Monday, November 30, 2009
PharmaGossip "engages" with the ABPI's Andy Powrie-Smith
Where do you think ABPI members currently sit (say on a scale from 1-10 - one being Hitler, 10 being Ghandi) with respect to "trust"?
How do you think they got there?
How do you think they might improve the situation?
Andy's reply:
Hope this finds you well and you had a good weekend. I don't have your
questions in front of me but I hope i can remember them.
On where do i think the industry is?
I am not sure about the 1-10 scale its probably very subjective and I have
only been in the industry for a year or so. My background is actually
NGO's. I was Director of the British Lung Foundation in Scotland for 4
years and with the Red Cross for 5 years before that. I probably arrived
at the ABPI with the same preconceived ideas as most but I can tell you
what I have found in terms of where i think the industry is.
As you know it is an incredibly broad church in terms of individual company
view's of the world and also you get different perspectives from people
depending on what part of the industry they come from.
We have done two member survey's (2008 and 2009) and trust was put at top
of the agenda by member companies in both. They have put their resources
where their mouth is on it and I have had a great number of volunteers from
within companies working on the various workstreams. We started with an
Trust taskforce comprised on industry and external people to identify the
UK issues and come up with a plan to address them. We made very clear this
wasn't a PR exercise but that the member survey had given us a mandate to
tackle issues head on. I know a lot of your posts have related to the US
and other parts but my remit is just UK. I can only focus on stuff I can
do something about and falls within our gift to tackle. The issues the
group identified was behaviours (specifically promotional aids and funding
education training and meetings), transparency and our narrow model of
engagement. We are coming up with proposals to address each one and will
aim to have them all finished by Spring next year. If we take promotional
items for example my personal view is - if there is a problem with the
dynamic of giving these things away which harms doctors and industry then
we stop giving them away, pretty simple.
So far support for the initiatives, particularly from the ABPI Board has
been very strong, in fact they are really driving the pace.
So all in all, my experience has been pretty positive on where the industry
is and particularly where it wants to get too.
On the how did we get here.....................
I am not that well qualified to say because of I'm new to the industry.
But like most things I guess it has been a process of evolution. I picked
up your views on the Code of Practice and I know its behaviours that are
key but my feeling is that the code has made a difference to the industry
in the UK by driving appropriate behaviours. I would be interested to hear
how you view it in the context of other countries codes and ways of working
etc
Dear Readers - feel free to comment.
A letter from Michael Moore
Monday, November 30th, 2009
Dear President Obama,
Do you really want to be the new "war president"? If you go to West Point tomorrow night (Tuesday, 8pm) and announce that you are increasing, rather than withdrawing, the troops in Afghanistan, you are the new war president. Pure and simple. And with that you will do the worst possible thing you could do -- destroy the hopes and dreams so many millions have placed in you. With just one speech tomorrow night you will turn a multitude of young people who were the backbone of your campaign into disillusioned cynics. You will teach them what they've always heard is true -- that all politicians are alike. I simply can't believe you're about to do what they say you are going to do. Please say it isn't so.
It is not your job to do what the generals tell you to do. We are a civilian-run government. WE tell the Joint Chiefs what to do, not the other way around. That's the way General Washington insisted it must be. That's what President Truman told General MacArthur when MacArthur wanted to invade China. "You're fired!," said Truman, and that was that. And you should have fired Gen. McChrystal when he went to the press to preempt you, telling the press what YOU had to do. Let me be blunt: We love our kids in the armed services, but we f*#&in' hate these generals, from Westmoreland in Vietnam to, yes, even Colin Powell for lying to the UN with his made-up drawings of WMD (he has since sought redemption).
So now you feel backed into a corner. 30 years ago this past Thursday (Thanksgiving) the Soviet generals had a cool idea -- "Let's invade Afghanistan!" Well, that turned out to be the final nail in the USSR coffin.
There's a reason they don't call Afghanistan the "Garden State" (though they probably should, seeing how the corrupt President Karzai, whom we back, has his brother in the heroin trade raising poppies). Afghanistan's nickname is the "Graveyard of Empires." If you don't believe it, give the British a call. I'd have you call Genghis Khan but I lost his number. I do have Gorbachev's number though. It's + 41 22 789 1662. I'm sure he could give you an earful about the historic blunder you're about to commit.
With our economic collapse still in full swing and our precious young men and women being sacrificed on the altar of arrogance and greed, the breakdown of this great civilization we call America will head, full throttle, into oblivion if you become the "war president." Empires never think the end is near, until the end is here. Empires think that more evil will force the heathens to toe the line -- and yet it never works. The heathens usually tear them to shreds.
Choose carefully, President Obama. You of all people know that it doesn't have to be this way. You still have a few hours to listen to your heart, and your own clear thinking. You know that nothing good can come from sending more troops halfway around the world to a place neither you nor they understand, to achieve an objective that neither you nor they understand, in a country that does not want us there. You can feel it in your bones.
I know you know that there are LESS than a hundred al-Qaeda left in Afghanistan! A hundred thousand troops trying to crush a hundred guys living in caves? Are you serious? Have you drunk Bush's Kool-Aid? I refuse to believe it.
