will be of particular interest to hear from the expert speakers how the needs of the pharmaceutical industry, regulators, academic researchers, publishers of learned journals and not least, the public, can accommodated", he notes.
Can any scientific endeavour be run without experimental bias? Have your say by joining us on September 23 at the Oxford Union. For more details and to register your attendance go to www.pharmatimes.com/god
Out Oct 2nd -can't wait
"I made this movie as if it was going to be the last movie I was allowed to make." And, on the film itself, "It's got it all - lust, passion, romance and 14,000 jobs being eliminated every day."
Most younger patients DON'T take their statins as prescribed
More than 50% of adults under the age of 45 who are prescribed a medication to treat high cholesterol are not taking their medication as prescribed, according to the findings of a study released Thursday by CVS Caremark.
In fact, the study found that 58% of adults between the ages of 18 and 34 are not taking their cholesterol-lowering medications as prescribed.
The study examined adherence to cholesterol-lowering medications by evaluating de-identified data for more than 74,000 adult patients from the CVS Caremark Health Management Claims Database who incurred claims from a cholesterol-lowering medication between Jan. 1, 2008 and Dec. 31, 2008.
They study found that 42% of patients between the ages of 18 and 34 were optimally adherent to their medications with a medication possession ratio of greater than 80%. In addition, among those patients ages 35 to 44, half were identified as optimally adherent to their high cholesterol medication.
In fact, the study found that 58% of adults between the ages of 18 and 34 are not taking their cholesterol-lowering medications as prescribed.
The study examined adherence to cholesterol-lowering medications by evaluating de-identified data for more than 74,000 adult patients from the CVS Caremark Health Management Claims Database who incurred claims from a cholesterol-lowering medication between Jan. 1, 2008 and Dec. 31, 2008.
They study found that 42% of patients between the ages of 18 and 34 were optimally adherent to their medications with a medication possession ratio of greater than 80%. In addition, among those patients ages 35 to 44, half were identified as optimally adherent to their high cholesterol medication.
Todays rumor
Are GlaxoSmithKline planning a $4 billion takeover bid for partner Human Genome Sciences, which is developing Benlysta, an experimental lupus drug?
You tell me.
Thursday, August 27, 2009
The supply chains that bind!
Industry supply chain controls in the UK have overwhelmingly made medicines more difficult to source and have put patients risk, according to a poll of of pharmacists.
Chemist & Druggist magazine found 78% of pharmacists surveyed said it has been harder to get hold of products from manufacturers running wholesaler distribution models.
Patients are suffering because of shortages in some branded medicines, with Roche's Xenical and Lilly's Zyprexa the most difficult to obtain.
On a wider measure of availability, nearly a quarter of chemists said between 20 and 50 drugs were currently out of stock at their wholesalers, with 14% saying the figure was more than 50.
Chemist & Druggist magazine found 78% of pharmacists surveyed said it has been harder to get hold of products from manufacturers running wholesaler distribution models.
Patients are suffering because of shortages in some branded medicines, with Roche's Xenical and Lilly's Zyprexa the most difficult to obtain.
On a wider measure of availability, nearly a quarter of chemists said between 20 and 50 drugs were currently out of stock at their wholesalers, with 14% saying the figure was more than 50.
Wednesday, August 26, 2009
Get your knowledge here
Clinical Knowledge Summaries (CKS) has been updated in August 2009 for the following clinical areas:
- Atrial fibrillation
- Bed-wetting (enuresis)
- Headache – assessment
- Headache – cluster
- Headache – medication overuse
- Headache – tension-type
- Influenza – seasonal
- Pelvic inflammatory disease
NICE kidney punches Big Pharma
The National Institute for Health and Clinical Excellence’s decision to reject an appeal to make Roche’s Avastin, Bayer's Nexavar and Wyeth's Torisel available on the National Health Service for renal cancer patients has unsurprisingly led to protests from the drugmakers and patient groups.
NICE has this morning issued guidance saying that Avastin (bevacizumab), Nexavar (sorafenib) and Torisel (temsirolimus) are not recommended as first-line treatment options for advanced and/or metastatic renal cell carcinoma. In addition, the agency has turned down the use of Nexavar andPfizer’s Sutent (sunitinib) as secondary treatment options for people with either form of the disease, adding that those patients who are currently receiving these treatments should have the option to continue their therapy until they and their clinicians consider it appropriate to stop.
A year ago, NICE turned down all four drugs for first-line use but then changed its guidance to recommend Sutent at the beginning of 2009. However an appeal against that Final Appraisal Determination brought by Roche, Wyeth the James Whale Fund for Kidney Cancer and a joint appeal from Rarers Cancer Forum and Macmillan Cancer Support, have not been upheld.
Peter Littlejohns, NICE’s clinical and public health director, noted that “we are very aware that renal cancer is a devastating disease for the individual and their family” and following the about-turn over Sutent in March, “one of these new treatments is now available”. However, he added that the evidence to support the use of the other first and second line treatments “isn’t strong enough to justify using NHS funds, which could be used for other cancer treatment programmes or in other treatment areas”.
