Once again. Hats off to the Pfizer fieldforce for showing the industry how to get into the Hallowe'en spirit!
Monday, October 31, 2005
Tricks or treats?
Once again. Hats off to the Pfizer fieldforce for showing the industry how to get into the Hallowe'en spirit!
Halloween Special 8
Th...th.....th....that's all folks! If anyone cant put a name to a particular "face" please leave a message and I'll be happy to help. Have a spooky but safe Halloween! Dont have nightmares.
Sunday, October 30, 2005
Halloween Special 1
Over the next 48 hours (or until he gets bored) Insider will post some "altered images" of big cheeses in Big Pharma. All made more appropriate for this spooky time of the year! Enjoy.
Saturday, October 29, 2005
Merck trial - next moves
The second Vioxx trial will end this coming week.
So what then?
W. Mark Lanier is one of several plaintiffs lawyers from around the country with Vioxx suits filed against Merck & Co. Inc. who are now banding together to coordinate discovery and devote their time to trying Vioxx suits in state (rather than federal) courts.
"It's our response to Merck's declaration that Merck wants to try all the cases everywhere," says Lanier.
Merck currently maintains it will try each and every Vioxx suit.
In theory, the plans of Lanier and his small, breakaway group of plaintiffs lawyers to try suits in state court will pressure New Jersey-based Merck to come to the settlement bargaining table. That would happen once a number of Vioxx verdicts are returned in those state court suits, effectively setting a market rate for Vioxx cases.
Insider says: Smart move Mark, "check mate" will come sooner and the final cost can be better estimated by the markets.
http://www.law.com/jsp/article.jsp?id=1130499499269
So what then?
W. Mark Lanier is one of several plaintiffs lawyers from around the country with Vioxx suits filed against Merck & Co. Inc. who are now banding together to coordinate discovery and devote their time to trying Vioxx suits in state (rather than federal) courts.
"It's our response to Merck's declaration that Merck wants to try all the cases everywhere," says Lanier.
Merck currently maintains it will try each and every Vioxx suit.
In theory, the plans of Lanier and his small, breakaway group of plaintiffs lawyers to try suits in state court will pressure New Jersey-based Merck to come to the settlement bargaining table. That would happen once a number of Vioxx verdicts are returned in those state court suits, effectively setting a market rate for Vioxx cases.
Insider says: Smart move Mark, "check mate" will come sooner and the final cost can be better estimated by the markets.
http://www.law.com/jsp/article.jsp?id=1130499499269
Friday, October 28, 2005
Crawford in the stocks
Poor ex-FDA commish Lester Crawford. The New York Times has suggested that he and his wife sold shares last year in companies regulated by the agency. Dr Crawford, who is facing an investigation into his reasons for leaving by the US Inspector General, Daniel Levinson, has strenuously denied suggestions that an inadvertent failure to make a financial disclosure triggered his departure.
He told Forbes.com his departure was partly based on the issues surrounding the emergency contraceptive Plan B, and the abortion drug RU-486, but conceded there was an upcoming routine investigation by the Government Accountability Office which "he didn't want to go through again".
Now, the NYT says it has seen financial disclosure forms - signed at the end of June this year - showing he or his wife sold stock in Sysco, Kimberly Clark, Teleflex, PepsiCo, Wendy's and Wal-Mart, all of which have food or medical divisions, or own pharmacies, as well as Embrex, an agriculture biotechnology company.
Source: PharmaTimes
He told Forbes.com his departure was partly based on the issues surrounding the emergency contraceptive Plan B, and the abortion drug RU-486, but conceded there was an upcoming routine investigation by the Government Accountability Office which "he didn't want to go through again".
Now, the NYT says it has seen financial disclosure forms - signed at the end of June this year - showing he or his wife sold stock in Sysco, Kimberly Clark, Teleflex, PepsiCo, Wendy's and Wal-Mart, all of which have food or medical divisions, or own pharmacies, as well as Embrex, an agriculture biotechnology company.
Source: PharmaTimes
Swiss BIg Pharma "after sales service"
Poor Novartis, Roche and Serono. An investigation is underway to examine allegations made in Paul Volckers final report on the United Nations Oil-for-Food program, that these Swiss Big Pharma companies offered kickbacks (or "after-sales service," as quaint Iraqi government officials termed it) to the Iraq government in exchange for business.
So. How much?
Well:
Novartis paid $135,836 in kickbacks for sales of $1.6 million (8%).
Roche: $296,225 for sales worth $3.4 million (9%).