Your potential decision to expand the war (while saying that you're doing it so you can "end the war") will do more to set your legacy in stone than any of the great things you've said and done in your first year. One more throwing a bone from you to the Republicans and the coalition of the hopeful and the hopeless may be gone -- and this nation will be back in the hands of the haters quicker than you can shout "tea bag!"
Choose carefully, Mr. President. Your corporate backers are going to abandon you as soon as it is clear you are a one-term president and that the nation will be safely back in the hands of the usual idiots who do their bidding. That could be Wednesday morning.
We the people still love you. We the people still have a sliver of hope. But we the people can't take it anymore. We can't take your caving in, over and over, when we elected you by a big, wide margin of millions to get in there and get the job done. What part of "landslide victory" don't you understand?
Don't be deceived into thinking that sending a few more troops into Afghanistan will make a difference, or earn you the respect of the haters. They will not stop until this country is torn asunder and every last dollar is extracted from the poor and soon-to-be poor. You could send a million troops over there and the crazy Right still wouldn't be happy. You would still be the victim of their incessant venom on hate radio and television because no matter what you do, you can't change the one thing about yourself that sends them over the edge.
The haters were not the ones who elected you, and they can't be won over by abandoning the rest of us.
President Obama, it's time to come home. Ask your neighbors in Chicago and the parents of the young men and women doing the fighting and dying if they want more billions and more troops sent to Afghanistan. Do you think they will say, "No, we don't need health care, we don't need jobs, we don't need homes. You go on ahead, Mr. President, and send our wealth and our sons and daughters overseas, 'cause we don't need them, either."
What would Martin Luther King, Jr. do? What would your grandmother do? Not send more poor people to kill other poor people who pose no threat to them, that's what they'd do. Not spend billions and trillions to wage war while American children are sleeping on the streets and standing in bread lines.
All of us that voted and prayed for you and cried the night of your victory have endured an Orwellian hell of eight years of crimes committed in our name: torture, rendition, suspension of the bill of rights, invading nations who had not attacked us, blowing up neighborhoods that Saddam "might" be in (but never was), slaughtering wedding parties in Afghanistan. We watched as hundreds of thousands of Iraqi civilians were slaughtered and tens of thousands of our brave young men and women were killed, maimed, or endured mental anguish -- the full terror of which we scarcely know.
When we elected you we didn't expect miracles. We didn't even expect much change. But we expected some. We thought you would stop the madness. Stop the killing. Stop the insane idea that men with guns can reorganize a nation that doesn't even function as a nation and never, ever has.
Stop, stop, stop! For the sake of the lives of young Americans and Afghan civilians, stop. For the sake of your presidency, hope, and the future of our nation, stop. For God's sake, stop.
Tonight we still have hope.
Tomorrow, we shall see. The ball is in your court. You DON'T have to do this. You can be a profile in courage. You can be your mother's son.
We're counting on you.
Yours,
Michael Moore
MMFlint@aol.com
MichaelMoore.com
Sunday, November 29, 2009
GSK's Abbas Hussain - pyramid seller
“We need to innovate down the pyramid, working the market backward,” he says. “Today, the product comes out of the clinic, the centre sets the price and affiliates market it. My preference is not a high price and 100 units of profit for 100 patients, but to drop the price and make 100 [units] of profit from 500 patients,”More
Saturday, November 28, 2009
More on Boots The Chemist selling homeopathy
The Boots brand is synonymous with health care in the United Kingdom. Your website speaks proudly about your role as a health care provider and your commitment to deliver exceptional patient care. For many people, you are their first resource for medical advice; and their chosen dispensary for prescription and non-prescription medicines. The British public trusts Boots.
However, in evidence given recently to the Commons Science and Technology Committee, you admitted that you do not believe homeopathy to be efficacious. Despite this, homeopathic products are offered for sale in Boots pharmacies – many of them bearing the trusted Boots brand.
Not only is this two-hundred-year-old pseudo-therapy implausible, it is scientifically absurd. The purported mechanisms of action fly in the face of our understanding of chemistry, physics, pharmacology and physiology. As you are aware, the best and most rigorous scientific research concludes that homeopathy offers no therapeutic effect beyond placebo, but you continue to sell these products regardless because “customers believe they work”. Is this the standard you set for yourselves?
The majority of people do not have the time or inclination to check whether the scientific literature supports the claims of efficacy made by products such as homeopathy. We trust brands such as Boots to check the facts for us, to provide sound medical advice that is in our interest and supply only those products with a demonstrable medical benefit.
We don’t expect to find products on the shelf at our local pharmacy which do not work.
Not only are these products ineffective, they can also be dangerous. Patients may delay seeking proper medical assistance because they believe homeopathy can treat their condition. Until recently, the Boots website even went so far as to tell patients that “after taking a homeopathic medicine your symptoms may become slightly worse,” and that this is “a sign that the body’s natural energies have started to counteract the illness”. Advice such as this directly encourages patients to wait before seeking real medical attention, even when their condition deteriorates.
