Hot on the heels of AZ's news comes this.
Johnson & Johnson said Tuesday it would reduce its global work force by up to 4 percent, or up to 4,820 jobs, to cut costs due to a slump in sales of its heart stents and its No. 2 drug, plus coming patent expirations for key drugs.
The health care giant, which employs about 120,500 people in 57 countries, said the restructuring - its largest ever - would bring pretax charges of $550 million to $750 million later this year, as well as other, unspecified steps besides job cuts.
More
Tuesday, July 31, 2007
Things that make you go "Hmmm!"
The executive vice president and chief financial officer of drug maker Merck, Judy C. Lewent, sold 50,000 shares of common stock, according to a Securities and Exchange Commission filing Monday.
Source
Source
Monday, July 30, 2007
The rise (and possible fall) of the glitazones - so far
January 1997: The FDA approves Rezulin to treat type 2 diabetes the first glitazone drug, a class of drugs that help the body use insulin more effectively.
May 1999: The FDA OKs Avandia, the second glitazone.
July 1999: The FDA approves Actos, the third glitazone.
March 2000: The FDA asks Rezulin's maker to withdraw the drug because it is more toxic to the liver than Avandia or Actos.
April 2002: Avandia and Actos labels get new warnings about an increased risk of heart failure.
December 2005: Avandia maker GlaxoSmithKline and the FDA notify doctors of reports of new or worsening diabetic macular edema, fluid retention in the eye that can cause vision impairment, in patients taking the drug.
February 2007: Glaxo sends out a "Dear Health Care Professional" letter saying a clinical trial found a "significantly" higher risk of fracture in women who received Avandia compared with those who received metformin or glyburide, two older diabetes medications.
March 2007: Actos maker Takeda sends out a "Dear Health Care Professional" letter saying a review of its clinical trials database found an increased risk of fracture in women who received the drug.
May 2007: A New England Journal of Medicine study suggests Avandia raises risk of heart attacks. The FDA issues an Avandia "safety alert."
Source: USA Today
May 1999: The FDA OKs Avandia, the second glitazone.
July 1999: The FDA approves Actos, the third glitazone.
March 2000: The FDA asks Rezulin's maker to withdraw the drug because it is more toxic to the liver than Avandia or Actos.
April 2002: Avandia and Actos labels get new warnings about an increased risk of heart failure.
December 2005: Avandia maker GlaxoSmithKline and the FDA notify doctors of reports of new or worsening diabetic macular edema, fluid retention in the eye that can cause vision impairment, in patients taking the drug.
February 2007: Glaxo sends out a "Dear Health Care Professional" letter saying a clinical trial found a "significantly" higher risk of fracture in women who received Avandia compared with those who received metformin or glyburide, two older diabetes medications.
March 2007: Actos maker Takeda sends out a "Dear Health Care Professional" letter saying a review of its clinical trials database found an increased risk of fracture in women who received the drug.
May 2007: A New England Journal of Medicine study suggests Avandia raises risk of heart attacks. The FDA issues an Avandia "safety alert."
Source: USA Today
Now Sanofi Aventis start buying back shares
Sanofi-Aventis SA, whose shares have fallen 10 percent since a U.S. panel rejected its most promising medicine last month, may follow rivals GlaxoSmithKline Plc and Pfizer Inc. and seek to win back investors with cash.
The world's third-largest drugmaker is expected to say second-quarter profit barely grew this week. The Paris-based company may also disclose plans to spend as much as 30 billion euros ($40.9 billion) on its own shares by 2011, buying it time to convince investors that other drugs in development are worth waiting for, says HSBC Securities analyst Kevin Scotcher.
Like Pfizer and Glaxo, Sanofi is struggling to boost profit as key medicines lose revenue to generics. Last month's setback will make it harder to replace sales lost to cheaper versions of some of the company's biggest drugs, including Ambien, the sleep pill that lost patent protection in April. A buyback would signal Sanofi is confident about drugs in its pipeline and quash speculation it may buy Bristol-Myers Squibb Co., analysts said.
``Saying they're going to put money into a buyback rather than make a big acquisition would be saying `we're sticking to what we're doing,''' New York-based Scotcher said in a July 25 telephone interview. ``What they need to do on Aug. 1 is make a statement about a specific amount for a specific period.''
More at Bloomberg
The world's third-largest drugmaker is expected to say second-quarter profit barely grew this week. The Paris-based company may also disclose plans to spend as much as 30 billion euros ($40.9 billion) on its own shares by 2011, buying it time to convince investors that other drugs in development are worth waiting for, says HSBC Securities analyst Kevin Scotcher.
Like Pfizer and Glaxo, Sanofi is struggling to boost profit as key medicines lose revenue to generics. Last month's setback will make it harder to replace sales lost to cheaper versions of some of the company's biggest drugs, including Ambien, the sleep pill that lost patent protection in April. A buyback would signal Sanofi is confident about drugs in its pipeline and quash speculation it may buy Bristol-Myers Squibb Co., analysts said.
``Saying they're going to put money into a buyback rather than make a big acquisition would be saying `we're sticking to what we're doing,''' New York-based Scotcher said in a July 25 telephone interview. ``What they need to do on Aug. 1 is make a statement about a specific amount for a specific period.''
More at Bloomberg
Now Sanofi Aventis climb on the wholesale bandwaggon
Sanofi-Aventis is set to become the third drug major to switch to an exclusive distribution system for its medicines in the UK, with the announcement that, from November 1, its products will be distributed by AAH, Phoenix and UniChem only.
The change is being made to improve supply-chain efficiency and integrity in the delivery of its medicines to patients, said the French-based drugmaker. The three firms will offer 100% national coverage across the UK, including Northern Ireland, there will be no change to their wholesaler status and they will continue to control both discounts and delivery frequency, it added.
Announcement of this latest limited distribution deal was embargoed until this morning (July 30), so representatives of the wholesaling industry have yet to comment. However, the British Association of Pharmaceutical Wholesalers (BAPW) has been fiercely critical of the first two such arrangements, announced by Pfizer last October and AstraZeneca in April this year, warning that these “new and varied distribution arrangements” could damage the robustness of the pharmaceutical supply chain and the ability of patients to receive medicines quickly and easily, with the potential for hidden costs to the National Health Service (NHS).
Pfizer announced its ground-breaking sole-supplier deal with Alliance Boots unit UniChem last September, stating that selling its prescription medicines direct to UK pharmacists and dispensing doctors would enable it secure the supply chain for its medicines and reduce the risk of counterfeit medicines.
In March this year, the deal was unsuccessfully challenged in the High Court by a group of eight wholesalers, including AAH, which then in April was named by AstraZeneca as one of just two wholesalers alongside UniChem, which would distribute its products in the UK from later this year.
Commented AAH group managing director Steve Dunn: “Pharmacists will be relieved that this is not another single-channel scheme like that implemented by Pfizer which relies upon one agent to meet the complex demands of every pharmacy, hospital and dispensing doctor everywhere in the UK.”
However, AstraZeneca has now said that implementation of the new distribution arrangements will be delayed until early next year.
Many observers are highly sceptical about the companies’ claims that they are taking these steps to minimise the risk of counterfeit medicines entering the supply chain, and believe that their real motive is to destroy the parallel imports market.
And some experts believe that such distribution deals will actually worsen the risk of patients receiving counterfeit medicines; an across-the-board take-up of such programmes could lead to pharmacists looking to buy their products elsewhere, including from “less reputable sources,” warned Dispensing Doctors Federation chief executive David Baker, speaking at the BAPW annual conference earlier this year.
However, according to Sanofi-Aventis UK supply chain director, Mike Isles, the new arrangements will enable the company “to maintain the service levels that our customers experience today, whilst improving supply chain efficiency in the delivery of our medicines to patients.”AAH, Phoenix and UniChem already distribute nearly 90% of all medicines in the UK, and pharmacists should already have existing arrangements with one or more of these wholesalers, ensuring continuity of supply, the company adds.
Meantime, as other drugmakers, including Eli Lilly and Novartis, are reported to be readying their own limited distribution deals, a market study into the new arrangements by government watchdog the Office of Fair Trading (OFT) is due to report its findings by the end of the year.
By Lynne Taylor, PharmaTimes
The change is being made to improve supply-chain efficiency and integrity in the delivery of its medicines to patients, said the French-based drugmaker. The three firms will offer 100% national coverage across the UK, including Northern Ireland, there will be no change to their wholesaler status and they will continue to control both discounts and delivery frequency, it added.
Announcement of this latest limited distribution deal was embargoed until this morning (July 30), so representatives of the wholesaling industry have yet to comment. However, the British Association of Pharmaceutical Wholesalers (BAPW) has been fiercely critical of the first two such arrangements, announced by Pfizer last October and AstraZeneca in April this year, warning that these “new and varied distribution arrangements” could damage the robustness of the pharmaceutical supply chain and the ability of patients to receive medicines quickly and easily, with the potential for hidden costs to the National Health Service (NHS).
Pfizer announced its ground-breaking sole-supplier deal with Alliance Boots unit UniChem last September, stating that selling its prescription medicines direct to UK pharmacists and dispensing doctors would enable it secure the supply chain for its medicines and reduce the risk of counterfeit medicines.
In March this year, the deal was unsuccessfully challenged in the High Court by a group of eight wholesalers, including AAH, which then in April was named by AstraZeneca as one of just two wholesalers alongside UniChem, which would distribute its products in the UK from later this year.
Commented AAH group managing director Steve Dunn: “Pharmacists will be relieved that this is not another single-channel scheme like that implemented by Pfizer which relies upon one agent to meet the complex demands of every pharmacy, hospital and dispensing doctor everywhere in the UK.”
However, AstraZeneca has now said that implementation of the new distribution arrangements will be delayed until early next year.
Many observers are highly sceptical about the companies’ claims that they are taking these steps to minimise the risk of counterfeit medicines entering the supply chain, and believe that their real motive is to destroy the parallel imports market.
And some experts believe that such distribution deals will actually worsen the risk of patients receiving counterfeit medicines; an across-the-board take-up of such programmes could lead to pharmacists looking to buy their products elsewhere, including from “less reputable sources,” warned Dispensing Doctors Federation chief executive David Baker, speaking at the BAPW annual conference earlier this year.
However, according to Sanofi-Aventis UK supply chain director, Mike Isles, the new arrangements will enable the company “to maintain the service levels that our customers experience today, whilst improving supply chain efficiency in the delivery of our medicines to patients.”AAH, Phoenix and UniChem already distribute nearly 90% of all medicines in the UK, and pharmacists should already have existing arrangements with one or more of these wholesalers, ensuring continuity of supply, the company adds.
Meantime, as other drugmakers, including Eli Lilly and Novartis, are reported to be readying their own limited distribution deals, a market study into the new arrangements by government watchdog the Office of Fair Trading (OFT) is due to report its findings by the end of the year.
By Lynne Taylor, PharmaTimes
SiCKO "hitman" interviewed
Julia Schopick has posted an audio interview on Honst Medicine, which she conducted with Lee Einer, the man Michael Moore dubbed (facetiously) the insurance industry "hitman" in SiCKO!
I hope you will give it a listen, because Lee was very forthcoming with lots of "secrets" that weren't addressed in SiCKO.
He also expands on other "secrets" that were exposed in the film.
Go here.
I hope you will give it a listen, because Lee was very forthcoming with lots of "secrets" that weren't addressed in SiCKO.
He also expands on other "secrets" that were exposed in the film.
Go here.
Genentech - UK docs rebel against Lucentis' gouging
Back stories here.
British doctors are to rebel against high prices set by pharmaceutical companies for their products by giving patients a cheap but unlicensed drug that prevents blindness, the Guardian has learned.
Unable to afford to treat all those losing their sight with a licensed and extremely expensive drug, Lucentis, some primary care trusts are giving NHS doctors the green light to use tiny shots of a similar drug, Avastin, which is marketed for bowel cancer, but costs a fraction of the price. Avastin is widely used for eye complaints in the United States.
A call from the former health secretary, Patricia Hewitt, for Avastin's manufacturer to put the drug through trials for wet age-related macular degeneration went unheeded. Now the NHS is funding a groundbreaking trial which will compare Avastin directly with Lucentis. Both drugs are manufactured by Genentech.