On top of that, Roche's diagnostics unit paid $184,618 for sales of $1.4 million (13%).
Finally, Serono paid $859, 001 for selling goods worth $9.5 million (9%).
That's a lot of after sales service! Kudos to Novartis for getting the best deal.
http://money.iwon.com/jsp/nw/nwdt_rt_top.jsp?cat=TOPBIZ&src=704&feed=dji§ion=news&news_id=dji-00063420051028&date=20051028&alias=/alias/money/cm/nw
So. How much?
Well:
Novartis paid $135,836 in kickbacks for sales of $1.6 million (8%).
Roche: $296,225 for sales worth $3.4 million (9%).
On top of that, Roche's diagnostics unit paid $184,618 for sales of $1.4 million (13%).
Finally, Serono paid $859, 001 for selling goods worth $9.5 million (9%).
That's a lot of after sales service! Kudos to Novartis for getting the best deal.
http://money.iwon.com/jsp/nw/nwdt_rt_top.jsp?cat=TOPBIZ&src=704&feed=dji§ion=news&news_id=dji-00063420051028&date=20051028&alias=/alias/money/cm/nw
Lundbeck - Freeze - it's a raid!
Poor Danish drugmaker H Lundbeck. They have recently been raided by investigators from the European Commission looking into alleged antitrust activities.
In a statement, Lundbeck said the surprise inspection is trying to ascertain whether it has 'misused a dominant position or has been involved in anticompetitive agreements in the markets for antidepressant drugs'.
The probe is believed to have centred on antidepressant Cipramil (citalopram), which started to face generic competition in the European Union in 2003.
Lundbeck filed a number of lawsuits against companies such as Ratiopharm and Destin Pharma after they started selling generic citalopram in Europe. Meanwhile, the company has been trying to switch patients to a "evergreen" follow-up product, Cipralex/Lexapro (escitalopram), based on one of the two optical isomers found in the parent product, although this product is also facing generic challenge.
Source: PharmaTimes
In a statement, Lundbeck said the surprise inspection is trying to ascertain whether it has 'misused a dominant position or has been involved in anticompetitive agreements in the markets for antidepressant drugs'.
The probe is believed to have centred on antidepressant Cipramil (citalopram), which started to face generic competition in the European Union in 2003.
Lundbeck filed a number of lawsuits against companies such as Ratiopharm and Destin Pharma after they started selling generic citalopram in Europe. Meanwhile, the company has been trying to switch patients to a "evergreen" follow-up product, Cipralex/Lexapro (escitalopram), based on one of the two optical isomers found in the parent product, although this product is also facing generic challenge.
Source: PharmaTimes
AZ - Quo Vadis?
Poor AstraZeneca! It appears to be a company looking for a way forward. It has just two products in Phase III, a stroke drug called Cerovive and a diabetes/lipids treatment called Galida, each with huge risks attached.
Stroke is the "graveyard of drug development" and a competitor to Galida, BMS/Mercks' Pargluva, has just hit the skids with the FDA in a very bad way.
Insider is sceptical about AZs' prospects as it remains unclear whether there are any potential blockbusters lurking in the portfolio of Phase II drugs. There has be if the shares are to close the gap on UK rival GlaxoSmithKline, which has twice as large a portfolio.
Cost-cutting and good third quarter sales of Seroquel and Nexium (both of which have their ongoing challenges) can only take AZ so far, particularly since changes to the way drugs are purchased in the US are likely to exert yet more downward pressure on prices in the coming years.
Crestor is a dog; stuck at 6% market share.
So, AZ. Quo vadis?
Sources: Independent, Telegraph
Ban DTC say 211 Med School Professors
Showing their opposition to prescription drug advertising, 211 professors from U.S. medical schools endorsed a statement that "direct-to-consumer marketing of prescription drugs should be prohibited".
The statement's endorsers include prominent medical school professors from Harvard, Johns Hopkins, University of Pennsylvania, Columbia, Stanford, Yale, Duke, University of California, San Francisco and other top medical schools, along with two former editors-in-chief of the New England Journal of Medicine.
To see the statement and all the signatories go here:
http://www.commercialalert.org/dtcstatement.pdf
Insiders' view: He thought the collective noun for academics was "a disagreement of professors"! Looks like they've found somthing to unite against!
The statement's endorsers include prominent medical school professors from Harvard, Johns Hopkins, University of Pennsylvania, Columbia, Stanford, Yale, Duke, University of California, San Francisco and other top medical schools, along with two former editors-in-chief of the New England Journal of Medicine.