Prof Littlejohns concluded that “our advisory committee used the additional flexibility we have recently given them to give special weight to drugs that extend life, at the end of life, but the benefit was still too small set against their cost”.
Roche has responded to the guidance by saying that it is “fundamentally flawed” and serves only to reduce treatment access and options “for those UK patients who are sadly dying from this disease whilst being available to other patients in comparable countries”. The company adds that the appraisal committee accepted Avastin in combination with interferon has a similar clinical and cost-effectiveness profile to the already-approved Sutent “but turned it down simply because it has a licence in other indications - despite the fact that these indications are not currently routinely reimbursed on the NHS”.
The implication of this guidance, Roche claims, is that patients who are unsuitable for sunitinib “may be condemned to faster disease progression of their terminal cancer”. John Melville, general manager of Roche UK, said the decision is “entirely illogical and neither addresses the needs of patients with renal cancer, nor advances the innovation agenda”.
He added that Avastin “demonstrates the same value to the NHS as sunitinib and this guidance goes against the spirit of end-of-life criteria which were devised for this very setting”. The company stated that it is “considering all options”.
Stella Pendleton, executive director of the Rarer Cancers Forum, said “this is a deeply disappointing decision and a bitter blow. It is “harrowing” for patients “to know that effective treatments are available but they can’t get them on the NHS”, she added.
Ms Pendleton went on to note that the guidance will be considered for review by June 2011 and that review and “reversal of this decision cannot come fast enough”.
By Kevin Grogan
NICE has this morning issued guidance saying that Avastin (bevacizumab), Nexavar (sorafenib) and Torisel (temsirolimus) are not recommended as first-line treatment options for advanced and/or metastatic renal cell carcinoma. In addition, the agency has turned down the use of Nexavar andPfizer’s Sutent (sunitinib) as secondary treatment options for people with either form of the disease, adding that those patients who are currently receiving these treatments should have the option to continue their therapy until they and their clinicians consider it appropriate to stop.
A year ago, NICE turned down all four drugs for first-line use but then changed its guidance to recommend Sutent at the beginning of 2009. However an appeal against that Final Appraisal Determination brought by Roche, Wyeth the James Whale Fund for Kidney Cancer and a joint appeal from Rarers Cancer Forum and Macmillan Cancer Support, have not been upheld.
Peter Littlejohns, NICE’s clinical and public health director, noted that “we are very aware that renal cancer is a devastating disease for the individual and their family” and following the about-turn over Sutent in March, “one of these new treatments is now available”. However, he added that the evidence to support the use of the other first and second line treatments “isn’t strong enough to justify using NHS funds, which could be used for other cancer treatment programmes or in other treatment areas”.
Prof Littlejohns concluded that “our advisory committee used the additional flexibility we have recently given them to give special weight to drugs that extend life, at the end of life, but the benefit was still too small set against their cost”.
Roche has responded to the guidance by saying that it is “fundamentally flawed” and serves only to reduce treatment access and options “for those UK patients who are sadly dying from this disease whilst being available to other patients in comparable countries”. The company adds that the appraisal committee accepted Avastin in combination with interferon has a similar clinical and cost-effectiveness profile to the already-approved Sutent “but turned it down simply because it has a licence in other indications - despite the fact that these indications are not currently routinely reimbursed on the NHS”.
The implication of this guidance, Roche claims, is that patients who are unsuitable for sunitinib “may be condemned to faster disease progression of their terminal cancer”. John Melville, general manager of Roche UK, said the decision is “entirely illogical and neither addresses the needs of patients with renal cancer, nor advances the innovation agenda”.
He added that Avastin “demonstrates the same value to the NHS as sunitinib and this guidance goes against the spirit of end-of-life criteria which were devised for this very setting”. The company stated that it is “considering all options”.
Stella Pendleton, executive director of the Rarer Cancers Forum, said “this is a deeply disappointing decision and a bitter blow. It is “harrowing” for patients “to know that effective treatments are available but they can’t get them on the NHS”, she added.
Ms Pendleton went on to note that the guidance will be considered for review by June 2011 and that review and “reversal of this decision cannot come fast enough”.
By Kevin Grogan
Amgen - Aranesp: clinical trials, ain't they a bitch!
Amgen ’s anemia drug Aranesp didn’t help the heart health of patients with chronic kidney disease, a company-sponsored trial found.
A study dubbed TREAT -- Trial to Reduce Cardiovascular Events with Aranesp Therapy -- found the drug had little effect on the heart health of patients with chronic kidney disease compared with patients who got placebos, Thousand Oaks, California-based Amgen said in a statement. The results showed more Aranesp users suffered strokes than did patients taking placebos.
A study dubbed TREAT -- Trial to Reduce Cardiovascular Events with Aranesp Therapy -- found the drug had little effect on the heart health of patients with chronic kidney disease compared with patients who got placebos, Thousand Oaks, California-based Amgen said in a statement. The results showed more Aranesp users suffered strokes than did patients taking placebos.