The moves represent the first real challenge in this country to high prices set by drug companies. There is growing unease at the cost of new drugs and high prices have led to the banning or rationing of some medicines in the NHS by the National Institute for Health and Clinical Excellence (Nice). The companies say they need billions of dollars in sales to recoup their research and development costs, but critics accuse them of profiteering.
More at The Guardian
British doctors are to rebel against high prices set by pharmaceutical companies for their products by giving patients a cheap but unlicensed drug that prevents blindness, the Guardian has learned.
Unable to afford to treat all those losing their sight with a licensed and extremely expensive drug, Lucentis, some primary care trusts are giving NHS doctors the green light to use tiny shots of a similar drug, Avastin, which is marketed for bowel cancer, but costs a fraction of the price. Avastin is widely used for eye complaints in the United States.
A call from the former health secretary, Patricia Hewitt, for Avastin's manufacturer to put the drug through trials for wet age-related macular degeneration went unheeded. Now the NHS is funding a groundbreaking trial which will compare Avastin directly with Lucentis. Both drugs are manufactured by Genentech.
The moves represent the first real challenge in this country to high prices set by drug companies. There is growing unease at the cost of new drugs and high prices have led to the banning or rationing of some medicines in the NHS by the National Institute for Health and Clinical Excellence (Nice). The companies say they need billions of dollars in sales to recoup their research and development costs, but critics accuse them of profiteering.
More at The Guardian
GSK - Avandia: today's the day
Heightened US drug safety concerns reach another critical testing point on Monday when a regulatory advisory panel weighs the heart risks and future of GlaxoSmithKline's diabetes drug, Avandia.
The Food and Drug Administration will convene an experts' panel to recommend whether the UK drugmaker's drug increases the risk of heart attacks and if it should remain on the market. The FDA routinely follows the recommendations made by its advisory panels, comprised of outside medical experts.
Regulation and questions over drug safety and risks have intensified in the aftermath of US drugmaker Merck's sudden withdrawal of Vioxx three years ago because of heart risks.
The FDA continues to come under pressure and scrutiny from Congress, patients groups and doctors to improve its drug-safety monitoring. Legislation is pending that could change the FDA so as to improve safety oversight.
Questions over Avandia have put the US commercial future of one of GSK's best-selling drugs in jeopardy.
The controversy exploded into the public in May. In an article in the New England Journal of Medicine, Dr Steven Nissen, a renowned US cardiologist, estimated that there was a significant increase in heart attack risk for Avandia patients by an overarching analysis of data from 42 previous clinical trials. Dr Nissen had been a major voice against Vioxx risks.
GSK and the FDA had already been evaluating data on Avandia risks and negotiating some changes to its prescription label directions.
More
Aside from the direct impact on sales, GSK is also facing the possible threat of costly litigation from users of the drug who claim to have suffered heart problems. David Vermont, a lawyer with Ashcraft & Gerel in Washington, one of several American law firms preparing legal action against GSK, said that it had already screened up to 300 inquiries from Avandia patients and their families, 80 per cent of whom he said had experienced heart attacks.
“We are getting calls and referrals every day — twice as many as we would have expected,” Mr Vermont told The Times.
The Food and Drug Administration will convene an experts' panel to recommend whether the UK drugmaker's drug increases the risk of heart attacks and if it should remain on the market. The FDA routinely follows the recommendations made by its advisory panels, comprised of outside medical experts.
Regulation and questions over drug safety and risks have intensified in the aftermath of US drugmaker Merck's sudden withdrawal of Vioxx three years ago because of heart risks.
The FDA continues to come under pressure and scrutiny from Congress, patients groups and doctors to improve its drug-safety monitoring. Legislation is pending that could change the FDA so as to improve safety oversight.
Questions over Avandia have put the US commercial future of one of GSK's best-selling drugs in jeopardy.
The controversy exploded into the public in May. In an article in the New England Journal of Medicine, Dr Steven Nissen, a renowned US cardiologist, estimated that there was a significant increase in heart attack risk for Avandia patients by an overarching analysis of data from 42 previous clinical trials. Dr Nissen had been a major voice against Vioxx risks.
GSK and the FDA had already been evaluating data on Avandia risks and negotiating some changes to its prescription label directions.
More
Aside from the direct impact on sales, GSK is also facing the possible threat of costly litigation from users of the drug who claim to have suffered heart problems. David Vermont, a lawyer with Ashcraft & Gerel in Washington, one of several American law firms preparing legal action against GSK, said that it had already screened up to 300 inquiries from Avandia patients and their families, 80 per cent of whom he said had experienced heart attacks.
“We are getting calls and referrals every day — twice as many as we would have expected,” Mr Vermont told The Times.
Sunday, July 29, 2007
Friday, July 27, 2007
GSK - Avandia: "several thousand could be harmed"
Just as GlaxoSmithKline’s diabetes drug Avandia (rosiglitazone) is preparing Monday to face a US Food and Drug Administration advisory panel on concerns over possible links to cardiovascular adverse events, new research coming out of the UK suggests that Avandia and Eli Lilly/Takeda’s Actos (pioglitazone) double the risk of heart failure, with fluid retention caused by the drugs providing the trigger.
The findings are based on a meta-analysis of more than 78,000 patients, which estimates that one in every 50 patients taking the drugs over a 26-month period will require hospital admission due to heart failure.
“This means that the diabetes drugs could have caused thousands of additional cases of heart failure, creating a substantial burden on hard-pressed health services,” said Dr Yoon Loke, a clinical pharmacologist at UEA’s School of Medicine, Health Policy and Practice. The results are published in the August edition of the journal Diabetes Care.
In the UK, prescriptions for the drugs, known as thiazolidinediones, have doubled over the last three years and they were taken by more than 1.5 million people in England alone last year.The new research was undertaken by Loke, working with colleagues at Wake Forest University in the US.
In the UK, Avandia and Actos are recommended for use on the country’s National Health Service, but Loke now says: “I think NICE [the UK's cost-effectiveness body, the National Institute for Health and Clinical Excellence] should re-evaluate their decision to recommend these diabetes drugs.”
The researchers also looked in detail at more than 200 cases of patients with heart failure related to the diabetes drugs and found that the problem developed even in patients taking low doses of the drugs. Furthermore, around 25% of cases occurred in people under the age of 60, even without a history of cardiovascular disease.
“Most patients in the studies did not have heart failure prior to starting on treatment with these drugs,” said Dr Loke. “There doesn’t seem to be a group of patients who are safe from these side effects.”
“These drugs are taken by more than seven million diabetic patients in the US alone, suggesting that several thousand could be harmed,” said co-author Dr Sonal Singh of Wake Forest University.
Source: PharmaTimes
The findings are based on a meta-analysis of more than 78,000 patients, which estimates that one in every 50 patients taking the drugs over a 26-month period will require hospital admission due to heart failure.
“This means that the diabetes drugs could have caused thousands of additional cases of heart failure, creating a substantial burden on hard-pressed health services,” said Dr Yoon Loke, a clinical pharmacologist at UEA’s School of Medicine, Health Policy and Practice. The results are published in the August edition of the journal Diabetes Care.
In the UK, prescriptions for the drugs, known as thiazolidinediones, have doubled over the last three years and they were taken by more than 1.5 million people in England alone last year.The new research was undertaken by Loke, working with colleagues at Wake Forest University in the US.
In the UK, Avandia and Actos are recommended for use on the country’s National Health Service, but Loke now says: “I think NICE [the UK's cost-effectiveness body, the National Institute for Health and Clinical Excellence] should re-evaluate their decision to recommend these diabetes drugs.”
The researchers also looked in detail at more than 200 cases of patients with heart failure related to the diabetes drugs and found that the problem developed even in patients taking low doses of the drugs. Furthermore, around 25% of cases occurred in people under the age of 60, even without a history of cardiovascular disease.
“Most patients in the studies did not have heart failure prior to starting on treatment with these drugs,” said Dr Loke. “There doesn’t seem to be a group of patients who are safe from these side effects.”
“These drugs are taken by more than seven million diabetic patients in the US alone, suggesting that several thousand could be harmed,” said co-author Dr Sonal Singh of Wake Forest University.
Source: PharmaTimes
Cardinal - red handed
Drug wholesaler Cardinal Health Inc. agreed to pay $35 million to settle charges that it engaged in nearly a four-year fraudulent revenue and earnings scheme, the U.S. Securities and Exchange Commission said on Thursday.
The company, one of the US's three top drug wholesalers, did not admit to or deny the SEC's allegations.
The SEC complaint alleges that from September 2000 to March 2004 the Ohio-based company presented a false picture of its operating results.
Cardinal materially overstated its operating revenue, earnings and growth trends in earnings releases and filings with the agency, the SEC alleged.
According to the complaint, Cardinal managed its reported revenue and earnings through a variety of undisclosed and improper actions.
It inflated reported operating revenue by misclassifying more than $5 billion of bulk sales as operating revenue, the SEC alleged.
The complaint also alleged that Cardinal began intentionally holding some bulk shipments for longer than 24 hours in order to shift revenue from the bulk revenue line to the operating revenue line.
Cardinal decided when to start and stop this practice based on the strength or weakness of quarterly sales and earnings, the complaint alleged.
"Cardinal's fraudulent mischaracterization of its operating revenues, as alleged, deprived investors of material information," Antonia Chion, associate director of the SEC's enforcement division, said in a statement.
Source
The company, one of the US's three top drug wholesalers, did not admit to or deny the SEC's allegations.
The SEC complaint alleges that from September 2000 to March 2004 the Ohio-based company presented a false picture of its operating results.
Cardinal materially overstated its operating revenue, earnings and growth trends in earnings releases and filings with the agency, the SEC alleged.
According to the complaint, Cardinal managed its reported revenue and earnings through a variety of undisclosed and improper actions.
It inflated reported operating revenue by misclassifying more than $5 billion of bulk sales as operating revenue, the SEC alleged.
The complaint also alleged that Cardinal began intentionally holding some bulk shipments for longer than 24 hours in order to shift revenue from the bulk revenue line to the operating revenue line.
Cardinal decided when to start and stop this practice based on the strength or weakness of quarterly sales and earnings, the complaint alleged.
"Cardinal's fraudulent mischaracterization of its operating revenues, as alleged, deprived investors of material information," Antonia Chion, associate director of the SEC's enforcement division, said in a statement.
Source
Thursday, July 26, 2007
SiCKO - the health care revolution might be televised
Thursday, July 26th, 2007
Friends,
I am overwhelmed by the response to "Sicko." And I'm not just talking about all the wonderful, heart-felt letters you've sent me and the stories you've shared with me about the abuse you've suffered from our health care system.
No, I'm talking about how thousands of you are taking matters into your own hands and using the movie to do something. From Seattle to New England, each day I learn of numerous groups holding meetings or dinners after the movie to discuss it and to plot a course for action.
A church in Plano, TX took its weekly bible study group to see "SiCKO." 70 people crammed into a Wisconsin coffee shop's back room. Groups are plotting over pancakes in Illinois and microbrew in Missouri. E-mail addresses are being exchanged in theater lobbies.
A Connecticut group is inviting legislators to see "Sicko" and keeping a tally on their website. Local groups have been buying out theaters to have special screenings for their members. Information tables are set up, literature is distributed, action groups are formed.
It's all an amazing sight. I can't tell you how thrilled I am to see the impact a movie can have. For all of you who have written me to ask, "What can I do," well, read more about what others have done, and then try these simple steps:
1. Call or write you member of Congress right now (I'll wait) and tell him or her that you insist they become a co-sponsor of H.R. 676 -- "The United States National Health Insurance Act." It's sponsored currently by Rep. John Conyers and 76 other members of Congress. Insist that your congressperson be one of those co-sponsors. I want to see 100 co-sponsors by Thanksgiving. Will you help make that happen?
2. Call and write to each of the candidates running for President. Tell them you expect them to back H.R. 676, and to take the Senator Brown pledge. Sen. Sherrod Brown of Ohio refuses to accept his free, government-run health insurance until EVERY American is covered.
3. Organize your own local HealthCare-Now! coalition. You can do it in your own neighborhood. It has to start somewhere. Everyday people have to make this happen. Don't wait for someone else to do this. Ask yourself, "if not me, who?"
4. Call your local media and tell them about your health care horror story. Many papers and TV stations have been running these since "Sicko" arrived in theaters. They like the local angle. Tell them you saw the movie and that there's a "Sicko" story happening right here in (fill in the blank). Tell them you are passing it on to me.