We call upon Boots to withdraw all homeopathic products from your shelves. You should not be involved in the sale of ineffective products, because your customers trust you to do what is right for their health. Surely you agree that your commitment to excellent patient care is better served by supplying only those products whose claims can be substantiated by rigorous scientific research? Or do you really believe that Boots should be in the business of selling placebos to the sick and the injured?
The support lent by Boots to this quack therapy contributes directly to its acceptance as a valid medical treatment by the British public, acceptance it does not warrant and support it does not deserve. Please do the right thing, and remove this bogus therapy from your shelves.
Yours sincerely,
http://www.merseysideskeptics.org.uk/an-open-letter-to-alliance-boots/Merseyside Skeptics Society
Andrew Jack in the FT misses out one statin! Guess which one
Pretty impressive, eh? No wonder he writes for the FT! Could almost be a defining piece regarding the statins......
But wait!
Guess which statin is missing?
Here's a hint!
Don't worry Andy - I've added a Sidewiki!
;-)
Friday, November 27, 2009
Pharma Giles writes .....
The chief executive of French pharmaceutical giant Sanawful Anvastmess has sneered at the past dominance of science over commerce in both his company and at others, as he laid out a destructive strategy almost one year into the job.
Chris Vileboaster said that further large-scale takeovers of the sort that had built the company were highly likely and that he would buy up smaller companies, in order to crush their entrepreneurial spirit and destroy any possible intellectual competition, just like every other major pharmaceutical company does.
In a veiled swipe at Gerald Le Pubes, his predecessor and former head of research and development, who had been appointed chief executive and then ousted within months, he said: “We had a scientific organisation that was quite good at science and which didn’t need a lot of external partnerships. That’s not the way we chartered accountants like things. We don’t understand R&D and we therefore fear it.”
Mr Vastego added: “Scientists are all lousy leaders and managers, completely unlike chartered accountants with MBAs and French medals of honour. Proper fiscally-driven managers like us like to create vast layers of financial accountability and complexity within R&D, and then somehow hope a blockbuster will emerge. When it doesn’t, you merge and then fire all of the scientists. Simple. That’s what every other pharmaceutical company does, and that’s what we’ll be doing.”
“I like to say things like, ‘Let’s build upon what we’ve got; let’s create growth and shareholder value, and let’s really make sure we find some new innovation’ but as an accountant, my natural tendency is to make R&D organisations that are very big, very complex and very difficult to manage, just to kill the innovative spirit.”
“We charted accountants don’t like innovation. That means making long term investments instead of short term gains. Our shareholders don’t like that.”
“So, big acquisitions, massive R&D cuts and outsourcing to the Far East are definitely on our radar screen.”
Mr Vileboaster also criticised the “ridiculous” Sanawful Anvastmess name in China, where he said most company names have just three or four syllables. “It will henceforth be lengthened to “Vileboaster World Domination Inc.”, he said.
“I want the company name to reflect my massive ego, and to prove to the world that Phoni UK was wrong to reject my vast managerial genus and my modest but brilliant leadership skills in their Executive Celebrity Love Island Challenge .”
“I will prove them wrong. I will make them pay for that insult. I will crush Phoni UK like insects. Vileboaster World Domination Inc. WILL RULE THE WORLD!!!...
Jack brings us tales of yet another pharmaceutical CEO sounding off in the parallel universe of reality, here.
Black Friday - lots of buyers for Ratiopharm!
The newspaper says that Claudio Albrecht has joined forces with EQT, the private equity arm of Sweden's Wallenberg family, to prepare a bid for the world's fourth-largest generic drugmaker, which has been valued at around 2 billion euros. Other private equity groups are also interested in getting hold of Ratiopharm are thought to include Advent International (in tandem with Goldman Sachs), Permira (which the FT says has teamed up with Hank Klakurka, the former chief executive of Merck Generics), Kohlberg Kravis Roberts and TPG.
It has also been reported that BNP Paribas and Commerzbank, the German bank running the sale on behalf of VEM Vermoegensverwaltung, the investment arm of the Merckle family, have agreed to make loans available to private-equity bidders in the auction. By committing to provide debt before a deal is agreed, this move is likely to have the effect of driving up the price and encouraging more competition among bidders.
A number of pharmaceutical companies are, of course, also interested in getting hold of Ratiopharm and the list of potential bidders includes generics specialists such as Teva, Mylan, Actavis, as well as pharma giants Pfizer and Sanofi-Aventis. The FT says that bidders have been asked to submit non-binding offers by December 3, and there is expected to be a fourth round of bidding before the winner is announced.
By Kevin Grogan
PharmaTimes
McCain helps Obama
More at WSJ
Thursday, November 26, 2009
Pharma Giles writes .....
Johnny B. Sinister, the American-born boss of global pharmaceutical giant Phoni Pharm. Inc., told the CBI conference that it is not just bankers who need to reform. He said: "If we fail to change things will not be pretty. And if you think you're exempt, you're wrong.”
Mr. Sinister, whose company recently paid a $1.8bn (£1.1bn) fine to the US government in September for misleading sales advice on one of its drugs, said, "People have had enough and the backlash is real."
“The public is tired of huge global companies like us regarding massive corporate malfeasance fines as a cost of business, and then just carrying breaking the law,” he said.