Tuesday, August 25, 2009
Are Boehringer cutting 600 US rep jobs?
That's what Insider hears. Thirty percent - gone!
Apparently horrible trial results for currently promoted drugs combined with Mirapex going off patent and losing Flomax to generic as well has led to a cut of 600 or more reps in the USA.
Apparently horrible trial results for currently promoted drugs combined with Mirapex going off patent and losing Flomax to generic as well has led to a cut of 600 or more reps in the USA.
Notifications were on Tuesday morning via a phone call to impacted reps.
Chanos targets Big Pharma
Jim Chanos, one of the world’s best-known and most successful short sellers, who made a fortune betting against banks and brokers, said yesterday that he was targeting big pharmaceuticals companies.
The billionaire founder and president of Kynikos, an American hedge fund, said: “The US healthcare system is probably the most interesting large group of companies that are heading for major problems that we’ve seen in a long, long time.”
Speaking on Radio 4’s Peston and the Money Men, Mr Chanos said: “Healthcare is growing now at about 10 per cent per annum in the US top line, versus 3 per cent for the economy. As someone with a sharp pencil and an eye for this kind of thing, this can’t last.”
Mr Chanos is estimated by Trader Monthly, an American trade magazine, to have made up to $350 million personally in 2007. He profited from the collapse of Enron and in April 2007 warned finance ministers of the Group of Eight leading economies that banks and brokerages were heading for a calamity.
The billionaire founder and president of Kynikos, an American hedge fund, said: “The US healthcare system is probably the most interesting large group of companies that are heading for major problems that we’ve seen in a long, long time.”
Speaking on Radio 4’s Peston and the Money Men, Mr Chanos said: “Healthcare is growing now at about 10 per cent per annum in the US top line, versus 3 per cent for the economy. As someone with a sharp pencil and an eye for this kind of thing, this can’t last.”
Mr Chanos is estimated by Trader Monthly, an American trade magazine, to have made up to $350 million personally in 2007. He profited from the collapse of Enron and in April 2007 warned finance ministers of the Group of Eight leading economies that banks and brokerages were heading for a calamity.
Orlistat - the liver is evil; it must be punished
The Food and Drug Administration said on Monday it had received 32 reports between 1999 and 2008 of serious liver injury in patients taking orlistat.
All but two involved prescription Xenical and occurred outside the United States.
Twenty-seven patients were hospitalised, and six cases resulted in liver failure, the FDA said.
Twenty-seven patients were hospitalised, and six cases resulted in liver failure, the FDA said.
Monday, August 24, 2009
Ghostwriting contd. - McGill prof "made an error"
"I wrote a portion of the article, but not all of it, although only my name was listed as its author. Other parts of that article were written with the assistance of DesignWrite, a firm which, it turns out, was employed by a pharmaceutical manufacturer to assist in the development of academic articles. I made an error in agreeing to have my name attached to that article without having it made clear that others contributed to it."Prof Barbara Sherwin comes clean
Don't leave us behind
Dr Doug Farrago writes: Over the past nine years I have been trying to make people laugh with my publications (Placebo Journal and Placebo Gazette). The stories and parodies illustrate much of the absurdity in our healthcare system. Hopefully, I have been able to entertain you and help put a smile on your face once in a while. Now I am asking a favor and it's not for me, but for all of us. Right now healthcare reform is all the rage and I fear that when it is all said and done (after the politicians make their backroom deals with the special interest groups) that patients will be left out of that final conversation. Please help me to remind the politicians not to leave the patients behind! |
| We have created a song and accompanying video that illustrates this concern. It is not one of our humorous pieces. This one is serious. You can download the song by going to the home page of our website www.placebojournal.com. |
Ghostwriting - the "publish or perish" defence
"We academics are under some pressure to 'publish or perish'. "Performance evaluation of at least Australian academics includes the number and quality of publications per year. In retrospect, I was probably naïve and I wouldn't do it now."
Prof John Eden starts to come clean
ADHD meds - speeding from childhood to adulthood
As more and more prescriptions are being written for medications to treat attention-deficit hyperactivity disorder (ADHD), more and more children are abusing these drugs.
That's the conclusion of new research in the September issue of Pediatrics that found the rate of ADHD medication abuse was up 76 percent from 1998 to 2005, and at the same time, the rates of prescriptions for these medications rose about 80 percent.
"We looked at all the poison control centers across the nation and found a significant increase in the number of calls for ADHD medication abuse that parallels the amount of prescriptions being written," said Dr. Jennifer Setlik, an emergency physician at Cincinnati Children's Hospital Medical Center in Ohio and a study author.
What's more, Setlik said, is that this study is "not an estimate of the total problem" because it looks only at data from poison control centers, but it gives doctors and parents a snapshot of the trend toward rising abuse of these medications with increasing availability.
More
That's the conclusion of new research in the September issue of Pediatrics that found the rate of ADHD medication abuse was up 76 percent from 1998 to 2005, and at the same time, the rates of prescriptions for these medications rose about 80 percent.