Well, that's a start. Here's what I'm going to do. Because last weekend's "Win a Trip to a Universal Healthcare Country" was so successful (the winner will be announced next week), this weekend we're going to try something different: it's "Take a Republican to 'Sicko!'" C'mon, we all have a conservative in the family! They mean well. It's just that they believe what they've been told about that scary "socialized medicine." Treat them to the movie this weekend and tell them to send me their ticket stub and entry form. I will hold a drawing and the lucky winner will get to have me come to their home and do their laundry -- just like in France! Now, what would make a Republican happier than to see me working away in their laundry room?!
I truly believe that the health care issue is one where we can find some common ground with those who may hold different opinions than us. After all, they're getting the shaft by the same insurance and pharmaceutical companies we are. And sooner or later, they're not going to take it any more, either.
Yours,
Michael Moore
mmflint@aol.com
MichaelMoore.com
P.S. I will be on Jay Leno (The Tonight Show on NBC) tonight (Thursday) at 11:35pm ET/PT. I will be making a special announcement on the show.
Friends,
I am overwhelmed by the response to "Sicko." And I'm not just talking about all the wonderful, heart-felt letters you've sent me and the stories you've shared with me about the abuse you've suffered from our health care system.
No, I'm talking about how thousands of you are taking matters into your own hands and using the movie to do something. From Seattle to New England, each day I learn of numerous groups holding meetings or dinners after the movie to discuss it and to plot a course for action.
A church in Plano, TX took its weekly bible study group to see "SiCKO." 70 people crammed into a Wisconsin coffee shop's back room. Groups are plotting over pancakes in Illinois and microbrew in Missouri. E-mail addresses are being exchanged in theater lobbies.
A Connecticut group is inviting legislators to see "Sicko" and keeping a tally on their website. Local groups have been buying out theaters to have special screenings for their members. Information tables are set up, literature is distributed, action groups are formed.
It's all an amazing sight. I can't tell you how thrilled I am to see the impact a movie can have. For all of you who have written me to ask, "What can I do," well, read more about what others have done, and then try these simple steps:
1. Call or write you member of Congress right now (I'll wait) and tell him or her that you insist they become a co-sponsor of H.R. 676 -- "The United States National Health Insurance Act." It's sponsored currently by Rep. John Conyers and 76 other members of Congress. Insist that your congressperson be one of those co-sponsors. I want to see 100 co-sponsors by Thanksgiving. Will you help make that happen?
2. Call and write to each of the candidates running for President. Tell them you expect them to back H.R. 676, and to take the Senator Brown pledge. Sen. Sherrod Brown of Ohio refuses to accept his free, government-run health insurance until EVERY American is covered.
3. Organize your own local HealthCare-Now! coalition. You can do it in your own neighborhood. It has to start somewhere. Everyday people have to make this happen. Don't wait for someone else to do this. Ask yourself, "if not me, who?"
4. Call your local media and tell them about your health care horror story. Many papers and TV stations have been running these since "Sicko" arrived in theaters. They like the local angle. Tell them you saw the movie and that there's a "Sicko" story happening right here in (fill in the blank). Tell them you are passing it on to me.
Well, that's a start. Here's what I'm going to do. Because last weekend's "Win a Trip to a Universal Healthcare Country" was so successful (the winner will be announced next week), this weekend we're going to try something different: it's "Take a Republican to 'Sicko!'" C'mon, we all have a conservative in the family! They mean well. It's just that they believe what they've been told about that scary "socialized medicine." Treat them to the movie this weekend and tell them to send me their ticket stub and entry form. I will hold a drawing and the lucky winner will get to have me come to their home and do their laundry -- just like in France! Now, what would make a Republican happier than to see me working away in their laundry room?!
I truly believe that the health care issue is one where we can find some common ground with those who may hold different opinions than us. After all, they're getting the shaft by the same insurance and pharmaceutical companies we are. And sooner or later, they're not going to take it any more, either.
Yours,
Michael Moore
mmflint@aol.com
MichaelMoore.com
P.S. I will be on Jay Leno (The Tonight Show on NBC) tonight (Thursday) at 11:35pm ET/PT. I will be making a special announcement on the show.
Merck - Vioxx: risky business
Merck's Vioxx pain medication, pulled from the market in September 2004 after it was linked to heart attacks and strokes, may have harmed some users faster than the drugmaker has asserted, according to a company-funded study.
the 23 confirmed heart attacks, strokes, deaths and other complications caused by blood clots in the people studied, 16 occurred in patients taking Vioxx or within two weeks of stopping the drug. Patients were followed for a median of 7.4 months, contradicting Merck's assertion that risk develops only after patients take Vioxx for 18 months.
The study bolsters plaintiff lawyers' arguments that Vioxx threatened consumers' health immediately, said Rick Meadow, a New York-based lawyer who represents former Vioxx users.
``The study confirms that Merck's 18-month theory was just public relations spin,'' Meadow said.
More at Bloomberg
the 23 confirmed heart attacks, strokes, deaths and other complications caused by blood clots in the people studied, 16 occurred in patients taking Vioxx or within two weeks of stopping the drug. Patients were followed for a median of 7.4 months, contradicting Merck's assertion that risk develops only after patients take Vioxx for 18 months.
The study bolsters plaintiff lawyers' arguments that Vioxx threatened consumers' health immediately, said Rick Meadow, a New York-based lawyer who represents former Vioxx users.
``The study confirms that Merck's 18-month theory was just public relations spin,'' Meadow said.
More at Bloomberg
Wednesday, July 25, 2007
Aspreva cuts
British Columbia-based Aspreva said Wednesday it will cut 33 jobs, or 25 percent of its workers, and replace its chief scientific officer as part of a restructuring plan.
The responsibilities of Dr. Richard Jones, who is leaving the company, will be assumed by Dr. Usman Azam, the company's chief medical officer. The move comes after a June announcement that an experimental lupus drug in a late-stage trial failed to meet objectives.
Source
The responsibilities of Dr. Richard Jones, who is leaving the company, will be assumed by Dr. Usman Azam, the company's chief medical officer. The move comes after a June announcement that an experimental lupus drug in a late-stage trial failed to meet objectives.
Source
Pfizer - Exubera: Oh Dear!
When Pfizer introduced Exubera, the first ever inhalable insulin product for people with diabetes, the New York-based drug giant estimated it would be a $2 billion-a-year blockbuster.
On July 18, a full year after launching Exubera, Pfizer disclosed the product's quarterly sales for the first time: An anemic $4 million.
Now the company has debuted a massive DTC ad campaign that some on Wall Street are calling a Hail Mary pass to jump-start Exubera sales.
BusinessWeek
On July 18, a full year after launching Exubera, Pfizer disclosed the product's quarterly sales for the first time: An anemic $4 million.
Now the company has debuted a massive DTC ad campaign that some on Wall Street are calling a Hail Mary pass to jump-start Exubera sales.
BusinessWeek
GSK - Avandia: the £100 million hole
GlaxoSmithKline is expected by analysts to report a fall in revenue of more than £100 million after a collapse in sales of Avandia, its diabetes medicine, which has been linked to an increased risk of heart attacks and strokes.
Britain’s biggest drugmaker is due to unveil its interim results tomorrow, its first quarterly figures since a controversial study by leading cardiologists claimed that the drug raised the risk of heart attack by 43 per cent.
More at The Times
Britain’s biggest drugmaker is due to unveil its interim results tomorrow, its first quarterly figures since a controversial study by leading cardiologists claimed that the drug raised the risk of heart attack by 43 per cent.
More at The Times
Tuesday, July 24, 2007
Wyeth - Pristiq: more depression
Wyeth shares dropped Tuesday after the company said the Food and Drug Administration did not approve its drug Pristiq as a treatment for night sweats and hot flashes associated with menopause.
The FDA sent Wyeth an approvable letter, saying it wants more data about the drug's side effects, which include cardiovascular problems. The agency said Wyeth should hold a clinical trial lasting as least one year to provide that data.
Wyeth said it will work with the FDA to provide the data, and said it plans to keep developing the drug.
Goldman Sachs analyst James Kelly said it may not make sense for Wyeth to keep developing Pristiq, as it will file a new drug application for a "better" drug, Aprela, that treats the same ailments later this year.
Aprela contains hormone therapy, Kelly said, and as a result it is probably more effective than Pristiq, which does not.
More at BusinessWeek
The FDA sent Wyeth an approvable letter, saying it wants more data about the drug's side effects, which include cardiovascular problems. The agency said Wyeth should hold a clinical trial lasting as least one year to provide that data.
Wyeth said it will work with the FDA to provide the data, and said it plans to keep developing the drug.
Goldman Sachs analyst James Kelly said it may not make sense for Wyeth to keep developing Pristiq, as it will file a new drug application for a "better" drug, Aprela, that treats the same ailments later this year.
Aprela contains hormone therapy, Kelly said, and as a result it is probably more effective than Pristiq, which does not.
More at BusinessWeek
Monday, July 23, 2007
Pfizer - forget Viva Zyprexa...... here comes Viva Viagra!
Thank you very much!
Pfizer is singing a new tune when it comes to reviving sales of its impotence pill Viagra.
Pfizer will begin airing new TV ads today that feature a band of men in their 40s and 50s singing ``Viva Viagra'' to the tune of Elvis Presley's ``Viva Las Vegas.'' The first ad, an attempt to make men less embarrassed about the disorder, will run during the NBC Nightly News, the company said.
More at Bloomberg
Novartis - all hail King Joerg?
Novartis chief executive Daniel Vasella might propose current Vaccines & Diagnostics chief executive Joerg Reinhardt as his successor, according to an article in Swiss weekly SonntagsZeitung.
With shrinking margins and pressure on its stock price, Novartis could use the breath of fresh air inspired by the naming of a new chief executive, said the report.
Vasella has in the past been criticised over his dual mandate as chairman and CEO.
Source
With shrinking margins and pressure on its stock price, Novartis could use the breath of fresh air inspired by the naming of a new chief executive, said the report.
Vasella has in the past been criticised over his dual mandate as chairman and CEO.
Source
Saturday, July 21, 2007
Purdue - OxyContin: make the punishment fit the crime
"My object all sublime. I shall achieve in time. To make the punishment fit the crime. The punishment fit the crime."
http://www.youtube.com/watch?v=JN59F77n6mo
Three of pharmaceutical giant Purdue Pharma's top current and former executives skirted a prison sentence in federal court today, winding up instead with three years probation and 400 hours of community service to serve instead.
Federal Judge James P. Jones ordered the maker of the prescription painkiller OxyContin and the three executives to pay a $634.5 million fine for misleading doctors about the narcotic's risk of addiction. The company had touted the drug as less addictive than more traditional narcotics, despite the fact that the pill can easily be crushed and converted into a powerful street drug.
Michael Friedman, who retired last month as the Connecticut-based company's president, lawyer Howard Udell and former chief medical officer Dr. Paul Goldenheim had pleaded guilty in May, in return for accepting the fine.
The surprise from today's ruling was the inclusion of the community service penalty — each man will have to serve his 400 hours working in drug abuse prevention or treatment, which would amount two and a half months of 40-hour work weeks spent fulfilling the sentence.
But the big question inside and outside the courthouse today was, does the punishment fit the crime?
Read the "Hillbilly Heroin" stories:
More at Time
Friday, July 20, 2007
Sanofi Aventis - Acomplia: fat but happy only
European drug regulators recommended that Acomplia, an antiobesity pill from French drug maker Sanofi-Aventis, shouldn't be prescribed for patients with depression or taking antidepressants.
The European Medicines Agency stopped short of suspending the drug but said Thursday that it should carry more stringent warnings to reflect the danger of potential psychiatric side effects.
The warning comes a month after a regulatory panel for the U.S. Food and Drug Administration rejected an application from Sanofi-Aventis to market the drug in the U.S. due to its possible side effects.
The European agency said it was upgrading an existing warning to European Union doctors. Acomplia, which is generically known as rimonabant and is marketed in the U.S. as Zimulti, was authorized for use in Europe in 2006.
Following a study, a European Medicines Agency committee "concluded that the benefits of Acomplia continue to outweigh its risks, except in patients with ongoing major depression or taking antidepressants," the agency said.
WSJ
The European Medicines Agency stopped short of suspending the drug but said Thursday that it should carry more stringent warnings to reflect the danger of potential psychiatric side effects.