To see the statement and all the signatories go here:
http://www.commercialalert.org/dtcstatement.pdf
Insiders' view: He thought the collective noun for academics was "a disagreement of professors"! Looks like they've found somthing to unite against!
Dapoxetine - a long time comin'
Poor J&J subsidiary Alza! Insider notes that the FDA have rejected their bid to market dapoxetine for premature ejaculation, a move that puts one of the company's best hopes for a blockbuster drug on hold (does that sound alright to you?).
Well, it was only an antidepressant, really!
Insider is contemplating what the DTC ad campaign might have looked like! Which celeb would have stepped up to the plate for this one? Suggestions please?
http://www.nj.com/business/ledger/index.ssf?/base/business-0/1130477879165620.xml&coll=1
Well, it was only an antidepressant, really!
Insider is contemplating what the DTC ad campaign might have looked like! Which celeb would have stepped up to the plate for this one? Suggestions please?
http://www.nj.com/business/ledger/index.ssf?/base/business-0/1130477879165620.xml&coll=1
Thursday, October 27, 2005
Big Pharma - just the facts!
• More than 100,000 deaths per year in the US come from medicines that are taken as directed by a physician ( i.e. not through misuse or overdose).
• Almost half of Americans take at least one prescription medicine every day; 1 in 6 take three or more daily.
• Big Pharma pays for about 90 percent of the continuing-education classes US physicians take.
• Washington has six times as many Big Pharma lobbyists as it does US senators.
• Of the 1,035 new medicines approved by the FDA from 1989 to 2000, more than half were "me-too's" that offered no significant new benefits over existing medicines.
Source: "Generation Rx" by Greg Crister
• Almost half of Americans take at least one prescription medicine every day; 1 in 6 take three or more daily.
• Big Pharma pays for about 90 percent of the continuing-education classes US physicians take.
• Washington has six times as many Big Pharma lobbyists as it does US senators.
• Of the 1,035 new medicines approved by the FDA from 1989 to 2000, more than half were "me-too's" that offered no significant new benefits over existing medicines.
Source: "Generation Rx" by Greg Crister
IM Clone - Porridge for seven years
A federal judge in New York refused to toss out the seven-year prison term that Samuel Waksal, the former ImClone Systems Inc. chief executive, is serving for insider trading.
Waksal's lawyers argued Wednesday that he was entitled to seek a shorter sentence because the guidelines under which he was sentenced are no longer binding on judges. The U.S. Supreme Court ruled in January that the guidelines are only advisory.
U.S. District Judge William Pauley rejected the claim, saying the Supreme Court's decision doesn't apply to Waksal because his conviction became final in June 2003 when he was sentenced.
This was commented on by Insider previously. OK Sam, you were busted. Now be like Martha and go do your porridge!
Wednesday, October 26, 2005
Who said this?
"In all seriousness, I think the companies need to cut back the sales force by half. When I started, there were about 35,000 reps in America. And now I read there are between 90,000 and 100,000. Doctors are just fed up. "
Brands vs Generics - who is right?
It could be possible that the predictions in both of these reports are correct, but Insider doubts it somewhat.
So, who to believe? That is the question.
For Generics
Consumers, their employers and health plans in the commercial market could have saved more than $20 billion last year through increased use of generic drugs, according to a new report by Express Scripts Inc., a pharmacy benefit manager.
Express Scripts estimates that if more actions aren't taken to increase generic use, $24 billion in saving will be lost this year and $25 billion will be left on the table in 2006. It said that on average a generic drug costs about $60 less per monthly prescription than a brand name medicine. Consumers also pay lower copayments for generics, saving $10 or more per prescription by forgoing a brand name medicine.
http://www.kare11.com/health/health_article.aspx?storyid=109857
For Brands
Prescription drug sales are projected to soar in the United States next year, fueled in part by a $400 billion expansion of the nation's Medicare program, a pharmaceutical research company reported Tuesday.
The U.S. drug market, which already accounts for 43 percent of global pharmaceutical sales, is projected to grow between 8 percent and 9 percent in 2006, according to IMS Health. That's above the expected growth rate globally of 6 percent to 7 percent.
http://www.kfmb.com/stories/story.26974.html
Maybe the truth lies here:
http://money.cnn.com/2005/10/25/news/midcaps/generic/index.htm
So, who to believe? That is the question.
For Generics
Consumers, their employers and health plans in the commercial market could have saved more than $20 billion last year through increased use of generic drugs, according to a new report by Express Scripts Inc., a pharmacy benefit manager.