"We looked at all the poison control centers across the nation and found a significant increase in the number of calls for ADHD medication abuse that parallels the amount of prescriptions being written," said Dr. Jennifer Setlik, an emergency physician at Cincinnati Children's Hospital Medical Center in Ohio and a study author.
What's more, Setlik said, is that this study is "not an estimate of the total problem" because it looks only at data from poison control centers, but it gives doctors and parents a snapshot of the trend toward rising abuse of these medications with increasing availability.
More
Warner Chilcott win
Sunday, according to The Wall Street Journal, specialty drug maker Warner Chilcott is acquiring the prescription-drug business of consumer goods giant Procter & Gamble. The report stated that the pharmaceutical unit could fetch about $3 billion, and that the official announcement on a deal could be made as early as Monday. The company's Ohio-based pharmaceutical unit was on the block for sale since December 2008.
Ardee, Ireland-based Warner Chilcott, which recently shifted base from Rockaway, New Jersey, is expected to run the acquired business as a wholly-owned unit. Both the companies were unavailable to comment. The report stated that others in the fray to buy the unit were private equity firm Cerberus Capital Management and rival drug-maker Forest Laboratories.
Ardee, Ireland-based Warner Chilcott, which recently shifted base from Rockaway, New Jersey, is expected to run the acquired business as a wholly-owned unit. Both the companies were unavailable to comment. The report stated that others in the fray to buy the unit were private equity firm Cerberus Capital Management and rival drug-maker Forest Laboratories.
Sunday, August 23, 2009
Saturday, August 22, 2009
Peer Review vs PR Review - Ben Goldacre explains
Media analysis company GroupM forecast that advertising revenues for newspapers will be down 25% this year.
They are short of cash, they are short of money to pay people to fill their pages, and they print PR-reviewed “research” straight from the press release, because it’s quick and it’s cheap: these stories are now ubiquitous, but they’re not science, or research, or reports, or studies, nor are they news. Even the accompanying photographs of celebrity Katy Hill – which papers would normally have to pay for – are provided by LipoBind.
These articles are adverts.
Cubs sold
"Our family is thrilled to have reached an agreement to acquire a controlling interest in the Chicago Cubs, one of the most storied franchises in sports," said Joe Ricketts, who founded the Omaha, Neb.-based online brokerage TD Ameritrade Holding Corp. "The Cubs have the greatest fans in the world, and we count our family among them."
Friday, August 21, 2009
Introducing Pixels and Pills
The Pixels & Pills blog is a collaborative effort between some passionate professionals in the Pharmaceutical Marketing and Communications space.
"Medical Research"
A growing body of evidence suggests that doctors at some of the nation’s top medical schools have been attaching their names and lending their reputations to scientific papers that were drafted by ghostwriters working for drug companies — articles that were carefully calibrated to help the manufacturers sell more products.
Thursday, August 20, 2009
GSK - Paxil: CASPPER - read the file for yourself
The pdf
CASPPER document now online:
Thanks to Fid
Author of Seroxat/Paxil Sufferers
http://fiddaman.blogspot.com
Thanks to Fid
Author of Seroxat/Paxil Sufferers
http://fiddaman.blogspot.com
Insider sees that the med comms company responsible for CASPPER was Complete Healthcare Communications. Phone: 610-358-3600
Michael Moore Q's & A's
By Matthew Belloni / The Hollywood Reporter
Since bursting onto the documentary scene 20 years ago with "Roger & Me," a blistering critique of General Motors, Michael Moore has directed the highest-grossing documentary of all time (2004's "Fahrenheit 9/11") and become a professional populist provocateur. The Flint, Mich., native is now busy finishing "Capitalism: A Love Story," his take on the U.S. financial crisis, which will premiere next month at the Venice and Toronto film festivals ahead of its wide release Oct. 2.
The Hollywood Reporter: Your new film was announced in May 2008 as a follow-up to "Fahrenheit 9/11" that would look at America's role in the world. Then the economy tanked. Do you feel pressure to make movies that respond to the zeitgeist?
Michael Moore: That was our cover. From the spring of '08, we were always doing a film about capitalism and corporate America. But, as you've seen from the recent revelations about the health insurance industry's secret campaign to attack my last film (2007's "Sicko"), I have to be extremely dodgy in order to outsmart these corporate guys. I had no way of knowing in May of 2008 that the economy would crash four months later. We were right in the middle of this Wall Street movie when it happened.
THR: The conventional wisdom in Hollywood is that in tough economic times, moviegoers want an escape. Is there a big audience for a film that looks at the financial crisis?
Moore: I have no doubts that people will want to come to a movie that goes after, with humor and reckless abandon, those bastards who've made their lives miserable. They deserve a night out at the movies where the movie is on their side.
THR: Given your history with "Roger & Me," what was your reaction to the initial bailout of GM, its subsequent bankruptcy and the firing of CEO Rick Wagoner?