The warning comes a month after a regulatory panel for the U.S. Food and Drug Administration rejected an application from Sanofi-Aventis to market the drug in the U.S. due to its possible side effects.
The European agency said it was upgrading an existing warning to European Union doctors. Acomplia, which is generically known as rimonabant and is marketed in the U.S. as Zimulti, was authorized for use in Europe in 2006.
Following a study, a European Medicines Agency committee "concluded that the benefits of Acomplia continue to outweigh its risks, except in patients with ongoing major depression or taking antidepressants," the agency said.
WSJ
Pfizer - Lois Baumerich RIP
A Pfizer human resources executive, Lois Baumerich, died of a heart attack she suffered when a steam pipe exploded in Midtown Manhattan on Wednesday, July 18.
Baumerich’s death was the lone fatality of the explosion, which sent tens of thousands of workers scrambling for safety at the height of the evening rush hour.
Minutes before the explosion, Baumerich, who was director of employment compliance at Pfizer, was on the phone planning an upcoming conference in New York for the National Industry Liaison Group, an organization promoting workplace equality, according to press reports.
Baumerich, who was 51 and lived by herself in New Jersey, was a board member. She helped found the group, according to its Web site.
Baumerich worked for 28 years at AT&T before retiring in January, a spokesman for the company wrote in an e-mail.
Baumerich’s death was the lone fatality of the explosion, which sent tens of thousands of workers scrambling for safety at the height of the evening rush hour.
Minutes before the explosion, Baumerich, who was director of employment compliance at Pfizer, was on the phone planning an upcoming conference in New York for the National Industry Liaison Group, an organization promoting workplace equality, according to press reports.
Baumerich, who was 51 and lived by herself in New Jersey, was a board member. She helped found the group, according to its Web site.
Baumerich worked for 28 years at AT&T before retiring in January, a spokesman for the company wrote in an e-mail.
Merck - Vioxx: the bad smell that just wont go away
Shareholders who saw billions wiped off the value of the drugmaker Merck when it withdrew its painkiller Vioxx in 2004 have been given new hope of compensation, following an appeal court ruling in New Jersey.
A three-judge panel ruled that a group of shareholder lawsuits should be sent back to the federal court which dismissed them last year, reviving a significant legal headache for Merck.
The company already faces more than 28,000 lawsuits from patients who say Vioxx caused them or their loved ones to suffer a heart attack, and that Merck managers covered up the risks for years before finally taking the pill off the market. In September 2004, it bowed to evidence from a large-scale clinical study which showed that Vioxx significantly increased the risks of heart attacks and strokes.
The plaintiffs in the shareholder suits say that, if managers had heeded earlier warning signs, they would not have opened the company up to expensive litigation and the share price may not have collapsed. The withdrawal of Vioxx eliminated $2.5bn in annual sales.
Plaintiffs' attorney Darren Robbins praised the appeal court ruling. "The decision is a tremendous victory for Merck shareholders who were victimised by company insiders in connection with the Vioxx debacle," he said. "We look forward to returning to the district court to prosecute the cover-up of one of the most egregious drug scandals in recent memory."
More
A three-judge panel ruled that a group of shareholder lawsuits should be sent back to the federal court which dismissed them last year, reviving a significant legal headache for Merck.
The company already faces more than 28,000 lawsuits from patients who say Vioxx caused them or their loved ones to suffer a heart attack, and that Merck managers covered up the risks for years before finally taking the pill off the market. In September 2004, it bowed to evidence from a large-scale clinical study which showed that Vioxx significantly increased the risks of heart attacks and strokes.
The plaintiffs in the shareholder suits say that, if managers had heeded earlier warning signs, they would not have opened the company up to expensive litigation and the share price may not have collapsed. The withdrawal of Vioxx eliminated $2.5bn in annual sales.
Plaintiffs' attorney Darren Robbins praised the appeal court ruling. "The decision is a tremendous victory for Merck shareholders who were victimised by company insiders in connection with the Vioxx debacle," he said. "We look forward to returning to the district court to prosecute the cover-up of one of the most egregious drug scandals in recent memory."
More
Thursday, July 19, 2007
Roche - all hail King Severin
Roche announced that Severin Schwan, currently CEO of Roche Diagnostics, will succeed Franz Humer as chief executive at the pharma group's next AGM on March 4, 2008.
Severin's CV:
Studies
Economics at University of Innsbruck, University of York and University of Oxford
Mag. rer.soc.oec. (Innsbruck, 1991)
Law at University of Innsbruck
Mag. iur. (Innsbruck, 1991)Doctorate in Law at University of Innsbruck
Research studies at University Louvain, Belgium
Dr. iur. (Innsbruck, 1993)
Professional Career
1993 - 1995:
Trainee at Corporate Finance, Roche Basel
1995 - 1998:
Head Finance & Administration, Roche Brussels
1998 - 2000:
Head Finance & Informatics at Roche Grenzach, Germany and Member of the Executive Board of Roche Deutschland Holding GmbH
2000 - 2004:
Head Global Finance & Services, Roche Diagnostics, Basel
2004 - 2006:
Head Region Asia Pacific, Roche Diagnostics Singapur
since 2006:
Chief Executive Officer Division Roche Diagnostics
Humer will focus on his role as chairman of Roche, the company said. Severin Schwan's successor as CEO of Roche Diagnostics will be announced in due course, it said.
Source
SiCKO spreads
Thursday, July 19th, 2007
Friends,
Good news! "Sicko," after less than three weeks in national release, has become one of the top five grossing documentaries of all time! So, this coming weekend, the distributor is expanding the movie by opening it in nearly 500 new theaters in small cities all over the country (for a total of nearly 1,200 screens nationwide)! From Rapid City to Carson City, from Gettysburg to Pearl Harbor, from Juneau to Battle Creek -- they're all getting "Sicko" tomorrow (Friday).
Scores of cities that never have a documentary come to their local theater will now be able to see this one. It's happening all thanks to you who live in the larger cities and have supported "Sicko" so strongly. It's led the studio to say, "Let's make more prints and ship them to Oshkosh (and Beaverton and Brattleboro and Sault Ste. Marie and...)." The entire country goes "Sicko" in less than 48 hours! (Check here for the complete list of theaters showing "Sicko" in North America.)
So, friends, this is it. This is the weekend to go see "Sicko" if you haven't seen it. I get a lot of letters from people saying they plan to "get around" to seeing it "soon."
Well, soon is here!
Trying to get theaters to give us screens when we are up against huge summer blockbusters is an almost impossible task. "Sicko" won't be around forever. And if you're waiting for the DVD, ask anyone who's seen "Sicko" -- this is a movie you want to see with a crowd of people in a theater.
So let's pack the movie houses this weekend! Send an email to everyone you know, call your friends and tell them, "It's 'Sicko' Night in America!"
And, to show my thanks to all of you who'll go see "Sicko" this weekend, I'm going to send one of you and a guest on a free weekend to the universal health care country of your choice!
That's right. You'll get to pick one of the three industrialized countries featured in the movie where, if you get sick, you get help for free, no matter who you are. All you have to do is send us your ticket stub (make sure it says "Sicko" on it and has the name of the theater and this weekend's date on it -- Friday, Saturday or Sunday - July 20th, 21st, 22nd).
Attach the stub to a piece of paper with your name, address, phone number and email and send it to: 'Sicko' Night in America, 888c 8th Avenue, Suite 443, New York, NY 10019. (Yes, you have to use that old 18th century device called the U.S. Postal Service, and it has to be postmarked on or by Tuesday, July 24th).
First prize is a weekend in the city of your choice: Paris, London or Toronto.
This includes airfare, hotel, meals and, most exciting, a representative from their fine universal health care system who will give you a personal tour so you can see how they treat their fellow citizens. You'll meet people who pay nothing for college and citizens who are in the fourth week of their six-week paid vacation. Oh, and you'll have time to see the Eiffel Tower, Big Ben or whatever they have in Toronto that is old and tall. (If you don't have a passport, we'll pay for that, too!)
Canadians who are reading this -- you're probably thinking, "Hey, what about us? Where do we get to go?" Quit complaining! You're already there! But just to make it up to you -- and to prove we don't hold it against you for smugly walking out of a hospital with the same amount of money in your wallet that you went in with -- we'll let you participate in the drawing, too.
Thanks again to everyone who has gone to see "Sicko." Take a friend or two this weekend and celebrate "'Sicko' Night in America."
Yours,
Michael Moore
mmflint@aol.com
www.michaelmoore.com
P.S. I'll be on "The Colbert Report" tonight (Thursday) on Comedy Central. On a sadder note, my appearance on CNN with Wolf Blitzer has been moved to a later date. Wolf just called to say he had a death in his family and that we would have to re-schedule. Our condolences to him and his family.
Friends,
Good news! "Sicko," after less than three weeks in national release, has become one of the top five grossing documentaries of all time! So, this coming weekend, the distributor is expanding the movie by opening it in nearly 500 new theaters in small cities all over the country (for a total of nearly 1,200 screens nationwide)! From Rapid City to Carson City, from Gettysburg to Pearl Harbor, from Juneau to Battle Creek -- they're all getting "Sicko" tomorrow (Friday).
Scores of cities that never have a documentary come to their local theater will now be able to see this one. It's happening all thanks to you who live in the larger cities and have supported "Sicko" so strongly. It's led the studio to say, "Let's make more prints and ship them to Oshkosh (and Beaverton and Brattleboro and Sault Ste. Marie and...)." The entire country goes "Sicko" in less than 48 hours! (Check here for the complete list of theaters showing "Sicko" in North America.)
So, friends, this is it. This is the weekend to go see "Sicko" if you haven't seen it. I get a lot of letters from people saying they plan to "get around" to seeing it "soon."
Well, soon is here!
Trying to get theaters to give us screens when we are up against huge summer blockbusters is an almost impossible task. "Sicko" won't be around forever. And if you're waiting for the DVD, ask anyone who's seen "Sicko" -- this is a movie you want to see with a crowd of people in a theater.
So let's pack the movie houses this weekend! Send an email to everyone you know, call your friends and tell them, "It's 'Sicko' Night in America!"
And, to show my thanks to all of you who'll go see "Sicko" this weekend, I'm going to send one of you and a guest on a free weekend to the universal health care country of your choice!
That's right. You'll get to pick one of the three industrialized countries featured in the movie where, if you get sick, you get help for free, no matter who you are. All you have to do is send us your ticket stub (make sure it says "Sicko" on it and has the name of the theater and this weekend's date on it -- Friday, Saturday or Sunday - July 20th, 21st, 22nd).
Attach the stub to a piece of paper with your name, address, phone number and email and send it to: 'Sicko' Night in America, 888c 8th Avenue, Suite 443, New York, NY 10019. (Yes, you have to use that old 18th century device called the U.S. Postal Service, and it has to be postmarked on or by Tuesday, July 24th).
First prize is a weekend in the city of your choice: Paris, London or Toronto.
This includes airfare, hotel, meals and, most exciting, a representative from their fine universal health care system who will give you a personal tour so you can see how they treat their fellow citizens. You'll meet people who pay nothing for college and citizens who are in the fourth week of their six-week paid vacation. Oh, and you'll have time to see the Eiffel Tower, Big Ben or whatever they have in Toronto that is old and tall. (If you don't have a passport, we'll pay for that, too!)
Canadians who are reading this -- you're probably thinking, "Hey, what about us? Where do we get to go?" Quit complaining! You're already there! But just to make it up to you -- and to prove we don't hold it against you for smugly walking out of a hospital with the same amount of money in your wallet that you went in with -- we'll let you participate in the drawing, too.
Thanks again to everyone who has gone to see "Sicko." Take a friend or two this weekend and celebrate "'Sicko' Night in America."
Yours,
Michael Moore
mmflint@aol.com
www.michaelmoore.com
P.S. I'll be on "The Colbert Report" tonight (Thursday) on Comedy Central. On a sadder note, my appearance on CNN with Wolf Blitzer has been moved to a later date. Wolf just called to say he had a death in his family and that we would have to re-schedule. Our condolences to him and his family.
Wednesday, July 18, 2007
Pfizer misses
Pfizer on Wednesday reported lower-than-expected quarterly earnings on competition with generics, and said global sales of cholesterol fighter Lipitor fell 13 percent amid slipping demand for the company's flagship product.