Express Scripts estimates that if more actions aren't taken to increase generic use, $24 billion in saving will be lost this year and $25 billion will be left on the table in 2006. It said that on average a generic drug costs about $60 less per monthly prescription than a brand name medicine. Consumers also pay lower copayments for generics, saving $10 or more per prescription by forgoing a brand name medicine.
http://www.kare11.com/health/health_article.aspx?storyid=109857
For Brands
Prescription drug sales are projected to soar in the United States next year, fueled in part by a $400 billion expansion of the nation's Medicare program, a pharmaceutical research company reported Tuesday.
The U.S. drug market, which already accounts for 43 percent of global pharmaceutical sales, is projected to grow between 8 percent and 9 percent in 2006, according to IMS Health. That's above the expected growth rate globally of 6 percent to 7 percent.
http://www.kfmb.com/stories/story.26974.html
Maybe the truth lies here:
http://money.cnn.com/2005/10/25/news/midcaps/generic/index.htm
Big Pharma - searching for their "sweet spot"
Poor Big Pharma salesforces. Senior management has finally got beyond "thinking the unthinkable" and has started cutting sales jobs.
Wyeth is in the process of cutting their 2,500-strong salesforce by 15 per cent ( that's 375 jobs for the numerically challenged out there). Actually, it has cut 750 of its full-time sales reps, replacing them with 375 part-time employees.
Insider hears that both Merck and Pfizer, after their recent poor Wall Street performances, are now about to look at similar strategies. This will copy AZs' recent austere approach, which delivered good numbers for their CEO in waiting David Brennan.
After years of building up their salesforces in an "arms race", Big Pharma has realised that they are well beyond the point of diminishing returns, a point Insider has made in previous posts.
An extra rep is not going to generate enough incremental revenue to justify the expense and so with all the other pressures, something has to give. The salesforce is an area where Big Pharma is looking to make cuts, which in the great scheme of things, would not have such a big impact on their top line.
“Everyone will be slowly edging back a little bit at a time to find the cost-benefit sweet spot,” a "decruitment" consultant told Insider recently.
Wyeth is in the process of cutting their 2,500-strong salesforce by 15 per cent ( that's 375 jobs for the numerically challenged out there). Actually, it has cut 750 of its full-time sales reps, replacing them with 375 part-time employees.
Insider hears that both Merck and Pfizer, after their recent poor Wall Street performances, are now about to look at similar strategies. This will copy AZs' recent austere approach, which delivered good numbers for their CEO in waiting David Brennan.
After years of building up their salesforces in an "arms race", Big Pharma has realised that they are well beyond the point of diminishing returns, a point Insider has made in previous posts.
An extra rep is not going to generate enough incremental revenue to justify the expense and so with all the other pressures, something has to give. The salesforce is an area where Big Pharma is looking to make cuts, which in the great scheme of things, would not have such a big impact on their top line.
“Everyone will be slowly edging back a little bit at a time to find the cost-benefit sweet spot,” a "decruitment" consultant told Insider recently.
Tuesday, October 25, 2005
Who said this?
"We've got the best courtroom lawyers, we've got the best mass tort lawyers ... and we've got the best negotiators that America has to offer working together on a dream team that is Merck's biggest nightmare. We call it kind of the 'Legal Godfathers.'"
Merck trial - Locking horns
"Here come the judge!"Once again, in the second Merck Vioxx trial Judge Higbee and Mercks' lawyer Diane Sullivan have locked horns.
"Ms. Sullivan, do you mind? That was inappropriate," Higbee said at one point before being interrupted again by the fair Diane. "Is it possible for you not to interrupt me?".
Not a good idea, Diane. Insiders' money is on the judge
The judge ruled against Merck and disallowed an obtuse FDA memo, which the judge admitted to having to read 10 times in order to gain any sense from it!
http://www.nj.com/business/ledger/index.ssf?/base/business-0/113022203610970.xml&coll=1
Insider cant see the judge being on Dianes' Christmas card list! Or vice versa.
Monday, October 24, 2005
PhRMA - True Colors
US drug industry mouthpiece the Pharmaceutical Research and Manufacturers of America is suing the state government of Washington DC over its legislation aimed at reducing prescription drug prices.
PhRMA alleges that the legislation - which would make it illegal for drug companies to charge excessive prices for drugs - will cripple hold back the development of new drugs, create shortages and leave the sector open to "a limitless parade of lawsuits" according to a report in the Washington Post.