Moore: All my films, in one way or another, speak to my experience of growing up in the hometown of General Motors. As for GM's demise, I tried to warn people about that some 20 years ago. Nothing made me happier than seeing President Obama fire the head of GM. It was every Flint boy's dream come true. They arrogantly kept making lousy cars that few people wanted to drive. They fought every safety measure from mandatory turn signals to controls that would protect the melting of our polar ice caps. They fired tens of thousands of people over the years for the short-term benefit of making their balance sheet appear to be in profit. That was a fraud of major proportions, and to date, no one has yet to go to prison.
THR: You supported President Obama in the election. How do you grade his response to the financial crisis and the health care issue? How about congressional Democrats?
Moore: I'm still in a stupor of stunned ecstasy that Obama won. And I approve of most everything he's done, from apologizing to the Iranians for America overthrowing their democratically elected president in 1953 to appointing Kumar (actor Kal Penn of the "Harold and Kumar" movies) to a White House position. He is doing the best he can with the mess he inherited, and I and millions of others are counting on him never to forget that he came from the working class and that his people need him now more than ever. As for the congressional Democrats, what a bunch of losers -- weak, scared, stupid. They had better get a clue pretty quick or the Dark Forces will return.
THR: Bill Maher recently said that "America is stupid" and "too dumb to be governed." Do you agree?
Moore: Eight years ago I wrote a book called "Stupid White Men." In that book, I wrote a chapter entitled "Idiot Nation." I think that says it all. Sad, sad, sad.
THR: Have you ever considered leaving the U.S.?
Moore: Thank you for asking! I had never considered this idea until you mentioned it, and now that you have, it doesn't sound like such a bad idea! I guess if I were going to live outside the U.S., I would live in Texas.
THR: What's the No. 1 thing you want to teach your kids?
Moore: Never trust anyone from Texas.
THR: In your opinion, what's the single worst legacy of George W. Bush?
Moore: That he has yet to be arrested for committing the worst crime the leader of a nation can commit: lie to the people and convince them to invade another country and kill its people with absolutely no provocation. There are 8,662 parents who might better answer this question.
THR: Your films are big boxoffice draws, and you won an Oscar for 2002's "Bowling for Columbine," but you've always been considered an outsider to the entertainment community. Do you like Hollywood?
Moore: Yes. I've met only very nice people out here, and if I wouldn't miss the 20-below winters, I'd live here for sure.
THR: What's the last movie you saw? The last book you read?
Moore: A Norwegian film called "Troubled Water." Best drama I've seen this year. The last book was "The Coming Insurrection" (a French leftist call-to-arms manifesto that has been labeled a "manual for terrorism" by the French government). I'm also reading the daily newspaper religiously, considering how there won't be any to read a year from now.
THR: There were reports you were feuding with Harvey and Bob Weinstein, who executive produced "Fahrenheit," "Sicko" and "Capitalism." Will you work with them again?
Moore: In 20 years of knowing the brothers, I have had only one fight with them, and that was over who would get the last cannoli.
Since bursting onto the documentary scene 20 years ago with "Roger & Me," a blistering critique of General Motors, Michael Moore has directed the highest-grossing documentary of all time (2004's "Fahrenheit 9/11") and become a professional populist provocateur. The Flint, Mich., native is now busy finishing "Capitalism: A Love Story," his take on the U.S. financial crisis, which will premiere next month at the Venice and Toronto film festivals ahead of its wide release Oct. 2.
The Hollywood Reporter: Your new film was announced in May 2008 as a follow-up to "Fahrenheit 9/11" that would look at America's role in the world. Then the economy tanked. Do you feel pressure to make movies that respond to the zeitgeist?
Michael Moore: That was our cover. From the spring of '08, we were always doing a film about capitalism and corporate America. But, as you've seen from the recent revelations about the health insurance industry's secret campaign to attack my last film (2007's "Sicko"), I have to be extremely dodgy in order to outsmart these corporate guys. I had no way of knowing in May of 2008 that the economy would crash four months later. We were right in the middle of this Wall Street movie when it happened.
THR: The conventional wisdom in Hollywood is that in tough economic times, moviegoers want an escape. Is there a big audience for a film that looks at the financial crisis?
Moore: I have no doubts that people will want to come to a movie that goes after, with humor and reckless abandon, those bastards who've made their lives miserable. They deserve a night out at the movies where the movie is on their side.
THR: Given your history with "Roger & Me," what was your reaction to the initial bailout of GM, its subsequent bankruptcy and the firing of CEO Rick Wagoner?
Moore: All my films, in one way or another, speak to my experience of growing up in the hometown of General Motors. As for GM's demise, I tried to warn people about that some 20 years ago. Nothing made me happier than seeing President Obama fire the head of GM. It was every Flint boy's dream come true. They arrogantly kept making lousy cars that few people wanted to drive. They fought every safety measure from mandatory turn signals to controls that would protect the melting of our polar ice caps. They fired tens of thousands of people over the years for the short-term benefit of making their balance sheet appear to be in profit. That was a fraud of major proportions, and to date, no one has yet to go to prison.
THR: You supported President Obama in the election. How do you grade his response to the financial crisis and the health care issue? How about congressional Democrats?