“They’re also tired of our price gouging. They’ve had enough of our lying about and hiding clinical data, just so we can get drugs of dubious benefit onto the market. They’ve had enough of us buying doctors and politicians to maintain the status quo and crush any chance of healthcare reform. They’ve had enough of executives like me, who are paid seven figure salaries for selling off the first world’s intellectual silverware to the Far East for the short term financial gain of themselves and their backers. And they’re fed up with the massive lay-offs and the resultant social costs that these off-shoring strategies and “slash and burn” mergers and takeovers are causing.”
“But we don’t really care”, Sinister admitted. “The public also knows that we’ll just carry on doing whatever we want anyway, because we are too big to be allowed to fail or to be stopped.”
The next speaker emphasized that the banking world agreed with Mr. Sinister’s perception of public antipathy.
“Greed is good,” said RBS’s Gordon Gecko (no relation), to a cheering audience, as he trousered a $100 million dollar bonus paid for out of public bail-out money...
Jack brings us tales from the real world of a similar gathering of the great and good here…
Merck - Zetia: Matt Herper nails the coffin shut
More
Boots has a "Ratner Moment"
Boots: 'we sell homeopathic remedies because they sell, not because they work'
Boots, the UK high street pharmacy chain that sells homeopathic remedies, has admitted that the products do not necessarily work.
Wednesday, November 25, 2009
PhRMA's Ken Johnson on the price increases
An industry spokesman dismissed the price data, suggesting that people should consider the drugs, higher prices and all, a form of savings. After all, said Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America, that costly medicine might keep you out of an even-costlier hospital.If you buy that one, he’s earned his bonus.
More
Tuesday, November 24, 2009
On the road
Ah Ha!
I have been posting some surprise Sidewikis......
Premarin / Prempro - Another Loss for Pfizer in Hormone Drug Suits
Pfizer has been ordered to pay a total of $103 million in punitive damages to two women who were found to have breast cancer after they used hormonal drugs, state court officials in Philadelphia said Monday.
Monday, November 23, 2009
Merck - Vioxx: Adverse Heart Effects May Have Been Identified Years Earlier
CHICAGO – Clinical trial data indicated an association between the anti-inflammatory medication rofecoxib and cardiovascular risk as early as December 2000, before the product was taken off the market in September 2004, according to a report in the November 23 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.
Rofecoxib was introduced to the market in May 1999 and quickly became a commercial success, with sales reaching $2 billion annually, according to background information in the article. The manufacturer marketed the product (with the brand name Vioxx) as a safer alternative to traditional nonsteroidal anti-inflammatory drugs. However, concerns about its cardiovascular adverse effects reportedly existed during the drug development process. In September 2004, the manufacturer voluntarily withdrew the product from the market after one large trial was terminated early due to an increased risk of cardiovascular events.
In November 2004, the manufacturer’s chief executive testified before a U.S. Senate committee that until the halted trial, combined data from all randomized controlled clinical trials showed no difference in the risk of confirmed heart events between patients taking rofecoxib and those taking placebo. To assess whether and when analysis of published and unpublished clinical trial data could have revealed the cardiovascular risks of rofecoxib, Joseph S. Ross, M.D., M.H.S., of Mount Sinai School of Medicine, New York, and colleagues conducted a pooled analysis of all such trials conducted by the manufacturer before September 2004.
The researchers identified 30 randomized, placebo-controlled trials that enrolled a combined 20,152 individuals, lasted from four weeks to four years and assigned a range of 17 to 2,586 participants to take doses of rofecoxib ranging from 12.5 milligrams to 50 milligrams. The authors pooled the data from these studies and analyzed the cumulative results.
“As of December 2000, 21 of these trials had been completed (70 percent) and the risk of a cardiovascular thromboembolic [heart- or blood clot–related] adverse event or death was greater among subjects assigned to the rofecoxib group, raising concerns from a safety standpoint,” the authors write. “Subsequently collected data through June 2001 showed that rofecoxib was associated with a 35-percent increased risk of a cardiovascular thromboembolic adverse event or death.” The association strengthened as additional data became available—as of April 2002 the pooled analysis showed a 39-percent increased risk, and as of September 2004, a 43-percent increased risk.
The analyses provide a roadmap for how drug safety can be assessed after a product has been introduced into the market, the authors note. New legislation requiring the public disclosure of trial results in the ClinicalTrials.gov database will make available substantial data that has not previously been used to understand drug safety or efficacy. Independent investigators will now be able to conduct comprehensive meta-analyses that can complement and corroborate surveillance done by the U.S. Food and Drug Administration.
“Physicians and the public deserve to be in a position to make informed choices about risks and benefits, and the disclosure and dissemination of information about potential risk immediately after its recognition is absolutely essential. Our study provides insight into what should have been known about the risks of rofecoxib,” the authors conclude. “If we are to detect harms early and protect the public’s health, while ensuring the availability of new, clinically effective therapeutics, a system must be established that makes full use of all existing evidence.”
(Arch Intern Med. 2009;169[21]:1976-1985. www.jamamedia.org
Editor’s Note: This project was not directly supported by any external grants or funds. However, Dr. Ross is currently supported by a National Institute on Aging grant and by the American Federation of Aging Research through the Paul B. Beeson Career Development Award Program. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.Attention USA - the milking has turned into gouging!