Reuters
Reuters
Tuesday, July 17, 2007
Moore back on CNN
July 17th, 2007
Friends,
The mighty CNN, in a lengthy and sad online defense of their woe-begotten 'Sicko' story of last Monday, has admitted that they did indeed fudge at least two of the facts in their coverage of my film and have apologized for it:
1. Dr. Sanjay Gupta, CNN: "To be clear, I got a number wrong in my original report, substituting the number 25, instead of 251." -- My Conversation with Michael Moore, July 11th, 2007;
and
2. CNN: "Moore is correct. Paul Keckley left Vanderbilt in late 2006." -- CNN's Response to Michael Moore, July 15th, 2007.
Furthermore, CNN confirmed that all of our statistics in "Sicko" are the correct numbers from the sources we cited. Although CNN still prefers to use older World Health Organization statistics, we will stick to using this year's Bush administration stats and more recent U.N. data. (In "Sicko," we consistently use only U.N. Human Development Statistics unless it's for studies they don't do or have recent numbers for.) CNN did apologize for these two factual errors, but no apology seems to be coming for the rest of their errors.
These days, to get the mainstream media to admit they were wrong is rare; to get them to admit it twice, as they have with "Sicko," I guess should be considered a whopping victory. Will they eventually apologize for the rest, or for their reporting on the war? Will the Cubs win the World Series this year?
So the truce has been signed, the peace pipe has been smoked. And the public is left with a much more cautious and wary eye when it comes to CNN. To be fair, this is what happens when you have to grind out "news" 24 hours a day, seven days a week, with a staff you have shrunk through layoffs over the years (like all the broadcast networks have done). You end up rushed and having interns do your research. You have robots replace live camera operators. And, if you're CNN, you are constantly dodging the accusation that you are "too liberal." So when you do a piece on someone like me, you have to make sure you add superfluous and standard ad hominems attacking me simply to prove that you are NOT too liberal. I get it.
Until the last month or so, I have not appeared on a single national TV show for nearly 2 and 1/2 years. After the attacks I had to endure three years ago, from a media intent on questioning my patriotism because I dared to speak out against the war when none in the media would, I decided I had had enough and would simply concentrate on making my next film. I had no desire to participate in networks that were complicit in the war because of their refusal the challenge the commander in chief.
I have to admit, though, I do feel kinda bad taking it all out on Wolf Blitzer. It's not like he's the official representative of the mainstream media. I mean, he's from Buffalo, for crying out loud! He said to me at the end of the show last week to please come back on "anytime you want." I will take him up on that offer and appear again with him tomorrow (Wednesday). I'm not expecting a dozen roses or make-up sex -- I only want a promise that there will be no more distorted distractions so we can have a decent discussion about the REAL issues like why 18,000 Americans die every year because they don't have a health insurance card. More than 300 of them died this week. As Ehrlichman said to Nixon in "Sicko": "The less care they give 'em, the more money they (the insurance companies) make."
THAT'S the only thing we should be talking about. How profit and greed are killing our fellow Americans. How profit and private insurance have to be removed from our health care system. CNN should join me in asking why our 9/11 rescue workers aren't receiving medical care. Somebody should send a crew to Canada to find out why they live longer than we do, and why no Canadian has ever gone bankrupt because of medical bills. And all of the media should start saying how much it costs to go to a doctor in these other top industrialized countries: Nothing. Zip. It's FREE. Don't patronize Americans by saying, "Well, it's not free -- they pay for it with taxes!"
Yes, we know that. Just like we know that we drive down a city street for FREE -- even though we paid for that street with our taxes. The street is FREE, the book at the library is FREE, if your house catches on fire, the fire department will come and put it out for FREE, and if someone snatches your purse, the police officer will chase down the culprit and bring your purse back to you -- AND HE WON'T CHARGE YOU A DIME FROM THAT PURSE!
These are all free services, collectively socialized and paid for with our tax dollars. To argue that health care -- a life and death issue for many -- should not be considered in the same league is ludicrous and archaic. And trust me, once you add up what you pay for out-of-pocket in premiums, deductibles, co-pays, overpriced medicines, and treatments that aren't covered (not to mention all the other things we pay for like college education, day care and other services that many countries provide for at little or no cost), we, as Americans, are paying far more than the Canadians or Brits or French are paying in taxes. We just don't call these things taxes, but that's exactly what they are.
See you all when I'm back on CNN tomorrow -- where the discussion will be not be about whose statistics are right, but rather about the guy without insurance who died while I was writing this letter.
Yours,
Michael Moore
mmflint@aol.com
www.michaelmoore.com
P.S. Oh... I forgot to tell you about Paris Hilton. Apparently cooped up for too long at home since getting out of jail, she decided to head out for a night on the town. But where does she go? Clubbing? Cruising down the Strip? No! She and her sister decide to go see "Sicko." Now THAT'S news! So, no more bad words about Paris Hilton!
Friends,
The mighty CNN, in a lengthy and sad online defense of their woe-begotten 'Sicko' story of last Monday, has admitted that they did indeed fudge at least two of the facts in their coverage of my film and have apologized for it:
1. Dr. Sanjay Gupta, CNN: "To be clear, I got a number wrong in my original report, substituting the number 25, instead of 251." -- My Conversation with Michael Moore, July 11th, 2007;
and
2. CNN: "Moore is correct. Paul Keckley left Vanderbilt in late 2006." -- CNN's Response to Michael Moore, July 15th, 2007.
Furthermore, CNN confirmed that all of our statistics in "Sicko" are the correct numbers from the sources we cited. Although CNN still prefers to use older World Health Organization statistics, we will stick to using this year's Bush administration stats and more recent U.N. data. (In "Sicko," we consistently use only U.N. Human Development Statistics unless it's for studies they don't do or have recent numbers for.) CNN did apologize for these two factual errors, but no apology seems to be coming for the rest of their errors.
These days, to get the mainstream media to admit they were wrong is rare; to get them to admit it twice, as they have with "Sicko," I guess should be considered a whopping victory. Will they eventually apologize for the rest, or for their reporting on the war? Will the Cubs win the World Series this year?
So the truce has been signed, the peace pipe has been smoked. And the public is left with a much more cautious and wary eye when it comes to CNN. To be fair, this is what happens when you have to grind out "news" 24 hours a day, seven days a week, with a staff you have shrunk through layoffs over the years (like all the broadcast networks have done). You end up rushed and having interns do your research. You have robots replace live camera operators. And, if you're CNN, you are constantly dodging the accusation that you are "too liberal." So when you do a piece on someone like me, you have to make sure you add superfluous and standard ad hominems attacking me simply to prove that you are NOT too liberal. I get it.
Until the last month or so, I have not appeared on a single national TV show for nearly 2 and 1/2 years. After the attacks I had to endure three years ago, from a media intent on questioning my patriotism because I dared to speak out against the war when none in the media would, I decided I had had enough and would simply concentrate on making my next film. I had no desire to participate in networks that were complicit in the war because of their refusal the challenge the commander in chief.
I have to admit, though, I do feel kinda bad taking it all out on Wolf Blitzer. It's not like he's the official representative of the mainstream media. I mean, he's from Buffalo, for crying out loud! He said to me at the end of the show last week to please come back on "anytime you want." I will take him up on that offer and appear again with him tomorrow (Wednesday). I'm not expecting a dozen roses or make-up sex -- I only want a promise that there will be no more distorted distractions so we can have a decent discussion about the REAL issues like why 18,000 Americans die every year because they don't have a health insurance card. More than 300 of them died this week. As Ehrlichman said to Nixon in "Sicko": "The less care they give 'em, the more money they (the insurance companies) make."
THAT'S the only thing we should be talking about. How profit and greed are killing our fellow Americans. How profit and private insurance have to be removed from our health care system. CNN should join me in asking why our 9/11 rescue workers aren't receiving medical care. Somebody should send a crew to Canada to find out why they live longer than we do, and why no Canadian has ever gone bankrupt because of medical bills. And all of the media should start saying how much it costs to go to a doctor in these other top industrialized countries: Nothing. Zip. It's FREE. Don't patronize Americans by saying, "Well, it's not free -- they pay for it with taxes!"
Yes, we know that. Just like we know that we drive down a city street for FREE -- even though we paid for that street with our taxes. The street is FREE, the book at the library is FREE, if your house catches on fire, the fire department will come and put it out for FREE, and if someone snatches your purse, the police officer will chase down the culprit and bring your purse back to you -- AND HE WON'T CHARGE YOU A DIME FROM THAT PURSE!
These are all free services, collectively socialized and paid for with our tax dollars. To argue that health care -- a life and death issue for many -- should not be considered in the same league is ludicrous and archaic. And trust me, once you add up what you pay for out-of-pocket in premiums, deductibles, co-pays, overpriced medicines, and treatments that aren't covered (not to mention all the other things we pay for like college education, day care and other services that many countries provide for at little or no cost), we, as Americans, are paying far more than the Canadians or Brits or French are paying in taxes. We just don't call these things taxes, but that's exactly what they are.
See you all when I'm back on CNN tomorrow -- where the discussion will be not be about whose statistics are right, but rather about the guy without insurance who died while I was writing this letter.
Yours,
Michael Moore
mmflint@aol.com
www.michaelmoore.com
P.S. Oh... I forgot to tell you about Paris Hilton. Apparently cooped up for too long at home since getting out of jail, she decided to head out for a night on the town. But where does she go? Clubbing? Cruising down the Strip? No! She and her sister decide to go see "Sicko." Now THAT'S news! So, no more bad words about Paris Hilton!
Novartis - triple trouble
Novartis this morning cut its full-year sales forecasts saying that generic competition in the USA will affect the second half performance of its blood-pressure-lowering drug Lotrel (almodipine/benazepril) and the antifungal Lamisal (terbinafine), while it also expects to see some fallout following the market withdrawal of the irritable bowel syndrome drug Zelnorm (tegaserod) after it was linked to possible heart attacks and strokes.
The three products combined reeled in 2006 sales of $2.5 billion.
The three products combined reeled in 2006 sales of $2.5 billion.
Monday, July 16, 2007
GSK - Avandia: conflicts of interest
Six doctors with financial ties to the pharmaceutical industry, including stock holdings or speaking fees, will be among members of a U.S. advisory panel on the use of a GlaxoSmithKline diabetes medicine linked to heart risks.
The doctors will discuss the safety of the drug, Avandia, and similar treatments at a July 30 meeting convened by the Food and Drug Administration. As many as four of the six doctors with conflicts may vote on recommendations to the FDA, according to financial disclosure documents released by the agency. The agency wouldn't say how many members the committee will have.
The FDA lets too many doctors with financial conflicts serve as advisers, lawmakers and consumer advocates say. Panelists with industry ties have backed drugs including Vioxx, the Merck & Co. painkiller that was withdrawn in 2004 after being linked to heart attacks and strokes. Legislation approved by the House last week would permit only one person with a financial conflict to vote on drug recommendations.
``They shouldn't appoint people with conflicts of interest,'' said Merrill Goozner, director of the Integrity in Science project at the Washington-based Center for Science in Public Interest, in an interview. ``The public perception of the evenhandedness of the process will be immeasurably enhanced if they appoint only people who do not have conflicts.''
More
The doctors will discuss the safety of the drug, Avandia, and similar treatments at a July 30 meeting convened by the Food and Drug Administration. As many as four of the six doctors with conflicts may vote on recommendations to the FDA, according to financial disclosure documents released by the agency. The agency wouldn't say how many members the committee will have.
The FDA lets too many doctors with financial conflicts serve as advisers, lawmakers and consumer advocates say. Panelists with industry ties have backed drugs including Vioxx, the Merck & Co. painkiller that was withdrawn in 2004 after being linked to heart attacks and strokes. Legislation approved by the House last week would permit only one person with a financial conflict to vote on drug recommendations.
``They shouldn't appoint people with conflicts of interest,'' said Merrill Goozner, director of the Integrity in Science project at the Washington-based Center for Science in Public Interest, in an interview. ``The public perception of the evenhandedness of the process will be immeasurably enhanced if they appoint only people who do not have conflicts.''
More
Sanofi Aventis - Acomplia: depression forming across Europe
Sanofi-Aventis's obesity pill Acomplia faces a tough review from European drug safety experts this week, with data suggesting officials see issues over the drug's link with suicidal thoughts.
The European Medicines Agency (EMEA) safety assessment comes a month after a U.S. advisory panel recommended the drug should not be approved in the world's biggest market because it may increase depression and suicidal thinking.