Moore: I'm still in a stupor of stunned ecstasy that Obama won. And I approve of most everything he's done, from apologizing to the Iranians for America overthrowing their democratically elected president in 1953 to appointing Kumar (actor Kal Penn of the "Harold and Kumar" movies) to a White House position. He is doing the best he can with the mess he inherited, and I and millions of others are counting on him never to forget that he came from the working class and that his people need him now more than ever. As for the congressional Democrats, what a bunch of losers -- weak, scared, stupid. They had better get a clue pretty quick or the Dark Forces will return.
THR: Bill Maher recently said that "America is stupid" and "too dumb to be governed." Do you agree?
Moore: Eight years ago I wrote a book called "Stupid White Men." In that book, I wrote a chapter entitled "Idiot Nation." I think that says it all. Sad, sad, sad.
THR: Have you ever considered leaving the U.S.?
Moore: Thank you for asking! I had never considered this idea until you mentioned it, and now that you have, it doesn't sound like such a bad idea! I guess if I were going to live outside the U.S., I would live in Texas.
THR: What's the No. 1 thing you want to teach your kids?
Moore: Never trust anyone from Texas.
THR: In your opinion, what's the single worst legacy of George W. Bush?
Moore: That he has yet to be arrested for committing the worst crime the leader of a nation can commit: lie to the people and convince them to invade another country and kill its people with absolutely no provocation. There are 8,662 parents who might better answer this question.
THR: Your films are big boxoffice draws, and you won an Oscar for 2002's "Bowling for Columbine," but you've always been considered an outsider to the entertainment community. Do you like Hollywood?
Moore: Yes. I've met only very nice people out here, and if I wouldn't miss the 20-below winters, I'd live here for sure.
THR: What's the last movie you saw? The last book you read?
Moore: A Norwegian film called "Troubled Water." Best drama I've seen this year. The last book was "The Coming Insurrection" (a French leftist call-to-arms manifesto that has been labeled a "manual for terrorism" by the French government). I'm also reading the daily newspaper religiously, considering how there won't be any to read a year from now.
THR: There were reports you were feuding with Harvey and Bob Weinstein, who executive produced "Fahrenheit," "Sicko" and "Capitalism." Will you work with them again?
Moore: In 20 years of knowing the brothers, I have had only one fight with them, and that was over who would get the last cannoli.
ObamaCare - Matt Herper speaks
The drug industry has transformed from a business that tries to sell pills to the masses to one that markets very expensive treatments to small groups of sick people--and that changes everything.
GSK - Avandia: "It is difficult for making a case for using rosiglitazone in anybody, because we have an alternative,"
The type 2 diabetes drug Avandia (rosiglitazone) increases the risk of heart failure and death more than another drug in the same class, Actos (pioglitazone), new Canadian research contends.
Avandia has been the subject of controversy since 2007, when it was linked to an increased risk for heart attack and death, although those claims have become clouded as other studies have discounted that risk to some degree. But taken together, many believe that the drug should not be used, especially since there appears to be a safer choice.
"It is difficult for making a case for using rosiglitazone in anybody, because we have an alternative," said lead researcher Dr. David Juurlink, division head of clinical pharmacology and toxicology at Sunnybrook Health Sciences Centre in Toronto.
Avandia has been the subject of controversy since 2007, when it was linked to an increased risk for heart attack and death, although those claims have become clouded as other studies have discounted that risk to some degree. But taken together, many believe that the drug should not be used, especially since there appears to be a safer choice.
"It is difficult for making a case for using rosiglitazone in anybody, because we have an alternative," said lead researcher Dr. David Juurlink, division head of clinical pharmacology and toxicology at Sunnybrook Health Sciences Centre in Toronto.
GSK - Paxil: CASPPER; file under hubris
Pharma Giles writes ,,,
A former scientist at Phoni’s Dry Prong, Louisiana plant alleges that she was told to stop documenting safety concerns at the lab even though she was a member of the company’s health and safety committee.
Dr. Cindy McTottie was subsequently “downsized” by Phoni, and is now suing the company, claiming that she was retaliated against because she kept raising safety concerns with management — such as the discovery of a genetically engineered virus in a lunchroom.
Phoni denies the claim and has moved to dismiss it.
“We haven’t heard a single complaint with respect to health and safety issues,” said Phoni’s Head of Global HR, Siobhan Mann-Hayter. “We take any such complaints extremely seriously, and would certainly look to initiate disciplinary proceedings against anyone seeking to damage our “zero incident” culture by actually reporting one.”
“Our safety culture is second to none,” Mann-Hayter added, “the ‘none’ being that which you find in our more cost-effective plants in the Far-East, of course.”
Regarding the lunchroom virus, McTottie says that “people found a virus where we ate and drank. One lady had finished her lunch and found a micro-centrifuge tube at the bottom of her Coke.”
Some of Phoni’s management’s responses were a little bit odd. For example, when questioned about the presence of genetically-engineered pathogens in the vending machine drinks, HR responded that this was simply a part of the headcount reduction program, in line with the company policies on dignity and respect for the employee.