Leaders of two powerful House committees have asked the Government Accountability Office (GAO) for “an expedited report on recent trends in prescription drug pricing” and a proposal for monitoring pricing practices, after recent studies and a report in the New York Times suggested that drugmakers may be artificially raising prices ahead of the health reform legislation now going through both houses of Congress and which could adversely affect drug price growth.
New analyses suggest that brand-name drug prices rose more than 9% last year and over 35% since 2006, say Democratic Representatives Charles Ranger, Henry Waxman, Pete Stark and John Lewis, in their letter to the GAO. “These price increases cannot be explained by increases in the Consumer Price Index (CPI), which fell last year. Pharmaceutical manufacturers used the same tactic before the start of Medicare Part D, raising drug prices dramatically in anticipation of gaining millions of new insured customers,” add the legislators, who lead the House Committees on Ways and Means, and Energy and Commerce.
And in the Senate, Democrat Bill Nelson of Florida has written to the Inspector General of the Department of Health and Human Services (HHS) requesting “an immediate and thorough investigation into drug industry pricing and recent increases, and the extent to which these increases may affect the Medicare and Medicaid programmes.”
“I want to know if there's a back-door move under way by the drugmakers to recover some of the concessions they’ve promised for health care reform,” he said.
The legislators’ demands follow the publication of a report last week by the seniors’ group AARP which claims that manufacturer prices for widely-used branded drugs have increased 9.3% since October 2008, considerably higher than the average 5.8%-8.3% of the past seven years, and against a 1.3% decline in the CPI. 96% of brand-name drugs’ prices have gone up in the last year, it adds.
“The pharmaceutical industry should be embarrassed when it sees its own price increases put side-by-side with the general inflation rate. Even as the cost of most goods and services drops, a person taking just one brand name drug now pays $200 more per year than a year ago,” said AARP executive vice president John Rother.
The NYT article quoted both the AARP study and new research by Credit Suisse analyst Catherine Arnold, who reports that the list prices of drugs made by the USA’s eight biggest drugmakers rose 8.7% on average during the 12 months ending September 30.
These price increases will add more than $10 billion to the US drug bill, which is forecast to surpass $300 billion this year, and at least one analysis puts this as the highest annual rate of drug price inflation since 1992, says the NYT.
The Pharmaceutical Research and Manufacturers of America has fired off a number of angry responses these claims, accusing the AARP of “trying to muddy the waters for its own political gain” and of having “a skewed view of the world in which medicines are always looked at as a cost and never seen as a saving.”
“It’s pretty obvious that the calls to hold hearings or involve GAO are based on the misleading use of statistics and sensationalised media reports,” says PhRMA executive vice president Ken Johnson. In fact, he adds, the CPI shows prescription drug prices grew 2.7% in the 12 months to September, not 5.4% as cited by AARP, while prices posted on medicare.gov shows that average annual growth for the products identified by the Association as top-selling was 3.3% over the last three years, less than half the 7.4% annual average cited by AARP.
The group’s conclusions are based on incomplete information because they do not take account of discounts and rebates which can significantly lower the cost of many brand-name drugs, benefiting patients nationwide, “but you wouldn’t know it by looking at pharmacy prices – or reading the New York Times,” he says. The newspaper article “only tells half a story, using selected statistics to make a flawed assumption that an increase in drug prices must somehow be tied to health care reform.”
“Here’s the real truth: financial results for nearly a dozen of our companies show zero revenue growth in the third quarter and -3% year to date. And it doesn’t appear to get much better down the road,” says Mr Johnson.
By Lynne Taylor
PharmaTimes
Concord Monitor - Drug price gouging
Pharmaceutical industry spokesmen must use Botox. How else could they keep a straight face while explaining that their employers raised prices by an average of 9 percent this year, the biggest single increase in nearly two decades, because they need to invest in the research and development of new drugs?
Earlier this year, credit card holders started receiving letters announcing huge increases in interest rates on outstanding balances, reduced rewards, higher fees and accelerated payment dates. Why? Because credit card reforms Congress enacted to rein in the rapacious industry are scheduled to go into effect in January. Last month, the Pew Health Group's Safe Credit Card Project reported that 100 percent of the credit cards offered by major issuers online included practices that will be banned.
In response to the rate increases, the House, in a measure supported by Reps. Paul Hodes and Carol Shea-Porter, passed legislation moving the effective date of the reforms to Dec. 1. The Senate has yet to act, but it should. Now that drugmakers are pulling the same stunt as credit card companies, Congress should revisit the deal it made with them in exchange for their acquiescence to health care reform.
Drugmakers want to install a new and higher price floor before Congress begins chipping away at the prescription drug component of unsustainably high health care costs. The industry agreed to reduce drug costs by $80 billion over the next decade because that loss would have been more than offset by the higher number of people who would have prescription drug coverage after health care reform. But this year's drug price increases will wipe out the sacrifice the industry made with its promise to reduce drug costs by $8 billion per year.