Washington's new regulations, signed into law on October 4, suggest that an excessive price for a drug would be one 30% or more above the level charged in Germany, Canada, Australia or the UK. Those companies found guilty of over-pricing will be exposed to civil penalties, unless they can justify the pricing strategy in court.
The architect of the new legislation, District Council Member David Catana, claims that people in Washington DC pay on average 68% more than their counterparts overseas for new prescription drugs.
(see; http://pharmagossip.blogspot.com/2005/10/myth-or-reality.html )
A US District Court judge rejected a PhRMA request last week for a temporary restraining order to block publication of the law. A hearing in the case is scheduled for November 18.
Insiders view: PhRMA have recently shown their "true colors" with the "Pill Fiction" scandal.
http://pharmagossip.blogspot.com/2005/10/pill-fiction.html
Their case will make interesting reading. Almost as interesting as, say, a scary work of fiction!
PhRMA alleges that the legislation - which would make it illegal for drug companies to charge excessive prices for drugs - will cripple hold back the development of new drugs, create shortages and leave the sector open to "a limitless parade of lawsuits" according to a report in the Washington Post.
Washington's new regulations, signed into law on October 4, suggest that an excessive price for a drug would be one 30% or more above the level charged in Germany, Canada, Australia or the UK. Those companies found guilty of over-pricing will be exposed to civil penalties, unless they can justify the pricing strategy in court.
The architect of the new legislation, District Council Member David Catana, claims that people in Washington DC pay on average 68% more than their counterparts overseas for new prescription drugs.
(see; http://pharmagossip.blogspot.com/2005/10/myth-or-reality.html )
A US District Court judge rejected a PhRMA request last week for a temporary restraining order to block publication of the law. A hearing in the case is scheduled for November 18.
Insiders view: PhRMA have recently shown their "true colors" with the "Pill Fiction" scandal.
http://pharmagossip.blogspot.com/2005/10/pill-fiction.html
Their case will make interesting reading. Almost as interesting as, say, a scary work of fiction!
Zocor - The endgame begins
Poor Merck. Their third-quarter figures reveal all. Global sales of their biggest product, Zocor (simvastatin), slumped 14 percent to $1.05 billion.
The drug's U.S. revenue fell 10 percent amid competition with the more-potent new combo drug Vytorin sold by both Merck and Schering-Plough Corp.
However, Zocor lost almost a quarter of its sales overseas, where it is facing cheaper generics.
Add the Vioxx litigation problems to the mix and you see Mother Mercks' problem. However, this time, whilst sales were down they still managed to raise profits, via cutbacks.
But, Insider notes, this is often a "deminishing return" option; there is only so much fat available for trimming!
The drug's U.S. revenue fell 10 percent amid competition with the more-potent new combo drug Vytorin sold by both Merck and Schering-Plough Corp.
However, Zocor lost almost a quarter of its sales overseas, where it is facing cheaper generics.
Add the Vioxx litigation problems to the mix and you see Mother Mercks' problem. However, this time, whilst sales were down they still managed to raise profits, via cutbacks.
But, Insider notes, this is often a "deminishing return" option; there is only so much fat available for trimming!
Sunday, October 23, 2005
Who said this?
"I view Pfizer as a duck. They're floating and it looks easy, but they're paddling like crazy underneath."
Pargluva - Curiouser and Curiouser.....
Insider has already commented on the "good/bad" news about Pargluva.
http://pharmagossip.blogspot.com/2005/10/bmsmerck-good-newsbad-news.html
But now a new perspective has been added to the issue. Derek Lowe of "In the Pipeline" has come up with some pretty deep and disturbing insights!
"The entire dual-PPAR-agonist idea is in trouble. The whole point of adding PPAR-alpha activity was to improve blood lipid profiles, and pretty much the whole point of doing that is to improve cardiovascular health. The first part is working, but the second part, the important part, just doesn't seem to be happening. Looking at the data, I find it hard to imagine why anyone would take muraglitazar over the exisiting therapies, when there's no evidence for what is supposed to be its main advantage."
In addition, on BMS/Merck:
"What on Earth were they thinking, submitting data in a way that makes it look like they were trying to pull a fast one with the cardiovascular risk factors? Now, of all times? Who knows, maybe people at BMS had just convinced themselves that things were fine, somehow - the capacity for human self-deception is limitless. But didn't anyone at Merck turn pale and have to sit down when they saw these numbers?"
http://www.corante.com/pipeline/ (Post: This had better be good!)