“Surely it’s better to be retired on ill-health grounds than suffer the usual indignity of us dismissing you on the basis of trumped-up disciplinary charges or manipulated performance appraisal criteria?” reasoned Siobhan Mann-Hayter.
“All of our operations are subjected to a thorough risk assessment. We would never condone unsafe working practices in order to save money if we thought there was a serious risk of getting caught and fined more than we saved…”
McTottie also claimed that a fume hood in one lab developed a leak and went unrepaired for months, sickening workers in the lab. When the hood was identified as the cause, Phoni apparently unplugged it and dumped it in McTottie’s office, with a note saying “the one who smelt it, dealt it – the one who supplied it, denied it…”.
Eventually, McTottie’s performance reviews went down, she became sick and was terminated.
“All according to plan,” said Siobhan Mann-Hayter, “and another cost-saving bonus for HR to put in their accomplishments…”
Phoni responded to a message requesting comment.
“Our safety budget is based on what is legal and not what is safe,” the spokesperson stated. “And then we cut it by 20%, same as we do with any budget…”
In the real world, another company also appears to take a cost-sensitive line on employee well-being. Allegedly...
Wednesday, August 19, 2009
Merck - Gardasil: questions, questions
Research findings from a safety review published in JAMA on Tuesday indicated that Merck & Co.'s cervical cancer vaccine Gardasil was associated with higher rates of blood clots and fainting compared with other vaccines, but that there was no evidence severe adverse events were caused by the product. In a separate article in JAMA, researchers who studied Merck's marketing practices for the vaccine questioned the "methods and messages by which [Gardasil] was marketed." Full story
Lilly - arzoxifine: clinical trials, ain't they a bitch!
Lilly has halted development of its experimental bone drug arzoxifene, once one of its most promising new treatments, after a study found it didn’t prevent nonspinal fractures and increased blood clots and hot flashes.
Let's (not) make a deal, contd.
The US industry is accused of selling out to President Obama's healthcare take-over, with its leaders seeking favourable treatment from government at the expense of its customers.
The industry's decision to agree to $80 billion in concessions to the White House was heavily criticised by House Republican Leader John Boehner.
Writing to his former colleague Billy Tauzin, who now heads the Pharmaceutical Research and Manufacturers of America (PHRMA), he called the deal a short-sighted bargain that leaves your own customers and employees behind.
Boehner added: "When a bully asks for your lunch money, you may have no choice but to fork it over. But cutting a deal with the bully is a different story, particularly if the 'deal' means helping him steal others' money as the price of protecting your own."
Obama has made it a priority to cut healthcare costs and see all Americans covered by medical insurance.
His administration sought a deal with the US industry association PHRMA, agreed last month, that will see an $80 billion cut in government spending on medicines, and this has been followed by a deal with three leading hospital groups. Overall, it is expected to save $155 billion in spending over 10 years, mainly by lowering charges for services to the poor and elderly.
But Boehner argues that reduced costs will threaten new research and leave customers with poorer quality services. He says pharma has chosen the deal at the expense of the American people in the hopes of favourable treatment and future profits.
He implored Tauzin, who previously served as a Republican congressman from Louisiana and chairman of the Energy and Commerce Committee, to abandon PHRMA's $150 million health care advertising campaign that supports the Obama administration.
As a further blow, he highlighted remarks from House Democratic leaders that they are not bound by the $80 billion deal between White House and PhRMA, and that they could push for further concessions.
The industry's decision to agree to $80 billion in concessions to the White House was heavily criticised by House Republican Leader John Boehner.
Writing to his former colleague Billy Tauzin, who now heads the Pharmaceutical Research and Manufacturers of America (PHRMA), he called the deal a short-sighted bargain that leaves your own customers and employees behind.
Boehner added: "When a bully asks for your lunch money, you may have no choice but to fork it over. But cutting a deal with the bully is a different story, particularly if the 'deal' means helping him steal others' money as the price of protecting your own."
Obama has made it a priority to cut healthcare costs and see all Americans covered by medical insurance.
His administration sought a deal with the US industry association PHRMA, agreed last month, that will see an $80 billion cut in government spending on medicines, and this has been followed by a deal with three leading hospital groups. Overall, it is expected to save $155 billion in spending over 10 years, mainly by lowering charges for services to the poor and elderly.
But Boehner argues that reduced costs will threaten new research and leave customers with poorer quality services. He says pharma has chosen the deal at the expense of the American people in the hopes of favourable treatment and future profits.
He implored Tauzin, who previously served as a Republican congressman from Louisiana and chairman of the Energy and Commerce Committee, to abandon PHRMA's $150 million health care advertising campaign that supports the Obama administration.
As a further blow, he highlighted remarks from House Democratic leaders that they are not bound by the $80 billion deal between White House and PhRMA, and that they could push for further concessions.
Tuesday, August 18, 2009
Genmab - Arzerra: clinical trials, ain't they a bitch!