Some members of Congress are calling for an investigation into the price increases. A close look could show that some of the price increases were justified. But if, as many suspect, the increases are driven by little more than greed, Congress should take a scalpel to its deal with the drug industry.
This article is: 0 days old.
Hear hear!
Pfizer - Prempro / Provera : approaching "squeal point"?
Jurors deliberated about five hours before finding that the combination of Wyeth’s Prempro and Pharmacia & Upjohn’s Provera menopause drugs was a substantial contributing factor in Donna Kendall’s breast cancer. Kendall, 66, had a double mastectomy in 2002 after taking the hormone-replacement drugs for 11 years.
The panel will hear evidence Nov. 23 on whether Wyeth and Upjohn should pay punitive damages over their handling of the drugs. Wyeth has lost six of nine jury verdicts, including the last four in a row, over the drugs since 2006. This is Upjohn’s third loss at the jury stage. A trial judge threw out one verdict and another is on appeal.
“We’ve very pleased with the compensatory verdict and we look forward to the jury hearing the rest of the case,” Tobi Millrood, an attorney for Kendall, said after the verdict was read.
Pfizer’s losses in Prempro cases may have company officials considering a global settlement proposal to resolve them, said David Logan, dean of the Roger Williams University Law School.
“There is definitely a squeal point for companies in these kinds of product-liability cases where they start thinking about settling,” Logan, who teaches classes on mass-tort law, said in an interview.
“When the trend starts running clearly against companies in these cases, and they keep getting pounded by juries, the issue of settlement become a popular topic in the boardroom,” he added.
Sunday, November 22, 2009
Australian ADHD guidelines pulled after payment scandal | National News | News.com.au
CONTROVERSIAL guidelines on ADHD have been pulled by the Federal Government following claims drug company payments to a doctor have tainted the work.
The Government has been forced to stop the release of the draft guidelines and may have to rewrite them following the embarrassing scandal.
A cloud has been cast over the draft's validity after one of the psychiatrists, whose research into anti-psychotic drugs helped form the guidelines, was accused of failing to reveal payments from drug companies.
US-based child psychiatrist Dr Joseph Biederman is under investigation in America by authorities who have uncovered $1.6 million in payments.
The US Congress investigation has found Dr Biederman failed to declare where all the money came from and has possibly breached federal and Harvard University research laws.
Australian authorities have been forced to admit the embarrassing discovery that has now put the guidelines – which recommend medication such as Ritalin as the best form of treatment for ADHD and are designed to help parents and doctors – in jeopardy.
Child welfare and ADHD experts want the guidelines rewritten entirely.
"This is an excellent opportunity for the Government to go back to the drawing board," University of South Australia education faculty lecturer Dr Brenton Prosser said.
"I advise parents to use medication as a last resort. Pills don't acquire skills. Medicines don't address social skills."
The Royal Australasian College of Physicians is in charge of devising the guidelines, following a Government review in 2007.
"The College was not aware of the US investigation when drafting the guidelines," a spokesman said.
"When (it) is completed the college and National Health Medical Research Council will determine the future status of the guidelines."
It was revealed last year that seven of the 10 people in charge of setting the guidelines had financial links to firms who make ADHD drugs.
Biederman again!
Sanofi's Viehbacher speaks
In a veiled swipe at Gerard Le Fur, his predecessor and former head of research and development, who was appointed chief executive and ousted within months, he said: “We had really a scientific organisation that really lived within its own walls; not a lot of external partnerships, virtually no contact with our commercial organisations.”
Mr Viehbacher added: “The best scientists are often lousy leaders [and] managers. You had a research and development god who hoped a blockbuster emerged. When it didn’t, you merged. The model was flawed.More
Saturday, November 21, 2009
Drug firms’ tired song and dance on reform - The Boston Globe
IN MAKING a fool of President Obama, Big Pharma has turned itself into a poison pill of health care reform. In the summer, the drug companies offered $8 billion a year over 10 years in drug cost cuts, as long as the government did not ask for further reductions in what Medicare provides them. Obama proclaimed this a huge breakthrough, given the drug industry’s prior attacks on reform. “The pharmaceutical industry has been quite constructive in this debate,’’ Obama said. “And the savings that they’ve put on the table are real and significant and appreciated.’’ Big Pharma has taken the savings off the table. A new AARP analysis has found that drug companies raised their prices for prescription drugs by 9.3 percent over the last year, amounting to $10 billion in new revenues. That is $2 billion more than the promised annual cost cuts./p>
Editorial: Promises of drug industry fall flat - Sacramento Opinion - Sacramento Editorial | Sacramento Bee
Is the support of the pharmaceutical industry needed for Congress to pass health care reform? Or is the price of that support too high for the people the reform package is trying to help?
Those questions took on new urgency this week with the release of a study by AARP, the seniors advocacy group, that found that drug makers had raised the wholesale price of brand-name prescription drugs by 9 percent, or $10 billion, in the past year. One analyst who was quoted in the report, which ran on The Bee’s front page, said the price increase was the biggest in 17 years.
What particularly outraged opponents of “Big Pharma” is that the industry’s lobbyists had made a deal with the Obama administration and key Senate leaders to do just the opposite. In agreeing to support the health care overhaul, the pharmaceutical industry pledged to cut up to $80 billion in prescription costs over the next decade – although many of the details of how this would be accomplished were never made public.