One final thought:
Both Actos and Avandia have been associated with heart failure, which has signaled the lawyers to start circling. MedPundit spotted a more nuanced look at the problem. So far, there have been no studies comparing Pargluva directly to Actos and Avandia.
http://pharmagossip.blogspot.com/2005/10/bmsmerck-good-newsbad-news.html
But now a new perspective has been added to the issue. Derek Lowe of "In the Pipeline" has come up with some pretty deep and disturbing insights!
"The entire dual-PPAR-agonist idea is in trouble. The whole point of adding PPAR-alpha activity was to improve blood lipid profiles, and pretty much the whole point of doing that is to improve cardiovascular health. The first part is working, but the second part, the important part, just doesn't seem to be happening. Looking at the data, I find it hard to imagine why anyone would take muraglitazar over the exisiting therapies, when there's no evidence for what is supposed to be its main advantage."
In addition, on BMS/Merck:
"What on Earth were they thinking, submitting data in a way that makes it look like they were trying to pull a fast one with the cardiovascular risk factors? Now, of all times? Who knows, maybe people at BMS had just convinced themselves that things were fine, somehow - the capacity for human self-deception is limitless. But didn't anyone at Merck turn pale and have to sit down when they saw these numbers?"
http://www.corante.com/pipeline/ (Post: This had better be good!)
One final thought:
Both Actos and Avandia have been associated with heart failure, which has signaled the lawyers to start circling. MedPundit spotted a more nuanced look at the problem. So far, there have been no studies comparing Pargluva directly to Actos and Avandia.
The 2005 IgNobel Prize Winners
Can be found here:
http://www.improbable.com/ig/ig-pastwinners.html#ig2005
Insider is pleased to note that he spotted this years medicine award winner:
http://pharmagossip.blogspot.com/2005/10/what-are-these.html
http://www.improbable.com/ig/ig-pastwinners.html#ig2005
Insider is pleased to note that he spotted this years medicine award winner:
http://pharmagossip.blogspot.com/2005/10/what-are-these.html
Merck trial - The running man
Poor Barry Gertz, Mercks' Executive VP of clinical services. He had such a hard grilling on the stand from the plaitiffs lawyers that even the judge started to feel sorry for him: "You're done, you can leave" state Superior Court Judge Carol Higbee said to Gertz. "I'm sure you can't wait to leave."
And Barry took her at her word.
After a day and a half of tense questioning marked by dozens of objections by both plantiff and defense attorneys, Gertz virtually ran out the door of the Atlantic City courtroom when told that his part in the show was over.
Chin up Barry. If Merck keep to their current vow to fight each trial one by one you will become far more used to this kind of thing over the next few months or even years! In fact, it will become a good part of your daily life.
Now there's a thought.
http://www.nj.com/search/index.ssf?/base/news-1/1129956841163450.xml?starledger?nnj&coll=1
Friday, October 21, 2005
Myth or Reality?
"Big Pharma has to charge high prices for medicines in the US to help pay for all the foreigners getting a "free ride" from US pharma R&D."
To quote Mike Lascelles of Pharma Watch: Bollocks!
http://bmj.bmjjournals.com/cgi/content/full/331/7522/958
Thursday, October 20, 2005
No S*** Sherlock!
A recently published report has revealed that less than 13 per cent of US consumers believe that information provided by pharmaceutical companies is more trustworthy than healthcare information provided by other organisations.
Other glimpses of the bleeding obvious in the report confirm what most industry analysts, including Insider, have long been saying. The Vioxx case, along with safety concerns over other blockbusters, have all but sounded the death knell on Big Pharmas' fragile reputation.
The stables need a good cleaning.
"The new research also finds that public opinion has the potential to negatively impact individual pharmaceutical companies far more dramatically than increased federal regulations," said Datamonitor eHealth analyst Kimberly O'Malley.
"In fact many consumers now question whether pharmaceutical companies have their best interests in mind when marketing a product."
Well blow me down!
Insiders' view: If you buy the report then come see me, I've got a great offer on a bridge!
Pfizer - The Big Chill
Poor Pfizer! The world's number one pharmaceutical company, saw its third quarter results hit by a plethora of challenges as its faced a sharp drop off in sales of its COX-2 inhibitor portfolio and its infamous blue pill Viagra (sildenafil) was hit by competition in the erectile dysfunction field.
Revenues tumbled 5% to $12.2 billion dollars, as the company's human health sector suffered a 7% drop to $10.5 billion. And net income too took a turn for the worse, more than halving to $1.6 billion from $3.3 billion for the third quarter last year.
For the full year, Pfizer has downgraded its revenue predictions because of the poorly-performing human health business, and says reported diluted earnings per share in 2005 of $1.02-$1.04 is now anticipated, compared to a previous estimate of about $1.24.