A clinical trial of Arzerra, a drug being developed by Danish biotechnology company Genmab and backed by Glaxo, had proven disappointing, Genmab management said yesterday.
Among patients with non-Hodgkin's lymphoma that were given a high dose of the drug, only 10% saw their cancer shrink - a response rate far lower than expected.
Among patients with non-Hodgkin's lymphoma that were given a high dose of the drug, only 10% saw their cancer shrink - a response rate far lower than expected.
Let's (not) make a deal!
PhRMA believes that a health care bill will pass Congress. That's why they've sort of agreed with the White House denials of the deal. They don't want to anger House Democrats into writing more punitive provisions.
J&J - Procrit: whistleblowers "marketed the spread"
The whistleblower pharmaceutical sales reps in the Procrit case reinstated in a Massachussetts federal court claim that their careers at Johnson & Johnson’s Ortho Biotech unit were based mostly on lies.
Mark Duxbury and Dean McClennan, both former sales reps at J&J, claim that the bulk of their business selling Procrit to hospitals and clinics was conducting Medicare fraud.
Monday, August 17, 2009
Lilly - Effient: worth every cent?
Elli Lilly is now launching the newly approved Effient (prasugrel). The company set nearly a 100% price premium for Effient over Plavix ($5.40 per Effient pill versus $3 per Plavix pill), despite the black box warnings on Effient. This comes at a time when healthcare reform talks are at a peak and drug price negotiations by Medicare Part D are “on the table” as a way to fund the reform bill.
The Healthcare Channel interviewed William O’Neill, Executive Dean for Clinical Affairs at the University of Miami School of Medicine. Dr. O’Neill is quite upset at the price for Effient and discusses how it is now common for his medical center to treat patients that cannot afford the price for oral medications.
Sunday, August 16, 2009
U.S. Health Care Spending: Comparison with Other OECD Countries
The United States spends more money on health care than any other country in the Organization for Economic Cooperation and Development (OECD). The OECD consists of 30 democracies, most of which are considered the most economically advanced countries in the world. According to OECD data, the United States spent $6,102 per capita on health care in 2004 — more than double the OECD average and 19.9% more than Luxembourg, the second-highest spending country. In 2004, 15.3% of the U.S. economy was devoted to health care, compared with 8.9% in the average OECD country and 11.6% in second-placed Switzerland.
Why does the United States spend this amount on health care?
What does the United States get for the money it spends?
However, research comparing the quality of care has not found the United States to be superior overall. Nor does the U.S. population have substantially better access to health care resources, even putting aside the issue of the uninsured. Although the United States does not have long wait times for non-emergency surgeries, unlike some OECD countries, Americans found it more difficult to make same-day doctor’s appointments when sick and had the most difficulty getting care on nights and weekends. They were also most likely to delay or forgo treatment because of cost.
The OECD data and other research provide some insight as to why health care spending is higher in the United States than in other countries, although many difficult research issues remain.
Why does the United States spend this amount on health care?
Economists break health care spending into two parts: price and quantity (which includes the number of visits to health care providers and the intensity of those visits). In terms of quantity, OECD data indicate that the United States has far fewer doctor visits per person compared with the OECD average; for hospitalizations, the United States ranks well below the OECD and is roughly comparable in terms of length of hospital stays. The intensity of service delivery is a different story: the United States uses more of the newest medical technologies and performs several invasive procedures (such as coronary bypasses and angioplasties) more frequently than the average OECD country. In terms of price, the OECD has stated that “there is no doubt that U.S. prices for medical care commodities and services are significantly higher than in other countries and serve as a key determinant of higher overall spending.”
What does the United States get for the money it spends?
Said slightly differently, does the United States get corresponding value from the money it spends on health care? The available data often do not provide clear answers. For example, among OECD countries in 2004, the United States had shorter-than-average life
expectancy and higher-than-average mortality rates. Does this mean that the U.S. system is inefficient in light of how much is spent on health care? Or does this reflect the greater prevalence of certain diseases in the United States (the United States has the highest incidence of cancer and AIDS in the OECD) and less healthy lifestyles (the United States has the highest obesity rates in the OECD)? These are some of the issues that confound international comparisons.
expectancy and higher-than-average mortality rates. Does this mean that the U.S. system is inefficient in light of how much is spent on health care? Or does this reflect the greater prevalence of certain diseases in the United States (the United States has the highest incidence of cancer and AIDS in the OECD) and less healthy lifestyles (the United States has the highest obesity rates in the OECD)? These are some of the issues that confound international comparisons.
However, research comparing the quality of care has not found the United States to be superior overall. Nor does the U.S. population have substantially better access to health care resources, even putting aside the issue of the uninsured. Although the United States does not have long wait times for non-emergency surgeries, unlike some OECD countries, Americans found it more difficult to make same-day doctor’s appointments when sick and had the most difficulty getting care on nights and weekends. They were also most likely to delay or forgo treatment because of cost.
The OECD data and other research provide some insight as to why health care spending is higher in the United States than in other countries, although many difficult research issues remain.
This report presents some of the available data and research and concludes with a summary of study findings.
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