In return, Medicare, a massive buyer of prescription drugs, was barred from negotiating lower prices or directing recipients away from expensive medicines when cheaper and equally effective options were available.
For certain Democrats in the House, the prescription price hike was new evidence of the industry’s chicanery. That distrust is the main reason the House didn’t sign on to the Obama administration’s deal, and came up with its own list of ways to cut drug company payments.
A key source of conflict: The multibillion-dollar payments the drug industry began receiving when 6.4 million low-income people were transferred from Medicaid – the government health program for the poor – to Medicare in 2006.
Rep. Henry Waxman, the Beverly Hills Democrat who was one of the key forces behind the House health-care bill, said this transfer provided the drug companies with a windfall. “I just don’t know why we should be overpaying pharmaceutical companies,” he grumbled.
The Senate is scheduled to begin debate tonight on its own version of health insurance reform. Undoubtedly, some senators will offer amendments that will allow the government to negotiate lower drug prices under Medicare.
For Senate Majority Leader Harry Reid, the choices are difficult. He faces enough challenges moving a bill through his chamber without reopening a skirmish with the drug industry. That’s why he likely will try to pass a “clean” bill, and then leave it to the conference committee to resolve differences over drug pricing.
The pharmaceutical industry stands to gain more than 30 million new customers under this legislation. That will more than make up for the expense of the $80 billion in prescription cost cuts they promised. That’s why the House can make a strong argument, both to the drug industry and the American people, that Medicare should be authorized to negotiate lower prices.
This is a momentous time. Congress and the White House are poised to expand health insurance coverage to millions of Americans who desperately need it. Even if the House doesn’t prevail with its version of this bill, this issue will not go away. The drug industry will be held to account for its promises.
U.S. Court of Appeals Upholds AstraZeneca AWP Settlement - Yahoo! Finance
Companies:
BOSTON, Nov. 20 /PRNewswire/ -- The United States Court of Appeals for the First Circuit upheld an earlier District Court ruling yesterday, approving a settlement in the long-running Average Wholesale Price (AWP) pharmaceutical litigation against AstraZeneca Pharmaceuticals (NYSE: AZN - News).
(Logo: http://www.newscom.com/cgi-bin/prnh/20080317/AQM144LOGO)
The ruling affirms a settlement that awarded consumers who purchased the pharmaceutical giant's prostate cancer drug Zoladex treble damages, a rare if not unprecedented event in consumer litigation.
The case, argued by Steve W. Berman a Seattle plaintiff's attorney with Hagens Berman Sobol Shapiro (HBSS), afforded thousands of consumers access to a $24 million settlement against the drug giant accused of manipulating the price of Zoladex.
Under the settlement approved by the U.S. District Court in November 2007, any consumer who could provide reasonable documentation can receive three times the actual damages. Any funds left over from the $24 million settlement would go to non-profit organizations. Experts representing the plaintiffs expect that only about $21 million will be claimed by class members, many of whom have passed away since the case was filed.
The distribution to charities falls under a legal doctrine cy pre, a Norman French expression for "as near as it comes," allowing for the unclaimed amount of the settlement to benefit those in the class, even if indirectly.
This is the first time the First Circuit has affirmed the use of cy pre in this way.
The ruling was in response to an appeal filed by a class member who objected to the settlement, claiming the cy pre fund lowered the amount of recovery to class members. The objecting claimant also argued that the payment methodology was flawed; that payments discriminated against class members with supplemental insurance and that a conflict of interest existed since one of the plaintiffs could receive cy pre funding.
The court dismissed each of the objector's claims filed by attorney Don Haviland as "meritless."
"We are heartened that the Court of Appeals agreed with U.S. District Court Judge Patti Saris' early ruling approving the settlement," said Berman, noting that HBSS filed the first AWP case in 2002. "This settlement is perhaps the first time a consumer class was awarded treble damages in a case of this size."
Berman noted that the court's conclusion that no conflict of interest existed in the cy pre could have positive ramifications in other settlements in the AWP litigation.
Under the terms of the settlement, consumers who paid or contributed to the purchase of Zoladex through co-payments between December 1997 and 2003 are entitled to treble damages. Other class members will receive treble damages if money is left from the $24 million settlement. Experts agree that there will be sufficient funds to pay treble damages for all class members, with approximately $6.8 million remaining for cy pre funding.
The First Circuit ruling noted the District Court's work, applauding Judge Patti Saris, saying her court has "handled this matter with sensitivity and care." Judge Saris has presided over this case since 2001.
About Hagens Berman Sobol Shapiro
Hagens Berman Sobol Shapiro is a nationally recognized class-action and complex-litigation law firm based in Seattle with offices in Chicago, Boston, Los Angeles, Phoenix and San Francisco. Among recent successes, HBSS negotiated a $300 million settlement in the DRAM memory antitrust litigation, the largest antitrust settlement in U.S. history, recovered $340 million on behalf of Enron employees, and was part of the leadership team in the $3 billion Visa/MasterCard settlement. In pharmaceutical litigation, the firm's recent successes include a $350 million settlement with McKesson, more than $200 million with other parties in drug-pricing litigation, and a $150 million settlement regarding Lupron. HBSS represented Washington and 12 other states against the tobacco industry that resulted in the largest settlement in history. For a complete listing of HBSS cases, visit www.hbsslaw.com.