That decision prompted France's Sanofi to withdraw its pending application to sell the medicine in the United States, dealing a major blow to what had been its biggest new drug hope.
In Europe, by contrast, Acomplia -- which is also known by the brand name Zimulti and generically as rimonabant -- has been on sale since last year.
Most industry analysts expect European officials to allow it to stay on the market but with stricter warnings that will limit its commercial potential. Acomplia use is already limited to patients with no history of major depression.
The EMEA's Committee for Medicinal Products for Human Use (CHMP) convened in London on Monday and is due to announce its decision on Thursday. It has a range of options available.
"They will recommend whatever they think is appropriate. It ranges from nothing to new warnings or other restrictions or contra-indications to suspension or withdrawal," an agency spokeswoman said.
Doing nothing seems unlikely.
More from Ben Hirschler at Reuters
The European Medicines Agency (EMEA) safety assessment comes a month after a U.S. advisory panel recommended the drug should not be approved in the world's biggest market because it may increase depression and suicidal thinking.
That decision prompted France's Sanofi to withdraw its pending application to sell the medicine in the United States, dealing a major blow to what had been its biggest new drug hope.
In Europe, by contrast, Acomplia -- which is also known by the brand name Zimulti and generically as rimonabant -- has been on sale since last year.
Most industry analysts expect European officials to allow it to stay on the market but with stricter warnings that will limit its commercial potential. Acomplia use is already limited to patients with no history of major depression.
The EMEA's Committee for Medicinal Products for Human Use (CHMP) convened in London on Monday and is due to announce its decision on Thursday. It has a range of options available.
"They will recommend whatever they think is appropriate. It ranges from nothing to new warnings or other restrictions or contra-indications to suspension or withdrawal," an agency spokeswoman said.
Doing nothing seems unlikely.
More from Ben Hirschler at Reuters
Sunday, July 15, 2007
Fair and balanced
You want balance? Balance this: The right of corporations to profit from illness against the right of every person to decent health care.
Source
Source
Payday!
Thieves have stolen nearly $300 million from a bank in Baghdad, police and a bank official said Thursday, in what is probably one of the biggest thefts in Iraq since the 2003 war to topple Saddam Hussein.
Police said the thieves were three guards who worked at the private Dar Es Salaam bank in Baghdad's Karrada district.
They said that when bank employees arrived for work on Wednesday they found the front door open and the money gone. The guards, who normally slept at the bank, had also disappeared, they said.
Reuters
Police said the thieves were three guards who worked at the private Dar Es Salaam bank in Baghdad's Karrada district.
They said that when bank employees arrived for work on Wednesday they found the front door open and the money gone. The guards, who normally slept at the bank, had also disappeared, they said.
Reuters
Saturday, July 14, 2007
SiCKO - Moore writes to CNN
An Open Letter to CNN from Michael Moore
7/14/07
Dear CNN,
Well, the week is over -- and still no apology, no retraction, no correction of your glaring mistakes.
I bet you thought my dust-up with Wolf Blitzer was just a cool ratings coup, that you really wouldn't have to correct the false statements you made about "Sicko." I bet you thought I was just going to go quietly away.
Think again. I'm about to become your worst nightmare. 'Cause I ain't ever going away. Not until you set the record straight, and apologize to your viewers. "The Most Trusted Name in News?" I think it's safe to say you can retire that slogan.
You have an occasional segment called "Keeping Them Honest." But who keeps you honest? After what the public saw with your report on "Sicko," and how many inaccuracies that report contained, how can anyone believe anything you say on your network? In the old days, before the Internet, you could get away with it. Your victims had no way to set the record straight, to show the viewers how you had misrepresented the truth. But now, we can post the truth -- and back it up with evidence and facts -- on the web, for all to see. And boy, judging from the mail both you and I have been receiving, the evidence I have posted on my site about your "Sicko" piece has led millions now to question your honesty.
I won't waste your time rehashing your errors. You know what they are.
What I want to do is help you come clean. Admit you were wrong. What is the shame in that? We all make mistakes. I know it's hard to admit it when you've screwed up, but it's also liberating and cathartic. It not only makes you a better person, it helps prevent you from screwing up again. Imagine how many people will be drawn to a network that says, "We made a mistake. We're human. We're sorry. We will make mistakes in the future -- but we will always correct them so that you know you can trust us." Now, how hard would that really be?
As you know, I hold no personal animosity against you or any of your staff. You and your parent company have been very good to me over the years. You distributed my first film, "Roger & Me" and you published "Dude, Where's My Country?" Larry King has had me on twice in the last two weeks. I couldn't ask for better treatment.
That's why I was so stunned when you let a doctor who knows a lot about brain surgery -- but apparently very little about public policy -- do a "fact check" story, not on the medical issues in "Sicko," but rather on the economic and political information in the film. Is this why there has been a delay in your apology, because you are trying to get a DOCTOR to say he was wrong?
Please tell him not to worry, no one is filing a malpractice claim against him. Dr. Gupta does excellent and compassionate stories on CNN about people's health and how we can take better care of ourselves. But when it came time to discuss universal health care, he rushed together a bunch of sloppy -- and old -- research. When his producer called us about his report the day before it aired, we sent to her, in an email, all the evidence so that he wouldn't make any mistakes on air. He chose to ignore ALL the evidence, and ran with all his falsehoods -- even though he had been given the facts a full day before! How could that happen? And now, for 5 days, I have posted on my website, for all to see, every mistake and error he made.
You, on the other hand, in the face of this overwhelming evidence and a huge public backlash, have chosen to remain silent, probably praying and hoping this will all go away.
Well it isn't. We are now going to start looking into the veracity of other reports you have aired on other topics. Nothing you say now can be believed. In 2002, the New York Times busted you for bringing celebrities on your shows and not telling your viewers they were paid spokespeople for the pharmaceutical companies. You promised never to do it again. But there you were, in 2005, talking to Joe Theismann, on air, as he pushed some drug company-sponsored website on prostate health. You said nothing about about his affiliation with GlaxoSmithKline.
Clearly, no one is keeping you honest, so I guess I'm going to have to do that job, too. $1.5 billion is spent each year by the drug companies on ads on CNN and the other four networks. I'm sure that has nothing to do with any of this. After all, if someone gave me $1.5 billion, I have to admit, I might say a kind word or two about them. Who wouldn't?!
I expect CNN to put this matter to rest. Say you're sorry and correct your story -- like any good journalist would.
Then we can get back to more important things. Like a REAL discussion about our broken health care system. Everything else is a distraction from what really matters.
Yours,
Michael Moore
mmflint@aol.com
www.michaelmoore.com
P.S. If you also want to apologize for not doing your job at the start of the Iraq War, I'm sure most Americans would be very happy to accept your apology. You and the other networks were willing partners with Bush, flying flags all over the TV screens and never asking the hard questions that you should have asked. You might have prevented a war. You might have saved the lives of those 3,610 soldiers who are no longer with us. Instead, you blew air kisses at a commander in chief who clearly was making it all up. Millions of us knew that -- why didn't you? I think you did. And, in my opinion, that makes you responsible for this war. Instead of doing the job the founding fathers wanted you to do -- keeping those in power honest (that's why they made it the FIRST amendment) -- you and much of the media went on the attack against the few public figures like myself who dared to question the nightmare we were about to enter.
You've never thanked me or the Dixie Chicks or Al Gore for doing your job for you. That's OK. Just tell the truth from this point on.
7/14/07
Dear CNN,
Well, the week is over -- and still no apology, no retraction, no correction of your glaring mistakes.
I bet you thought my dust-up with Wolf Blitzer was just a cool ratings coup, that you really wouldn't have to correct the false statements you made about "Sicko." I bet you thought I was just going to go quietly away.
Think again. I'm about to become your worst nightmare. 'Cause I ain't ever going away. Not until you set the record straight, and apologize to your viewers. "The Most Trusted Name in News?" I think it's safe to say you can retire that slogan.
You have an occasional segment called "Keeping Them Honest." But who keeps you honest? After what the public saw with your report on "Sicko," and how many inaccuracies that report contained, how can anyone believe anything you say on your network? In the old days, before the Internet, you could get away with it. Your victims had no way to set the record straight, to show the viewers how you had misrepresented the truth. But now, we can post the truth -- and back it up with evidence and facts -- on the web, for all to see. And boy, judging from the mail both you and I have been receiving, the evidence I have posted on my site about your "Sicko" piece has led millions now to question your honesty.
I won't waste your time rehashing your errors. You know what they are.
What I want to do is help you come clean. Admit you were wrong. What is the shame in that? We all make mistakes. I know it's hard to admit it when you've screwed up, but it's also liberating and cathartic. It not only makes you a better person, it helps prevent you from screwing up again. Imagine how many people will be drawn to a network that says, "We made a mistake. We're human. We're sorry. We will make mistakes in the future -- but we will always correct them so that you know you can trust us." Now, how hard would that really be?
As you know, I hold no personal animosity against you or any of your staff. You and your parent company have been very good to me over the years. You distributed my first film, "Roger & Me" and you published "Dude, Where's My Country?" Larry King has had me on twice in the last two weeks. I couldn't ask for better treatment.
That's why I was so stunned when you let a doctor who knows a lot about brain surgery -- but apparently very little about public policy -- do a "fact check" story, not on the medical issues in "Sicko," but rather on the economic and political information in the film. Is this why there has been a delay in your apology, because you are trying to get a DOCTOR to say he was wrong?
Please tell him not to worry, no one is filing a malpractice claim against him. Dr. Gupta does excellent and compassionate stories on CNN about people's health and how we can take better care of ourselves. But when it came time to discuss universal health care, he rushed together a bunch of sloppy -- and old -- research. When his producer called us about his report the day before it aired, we sent to her, in an email, all the evidence so that he wouldn't make any mistakes on air. He chose to ignore ALL the evidence, and ran with all his falsehoods -- even though he had been given the facts a full day before! How could that happen? And now, for 5 days, I have posted on my website, for all to see, every mistake and error he made.
You, on the other hand, in the face of this overwhelming evidence and a huge public backlash, have chosen to remain silent, probably praying and hoping this will all go away.
Well it isn't. We are now going to start looking into the veracity of other reports you have aired on other topics. Nothing you say now can be believed. In 2002, the New York Times busted you for bringing celebrities on your shows and not telling your viewers they were paid spokespeople for the pharmaceutical companies. You promised never to do it again. But there you were, in 2005, talking to Joe Theismann, on air, as he pushed some drug company-sponsored website on prostate health. You said nothing about about his affiliation with GlaxoSmithKline.
Clearly, no one is keeping you honest, so I guess I'm going to have to do that job, too. $1.5 billion is spent each year by the drug companies on ads on CNN and the other four networks. I'm sure that has nothing to do with any of this. After all, if someone gave me $1.5 billion, I have to admit, I might say a kind word or two about them. Who wouldn't?!
I expect CNN to put this matter to rest. Say you're sorry and correct your story -- like any good journalist would.
Then we can get back to more important things. Like a REAL discussion about our broken health care system. Everything else is a distraction from what really matters.
Yours,
Michael Moore
mmflint@aol.com
www.michaelmoore.com
P.S. If you also want to apologize for not doing your job at the start of the Iraq War, I'm sure most Americans would be very happy to accept your apology. You and the other networks were willing partners with Bush, flying flags all over the TV screens and never asking the hard questions that you should have asked. You might have prevented a war. You might have saved the lives of those 3,610 soldiers who are no longer with us. Instead, you blew air kisses at a commander in chief who clearly was making it all up. Millions of us knew that -- why didn't you? I think you did. And, in my opinion, that makes you responsible for this war. Instead of doing the job the founding fathers wanted you to do -- keeping those in power honest (that's why they made it the FIRST amendment) -- you and much of the media went on the attack against the few public figures like myself who dared to question the nightmare we were about to enter.
You've never thanked me or the Dixie Chicks or Al Gore for doing your job for you. That's OK. Just tell the truth from this point on.
Friday, July 13, 2007
Jazz cop a plea - ex-rep whistleblower gets payday
Jazz Pharmaceuticals has agreed to pay $20 million in penalties and victim compensation to resolve parallel criminal and civil investigations conducted by the United States Attorney's Office for the Eastern District of New York relating to the illegal marketing practices of its wholly-owned subsidiary Orphan Medical, Inc. (Orphan).