It has also scrapped its guidance for 2006/2007 and will provide new expectations at the beginning of next year.
Insider says: uh oh! The softening up process has started. Rep "postings of unhappiness" are way up on CafePharma signifying that chilly times have started. It's always much cheaper to micromanage someone out of their job than lay them off and then have to make redundancy payments!
Merck trial - MeeeOwww!
Mercks' team of expensive lawyers are like wildcats fighting........... with each other!
It started when Judge Higbee warned Diane Sullivan to drop a line of questioning because it touched on an issue the judge earlier ruled was not supported by science.
"Don't do it again, Ms. Sullivan," Higbee said in a stern voice. "Don't do it again, or we're going to have a problem."
At that point, another member of Merck's legal team, Stephen Raber, gestured for Sullivan to return to the defense table.
Then there followed a nasty exchange between the co-counsels.
"You do that again and you're %$&"((& out of here," Sullivan said to Raber in a voice audible to others in the courtroom.
Nice! Way to go guys! Earn the respect of the jury.
http://www.nj.com/business/ledger/index.ssf?/base/business-0/1129787426261970.xml&coll=1&thispage=1
Herceptin -"Simply Stunning"
Prix Gallien, gold medal (right)Two stories, both from The Times, firstly:
Study results of more than 8,000 women worldwide who took the breast-cancer drug Herceptin (trastuzumab) are "simply stunning" and suggest the treatment is a potential cure for the disease, according to an editorial published today in the New England Journal of Medicine.
Treatment must change today so that all patients who would benefit from the drug can receive it, according to the editorial written by Gabriel Hortobagyi, director of the Breast Cancer Research Program at the M. D. Anderson Cancer Center of the University of Texas.
"This observation suggests a dramatic and perhaps permanent perturbation of the natural history of the disease, maybe even a cure," Dr. Hortobagyi wrote. "Longer follow-up will determine whether this interpretation is correct."
Dr. Hortobagyi also wrote that the study results "are not evolutionary but revolutionary."
http://www.timesonline.co.uk/article/0,,3-1834220,00.html
Now the second story:
A breast cancer sufferer is spending more than £25,000 to be treated with Herceptin by a private clinic in India.
Linda Vijeh, 50, of Ilminster, Somerset, UK is selling her £125,000 house to pay for the drug. She is believed to be the first British patient to travel abroad for Herceptin.
Speaking from India yesterday, she said: “Herceptin is only licensed in the UK for use where cancer has spread to other parts of the body. Well it’s a bit bloody late then.
“It takes some leap of faith to fly to a Third World country to be treated by a doctor you’ve never met in a hospital you’ve never heard of. That is how desperate I was.”
http://www.timesonline.co.uk/article/0,,2-1833793,00.html
Now, look at the cartoon below again! It's harder to laugh, isn't it?
Update 24/10/05
Insider spotted this comment on Healthy Skepticisms' website from Barbara Brenner of Breast Cancer Action. It relates to Dr. Hortobagyi and his past record:
"Additionally, readers should know that Dr. Hortobagyi, who wrote the New England Journal of Medicine editorial encouraging widespread use of Herceptin for early stage breast cancer, is the same person who, in the early 1980s promoted high-dose chemotherapy for breast cancer before all the data were in.
Treatment changed nearly overnight, but by the time meaningful data were available, many women had suffered, many lives had been lost and we learned that the treatment didn’t work for breast cancer. In 1999, Dr. Hortobagyi recanted to the New York Times, saying about the treatment, “We deceived ourselves and we deceived our patients... We oversold it.” ".
Wednesday, October 19, 2005
Merck Trial - Stenographer meltdown!
The back-and-forth of several testy, rapid-fire exchanges in morning testimony at one point today prompted the court stenographer to ask Superior Court Judge Carol E. Higbee to stop Mercks' cardiology expert witness and the plaintiffs lawyer from talking at the same time.
Juries dont like this kind of thing!
Insiders' view: it's a VERY clever expert who knows as a matter of fact what causes a heart attack to strike at a certain time!
http://www.centredaily.com/mld/centredaily/business/12942803.htm
Tamiflu - Bless you!
Tamiflu capsule not actual size!Roche benefited from booming sales of its Tamiflu anti-influenza treatment to report stronger than expected sales in the third quarter.
As governments stockpile Tamiflu, in preparation for a flu pandemic, Roche said on Wednesday that Tamiflu sales had soared by 263 per cent to SFr859m in the first nine months of this year. Sales in the third quarter more than doubled to SFr279m.