CASE 09-1196
CONTACT: Steve Berman 206-623-7292 steve@hbsslaw.com Mark Firmani 206-443-9357 Mark@firmani.com
Friday, November 20, 2009
Pfizer - Prempro: Kris Hundley writes
Is Prempro, the hormone drug known to increase the risk of breast cancer, a public hazard?
If a judge in Pinellas County determines that it is, hundreds of thousands of documents now under seal in lawsuits against the drug's manufacturer nationwide could be released for the public to inspect.
The key to the confidential company records has ended up in Pinellas-Pasco Circuit Judge Anthony Rondolino's hands because of a clerical misstep and a unique Florida statute.
A hearing on the matter is scheduled for Monday, though attorneys were negotiating a possible resolution late Thursday.
More than 9,000 women have sued Pfizer's Wyeth unit, the maker of Prempro and Premarin, claiming its bestselling hormone drugs caused breast cancer and stroke. The vast majority of those lawsuits have been consolidated in federal courts in Arkansas, Pennsylvania and Nevada.
But the case of Loretta Esposito, a 63-year-old Clearwater resident who died of breast cancer in 2006, slipped through the cracks, making it the only Wyeth case in a Florida court. That could subject it to the state's Sunshine in Litigation Law, which prohibits the court from keeping papers secret if they concern a public hazard.
Citing this statute, Esposito's attorneys have refused to agree to the confidentiality order Wyeth has required other plaintiffs' attorneys to sign before giving them access to an estimated 16 million discovery documents.
During a hearing in the spring, James Clark, the Tampa lawyer who represents the deceased woman's husband, Peter Esposito, said the agreement would "be asking us and enticing us and luring our client through us — and the court — to violate Florida law … because it's our position that the product isn't okay."
How to report a possible medicine related adverse event to the FDA
https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
2. Click on "BEGIN" - it's on the right of the page
Click the BEGIN button to report serious adverse events for human medical products, including potential and actual product use errors and product quality problems associated with the use of:
- FDA-regulated drugs,
- biologics (including human cells, tissues, and cellular and tissue-based products)
- medical devices (including in vitro diagnostics)
- special nutritional products and cosmetics
Justice Department Recovers $1.6 Billion in Healthcare False Claims Cases in 2009
Justice Department Recovers $2.4 Billion in False Claims Cases in Fiscal Year 2009; More Than $24 Billion Since 1986
FY09 Recovery is Second Largest in History
WASHINGTON, Nov. 19 /PRNewswire-USNewswire/ -- The United States secured $2.4 billion in settlements and judgments in cases involving fraud against the government in the fiscal year ending Sept. 30, 2009, the Justice Department announced today. This represents the second largest annual recovery of civil fraud claims in history, and brings total recoveries since 1986, when Congress substantially strengthened the civil False Claims Act, to more than $24 billion.
A top priority for this administration is fighting health care fraud. On May 20, 2009, the Attorney General and the Secretary of the Department of Health and Human Services (HHS) announced the creation of a new interagency task force, the Health Care Fraud Prevention and Enforcement Team (HEAT), to increase coordination and optimize criminal and civil enforcement. These efforts not only protect the Medicare Trust Fund for seniors and the Medicaid program for the country's neediest citizens, they result in higher quality health care at a more reasonable price.
In fiscal year 2009, health care fraud recoveries reached $1.6 billion, two-thirds of the year's total. The Department of Health and Human Services reaped the biggest recoveries, largely attributable to its Medicare and Medicaid programs. Recoveries were also made by the Office of Personnel Management, which administers the Federal Employees Health Benefits Program, the Department of Defense for its TRICARE insurance program and the Department of Veterans Affairs, among others.
The largest health care recoveries came from the pharmaceutical and medical device industries, which accounted for $866.7 million in settlements, including Aventis Pharmaceuticals Inc., Bayer HealthCare LLC, Eli Lilly & Company and Quest Diagnostics Inc. and its subsidiary, Nichols Institute Diagnostics Inc. In addition to federal recoveries, these pharmaceutical and medical device fraud cases returned $402 million to state Medicaid programs.
The Civil Division's investigation of the pharmaceutical industry is part of a department-wide effort. The Civil Division is pursuing allegations of a variety of schemes, including "off-label" marketing, which is the illegal promotion of drugs or devices that are billed to Medicare and other federal health care programs for uses that were neither found safe and effective by the Food and Drug Administration (FDA) nor supported by the medical literature; paying kickbacks to physicians, wholesalers and pharmacies to induce drug or device purchases; establishing inflated drug prices knowing that federal health care programs use these prices to reimburse providers, then marketing the "spread" between the federal reimbursement and the provider's lower cost to induce drug purchases; and knowingly failing to report the company's true "best price" for a drug in order to reduce rebates owed to the Medicaid program.
SOURCE U.S. Department of Justice