As part of this resolution, Orphan plead guilty this morning to felony misbranding, in violation of the Food, Drug, and Cosmetic Act in connection with its illegal promotion of the prescription medication Xyrem, also known as gamma-hydroxybutyrate or "GHB," for unapproved uses. GHB is a powerful and fast-acting central nervous system depressant that has been subject to abuse as a recreational drug and is classified by the Department of Health and Human Services (HHS) as a "date rape" drug. The guilty plea proceeding was held before United States District Judge Eric N. Vitaliano.
The criminal misbranding scheme induced physicians throughout the country to write prescriptions for Xyrem that were not reimbursable by private health insurers or public insurance programs like Medicare and Medicaid, and caused millions of dollars of losses to these insurers. Pursuant to a non- prosecution agreement with the United States, Jazz has agreed to guarantee Orphan's obligation to pay criminal restitution to public and private insurers of approximately $12.2 million and a criminal fine of $5 million, and to provide ongoing cooperation to the government in connection with its investigation and prosecution of the underlying illegal marketing scheme. Pursuant to the civil settlement agreement, Jazz and Orphan have agreed to resolve the government's civil False Claims Act claims by paying $3.75 million, plus interest. A portion of the restitution ordered in the criminal case is also accounted for as a part of the civil settlement, resulting in a total payment by Jazz and Orphan of $20 million.
Jazz has also agreed to implement the terms of a corporate integrity agreement required by the Office of Inspector General for HHS, and has taken other proactive and remedial measures, including implementing a Code of Conduct prohibiting promotion for unapproved or "off-label" use, requiring compliance training for promotional speakers and sales representatives, and replacing the former Orphan regional sales managers who were responsible for overseeing the conduct of sales representatives in their respective territories.
The government's investigation was commenced after a former sales representative for Orphan filed a suit in the Eastern District of New York on behalf of the United States.
Under the federal False Claims Act, a private individual is allowed to file a whistleblower suit to bring the United States information about wrongdoing. If the United States is successful in resolving or litigating the whistleblower's claims, the whistleblower may share in part of the recovery.
More at NYT
As part of this resolution, Orphan plead guilty this morning to felony misbranding, in violation of the Food, Drug, and Cosmetic Act in connection with its illegal promotion of the prescription medication Xyrem, also known as gamma-hydroxybutyrate or "GHB," for unapproved uses. GHB is a powerful and fast-acting central nervous system depressant that has been subject to abuse as a recreational drug and is classified by the Department of Health and Human Services (HHS) as a "date rape" drug. The guilty plea proceeding was held before United States District Judge Eric N. Vitaliano.
The criminal misbranding scheme induced physicians throughout the country to write prescriptions for Xyrem that were not reimbursable by private health insurers or public insurance programs like Medicare and Medicaid, and caused millions of dollars of losses to these insurers. Pursuant to a non- prosecution agreement with the United States, Jazz has agreed to guarantee Orphan's obligation to pay criminal restitution to public and private insurers of approximately $12.2 million and a criminal fine of $5 million, and to provide ongoing cooperation to the government in connection with its investigation and prosecution of the underlying illegal marketing scheme. Pursuant to the civil settlement agreement, Jazz and Orphan have agreed to resolve the government's civil False Claims Act claims by paying $3.75 million, plus interest. A portion of the restitution ordered in the criminal case is also accounted for as a part of the civil settlement, resulting in a total payment by Jazz and Orphan of $20 million.
Jazz has also agreed to implement the terms of a corporate integrity agreement required by the Office of Inspector General for HHS, and has taken other proactive and remedial measures, including implementing a Code of Conduct prohibiting promotion for unapproved or "off-label" use, requiring compliance training for promotional speakers and sales representatives, and replacing the former Orphan regional sales managers who were responsible for overseeing the conduct of sales representatives in their respective territories.
The government's investigation was commenced after a former sales representative for Orphan filed a suit in the Eastern District of New York on behalf of the United States.
Under the federal False Claims Act, a private individual is allowed to file a whistleblower suit to bring the United States information about wrongdoing. If the United States is successful in resolving or litigating the whistleblower's claims, the whistleblower may share in part of the recovery.
More at NYT
PharmedOut - The Art of Medical Writing
"The Art of Medical Writing", featuring Susanna Dodgson, PhD, Professor of Biomedical Writing at the University of Sciences of Philadelphia. Medical writers often work anonymously for the healthcare industry, primarily for pharmaceutical companies. " A competent medical writer can make $100,000 or 200,000 a year," says Dr. Dodgson, who advocates for medical writers to be given credit for the articles that they ghostwrite for academics.
PharmedOut (http://www.pharmedout.org)/ is an independent project funded through the Attorney General Consumer and Prescriber Education grant program that educates physicians on how pharmaceutical companies influence prescribing.
Trust me doctor, I'm a drug rep!
Which? has published the results of a survey of 200 UK GPs that collected data on the frequency of promotional contacts and mailings.
The BBC and PharmaTimes have both carried this story.
The survey found that, on average, the sample group could expect 4 representative visits per month and five mailings per week. One respondent revealed that, in one month, they received nine visits, 34 mailings and were also invited to attend several conferences or meals.
It was also apparent that the respondents did not trust the information they received with only 7% reporting that they trust the information as much as they trust independent sources. Additionally, almost half (48%) of respondents agreed that more trusted independent sources are needed.
Which? are also critical of the lack of transparency in some drug companies and patient groups about the extent of funding and the projects that these donations are used to support.
http://www.prescriber.org.uk/
The BBC and PharmaTimes have both carried this story.
The survey found that, on average, the sample group could expect 4 representative visits per month and five mailings per week. One respondent revealed that, in one month, they received nine visits, 34 mailings and were also invited to attend several conferences or meals.
It was also apparent that the respondents did not trust the information they received with only 7% reporting that they trust the information as much as they trust independent sources. Additionally, almost half (48%) of respondents agreed that more trusted independent sources are needed.
Which? are also critical of the lack of transparency in some drug companies and patient groups about the extent of funding and the projects that these donations are used to support.
http://www.prescriber.org.uk/
GSK - Avandia: Uh oh! Here comes trouble
In the month after a surprising analysis revealed possible heart risks from the blockbuster diabetes drug Avandia, reports of side effects to federal regulators tripled.
The sudden spike is a sign that doctors probably were unaware of the drug's possible role in their patients' heart problems and therefore may not have reported many such cases in the past, several experts said.
More at the WaPo
The sudden spike is a sign that doctors probably were unaware of the drug's possible role in their patients' heart problems and therefore may not have reported many such cases in the past, several experts said.
More at the WaPo
SiCKO - Moore on Olbermann
Go Bismarck!
Michael Moore discusses his blitz on Wolf Blitzer and George's War that is quickly becoming the Democrats' War. Why are we there? When will it stop? Help us answer these questions and more at http://www.michaelmoore.com/ .
Merck wants a bucket of money too
Merck is expanding its presence in the oncology arena and will co-develop and commercialise Ariad Pharmaceuticals’ late-stage cancer agent in a deal that could be worth over $1 billion.
The firms have entered into a global collaboration for AP23573, ARIAD's novel mTOR (mammalian target of rapamycin) inhibitor which is expected to go into Phase III trials this quarter for the treatment of metastatic sarcomas.
Under the terms of the deal, Ariad will receive an initial payment of $75 million and up to $452 million more in milestones based on the successful development of AP23573 in multiple cancer indications. This figure includes $13.5 million for the initiation of the Phase III metastatic sarcomas trial and $114.5 million for the initiation of other Phase II and Phase III studies.
The financial package also includes up to $200 million based on “achievement of significant sales thresholds”, at least $200 million in estimated contributions by Merck to global development and up to $200 million in interest-bearing repayable development-cost advances from the New Jersey-based drugs giant to cover a portion of Ariad's expenses. The latter will have primary responsibility for development of AP23573 in the metastatic sarcoma indication and the two firms will work together in the USA for all other cancer indications being pursued.
Abroad, Merck will have responsibility for development and will book any sales, paying Ariad double-digit royalties.
Ariad chief executive Harvey Berger said that “we implemented a rigorous partnering process that generated substantial interest from multiple companies and ultimately enabled us to select Merck as our partner of choice”, while the firm’s chief commercial officer Richard Pascoe noted that “the structure of this partnership allows the partners to pursue the clinical development of AP23573 in multiple indications concurrently throughout the world”.
The deal reveals Merck's determination to grow its oncology franchise and comes on the back of the success of its cervical vaccine Gardasil and the approval granted by the US Food and Drug Administration last October for Zolinza (vorinostat), a new drug to treat cutaneous T cell lymphoma.
Source: PharmaTimes
The firms have entered into a global collaboration for AP23573, ARIAD's novel mTOR (mammalian target of rapamycin) inhibitor which is expected to go into Phase III trials this quarter for the treatment of metastatic sarcomas.
Under the terms of the deal, Ariad will receive an initial payment of $75 million and up to $452 million more in milestones based on the successful development of AP23573 in multiple cancer indications. This figure includes $13.5 million for the initiation of the Phase III metastatic sarcomas trial and $114.5 million for the initiation of other Phase II and Phase III studies.
The financial package also includes up to $200 million based on “achievement of significant sales thresholds”, at least $200 million in estimated contributions by Merck to global development and up to $200 million in interest-bearing repayable development-cost advances from the New Jersey-based drugs giant to cover a portion of Ariad's expenses. The latter will have primary responsibility for development of AP23573 in the metastatic sarcoma indication and the two firms will work together in the USA for all other cancer indications being pursued.
Abroad, Merck will have responsibility for development and will book any sales, paying Ariad double-digit royalties.
Ariad chief executive Harvey Berger said that “we implemented a rigorous partnering process that generated substantial interest from multiple companies and ultimately enabled us to select Merck as our partner of choice”, while the firm’s chief commercial officer Richard Pascoe noted that “the structure of this partnership allows the partners to pursue the clinical development of AP23573 in multiple indications concurrently throughout the world”.
The deal reveals Merck's determination to grow its oncology franchise and comes on the back of the success of its cervical vaccine Gardasil and the approval granted by the US Food and Drug Administration last October for Zolinza (vorinostat), a new drug to treat cutaneous T cell lymphoma.
Source: PharmaTimes
Thursday, July 12, 2007
Moore on Olbermann
Mike on Keith Olbermann Thursday, July 12th, 2007 .
Today, Michael Moore will be live on Countdown with Keith Olbermann on MSNBC at 8:00 PM (EST).
It will be on again at midnight (also EST).
Today, Michael Moore will be live on Countdown with Keith Olbermann on MSNBC at 8:00 PM (EST).
It will be on again at midnight (also EST).
SiCKO - Moore vs Gupta/CNN contd.
We all witnessed “Sicko” film director Michael Moore verbally body slam a flatfooted Wolf Blitzer on Monday.
We know what set Moore off: CNN chief medical correspondent Dr. Sanjay Gupta’s factually challenged “reality check," to which Moore had alerted Gupta in an email sent to his staff before it first ran on June 29, 10 days before Blitzer played again prior to his interview with Moore. Nevertheless, Gupta ignored it, changing nothing. Moore's “Sicko” truth squad then posted a reality check, eviscerating Gupta’s claims.
Last night, Gupta joined Moore on Larry King Live, where, in one of the most revealing moments, he responded to Moore’s point that the “one expert” in his report has deep ties to big pharma and conservative allies in government. Gupta replied, “His only affiliation is with Vanderbilt University. We checked it, Michael.” That, too, turns out to be utterly false.
More at MediaBloodHound
We know what set Moore off: CNN chief medical correspondent Dr. Sanjay Gupta’s factually challenged “reality check," to which Moore had alerted Gupta in an email sent to his staff before it first ran on June 29, 10 days before Blitzer played again prior to his interview with Moore. Nevertheless, Gupta ignored it, changing nothing. Moore's “Sicko” truth squad then posted a reality check, eviscerating Gupta’s claims.
Last night, Gupta joined Moore on Larry King Live, where, in one of the most revealing moments, he responded to Moore’s point that the “one expert” in his report has deep ties to big pharma and conservative allies in government. Gupta replied, “His only affiliation is with Vanderbilt University. We checked it, Michael.” That, too, turns out to be utterly false.
More at MediaBloodHound
Genentech - Ava$tin
Genentech has started the reporting season by posting a 41% jump in second-quarter net income to $747 million and revenues of just over $3 billion (+37%) on the back of strong growth from its cancer agent Avastin.