Insider remains sceptical about Tamiflu. The evidence for all this stockpiling, to him, seems thin. Is this more a case of polictical need? Governments like to be seen to be active rather than passive.
Source: FT
Who said this?
"Healthcare is a massive area and it is one that has not been fully examined. It is a market where, on the face of it, there seem to be some probable issues. It is of great interest to the government in terms of cost and a great interest to consumers in terms of what they pay."
A chemical cosh?
Big Pharmas' heavily promoted atypical antipsychotic medications can be dangerous in elderly patients with significant depression, dementia, or "organic brain syndrome". These poor people can develop associated psychotic symptoms including hallucinations and delusions.
But using such atypical antipsychotic medications (Zyprexa, Risperdal, Seroquel) in elderly dementia patients may be dangerous according to a meta-analysis of 15 other studies. This new analysis found an increased risk of death among patients treated with these medications (118 deaths out of 3,353 treated patients or 3.5%) vs patients taking a placebo (40 deaths out of 1757 placebo patients or 2.3%).
Add this to the CATIE study results and the atypical "gravy train" looks like it's drying up a bit!
http://pharmagossip.blogspot.com/2005/09/catiepsych.html
Mercky!
Buzzword of the day, courtesy of Buzzwhack.com:
mercky: Pharmaceutically dubious. “Data from the Vioxx trials are in and the results appear to be mercky.”
Hat tip: Capsules
mercky: Pharmaceutically dubious. “Data from the Vioxx trials are in and the results appear to be mercky.”
Hat tip: Capsules
Tuesday, October 18, 2005
BMS/Merck - Good news/Bad news
Good News: The FDA have "approved" the oral diabetes/obesity drug Pargluva (muraglitazar). The drug could be the "first in class" of dual peroxisome proliferators-activator receptor agonists, or PPAR agonists launched.
Bad News: The FDA want more data to confirm it doesn't increase the chance of heart attacks (a message from the FDA for Merck, there, Insider wonders). This will delay any US launch by at least a year, possibly even two.
Sounds reasonable to Insider, given the current chilly regulatory climate. In addition to the MI concerns adverse effects seen with some dual-acting PPAR agonists in advanced-stage development have included oedema, raised levels of hepatic enzymes and tumours in rodents.
It may also be good news for AZs' Galida, which might be able to catch up a little.
Sources: The Street.
http://www.diabetesincontrol.com/modules.php?name=News&file=article&sid=2851
http://www.drugdevelopment-technology.com/projects/galida/
Update:
Uh oh! Looking "difficult" for Pargluva:
http://jama.ama-assn.org/cgi/content/full/294.20.joc50147v1
Bad News: The FDA want more data to confirm it doesn't increase the chance of heart attacks (a message from the FDA for Merck, there, Insider wonders). This will delay any US launch by at least a year, possibly even two.
Sounds reasonable to Insider, given the current chilly regulatory climate. In addition to the MI concerns adverse effects seen with some dual-acting PPAR agonists in advanced-stage development have included oedema, raised levels of hepatic enzymes and tumours in rodents.
It may also be good news for AZs' Galida, which might be able to catch up a little.
Sources: The Street.
http://www.diabetesincontrol.com/modules.php?name=News&file=article&sid=2851
http://www.drugdevelopment-technology.com/projects/galida/
Update:
Uh oh! Looking "difficult" for Pargluva:
http://jama.ama-assn.org/cgi/content/full/294.20.joc50147v1
Merck - Smile (though your heart is breaking)
Day four of testimony from Mercks' very own Dr. Alise Reicin and she, once again, exhibited a tour de force. She managed to maintain her smiling demeanour and looked at the jury when answering questions, showing that she has been well trained in courtroom theatre.
However, her long answers did bring one rebuke.....from the judge!
It's not clear if her personal approach won over the jury, but Reicin's failure to respond succinctly to cross examination questions eventually drew a rebuke from state Superior Court Judge Carol Higbee, who told her to "answer yes or no, 'I don't know,' or 'I can't answer that question with a yes or no.'"
A few words of encouragement from Insider:
"Smile,Though your heart is aching
Smile, Even though it's breaking
When there are clouds
In the sky,
You'll get by
If you smile
Through your fear and sorrow
Smile
And maybe tomorrow
You'll see the sun
Come shining through
If you just smile"
Words by John Turner and Geoffrey Parsons. Music by Charlie Chaplin for his play "Modern Times" 1936.
Source: NJ.com
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