US product sales climbed 25% to $2.15 billion in the quarter, with Avastin (bevacizumab) shooting up 33% to $564 million, helped by the Food and Drug Administration's approval at the end of last year to expand use of the treatment to patients with non-small cell lung cancer.
Source: PharmaTimes
US product sales climbed 25% to $2.15 billion in the quarter, with Avastin (bevacizumab) shooting up 33% to $564 million, helped by the Food and Drug Administration's approval at the end of last year to expand use of the treatment to patients with non-small cell lung cancer.
Source: PharmaTimes
Wednesday, July 11, 2007
The emperors' new diabetic medicines
Newer diabetes medicines from makers including Merck and Lilly work no better than older, cheaper drugs, researchers said.
Doctors have embraced the drugs -- including Merck's Januvia, and, in a second new class, Byetta from Amylin Pharmaceuticals Inc. and Lilly -- largely because they don't cause low blood sugar and can lead to weight loss. Analysts say the products may each generate peak annual sales of $1 billion or more within three years.
A review of 29 studies -- only three of which lasted more than 30 weeks -- found that while the drugs work better than placebos in controlling blood sugar, they are no more effective than medications available for pennies a pill. The research also showed the drugs carry side effects older treatments don't, including nausea, vomiting and infections.
``It would be premature to fully embrace and use both these classes of medications over older, more-established medications for a chronic condition such as diabetes,'' said the lead researcher, Anastassios Pittas, an assistant professor of medicine at Tufts-New England Medical Center in Boston, in a telephone interview today.
A month's supply of 100-milligram tablets of Januvia costs $163.99, or almost $5.50 a pill, from Drugstore.com, while a single cartridge of the injected Byetta costs $200. Sixty tablets of metformin, a drug that makes the cells more sensitive to insulin, is $33.99.
``They are 10 to 12 times more expensive,'' Pittas said. ``The question is, are they 10 times better? It's pretty amazing to me that we have six-month data and a lot of people are willing to jump on this, even though the drugs haven't proven themselves yet and they are very, very expensive.''
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Doctors have embraced the drugs -- including Merck's Januvia, and, in a second new class, Byetta from Amylin Pharmaceuticals Inc. and Lilly -- largely because they don't cause low blood sugar and can lead to weight loss. Analysts say the products may each generate peak annual sales of $1 billion or more within three years.
A review of 29 studies -- only three of which lasted more than 30 weeks -- found that while the drugs work better than placebos in controlling blood sugar, they are no more effective than medications available for pennies a pill. The research also showed the drugs carry side effects older treatments don't, including nausea, vomiting and infections.
``It would be premature to fully embrace and use both these classes of medications over older, more-established medications for a chronic condition such as diabetes,'' said the lead researcher, Anastassios Pittas, an assistant professor of medicine at Tufts-New England Medical Center in Boston, in a telephone interview today.
A month's supply of 100-milligram tablets of Januvia costs $163.99, or almost $5.50 a pill, from Drugstore.com, while a single cartridge of the injected Byetta costs $200. Sixty tablets of metformin, a drug that makes the cells more sensitive to insulin, is $33.99.
``They are 10 to 12 times more expensive,'' Pittas said. ``The question is, are they 10 times better? It's pretty amazing to me that we have six-month data and a lot of people are willing to jump on this, even though the drugs haven't proven themselves yet and they are very, very expensive.''
More
Pfizer - Exubera: sales forecasts cuts
Bespak Plc, a U.K. maker of inhalers for Pfizer Inc., said profit will be little changed this fiscal year because Pfizer reduced the sales outlook for its Exubera insulin treatment.
Production of inhalers for Pfizer's Exubera insulin will decline in the current year, Bespak said today. Sales of valves for ozone-depleting CFC formulations also dropped in the U.S. as rules phased out that type of inhaler, the company said.
Pfizer, the world's largest drugmaker, and its partner Nektar Therapeutics lowered sales forecasts for Exubera. Bespak has notified 160 workers in Milton Keynes, England, that they may lose their jobs because of the sales outlook for Exubera, Chief Executive Mark Throdahl said today in an interview.
``We don't expect we will have 160 redundancies,'' Throdahl said. ``Frankly, we don't know. We're using the time to talk to our partner. The Exubera situation remains very fluid and the U.S. consumer advertising campaign had just begun.''
More at Bloomberg
Production of inhalers for Pfizer's Exubera insulin will decline in the current year, Bespak said today. Sales of valves for ozone-depleting CFC formulations also dropped in the U.S. as rules phased out that type of inhaler, the company said.
Pfizer, the world's largest drugmaker, and its partner Nektar Therapeutics lowered sales forecasts for Exubera. Bespak has notified 160 workers in Milton Keynes, England, that they may lose their jobs because of the sales outlook for Exubera, Chief Executive Mark Throdahl said today in an interview.
``We don't expect we will have 160 redundancies,'' Throdahl said. ``Frankly, we don't know. We're using the time to talk to our partner. The Exubera situation remains very fluid and the U.S. consumer advertising campaign had just begun.''
More at Bloomberg
Tuesday, July 10, 2007
Moore vs Blitzer/CNN
Ouch! Wolf got owned!
DR. SANJAY GUPTA, CNN: "(Moore says) the United States slipped to number 37 in the world's health care systems. It's true. ... Moore brings a group of patients, including 9/11 workers, to Cuba and marvels at their free treatment and quality of care. But hold on - that WHO list puts Cuba's health care system even lower than the United States, coming in at #39."
THE TRUTH:
"But hold on?" 'SiCKO' clearly shows the WHO list, with the United States at number #37, and Cuba at #39. Right up on the screen in big five-foot letters. It's even in the trailer! CNN should have its reporter see his eye doctor. The movie isn't hiding from this fact. Just the opposite.
The fact that the healthcare system in an impoverished nation crippled by our decades-old blockade (including medical supplies and drugs) ranks so closely to ours is more an indictment of the American system than the Cuban system.
Although Cuba ranks lower overall than the United States, it still has a lower infant mortality rate and longer life span. (see below)
And unlike the United States, Cuba offers healthcare to absolutely everyone. In an independent Gallup poll conducted in Cuba, "a near unanimous 96 percent of respondents say that health care in Cuba is accessible to everyone." ("Cubans Show Little Satisfaction with Opportunities and Individual Freedom Rare Independent Survey Finds Large Majorities Are Still Proud of Island's Health Care and Education," January 10, 2007. Link)
CNN: "Moore asserts that the American health care system spends $7,000 per person on health. Cuba spends $25 dollars per person. Not true. But not too far off. The United States spends $6,096 per person, versus $229 per person in Cuba."
THE TRUTH:
According to our own government – the Department of Health and Human Services' National Health Expenditures Projections – the United States will spend $7,092 per capita on health in 2006 and $7,498 in 2007. (Department of Health and Human Services Center for Medicare and Medicaid Expenditures, National Health Expenditures Projections 2006-2016. Link)
As for Cuba – Dr. Gupta and CNN need to watch 'SiCKO' first before commenting on it. 'SiCKO' says Cuba spends $251 per person on health care, not $25, as Gupta reports. And the BBC reports that Cuba's per capita health expenditure is… $251! (Keeping Cuba Healthy, BBC, Aug. 1 2006. Link )
As Gupta points out, the World Health Organization does calculate Cuba's per capita health expenditure at $229 per person – a lot closer to $251 than $25.
CNN: In fact, Americans live just a little bit longer than Cubans on average.
THE TRUTH:
Just the opposite. The 2006 United Nations Human Development Report's human development index states the life expectancy in the United States is 77.5 years. It is 77.6 years in Cuba. (Human Development Report 2006, United Nations Development Programme, 2006 at 283. http://hdr.undp.org/hdr2006/pdfs/report/HDR06-complete.pdf)
CNN: The United States ranks highest in patient satisfaction.
THE TRUTH:
True, but even when the WHO took patient satisfaction into account in its comprehensive review of the world's health systems, we still came in at #37. ("World Health Organization Assesses The World's Health Systems," Press Release, WHO/44, June 21, 2000. http://www.who.int/inf-pr-2000/en/pr2000-44.html ).
Patients may be satisfied in America, but not everyone gets to be a patient. 47 million are uninsured and are rarely patients - until it's too late. In the rest of the Western world, everyone and anyone can be a patient because everyone is covered. (And don't face exclusions for pre-existing conditions, co-pays, deductibles, and costly monthly premiums).
It's not that other countries are unhappy with their health care – for example, "70 to 80 percent of Canadians find their waiting times acceptable." ("Access to health care services in Canada, Waiting times for specialized services (January to December 2005)," Statistics Canada, Link )
CNN: Americans have shorter wait times than everyone but Germans when seeking non-emergency elective procedures, like hip replacement, cataract surgery, or knee repair.
THE TRUTH:
This isn't the whole truth. CNN pulled out a statistic about elective procedures. Of the six countries surveyed in that study (United States, Canada, New Zealand, UK, Germany, Australia) only Canada had longer waiting times than America for sick adults waiting to schedule a doctor's appointment for a medical problem. 81% of patients in New Zealand got a same or next-day appointment for a non-routine visit, 71% in Britain, 69% in Germany, 66% in Australia, 47% in the U.S., and 36% in Canada. (The Doc's in, but It'll be AWhile. Catherine Arnst, Business Week. June 22, 2007 Link)
"Gerard Anderson, a Johns Hopkins health policy professor who has spent his career examining the world's healthcare, said there are delays, but not as many as conservatives state. In Canada, the United Kingdom and France, 'three percent of hospital discharges had delays in treatment,' Anderson told The Miami Herald. 'That's a relatively small number, and they're all elective surgeries, such as hip and knee replacement.' (John Dorschner, "'SiCKO' film is set to spark debate; Reformers are gearing up for 'Sicko,' the first major movie to examine America's often maligned healthcare system," Miami Herald, June 29, 2007.)
One way America is able to achieve decent waiting times is that it leaves 47 million people out of the health care system entirely, unlike any other Western country. When you remove 47 million people from the line, your wait should be shorter. So why is the U.S. second to last in wait times?
And there are even more Americans who keep themselves out of the system because of cost - in the United States, 24 percent of the population did not get medical care due to cost. That number is 5 percent in Canada, and 3 percent in the UK. (Inequities in Health Care: A Five-Country Survey. Robert Blendon et al, Health Affairs. Exhibit 5. Link)
CNN: (PAUL KECKLEY-Deloitte Health Care Analyst): "The concept that care is free in France, in Canada, in Cuba - and it's not. Those citizens pay for health services out of taxes. As a proportion of their household income, it's a significant number … (GUPTA): It's true that the French pay higher taxes, and so does nearly every country ahead of the United States on that list."
THE TRUTH:
'SiCKO' never claims that health care is provided absolutely for free in other countries, without tax contributions from citizens. Former MP Tony Benn reads from the NHS founding pamphlet, which explicitly states that "this is not a charity. You are paying for it mainly as taxpayers." 'SiCKO' also acknowledges that the French are "drowning in taxes." Comparatively, many Americans are drowning in insurance premiums, deductibles, co-pays and medical debt and the resulting threat of bankruptcy – half of all bankruptcies in the United States are triggered by medical bills. (Medical Bills Make up Half of Bankruptcies. Feb. 2005, MSNBC. http://www.msnbc.msn.com/id/6895896/)
CNN: "But even higher taxes don't guarantee the coverage everyone wants … (KECKLEY): 15 to 20 percent of the population will purchase services outside the system of care run by the government."
THE TRUTH:
It's not clear what country Keckley is referring to. In the United Kingdom, only 11.5 percent of the population has supplementary insurance, but it doesn't take the place of NHS insurance. Nobody in France buys insurance that replaces government insurance either, although a substantial amount buys some form of complimentary insurance. ( Private health insurance and access to health care in the European Union. Spring 2004. Link)
CNN: "But no matter how much Moore fudged the facts, and he did fudge some facts…"
This is libel. There is not a single fact that is "fudged" in the film. No one has proven a single fact in the film wrong. We expect CNN to correct their mistakes on the air and to apologize to their viewers.
GSK - Avandia: Dont panic Captain Mainwaring!
How about the following:
- Acknowledge that your drug is not "God's Gift to Diabetics"
- Start proper mortality studies earlier
- Don't bully medics who raise legitimate concerns
- Don't promote the hell out of product and deny any issues exist.
More suggestions gratefully received.
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